Kaidaxer 75 mg. 30 tablets

1. What Kaidaxer is and what it is used for

Kaidaxer contains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood components that clump together during the formation of blood clots. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots forming (a process called thrombosis).

Kaidaxer is taken by adult patients to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries) in a process known as atherothrombosis, which leads to atherothrombotic events (such as stroke, heart attack, or death).

Kaidaxer has been prescribed to you to prevent blood clots and reduce the risk of these serious events because:

you have a condition involving hardening of the arteries (also known as atherosclerosis);

you have previously had a heart attack or stroke, or have a condition known as peripheral arterial disease;

you have experienced severe chest pain, a condition known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. Your doctor may also prescribe acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting).

you have experienced symptoms of a stroke that resolved within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also prescribe acetylsalicylic acid, to be started within the first 24 hours.

you have an irregular heartbeat—a condition called "atrial fibrillation"—and cannot take medicines known as "oral anticoagulants" (vitamin K antagonists), which prevent the formation and growth of blood clots. You should be aware that oral anticoagulants are more effective than acetylsalicylic acid or the combination of Kaidaxer and acetylsalicylic acid.

Your doctor should prescribe Kaidaxer plus acetylsalicylic acid if you cannot take "oral anticoagulants" and are not at risk of major bleeding.

2. What you need to know before you take Kaidaxer

Do not take Kaidaxer:

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); if you suffer from a condition that is currently causing bleeding, such as a stomach ulcer or bleeding in the brain;

if you suffer from severe liver disease.

If you think any of the above apply to you, or if you have any doubts, consult your doctor before taking Kaidaxer.

Warnings and precautions

Talk to your doctor or pharmacist before taking Kaidaxer.

If any of the conditions listed below apply to you, you must inform your doctor immediately before starting to take Kaidaxer:

if you are at risk of bleeding, such as:

a condition that puts you at risk of internal bleeding (such as a stomach ulcer); a blood disorder that predisposes you to internal bleeding (bleeding into your body's tissues, organs, or joints);

recent severe injury;

recent surgery (including dental surgery);

upcoming surgery (including dental surgery) within the next seven days.

if you have had a blood clot in a brain artery (ischemic stroke) within the last 7 days;

if you have kidney or liver disease;

if you have had an allergy or reaction to any of the medicines used to treat your condition;

if you have previously experienced non-traumatic bleeding in the brain.

While taking Kaidaxer:

You must inform your doctor if you are planning surgery (including dental surgery). You must also immediately inform your doctor if you develop a condition (also known as thrombotic thrombocytopenic purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoints, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is due to the way the medicine works to prevent blood clots. For minor cuts and injuries, such as a shaving cut, this is usually of no concern. However, if the bleeding worries you, you should contact your doctor immediately (see section 4 "Possible side effects").

Your doctor may order blood tests.

Children and adolescents

Do not give this medicine to children because it is ineffective.

Other medicines

and Kaidaxer

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Some other medicines may affect the use of Kaidaxer, or vice versa.

You must tell your doctor if you are taking medicines that may increase the risk of bleeding, such as:

oral anticoagulants, medicines used to reduce blood clotting;

non-steroidal anti-inflammatory drugs (NSAIDs), commonly used to treat painful and/or inflammatory conditions of the muscles or joints;

heparin or other injectable medicines used to reduce blood clotting;

ticlopidine or other antiplatelet medicines;

selective serotonin reuptake inhibitors (including, but not limited to, fluoxetine or fluvoxamine), medicines commonly used to treat depression;

rifampicin (used to treat severe infections);

omeprazole or esomeprazole, medicines used to treat stomach disorders;

fluconazole or voriconazole, medicines used to treat fungal infections;

efavirenz or other antiretroviral medicines (used to treat HIV infection);

carbamazepine, a medicine used to treat certain forms of epilepsy;

moclobemide, a medicine used to treat depression;

repaglinide, a medicine used to treat diabetes;

paclitaxel, a medicine used to treat cancer; opioids: while being treated with clopidogrel, you should inform your doctor before being prescribed an opioid (used to treat severe pain);

rosuvastatin (used to lower cholesterol levels).

If you have experienced severe chest pain (unstable angina or heart attack), a transient ischemic attack, or a mild ischemic stroke, you may be prescribed Kaydaxer in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and lower fever. Occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24-hour period) should not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Kaydaxer with food and drink

Kaydaxer can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you might be pregnant, you should tell your doctor or pharmacist before taking Kaydaxer. If you become pregnant while taking Kaydaxer, consult your doctor immediately, as the use of clopidogrel during pregnancy is not recommended.

You should not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Kaidaxer is unlikely to affect your ability to drive or use machines.

Kaidaxer contains lactose

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

Kaidaxer contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Kaidaxer

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure about anything, ask your doctor or pharmacist.

The recommended dose, including for patients with a condition called "atrial fibrillation" (irregular heartbeat), is one 75 mg Kaidaxer tablet daily, taken by mouth with or without food and at the same time each day.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may give you 300 mg or 600 mg of Kaidaxer (4 or 8 tablets of 75 mg) as a single dose at the start of treatment. Thereafter, the recommended dose is one 75 mg Kaidaxer tablet daily, as described above. If you have experienced symptoms of a stroke that resolved within a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe a 300 mg dose of Kaidaxer (four 75 mg tablets) at the start of treatment. Subsequently, the recommended dose is one 75 mg Kaidaxer tablet daily, as described above, taken in combination with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either Kaidaxer alone or acetylsalicylic acid alone.

You should continue taking Kaidaxer for as long as your doctor prescribes it.

If you have taken more Kaidaxer than you should

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

If you miss a dose of Kaidaxer

If you miss a dose of Kaidaxer but remember within...

...within 12 hours of your usual time, take the tablet immediately and then take the next one at the usual time.

If you have missed a dose by 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 missed tablet.

For packs of 7, 14, 28, 84, and 112 tablets, you can check the day you last took a Kaidaxer tablet using the calendar printed on the blister pack.

If you stop taking Kaidaxer

Do not stop treatment unless advised to do so by your doctor. Contact your doctor or pharmacist before stopping.

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

4. Possible side effects

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

Inform your doctor immediately if you experience:

high fever, signs of infection, or extreme fatigue. This may be due to a drop in the levels of certain blood cells, which is rare;

signs of liver problems, such as yellowing of the skin and/or eyes (jaundice);

symptoms—whether or not accompanied by subcutaneous bleeding appearing as small red dots and/or confusion (see section 2 "Warnings and precautions");

swelling of the mouth or skin reactions such as rashes, itching, or blistering. These may be symptoms of an allergic reaction.

The most commonly reported side effect with Kaidaxer is bleeding.

Bleeding may manifest as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In a small number of cases, bleeding in the eyes, head, lungs, or joints has also been reported.

If you experience prolonged bleeding while taking Kaidaxer

If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works to prevent blood clots from forming. For minor cuts and injuries, such as a cut while shaving, this is usually of no concern. However, if the bleeding worries you, you should 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):

Diarrhoea, abdominal pain, indigestion, or heartburn.

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

Headache, stomach ulcer, nausea, vomiting, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, and a sensation of numbness or tingling. Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

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

Jaundice; severe abdominal pain with or without back pain; high fever, breathing difficulties sometimes accompanied by a cough; general allergic reactions (e.g., a general sensation of warmth accompanied by sudden malaise and fainting); swelling of the mouth; blistering of the skin; allergic skin reactions; inflammation of the mouth (stomatitis); drop in blood pressure; confusion; hallucinations; joint pain; muscle pain; altered sense of taste or loss of taste.

Side effects with unknown frequency (cannot be estimated from the available data):

Hypersensitivity reactions with chest or abdominal pain, symptoms of persistent low blood sugar.

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

5. How to store Kaidaxer

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Kaidaxer contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

Excipients:

Tablet core: mannitol, microcrystalline cellulose (PH 112), macrogol, colloidal hydrated silica, low-substituted hydroxypropyl cellulose, hydrogenated castor oil.

Tablet coating: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, red iron oxide, black iron oxide.

See section 2 "Kaidaxer contains hydrogenated castor oil" and "Kaidaxer contains lactose". What Kaidaxer looks like and contents of the pack

Kaidaxer 75 mg film-coated tablets are pink, round, film-coated tablets with the debossed marking "MC 5" on one side and smooth on the other side.

Kaidaxer 75 mg film-coated tablets are available in cartons containing:

7, 14, 28, 30, 56, 60, 84, 90, 100, 112, and 120 film-coated tablets in blisters (with or without a calendar blister);

50x1 film-coated tablets in unit-dose blisters.

Not all pack sizes may be marketed.