Loratadine 10mg Film-Coated Tablets
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Loratadine 10 mg Film-Coated Tablets
loratadine
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.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Loratadine is and what it is used for
2. What you need to know before you take Loratadine
3. How to take Loratadine
4. Possible side effects
5. How to store Loratadine
6. Contents of the pack and other information
1. What Loratadine is and what it is used for
Loratadine belongs to a group of medicines called antihistamines which are used to treat the symptoms of allergies such as with hayfever and year-round allergies, for example from house dust mites.
Loratadine acts to reduce the allergic reactions and their unpleasant symptoms such as sneezing, runny or itchy nose, and burning or itchy eyes in adults and children over the age of 2 years and with a body weight more than 30 kg.
Loratadine can also be used to help relieve symptoms of urticaria, an allergic skin reaction like itching, rashes, hives nettle rash.
2. What you need to know before you take Loratadine Do not take Loratadine:
- if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Loratadine:
- if you have severe liver problems
During treatment with Loratadine:
If you are due to have some skin tests. You should stop taking Loratadine 48 hours before the test to avoid affecting the test results.
Children and adolescents
Do not give Loratadine to children under 2 years old. Do not give Loratadine to children between 2 and 12 years old with a body weight less than 30 kg.
Other medicines and Loratadine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
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.
It is not recommended to take Loratadine during pregnancy.
Loratadine should not be used during breast-feeding as it can pass into breast milk.
Driving and using machines
Very rarely some people experience tiredness while taking Loratadine; if this happens to you it may affect your ability to drive and operate machinery.
Loratadine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Loratadine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablet with a glass of water. The tablet can be divided into equal doses. You can take Loratadine with or without food.
For adults, the elderly and children over 12 years old:
The recommended dose is one tablet per day.
Use in children and adolescents
30 kg: 30 kg:
For children under 12 years with a bodyweight more than The recommended dose is one tablet per day.
For children under 2 years or with a bodyweight less than Do not give Loratadine.
For patients with severe liver problems: Your dose may need to be reduced, discuss this with your doctor before taking these tablets.
If you take more Loratadine than you should
Contact your doctor or the nearest casualty department immediately. Take the container and any remaining tablets with you. You might feel sleepy or get a headache or have a fast heart beat.
If you forget to take Loratadine
Take it as soon as possible. However, if you do not remember until the following day, do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest hospital casualty department straight away.
Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing or swallowing. Fits.
Other possible side effects
Common: may affect up to 1 in 10 people
• Sleepiness
Uncommon: may affect up to 1 in 1,000 people
• Headache
• Increased appetite
• Difficulty sleeping (insomnia)
Very rare: may affect up to 1 in 10,000 people
• Dizziness
• Feeling sick (nausea), dry mouth or inflammation of the stomach (symptoms are pain, vomiting, diarrhoea, nausea)
• Fast heart beat or palpitation
• Liver problems
• Rash or hair loss
• Tiredness (fatigue)
Additional side effects in children
In children aged 2 to 12, headache, nervousness and tiredness (fatigue) were reported as common side effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Loratadine
Keep this medicine out of the sight and reach 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 the month.
Store in the original package.
Do not throw away any medicines via wasterwater 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 Loratadine contains
- The active substance is loratadine. Each tablet contains 10 mg loratadine.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, pregelatinised starch, hydrated colloidal silica, magnesium stearate, hypromellose, macrogol, carnauba wax and talc.
What Loratadine looks like and contents of the pack
Loratadine 10 mg Film-coated Tablets are white, round with a score line on one side and marked “LR10” on the other side.
The tablets are available in blister packs of 5, 7, 10, 14, 15, 20, 21, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
Manufacturer
Laboratorios Lesvi, SL, Avda Barcelona 69, 08970 Sant Joan Despi, Barcelona, Spain. McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Loratadin Arcana 10 mg - Filmtabletten
Belgium Loratadine Mylan 10 mg filmomhulde tabletten
France LORATADINE MYLAN 10 mg, comprime pellicule
Greece LORATADINE/GENERICS F.C TAB 10 mg/TAB
Ireland Histaclar 10mg film coated Tablets
Luxembourg Loratadine Mylan 10 mg
Portugal Loratadina Mylan
The Netherlands Loratadine Mylan 10 mg, fimlomhulde tabletten United Kingdom Loratadine 10mg Film-Coated Tablets
This leaflet was last revised in March 2015