Allergozan 25 mg x20 tablets Sopharma

 
ALLERGOSAN indications: Used for the treatment of allergic rhinitis (runny nose) and conjunctivitis (inflammation of the conjunctiva of the eye); hay fever; skin allergic reactions, such as rash, itching, insect bites. Allergic reactions associated with the use of certain foods and medications.
 
ALLERGOSAN composition: Chloropyramine hydrochloride 25 mg H1-blocker, first generation.
 
ALLERGOSAN dosage and administration: The tablets are taken orally with a little water during or after meals without chewing. Adults are prescribed 25 mg 3-4 times a day, if necessary the daily dose is increased to 150 mg. Children over 5 years of age are prescribed 2-3 times a day, 1 tablet
 
Leaflet: information for the patient ALERGOZAN 25 nig coated tablets ALLERG OSAN* 25 nig coated tablets chloropyramine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. This medicine is available without a prescription for adults and children over 14 years of age. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you need any further information or advice, ask your pharmacist. For children aged 6 to 14 years, it is available on prescription. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, tell your doctor, pharmacist or nurse. This also includes any possible side effects not described in this leaflet. What this leaflet contains 1. What Allergozan tablets are and what they are used for 2. What you need to know before you take Allergozan tablets 3. How to take Allergozan tablets 4. Possible side effects 5. How to store Allergozan tablets 6. Contents of the pack and other information 1. What Allergozan tablets are and what they are used for Allergozan tablets contain the active substance chloropyramine hydrochloride, which belongs to the group of classical antihistamines for the treatment of allergic reactions. It suppresses the effects of histamine, which is formed in the body and causes allergic reactions. Allergozan tablets are used for the symptomatic treatment of seasonal allergic rhinitis and conjunctivitis, urticaria, dermographism, contact dermatitis, drug and food allergies, insect bites and pruritus (itching). Allergozan tablets can also be used as an adjunct to the treatment of systemic anaphylactic reactions and angioedema (sudden life-threatening allergic reaction, sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue, throat or other parts of the body, shortness of breath, difficulty swallowing, wheezing or difficulty breathing), but only after basic treatment (with adrenaline). 2. What you need to know before you take Allergozan tablets Do not take Allergozan tablets if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); in asthma attack conditions; if you are pregnant or breastfeeding; in newborns or premature babies. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Allergozan if: you have hyperthyroidism (increased thyroid function); you have cardiovascular disease; you have liver disease; you have glaucoma (increased intraocular pressure); you have an adenoma (benign tumor) of the prostate gland; you suffer from bronchial asthma; you suffer from gastroesophageal reflux disease (passage of gastric contents into the esophagus); In elderly patients (over 65 years of age) or debilitated patients, the possibility of dizziness, sedation (calming without causing sleep) and a decrease in blood pressure is greater. Children and adolescents Treatment with chloropyramine in children should be carried out under medical supervision, since they are more likely to experience adverse effects - manifestations of agitation. Other medicines and Allergozan tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The simultaneous use of Allergozan with atropine, buscolisine or other agents with atropine-like action may increase the risk of adverse drug reactions, such as urinary retention, constipation, dry mouth. It is also possible to enhance the effect of sedatives (sedatives, tranquilizers), hypnotics, painkillers (narcotic analgesics), other antiallergic (antihistamine) drugs, alcohol and alcohol-containing products, which is why such combinations with Allergozan should be avoided. Tricyclic antidepressants (amitriptyline, imipramine) may enhance the sedative effect and its adverse drug reactions. Allergozan may mask the effects of drugs that cause hearing damage. Concomitant use with MAO inhibitors (moclobemide) may cause an increase in adverse drug reactions. In order to start treatment with Allergozan, an interval of 2 weeks is required after stopping MAO inhibitors. Allergozan should not be taken while skin tests for allergen detection are being performed simultaneously. The latter can be performed a few days after stopping treatment with Allergozan. Allergozan tablets are food, drinks and alcohol The tablets are taken during meals with water. Avoid drinking alcohol during treatment with Allergozan. Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. The use of Allergozan tablets during pregnancy and breastfeeding is contraindicated. If treatment is necessary, breastfeeding should be discontinued. Driving and using machines Allergozan moderately affects the ability to drive and use machines. When using Allergozan tablets, drowsiness, impaired coordination and slowed reactions are possible. If it is necessary to treat drivers of vehicles and machine operators with Allergozan, it is recommended to stop activities requiring increased attention and speed of reactions. Allergozan tablets contain lactose and sucrose as excipients. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Allergosan. Allergosan tablets contain wheat starch. It is suitable for people with celiac disease (gluten enteropathy). Patients with an allergy to wheat (other than celiac disease) should not take this product. 3. How to take Allergosan tablets Always take this medicine exactly as your doctor or pharmacist has told you or exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist. The recommended dose is: Adults: 1 tablet 3-4 times a day. The maximum dose is 6 tablets a day, divided into 3 doses of 2 tablets. Use in children and adolescents Days over 14 years: 1 tablet 3-4 times a day. The maximum dose is 6 tablets a day, divided into 3 doses of 2 tablets. Children from 6 to 14 years: 1/2 tablet 3 times a day. Children under 6 years: this dosage form is not suitable for children under 6 years of age. The maximum daily dose is 2 mg/kg body weight. Elderly patients (over 65 years) and debilitated patients The use of the medicinal product in this category of patients requires increased caution due to increased sensitivity to antihistamines in terms of their undesirable effects. Patients with liver damage In patients with impaired liver function, it is recommended to use a lower than recommended daily dose. Patients with kidney damage In patients with kidney failure, it is necessary to reduce the recommended daily dose. Method of administration The tablets are taken whole, during meals, with water. Duration of treatment The duration of treatment depends on the type and severity of the symptoms. If you take more Alleruzan tablets than you should If you take a dose higher than prescribed, you may feel dizzy, drowsy, have reduced reflexes and active attention; psychomotor agitation, seizures and coma are also possible, rarely fever and redness of the skin. In children – dilated pupils, fever and redness of the skin, impaired coordination, anxiety, agitation, hallucinations, convulsions, rapid heartbeat, coma. Consult your doctor immediately. Treatment is carried out in a hospital setting. If you forget to take Alleruzan tablets Do not take a double dose to make up for the missed one. If you miss a dose, take it as soon as possible. If it is almost time for the next dose, take it as usual, skipping the dose you forgot. Continue taking the medicine as prescribed by your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare (affects less than 1 in 1,000 patients) - leukopenia (reduced white blood cell count), agranulocytosis (lack of a type of white blood cell), haemolytic anaemia (destruction of red blood cells), other blood disorders, sedation, tiredness, dizziness, ataxia (lack of coordination), nervousness, tremor, convulsions, headache, euphoria, encephalopathy (brain disease), blurred vision, increased intraocular pressure and glaucoma attack, arrhythmia, tachycardia (rapid heartbeat), low blood pressure, difficulty urinating, urinary retention. Very rare (affects less than 1 in 10,000 patients) - dry mouth, nausea, vomiting, constipation, diarrhea, lack of appetite or increased appetite, stomach pain and discomfort, photosensitivity. Unknown frequency (frequency cannot be estimated from the available data) - myopathy (muscle pain, muscle tenderness or weakness), allergic reactions. Additional side effects in children and adolescents In rare cases, paradoxical reactions (increased excitability, nervousness, irritability, insomnia) are possible, more common and more pronounced in children and elderly patients. If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects described in this leaflet. 5. How to store Allergozan tablets Store in the original packaging, at a temperature below 25 ° C. Keep out of the reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Alergosan tablets contain The active substance is: chloropyramine hydrochloride 25 mg in one tablet. The other ingredients are: lactose monohydrate, wheat starch; cellulose, microcrystalline (type 101); carmellose sodium, talc, magnesium stearate; silicon dioxide, colloidal anhydrous. Coating: basic butyl methacrylate copolymer, polysorbate 80, talc, titanium dioxide (El71), sucrose, gelatin; gum arabic, spray-dried; macrogol 6000 glycerol, acetone, isopropyl alcohol. What Alergozan tablets look like and what the package contains Round, biconvex tablets with a regular shape and a glossy surface, white, odorless. 20 tablets in a blister of hard, colorless, transparent PVC/aluminum foil; but 1 blister in a cardboard box, together with a leaflet. Marketing Authorization Holder and Manufacturer SOPHARMA AD 16 Iliensko Shose Street, 1220 Sofia, Bulgaria Date of last revision of the leaflet: November, 2011.