Heart Health

“You can’t beat a healthy heart.”

Antiplatelet Medication

Platelet Aggregation Inhibitors

CVS-PDclopidogrel

Scheduling Status S3

Proprietary name, Strength and Pharmaceutical Form
PHARMA DYNAMICS CLOPIDOGREL 75 mg (Film-Coated Tablet)

Please read this leaflet carefully before using PHARMA DYNAMICS CLOPIDOGREL 75 mg TABLETS

  • Keep this leaflet.  You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not share your medicine with other people.  It may harm them, even if their symptoms are the same as yours.

WHAT PHARMA DYNAMICS CLOPIDOGREL 75 MG TABLET CONTAINS

Each PHARMA DYNAMICS CLOPIDOGREL 75 mg film-coated tablet contains clopidogrel hydrogen sulphate equivalent to 75 mg of clopidogrel as the active ingredient.

PHARMA DYNAMICS CLOPIDOGREL 75 mg tablets contain the following inactive ingredients: Anhydrous lactose, castor oil hydrogenated, hypromellose, macrogol 6000, microcrystalline cellulose, pregelatinised starch, propylene glycol, purified talc and the colourants titanium dioxide & iron oxide red.

WHAT PHARMA DYNAMICS CLOPIDOGREL 75 MG TABLETS ARE USED FOR

PHARMA DYNAMICS CLOPIDOGREL 75 MG is used to lessen the chance of heart attack or stroke.

It is given to people who have already had a heart attack or stroke or to people with other blood circulation problems that could lead to a stroke or heart attack

BEFORE YOU TAKE PHARMA DYNAMICS CLOPIDOGREL 75 MG:

Do not take PHARMA DYNAMICS CLOPIDOGREL 75 MG:

  • If you are hypersensitive (allergic) to clopidogrel or any of the other ingredients of PHARMA DYNAMICS CLOPIDOGREL 75 mg tablets.
  • If you have bleeding problems (such as bleeding stomach ulcer).
  • If your liver function is severely impaired.
  • PHARMA DYNAMICS CLOPIDOGREL should not be given to patients younger  than 18 years

Take special care with PHARMA DYNAMICS CLOPIDOGREL 75 MG:

  • If you have a serious blood disorder called thrombotic thrombocytopenic purpura [TTP].
  • If you are going to have surgery or have dental work done.  PHARMA DYNAMICS CLOPIDOGREL 75 MG may increase the risk of serious bleeding during operation.  Therefore, treatment may have to be stopped about 7 days before the operation or dental work is done.
  • Tell all medical doctors, dentists, nurses and pharmacists you go to that you are taking PHARMA DYNAMICS CLOPIDOGREL 75 MG.

Taking PHARMA DYNAMICS CLOPIDOGREL 75 MG tablets with food or drink:
PHARMA DYNAMICS CLOPIDOGREL 75 MG tablets may be taken with food or on an empty stomach. PHARMA DYNAMICS CLOPIDOGREL tablets should be swallowed whole with water, do not chew or crush the tablets.

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.  Safety in pregnancy and breast-feeding has not been established.

Driving and using machinery:
PHARMA DYNAMICS CLOPIDOGREL 75 MG may cause headache or dizziness. You should refrain from driving or using machinery until you know how this medicine affects you.

Using other medicines with PHARMA DYNAMICS CLOPIDOGREL 75 MG tablets:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of PHARMA DYNAMICS CLOPIDOGREL 75 MG tablets with these medicines may cause undesirable interactions.  Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop.  Please consult your doctor, pharmacist or other healthcare professional for advice if you are using any of the following products:

  • Non-Steroidal Anti-Inflammatory Agents (such as aspirin, ibuprofen, indomethacin, diclofenac etc.)
  • Heparin or warfarin
  • Phenytoin (antiepileptic drug)
  • Tolbutamide (medicine for type-2 diabetes)
  • Tamoxifen (medicine used for breast cancer)
  • Fluvastatin (drug to treat high cholesterol)

HOW TO USE PHARMA DYNAMICS CLOPIDOGREL 75 MG

Always take PHARMA DYNAMICS CLOPIDOGREL 75 MG exactly as your doctor has instructed you.  You should check with your doctor if you are unsure. If you have the impression that the effect of PHARMA DYNAMICS CLOPIDOGREL 75 MG is too strong or weak, talk to your doctor or pharmacist.

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The adult dosage is a single daily dose of PHARMA DYNAMICS CLOPIDOGREL 75 mg daily, with or without food.

If you take more PHARMA DYNAMICS CLOPIDOGREL 75 mg than you should:
When an overdosage is suspected contact your doctor or pharmacist as soon as possible. If neither is available, seek help at the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what the person has taken. 

If you forget to take PHARMA DYNAMICS CLOPIDOGREL 75 mg:
If you missed a dose, take it as soon as you remember.  If it is almost time for your next dose, skip the missed dose and continue to take the tablet at the usual time.  Do not take a double or larger dose to make up for the forgotten individual doses. 

POSSIBLE SIDE-EFFECTS

Along with its needed effects PHARMA DYNAMICS CLOPIDOGREL 75 mg can cause side-effects in some patients.

Although not all of these effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side-effects occur:
The following side-effects have been reported frequently:

  • Red or purple spots on skin, varying in size from pin point to large bruises.

The following side-effects have been reported less frequently:

  • Nose bleed
  • Vomiting of blood or material that looks like coffee ground
  • Balck, tarr stools and blood in urine or stools.
  • Blistering, flaking, or peeling of skin.
  • Fever, chills, or sore throat; headache (sudden, severe).
  • Stomach pain (severe).
  • Ulcers, sores, or white spots in mouth.
  • Unusual bleeding or bruising or sudden weakness.

Check with your doctor immediately if any of the following side-effects occur:

The following side-effects have been reported frequently:

  • Chest pain
  • Runny nose or sneezing

The following side-effects have been reported less frequently:

  • Fainting
  • Frequent urination or painful or difficult urination
  • Irregular heartbeat
  • Joint pain.
  • Swelling of feet or lower legs

You may experience other side-effects that usually do not need medical attention. These side-effects may go away during treatment as your body adjust to the medicine. However, check with your doctor if any of the following side-effects continue or are bothersome:

The following side-effects have been reported frequently:

  • Diarrhoea or constipation
  • Flatulence

The following side-effects have been reported less frequently:

  • Dizziness
  • Muscle rigidness or stiffness

The following side-effects have been reported less frequently:

  • Mild abdominal or stomach pain
  • Vomiting or nausea
  • Loss of taste
  • Dizziness
  • Anxiety
  • Trouble in sleeping
  • Tiredness

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

STORING AND DISPOSING OF PHARMA DYNAMICS CLOPIDOGREL 75 MG

  • Store below 25 °C.
  • KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
  • Do not use the tablets after the expiry date printed on the label or blister.
  • Return all unused medicine to your pharmacist
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets)

PRESENTATION OF PHARMA DYNAMICS CLOPIDOGREL 75 MG

PHARMA DYNAMICS CLOPIDOGREL 75 mg tablets are packed in OPA/AL/PVC film and heat sealing aluminium blister strips.  Each strip containing seven or ten tablets.  The blister strips are packed in an outer carton.

IDENTIFICATION OF PHARMA DYNAMICS CLOPIDOGREL 75 MG

Pink, round, slightly biconvex, film-coated tablet.

REGISTRATION NUMBER

PHARMA DYNAMICS CLOPIDOGREL 75 mg:

RSA      S3           42/8.2/0128
NAM    NS2          10/7.1/0377

NAME AND ADDRESS OF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd.
F02
Grapevine House
Steenberg
Office Park
WESTLAKE
7945

11. DATE OF PUBLICATION

October 2008
Version: PD9007A

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