GENERIC NAME OF THE MEDICINAL PRODUCT:

Hydroxychloroquine Sulphate Tablets IP 200mg Taj Pharma
Hydroxychloroquine Sulphate Tablets IP 300mg Taj Pharma
Hydroxychloroquine Sulphate Tablets IP 400mg Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Each film-coated tablet contains:
Hydroxychloroquine Sulphate IP 200mg
Excipients q.s.
Colour: Titanium Dioxide IP
b) Each film-coated tablet contains:
Hydroxychloroquine Sulphate IP 300mg
Excipients q.s.
Colour: Titanium Dioxide IP
c) Each film-coated tablet contains:
Hydroxychloroquine Sulphate IP 400mg
Excipients q.s.
Colour: Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Adults: Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight. Paediatric population: Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.

COVID-19 (CoronaVirus)

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

PIL: Patient Information Leaflet

Hydroxychloroquine Sulphate Tablets IP 400mg Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Hydroxychloroquine Sulphate Tablets IP 200mg Taj Pharma

Hydroxychloroquine Sulphate Tablets IP 300mg Taj Pharma

Hydroxychloroquine Sulphate Tablets IP 400mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Each film-coated tablet contains:
Hydroxychloroquine Sulphate IP                 200mg
Excipients                                                         q.s.
Colour: Titanium Dioxide IP

b) Each film-coated tablet contains:
Hydroxychloroquine Sulphate IP                 300mg
Excipients                                                        q.s.
Colour: Titanium Dioxide IP

c) Each film-coated tablet contains:
Hydroxychloroquine Sulphate IP              400mg
Excipients                                                     q.s.
Colour: Titanium Dioxide IP

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Film-Coated Tablet

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Adults

Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.

Paediatric population

Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.

4.2 Posology and method of administration

Adults (including the elderly)

The minimum effective dose should be employed. This dose should not exceed 6.5mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200mg or 400mg per day.

In patients able to receive 400mg daily:

Initially 400mg daily in divided doses. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 400mg daily if the response lessens.

Paediatric population

The minimum effective dose should be employed and should not exceed 6.5mg/kg/day based on ideal body weight. The 200mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg.

Each dose should be taken with a meal or glass of milk.

Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light.

The tablets are for oral administration.

4.3 Contraindications

– known hypersensitivity to 4-aminoquinoline compounds

– pre-existing maculopathy of the eye

– pregnancy (see section 4.6 Pregnancy and lactation)

4.4 Special warnings and precautions for use

General

  • The occurrence of retinopathy is very uncommon if the recommended daily dose is not exceeded. The administration of doses in excess of the recommended maximum is likely to increase the risk of retinopathy, and accelerate its onset.
  • All patients should have an ophthalmological examination before initiating treatment with Plaquenil. Thereafter, ophthalmological examinations must be repeated at least every 12 months.

The examination should include testing visual acuity, careful ophthalmoscopy, fundoscopy, central visual field testing with a red target, and colour vision.

This examination should be more frequent and adapted to the patient in the following situations:

– daily dosage exceeds 6.5 mg/kg lean body weight. Absolute body weight used as a guide to dosage could result in an overdosage in the obese.

– renal insufficiency

– visual acuity below 6/8

– age above 65 years

– cumulative dose more than 200g.

Plaquenil should be discontinued immediately in any patient who develops a pigmentary abnormality, visual field defect, or any other abnormality not explainable by difficulty in accommodation or presence of corneal opacities. Patients should continue to be observed for possible progression of the changes.

Patients should be advised to stop taking the drug immediately and seek the advice of their prescribing doctor if any disturbances of vision are noted, including abnormal colour vision.

Cases of cardiomyopathy resulting in cardiac failure, in some cases with fatal outcome, have been reported in patients treated with Plaquenil (see section 4.8 and 4.9). Clinical monitoring for signs and symptoms of cardiomyopathy is advised and Plaquenil should be discontinued if cardiomyopathy develops. Chronic toxicity should be considered when conduction disorders (bundle branch block / atrio-ventricular heart block) as well as biventricular hypertrophy are diagnosed (see section 4.8).

Plaquenil should be used with caution in patients taking medicines which may cause adverse ocular or skin reactions. Caution should also be applied when it is used in the following:

  • patients with hepatic or renal disease, and in those taking drugs known to affect those organs. Estimation of plasma hydroxychloroquine levels should be undertaken in patients with severely compromised renal or hepatic function and dosage adjusted accordingly.
  • patients with severe gastrointestinal, neurological or blood disorders.

Although the risk of bone marrow depression is low, periodic blood counts are advisable as anaemia, aplastic anaemia, agranulocytosis, a decrease in white blood cells, and thrombocytopenia have been reported. Plaquenil should be discontinued if abnormalities develop.

Caution is also advised in patients with a sensitivity to quinine, those with glucose-6-phosphate dehydrogenase deficiency, those with porphyria cutanea tarda which can be exacerbated by hydroxychloroquine and in patients with psoriasis since it appears to increase the risk of skin reactions.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Small children are particularly sensitive to the toxic effects of 4-aminoquinolines; therefore patients should be warned to keep Plaquenil out of the reach of children.

All patients on long-term therapy should undergo periodic examination of skeletal muscle function and tendon reflexes. If weakness occurs, the drug should be withdrawn.

Hydroxychloroquine 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  hydroxychloroquine 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 hydroxychloroquine should have their blood glucose level checked and treatment reviewed as necessary.

Extrapyramidal disorders may occur with Hydroxychloroquine Sulphate (see section 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

Hydroxychloroquine sulfate has been reported to increase plasma digoxin levels: serum digoxin levels should be closely monitored in patients receiving concomitant treatment.

Hydroxychloroquine sulfate may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared. These include: potentiation of its direct blocking action at the neuromuscular junction by aminoglycoside antibiotics;           inhibition of its metabolism by cimetidine which may increase plasma concentration of the antimalarial; antagonism of effect of neostigmine and pyridostigmine; reduction of the antibody response to primary immunisation with intradermal human diploid-cell rabies vaccine.

As with chloroquine, antacids may reduce absorption of hydroxychloroquine so it is advised that a 4 hour interval be observed between Plaquenil and antacid dosaging.

As hydroxychloroquine may enhance the effects of a hypoglycaemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required.

Halofantrine prolongs the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias, including hydroxychloroquine. Also, there may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine is used concomitantly with other arrhythmogenic drugs, such as amiodarone and moxifloxacin.

An increased plasma ciclosporin level was reported when ciclosporin and hydroxychloroquine were co-administered.

Hydroxychloroquine can lower the convulsive threshold. Co-administration of hydroxychloroquine with other antimalarials known to lower the convulsion threshold (e.g mefloquine) may increase the risk of convulsions.

Also, the activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine.

In a single-dose interaction study, chloroquine has been reported to reduce the bioavailability of praziquantel. It is not known if there is a similar effect when hydroxychloroquine and praziquantel are coadministered.

Per extrapolation, due to the similarities in structure and pharmacokinetic parameters between hydroxychloroquine and chloroquine, a similar effect may be expected for hydroxychloroquine.

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

4.6 Pregnancy and lactation

Pregnancy

Hydroxychloroquine crosses the placenta. Data are limited regarding the use of hydroxychloroquine during pregnancy. It should be noted that 4-aminoquinolines in therapeutic doses have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation. Therefore Plaquenil should not be used in pregnancy.

Lactation

Careful consideration should be given to using hydroxychloroquine during lactation, since it has been shown to be excreted in small amounts in human breast milk, and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

4.7 Effects on ability to drive and use machines

Impaired visual accommodation soon after the start of treatment has been reported and patients should be warned regarding driving or operating machinery. If the condition is not self-limiting, it will resolve on reducing the dose or stopping treatment.

4.8 Undesirable effects

The following CIOMS frequency rating is used, when applicable:

Very common ≥ 10 %; Common ≥ 1 and <10 %; Uncommon ≥ 0.1 and < 1 %; Rare ≥ 0.01 and <0.1 %; Very rare < 0.01 %; Not known (frequency cannot be estimated from available data).

Blood and Lymphatic system disorders

Not known: Bone-marrow depression, anaemia, aplastic anaemia, agranulocytosis, leucopenia and thrombocytopenia

Immune system disorders

Not known: Urticaria, angioedema, bronchospasm

Metabolism and nutrition disorders

Common: Anorexia

Not known: Hypoglycemia

Hydroxychloroquine may precipitate or exacerbate porphyria.

Psychiatric disorders

Common: Affect lability

Uncommon: Nervousness

Not known: Psychosis

Nervous system disorders

Common: Headache

Uncommon: Dizziness

Not known:Convulsions have been reported with this class of drugs

Extrapyramidal disorders such as dystonia, dyskinesia, tremor (see section 4.4).

Eye disorders

Common: Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible

Uncommon: Retinopathy with changes in pigmentation and visual field defects can occur, but appears to be uncommon if the recommended daily dose is not exceeded. In its early form it appears reversible on discontinuation of Plaquenil. If allowed to develop, there may be a risk of progression even after treatment withdrawal.

Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas and abnormal colour vision.

Corneal changes including oedema and opacities have been reported. They are either symptomless or may cause disturbances such as haloes, blurring of vision or photophobia. They may be transient and are reversible on stopping treatment.

Not known: Cases of maculopathies and macular degeneration have been reported (the onset ranging from 3 months to several years of exposure to hydroxychloroquine) and may be irreversible.

Ear and labyrinth disorders

Uncommon: Vertigo, tinnitus

Not known: Hearing loss

Cardiac disorders

Not known: Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see SPC section 4.4 and 4.9)

Chronic toxicity should be considered when conduction disorders (bundle branch block/atrioventricular heart block) as well as biventricular hypertrophy are found. Drug withdrawal may lead to recovery.

Gastrointestinal disorders

Very common: Abdominal pain, nausea

Common: Diarrhoea, vomiting.

These symptoms usually resolve immediately on reducing the dose or on stopping treatment.

Hepatobiliary disorders

Uncommon: Abnormal liver function tests

Not known: Fulminant hepatic failure

Skin and subcutaneous tissue disorders

Common: Skin rash, pruritus

Uncommon: Pigmentation disorders in skin and mucous membranes, bleaching of hair, alopecia

These usually resolve readily on stopping treatment.

Not known: Bullous eruptions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) photosensitivity, exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP).

AGEP has to be distinguished from psoriasis, although hydroxychloroquine may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favourable after drug withdrawal.

Musculoskeletal and connective tissue disorders

Uncommon: Sensory motor disorders

Not known: Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups.

Myopathy may be reversible after drug discontinuation, but recovery may take many months.

Depression of tendon reflexes and abnormal nerve conduction studies.

Metabolism and nutrition disorders

Hypoglycaemia (see section 4.4). Frequency: unknown.

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

Overdosage with the 4-aminoquinolines is dangerous particularly in infants, as little as 1-2 g having proved fatal.

The symptoms of overdosage may include headache, visual disturbances, cardiovascular collapse, convulsions, and hypokalaemia. Rhythm and conduction disorders, including QT prolongation, Torsade de Pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required, as these effects may appear shortly after the overdose.

The stomach should be immediately evacuated either by emesis or by gastric lavage. Activated charcoal in a dose at least five times of the  overdose may inhibit further absorption if introduced into the stomach by tube following lavage and within 30 minutes of ingestion of the overdose.

Consideration should be given to administration of parenteral diazepam in cases of overdosage; it has been shown to be beneficial in reversing chloroquine cardiotoxicity.

Respiratory support and shock management should be instituted as necessary.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Antimalarial agents like chloroquine and hydroxychloroquine have several pharmacological actions which may be involved in their therapeutic effect in the treatment of rheumatic disease, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, NADH – cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosomal membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis, possible interference with interleukin 1 production from monocytes and inhibition of neutrophil superoxide release.

5.2 Pharmacokinetic properties

Hydroxychloroquine has actions, pharmacokinetics and metabolism similar to those of chloroquine. Following oral administration, hydroxychloroquine is rapidly and almost completely absorbed. In one study, mean peak plasma hydroxychloroquine concentrations following a single dose of 400mg in healthy subjects ranged from 53-208 ng/ml with a mean of 105ng/ml. The mean time to peak plasma concentration was 1.83 hours. The mean plasma elimination half-life varied, depending on the post administration period, as follows: 5.9 hours at Cmax –10 hours), 26.1 hours (at 10-48 hours and 299 hours (at 48-504 hours). The parent compound and metabolites are widely distributed in the body and elimination is mainly via the urine, where 3% of the administered dose was recovered over 24 hours in one study.

5.3 Preclinical safety data

There are no preclinical safety data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Lactose monohydrate, maize starch, magnesium stearate, polyvidone, Opadry OY-L-28900 (containing hypromellose, macrogol 4000, titanium dioxide, lactose

6.2 Incompatibilities
No incompatibilities are known.

6.3 Shelf life
36 months.

6.4 Special precautions for storage
Store below 25°C.

6.5 Nature and contents of container
Amber glass bottles with a tin plate screw cap containing 100 tablets.
HDPE bottle with LDPE cap containing 56 tablets.
250µm clear PVC/20µm aluminium foil blister pack containing 56 or 60 tablets.

6.6 Special precautions for disposal and other handling
None.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LIMITED
At Plot No.: 220, Mahagujarat Industrial Estate,
At & Post: Moraiya, Tal – Sanand, Dist. Ahmedabad, Gujarat, INDIA.

 

Hydroxychloroquine Sulphate Tablets IP 400mg Taj Pharma

Hydroxychloroquine Sulphate Tablets IP 200mg Taj Pharma

Hydroxychloroquine Sulphate Tablets IP 300mg Taj Pharma

Hydroxychloroquine Sulphate Tablets IP 400mg Taj Pharma

Hydroxychloroquine Sulphate

Package leaflet: Information for the patient

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 or pharmacist.

What is in this leaflet:

  1. What Hydroxychloroquine Sulphate is and what it is used for
  2. What you need to know before you take Hydroxychloroquine Sulphate
  3. How to take Hydroxychloroquine Sulphate
  4. Possible side effects
  5. How to store Hydroxychloroquine Sulphate
  6. Further information
1 WHAT HYDROXYCHLOROQUINE SULPHATE  IS AND WHAT IT IS USED FOR

Hydroxychloroquine sulfate works by reducing inflammation in people with autoimmune diseases (this is where the body’s immune system attacks itself by mistake).

It can be used for:

  • Rheumatoid arthritis (inflammation of the joints)
  • Juvenile idiopathic arthritis (in children)
  • Discoid and systemic lupus erythematosus (a disease of the skin or the internal organs)
  • Skin problems which are sensitive to sunlight

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROXYCHLOROQUINE SULPHATE

Do not take this medicine and tell your doctor if:

  • You are allergic (hypersensitive) to:
  • hydroxychloroquine
  • other similar medicines such as quinolones and quinine
  • any of the other ingredients of hydroxychloroquine sulfate (listed in Section 6 below)

Signs of allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

  • You have an eye problem which affects the retina, the inside of the eye (maculopathy) or you get a change in eye colour or any other eye problem
  • You are pregnant, might become pregnant or think you may be pregnant (see ‘Pregnancy and breast- feeding’ below)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking hydroxychloroquine sulfate.

Take special care with Hydroxychloroquine sulfate

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

  • you have liver or kidney problems
  • you have serious stomach or gut problems
  • you have heart problems
  • you have any problems with your blood. You may have blood tests to check this.
  • You have any problems with your nervous system or brain
  • You have psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp) You have had a bad reaction to quinine in the past You have a genetic condition known as ‘glucose-6- dehydrogenase deficiency’
  • You have a rare illness called ‘porphyria’ which affects your metabolism

Before treatment with Hydroxychloroquine sulfate

  • Before you take this medicine you should have your eyes examined
  • This testing should be repeated at least every 12 months whilst taking hydroxychloroquine sulfate If you are over 65, need to take a high dose (2 tablets a day) or have kidney problems then this examination should be performed more often Hydroxychloroquine can cause lowering of blood glucose level. Please ask your doctor to inform you of signs and symptoms of low blood glucose A check of the blood glucose level may be necessary

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking hydroxychloroquine sulfate.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because hydroxychloroquine sulfate can affect the way some other medicines work. Also some medicines can affect the way hydroxychloroquine sulfate works.

In particular, tell your doctor if you are taking any of the following:

The following medicines may increase the chance of you getting side effects when taken with Hydroxychloroquine sulfate:
  • Some antibiotics used for infections (such as gentamicin, neomycin or tobramycin)
  • Cimetidine – used for stomach ulcers
  • Neostigmine and pyridostigmine – used for muscle weakness (myasthenia gravis)
  • Medicines that may affect the kidneys or liver
  • Medicines that affect the skin or the eyes
  • Halofantrine, mefloquine – used for malaria
  • Amiodarone – used for heart problems
  • Moxifloxacin – used to treat infections
  • Medicines used for epilepsy
The following medicines can change the way Hydroxychloroquine sulfate works or Hydroxychloroquine sulfate may affect the way some of these medicines work:
  • Digoxin – used for heart problems
  • Medicines for diabetes (such as insulin or metformin)
  • Antacids – used for heartburn or You should leave a gap of at least 4 hours between taking these medicines and hydroxychloroquine sulfate
  • Rabies vaccine
  • Ciclosporin – used after an organ transplantation to help prevent rejection
  • Praziquantel – used to treat worm infections
  • Agalsidase – used to treat a rare condition called Fabry’s disease
Pregnancy and breast-feeding

Do not take hydroxychloroquine sulfate if:

  • You are pregnant, might become pregnant or think you may be pregnant
  • You are breast-feeding or planning to breast- This is because small amounts may pass into mother’s milk

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may get eye problems while taking this medicine. If this happens, do not drive or use any tools or machines, and tell your doctor straight away.

Important information about some of the ingredients of Hydroxychloroquine sulfate

This medicine contains lactose. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking hydroxychloroquine sulfate.

3 HOW TO TAKE HYDROXYCHLOROQUINE SULPHATE

Always take hydroxychloroquine sulphate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine
  • Take this medicine by mouth
  • Swallow the tablets whole with a meal or a glass of milk. Do not crush or chew your tablets
  • If you are taking this medicine for skin problems that are sensitive to sunlight, only take hydroxychloroquine sulfate during periods of high exposure to light
  • The doctor will work out the dose depending on your body weight. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
  • If you have been taking this medicine for rheumatoid arthritis for a long time (more than 6 months) and you do not feel that it is helping you, see your This is because the treatment may need to be stopped.
How much to take

Adults, including the elderly

  • One or two tablets each day
Children and Adolescents
  • One tablet each day
  • This medicine is only suitable for children who weigh more than 31 kg (around 5 stones)

It may take several weeks before you notice the benefit of taking hydroxychloroquine sulfate.

If you take more Hydroxychloroquine sulfate than you should
  • If you take more hydroxychloroquine sulfate than you should, tell your doctor or go to a hospital casualty department straight Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: headache, problems with your eyesight, fall in blood pressure, convulsions (fits), heart problems, followed by sudden severe breathing problems and possibly heart attack
  • Young children and babies are particularly at risk if they accidentally take hydroxychloroquine sulfate. Take the child to hospital straight away
If you forget to take Hydroxychloroquine sulfate

If you forget a dose, take it as soon as your remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Hydroxychloroquine sulfate

Keep taking hydroxychloroquine sulfate until your doctor tells you to stop. Do not stop taking hydroxychloroquine sulfate just because you feel better. If you stop, your illness may get worse again.

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

4 POSSIBLE SIDE EFFECTS

Like all medicines, hydroxychloroquine can cause side effects, although not everybody gets them.

Stop taking Hydroxychloroquine sulfate and see a doctor or go to a hospital straight away if: Frequency unknown
  • You have an allergic The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of the eyelids, lips, face, throat or tongue
  • Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together with a high temperature, reddening and being more sensitive to the sun
  • Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and This could be a condition called Stevens- Johnson Syndrome
Stop taking Hydroxychloroquine sulfate and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
 Common (affects 1 to 10 people in 100 people)
  • You have any eye problems. This includes changes in the colour of your eye and problems with your eyesight such as blurring, sensitivity to light or the way you see colour

Uncommon (affects 1 to 10 people in 1,000)

  • You have any muscle weakness, cramps, stiffness or spasms or changes in sensation such as If you take this medicine for a long time, your doctor will occasionally check your muscles and tendons to make sure they are working properly
  • Frequency unknown
  • You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leucopenia’ or ‘agranulocytosis’
  • You may bruise more easily than usual. These could be due to a blood problem called ‘thrombocytopenia’
  • You feel tired, faint or dizzy and have pale skin.

These could be symptoms of something called ‘anaemia’

  • You feel weak, short of breath, bruise more easily than usual and get infections more easily than These could be symptoms of something called ‘aplastic anaemia’
  • Weakening of the heart muscle (cardiomyopathy) resulting in difficulty breathing, coughing, high blood pressure, swelling, increased heart rate, low amount of urine
  • Low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or sweaty
  • You notice yellowing or your skin or your eyes or your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis
  • Fits
  • Lack of movement, stiffness, shaking or abnormal movements in the mouth

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

  • Stomach pain
  • Feeling sick

Common (affects 1 to 10 people in a 100 people)

  • Skin rashes, itching
  • Being sick, diarrhoea
  • Loss of appetite (anorexia)
  • Headache
  • Changes in mood with uncontrollable laughing or crying

Uncommon (affects 1 to 10 people in a 1,000)

  • Changes in the colour of your skin or the inside of your nose or mouth
  • Hair loss or loss of hair colour
  • Feeling nervous
  • Ringing in the ear (tinnitus)
  • Balance problems (vertigo) or feeling dizzy
  • Liver problems shown by blood tests

Frequency unknown

  • Psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)
  • Hearing loss
  • Mental problems (such as delusions, hallucinations and changes in mood)
  • Symptoms of a condition called ‘porphyria’ which may include stomach pain, being sick, fits, blisters, itching
Heart and blood tests
  • Your doctor may look at your heart’s electrical activity using an ECG (electrocardiogram)
  • A blood test may show changes in the way the liver is working and occasionally the liver may stop working
Reporting of side effects

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

5 HOW TO STORE HYDROXYCHLOROQUINE SULPHATE

Keep out of the reach and sight of children. Store below 25˚C. Do not use hydroxychloroquine sulfate after the expiry date which is 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 no longer required. These measures will help to protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Hydroxychloroquine Sulphate contains

  • Each tablet contains 200mg or 300mg or 400mg of the active substance, hydroxychloroquine sulfate.
  • The other ingredients are lactose monohydrate, maize starch, magnesium stearate, polypovidone, hypromellose, macrogol and titanium
Contents of the pack

They are supplied in boxes of 60 tablets.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LIMITED
At Plot No.: 220, Mahagujarat Industrial Estate,
At & Post: Moraiya, Tal – Sanand, Dist. Ahmedabad, Gujarat, INDIA.