Roletra 10 mg for allergy symptoms relief x10 tablets

ROLETRA / ROLETRA TABLE. 10MG. X 10 readings:
 
It is indicated as a symptomatic remedy for all allergic conditions, including acute and chronic urticaria, angioedema, serum sickness, insect dermatitis, food allergy, etc. It is used to treat allergic and vasomotor rhinitis. 
ROLETRA / ROLETRA TABLE. 10MG. X 10 dosage and application:
Adults and children over 12 years of age:
10 mg once daily (1 tablet daily).
Children from 2 to 12 years old:
– weighing >30 kg: 10 mg once daily (1 tablet daily).
ROLETRA is not recommended for children under 2 years of age and children weighing less than 30 kg. No dose adjustment is required if you are elderly or have kidney failure.
ROLETRA / ROLETRA TABLET. 10MG. X 10 ingredients:
Active ingredient: each tablet contains 10 mg. loratadine.
Excipients: lactose monohydrate, corn starch, pregelatinized, purified water, magnesium stearate
Leaflet: information for the user ROLETRA 10 mg tablets (Loratadine) ROLETRA 10 mg tablets (Loratadine) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor, pharmacist or nurse. This also includes any side effects not listed in this leaflet. If you do not feel better or your condition gets worse, you should seek medical advice. See section 4, What this leaflet contains: 1. What ROLETRA is and what it is used for 2. What you need to know before you take ROLETRA 3. How to take ROLETRA 4. Possible side effects 5. How to store ROLETRA 6. Contents of the pack and other information 1. What ROLETRA is and what it is used for ROLETRA contains loratadine. Loratadine belongs to a group of medicines called antihistamines. They work by blocking a substance in the body called histamine. This helps to reduce allergy symptoms. ROLETRA is used: To relieve symptoms associated with allergic rhinitis (hay fever, dust allergy, etc.), such as sneezing, runny or itchy nose, red, watery eyes with burning or itching. You may suffer from these symptoms only during a certain season or all year round. To relieve swelling, redness, itching of a part of the skin caused by prolonged skin rashes or hives (chronic idiopathic urticaria). 2. What you need to know before you take ROLETRA Do not take ROLETRA • if you are allergic (hypersensitive) to loratadine or any of the other ingredients of ROLETRA (see the list of excipients in section 6 Contents of the pack and further information). An allergic reaction may include rash, itching, swelling of the face, lips or hands/feet or difficulty breathing. Take special care with ROLETRA if: • you suffer from severe liver disease; Please tell your doctor even if you have had similar problems in the past. Laboratory tests This medicine may affect the results of skin allergy tests. Make sure your doctor and nurse know that you are taking this medicine. You must stop taking it at least 48 hours before undergoing these tests. Other medicines and POLETPA Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. When taken at the same time, some medicines (ketoconazole, erythromycin, cimetidine) may increase the level of loratadine in the blood and may cause side effects. POLETPA with food, drink and alcohol POLETPA can be taken with or without food. The tablets should be swallowed whole with a glass of water. Avoid alcoholic beverages until you have discussed their use with your doctor. Pregnancy, breast-feeding and fertility POLETPA tablets are not recommended during pregnancy and breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines POLETPA may cause drowsiness or visual disturbances in some patients. This may affect the ability to drive or use machines. Be sure of how you react to the medicine before you drive, use machines or do any other activity that could be dangerous if you are not alert. POLETPA contains lactose Your medicine contains small amounts of the inactive ingredient called lactose. If you have been told that you have lactose intolerance (galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption) or have an intolerance to some sugars, tell your doctor before taking this medicine. 3. How to take POLETPA 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, ask your doctor or pharmacist. Roletra tablets should be swallowed whole or with water. The recommended dose is: Adults and children over 12 years: 10 mg once a day (1 tablet a day) Children from 2 to 12 years and weighing more than 30 kg: 10 mg once a day (1 tablet a day) Children over 2 years of age who do not weigh more than 30 kg should not take this medicine. POLETPA tablets should not be given to children under 2 years of age. Patients with severe liver failure Your doctor will assess the dose depending on your liver function. You will take Roletra less frequently than other adults. The usual recommended daily dose in patients with severe liver failure is one tablet (containing 10 mg of loratadine) every other day. Children weighing less than or equal to 30 kg with severe liver disease should take a dose of 5 mg of loratadine every other day. If you have taken more than the required dose of ROLETRA, you may experience drowsiness, rapid heartbeat and headache. Tell your doctor immediately or go to the nearest emergency room. Take this leaflet or some tablets with you so that the doctor knows what you have taken. If you forget to take ROLETRA, take the dose as soon as possible, then go back to your usual dose. Do not take a double dose to make up for a forgotten dose. It is best to take your medicine at the same time each day, this will help you remember to take it regularly. If you have stopped taking ROLETRA You should take the medicine for as long as you have been told. It is important not to stop taking it just because you feel better, as your symptoms may return. If you have the impression that the effect of ROLETRA is too strong or too weak, or if you have any other questions on the use of this product, talk to your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The most commonly reported adverse drug reactions in children aged 2 to 12 years are headache, nervousness and fatigue. The most commonly reported adverse drug reactions in adults and adolescents are headache, insomnia, difficulty falling asleep and increased appetite. In the post-marketing period for loratadine, cases of severe allergic reaction, dizziness, arrhythmia, rapid heartbeat, nausea, dry mouth, stomach upset, liver problems, hair loss, rash and fatigue have been reported very rarely. Reporting of side effects If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to: Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, Tel.: +35928903417, website: www.bda.bg. By reporting side effects, you can help to provide more information on the safety of this medicine. 5. How to store ROLLETRA Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton after (EXP). The expiry date refers to the last day of that month. Store in the original package. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and other information What ROLETRA contains • Active substance: each tablet contains 10 mg of loratadine, • Excipients: lactose monohydrate, corn starch, pregelatinized, purified water, magnesium stearate What POLETPA looks like and contents of the pack ROLETRA tablets are white to off-white, round, uncoated tablets with the symbol on one side and „10“ on the other. The tablets are packed in PVC/PVdC/aluminium foil blister strips of 10 tablets each. ROLETRA is available in packs of 1 or 3 blisters, placed in a cardboard box. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder Ecopharm Group AD, 14, Cherni Vrah Blvd., bl.Z 1421 Sofia Bulgaria Tel.: +359 2 963 15 96 Fax: +359 2 963 15 61 Manufacturer responsible for batch release: Ecofarm EOOD 14, Cherni Vrah Blvd., bl.Z 1421 Sofia Bulgaria For any further information about this medicinal product, please contact the Marketing Authorisation Holder ECOPHARM GROUP AD. Date of last revision of this leaflet: June 2013