Loratadine 10mg Allergy Relief Film-Coated Tablets
PACKAGE LEAFLET
Package leaflet: Information for the patient Loratadine 10 mg Allergy Relief Film-Coated Tablets
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.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk a doctor if you do not feel better or if your symptoms feel worse.
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.
This medicine is used to treat the symptoms of allergies. These allergies can happen all year round or they can be seasonal eg. hayfever. The symptoms include sneezing, itchy runny nose and itchy skin. Loratadine 10 mg Allergy Relief Film-Coated Tablets can also be used to relieve itchy, burning eyes.
2. What you need to know before you take Loratadine Do not take Loratadine if:
• If you are allergic to loratadine or any of the other ingredients in this medicine (listed in see section 6 above).
• you are pregnant or are breast-feeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Loratadine if:
• you haveliver problems
• you are going to have a skin (allergy) test, tell the doctor you are taking Loratadine, as antihistamines can effect skin test results. You will need to stop treatment 48 hours before the test.
Long term treatment with Loratadine can cause dry mouth, so good oral hygiene is important. Brush your teeth regularly.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Loratadine.
Children
Do not give Loratadine to children under 2 years of age or with a bodyweight less than 30 kg.
There are other formulations that are more suitable for children under 2 years of age or weighing less than 30 kg.
Other Medicines and Loratadine
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines taken without a prescription.
• Cimetidine , to treat heartburn or stomach ulcers
• Antibiotics such as Erythromycin,
• Antifungals such as Fluconazole and Ketoconazole
• Quinidine, to treat a heart condition
• Fluoxetine, to treat depression
• Amfebutamone/ Buproprion as an aid to stop smoking.
Pregnancy and breast-feeding
Do not take Loratadine if you are pregnant.
Do not take Loratadine if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines
Loratadine is not expected to cause drowsiness. However, very rarely some people experience drowsiness, which may affect their ability to drive of use machines.
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 this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Swallow the tablet whole with a glass of water.
The recommended dose is:
For adults and children over 12 years old: Take one 10 mg tablet per day.
For children under 12 years who weigh more than 30 kg: Take one 10 mg tablet per day.
Loratadineshould not be given to children under 2 years or with a bodyweight less than 30 kg.
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
If you take more Loratadine than you should, talk to your doctor or nearest hospital casualty department straight away. Symptoms of an overdose include drowsiness, a very fast heartbeat and headache.
If you forget to take Loratadine
Take the recommended dose as soon as you remember. Wait at least 24 hours before taking another tablet. Do not take a double dose to make up for a forgotten tablet.
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.
Stop taking Loratadine immediately and see a doctor or go to a hospital straight away if you have the following side effects:
Very Rare (may affect up to 1 in 10,000 people)
• Severe allergic reaction, symptoms include itching, skin rashes, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing, narrowing of airways.
The following side effects may be seen with Loratadine:
Common (may affect more than 1 in 10 people):
• Headache
• Drowsiness
• Nervousness
Uncommon (may affect up to 1 in 100 people):
• Increased appetite
• Difficulty sleeping
Very Rare (may affect up to 1 in 10,000 people):
• Fits
• Dizziness
• Fast or irregular heart beat
• Palpitations
• Feeling sick
• Inflammation of the stomach which can cause stomach pain and sickness
• Dry mouth
• Changes in the way your liver works
• Rash
• Hair loss
• Tiredness
• Nose bleeds
• Sore throat
In children aged between 2 and 12 years, common side effects include tiredness, headache and feeling nervous.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 label, carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Loratadine contains
The active substance is loratadine. Each film-coated tablet contains 10 mg of loratadine.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, pregelatinized starch, hydrated colloidal silica, magnesium stearate, carnauba wax and talc.
The film-coat contains hypromellose and macrogol 400 and 6000.
What Loratadine looks like and contents of the pack
Loratadine tablets are white round biconvex shape with ‘LR 10’ on one side. Loratadine is available in blister packs of 7 tablets.
Marketing Authorisation Holder and Manufacturer
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom
This leaflet was last revised in 05/2015.
5