Teva

Enterotablett 75 mg
(Not provided)(Oval, white, biconvex, 9.2 x 5.2 mm)

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 side effects that are not mentioned in this information. See section 4.

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

What Acetylsalicylic Actavis is and what it is used for

Acetylsalicylic acid Actavis contains acetylsalicylic acid, which in low doses belongs to a group of medicines called platelet aggregation inhibitors. Platelets ( platelets ) are small cells in the blood that cause the blood to coagulate and can cause blood clots to form. When a blood clot occurs in an artery, blood flow is stopped and the oxygen supply is turned off. When this happens in the heart, it can cause a heart attack or angina pectoris; in the brain, it can cause strokes.

Acetylsalicylic acid Actavis is taken to reduce the risk of blood clots and thus further prevent:

  • Heart attacks
  • Stroke
  • Cardiovascular problems in patients suffering from stable or unstable angina Pectoris (a type of chest pain).

Acetylsalicylic acid Actavis is also used to prevent the formation of blood clots after certain types of heart surgery performed to dilate a vessel or remove the clot.

This medicine is not recommended in case of an emergency. It can only be used for preventive purposes.

Acetylsalicylic acid contained in Acetylsalicylic acid Actavis may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Acetylsalicylic acid Actavis

Do not use Acetylsalicylic acid Actavis

  • If you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
  • If you are allergic to other salicylates or non-steroidal anti-inflammatory drugs ( NSAIDs ). NSAIDs are often used for arthritis or rheumatism and pain.
  • If you have had an asthma attack or swelling of certain parts of your body, such as your face, lips, throat, or tongue ( angioedema ) after taking salicylates or NSAIDs.
  • If you currently have or have had stomach ulcers or duodenal ulcers or any other type of bleeding, such as a stroke.
  • If you have ever had a problem with your blood not coagulating properly.
  • If you have severe liver or kidney problems.
  • If you are in the last 3 months of pregnancy, do not use doses higher than 100 mg/day (see section “Pregnancy and breast-feeding”).
  • If you are taking a medicine called methotrexate (eg for cancer or rheumatism) in a dose above 15 mg/week.

Warnings and cautions

Talk to your doctor or pharmacist before taking Acetylsalicylic Actavis if you:

  • Have problems with your kidneys, liver, or heart.
  • Have or have had problems with your stomach or intestines.
  • Has high blood pressure.
  • Have asthma, hay fever, nasal polyps, or other chronic respiratory problems; Acetylsalicylic acid can trigger an asthmatic attack.
  • Have had gout.
  • Have heavy menstrual bleeding.

You must seek immediate medical attention if your symptoms worsen or if you experience severe or unforeseen side effects, such as unusual bleeding, severe skin rash, or other signs of severe allergy (see section “Possible side effects”).

Tell your doctor if you know you are having surgery (even minor surgeries such as a tooth extraction), as acetylsalicylic acid is a blood thinner and there may be an increased risk of bleeding.

Acetylsalicylic acid can cause Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease that affects the brain and liver and can be life-threatening. Due to this, Acetylsalicylic acid Actavis should not be given to children under 16 years of age without a doctor’s prescription.

You should make sure that you do not become dehydrated (feeling thirsty and dry mouth ) as intake of acetylsalicylic acid in such cases can impair kidney function.

This medicine is not suitable as an analgesic or antipyretic.

If any of the above applies to you or you are not sure, talk to your doctor or pharmacist.

Other medicines and Acetylsalicylic acid Actavis

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

The effect of the treatment can be affected if acetylsalicylic acid is taken at the same time as other drugs such as:

  • Blood thinners/anticoagulants (eg warfarin, heparin, clopidogrel)
  • Immunosuppressive drugs after transplantation (cyclosporine, tacrolimus)
  • Antihypertensive drugs (eg diuretics and ACE inhibitors )
  • Heart rate medication ( digoxin )
  • Drugs for manic depression (lithium)
  • Painkillers and anti-inflammatory drugs (eg NSAIDs such as ibuprofen or steroids )
  • 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 acetylsalicylic acid for cardiac protection.
  • Medicines for gout (eg probenecid)
  • Antiepileptic drugs ( valproate, phenytoin )
  • Drugs for glaucoma (acetazolamide)
  • Medicines for cancer or rheumatism (methotrexate in doses less than 15 mg/week)
  • Medicines for diabetes (eg glibenclamide)
  • Antidepressants (selective serotonin reuptake inhibitors ( SSRIs ) such as sertraline or paroxetine )
  • Hormone replacement when the adrenal glands or pituitary gland have been destroyed or removed, or for the treatment of inflammation, including rheumatic diseases and intestinal inflammations ( corticosteroids ).

Acetylsalicylic acid with an alcohol

Consumption of alcohol may increase the risk of gastrointestinal bleeding and increase the bleeding time.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless directed to do so by their doctor. You should not take Acetylsalicylic acid Actavis if you are in the last three months of pregnancy unless your doctor tells you to and then the daily dose should not exceed 100 mg (see section “Do not take Acetylsalicylic acid Actavis”). Normal or high doses of this medicine during the late part of pregnancy can cause serious complications in the mother or baby.

Breast-feeding women should not take acetylsalicylic acid unless instructed to do so by their doctor.

Driving and using machines

Acetylsalicylic acid Actavis does not affect your ability to drive or use machines.

Acetylsalicylic acid contains sodium

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

How to use Acetylsalicylic acid Actavis

Always take Acetylsalicylic acid Actavis exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults

Prevention of myocardial infarction:

The recommended dose is 75-160 mg once daily.

Stroke prevention:

The recommended dose is 75-325 mg once daily.

Prevention of cardiovascular problems in patients with stable or unstable angina Pectoris (a type of chest pain):

The recommended dose is 75-160 mg once daily.

Prevention of blood clots after certain types of heart surgery:

The recommended dose is 75-160 mg once daily.

Older

As for adults. In general, acetylsalicylic acid should be used with caution in elderly patients who may experience more side effects. The treatment should be reviewed regularly.

Use for children and adolescents

Acetylsalicylic acid should not be given to children or adolescents under 16 years of age unless prescribed by a doctor (see section Warnings and precautions).

Administration

The tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water). The tablets have a stomach acid-resistant coating that counteracts irritation of the gastric mucosa and the tablets should therefore not be crushed, divided, or chewed.

Show any remaining tablets or the empty container to your doctor.

Symptoms of an overdose may include tinnitus, hearing loss, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A larger overdose can lead to faster breathing is normal ( hyperventilation ), fever, sweating, restlessness, seizures, hallucinations, low blood sugar, coma, and shock.

If you forget to use Acetylsalicylic acid Actavis

If you miss a dose, wait until it is time for your next dose and then continue as usual.

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Acetylsalicylic acid Actavis can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Acetylsalicylic Actavis and contact your doctor immediately.

  • Sudden wheezing, swelling of the lips, face, or body, rash, fainting, or difficulty swallowing (severe allergic reaction ).
  • Redness of the skin with blisters or flaking may be linked to fever and joint pain. This can be erythema multiforme, Stevens-Johnson syndrome, or Lyell’s syndrome.
  • Abnormal bleeding, such as coughing up blood, blood in vomit or urine, or black stools.

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

  • Digestive problems
  • Increased tendency to bleed.

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

  • Hives
  • Runny nose
  • Breathing difficulties.

Rare side effects (may affect up to 1 in 1000 people)

  • Severe bleeding in the stomach or intestines, brain hemorrhage, change in the number of blood s
  • Nausea and vomiting
  • Lower respiratory tract cramps, asthma attacks
  • Inflammation of the blood vessels
  • Bruises with purple tone (superficial bleeding)
  • Severe rashes such as erythema multiforme and its life-threatening forms Stevens-Johnson syndrome and Lyell’s syndrome
  • Hypersensitivity reactions, such as swelling of, for example, lips, face or body, or shock
  • Abnormally heavy or long menstrual periods.

Adverse reactions with unknown frequency (cannot be calculated from the available data)

  • Tinnitus ( tinnitus ) or hearing
  • Headache
  • Dizziness
  • Ulcers in the stomach or intestines and perforation
  • Prolonged bleeding time
  • Impaired renal function
  • Hepatic impairment
  • High levels of uric acid in the blood.

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 Acetylsalicylic acid Actavis

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

Do not store above 25 ° C.

Blister: Store in the original package. Moisture sensitive.

Jar: Keep the jar tightly closed. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton after EXP ../ EXP. The expiration date is the last day of the specified month.

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

  • The active substance is acetylsalicylic acid. Each enteric- containing tablet contains 75, 100, 150, or 160 mg of acetylsalicylic acid.
  • The other ingredients are tablet core: microcrystalline cellulose, corn starch, colloidal anhydrous silica, stearic acid; film coating: methacrylic acid – ethyl acrylate copolymer (1: 1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

What the medicine looks like and the contents of the pack

Acetylsalicylic acid Actavis enteric tablet is 75 mg: oval, white, biconvex film-coated tablet, 9.2 x 5.2 mm.

Acetylsalicylic acid Actavis enteric tablet is 100 mg: a round, white, biconvex film-coated tablet with a diameter of 7.2 mm.

Acetylsalicylic acid Actavis enteric tablet is 150 mg: oval, white, biconvex film-coated tablet, 11.7 x 6.7 mm.

Acetylsalicylic acid Actavis entero-tablet is 160 mg: a round, white, biconvex film-coated tablet with a diameter of 8.7 mm.

Pack sizes

Blisters: 10, 20, 28, 30, 50, 56, 60, 90, 100 enteric tablets .

Jar: 10, 30, 50, 100, 500 enteric tablets are.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Muhammad Nadeem

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