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 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 Levocetirizine dihydrochloride 5 mg is and what it is used for
2. What you need to know before you take Levocetirizine dihydrochloride 5 mg
3. How to take Levocetirizine dihydrochloride 5 mg
4. Possible side effects
5. How to store Levocetirizine dihydrochloride 5 mg
6. Contents of the pack and other information
1. What Levocetirizine dihydrochloride 5 mg is and what it is used for
This medicine is an anti-allergic agent. It is used to treat symptoms associated with allergic conditions, such as:
• hay fever
• year round allergies such as dust or pet allergies
• chronic nettle rash
2. What you need to know before you take Levocetirizine dihydrochloride 5 mg
Do not take Levocetirizine dihydrochloride 5 mg:
• if you are allergic to levocetirizine, any other related substance, or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from severe kidney failure (less than 10 ml/min creatinine clearance).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine dihydrochloride 5 mg,
• if you suffer from epilepsy or are in any other way at risk of suffering from fits. You should ask your doctor for advice.
• if you suffer from kidney failure. You may require a lower dosage and should discuss your situation with your doctor.
• if you are likely to be unable to empty your bladder (with condition such as spinal cord injury or enlarged prostate), please ask your doctor for advice.
Children
Levocetirizine is not recommended in children less than 6 years since the currently available film-coated tablets do not allow dose adaptation.
Other medicines and Levocetirizine dihydrochloride 5 mg
Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use any other medicines.
Levocetirizine dihydrochloride 5 mg with food, drink and alcohol
Levocetirizine may be taken with or without food.
Caution is advised if Levocetirizine dihydrochloride 5 mg is taken at the same time as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of Levocetirizine dihydrochloride 5 mg and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
Levocetirizine dihydrochloride 5 mg can be taken with or without food.
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.
Driving and using machines
Some patients being treated with Levocetirizine dihydrochloride 5 mg may experience somnolence/drowsiness, tiredness and exhaustion. Use caution when driving or operating machinary untill you know how this medicine affects you. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage.
Levocetirizine dihydrochloride 5 mg contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take levocetirizine dihydrochloride 5 mg
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should swallow the tablet whole with water or another liquid.
Dosage
The recommended dose for adults and children aged 6 years and over is one tablet daily. Special dosage instructions for specific populations:
Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.
Patients who have severe impairment of kidney function must not take Levocetirizine dihydrochloride 5 mg.
Patients who only have impaired liver function should take the usual prescribed dose.
Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.
No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.
Children under 6 years of age should not take levocetirizine.
Levocetirizine may be taken with or without food.
The duration of treatment depends on the type, duration and course of the complaints. Your doctor or pharmacist will advise you on this.
If you take more Levocetirizine dihydrochloride 5 mg than you should
If you take more Levocetirizine dihydrochloride 5 mg than you should, somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Levocetirizine dihydrochloride 5 mg, please tell your doctor who will then decide what action should be taken.
If you forget to take Levocetirizine dihydrochloride 5 mg
Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next tablet at the usual time.
If you stop taking Levocetirizine dihydrochloride 5 mg
If you stop the treatment with this medicine earlier than foreseen this should not cause any side effects. The symptoms you took levocetirizine for, may reappear however.
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.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizine dihydrochloride 5 mg and tell your doctor. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing) hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.
Other side effects
Common side effects (may affect up to 1 in 10 people)
Dry mouth, headache, tiredness and somnolence/drowsiness
Uncommon side effects (may affect up to 1 in 100 people):
Exhaustion and abdominal pain
Not known: frequency cannot be estimated from the available data
Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness, syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, painful or difficult urination, inability to completely empty the bladder, oedema, pruritus (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, ,shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizine dihydrochloride
5 mg and tell your doctor. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing) hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.
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 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 Levocetirizine dihydrochloride 5 mg
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 packaging after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year.
The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture
Do not throw away any medicines via wastewater 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 Levocetirizine dihydrochloride 5 mg contains
• The active substance is levocetirizine. Each tablet contains 5 mg of levocetirizine dihydrochloride equivalent to 4. 2 mg of levocetirizine.
• The other ingredients are
Tablet core: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica and magnesium stearate (E572).
Film-coating: hypromellose (E464), titanium dioxide (E171), and macrogol 400.
What this medicine looks like and the contents of the pack
Levocetirizine dihydrochloride 5 mg film-coated tablets are white to off white, film coated oval shaped tablet; one side of the tablet is debossed with "LC5". The other side of the tablet is plain.
They are supplied in blister packs of 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112 or 120 tablets per box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str.3, 89079Ulm, Germany.
Manufacturers:
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands. or
Synthon Hispania S.L., Castello 1, Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain. or
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany This leaflet was last revised in May 2016
PL 15773/0861-4