Description Zidenac is used to treat the symptoms of allergic diseases affecting the skin (rash, hives) and the respiratory tract (perennial and seasonal rhinitis). Composition The active substance is dimethindene maleate ( Dimetindeni maleas ). 1 ml of solution contains 1 mg of dimethindene maleate (1 ml = 20 drops). Excipients: propylene glycol (E 1520), disodium phosphate dodecahydrate, citric acid monohydrate, benzoic acid (E 210), disodium edetate, sodium saccharin (E 954), purified water. Dosage Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist. Adults and adolescents over 12 years of age: 20 to 40 drops 3 times daily. The recommended daily dose is 3 to 6 mg dimethindene maleate in 3 equally divided doses. Patients prone to drowsiness should use 40 drops before bedtime and 20 drops in the morning. Children: 2 drops per kg of body weight daily, in 3 divided doses. The recommended daily dose for children aged 1 to 12 years is 0.1 mg dimethindene maleate per kg of body weight. Weight (kg) Single dose (number of drops) Daily dose (total number of drops) 7 - 8 5 15 9 6 18 10 - 11 7 21 12 8 24 13 - 14 9 27 15 10 30 16 - 17 11 33 18 12 36 19 - 20 13 39 21 14 42 22 - 23 15 45 24 16 48 25 - 26 17 51 27 18 54 28 - 29 19 57 30 20 60 Zidenac should not be used for longer than 14 days without consulting a doctor. The drops should be taken undiluted (for example, on a teaspoon). Action Zidenac contains the active substance dimethindene maleate, which belongs to a group of medicines called antihistamines. It blocks the action of histamine, which is released by the body during allergic reactions. Indications Symptomatic treatment of allergic diseases: - skin: hives, itching of various origins, endogenous eczema, if the doctor has previously diagnosed the patient with these diseases, - respiratory system: seasonal allergic rhinitis (hay fever) and perennial rhinitis, if your doctor has previously diagnosed you with these diseases. The medicinal product relieves itching associated with infectious diseases (e.g. chickenpox), if the patient has previously been diagnosed with these diseases by a doctor, or after an insect bite or sting. Contraindications The medicine should not be used in case of hypersensitivity to any of the ingredients and in infants and children under 1 year of age. Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, which may be signs of an allergic reaction, stop taking Zidenac and seek medical help immediately. ‒ Shortness of breath or difficulty swallowing. ‒ Swelling of the face, lips, tongue or throat. ‒ Intense itching of the skin with a red rash or pimples, muscle cramps. These side effects are very rare (may affect less than 1 in 10,000 people). Very common (may affect more than 1 in 10 people): Tiredness. Common (may affect less than 1 in 10 people): Drowsiness, nervousness. Rare (may affect up to 1 in 1,000 people): Anxiety, headache, dizziness, digestive problems, nausea, dry mouth and throat. Warnings and precautions Caution should be exercised in patients with epilepsy, glaucoma, or urinary retention (e.g., prostatic hyperplasia). Use is not recommended in seniors with disorientation. The medicine contains propylene glycol and benzoic acid. Keep the medicine out of the sight and reach of children, at a temperature below 25°C, in the outer packaging to protect from light. The shelf life after first opening the immediate packaging is 6 months. Use of other medications Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription. Do not use this medicine if you are taking any of the following medicines (unless your doctor tells you otherwise): antidepressants, anticholinergics (used in asthma, abdominal cramps, dilating the pupil, urinary incontinence), sedatives, anxiolytics, hypnotics, anticonvulsants, opioid analgesics, antihistamines, antiemetics, scopolamine, procarbazine, antipsychotics. Taking the medicine with food and drink You should not drink alcohol during treatment. Pregnancy and breastfeeding 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. The drug is not recommended for breastfeeding women. During pregnancy, the drug should only be taken on the advice of a doctor. Use of the drug in children and adolescents The medicine is intended for children over 1 year of age. Driving and operating machinery This medication may cause fatigue, reduce concentration, and slow down your reactions. Use with caution.