Clopidogrel

Main information

  • Trade name:
  • Clopidogrel Stada Film- Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Clopidogrel Stada Film- Coated Tablets
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL12055034
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer Medication Information Leaflet (RiMUP)

CLOPIDOGREL STADA

®

FILM-COATED

TABLETS

Clopidogrel (75 mg)

What is in this leaflet

What Clopidogrel Stada

is used for

How Clopidogrel Stada

works

Before you take Clopidogrel Stada

How to take Clopidogrel Stada

While you are using Clopidogrel

Stada

Side effects

Storage and disposal of Clopidogrel

STADA

75mg

Product description

Manufacturer and Product

Registration Holder

Date of revision

What Clopidogrel Stada

®

is

used for

Clopidogrel is indicated for the

prevention of blood clot formation

inside blood vessels, such as:

You suffer from heart attack (from a

few days until less than 35 days),

stroke (from 7 days until less than 6

months) or condition known as artery

narrowing disease.

You have experienced a severe type of

chest pain known as unstable angina

or heart attack. For the treatment of

this condition your doctor may have

placed a stent in the blocked or

narrowed artery to restore effective

blood flow.

How Clopidogrel Stada

®

works

Clopidogrel tablets belong to a group of

medicines called antiplatelet. Platelets

are very small structures in the blood,

smaller than red or white blood cells,

which clump together during blood

clotting. By preventing this clumping,

antiplatelet medicinal products reduce

the chances of blood clots forming.

Before you take Clopidogrel Stada

®

-When you must not take it

If you are known to have

hypersensitivity to clopidogrel or any

ingredients in the formulation.

If you have severe liver impairment.

If you have a medical condition that is

currently causing bleeding such as a

peptic ulcer or bleeding within the

brain.

If you think any of these apply to you,

or if you are in any doubt at all,

consult your doctor before taking this

medication.

-Before you start to take it

If any of the situations mentioned below

apply to you, you should tell your

doctor before taking this medication:

If you have a risk of bleeding such as

serious injury, surgery, risk of internal

bleeding (such as stomach ulcer), a

blood disorder (bleeding inside any

tissues, organs or joints of your body).

If you have severe kidney problems.

If you are pregnant.

If you are breast-feeding.

-Taking other medicines

Please tell your doctor or pharmacist if

you are taking or have recently taken

any other medicines, including

medicines obtained without a

prescription.

You should specifically tell your doctor

if you receive other medications that:

increase the risk of bleeding, including

medicines used to reduce blood

clotting(anticoagulation) and reduce

platelet clumping and clotting

(antiplatelets) such as heparin and

warfarin.

medicines used to treat painful and/or

inflammatory conditions of muscle or

joints (Nonsteroidal Anti-

inflammatory Drugs) such as aspirin;

and medicines used to treat gastritis or

stomach problems (proton pump

inhibitors).

How to take Clopidogrel Stada

®

-How much to take

Always take this medication exactly as

your doctor has told you. You should

check with your doctor or pharmacist if

you are not sure.

The usual dose is one 75- mg tablet of

Clopidogrel tablet for adults and elderly

patients.

If you have experienced severe chest

pain, your doctor may give you 300 mg

of Clopidogrel tablet once at the start of

treatment, followed by 75 mg daily

given (with aspirin 75 mg- 325 mg

daily).

-When to take it

Clopidogrel tablets should be taken

orally with or without food. You should

take your medicine regularly and at the

same time each day.

-How long to take it

You should take this medication for as

long as your doctor continues to

prescribe it.

-If you forget to take it

If you forget to take a dose of this

medication, simply take the next single

dose at the usual time. Do not take a

double dose to make up for the

forgotten individual doses.

-If you take too much (overdose)

It may increase risk of bleeding and

prolonged bleeding time.

If you have any further questions on the

use of this product, ask your doctor or

pharmacist.

While you are using Clopidogrel

Stada

®

-Things you must do

Tell your doctor if a surgery is

planned.

If bleeding or blood disorders are

suspected, your doctor may order

blood tests.

-Things you must not do

Do not stop the treatment. Contact your

doctor or pharmacist before stopping.

-Things to be careful of

Clopidogrel prolongs bleeding time.

Use with caution if you have a risk of

bleeding.

Use with caution if you have kidney or

liver disease.

Side effects

Like all medicines, Clopidogrel Stada

can cause side effects, although not

everybody gets them.

The most common side effect is

bleeding. Bleeding may occur as,

unusual bleeding or bruising under the

skin, nose bleed, bleeding in the

stomach or bowels, bruising. In a small

number of cases, serious bleeding,

Consumer Medication Information Leaflet (RiMUP)

CLOPIDOGREL STADA

®

FILM-COATED

TABLETS

Clopidogrel (75 mg)

bleeding of operative wound, bleeding

in the eye, inside the head and the lung

have been reported.

Other side effects reported are:

Common: diarrhoea, abdominal pain,

disordered digestion (dyspepsia).

Uncommon: reduction in the number of

platelet, white blood cells, headache,

abnormal skin sensations, dizziness,

ulcer in the stomach and duodenum,

inflammation of the lining of the

stomach, vomiting, nausea,

constipation, flatulence, rash, itching,

any intense sensation of itching, skin

bleeding, blood in the urine.

Rare: decrease in the number of

neutrophils in the blood including

severe neutropenia, vertigo and bleeding

behind the membrane and wall of the

abdominal cavity.

Very rare: a disorder of the blood

coagulation system, a disorder

in which the bone marrow greatly

decreases and stops production of blood

cells, a pronounced reduction in number

of red blood cells, white blood cells and

platelets in the blood, serum sickness,

generalised allergic reactions,

hallucinations, confusion, taste

disturbances, inflammation of the blood

vessels, decrease in blood pressure,

narrowing of bronchi, severe lung

disease, stomach and intestine bleeding

with fatal outcome, inflammation of the

pancreas, of the colon, of the mouth, of

the skin and of the liver, acute liver

failure, abnormal liver function test,

blisters of the skin, rapid swelling of the

skin, skin disorder, skin allergy, skin

disease, musculoskeletal bleeding,

arthritis, joint pain, muscle pain, kidney

disease and fever.

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.

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel: 03-

78835550, or visiting the website

npra.moh.gov.my (Public

Reporting

Medicinal Problems / Side Effects /

AEFI / Vaccine Safety).

Storage and disposal of Clopidogrel

Stada

®

-Storage

The expiry date of this pack is printed

on the box. Do not use this pack after

this date. Keep all medicines out of

reach of children.

Do not store above 30°C. Store in a dry

and cool place.

Do not use Clopidogrel Stada

if you

notice any visible sign of

deterioration.

-Disposal

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.

Product description

-What it looks like

Clopidogrel Stada

appears

as a pink, round-shaped, biconvex,

filmcoated tablet, engraved ”75” on one

side and plain on the other side.

-Ingredients

Active ingredient: One tablet contains

Clopidogrel bisulfate equivalent to 75

mg Clopidogrel.

Inactive ingredients: Lactose

monohydrate, microcrystalline

cellulose, maize starch, crospovidone,

povidone K30, hydrogenated castor oil,

colloidal anhydrous silica,

hypromellose, macrogol 6000, talc,

titanium dioxide, red ferric oxide.

MAL number

MAL12055034AZ

Manufacturer

The manufacturer is STADA-VN J.V.

Co., Ltd, (A Joint Venture Company of

STADA Arzneimittel AG, Germany),

40 Tu Do Avenue, Vietnam-Singapore

Industrial Park, Thuan An, Binh Duong

Province, Vietnam.

Product Registration Holder

Stadpharm Sdn. Bhd.

E-9-01, Oasis Square,

Ara Damansara,

No. 2, Jalan PJU 1A/7A,

47301 Petaling Jaya, Selangor.

Date of revision

30/10/2017

Serial Number:

BPFK(R4/1)140317/00029