INTRODUCTION

CLOFIRST 75MG TABLET contains Clopidogrel which belongs to the group of medicines called Antiplatelets. CLOFIRST 75MG TABLET is used to prevent blood clots (thrombi) due to atherothrombosis which may lead to atherothrombotic events such as stroke or heart attack and atherosclerotic events (myocardial infraction) in patients with atherosclerosis. It is also used to prevent in-stent restenosis in patients undergo percutaneous coronary Intervention (PCI).

Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Atherothrombosis is an inflammatory process of the arteries that affects the coronary (heart), cerebral (brain) and peripheral circulation (blood circulation to arms, hands, legs and feet) by aberrant thickening of the blood vessel wall and reducing the blood flow to the tissue that triggers the occurrence of myocardial infarction, stroke and peripheral arterial disease.

Along with this treatment, your doctor may advise regular blood tests to check your blood clotting time.

Avoid taking CLOFIRST 75MG TABLET, if you are allergic to Clopidogrel or have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain, severe liver disease.

Before taking CLOFIRST 75MG TABLET, inform your doctor if you are at a risk of internal bleeding, have or ever had a clot in artery of your brain (ischemic stroke) which might have occurred within the last seven days or have heart or kidney problems.

CLOFIRST 75MG TABLET is not recommended for use in pregnant and breastfeeding women. It is not recommended for use in children and adolescents (below 18 years of age). Consult your doctor before taking CLOFIRST 75MG TABLET.

The most common side effects of taking CLOFIRST 75MG TABLET are bleeding, diarrhea, abdominal pain, indigestion and heartburn. Consult your doctor if any of these above symptoms gets worse.

USES OF CLOFIRST 75MG TABLET

It is used to:

• prevent blood clots (thrombi) forming in hardened blood vessels (atherothrombosis)
• treat atherosclerotic events (myocardial infraction)
• prevent in-stent restenosis in patients undergo percutaneous coronary intervention (PCI)

HOW CLOFIRST 75MG TABLET WORKS

CLOFIRST 75MG TABLET works by preventing platelets from sticking together, thereby decreasing the formation of harmful blood clots that results in the lower chance of occurrence of heart attack or stroke.

DIRECTIONS FOR USE

Take CLOFIRST 75MG TABLET as advised by your physician. Swallow CLOFIRST 75MG TABLET with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF CLOFIRST 75MG TABLET

HOW TO MANAGE SIDE EFFECTS

Constipation:

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals and drink plenty of water. If this does not help, inform your doctor for receiving alternate treatments for constipation.

Dizziness:

Try to rest and relax and get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Limit your consumption of alcohol, as it can aggravate your dizziness. Consult and inform your doctor if the symptom does not improve.

Headache:

If CLOFIRST 75MG TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking CLOFIRST 75MG TABLET. If headaches last more than a week or severe, inform your doctor.

Nausea and Vomiting:

Try to take CLOFIRST 75MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

Indigestion:

Try to have smaller and more frequent meals and reduce consumption of tea, coffee, cola or alcohol and lose weight if you are obese. Avoid smoking and do not have rich, spicy or fatty foods. Consult and inform your doctor if the symptom does not improve.

Diarrhea:

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking CLOFIRST 75MG TABLET, inform your doctor, if you are taking any of the following medicine:

• oral anticoagulants (medicines used to reduce blood clotting) such as dabigatran, rivaroxaban, apixaban
• non-steroidal anti-inflammatory drugs (medicines used to treat painful and/or inflammatory conditions of muscle or joints) such as ibuprofen, naproxen, diclofenac
• injectable medicine used to reduce blood clotting (Ex heparin, enoxaparin)
• antiplatelet agent (medicine used to prevent formation of blood clot) Ex. ticlopidine
• medicines used to treat depression (Ex. fluoxetine, fluvoxamine, moclobemide)
• rifampicin (medicine used to treat severe infections)
• omeprazole or esomeprazole (medicines used to treat stomach upset)
• fluconazole or voriconazole (medicines to treat fungal infections)
• antiretroviral drugs (medicines used to treat HIV infections) Ex. efavirenz, atazanavir, darunavir, fosamprenavir
• carbamazepine (medicine to treat some forms of epilepsy)
• repaglinide (medicine used to treat diabetes)
• paclitaxel (medicine used to treat cancer)
• medicines used to treat severe pain (Ex. oxycodone, hydrocodone, codeine)

Overdosage:

If you or anyone else accidentally takes too much of CLOFIRST 75MG TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage may lead to increased risk of bleeding.

SYNOPSIS

MORE INFORMATION

• Keep the medicine out of reach in children
• Store CLOFIRST 75MG TABLET at room temperature

FAQs ABOUT CLOFIRST 75MG TABLET

What CLOFIRST 75MG TABLET is used for?

CLOFIRST 75MG TABLET is used in adult patients to prevent blood clots (thrombi) due to atherothrombosis (condition marked by formation of blood clot within an artery) which leads to atherothrombotic events such as stroke or heart attack.

How should CLOFIRST 75MG TABLET be taken?

Take CLOFIRST 75MG TABLET as advised by your physician. Swallow CLOFIRST 75MG TABLET with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

What are the side effects of CLOFIRST 75MG TABLET?

The most common symptoms of taking CLOFIRST 75MG TABLET are bleeding, diarrhea, abdominal pain, indigestion and heartburn. Consult your doctor if any of these symptoms gets worse.

Who should avoid taking CLOFIRST 75MG TABLET?

CLOFIRST 75MG TABLET is not recommended for use in patients allergic to Clopidogrel, have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain or severe liver disease.

Is CLOFIRST 75MG TABLET safe to use in children?

CLOFIRST 75MG TABLET is not recommended for use in children since the medicine does not work in this population. Consult your doctor before taking CLOFIRST 75MG TABLET.

REFERENCES

1. KD. Tripathi. Drugs Affecting Coagulation, Bleeding and Thrombosis. Seventh edition. 2013. Page – 630.

2. Mylan Pharmaceuticals. Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix Tablets 75 mg. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2008] [Accessed on 31st May 2022] https://clinicaltrials.gov/ct2/show/NCT00650169

3. Craig J. Beavers; Imama A. Naqvi. Clopidogrel.  NIH National Library of Medicine, National center for biotechnology information. May 2022 [Accessed on 31st May 2022] https://www.ncbi.nlm.nih.gov/books/NBK470539/

4. Peng-Xin Ge , Li-Ping Jiang , Ting Tai , Ting Zhu , Jin-Zi Ji , Yi-Fei Li , Qiong-Yu Mi , Hong-Guang Xie. Short-term standard alcohol consumption enhances platelet response to clopidogrel through inhibition of the Nrf2/Ces1 pathway and induction of Cyp2c in mice.  NIH National Library of Medicine, National center for biotechnology information. PubMed.gov. August 2021 [Accessed on 31st May 2022] https://pubmed.ncbi.nlm.nih.gov/33626394/

5. Matthew T Roe , Shaun G Goodman, E Magnus Ohman, Susanna R Stevens, Judith S Hochman, Shmuel Gottlieb, Felipe Martinez, Anthony J Dalby, William E Boden, Harvey D White, Dorairaj Prabhakaran, Kenneth J Winters, Philip E Aylward, Jean-Pierre Bassand, Darren K McGuire, Diego Ardissino, Keith A A Fox, Paul W Armstrong. Elderly patients with acute coronary syndromes managed without revascularization: insights into the safety of long-term dual antiplatelet therapy with reduced-dose prasugrel versus standard-dose clopidogrel  NIH National Library of Medicine, National center for biotechnology information. PubMed.gov. August 2013 [Accessed on 31th May 2022] https://pubmed.ncbi.nlm.nih.gov/23852610/

6. APL Swift Services (Malta) Limited. Electronic medicines compendium (EMC). [Revised in March 2021] [Accessed on 31st May 2022] https://www.medicines.org.uk/emc/files/pil.5207.pdf

7. Sanofi Winthrop Industrie. Electronic medicines compendium (EMC). [Revised in September 2021] [Accessed on 31st May 2022] https://www.medicines.org.uk/emc/files/pil.5934.pdf

USEFUL DIAGNOSTIC TESTS

• Complete blood count
• Liver function tests