GENERIC NAME OF THE MEDICINAL PRODUCT:

Heparin 25,000 I.U./5ml, solution for injection (Beprin) Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Each vial with 5 ml solution for injection contains 25,000 I.U. of sodium heparin (from porcine intestinal mucosa).

THERAPEUTIC INDICATIONS:

Heparin (Beprin) is used to treat and prevent:
Blood clots in leg veins (deep vein thrombosis)
Blood clots in the lung (pulmonary embolism) as well as for:
The treatment of chest pains resulting from disease of the heart arteries (unstable angina pectoris)
The treatment of severe blockages affecting arteries in the legs (acute peripheral arterial occlusion)
The prevention of blood clots in the heart following a heart attack (mural thrombosis).
It is also used during heart and lung operations and during kidney dialysis.

DIRECTION OF USE:

Reconstituted and Infusion Solutions: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature.

CAUTION & SCHEDULE:

CAUTION: KEEP OUT OF REACH AND SIGHT OF CHILDREN.
SCHEDULE: SCHEDULE ‘H’ DRUG – To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store below 25°C.
Protect from light.
Do not freeze.
DOSAGE: As directed by Physician.

Heparin Injection IP 25000 IU (Beprin) Taj Pharma

Overview

INTRODUCTION OF BEPRIN INJECTION

Beprin 25000iu Injection is an anticoagulant that prevents abnormal clotting of blood. It not only prevents the formation of harmful blood clots in the legs, lungs, and heart but also stops them from growing bigger.

Using Beprin 25000iu Injection may increase the risk of bleeding, use caution while shaving, cutting nails, using sharp objects, or engaging in contact sports (e.g., football, wrestling). It is considered to be safer than other anticoagulants for pregnant and breastfeeding women. Your doctor may get regular blood tests done to make sure this medicine is working well and monitor the levels of potassium and platelets.

USES OF BEPRIN INJECTION

  • Blood clots
  • Deep vein thrombosis
  • Pulmonary embolism

BEPRIN INJECTION SIDE EFFECTS

Common
  • Bleeding

HOW TO USE BEPRIN INJECTION

Your doctor or nurse will give you this medicine. Kindly do not self administer.

HOW BEPRIN INJECTION WORKS

Beprin 25000iu Injection is an anticoagulant. It works by preventing the formation of harmful blood clots. Although it does not dissolve the existing blood clots, it prevents them from growing larger and causing blockages in the blood vessels.

BEPRIN INJECTION RELATED WARNINGS

warnings

Alcohol

UNSAFE
It is unsafe to consume alcohol with Beprin 25000iu Injection
warnings

Pregnancy

CONSULT YOUR DOCTOR
Beprin 25000iu Injection may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
warnings

Lactation

SAFE IF PRESCRIBED
Beprin 25000iu Injection is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.
Beprin 25000iu Injection is released in small amounts in the breast milk and amounts reaching the baby are also small, which would not be expected to cause any harmful effects to the baby.
warnings

Driving

SAFE
Beprin 25000iu Injection does not usually affect your ability to drive.
warnings

Kidney

SAFE IF PRESCRIBED
Beprin 25000iu Injection is safe to use in patients with kidney disease. No dose adjustment of Beprin 25000iu Injection is recommended.
However, inform your doctor if you have any underlying kidney disease.
warnings

Liver

CONSULT YOUR DOCTOR
There is limited information available on the use of Beprin 25000iu Injection in patients with liver disease. Please consult your doctor.

WHAT IF YOU MISS A DOSE OF BEPRIN INJECTION?

If you miss a dose of Beprin 25000iu Injection, please consult your doctor.

Heparin 5,000 I.U./ml and 25,000 I.U./5ml solution for injection (Beprin) Taj Pharma

  1. Name of the medicinal product

Heparin 5,000 I.U./ml, solution for injection (Beprin) Taj Pharma
Heparin 25,000 I.U./5ml, solution for injection (Beprin) Taj Pharma

  1. Qualitative and quantitative composition

(a) Each vial with 1 ml solution for injection contains 5,000 I.U. of sodium heparin (from porcine intestinal mucosa).

(b) Each vial with 5 ml solution for injection contains 25,000 I.U. of sodium heparin (from porcine intestinal mucosa).

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Solution for injection

  1. Clinical particulars

4.1 Therapeutic indications

– Prophylaxis of deep vein thrombosis and pulmonary embolism.

– Treatment of deep vein thrombosis and pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion.

– Prophylaxis of mural thrombosis following myocardial infarction.

– In extracorporeal circulation and haemodialysis.

4.2 Posology and method of administration

Method of administration

By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection, or by subcutaneous injection.

The intravenous injection volume of heparin injection should not exceed 15ml. As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections.

Posology

Prophylaxis of deep vein thrombosis and pulmonary embolism

Adults:

2 hours pre-operatively:5,000 units subcutaneously
followed by:5,000 units subcutaneously every 8-12 hours, for 7-10 days or until the patient is fully ambulant.

No laboratory monitoring should be necessary during low dose heparin prophylaxis. If monitoring is considered desirable, anti-Xa assays should be used as the activated partial thromboplastin time (APTT) is not significantly prolonged.

Elderly:

Dosage reduction and monitoring of APTT may be advisable.

Paediatric population: No dosage recommendations.

Treatment of deep vein thrombosis and pulmonary embolism:

Adults:

Loading dose:5,000 units intravenously (10,000 units may be required in severe pulmonary embolism)
Maintenance:1,000-2,000 units/hour by intravenous infusion, or 10,000-20,000 units 12 hourly subcutaneously, or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose:50 units/kg intravenously
Maintenance:15-25 units/kg/hour by intravenous infusion, or 250 units/kg 12 hourly subcutaneously, or 100 units/kg 4-hourly by intravenous injection.

Treatment of unstable angina pectoris and acute peripheral arterial occlusion:

Adults:

Loading dose:5,000 units intravenously
Maintenance:1,000-2,000 units/hour by intravenous infusion, or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose:50 units/kg intravenously
Maintenance:15-25 units/kg/hour by intravenous infusion, or 100 units/kg 4-hourly by intravenous injection.

Daily laboratory monitoring (ideally at the same time each day, starting 4-6 hours after initiation of treatment) is essential during full-dose heparin treatment, with adjustment of dosage to maintain an APTT value 1.5-2.5 x midpoint of normal range or control value.

Prophylaxis of mural thrombosis following myocardial infarction

Adults:

12,500 units 12 hourly subcutaneously for at least 10 days.

Elderly:

Dosage reduction may be advisable

In extracorporeal circulation and haemodialysis

Adults:

Cardiopulmonary bypass:

Initially 300 units/kg intravenously, adjusted thereafter to maintain the activated clotting time (ACT) in the range 400-500 seconds.

Haemodialysis and haemofiltration: Initially 1,000-5,000 units,

Maintenance: 1,000-2,000 units/hour, adjusted to maintain clotting time >40 minutes.

Heparin resistance

Patients with altered heparin responsiveness or heparin resistance may require disproportionately higher doses of heparin to achieve the desired effect. Also refer to section 4.4, Special warnings and precautions for use.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

This heparin formulation contains the preservative benzyl alcohol and so must not be given to children up to 3yrs old or neonates. As benzyl alcohol may cross the placenta the use of this formulation must be avoided in pregnancy.

Current (or history of) heparin-induced thrombocytopenia. Generalised or local haemorrhagic tendency.

An epidural anaesthesia during birth in pregnant women treated with heparin is contraindicated.

Regional anaesthesia in elective surgical procedures is contra-indicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.

4.4 Special warnings and precautions for use

Heparin should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Care should be taken when heparin is administered to patients with increased risk of bleeding complications, hypertension, renal or hepatic insufficiency.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium sparing drugs. The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with heparin (see Section 4.5).

In patients undergoing peri-dural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peri-dural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti- inflammatory drugs, platelet inhibitors or anticoagulants and by traumatic or repeated puncture. In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peri-dural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these.

Heparin should not be administered by intramuscular injection due to the risk of haematoma.

Due to increased bleeding risk, care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis.

Heparin Injection contains benzyl alcohol (10mg/ml) as preservatives. Caution should be used if prescribing Heparin Injection to susceptible patients. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to three years old.

4.5 Interaction with other medicinal products and other forms of interaction

Heparin may prolong the one stage prothrombin time. Accordingly, when Heparin is given with dicoumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose of heparin should elapse before blood is drawn, if a valid prothrombin time is to be obtained.

The anticoagulant effect of heparin may be enhanced by concomitant medication with other drugs affecting platelet function or the coagulation system, e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, non-steroidal anti-inflammatory drugs, vitamin K antagonists, dextrans, activated protein C. Where such combination cannot be avoided, careful clinical and biological monitoring is required.

Combined use with ACE inhibitors or angiotensin II antagonists may increase the risk of hyperkalaemia.

4.6 Fertility, pregnancy and lactation

As benzyl alcohol may cross the placenta, the use of this formulation should be avoided during pregnancy.

The use of heparin in women with abortus imminens is contraindicated (see Section 4.3). Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

The following adverse reactions have been observed and reported during treatment with Heparin Sodium with the following frequencies: 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 available data).

Adverse Drug Reactions

System Organ Class (SOC)MedDRA Preferred TermFrequency
Vascular disordersHaemorrhageNot known
EpistaxisNot known
ContusionNot known
Blood and lymphatic system disordersThrombocytopeniaNot known
Renal and urinary disordersHaematuriaNot known
Endocrine disordersAdrenal insufficiencyNot known
HypoaldosteronismNot known
Skin and subcutaneous tissue disordersAlopeciaNot known
Skin necrosisNot known
Musculoskeletal, connective tissue and bone disordersOsteoporosisNot known
Immune system disordersHypersensitivityNot known
Metabolism and nutrition disordersRebound hyperlipidaemiaNot known
Hyperkalaemia HypokalaemiaNot known
Reproductive system and breast disordersPriapismNot known
General disorders and administration site conditionsInjection site reactionNot known
InvestigationsAlanine aminotransferase increased;

Aspartate aminotransferase increased

Not known

Erythematous nodules, or infiltrated and sometimes eczema-like plaques, at the site of subcutaneous injections are common, occurring 3-21 days after starting heparin treatment.

Haemorrhage:

Haemorrhage is the chief complication that may result from heparin therapy. An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug. It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific haemorrhage complications may be difficult to detect.

Adrenal haemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal haemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.

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

Bleeding is the main sign of overdose with heparin.

As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents,

Heparin prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic properties

Absorption

Heparin is not absorbed from the gastrointestinal tract. Heparin is administered by injection.

Distribution

Heparin binds extensively to plasma proteins.

Elimination

Heparin and its metabolites are excreted in the urine.

The half-life of heparin depends on the dose administered, the route of administration and is subject to wide inter- and intra-individual variation.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections.

  1. Pharmaceutical particulars

6.1 List of excipients

Benzyl alcohol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

5 years

Shelf-life after reconstitution

Chemical and physical in-use stability after reconstitution in glucose 5% and in 0.9% sodium chloride solution has been demonstrated for 48 hours at 18-22°C.

6.4 Special precautions for storage

Do not freeze.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Pack of 10 vials of 5 ml of solution for injection.

Glass vial of type I or type II, capacity of 5 ml, closed by a chlorobutyl rubber stoppers with aluminum flip-off cap.

Not all the packs sizes may be marketed.

6.6 Special precautions for disposal and other handling

No specific requirements.

  1. Manufactured in India By:
    Taj Pharmaceuticals Ltd;
    Survey No. 622/2/1/4, Dedhrota,
    Himatnagar-Vijapur Highway,
    Dist-Sabarkantha, 383220, Gujarat.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Heparin 5,000 I.U./ml and 25,000 I.U./5ml solution for injection (Beprin) Taj Pharma
Heparin sodium

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • 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 you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Heparin (Beprin) is and what it is used for
  2. What you need to know before you are given Heparin (Beprin)
  3. How Heparin (Beprin) is given
  4. Possible side effects
  5. How to store Heparin (Beprin)
  6. Contents of the pack and other information

    1. WHAT HEPARIN (Beprin) IS AND WHAT IT IS USED FOR

The name of this medicine is Heparin (Beprin) Solution for injection (referred to as ‘Heparin (Beprin)’ in this leaflet). Heparin (Beprin) belongs to a group of medicines called anticoagulants. Heparin prevents blood clotting

Heparin (Beprin) is used to treat and prevent:

  • Blood clots in leg veins (deep vein thrombosis)
  • Blood clots in the lung (pulmonary embolism) as well as for:
  • The treatment of chest pains resulting from disease of the heart arteries (unstable angina pectoris)
  • The treatment of severe blockages affecting arteries in the legs (acute peripheral arterial occlusion)
  • The prevention of blood clots in the heart following a heart attack (mural thrombosis)

It is also used during heart and lung operations and during kidney dialysis.

  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEPARIN (Beprin)

You should not be given Heparin (Beprin) if you:

  • are allergic to heparin or any of the other ingredients of this medicine (listed in section 6)
  • are pregnant
  • bleed or bruise easily
  • have had severe skin problems resulting from previous heparin treatment
  • are about to have surgery of the brain, spine or eye, a lumbar puncture or local anaesthetic nerve block or some other procedure where bleeding could be a problem

Heparin (Beprin) must not be given to premature or newborn babies or children up to 3 years of age.

Warnings and precautions

Talk to your doctor or nurse before receiving Heparin (Beprin). Particularly careful medical supervision is required if you:

  • are over 60 years of age
  • have any condition which makes you likely to bleed more easily. If you are unsure, ask your doctor or nurse.
  • are diabetic
  • have high levels or potassium in your blood or are taking a medicine that may increase the potassium level in your blood
  • have kidney or liver disease. Your doctor may decide that a lower dose is necessary
  • suffer from allergies or have previously had an allergic reaction to heparin.

Your doctor will check your blood if you receive treatment for longer than five days and may do other blood tests if you have major surgery.

Children

Heparin (Beprin) must not be given to premature or newborn babies or children up to 3 years of age.

Other medicines and Heparin (Beprin)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way heparin injection works. Taking some medicines at the same time as heparin may mean you may be likely to bleed more.

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

  • Aspirin or other non-steroidal anti-inflammatory drugs (e.g diclofenac or ibuprofen)
  • Medicines which may interfere with the proper clotting of the blood (e.g. dipyridamole, epoprostenol, clopidogrel or streptokinase)
  • Medicines that may increase the potassium level in your blood
  • Glyceryl trinitrate (for heart disease)

If you need one of the above medicines your doctor may decide to alter the dose of heparin injection or the other medication.

If you have any doubts about whether this medicine should be administered then discuss things more fully with your doctor or nurse before Heparin (Beprin) is given.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.

You should not be given Heparin (Beprin) if you are pregnant.

Driving and using machines

Heparin injection has not been reported to affect ability to drive or operate machines.

Heparin (Beprin) contains benzyl alcohol

Heparin (Beprin) contains benzyl alcohol which may cause toxic and allergic reactions (possibly delayed) and exceptionally bronchospasm.

  1. HOW HEPARIN (Beprin) IS GIVEN

Your doctor or nurse will inject your dose of heparin into a vein either all at once or over a longer period of time (usually via a drip). Alternatively they may inject your heparin underneath your skin.

The amount injected all at once into a vein should not be greater than 15ml.

You may need to have blood tests if you are receiving higher doses of heparin to check on the effects of your heparin treatment.

Heparin injection must not be given to premature or newborn babies.

You may require a lower dose if you have kidney or liver disease.

To prevent blood clots in leg veins (deep vein thrombosis) and blood clots in the lung (pulmonary embolism)

Adults

The usual dose of heparin injection in adults is 5,000 units injected under the skin 2 hours before your operation, followed by

  • 5,000 units injected under the skin every 8-12 hours, for 7-10 days or until you are fully able to move about.

Elderly

Lower doses may be used in the elderly. You may need to have blood tests if you are elderly, to check on the effects of your heparin treatment.

Children

No specific doses are recommended.

To treat blood clots in leg veins (deep vein thrombosis) and blood clots in the lung (pulmonary embolism).

Adults

The usual dose in adults is 5,000 units injected into a vein. This is followed by:

  • 1,000-2,000 units/hour injected slowly into a vein or
  • 10,000-20,000 units 12 hourly injected under the skin or
  • 5,000-10,000 units 4 hourly injected all at once into a vein.

Elderly

Lower doses may be used in the elderly

Small adults and children

Small adults and children will be given 50 units/kg bodyweight injected into a vein followed by:

  • 15-25 units/kg bodyweight/hour injected slowly into a vein or
  • 250 units/kg bodyweight 12 hourly injected under the skin or
  • 100 units/kg bodyweight 4 hourly injected all at once into a vein

To treat chest pains (unstable angina pectoris) and severe blood clots in the arteries (acute peripheral arterial occlusion)

Adults

The usual dose in adults is 5,000 units injected into a vein. This is followed by:

  • 1,000-2,000 units/hour injected slowly into a vein or
  • 5,000-10,000 units 4 hourly injected all at once into a vein.

Elderly

Lower doses maybe used in the elderly

Small adults and children

Small adults and children will be given 50 units/kg body weight injected into a vein followed by:

  • 15-25 units/kg bodyweight/hour injected slowly into a vein or
  • 100 units/kg body weight 4 hourly injected all at once into a vein

You will have blood tests every day to check the effects of your heparin to prevent a blood clot in the heart following a heart attack.

 Adults

The usual dose for adults is 12,500 units 12 hourly injected under the skin for at least 10 days.

Elderly

A lower dose may be needed.

During Heart and Lung Surgery (Adults)

Initially you will be given 300 units/kg body weight. This will be changed according to the results of your blood tests.

During kidney dialysis (Adults)

Initially you will be given 1,000-5,000 units. This will be changed according to the results of your blood tests.

If you think you have been given too much Heparin (Beprin)

Your doctor will decide which dose is best for you.

Too much heparin can cause bleeding. Slight bleeding can be stopped by stopping your heparin treatment. However if you have more severe bleeding you may need blood tests and an injection of a medicine called protamine sulphate.

If you think too much medicine has been given to you, contact your doctor or nurse.

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

  1. POSSIBLE SIDE EFFECTS

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Important side effects to lookout for (frequency not stated): Severe allergic reactions

Heparin can cause a severe allergic reaction with wheezing, difficulty breathing, a blue tinge to the lips, fever, chills, swelling of the eyes and lips and shock.

If you think you are having a severe allergic reaction you must stop receiving heparin and tell your doctor or nurse immediately.

Bleeding and Bruising

Signs that you are bleeding more easily include:

  • unusual bruising or purple spots on your skin
  • unusual bleeding from your gums
  • unusual nose bleeds
  • blood in your urine (which may cause this to go dark)
  • black, tarry-looking stools
  • bleeding that will not stop from any operation site or other injury

If you are concerned about unusual bleeding you must tell your doctor or nurse immediately as you may need to stop your heparin treatment.

Other side effects (frequency not stated) include:

  • red lumps or red, itchy patches like eczema often develop 3-21 days after the start of heparin treatment, where injections have been given under the skin
  • sloughing of skin may occur around the injection site.
  • persistent erection of the penis
  • abnormal results for blood tests that report on how the liver is working
  • high level of blood fats after stopping heparin
  • high or low blood potassium. If affected you may feel tired and weak.

If heparin injection is given over many months then the following may occur:

  • loss of hair
  • thinning of the bones (osteoporosis)

Reporting of side effects

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

  1. HOW TO STORE HEPARIN (Beprin)

Keep this medicine out of the sight and reach of children.

Your doctor or nurse will usually be responsible for storing and preparing injection before use and for checking that the vials have not passed their expiry date stated on the carton and the label. This medicine must not be used after the expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month.

Heparin injection should not be given if it shows signs of deterioration such as discolouration.

After reconstitution:

Chemical and physical in-use stability after reconstitution in glucose 5% and in 0.9% sodium chloride solution has been demonstrated for 48 hours at 18-22°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION
    What Heparin (Beprin) contains

– The active substance is heparin sodium

Each vial with 1 ml solution for injection contains 5,000 I.U. of heparin sodium.

Each vial with 5 ml solution for injection contains 25,000 I.U. of heparin sodium.

  • The other ingredients are benzyl alcohol, sodium hydroxide, hydrochloric acid, water for injections.

What Heparin (Beprin) looks like and contents of the pack

Heparin (Beprin) is available in packs of 10 vials.

  1. Manufactured in India By:
    Taj Pharmaceuticals Ltd;
    Survey No. 622/2/1/4, Dedhrota,
    Himatnagar-Vijapur Highway,
    Dist-Sabarkantha, 383220, Gujarat.