75 mg / 75 mg, 75 mg / 100 mg film-coated tablets 
clopidogrel / acetylsalicylic acid

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Clopidogrel / Acetylsalicylic acid Mylan is and what it is used for 
2. What you need to know before you take Clopidogrel / Acetylsalicylic acid Mylan 
3. How to take Clopidogrel / Acetylsalicylic acid Mylan 
4. Possible side effects 
5. How to store Clopidogrel / Acetylsalicylic acid Mylan 
6. Contents of the packaging and other information 

What Clopidogrel / Acetylsalicylic acid Mylan is and what it is used for

Clopidogrel / Acetylsalicylic acid Mylan contains clopidogrel and acetylsalicylic acid(ASA) and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood that form clots ( clots ) during coagulation of the blood (blood clotting). By preventing this clot formation in certain types of blood vessels (called arteries ), antiplatelet drugs reduce the risk of blood clots forming (a process called thrombosis ).

Clopidogrel / Acetylsalicylic acid Mylan used by adults to prevent blood clots in atherosclerotic artery s that can lead to atherothrombotic events (such as stroke ( stroke ), heart attack, or death).

You have been given Clopidogrel / Acetylsalicylic acid Mylan instead of two separate medicines, clopidogrel, and ASA, to prevent the formation of blood clots because you have had severe angina ( unstable angina ) or heart attack (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed blood vessel to restore effective blood flow.

What you need to know before you take Clopidogrel / Acetylsalicylic acid Mylan

Do not take Clopidogrel / Acetylsalicylic acid Mylan

  • if you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to other medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ), which are commonly used to treat painful and / or inflammatory conditions in muscle or joints
  • if you suffer from any disease that includes a combination of asthma , runny nose and polyps (a type of growth in the nose)
  • if you suffer from any disease that causes you to have an active bleeding, such as. gastric ulcer or bleeding in the brain
  • if you suffer from severe liver disease
  • if you suffer from severe kidney disease
  • if you are in the last trimester of pregnancy

Warnings and cautions

If any of the following apply to you, tell your doctor before taking Clopidogrel / Acetylsalicylic acid Mylan:

  • if you are at risk of bleeding such as:
    • a disease that puts you at risk for internal bleeding (such as stomach ulcers ).
    • a blood disease that puts you at risk of internal bleeding (in the body’s tissues , organs or joints).
    • a recent serious injury.
    • a recent surgery (including dental surgery).
    • a planned operation (including dental operations) within the next week.
  • if you have had a blockage in an artery in your brain (ischemic stroke ) that occurred within the last week.
  • if you suffer from kidney or liver disease.
  • if you have previously had asthma or allergic reactions including allergies to other medicines to treat your illness.
  • if you suffer from gout .
  • if you drink alcohol, due to the increased risk of bleeding or damage to the gastrointestinal tract.
  • if you have a condition called glucose ‑6 ‑ phosphate dehydrogenase deficiency (G6PD), as there is a risk of a specific form of anemia (low red blood cell count ).

While taking Clopidogrel / Acetylsalicylic acid Mylan

  • You should inform your doctor
    • if an operation (including dental surgery) is planned.
    • if you have stomach or abdominal pain or bleeding in the stomach or intestines (red or black stools)
  • You should also inform your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura or TTP which includes fever and bruising under the skin that may occur as red pin-sized dots, with or without unexplained severe weakness, confusion, yellowing of the skin or eyes (jaundice ) (see section 4).
  • If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries such as. if you cut yourself when shaving. However, if you are concerned about your bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
  • Your doctor may order blood tests.

Children and young people

Clopidogrel / Acetylsalicylic acid Mylan is not intended for use in children or adolescents under 18 years of age. There is a likely link between acetylsalicylic acid(ASA) and Reye’s syndrome when medicines containing ASA are given to children and adolescents with a viral infection. Reye’s syndrome is a very rare disease that can be fatal.

Other medicines and Clopidogrel / Acetylsalicylic acid Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some other medicines may affect the use of Clopidogrel / Acetylsalicylic acid Mylan or vice versa.

It is especially important that you tell your doctor if you are taking

  • medicines that may increase your bleeding risk such as:
    • blood-thinning medicines taken by mouth, medicines to reduce the formation of blood clots,
    • ASA or non-steroidal anti-inflammatory drugs, commonly used in the treatment of painful and / or inflammatory conditions in muscles and joints,
    • heparin or other medicines injected to reduce the formation of blood clots,
    • ticlopidine, another antiplatelet agent,
    • selective serotonin reuptake inhibitors (including but not limited to fluoxetineor fluvoxamine), medicines commonly used to treat depression,
    • rifampicin (used to treat severe infections ).
  • omeprazole or esomeprazole, medicines used to treat stomach problems,
  • methotrexate, a medicine used to treat severe joint diseases ( rheumatoid arthritis ) or skin diseases ( psoriasis ),
  • acetazolamide, a medicine used to treat glaucoma (increased pressure in the eye), epilepsy or to increase urine flow,
  • probenecid, benzbromarone or sulfinpyrazone, medicines used to treat gout ,
  • fluconazole or voriconazole, medicines used to treat fungal infections,
  • antiretroviral drugs (drugs used to treat HIV – infection s),
  • valproic acid , valproate or carbamazepine, medicines used to treat various forms of epilepsy ,
  • varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of using Clopidogrel / Acetylsalicylic acid Mylan, or if you have chickenpox or shingles (see section 2. ‘Children and adolescents’).
  • moclobemide, medicines used to treat depression,
  • repaglinide, medicines used to treat diabetes ,
  • paclitaxel, medicines used to treat cancer,
  • nikorandil, a medicine used to treat heart-related chest pain,
  • opioids: while you are being treated with clopidogrel, tell your doctor before prescribing any opioid treatments.

You should stop other clopidogrel treatment while taking Clopidogrel / Acetylsalicylic acid Mylan.

Temporary use of ASA (not more than 1000 mg for 24 hours) is not generally considered a problem, but long-term use of ASA in other conditions should be discussed with a physician or pharmacist.

Metamizole (a substance that reduces pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation ( blood cells that attach together and form a blood clot) when taken at the same time. Therefore, this combination should be used with caution in patients taking a low dose of acetylsalic for cardiac protection.

Pregnancy and breastfeeding

Do not take Clopidogrel / Acetylsalicylic acid Mylan during the third trimester of pregnancy.

This medicine should preferably not be taken during the first and second trimesters of pregnancy.

If you are pregnant or think you may be pregnant, tell your doctor or pharmacist before taking Clopidogrel / Acetylsalicylic acid Mylan. If you become pregnant while taking Clopidogrel / Acetylsalicylic acid Mylan, you should contact your doctor immediately as it is not recommended to take Clopidogrel / Acetylsalicylic acid Mylan during pregnancy.

You should not breast-feed while taking this medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Clopidogrel / Acetylsalicylic acid Mylan should not affect your ability to drive or use machines.

Clopidogrel / Acetylsalicylic acid Mylan contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Clopidogrel / Acetylsalicylic acid Mylan contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

Clopidogrel / Acetylsalicylic acid Mylan 75 mg / 100 mg file-coated tablets also contain Allura Red AC

Allura red AC can cause allergic reactions

How to take Clopidogrel / Acetylsalicylic acid Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one Clopidogrel / Acetylsalicylic acid Mylan tablet per day, which should be swallowed with a glass of water, with or without food.

You should take your medicine at the same time each day.

Your doctor will decide how long you need to take Clopidogrel / Acetylsalicylic acid Mylan depending on your condition. If you have had a heart attack, the medicine should be prescribed for at least four weeks. In any case, you should take the medicine for as long as your doctor prescribes it.

If you take more Clopidogrel / Acetylsalicylic acid Mylan than you should

Contact your doctor or the nearest hospital emergency department due to the increased risk of bleeding.

If you forget to take Clopidogrel / Acetylsalicylic acid Mylan

If you forget to take a dose of Clopidogrel / Acetylsalicylic acid Mylan and discover it within 12 hours, take the tablet as soon as you notice and take the next tablet at the usual time.

If it takes more than 12 hours before you discover it, simply take the next daily doseat the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel / Acetylsalicylic acid Mylan

Do not stop treatment unless your doctor tells you to. Contact a doctor before stopping treatment or starting treatment again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Contact your doctor immediately if you have

  • fever, signs of infection or severe weakness. This may be due to a rare decrease in certain blood cells.
  • signs of liver problems such as yellowing of the skin and / or eyes (jaundice), with or without concomitant small punctate hemorrhages under the skin (visible as red dots) and / or confusion (see section 2 “Warnings and precautions”).
  • swelling of the mouth or skin problems such as rash and itching , blisters on the skin. This may be a sign of an allergic reaction .

The most common side effect reported with Clopidogrel / Acetylsalicylic acid Mylan is bleeding. Bleeding can occur as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In a few cases, bleeding in the eye, internal bleeding in the head (especially in the elderly), lungs or joints have also been reported.

If you experience prolonged bleeding while taking Clopidogrel / Acetylsalicylic acid Mylan

If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries such as. if you cut yourself when shaving. However, if you are concerned about your bleeding, contact your doctor immediately (see section 2 “Warnings and precautions”).

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion or heartburn.

Uncommon side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer , vomiting, nausea, constipation, increased gas in the stomach or intestines, rash, itching , dizziness, feeling of tingling and numbness.

Rare side effects (may affect up to 1 in 1,000 patients):

Dizziness, enlarged breasts in men.

Very rare side effects (may affect up to 1 in 10,000 patients):

Jaundice (yellowing of the skin and / or eyes), burning sensation in the stomach and / or esophagus, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes with cough, generalized (widespread) allergic reactions (eg a feeling of heat with sudden discomfort until fainting), swelling in the mouth, blisters on the skin, skin allergy, mouth pain ( stomatitis ), decrease in blood pressure , confusion, hallucinations, joint pain, muscle aches, taste changes, loss of taste, inflammation in small blood vessels.

Adverse reactions that have been reported (occurring in an unknown number of users:

Bleeding ulcer , ringing in the ears, hearing loss, sudden life threatening allergic or hypersensitivity s with chest pain or abdominal pain, kidney disease, low blood sugar, gout (a condition of painful, swollen joints caused by uric acid crystals) and deterioration of food allergies, a special kind of anemia (low red blood cell count ) (see section 2. Warnings and precautions), swelling.

In addition, your doctor may detect changes in your blood or urine tests.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Clopidogrel / Acetylsalicylic acid Mylan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and jar

after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

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.

6. Contents of the packaging and other information

Content declaration

Clopidogrel / Acetylsalicylic acid Mylan 75 mg / 75 mg film-coated tablets

The active substances are clopidogrel and acetylsalicylic acid . Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid .

Other ingredients are:

  • Tablet core : microcrystalline cellulose, lactose (see section 2 “Clopidogrel / Acetylsalicylic acid Mylan contains lactose”), croscarmellose sodium, hydroxypropylcellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, pregelatinised starch (E17 stearic acid)
  • Film coating hypromellose , triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocapryl caprate (E422), sodium lauryl sulfate, iron oxide yellow (E172).

Clopidogrel / Acetylsalicylic acid Mylan 75 mg / 100 mg film-coated tablets

The active substances are clopidogrel and acetylsalicylic acid . Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid .

Other ingredients are:

  • Tablet core : microcrystalline cellulose, lactose (see section 2 “Clopidogrel / Acetylsalicylic acid Mylan contains lactose”), croscarmellose sodium, hydroxypropylcellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, pregelatinised starch (E17 stearic acid)
  • Film coating hypromellose , triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocapryl caprate (E422), sodium lauryl sulphate, Allura red AC (E129), (see section 2 Clopidogrel / Acetylsalicylic acid Mylan)

What the medicine looks like and contents of the pack

Clopidogrel / Acetylsalicylic acid Mylan 75 mg / 75 mg film-coated tablets are yellow, oval, biconvex labeled with CA2 on one side of the tablet and M on the other.

Clopidogrel / Acetylsalicylic acid Mylan 75 mg / 100 mg film-coated tablets are pink, oval, biconvex labeled with CA3 on one side of the tablet and M on the other.

The tablets are supplied in blister packs containing 28 or 30 tablets or perforated unit dose blisters containing 28 or 30 tablets or plastic cans of 100 tablets. The jars contain a desiccant. The desiccant should not be eaten.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

MylanS.AS 117 Allée Des Parcs, 69 800 Saint Priest, France

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft, H ‑ 2900 Komárom, Mylan utca 1,, Hungary.

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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