250 mg tablet of 
acetylsalicylic acid

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

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • 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.
  • You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

This leaflet contains information about: 
1. What Albyl mines are and what they are used for 
2. What you need to know before using Albyl mines 
3. How to take Albyl mines 
4. Possible side effects 
5. How to store Albyl mines 
6. Contents of the packaging and other information 

1. What Albyl mines are and what they are used for

Albyl minor has both analgesic and antipyretic effects.

Albyl minor relieves pain by counteracting the formation of special substances, prostaglandins, which increase the sensitivity of the pain nerves. The antipyretic effect is due to the fact that acetylsalicylic acid increases the body’s heat release.

In case of temporary mild to moderate pain conditions, e.g. headache, toothache, muscle and joint pain, menstrual pain, and fever in colds.

Temporary pain in children. Fever in children and adolescents under 18 years of age only after contact with a doctor.

2. What you need to know before using Albyl mines

Do not use Albyl mines

  • if you are hypersensitive to acetylsalicylic acid or other salicylates or any of the other ingredients of this medicine (listed in section 6).
  • if you have hemophilia.
  • if you have a platelet deficiency ( thrombocytopenia ).
  • if you have had a hypersensitivity reaction such as asthma, difficulty breathing, hay fever, or hives when taking acetylsalicylic acid or certain other anti-inflammatory drugs.
  • if you have severe hepatic impairment.
  • if you have severe heart failure.
  • if you have severe kidney disease.
  • if you are pregnant during the last three months of pregnancy (see section ‘Pregnancy, breast-feeding and fertility’).
  • if you have or have had stomach ulcers.
  • if you have previously had stomach ulcers during treatment with Albyl minor or similar preparations, especially NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic drugs).

Warnings and cautions

Higher doses than those recommended can lead to serious risks. Do not use different types of painkillers at the same time without a doctor’s prescription.

Talk to your doctor or pharmacist before using Albyl minor:

  • if you are being treated with medicines that inhibit blood clotting.
  • if you have kidney disease or liver disease.
  • if you have or have had stomach ulcers.
  • if you are hypersensitive to acetylsalicylic acid, ibuprofen, or other anti-inflammatory drugs.
  • if you have asthma.
  • if you have any gastrointestinal disease (eg ulcerative colitis or Crohn’s disease) as your condition may worsen.
  • if you have high blood pressure and/or heart failure.
  • if you are going to have surgery, even for minor procedures such as tooth extraction, as Albyl mines reduce the body’s ability to stop bleeding.
  • if you regularly take several different painkillers as there is a risk of developing permanent kidney damage.
  • if you have a severe lack of glucose -6-phosphate dehydrogenase (a hereditary disease), as Albyl mines can reduce the number of red blood cells.
  • if you have an increased risk of having gout attacks.
  • if you have menstrual bleeding or heavy menstrual bleeding, use Albyl Mines with caution.

If you get any problems with your gastrointestinal tract, stop taking this medicine, and contact your doctor.

With long-term use of Albyl minor, there is a risk that you may develop a headache or that the headache will get worse. If you think your headache is due to this, you should not increase your dose of Albyl minor but consult your doctor.

Children and young people

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 condition.

Albyl mines should not be given to children under 3 years of age.

Other drugs and Albyl mines

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

The treatment effect can be affected if Albyl minor is taken at the same time as other medicines. The treating physician should therefore be aware of such concomitant treatment. This applies:

  • certain medicines that counteract blood clotting (eg warfarin ).
  • analgesics and anti-inflammatory drugs (eg corticosteroids, NSAIDs such as ibuprofen or other salicylates, and COX-2 inhibitors).
  • certain medicines used to treat cancer or rheumatism (methotrexate, pemetrexed (for cancer only)).
  • some medicines for high blood pressure ( glaucoma ) (eg acetazolamide).
  • certain medicines for epilepsy (eg valproic acid, phenytoin ).
  • certain ACE inhibitors and angiotensin II antagonists (medicines for high blood pressure and heart failure ).
  • antidepressants (selective serotonin reuptake inhibitors ( SSRIs )).
  • antacids for digestive problems. Albyl mines and these medicines should be taken at least 2 hours apart.
  • medicines for gout (eg benzbromarone, probenecid).
  • medicament which is a diuretic ( diuretics ).
  • type II diabetes (sulphonylureas, glibenclamide).
  • high blood fats ( nicotinic acid ).

Some other medicines may also affect or be affected by treatment with Albyl minor.

Pregnancy, breastfeeding, and fertility

Pregnant women should not use Albyl mines during the last three months of pregnancy. Intake of Albyl mines should be avoided by women who are planning to become pregnant or are pregnant.

Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

Albyl mines pass into breast milk, therefore the use of Albyl mines is not recommended.

Albyl mines can make it difficult to conceive and are therefore not recommended for women trying to conceive. The effect is temporary and ceases if the medication is stopped.

Driving and using machines

Albyl mines have no known effect on the ability to drive and use machines.

3. How to take Albyl minor

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

By using the lowest effective dose for the shortest possible time during treatment, the risk of side effects can be reduced.

Use for children and adolescents

Warning: Do not give to people under 18 years of age with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.

Children and adolescents:

3-5 years (15-20 kg): ½ tablet no more than 3 times a day. Maximum 375 mg per day.

6-9 years (20-30 kg): 1 tablet no more than 3 times a day. Maximum 750 mg per day.

10-14 years (30-50 kg) 1½-2 tablets no more than 3 times a day. Maximum 1,500 mg per day.

Never give Albyl mines for more than 2 days to children under 14 years of age and never to children under 3 years of age without consulting a doctor! In these cases, the doctor determines the dosage one.

The tablet can be divided in the breaker notch into two equal doses.

Give the tablets with water or another beverage. Children are especially sensitive to acetylsalicylic acid. Therefore, it is very important not to exceed the recommended doses.

The risk of overdose is higher especially in younger children and also older patients. Overdose can be life-threatening.

Symptoms of overdose may include: headache, dizziness, tremors, convulsions, nausea, vomiting, thirst, redness, sweating, tinnitus, hearing loss, palpitations, abdominal pain, anxiety, shortness of breath, confusion, hallucinations, dehydration, increased breathing, abnormal fatigue unconsciousness, high or low blood sugar, abnormally increased body temperature.

4. Possible side effects

Like all medicines, Albyl Minor can cause side effects, although not everybody gets them.

Stop taking Albyl mines and contact a doctor immediately or see the nearest emergency department if you experience the following symptoms:

  • Angioedema: swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing (rare (may affect up to 1 in 1,000 people)).
  • Lyell’s syndrome ( toxic epidermal necrolysis ): Severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) (very rare (may affect up to 1 in 10,000 people)).
  • Stevens-Johnson syndrome: An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as genitals (very rare (may occur in up to 1 in 10,000 users).
  • Abnormal bleeding, such as nosebleeds and bleeding gums and coughing up blood, blood in vomit or urine or black stools (rare (may affect up to 1 in 1,000 people)).

Other side effects are

The most common side effects are gastrointestinal symptoms, e.g. stomach ulcers, nausea, vomiting, diarrhea, flatulence, constipation, abdominal pain, exacerbation of certain intestinal diseases.

Very common (may affect more than 1 user in 10): Prolonged bleeding time.

Common (may affect up to 1 in 10 people): Headache, stomach upset (acid regurgitation, heartburn, nausea). The problems are reduced if Albyl mines are taken with food. Increased risk of bleeding, especially from the lining of the gastrointestinal tract.

Uncommon ( may affect up to 1 in 100 people): Hypersensitivity reactions, usually in the form of hives, hives, hay fever, or asthma. The risk of hypersensitivity reaction increases in patients with allergies of any kind. Gastric or peptic ulcer: With regular use. Fatigue, dizziness, tinnitus, sweating.

Rare ( may affect up to 1 in 1,000 people): Cerebral haemorrhage, decreased platelet count. Dissolution of red blood cells in the hereditary deficiency of a special metabolic enzyme ( glucose -6-phosphate dehydrogenase). Liver effects. Kidney impact. Severe bleeding from the gastrointestinal tract. Severe skin reactions, skin rash. Hearing loss (usually a sign of an overdose).

Very rare (may affect up to 1 in 10,000 people): Pointed blood clots in the skin (purpura).

Has been reported (occurs in an unknown number of users): Edema, high blood pressure, heart failure, nosebleeds, bleeding gums, bleeding after surgery, anemia after bleeding, asthma caused by acetylsalicylic acid, exacerbation of acetylsalicylic acid lung disease, liver damage.

Acetylsalicylic acid may increase the risk of Reye’s syndrome in children and adolescents associated with viral diseases, especially chickenpox and influenza. Reye’s syndrome is very rare. The symptoms are signs of brain swelling and liver damage, sometimes with low blood sugar.

Note that some of the side effects may also be signs of overdose. See section “If you have used excessive amounts of Albyl mines.

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 Albyl mines

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

Used before the expiry date which is stated on the carton. Expiration date means the last day of the specified month.

The medicine 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.

Empty packaging can be recycled via the Packaging Collection. Jar and lid are sorted as hard plastic packaging.

6. Contents of the packaging and other information

Content declaration

  • The active substance is acetylsalicylic acid 250 mg.
  • The other ingredients are magnesium hydroxide, corn starch, gelatin, anhydrous colloidal diesel dioxide, and talc.

What the medicine looks like and the contents of the pack

50 tablets in a plastic jar.

White, round tablet with a scoreline on one side. Diameter: 10.5 mm.

Marketing Authorisation Holder

RPH Pharmaceuticals AB

Lagervägen 7

136 50 Jordbro

Manufacturer

Recipharm Stockholm AB

Lagervägen 7

136 50 Jordbro

Local representative

Astimex Pharma AB

Isafjordsgatan 36

164 40 Kista

Tel. 08-5151 1535

info@astimex.se

Muhammad Nadeem

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