PATIENT INFORMATION LEAFLET LORATADINE 10mg TABLETS

What you should know about Loratadine 10mg Tablets Please read this leaflet carefully before you start taking your medicine. This leaflet provides a summary of the information available on your medicine. Keep it so you can read it again if you need to. If you have any questions or are not sure about anything ask your doctor or pharmacist. The name of your medicine is Loratadine 10mg Tablets. What is in your medicine? Each tablet contains 10mg of the active ingredient loratadine. The tablet also contains lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose ... Loratadine 10mg Tablets are available in packs of 30. The active ingredient loratadine belongs to a group of medioines called non-sedating antihistamines, which are used to treat the symptoms of some allergies. The product licence holder is: Sandoz Ltd., Woolmer Way, Bordon, Hants, GU359QE. The manufacturer is: Sandoz Pharmaceuticals GmbH. Carl-Zeiss-Ring 3, 85737 Ismaning. Germany. Uses Loratadine 10mg Tablets are used to relieve symptoms such as sneezing, runny nose and itching or burning nose (rhinitis) or eyes which are due to hayfever. Loratadine tablets also treat symptoms such as rash and itching due to an allergic skin condition known as urticaria (hives). When should you never take the tablets? Do not take the tablets if you have had an allergic reaction or are sensitive to loratadine or any of the other ingredients in the tablets. Loratadine tablets should not be taken by children under the age of two and this formulation of loratadine is not intended for children weighing less than 30kg. When should you take special care with the tablets? You should consult your doctor before taking the tablets if • you have severe problems with your liver $ you are or may be pregnant or are breast-feeding or • you suffer from galactose intolerance, lactose intolerance or glUCOSe-galactose malabsorption. Loratadine may cause dry mouth in certain patients. Therefore during longterm treatment, good oral hygiene is important because dry mouth may increase the risk of caries. Will these tablets react with other medicines? There have been no significant reports of adverse effects occurring when Loratadine tablets are taken at the same time as other medicines. However,

before taking these tablets, you should consult your pharmacist or doctor if you are taking any other medicines. If you are going to have skin tests to find out what substances you are allergi-c to (called skin sensitisation tests) you should stop taking the tablets at least 5 days before you have the tests. What else do you need to know? Loratadine tablets may cause drowsiness and you should not drive or operate machinery whilst taking these tablets. Excessive alcohol should be avoided when taking Loratadine tablets. What is the right dose? For adults, and children weighing more than 30kg, the dose is one tablet taken once a day. The tablet should preferably be taken before meals. DO NOT EXCEED THE STATED DOSE. If you forget to take one or more doses, start taking the tablets again when you remember. Do not take extra tablets to make up for the ones you forgot. If your symptoms have not improved after three days you snould consult your pharmacist or doctor. If you have taken too many tablets, contact your doctor or hospital accident and emergency department immediately. If you are able to, you should try to make yourself vomit. Side-effects Like all medicines, Loratadine tablets can have side-effects. The most frequently occurring side-effects include tiredness, headache, dry mouth, increase in appetite, nausea, gastritis (inflammation of the stomach), indigestion, pharyngitis (inflammation of the pharynx), nose bleeds and rash. Hair loss, allergic shock and abnormal liver function have been reported rarely. Isolated reports of rapid or irregular heart beat have been reported. If you are concerned about any side-effects you should discuss them with your pharmacist or doctor. Please tell your pharmacist or doctor if you notice any side-effects not mentioned in this leaflet. Storing your medicine Do not take Loratadine 1Omg Tablets after the expiry date shown on the packaging. Any out of date medicines should be returned to your pharmacist for disposal. There are no precautions for storage. REMEMBER keep all medicines out of the reach and sight of children. Your medicines may harm them. Date of Leaflet Preparation: July 2003 This leaflet applies to Loratadine 10mg Tablets only. 82901 02LT01 A