Orifarm Generics AB

Tablet 75 mg
Deregistration date: 2021-01-31(White or almost white, round, biconvex tablets, unmarked on both sides. The diameter of the tablet is 7 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, pharmacist, or nurse.

– 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Acetylsalicylic Acid Orifarm is and what it is used for

Acetylsalicylic acid Orifarm is a so-called blood thinner, which reduces the risk of blood clots by preventing platelets from clotting.

Acetylsalicylic acid Orifarm is used by patients who have severe angina pectoris ( unstable angina pectoris) or who have previously suffered a heart attack or stroke. Acetylsalicylic acid Orifarm helps reduce the risk of recurrence in a new infarction, by preventing clots from forming in the blood vessels of the heart and brain.

Acetylsalicylic acid contained in Acetylsalicylic acid Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. 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 Orifarm

Do not use Acetylsalicylic acid Orifarm

  • if you are allergic to acetylsalicylic acid, other medicines with analgesic and anti-inflammatory effect (so-called non-steroidal anti-inflammatory drugs), or any of the other ingredients of this medicine (listed in section 6)
  • if you have asthma
  • if you suffer from stomach ulcers
  • if you have hemophilia
  • if you are deficient in the platelets that help clot the blood
  • if you have cirrhosis of the liver
  • if you have severe heart failure.

The daily dose of Acetylsalicylic acid Orifarm must not exceed 100 mg during the last three months of pregnancy (see section Pregnancy, lactation, and fertility ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Acetylsalicylic acid Orifarm:

  • if you are being treated with medicines that prevent the formation of blood clots or are diuretic
  • if you have gastrointestinal disease
  • if you have heart failure
  • if you have kidney or liver disease. Medicines containing acetylsalicylic acid should not be given to people under 18 years of age without a fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition. People with bronchial asthma, chronic lung disease, hay fever or nasal polyps have an increased risk of hypersensitivity reactions.

Other medicines and Acetylsalicylic acid Orifarm

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

The effect of the treatment can be affected if Acetylsalicylic acid Orifarm is taken at the same time as certain other medicines for:

  • blood clots (eg warfarin )
  • organ rejection after transplantation (cyclosporine, tacrolimus)
  • high blood pressure (eg diuretics and ACE inhibitors )
  • pain and inflammation (eg corticosteroids and NSAIDs )
  • gout (probenecid)
  • cancer and rheumatoid arthritis (methotrexate)
  • arrhythmias in the heart ( digoxin )
  • manic depressive illness (lithium)
  • epilepsy ( phenytoin and valproic acid )
  • type II diabetes (sulphonylureas)
  • high blood fats ( nicotinic acid ).

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.

Acetylsalicylic acid Orifarm with food, drink, and alcohol

Acetylsalicylic acid Orifarm in combination with alcohol may increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

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 a doctor. The daily dose should not exceed 100 mg during the last three months of pregnancy (see section Do not take Acetylsalicylic acid Orifarm). Regular or high doses of this drug during late pregnancy can cause serious complications for both mother and baby.

Acetylsalicylic acid passes into breast milk, but is unlikely to affect breastfed infants. However, talk to your doctor if you use Acetylsalicylic acid Orifarm more than occasionally during breast-feeding.

Acetylsalicylic acid Orifarm, like many anti-inflammatory drugs (so-called NSAIDs ), can make it difficult to conceive and is therefore not recommended for women trying to conceive.

Driving and using machines

Acetylsalicylic acid Orifarm has no known effects on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Howo use Acetylsalicylic acid Orifarm

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

Dose one should be determined by a doctor who adjusts it individually for you.

The recommended dose is 1 75 mg tablet a day.

If you forget to use Acetylsalicylic acid Orifarm

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

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

4. Possible side effects

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

Serious side effects are 
the following side effects are very serious and may require immediate treatment. If any of the following side effects occur, stop taking Acetylsalicylic acid Orifarm and 
contact your doctor immediately if the following serious side effects occur:

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

Severe gastrointestinal bleeding, cerebral hemorrhage.

Less common side effects are  (may affect up to 1 in 100):

Hypersensitivity reactions, usually in the form of hives, hives, hay fever, or asthma. The risk of hypersensitivity reaction increases in patients with allergies or asthma.

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

Severe skin reactions.

Other side effects may occur:

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

Kidney impact.

Minor blood loss can in some cases lead to anemia.

Dizziness and tinnitus can be symptoms of overdose.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Acetylsalicylic acid Orifarm

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

Store in the original package. Sensitive to light. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton. 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 75 mg and 160 mg respectively.
  • The other ingredients are magnesium oxide, corn starch; gelatine; cellulose, microcrystalline; silica, colloidal, anhydrous.

What the medicine looks like and the contents of the pack

Appearance

75 mg tablets: White or almost white, round, biconvex tablets, unlabeled on both sides. The diameter of the tablet is 7 mm.

160 mg tablets: White or almost white, round, biconvex tablets, with a scoreline on one side. The diameter of the tablet is 8.5 mm. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Pack sizes

Plastic jar with PP safety screw cap containing desiccant in the lid. The desiccant consists of a capsule containing silica gel.

75 mg: 50, 98, 100, 1000 tablets.

160 mg: Plastic jar: 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB

BOX 56048

10217 Stockholm

info@orifarm.com

Manufacturer

Extractum Pharma Co. Ltd., 6413 Kunfehértó. IV. Körzet 6, Hungary

Muhammad Nadeem

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