Aspetax Adipharm is intended for the symptomatic treatment of colds with fever and mild to moderate pain, neuralgia, toothache, migraine. It is also used as an anti-inflammatory agent in rheumatoid arthritis, neuritis and polyneuritis. Aspetax Adipharm is an analgesic, antipyretic and anti-inflammatory drug (non-steroidal anti-inflammatory drug).
Do not take Aspetax Adipharm:
· If you have active stomach or duodenal ulcers;
· If you have a pathologically increased tendency to bleed;
· If you are hypersensitive (allergic) to acetylsalicylic acid or to any of the other ingredients;
· If you have a history of hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs with asthma attacks or similar attacks;
· If you are taking concomitant methotrexate at doses of 15 mg or more per week;
· During the first and last trimester of pregnancy;
· For children under 16 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Aspetax Adipharm.
· If you are being treated with anticoagulants at the same time;
· If you have a stomach ulcer or duodenal ulcer, or a history of gastrointestinal bleeding;
· If you have impaired liver or kidney function;
· If you are hypersensitive to other anti-inflammatory or anti-rheumatic drugs or other allergens;
· Acetylsalicylic acid can cause bronchospasm and induce an asthma attack or other hypersensitivity reactions. Risk factors include pre-existing bronchial asthma, hay fever, nasal polyps, or chronic lung disease;
· This also applies to patients with allergic reactions (eg skin reactions, itching, urticaria) to other substances;
· Before surgery (including minor surgeries, such as tooth extraction), the bleeding time may be prolonged. Please tell your doctor or pharmacist that you are taking Aspetax Adipharm;
· In low doses, acetylsalicylic acid reduces the excretion of uric acid. This can provoke gout in patients with a tendency for low uric acid excretion.
Children and adolescents
Aspetax Adipharm should only be used in children and adolescents under medical supervision. In children and adolescents up to 16 years of age with febrile conditions (diseases with very high fever), Aspetax Adipharm can be used only after careful consideration of the risks and benefits of such treatment, due to the possibility of developing Reye's syndrome, rarely but very serious illness;
Other medicines and Aspetax Adipharm:
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of Aspetax Adipharm with other medicinal products may increase or decrease their effects:
Increased effects resulting in an increased risk of side effects:
· Anticoagulants, e.g. coumarin, heparin: acetylsalicylic acid may increase the risk of bleeding if taken before thrombolytic treatment. Therefore, you should pay attention to the symptoms of internal or external bleeding (eg after trauma) if you are undergoing such treatment;
· Medicines containing cortisone or cortisone substances (except products that are applied topically or cortisone used as a substitute for Addison's disease) or alcohol consumption: increased risk of gastrointestinal ulcers or bleeding;
· Medicines that lower blood sugar;
· Methotrexate (a medicine used to treat cancer and certain rheumatic disorders);
· Digoxin (a medicine that increases the contraction of the heart muscle);
· Other non-steroidal anti-inflammatory drugs / analgesics and Aspetax Adipharm in doses of 3 g of acetylsalicylic acid;
· Valproic acid (a medicine used to treat seizures).
Aspetax Adipharm weakens the effect of:
· Diuretics (medicines that increase urinary excretion) and Aspetax Adipharm in doses of 3 g of acetylsalicylic acid daily and more;
· ACE inhibitors (a group of drugs that lower blood pressure) and Aspetax Adipharm in doses of 3 g of acetylsalicylic acid daily and more;
· Medicines for gout that increase the excretion of uric acid (probenecid, benzbromarone).
Aspetax Adipharm with food, drink and alcohol:
Treatment with Aspetax Adipharm and alcohol increases the risk of bleeding from the gastrointestinal tract.
Aspetax Adipharm Pregnancy:
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.
Aspetax Adipharm should not be taken during the first and last trimester of pregnancy. Consult your doctor before taking Aspetax Adipharm during the second 3 months of pregnancy.
Salicylates pass into breast milk. Breast-feeding women can take Aspetax Adipharm only under medical supervision. With regular or high doses, breast-feeding should be discontinued.
Driving and using machines
No effects on the ability to drive and use machines were observed.
Aspetax Adipharm contains wheat starch
Due to the presence of wheat starch in Aspetax Adipharm, do not use in patients with gluten enteropathy (congenital small bowel disease manifested by diarrhea when using wheat products).
Aspetax Adipharm Dosage:
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist or nurse.
Adults: 500 - 1000 mg (1-2 tablets) as a single dose, repeated at intervals of 4-8 hours, but not more than 4 grams per day.
Use in children and adolescents:
Do not use in children under 16 years of age, except on prescription.
Do not take more than 3 days without consulting a doctor.
The tablets are taken orally after a meal, with plenty of fluids.
If you take more Aspetax Adipharm than
you should If you take more than the prescribed dose, talk to your doctor.
If you forget to take Aspetax Adipharm
If you miss a dose, take the medicine at the time of the next regular dose without increasing the dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, Aspetax Adipharm can cause side effects, although not everybody gets them.
Adverse drug reactions are divided into groups according to the terminology of the Medical Dictionary of Regulatory Activities (MedDRA) together with the corresponding frequency:
Very common: may affect more than 1 in 10 people;
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people;
Rare: may affect up to 1 in 1,000 people;
Very rare: may affect up to 1 in 10,000 people;
Not known (cannot be estimated from the available data).
· Abdominal pain, heartburn, nausea, vomiting;
· Ulcers (haematemesis, melena) or occult gastrointestinal bleeding that can cause iron deficiency anemia. Such hemorrhages are more common when the dosage is higher;
· Gastrointestinal ulcerations (ulcers) and perforation;
· Isolated cases of hepatic impairment have been reported.
Nervous system disorders: Dizziness and tinnitus, which are usually characteristic of overdose.
Haematological disorders: Acetylsalicylic acid may be associated with an increased risk of haemorrhage due to the effect on platelet aggregation.
Hypersensitivity reactions: Urticaria, skin reactions, anaphylactic reactions, asthma, Quincke's edema.
If you notice difficulty breathing or coughing, tinnitus, rash, black stools, confusion, dizziness, stomach pain - stop taking Aspetax Adipharm immediately and tell your doctor about your condition.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Active substance: acetylsalicylic acid. Each tablet contains 500 mg of acetylsalicylic acid.
The other ingredients (excipients) are: microcrystalline cellulose, wheat starch, sodium starch glycolate, silica, colloidal anhydrous and talc.