500 mg effervescent tablet 
acetylsalicylic acid

500 mg tablet of acetylsalicylic acid

1. What Bamyl is and what it is used for

Bamyl has analgesic, anti-inflammatory, and antipyretic properties. Bamyl is an effervescent tablet and therefore the acetylsalicylic acid is quickly absorbed by the body. Bamyl effervescent tablet gives you water a clear solution that is gentler on the stomach than regular solid tablets with acetylsalicylic acid. The tablet usually starts working within about 30 minutes. The effect is greatest after 1-2 hours.

This medicine is used for pain conditions such as headaches, toothaches, joint, and muscle pains and menstrual pains, fever in colds, and after a doctor’s prescription rheumatoid arthritis ( rheumatoid arthritis ).

2. What you need to know before using Bamyl

Do not use Bamyl

  • if you are allergic to acetylsalicylic acid or other salicylates or any of the other ingredients of this medicine (listed in section 6).
  • if you have had a hypersensitivity reaction such as asthma, difficulty breathing, hay fever, or hives when taking acetylsalicylic acid or certain other medicines for inflammation
  • if you have or have had stomach ulcers 
  • if you have previously had stomach ulcers while taking Bamyl or similar preparations, especially NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic drugs).
  • if you have hemophilia or decreased platelet count ( thrombocytopenia )
  • 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 ).

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 Bamyl:

  • if you have asthma
  • if you have mild to moderate heart failure
  • if you have kidney disease or liver disease, especially during concomitant treatment with diuretics
  • if you are being treated with medicines that inhibit blood clotting
  • if you have or have had stomach ulcers
  • if you are hypersensitive to acetylsalicylic acid, ibuprofen, or other anti-inflammatory drugs
  • if you have a gastrointestinal disease (such as ulcerative colitis or Crohn’s disease) as your condition may worsen.
  • if you have high blood pressure and/or heart failure.
  • if you are to have surgery, even for minor procedures such as tooth extraction, as Bamyl reduces 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 deficiency of glucose -6-phosphate dehydrogenase (a hereditary disease), as Bamyl may 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 Bamyl with caution.

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

With long-term use of Bamyl, 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 Bamyl but consult your doctor.

Children and young people

Bamyl should not be used by children under 14 years of age.

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.

Older

Elderly patients have an increased risk of side effects from acetylsalicylic acid, especially stomach bleeding and stomach ulcers, which can be life-threatening. Therefore, the lowest effective dose should be given and other drugs and diseases should also be considered.

Other drugs and Bamyl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.

Bamyl may affect or be affected if taken at the same time as certain other medicinal substances against:

  • blood clots (eg warfarin )
  • organ rejection after transplantation (cyclosporine, tacrolimus)
  • high blood pressure (eg diuretics, ACE inhibitors, angiotensin II antagonists )
  • pain and inflammation (eg corticosteroid s, NSAIDs such as ibuprofen, COX-2inhibitors)
  • gout (probenecid)
  • cancer and rheumatoid arthritis (methotrexate, pemetrexed (for cancer only))
  • Certain medicines for glaucoma also called glaucoma (such as acetazolamide)
  • arrhythmias in the heart ( digoxin )
  • depression (selective serotonin reuptake inhibitors ( SSRIs ) eg fluvoxamine)
  • manic depressive illness, schizophrenia (lithium, clozapine)
  • epilepsy ( phenytoin, valproic acid, carbamazepine)
  • type II diabetes (sulphonylureas)
  • high blood fats ( nicotinic acid )
  • antacids for digestive problems. Bamyl and these medicines should be taken at least 2 hours apart.

Use of Bamyl with food and drink

Bamyl in combination with alcohol may increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

Pregnant women should not use Bamyl during the last three months of pregnancy. Taking Bamyl 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.

Acetylsalicylic acid passes into breast milk, therefore the use of Bamyl is not recommended during breast-feeding.

Bamyl, like many anti-inflammatory drugs (so-called NSAIDs ), can make it difficult to conceive and is therefore not recommended for women trying to conceive. The effect is temporary and ceases when you stop using these types of drugs.

Driving and using machines

Bamyl may impair the ability of some people to react, for example, due to side effects such as dizziness and fatigue. This should be kept in mind at times when sharper attention is required, for example when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Bamyl contains sodium

Talk to your doctor or pharmacist if your need for Bamyl is more than 1 effervescent tablet daily for an extended period of time, especially if you have been prescribed a low-salt (sodium-poor) diet.

This medicine contains 276 mg sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 14% of the maximum recommended daily intake of sodium for adults.

3. How to use Bamyl

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.

Adults and adolescents over 14 years of age: 1-2 effervescent tablets 1-3 times a day or according to a doctor’s prescription, a maximum of 6 tablets per day. More than 2 tablets at a time do not provide a better analgesic effect. Contact your doctor if symptoms worsen or do not improve within 3 days in case of fever and within 5 days in case of pain.

Use for children

Bamyl should not be given to children under 14 years of age.

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.

Older

Elderly people have an increased risk of stomach ulcers and stomach bleeding. Therefore, the lowest effective dose should be given and other drugs and diseases should also be considered.

Effervescent tablet one should be dissolved in ½ glass of water.

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, reddening of the skin, 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

If you forget to use Bamyl

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 or pharmacist.

4. Possible side effects

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

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

  • Abnormal bleeding, such as nosebleeds and bleeding gums and coughing up blood, vomiting blood or urine, or black stools (rare (may affect up to 1 in 1,000 people)).
  • Angioedema: swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing (rare (may affect up to 1 in 1,000 people)).
  • Lyellas 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 affect up to 1 in 10,000 users)).

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, such as acid reflux, heartburn, and nausea. Increased tendency for bleeding. Palpitations, tremors, anxiety, insomnia.

Uncommon (may affect up to 1 in 100 people): Fatigue, sweating, dizziness, and tinnitus. Hypersensitivity reactions such as hives, hay fever, or shortness of breath. The risk of hypersensitivity reaction increases in patients with allergies of any kind. Stomach ulcers and stomach bleeding.

Rare (may affect up to 1 in 1,000 people): Cerebral haemorrhage, reduction in platelet count ( thrombocytopenia ), red blood cell dissolution ( hemolysis ) in those with hereditary metabolic enzyme glucose -6-phosphate dehydrogenase, severe hemorrhagic hemorrhage, severe skin reactions, rash, hepatic impairment, renal impairment, 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, hypertension, heart failure, nosebleeds, bleeding gums, postoperative bleeding, asthma caused by acetylsalicylic acid, exacerbation of acetylsalicylic acid lung disease, liver damage.

Minor blood loss can in some cases lead to anemia.

Note that some of the side effects may also be symptoms of overdose, see section If you have used too much Bamyl .

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.

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 Bamyl

No special storage instructions.

Keep out of sight and reach of children.

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 500 mg.
  • The other ingredients are: anhydrous citric acid, povidone, sodium bicarbonate, anhydrous sodium carbonate, simethicone, sodium dihydrogen citrate, sodium citrate, mannitol, docusate sodium

What the medicine looks like and the contents of the pack

Bamyl effervescent tablets are white, flat, 22 mm in diameter.

Plastic pipes

25 st

Marketing Authorisation Holder:

Meda AB

Box 906

170 09 Solna

Phone: 08-630 19 00

Email: info@medasverige.se

Manufacturer

Hermes Arzneimittel GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

Muhammad Nadeem

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