COVID-19 (CoronaVirus)

FDA approves hydroxychloroquine new drug application to address COVID-19 related shortage 7th April 2020

PIL: Patient Information Leaflet

1. NAME OF THE MEDICINAL PRODUCT
a) Chloroquine phosphate 250mg Tablets 
b) Chloroquine phosphate 500mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains:
Chloroquine phosphate, IP……250mg
(Equivalent to 155mg Chloroquine base)

b)Each tablet contains:
Chloroquine phosphate, IP……500mg
(Equivalent to 310mg Chloroquine base)

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablets

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

  1. a) Treatment of malaria.
  2. b) Prophylaxis and suppression of malaria.
  3. c) Treatment of amoebic hepatitis and abscess.
  4. d) Treatment of discoid and systemic lupus erythematosus.
  5. e) Treatment of rheumatoid arthritis.

 4.2  Posology and method of administration
The dose should be taken after food.

a) Treatment of malaria

i) P. falciparum and P. malariae infections

 Adults: A single dose of four tablets, followed by two tablets six hours later and then two tablets a day for two days.

Children: A single dose of 10mg base/kg, followed by 5mg base/kg six hours later and then 5mg base/kg a day for two days.

Age (years)Initial doseSecond dose 6 hours after firstDose on each of the two subsequent days
1 – 41 Tablet½ Tablet½Tablet
5 – 82 Tablets1 Tablet1 Tablet
9 -143 Tablets1½ Tablets1½ Tablets


ii) P. vivax and P. ovale infections

Adults: A single dose of four tablets, followed by two tablets six hours later and then two tablets a day for two days. Follow with a course of treatment with primaquine if a radical cure is required.

Children: A single dose of 10mg base/kg, followed by 5mg base/kg six hours later and then 5mg base/kg a day for two days. Follow with a course of treatment with primaquine if a radical cure is required.

Elderly Patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Hepatic or Renally Impaired Patients: Caution is necessary when giving Chloroquine phosphate to patients with renal disease or hepatic disease.

b) Prophylaxis and suppression of malaria

Adults: Two tablets taken once a week, on the same day each week. Start one week before exposure to risk and continue until four weeks after leaving the malarious area.

Children: A single dose of 5mg chloroquine base/kg per week on the same day each week. Start one week before exposure to risk and continue until four weeks after leaving the malarious area.

For practical purposes, children aged over 14 years may be treated as adults. The dose given to infants and children should be calculated on their body weight and must not exceed the adult dose regardless of weight.

1 – 4 years ½ tablet

5 – 8 years 1 tablet

9 – 14 years 1½ tablets

Elderly Patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Hepatic or Renally Impaired Patients: Caution is necessary when giving Chloroquine phosphate to patients with renal disease or hepatic disease.

c) Amoebic hepatitis

Adults: Four tablets daily for two days followed by one tablet twice daily for two or three weeks.

Elderly Patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Hepatic or Renally Impaired Patients: Caution is necessary when giving Chloroquine phosphate to patients with renal disease or hepatic disease.

d) Lupus erythematosus

Adults: One tablet twice daily for one to two weeks followed by a maintenance dosage of one tablet daily.

Elderly Patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Hepatic or Renally Impaired Patients: Caution is necessary when giving Chloroquine phosphate to patients with renal disease or hepatic disease.

e) Rheumatoid arthritis

Adults: The usual dosage is one tablet daily.

Elderly Patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Hepatic or Renally Impaired Patients: Caution is necessary when giving Chloroquine phosphate to patients with renal disease or hepatic disease.

4.3 Contraindications
Known hypersensitivity to chloroquine or any other ingredients of the formulation.

Concomitant use with amiodarone. (See section 4.5)

4.4 Special Warnings and precautions for use

When used as malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration.

Chloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. Patients treated with chloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with chloroquine should have their blood glucose level checked and treatment reviewed as necessary.

Prolongation of QTc interval

Chloroquine has been shown to prolong the QTc interval in some patients.

Chloroquine should be used with caution in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval such as:

– cardiac disease e.g. heart failure, myocardial infarction,

– proarrhythmic conditions e.g bradycardia (< 50 bpm)

– a history of ventricular dysrhythmias

– uncorrected hypokalemia and/or hypomagnesemia

– and during concomitant administration with QT interval prolonging agents (see section 4.5)

as this may lead to an increased risk for ventricular arrhythmias, sometimes with fatal outcome.

The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded (see also sections 4.8 and 4.9).

If signs of cardiac arrhythmia occur during treatment with chloroquine, treatment should be stopped and an ECG should be performed.

Cardiomyopathy

In patients receiving chloroquine therapy cases of cardiomyopathy have been reported, leading to heart failure, sometimes with fatal outcome (see sections 4.8 and 4.9). If signs and symptoms of cardiomyopathy occur during treatment with chloroquine, treatment should be stopped.

Caution is necessary when giving Chloroquine phosphate to patients with impaired hepatic function, particularly when associated with cirrhosis.

Caution is also necessary in patients with porphyria. Chloroquine phosphate may precipitate severe constitutional symptoms and an increase in the amount of porphyrins excreted in the urine. This reaction is especially apparent in patients with high alcohol intake.

A small number of cases of diffuse parenchymal lung disease have been identified in patients taking chloroquine. A response after therapy with steroids has been observed in some of these cases.

Cases of drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been identified in patients taking chloroquine alone or in combination with proguanil. Recovery after discontinuation of treatment and response after therapy with steroids has been observed.

Caution is necessary when giving Chloroquine phosphate to patients with renal disease.

Chloroquine phosphate should be used with care in patients with a history of epilepsy. Potential risks and benefits should be carefully evaluated before use in subjects on anticonvulsant therapy or with a history of epilepsy as rare cases of convulsions have been reported in association with chloroquine (see section 4.5).

Considerable caution is needed in the use of Chloroquine phosphate for long-term high dosage therapy and such use should only be considered when no other drug is available. Patients on long-term therapy should also be monitored for cardiomyopathy (see section 4.8).

Irreversible retinal damage and corneal changes may develop during long term therapy and after the drug has been discontinued. Ophthalmic examination prior to and at 3–6 monthly intervals during use is required if patients are receiving chloroquine

  • at continuous high doses for longer than 12 months
  • as weekly treatment for longer than 3 years
  • when total consumption exceeds 1.6 g/kg (cumulative dose 100 g)

Full blood counts should be carried out regularly during extended treatment as bone marrow suppression may occur rarely. Caution is required if drugs known to induce blood disorders are used concurrently.

The use of Chloroquine phosphate in patients with psoriasis may precipitate a severe attack.

Caution is advised in patients with glucose-6-phosphate dehydrogenase deficiency, as there may be a risk of haemolysis.

Acute extrapyramidal disorders (see section 4.8) have been reported during treatment with chloroquine, usually disappearing on discontinuation of treatment and /or on symptomatic treatment.

4.5 Interaction with other medicinal products and other forms of interaction

Drugs known to prolong QT interval / with potential to induce cardiac arrhythmia

Chloroquine should be used with caution in patients receiving drugs known to prolong the QT interval e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, some anti-infectives due to increased risk of ventricular arrhythmia (see sections 4.4 and 4.9). Halofantrine should not be administered with chloroquine. In particular, amiodarone should not be used and its use is contraindicated. Antacids (aluminium, calcium and magnesium salts) and adsorbents (e.g. kaolin) may reduce the absorption of chloroquine, so should be taken well separated from Chloroquine phosphate (at least four hours apart).

If the patient is taking ciclosporin then chloroquine may cause an increase in ciclosporin levels.

Pre-exposure intradermal human diploid-cell rabies vaccine should not be administered to patients taking chloroquine as this may suppress the antibody response. When vaccinated against rabies, that vaccine should precede the start of the antimalarial dosing, otherwise the effectiveness of the vaccine might be reduced.

Chloroquine significantly reduces levels of praziquantel. Caution is therefore advised during co-administration. Prescribers may consider increasing the dose of praziquantel if the patient does not respond to the initial dose.

Other antimalarials:increased risk of convulsion with mefloquine.
Cardiac glycosides:hydroxychloroquine and possibly chloroquine increase plasma concentration of digoxin.
Parasympathomimetics:chloroquine and hydroxychloroquine have potential to increase symptoms of myasthenia gravis and thus diminish effect of neostigmine and pyridostigmine.
Ulcer healing drugs:cimetidine inhibits metabolism of chloroquine (increased plasma concentration).

In vitro work has shown that the concomitant use of drugs such as multidrug and toxin extrusion protein (MATE1) inhibitors (e.g., ciprofloxacin, cimetidine, omeprazole, pyrimethamine) may impact the renal clearance of chloroquine, which could theoretically lead to increased levels of chloroquine and potentially overdosage (see section 4.9). In addition, care should be taken when alkalinization of urine occurs as this may reduce chloroquine renal excretion.

Chloroquine may lower the convulsive threshold and thus antagonise the actions of antiepileptics (See section 4.4).

Thyroid medication: increased Thyroid Stimulating Hormone levels have been observed with the concomitant use of levothyroxine, dosage adjustment of thyroid medication may be necessary.

There is a theoretical risk of inhibition of intra-cellular α-galactosidase activity when chloroquine is co-administered with agalsidase.

4.6 Fertility, Pregnancy and lactation

Pregnancy

Chloroquine phosphate should not be used during pregnancy unless, in the judgement of the physician, potential benefit outweighs the risk.

Short-term malaria prophylaxis:

Malaria in pregnant women increases the risk of maternal death, miscarriage, still-birth and low birth weight with the associated risk of neonatal death. Travel to malarious areas should be avoided during pregnancy but, if this is not possible, women should receive effective prophylaxis.

Long-term high dose:

There is evidence to suggest that Chloroquine phosphate given to women in high doses throughout pregnancy can give rise to foetal abnormalities including visual loss, ototoxicity and cochlear-vestibular dysfunction.

Lactation

Although Chloroquine phosphate is excreted in breast milk, the amount is too small to be harmful when used for malaria prophylaxis but as a consequence is insufficient to confer any benefit on the infant. Separate chemoprophylaxis for the infant is required. However, when long-term high doses are used for rheumatoid disease, breast feeding is not recommended.

4.7 Effects on ability to drive and use machines
Defects in visual accommodation may occur on first taking Chloroquine phosphate and patients should be warned regarding driving or operating machinery.

4.8 Undesirable Effects
The adverse reactions which may occur at doses used in the prophylaxis or treatment of malaria are generally not of a serious nature. Where prolonged high dosage is required, i.e. in the treatment of rheumatoid arthritis, adverse reactions can be of a more serious nature.

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ ClassUndesirable Effect and Frequency
Blood and lymphatic system disordersNot known

Bone marrow failure

Aplastic anaemia

Agranulocytosis

Thrombocytopenia

Neutropenia

Pancytopenia

Immune system disordersNot known

Hypersensitivity and anaphylactic reactions, including urticaria, angioedema and vasculitis.

Metabolism and nutrition disordersNot known

Hypoglycaemia (see section 4.4).

Psychiatric DisordersRare

Hallucinations

Not known

Psychotic disorder including anxiety, personality change

Insomnia

Confusion

Depression

Nervous system disordersNot known

Convulsion (see section 4.4)

Visual field defects

Headache

Neuromyopathy

Acute extrapyramidal disorders (such as dystonia, dyskinesia, tongue protrusion, torticollis) (see section 4.4)

Eye disordersNot known

Retinal degeneration

Macular defects of colour vision

Pigmentation

Optic atrophy scotomas

Blindness

Corneal opacity and pigmented deposits

Vision blurred

Accommodation disorder

Diplopia

Ear and labyrinth disordersNot known

Tinnitus

Hypoacusis

Deafness neurosensory

Cardiac disordersRare

Cardiomyopathy (see section 4.4)

Not known

Atrioventricular block , QT-prolongation (see sections 4.4 and 4.9)

Vascular DisordersNot known

Hypotension

Respiratory, thoracic and mediastinalNot known

Diffuse parenchymal lung disease

Gastrointestinal disorders:Not known

Gastrointestinal disorder

Nausea

Vomiting

Diarrhoea

Abdominal pain

Hepatobiliary disordersRare

Changes in liver function, including hepatitis and abnormal liver function tests

Skin and subcutaneous tissue disordersNot known

Macular, urticarial and purpuric skin eruptions

Alopecia

Erythema multiforme

Drug reaction with eosinophilia and systemic symptoms syndrome (DRESS)

Stevens-Johnson syndrome (SJS)

Toxic epidermal necrolysis (TEN)

Precipitation of psoriasis

Pruritus

Photosensitivity reaction

Lichenoid keratosis

Pigmentation disorder *

Exfoliative dermatitis

Acute generlised exanthematous pustulosis (AGEP)

Musculoskeletal and connective tissue disordersNot known

Myopathy

InvestigationsNot known

Electrocardiogram change**

* Long term use

**At high doses

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Features

Chloroquine is highly toxic in overdose and children are particularly susceptible. The chief symptoms of overdosage include circulatory collapse due to a potent cardiotoxic effect, respiratory arrest and coma. Symptoms may progress rapidly and include:

– General features include nausea and vomiting. Hypokalaemia is common in severe poisoning and metabolic acidosis may also develop. Rarely hepatotoxicity, nephritis, gastric haemorrhage, haematological abnormalities and psychiatric features may occur.

– Neurological features include headache, dizziness, drowsiness, blurred vision, diplopia and, rarely, blindness, may precede restlessness, increased excitability and convulsions. Coma is less common.

– Cardiac features often appear at an early stage. Cardiac arrest may be a presenting feature. Hypotension is very common and may progress to cardiogenic shock and pulmonary oedema.

With serious intoxication, width-increased QRS complex, bradyarrhythmias, nodal rhythm, QT prolongation, atrioventricular block, ventricular tachycardia, torsades de pointes, ventricular fibrillation may occur.

Intraventricular conduction defects with a wide QRS, and prolongation of the QT interval are more common than A-V (atrioventricular) conduction defects. Ventricular tachycardia and fibrillation tend to occur early while torsade de pointes develops after about 8 hours.

Management

Acute overdose with chloroquine can be rapidly lethal and intensive supportive treatment should be started immediately.

Death may result from circulatory or respiratory failure or cardiac arrhythmia but is usually due to cardiac arrest related to the direct effects on the myocardium. If there is no demonstrable cardiac output due to arrhythmias, asystole or electromechanical dissociation, external chest compression should be persisted with for as long as necessary, or until adrenaline and diazepam can be given (see below).

Firstly, maintain a clear airway and ensure adequate ventilation. The benefit of gastric decontamination is uncertain, but activated charcoal can be considered for adults and children aged over 5 years, within 1 hour of ingestion of more than 10 mg/kg of chloroquine base as a single dose or for any amount in a child aged 5 years and under, as it may reduce absorption of any remaining chloroquine from the gut. Activated charcoal should also be considered within 1 hour of ingestion of a weekly dose taken on 2 or more consecutive days. Alternatively, gastric lavage may be considered in adults within 1 hour of a potentially life threatening overdose. There is a risk of cardiac arrest following aspiration of gastric contents in more serious cases.

Monitor circulatory status (with central venous pressure measurement), cardiac rhythm, respiration, conscious level and urinary output. Check urea & electrolytes, liver function and full blood count in symptomatic patients. Consider arterial blood gas analysis in patients who have a reduced level of consciousness or have reduced oxygen saturation on pulse oximetry.

It is not clear if correction of hypokalaemia is essential but it may have a protective effect and should not be corrected in the early stages of poisoning. The degree of hypokalaemia may be correlated with the severity of chloroquine intoxication. If it persists beyond 8 hours, cautious correction should be undertaken with frequent biochemical monitoring of progress. Rebound hyperkalaemia is a risk during recovery.

In case of persistent metabolic acidosis consider intravenous sodium bicarbonate. Rapid correction is particularly important if there is prolongation of the QRS interval. DC (direct current) shock is indicated for ventricular tachycardia and ventricular fibrillation.

Cardiac arrhythmias should be treated with caution. The use of anti-arrhythmic drugs (such as those with quinidine-like effects) is best avoided since they may depress the myocardium further and exacerbate hypotension.

Early administration of the following has been shown to improve survival in cases of serious poisoning:

  1. Adrenaline infusion until adequate systolic blood pressure (more than 100mg/Hg) is restored; adrenaline reduces the effects of chloroquine on the heart through its inotropic and vasoconstrictor effects.
  2. Diazepam infusion; diazepam may decrease the cardiotoxicity of chloroquine.

Acidification of the urine, haemodialysis, peritoneal dialysis or exchange transfusion have not been shown to be of value in treating chloroquine poisoning. Chloroquine is excreted very slowly, therefore cases of overdosage require observation for several days.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiprotozoals, Antimalarials

The mode of action of chloroquine on plasmodia has not been fully elucidated. Chloroquine binds to and alters the properties of DNA. Chloroquine also binds to ferriprotoporphyrin IX and this leads to lysis of the plasmodial membrane.

In suppressive treatment, chloroquine inhibits the erythrocytic stage of development of plasmodia. In acute attacks of malaria, it interrupts erythrocytic schizogony of the parasite. Its ability to concentrate in parasitised erythrocytes may account for the selective toxicity against the erythrocytic stages of plasmodial infection.

 5.2 Pharmacokinetic properties

Studies in volunteers using single doses of chloroquine phosphate equivalent to 300mg base have found peak plasma levels to be achieved within one to six hours. These levels are in the region of 54 – 102microgram/litre, the concentration in whole blood being some 4 to 10 times higher. Following a single dose, chloroquine may be detected in plasma for more than four weeks. Mean bioavailability from tablets of chloroquine phosphate is 89%. Chloroquine is widely distributed in body tissues such as the eyes, kidneys, liver, and lungs where retention is prolonged. The elimination of chloroquine is slow, with a multi exponential decline in plasma concentration. The initial distribution phase has a half-life of 2-6 days while the terminal elimination phase is 10-60 days. Approximately 50-70% of chloroquine in plasma is bound to the plasma proteins.

The principal metabolite is monodesethylchloroquine, which reaches a peak concentration of 10-20 microgram/litre within a few hours. Mean urinary recovery, within 3-13 weeks, is approximately 50% of the administered dose, most being unchanged drug and the remainder as metabolite. Chloroquine may be detected in urine for several months.

 5.3 Preclinical safety data

Chloroquine phosphate has been widely used for many years in clinical practice. There is no animal data which adds significant information relevant to the prescriber, to that covered elsewhere in this document.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Magnesium stearate.

Maize starch.

 6.2 Incompatibilities
None have been reported or are known.

6.3  Shelf life
3 Year, 5 years.

6.4 Special precautions for storage
Do not store above 30°C. Protect from light and moisture.

6.5 Nature and contents of container

HDPE bottle of 100’s and PVC/Aluminium Foil Blister Pack of 20, 30, 50, 60, 100

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special instructions.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

CHLOROQUINE PHOSPHATE TABLETS
(Taj Pharma) 250MG / 500MG

Package leaflet: Information for the patient

a) Taj Pharma Chloroquine phosphate 250 mg Tablets IP.
b) Taj Pharma Chloroquine phosphate 500 mg Tablets IP.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet

1. What  Taj Pharma Chloroquine phosphate is and what it is used for
2. Before you are given Taj Pharma Chloroquine phosphate
3. How you will be given  Taj Pharma Chloroquine phosphate
4. Possible side effects
5. How Taj Pharma Chloroquine phosphate is stored
6. Further Information

1. What Taj Pharma Chloroquine phosphate is and what it is used for
Taj Pharma Chloroquine phosphate Tablets contains a medicine called Taj Pharma Chloroquine phosphate. This belongs to a group of medicines called ‘anti-malarials’.

‘Anti-malarials’ can be taken in certain parts of the world to help prevent malaria. This is a serious disease spread by infected mosquitoes. Taj Pharma Chloroquine phosphate will give some degree of protection (prophylaxis) against malaria in certain countries.

Medicines to help prevent malaria (malaria prophylaxis) are recommended for:

  • People travelling to countries where malaria occurs.
  • People living in malaria areas who are not immune to malaria.

These people have little or no immunity to malaria, so they are at risk of severe attacks.

You must get medical advice on which anti-malarial medicines to take. You must ask your doctor or pharmacist if Taj Pharma Chloroquine phosphate is suitable for the part of the world that you are visiting. In some countries you may have to take Taj Pharma Chloroquine phosphate with another medicine for maximum protection.

Avoiding mosquito bites

When you are taking this medicine to prevent malaria, you should also reduce the chances of being bitten by mosquitoes.

  • Wear light-coloured, long-sleeved clothing and long trousers when you are outside after sunset.
  • Use insect repellent creams or sprays on parts of your body not covered by clothing.
  • Sleep in a properly screened room or under a mosquito net.
  • Spray to kill any mosquitoes that may have entered rooms in spite of screening.

Signs of malaria

No medicine can be guaranteed to protect against malaria in every case. If you have a high temperature (fever) during your visit to a malaria area, or up to a year after returning home, you should suspect malaria. Contact a doctor straight away and let him or her know that you have visited a malaria area.

2. Before you are given Taj Pharma Chloroquine phosphate
Do not take Taj Pharma Chloroquine phosphate if:

  • You are allergic to Taj Pharma Chloroquine phosphate or any of the other ingredients of Taj Pharma Chloroquine phosphate (see Section 6: Contents of the pack and other information).
  • You are taking a medicine called amiodarone (used to control the heart rate). Taj Pharma Chloroquine phosphate may increase the risk of uneven heart beats (cardiac arrhythmias) when it is taken at the same time as amiodarone. Check with your doctor or pharmacist if you are not sure.

Warnings and precautions

Check with your doctor or pharmacist before taking your medicine if:

  • You have ever had epilepsy, convulsions or fits.
  • You have ever had problems with your liver or kidneys.
  • You have ever been told that you have a rare disease of the blood pigment called ‘porphyria’ or anyone in your family has it. This is because Taj Pharma Chloroquine phosphate may cause severe symptoms of porphyria, particularly if you drink alcohol.
  • You have a scaly condition of the skin called psoriasis.
  • You have a muscle problem called ‘myasthenia gravis’. Taj Pharma Chloroquine phosphate can increase the symptoms of this condition. It can also reduce the effect of medicines used to treat this condition (neostigmine and pyridostigmine).
  • You have a blood problem called ‘glucose-6-phosphate dehydrogenase deficiency’. Taj Pharma Chloroquine phosphate may damage blood cells in people with this blood condition.

Chloroquine can cause lowering of the blood glucose level. Please ask your doctor to inform you of signs and symptoms of low blood glucose levels. A check of the blood glucose level may be necessary.

Chloroquine may cause heart rhythm disorders in some patients: caution should be taken when using chloroquine, if you were born with or have family history of prolonged QT interval, if you have acquired QT prolongation (seen on ECG, electrical recording of the heart), if you have heart disorders or have a history of heart attack (myocardial infarction), if you have salt imbalance in the blood (especially low level of potassium or magnesium, see section “Other medicines and Taj Pharma Chloroquine phosphate”).

If you experience palpitations or irregular heart beat during the period of treatment, you should inform your doctor immediately. The risk of heart problems may increase with increase of the dose. Therefore, the recommended dosage should be followed.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Taj Pharma Chloroquine phosphate.

If you go into hospital, tell the medical staff that you are taking Taj Pharma Chloroquine phosphate.

If you live in a country where malaria occurs, you may already be slightly immune to the disease. You must ask a doctor or pharmacist for advice before you take anti-malarial medicines.

Other medicines and Taj Pharma Chloroquine phosphate

Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

Amiodarone (used to control heart rate) must not be taken at the same time as Taj Pharma Chloroquine phosphate (see section 2: what you need to know before you take Taj Pharma Chloroquine phosphate).

Tell your doctor or pharmacist if you are taking any of the following medicines. This is because Taj Pharma Chloroquine phosphate may affect the amount of these medicines in your blood.

  • Praziquantel (used to treat infections of the bowel and bladder caused by parasites).
  • Ciclosporin (mainly used by transplant patients but also used to treat rheumatoid arthritis and psoriasis).
  • Anti-convulsant medicines (used to prevent convulsions or fits).
  • Digoxin (used to treat heart problems).

Also tell your doctor or pharmacist if you are taking any of the following medicines:

  • Medicines known to affect the rhythm of your heart. This includes medicines used for abnormal heart rhythm (antiarrhythmics), for depression (tricyclic antidepressants) for psychiatric disorders (antipsychotics), for bacterial infections or against malaria (e.g. halofantrine).
  • Mefloquine (taken to prevent malaria) may increase the risk of convulsions or fits when taken at the same time as Taj Pharma Chloroquine phosphate.
  • Medicines used to treat epilepsy, as Taj Pharma Chloroquine phosphate may reduce their effectiveness.
  • Agalsidase (used to treat Fabry Disease), as Taj Pharma Chloroquine phosphate may reduce its activity.
  • Cimetidine (used to treat stomach problems). This medicine affects how Taj Pharma Chloroquine phosphate is broken down by your body and may affect the amount of Taj Pharma Chloroquine phosphate in your blood.
  • Levothyroxine (thyroid medicine).
  • Medicines like kaolin (used for diarrhoea) which are called ‘adsorbents’.
  • Antacid medicines (aluminium, calcium and magnesium salts that are used to treat heartburn or indigestion).

Adsorbents and antacid medicines may reduce the amount of Taj Pharma Chloroquine phosphate absorbed from your gut. This may mean that the full dose of Taj Pharma Chloroquine phosphate is not absorbed into your body and it will not work properly. Therefore, you should take these medicines at least four hours before or after taking your Taj Pharma Chloroquine phosphate dose.

Some medicines (for example, ciprofloxacin, cimetidine, omeprazole, pyrimethamine) may increase the amount of Taj Pharma Chloroquine phosphate in your body and this can cause side effects. It is important that you do not take any additional medicines (either prescribed or non-prescribed) before speaking to your doctor.

If you need a vaccination against rabies, make sure you have it before you start your anti-malarial medicine. If you have your rabies injection at the same time as taking your anti-malarial medicine, your rabies vaccine might not work so well.

Pregnancy

If you are pregnant or may become pregnant, talk to a doctor or pharmacist:

  • before you take Taj Pharma Chloroquine phosphate,
  • before you take any medicine to prevent malaria,
  • and before you go to a country where there is malaria.

Breast-feeding

  • If you are breast-feeding, talk to a doctor or pharmacist before taking Taj Pharma Chloroquine phosphate.
  • Although Taj Pharma Chloroquine phosphate passes into the breast milk, the amount is not enough to protect your baby from malaria. Therefore, your baby will still need to be given anti-malarial medicines. Ask your doctor or pharmacist who will be able to give you advice.

Driving and using machines

Sometimes Taj Pharma Chloroquine phosphate causes blurred eyesight or makes it difficult to focus your eyes. If this happens to you, do not drive or use any tools or machines.

3. How you will be given Taj Pharma Chloroquine phosphate
Always take Taj Pharma Chloroquine phosphate exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

When to start taking your medicine

  • Start taking this medicine one week before you enter the malaria area.
  • You must continue to take it during your stay.
  • You must keep taking this medicine for 4 weeks after leaving the malaria area.

Adults and children over 14 years

  • Take two Taj Pharma Chloroquine phosphate tablets once a week on the same day each week.

Elderly people

  • If you are an elderly person your doctor may suggest that you have blood tests. Your doctor may also decide to give you a different dose.

Children

Do not give Taj Pharma Chloroquine phosphate to children under 1 year of age. For children over 1 year of age, the dose depends on the child’s age.

  • Ages 1 to 4 years:Take half an Taj Pharma Chloroquine phosphate tablet once a week (on the same day each week).
  • Ages 5 to 8 years:Take one Taj Pharma Chloroquine phosphate tablet once a week (on the same day each week).
  • Ages 9 to 14 years:Take one and a half Taj Pharma Chloroquine phosphate tablets once a week (on the same day each week).

How to take your tablets

  • Take the tablet(s) after food.
  • Swallow the tablet(s), or part tablets, whole with a drink of water.

If you take more Taj Pharma Chloroquine phosphate tablets than you should

If you accidentally take more Taj Pharma Chloroquine phosphate tablets than you should, tell a doctor straight away. The following effects may happen: heart problems – leading to uneven heart beats.

If you forget to take your Taj Pharma Chloroquine phosphate tablets

  • If you forget to take a dose of Taj Pharma Chloroquine phosphate, take it as soon as you remember.
  • Then wait for 7 days before you take the next dose of Taj Pharma Chloroquine phosphate.
  • Carry on taking your Taj Pharma Chloroquine phosphate tablets each week, on this new day of the week.

Stopping Taj Pharma Chloroquine phosphate

Only stop taking Taj Pharma Chloroquine phosphate four weeks after leaving the malaria area or if your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, Taj Pharma Chloroquine phosphate can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following side effects, stop taking Taj Pharma Chloroquine phosphate and get medical help or contact your doctor straight away.

  • Allergic reactions including difficulty breathing, swelling of the face, lips, tongue or throat which may cause difficulty in swallowing and an itchy rash (similar to nettle rash or hives)
  • A severe rash with blisters or peeling of the skin and possibly blisters in the mouth and nose.
  • Seeing, feeling or hearing things that are not there (hallucinations) (rare).
  • Cardiac muscle disease (cardiomyopathy) which may be fatal in case of high-dose long-term use. See section 2, warnings and precautions (rare).
  • Abnormal heart rhythm, life-threatening irregular heart rhythm (seen on ECG). See section 2, Warnings and precautions (frequency not known).
  • Liver problems which may cause yellowing of your skin or the whites of your eyes.
    If you are taking Taj Pharma Chloroquine phosphate for a long time, your doctor may suggest that you have blood tests to check how well your liver is working (rare).
  • Inflammation of the lungs causing a condition known as diffuse parenchymal lung disease.
    If you develop serious breathlessness or worsening of breathlessness seek prompt medical advice.
  • Convulsions or fits.
  • Some or complete loss of eyesight.
  • Changes to the retina of your eye (retinopathy) or to the cornea. This can lead to ‘patchy’ eyesight.
  • A rash caused by the medicine associated with an increase in the number of white blood cells (that may show up in blood tests) and symptoms involving the whole body. You may notice some or all of the following symptoms: a skin rash and fever, swelling of the face, tender generalized swollen or enlarged lymph nodes, or other symptoms suggesting involvement of other body organs including the liver, kidney or lung (such as yellowing of the skin or eyes, urinary problems, breathlessness).
  • A reduced number of blood cells. This can make you bruise more easily, get serious infections, have sudden bleeding or feel very tired or breathless. If you are taking Taj Pharma Chloroquine phosphate for a long time, your doctor may suggest that you have blood tests.

Other possible side effects (frequency not known)

When Taj Pharma Chloroquine phosphate is used to prevent or suppress malaria, these are generally not serious. If Taj Pharma Chloroquine phosphate is used for a long time, they can be more serious.

Heart

  • Changes in the way your heart works (known as ‘electrocardiographic changes’).
  • Low blood pressure. This may make you feel faint or dizzy.

Nervous system

  • Feeling dizzy or light-headed.
  • Involuntary muscle movements or spasms.

Behaviour

  • Mood changes or other effects on behaviour. These include feeling depressed, confused or anxious.

Skin

  • Skin rash, including a scaly rash (psoriasis) or itch.
  • Peeling skin.
  • Discolouration of the skin or mucous membranes (such as the inside of your mouth).
  • Being sensitive to sun light which may require medical treatment.
  • The appearance of small fluid filled bumps on the skin.

Hair

  • Changes in hair colour.
  • Hair loss.

Eyes

  • Blurred eyesight.
  • Problems with your colour vision.
  • Difficulty in focussing your eyes.
  • Double vision.

If you are taking Taj Pharma Chloroquine phosphate for a long time, your doctor may suggest that you have eye tests.

Ears

  • Hearing loss.
  • Ringing in the ears (tinnitus).

Stomach and gut

  • Stomach upsets, feeling sick (nausea), being sick (vomiting), diarrhoea or stomach cramps.

Other

  • Weakening of your muscles (neuromyopathy and myopathy).
  • Lowering of the blood glucose level.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How Taj Pharma Chloroquine phosphate is stored
Keep this medicine out of the sight and reach of children. . Your medicine could harm them.
Do not store your medicine above 30°C.
Protect the tablets from light and moisture.
Keep the tablets in the container they came in.
Do not take Taj Pharma Chloroquine phosphate after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.

6. Further information

What Taj Pharma Chloroquine phosphate contains
The active substance in Taj Pharma Chloroquine phosphate Tablets is Chloroquine phosphate.
A)  Each tablet contains 250mg of Taj Pharma Chloroquine phosphate (equivalent to 155 mg of chloroquine base).
B)  Each tablet contains 500mg of Taj Pharma Chloroquine phosphate (equivalent to 155 mg of chloroquine base).

The other ingredients are magnesium stearate and maize starch.

 What Taj Pharma Chloroquine phosphate looks like and contents of the pack
Taj Pharma Chloroquine phosphate Tablets are white and round.
Taj Pharma Chloroquine phosphate Tablets come in packs of 20, 30, 50, 60, 100 tablets.
Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com