Bamyl 500mg Effervescent Acetylsalicylic Acid Tablet
1. What Bamyl Is And What It Is Used For
Bamyl has analgesic, anti-inflammatory, and antipyretic properties. Bamyl tablet is an effervescent tablet; therefore, the body quickly absorbs acetylsalicylic acid. The bamyl-effervescent tablet gives water a clear solution 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
- 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 Tablet
- If you are allergic to acetylsalicylic acid, 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 haemophilia 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
- Your condition may worsen if you have a gastrointestinal disease (such as ulcerative colitis or Crohn’s disease)
- If you have high blood pressure and heart failure.
- If you are to have surgery, even for minor procedures such as tooth extraction, Bamyl reduces the body’s ability to stop bleeding.
- If you regularly take several different painkillers, you risk developing permanent kidney damage.
- If you have a severe deficiency of glucose -6-phosphate dehydrogenase (a hereditary disease), 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 have any gastrointestinal tract problems, 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 consult your doctor and not increase your dose of Bamyl.
Children And Young People
Children should not use Bamyl tablet 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 (e.g. warfarin )
- Organ rejection after transplantation (cyclosporine, tacrolimus)
- High blood pressure (e.g. diuretics, ACE inhibitors, angiotensin II antagonists )
- Pain and inflammation (e.g. corticosteroids, 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 ), e.g. 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, using Bamyl is not recommended during breastfeeding.
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 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 considered when sharper attention is required, for example, driving a car.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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, especially if you have been prescribed a low-salt (sodium-poor) diet.
This medicine contains 276 mg of sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 14% of adults recommended daily sodium intake.
3. How To Use Bamyl
Always use this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The risk of side effects can be reduced by using the lowest effective dose for the shortest possible time during treatment.
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 and older children. Overdose can be life-threatening.
Overdose symptoms 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 about the use of this product, ask your doctor or pharmacist.
4. Possible Bamyl Side Effects
Bamyl can cause side effects like all medicines, 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)).
- 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 affect up to 1 in 10,000 users)).
Other side effects are
The most common bamyl side effects are gastrointestinal symptoms, e.g.
- Stomach ulcers
- Nausea
- Vomiting
- Diarrhoea
- 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 reflux
- Heartburn
- Nausea
- Increased tendency for bleeding
- Palpitations
- Tremors
- Anxiety
- Insomnia
Uncommon (may affect up to 1 in 100 people):
- Fatigue
- Sweating
- Dizziness
- 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 haemorrhage
- 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 anaemia.
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
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 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 that are 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, and 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