Deplatt 75 mg Film-Coated Tablets

Platelets are small structures in the blood and by clumping together they are responsible for blood clotting. Blood clots (thrombi) can easily form in hardened blood vessels (arteries), which can increase the risk of a stroke or a heart attack. DEPLATT belongs to a group of medicines that prevent platelets from clumping and therefore prevents blood clots from forming.

You have been prescribed DEPLATT because you have either previously experienced a heart attack or stroke, or you have a circulatory problem in which narrowed blood vessels (arteries) reduce blood flow to your limbs. DEPLATT is also prescribed when you have a condition known as hardening of the arteries (atherosclerosis). Atherosclerosis results in a narrowing of the blood vessels (arteries) and an increased risk of blood clots (thrombi). DEPLATT is taken to prevent blood clots forming in the hardened arteries thus reducing the risk of a stroke or a heart attack.

Do not take DEPLATT :

• I f you are hypersensitive (allergic) to clopidogrel or any of the other ingredients of DEPLATT (listed in section 6).
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain
• If you suffer from severe liver disease
• If you suffer from low platelet count (thrombocytopenia)
• If you suffer from low white blood cell count (neutropenia)
• If you suffer from a blood disorder that affects your body’s ability to form new blood cells (haematopoietic disorder)
• If you suffer from a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) (haemorrhagic disorder)
• Use in children is not recommended as there is not sufficient data for the use of DEPLATT
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Special care should be taken with DEPLATT :

• If you have had a recent serious injury
• If you have recently undergone surgery (including dental)
• If you have recently received spinal anaesthesia or anaesthesia which produced loss of sensation below the waist (epidural anaesthesia)
• If you have a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body)
• If you have a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer or bleeding within the brain)
• If you will be having surgery (including dental) in the next 7 days
• If you are taking medicines that are used to thin your blood or for inflammation such as aspirin, heparin, warfarin and NSAIDs. This includes all medications, even those which you have purchased yourself without a medical prescription
• If you have kidney or liver disease.

While you are taking DEPLATT:

• You should tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as purplish spots, with or without unexplained extreme tiredness, headaches, confusion, slurred speech, yellowing of the skin or eyes (jaundice) (see POSSIBLE SIDE EFFECTS)
• If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way your medicine works. For minor cuts and injuries e.g. cutting yourself shaving, this is of no concern. However, if you are in any doubt at all, you should contact your doctor immediately.

Do not share medicines prescribed for you with any other person. Always take DEPLATT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults (including the elderly): The usual dose is one 75 mg tablet of DEPLATT per day, with or without food. You should take your medicine regularly and at the same time each day.

I f you take more DEPLATT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. An overdose of DEPLATT may lead to longer bleeding time than usual in the event that you cut or injure yourself.

If you forget to t ake DEPLATT

If you forget to take a dose of DEPLATT , but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the normal time. If you forget for more than 12 hours simply take the next single dose at the usual time. Do not take a double dose to make up for the forgotten individual dose.

If you stop taking DEPLATT

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

DEPLATT can have side effects.

Not all side effects reported for DEPLATT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DEPLATT , please consult your health care provider for advice.

If any of the following happens, stop taking DEPLATT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting
• Yellowing of the skin and eyes, also called jaundice
• Bleeding which appears under the skin as red pinpoint dots and/or confusion and fever
• Bleeding in the stomach or bowels, bleeding inside the head or from an operation wound; bleeding in the eye, the lung or the joints.

These are all very serious side effects. If you have them, you may have had a serious reaction to DEPLATT . You may need urgent medical attention or hospitalisation.

Tell your doctor , or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent

• Bleeding in the stomach or bowels; haematoma (unusual bleeding or bruising under the skin, solid swelling of clotted blood); nose bleed.

Less frequent

• Deficiency of platelets in the blood (which results in bruising and slow blood clotting); deficiency of all blood cell types; reduction in the ability of blood to clot; jaundice; abnormal liver function blood tests; breathing difficulties sometimes associated with cough; decrease in blood pressure; confusion; hallucinations; inflammation of the pancreas or the lining of the large intestine; liver failure; blood in the urine; inflammation of the kidney.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• Diarrhoea; abdominal pain; indigestion or heartburn; bruising; bleeding at puncture site.

Less frequent:

• Reduction in the number of white blood cells; headache; inflammation of a blood vessel or of the lining of the stomach; stomach ulcer; vomiting; nausea; constipation; excessive gas in the stomach or intestines; rashes; itching; dizziness; sensation of tingling and numbness; vertigo (a sensation of whirling and loss of balance); joint stiffness; muscular pain; scarring of the lung; change in taste of food; inflammation of the lining of the mouth; fluid filled blisters on the skin; swelling of the deep layers of the skin; eczema (patches of skin become rough and inflamed with blister which cause itching and bleeding); fever; bleeding time prolonged.

Side effects with frequency not known (frequency cannot be estimated from the available data): Insulin autoimmune syndrome (IAS) is a rare endocrine disorder of persistent low blood sugar symptoms. Your doctor will order blood tests to confirm this diagnosis.

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 docto r or pharmacis t . 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 DEPLATT .

Store all medicines out of reach of children.

• Store at or below 30 °C
• Store in the original package
• Keep blister in outer carton until required for use
• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).