ASPIRIN COMPLEX 500mg / 30 mg (20 sachets)

Interactions

Use in elderly patients Elderly patients may be particularly sensitive to pseudoephedrine and may react with insomnia or experience things that do not really appear (hallucinations).

Children and adolescents There is a possible link between acetylsalicylic acid and Reye's syndrome when the drug is given to children and adolescents Reye's syndrome is a very rare but life-threatening disease. Therefore, Aspirin Complex granules should not be used in children and adolescents under 16 years of age without medical advice.

Aspirin Complex granules and other medicines Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effect of the following drugs or classes of drugs may be affected if they are taken simultaneously with Aspirin Complex granules. Please inform your doctor so that a possible dose adjustment can be made.

Aspirin Complex – granules can enhance the effect of the following agents:

• Medicines that thin the blood (anticoagulants) and that inhibit blood clotting (antiplatelet agents), such as ticlopidine.
• medicines such as cortisone or prednisolone, if taken or injected.
• Digoxin (used to treat heart failure or irregular heartbeat): the amount of digoxin in the blood is increased.
• anti-inflammatory and analgesic drugs (non-steroidal analgesics/anti-inflammatory drugs).
• hypoglycemic medicines (antidiabetic drugs).
• Methotrexate: possibly increased risk of side effects.
• Valproic acid (medicine used to treat epilepsy).
• Antidepressants including MAO inhibitors.
• Salbutamol tablets: the heart may beat irregularly or faster. However, bronchodilator inhalation sprays may continue to be used (as prescribed).
• other medicines containing phenylephrine and ephedrine, or other sympathomimetics such as those found in local nasal mucosal decongestants, such as nasal drops.

Aspirin Complex granules can weaken the effect of the following means:

• dehydrating drugs (aldosterone antagonists and loop diuretics).
• antihypertensive drugs (antihypertensive drugs such as guathinidine, methyldopa, ßBlocker).
• uric acid-excreting gout drugs (eg, probenecid, sulfinpyrazone).

• Taking Aspirin Complex granules together with food, drink and alcohol
• You can take the medicine regardless of a meal. Before taking, you need to add the granules to a glass of water and stir well.
• Taking it with alcohol increases the risk of gastrointestinal bleeding and impairs your ability to react.

Application

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you're not sure. Unless otherwise prescribed by the doctor, the usual dose for adults and adolescents aged 16 and over is:

Age, adults and adolescents: single dose: 1-2 sachets, total daily dose, up to 6 sachets

• If necessary, the intake of the single dose can be repeated at intervals of 4 - 8 hours.
• Do not exceed a total daily dose of 6 sachets.
• Before taking, add the contents of one to two sachets of granules to a glass of water and stir well. The resulting suspension has an orange flavor. Drink the entire glass immediately. Note: The granules do not dissolve completely.
• Do not take the medicine for more than 3 days without medical advice.

Children and adolescents:ASPIRIN Complex is intended for adults and adolescents aged 16 and over. Aspirin Complex granules should not be used in children and adolescents under 16 years of age without a doctor's advice. Due to the lack of experience, dose recommendations cannot be given for adolescents.

Pregnancy, lactation and fertility

Due to a lack of experience with the combination of both active ingredients in Aspirin Complex granules, the product must not be used during pregnancy and breastfeeding. If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medicine. Aspirin Complex – granules belong to a group of drugs (NSAIDs) that can make it difficult for women to get pregnant. This effect is only temporary and decreases after cessation of intake.

Contraindications

Do not take Aspirin Complex granules,

• if you are allergic to acetylsalicylic acid, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of asthma caused by treatment with salicylates or substances with a similar effect (so-called non-steroidal anti-inflammatory drugs).
• if you suffer from stomach ulcers.
• if you have an increased tendency to bleed.
• if you are pregnant or breastfeeding.
• if you have liver and kidney failure.
• if you suffer from severe heart failure (heart failure).
• if you are taking 15 mg or more methotrexate per week at the same time.
• if you have severe high blood pressure or severe coronary artery disease.
• if you are taking (or have taken within the last 2 weeks) a medicine from the class of monoamine oxidase (MAO) inhibitors (antidepressants) at the same time.

Side effects

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

Frequency: not known (frequency cannot be estimated from the available data)

The possible side effects of acetylsalicylic acid are: These are all very serious side effects, and you may need urgent medical observation or hospitalization. Seek immediate medical attention or the nearest hospital if you notice any of the following:

• peptic ulcer, which in isolated cases can lead to a rupture of the stomach;
• Gastrointestinal bleeding, which in isolated cases can lead to iron deficiency anemia. Signs of this are black stools or bloody vomiting;
• Allergic reactions (such as shortness of breath, skin reactions possibly with a drop in blood pressure), especially in asthmatics;
• hemolysis (destruction of red blood cells) in severe glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• impaired renal function, renal failure.

These are all serious side effects, and you may need urgent medical attention. Talk to your doctor if you notice any of the following:

• increase in the risk of bleeding;
• gastrointestinal complaints such as stomach pain; indigestion and inflammation of the gastric mucosa;
• increase in liver enzymes;
• Dizziness, tinnitus (ringing in the ear)

These are mild side effects

• Nausea, vomiting, diarrhea.

Possible side effects of pseudoephedrine include: These are all serious side effects, and you may need urgent medical attention. Talk to your doctor if you notice any of the following:

• effects on the heart (e.g. tachycardia or irregular heartbeat);
• urinary retention, especially in patients with prostate enlargement;
• increase in blood pressure, but not with treated hypertension;
• insomnia, rarely hallucinations and other stimulations of the central nervous system;
• effects on the skin (e.g. rash, hives, itching);
• Sudden onset of fever, redness of the skin, or many small pustules (possible signs of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of treatment with Aspirin Complex granules. See section 2.

If you experience these symptoms, stop taking Aspirin Complex granules and consult a doctor immediately.

• Inflammation of the colon due to insufficient blood supply (ischemic colitis). If you notice any of the above side effects, you must immediately discontinue Aspirin Complex granules. Tell your doctor so that they can assess the severity of the reaction and decide what action to take.

Composition

The active ingredients are acetylsalicylic acid (500 mg) and pseudoephedrine hydrochloride (30 mg). The other ingredients are: anhydrous citric acid, sucrose, hypromellose, saccharin, orange flavor (with acetic acid, alpha-tocopherol, modified starch and maltodextrin).