500 mg / 50 mg effervescent tablet is
acetylsalicylic acid / caffeine
What Acetylsalicylic Acid / Caffeine ABECE is and what it is used for
Acetylsalicylic acid / Caffeine Abece contains two active substances, acetylsalicylic acid, and caffeine. Acetylsalicylic acid / Caffeine Abece has analgesic, anti-inflammatory, and antipyretic properties. Acetylsalicylic acid relieves pain by counteracting the formation of special substances, prostaglandins. The antipyretic effect is due to the fact that acetylsalicylic acid increases the body’s heat release. Caffeine enhances the analgesic effect of acetylsalicylic acid. Caffeine also has an analgesic effect through its astringent effect on dilated blood vessels in the brain e.g. in migraine. Caffeine also has an invigorating effect.
This medicine is used for temporary mild to moderate pain conditions, e.g. headaches, including migraine headaches, toothaches, muscle, and joint pain, menstrual cramps, and fever in colds.
Acetylsalicylic acid and caffeine contained in Acetylsalicylic acid / Caffeine Abuse 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.
2. What you need to know before using Acetylsalicylic acid / Caffeine ABECE
Do not use Acetylsalicylic acid / Caffeine ABECE
- if you are allergic to acetylsalicylic acid, caffeine, 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 pain and inflammation within the group NSAIDs (non-steroidal anti-inflammatory drugs)
- if you are bleeding
- if you have reduced platelet count ( thrombocytopenia )
- if you have stomach ulcers
- if you have severe kidney disease or cirrhosis ( liver cirrhosis )
- if you have severe heart failure
- during the last three months of pregnancy (see “Pregnancy and breast-feeding”)
Warnings and cautions
Talk to your doctor before using Acetylsalicylic acid / Caffeine ABECE:
- if you know you are allergic (hypersensitive) to acetylsalicylic acid, ibuprofen, or other anti-inflammatory drugs.
- if you are taking medicines that thin the blood to prevent blood clots ( anticoagulants )
- if you are taking diuretics
- if you have mild to moderate heart failure
- if you have mild to the moderate liver or kidney function
- if you have high blood pressure
- if you have asthma
- if you have had stomach ulcers
Children and young people
Acetylsalicylic acid / Caffeine Abuse should not be given to 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 medical condition.
Other medicines and Acetylsalicylic acid / Caffeine ABECE
Acetylsalicylic acid / Caffeine Abece may affect or be affected by certain drug substances against:
- blood clots (eg warfarin )
- organ rejection after transplantation (cyclosporine, tacrolimus)
- high blood pressure (eg diuretics )
- pain and inflammation (eg corticosteroids )
- pain and fever (metamizole)
- gout (probenecid)
- cancer and rheumatoid arthritis (methotrexate)
- glaucoma also called glaucoma (such as acetazolamide)
- arrhythmias in the heart ( digoxin, adenosine )
- 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 )
- infection ( ciprofloxacin, norfloxacin)
- allergy (phenylpropanolamine)
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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.
Acetylsalicylic acid / Caffeine ABECE with food, drink, and alcohol
Acetylsalicylic acid / Caffeine Abece in combination with alcohol may increase the risk of stomach ulcers.
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.
Acetylsalicylic acid / Caffeine Abuse, 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, ie ceases when you stop using these types of drugs.
Pregnant women should not use Acetylsalicylic acid / Caffeine Abece during the last three months of pregnancy. Intake of Acetylsalicylic Acid / Caffeine Abece should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should be done only after a doctor’s prescription.
Acetylsalicylic acid / Caffeine Abece passes into breast milk but is unlikely to affect the breast-feeding baby. However, consult a physician if more than temporary use of Acetylsalicylic Acid / Caffeine Abece during breast-feeding.
Driving and using machines
Acetylsalicylic acid / Caffeine Abece may impair the ability of some people to react, for example, due to side effects such as dizziness and fatigue. This should be borne 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 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.
Acetylsalicylic acid / Caffeine ABECE contains sodium
Each Acetylsalicylic Acid / Caffeine Abece effervescent tablet contains 12 mmol sodium. This should be considered by patients on a low-salt diet.
3. How to use Acetylsalicylic acid / Caffeine ABECE
Always take 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.
Acetylsalicylic acid / Caffeine Abece effervescent tablets are intended for temporary discomfort.
The recommended dose for adults and adolescents over 14 years: 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 a doctor if symptoms worsen or do not improve within 3 days for fever and migraine and within 5 days for pain.
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.
Acetylsalicylic acid / Caffeine Abuse should not be given to children under 14 years of age.
Dissolve the effervescent tablets in half a glass of water.
Because caffeine is invigorating, it may be inappropriate to take this medicine at night.
Symptoms of overdose can be: headache, dizziness, cramps, vomiting, tinnitus, palpitations ( tachycardia ), abdominal pain, irritation, anxiety, and shortness of breath are examples of symptoms of overdose.
If you forget to use Acetylsalicylic acid / Caffeine ABECE
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, this medicine can cause side effects, although not everybody gets them.
Common (affects more than 1 user in 100):
- stomach upset, such as acid reflux, heartburn, and nausea
- increased susceptibility to bleeding
- palpitations, tremors, anxiety, insomnia.
Uncommon (affects less than 1 user in 100):
- fatigue, sweating, dizziness, and tinnitus
- hypersensitivity reactions such as hives, hay fever, or shortness of breath
- stomach ulcers and stomach bleeding.
Rare (affects less than 1 user in 1,000):
- reduction in platelet count ( thrombocytopenia )
- red blood cell dissolution ( hemolysis ) in those who have a hereditary deficiency of the metabolic enzyme glucose -6-phosphate dehydrogenase
- severe bleeding in the gastrointestinal tract
- severe skin reactions
- liver effects
- kidney effects.
Minor blood loss can in some cases lead to anemia.
Additional side effects are in children and adolescents
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.
5. How to store Acetylsalicylic acid / Caffeine ABECE
Keep this medicine out of the sight and reach of children.
Store in the original package. Close the tube tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. date. 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 substances are acetylsalicylic acid 500 mg, caffeine 50 mg.
- The other ingredients are anhydrous citric acid, povidone, sodium bicarbonate, anhydrous sodium carbonate, simethicone, sodium dihydrogen citrate, anhydrous sodium citrate, mannitol, docusate sodium.
What the medicine looks like and the contents of the pack
The effervescent tablets are white, round, flat and 22 mm in diameter.
The effervescent tablets are available in plastic tubes containing 10, 15, 20 or 25 effervescent tablets.
Pack sizes:
10, 15, 20, and 25 effervescent tablets in plastic tubes.
10 pcs (1 plastic tube x 10 effervescent tablets ), 15 pcs (1×15), 20 pcs (1×20, 2×10), 25 pcs (1×25), 30 pcs (3×10, 2×15), 40 pcs (4×10, 2×20), 45 pcs ( 3×15), 50 pcs (5×10, 2×25 pcs), 60 pcs (6×10, 4×15, 3×20) in outer carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Evolve Pharma AB
Box 120
182 12 Danderyd
Tel .: 08-544 960 30
Manufacturer
RosenPharma as
no. of descriptive 265
664 81 Veverské Knínice
Czech Republic