Heparin Sodium 1 ml Solution

HEPARIN SODIUM FRESENIUS belongs to a group of medicines known as anticoagulants. Anticoagulants work by decreasing the clotting ability of your blood and help to stop clots forming in the blood vessels. HEPARIN SODIUM FRESENIUS injection is used for prevention and treatment of diseases caused by blood clots in your veins and/or arteries.

You should not be given HEPARIN SODIUM FRESENIUS:

• if you have an allergy to heparin
• if you have, or may have, a tendency to bleed easily or a problem with your blood vessels
• if you have a low blood platelet count
• in conditions where bleeding is at particular risk, for example:
• heart problems or high blood pressure
• blood disease or bleeding problems
• recent childbirth
• threatened abortion
• liver disease
• kidney disease
• stomach ulcer
• surgery or wounds resulting in large open wounds
• prior to lumber puncture (a procedure performed in order to collect a sample of spinal fluid) or regional anaesthetic block (local anaesthetic block)
• during or after eye, brain, or spinal cord surgery
• pulmonary tuberculosis (TB in the lung).

Warnings and precautions

Special care should be taken with HEPARIN SODIUM FRESENIUS. Tell your doctor or healthcare provider before being given the injection if:

• you are undergoing treatment for lymphoblastic leukaemia (blood cancer),
• you are undergoing renal dialysis,
• 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,
• have high levels of potassium in your blood or are taking a medicine that may increase the potassium level in your blood,
• suffer from allergies or have previously had an allergic reaction to heparin,
• you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called metabolic acidosis).

Other medicines and HEPARIN SODIUM FRESENIUS

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Some medicines and HEPARIN SODIUM FRESENIUS may interfere with each other. These include:

• Medicines which affect blood clotting such as aspirin and warfarin, epoprostenol, alteplase and dipyridamole.
• Medicines for hay fever such as antihistamines.
• Other nonsteroidal anti-inflammatory medicines (e.g. diclofenac or ibuprofen) for pain.
• Penicillins and other types of antibiotics.
• Medicines which cause increased volume of urine (diuretic).
• Potassium supplements such as potassium-containing salt substitutes.
• Glyceryl trinitrate (for heart disease).

You will not be expected to administer HEPARIN SODIUM FRESENIUS to yourself. Your doctor or healthcare provider will administer HEPARIN SODIUM FRESENIUS to you for a specific condition. HEPARIN SODIUM FRESENIUS injection is usually given directly into your vein (intravenously) or under your skin at regular intervals and at a dose depending on the clotting time of your blood. HEPARIN SODIUM FRESENIUS can also be given by continuous infusion whereby the HEPARIN SODIUM FRESENIUS is mixed with either a dextrose or 0,9% sodium chloride solution and given by slow injection into your vein (this is called an intravenous infusion).

Your doctor will decide what dose, how often and how long you will receive HEPARIN SODIUM FRESENIUS. This depends on your condition and other factors, such as age, blood tests, method it is being given and whether or not other medicines are being given at the same time.

If you receive more HEPARIN SODIUM FRESENIUS than you should Since a healthcare provider will administer this medicine, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Symptoms that you need to be aware of in case of an overdose are:

• nose bleeds
• easy or unexplained bruising or bleeding
• blood in your urine or stool.

Tell your doctor if any of the above occurs. If you missed a dose of HEPARIN SODIUM FRESENIUS Since a healthcare provider will administer HEPARIN SODIUM FRESENIUS, it is unlikely that a dose will be missed.

HEPARIN SODIUM FRESENIUS can have side effects. Not all side effects reported for HEPARIN SODIUM FRESENIUS are included in this leaflet. Should your general health worsen or you experience any untoward effects while receiving HEPARIN SODIUM FRESENIUS, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop administration of HEPARIN SODIUM FRESENIUS immediately:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to HEPARIN SODIUM FRESENIUS. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if you experience any of the following reactions after receiving HEPARIN SODIUM FRESENIUS:

• any prolonged or unexplained bleeding
• pain, warmth, or redness in your arm or leg which could indicate a blood clot.

These are all serious side effects. You may need urgent medical attention. Tell your doctor as soon as possible if you experience any of the following reactions after receiving HEPARIN SODIUM FRESENIUS:

Frequency unknown:

• irritation at the site of injection,
• hair loss,
• osteoporosis (following long-term use) – a bone disease that leads to increased bone fractures,
• prolonged, painful erection,
• 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 you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of HEPARIN SODIUM FRESENIUS. Health care providers are asked to report any suspected adverse reactions to the Holder of the Certificate of Registration at the following email address: [email protected], and to the relevant medicines regulatory authority in the country where the medicine is marketed.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. HEPARIN SODIUM FRESENIUS will be stored in the pharmacy or in the hospital wards at or below 25 °C. After dilution the solutions should be used immediately.