Levocetirizine Dihydrochloride 5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
levocetirizine dihydrochloride 5 mg film-coated tablets
* > 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 symptoms 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.
- The name of this medicine is Levocetirizine dihydrochloride 5 mg film-coated tablets but it will be referred to as Levocetirizine throughout this leaflet.
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Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor before taking Levocetirizine.
other medicines and Levocetirizine.
Levocetirizine is not known to interact with other medicines, however, you should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even medicines bought without a prescription.
Levocetirizine with food, drink and alcohol.
Alcohol can cause drowsiness in some people if taken at the same time as Levocetirizine. You should avoid drinking alcohol whilst taking Levocetirizine.
Pregnancy and breast-feeding.
If you are pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines.
Levocetirizine may cause drowsiness, tiredness and weakness. If affected, do not drive or operate machinery.
Levocetirizine 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.
1. What Levocetirizine is for.
2. Before you take Levocetirizine.
3. How to take Levocetirizine.
4. Possible side effects.
5. How to store Levocetirizine.
6. Further information.
Levocetirizine belongs to a group of medicines called antihistamines. These are used to treat the symptoms of allergies, such as:
• swelling and irritation inside the nose (rhinitis)
• raised, red itchy skin (urticaria)
If you are not sure why you have been prescribed these tablets then please ask your doctor.
Do not take Levocetirizine if you:
• are allergic to Levocetirizine dihydrochloride or to any other antihistamine or to any of the other ingredients (listed in section 6 of this leaflet).
• have severe kidney problems.
Always take Levocetirizine exactly as your doctor has told you.
The tablets should be swallowed whole, with a drink of water. Do not chew or crush. Levocetirizine may be taken with or without food.
You should check with your doctor or pharmacist if you are not sure.
Dosage
Adults and children over 6 years of age: The usual dose is one tablet daily.
Children between 2-6 years of age: The use of Levoceti-rizine Tablets is not recommended. A liquid form of this medicine should be used in this age group.
Children under 2 years of age: Not recommended
Elderly: Your doctor will decide on the best dose for you based on how well your kidneys are working.
Patients with kidney problems: Your doctor will decide on the best dose for you based on how well your kidneys are working.
Patients with liver problems: The usual adult dose can be taken.
if you take more Levocetirizine than you should
Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the packaging with you so that the doctor knows what you have taken. The symptoms of an overdose in adults may include drowsiness, and in children initially agitation and restlessness, followed by drowsiness.
if you forget to take Levocetirizine
If you forget to take a dose, take it as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
if you get any of the following side effects, STOP TAKING this medicine and see a doctor or go to a hospital straight away:
• an allergic reaction, the signs of which may include swelling of the face, lips, mouth or throat leading to difficulty in breathing or swallowing; skin rash, itching or hives
Tell your doctor or pharmacist if any of the following side effects become serious or last longer than a few days:
Frequency not known:
• headache, drowsiness
• dry mouth
• tiredness
• weakness
• abdominal pain
• increased appetite
• aggressive or agitated behaviour, hallucinations, depression, sleeplessness, suicidal thoughts
• fits, a pins and needles sensation, dizziness, a brief loss of consciousness, tremor, distortion of sense of taste
• vertigo
• problems with your vision
• increased awareness of your heart beat (palpitations) or increased heart beat (tachycardia)
• shortness of breath
• feeling sick (nausea) or being sick (vomiting)
• hepatitis, which may cause yellowing of the skin or whites of the eyes (jaundice)
• painful urination, lack of ability to urinate
• muscle pain
• weight increase
• abnormal liver function blood tests
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use these tablets after the expiry date, which is stated on the packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
what Levocetirizine contain
The active substance, (the ingredient which makes the medicine work), is levocetirizine dihydrochloride. Each tablet contains 5 mg of levocetirizine dihydrochloride.
The other ingredients are; microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E 171), macrogol 400, polysorbate 80.
what Levocetirizine looks like and contents of the pack
Levocetirizine Tablets are round, white, film-coated tablets with ‘161’ on one side and ‘H’ and a score line on the other.
Levocetirizine is supplied in blister packs of 1, 2, 4, 5, 7, 10, 14, 15, 20, 21,28, 30, 40, 50, 56, 60, 70, 90, 100 and 110 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd floor, PC. 1060, Nicosia, Cyprus
Manufacturer
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 01/2015
A0142/O/PIL/A1