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LORATADINE 5MG/5ML SYRUP

Active substance(s): LORATADINE / LORATADINE / LORATADINE

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PATIENT INFORMATION LEAFLET

Loratadine 5 mg/5ml Syrup
Read this leaflet carefully because it contains important information for you. This medicine is available without prescription for you to treat a mild illness without a doctors help. Nevertheless, you still need to use Loratadine carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must see your doctor if your symptoms worsen or do not improve. In this leaflet: 1. Loratadine; what it is and what its used for 2. Before you take Loratadine Syrup 3. How to take Loratadine Syrup 4. Possible side effects 5. Storing Loratadine Syrup The name of your medicine is Loratadine 5 mg/5ml Syrup. The active ingredient is Loratadine. Other ingredients are sucrose, sodium benzoate (E211), citric acid, peach flavour, benzyl alcohol, glycerol, propylene glycol and purified water Marketing Authorisation holder and company responsible for manufacture: Teva UK Limited, Eastbourne BN22 9AG UK.

1. LORATADINE SYRUP; WHAT IT IS AND WHAT ITS USED FOR




Each 5ml spoonful contains 5 mg of loratadine. Loratadine belongs to a group of drugs called antihistamines which help to relieve the symptoms of some allergies. The product is available in bottles containing 50, 60, 70, 100,150 and 200 ml. Your medicine is used to relieve symptoms such as sneezing, running nose and burning, itchy eyes due to hayfever and other allergies. Loratadine syrup can also be taken to relieve symptoms due to skin allergies such as rash, itching or urticaria (hives). It can also be given to children aged 2 to 12 years to relieve the symptoms of hay fever or skin allergies.

2. BEFORE YOU TAKE LORATADINE SYRUP
Do not take if you: Are sensitive to any of the ingredients in the medicine, listed above.

Take special care with Loratadine if you have: Liver problems. Other precautions you should take Antihistamines may prevent a response to allergens in skin allergy testing; therefore you should stop taking this medicine at least 2 days before any such testing. Pregnancy and Breast-feeding Do not take Loratadine if you are pregnant or breast-feeding. Important information about some of the ingredients of this product Each 5 ml measure of the medicine contains 3.125 g of sucrose (sugar). Sucrose is unsuitable for people with fructose, glucose or sucrose intolerance Glycerol can be harmful in high doses as it can cause headache, stomach upset and diarrhoea Sodium benzoate (E211) is a mild irritant. Driving and using machines: Loratadine may make you feel drowsy. Do not drive or operate any tools or machines if affected.

3. HOW TO TAKE LORATADINE SYRUP
If your doctor has prescribed this medicine, always follow your doctors instructions. Otherwise, follow the instructions below. If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist. Use the spoon provided to make sure you have the correct dose. Adults and Children over 12 years of age Two 5 ml spoonfuls (10 mg) once daily. Children aged 2 to 12 years Bodyweight more than 30kg: Two 5 ml spoonfuls (10 mg) once daily. Bodyweight 30kg or less: One 5 ml spoonful (5 mg) once daily. Children under 2 years of age Not recommended. Patients with severe liver impairment Adults and children over 2 years of age Bodyweight more than 30kg: Two 5 ml spoonfuls (10 mg) every other day. Bodyweight 30kg or less: One 5 ml spoonful (5 mg) every other day. If you take more than you should

If you (or someone else) swallow a lot of the liquid all together or if you think a child has accidentally swallowed any of the liquid, contact your nearest hospital casualty department or your doctor immediately. Overdose may cause sleepiness, fast heart rate and headache. If you forget to take your medicine If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Loratadine can have side effects. If you experience the following, stop taking Loratadine and tell you doctor immediately or go to the casualty department at your nearest hospital: a severe allergic reaction (swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. The following common side effects have been reported: Children aged 2 to 12 years: headache, nervousness and tiredness. Adults and children over 12 years: sleepiness, headache, increased appetite and difficulty sleeping. Other reported side effects are: Nervous system disorders: dizziness Cardiac disorders: palpitation (feeling your heartbeat) and fast heart rate Gastrointestional disorders: nausea (feeling sick), dry mouth, gastritis (nausea and vomiting) Hepato-biliary disorders: liver problems Skin disorders: rash and hair loss General disorders: tiredness. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist

5. STORING LORATADINE SYRUP
Keep Loratadine out of the reach and sight of children. There are no special storage instructions. Do not transfer the liquid to another container. Do not use Loratadine after the use before date on the outer carton. Once opened, use within 28 days. Return all unused medicines to your pharmacist for safe disposal.

Revised: July 2012 PL 00289/0643

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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