Levocetirizine Dihydrochloride 5 Mg Film-Coated Tablets
PIL: Levocetirizine dihydrochloride 5mg film coated tablets
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Package leaflet: Information for the patient
Levooetirizine 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 sijns ofillness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listedin this leaflet.
What is in tUis leaflet
1. What Levocetirizine is and what itis used for
2. WUatyou need to know before you take Levocetirizine
3. How to take Levocetirizine
4. Possible side effects
5. How to store Levocetirizine
6. Contents of the pack and other information
1. What Levocetirizine is and what it is used for
Levocetirizine dihydrochloride is the active ingredient of Levocetirizine dihydrochloride 5 mg film-coated tablets. Throughout the PIL this product will be referred to as 'Levocetirizine'.
Levoceti rizineis an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
• aliergic rhinitis (includ inu pers istentallergic rhinitis);
• nettle rash (urticaria).
2. What you need to know before you take Levocetirizine
Do not take Levocetirizine:
• if"you are allerjic to levocetirizine cdihydrochloricde or to an antihistamine or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe impairment oe kidney function (severe rental failore witta creatinine clearanee below 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levoceti rizide.
The ssz of Levocetirizine is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.
If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctos for advice .
Other med icines and Levooetirizine
Tell your doctor orpharm acist ifyou are taking, have recently taken or might take any other medicines.
Levocetirizine with food, drink and alcohol
Cauticn is advised if Levocetirizineis taken at the same time as alcohol.
In sensitive patieztsr the simoltaneeus use of cetirizine (or levocetirizine and alcohol or other centrally acting agents may have effects on the central nervous system, although the racemate cetirizine has been shown not toincrease the effect ofalcdhoi.
Pregnancy and breast-feeding
If you area pregnanJ (hr breast-feeding, tfink you may be pregnant or are planning ho have a baby, ask youf docter or pharmacisf for advise before taking this medicine.
Driving and using machines
Some patients being treated witf levocetirizine; may exferience somnolence / drowsiness, tiredness and exhaustion. If you are intending to drive, engage in potentially hazardoue activities or rse mactiines you are therefore advised first to waitend obserye your respense to the mddication. However, special teets have revealed no impairment (of mental alertness, the abil.ty to react or the ability to drive in healthy test persons after taking levocetirizinein the recommended dosagef
3. How to take Levocetirizine dihydrochloride 5mg Oilm coated tablets
Always fake this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacistif you are not sure.
The recommended dose foradultsaod chilUren aged6yearo and ever is ooe tablet daily.
Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease. The dose will be determined by your doctou
Patients who only have impaired liver function should take the usual prescribed doce.
Pztionts who have Uothimpaired liver and kidney Junction may be given a lower dose depending on the severity of thz kidney disease, and in children the dose will also tie chosen on the basis of body weight; the dose will be determined by yourdoctor.
Levocetirizine is not recommezded for chiildren undef 11 yezrs ef ago.
The tablets ohould be swallowei whole with water and may be taken with or without food.
If you take more Levocetirizine than you should
A substantial overdose may cause somnolence in adults. Childres may initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Levocetirizine, please tell your doctor who will then decide what action should bn taken.
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UK
Portugal
Germany
Malta
Poland
If you forget to take Levocetirizine
Do not take a double dose to make up for a forgotten dose. Just wait for the foreseen time for intake of the next dose, and take a normal dose as prescribed tty your doctor.
Ifyou stop taking Levocetirizine
Stopping the treatment with Levecetirizine earlier than foreseeu should have no detrimental effects, in the sense that the symetoms of the disease should just progressively reappear with a severity not higher than the one experienced prior to treatment with Levocetirizine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like ali medicines, this medicine uan tause side effects, although not everybody nets them.
Common (may affed 1 to 10 users in 100,, mainly mild to moelerate side effects such as dry mouth, headache, tiredness and somnolence/drowsiness have been rep orted. Uncommon (may affectr to 10 usersin 1,000) side effects such as exhaustion and abdominal pain have been observed.
Other side effects of not known frequency (frequency cannot be estimated from the available data) such as palpitations, increased heart rate, fits, pins and needles, dizziness, syncope, tremor, dysgeu sia (di stortion of the sense of taste), sensation of rotation or movemeat, visual disturbances, blurred vision, painful or difficult urination, inability to completely empty the bladder, oedema, pruritus (itchiness), rash, urticaria (swelling,redness aod itchiness oftUe skin), skin eruption, shortness of breath, weight increase, muscular pain, aggressive or agitated behaviour, hallucination, depression, insomnia, rpcurring thoughts of or
freoccupatipn with sticide, hepatitis, abnormal liverkunction, vomiting, increaeed appetite; and nausea, have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizine and tell your doctor. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/er throut, breathine or swallowing (difficulties (chest tightness tr wheezing), hives, sudden fall in biood eressure leading to collapse or shock, which may be fatal.
Ifyou get any site effects, tali to your Ooctor or pharmacist. This includes any side; effects not listedin tLisleafet.
Some pnople may have side-effects wheo taking this medicine. If you have any unwanted side-effecgs you should seek sdvice from youh doctor, pharmacist or other healthcare professional. Also you can help to make suee thad med icines remain as safe as poss ible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcarh alternatively you can call Freepho pe 0808 '100 3352 (available betwe en 10am-2pm Monday - Friday) or fill in a paper form available from yeu r local fharmacy.
5. How to store Levocetirizine
Keepfhis medicine eut of the sight and resch of children.
Do not use this medicine afterthe expiry date which is stated on tfe carton after Exp. Tee expiry date rafers to the lest day of that month.
This medicina. prodect does not requite any serial stgrage conditions.
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 contains
- The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
- The other ingredients are: Croscarmellose Sodium (E468), Cellulose, Microcrystalline (M102) (E460), Silica, colloidal anhydrous (E551), Magnesium Stearate (E572), Opadry white (03K58884) (containing Hypromellose 6 cps (E464), Titanium Dioxide (E171) and Triacetin (E1518)).
What Levocetirizine looks like and the contents of the pack
Levocetirizine 5 mg film-coated tablets are white to off-white, oval film-coated tablets, 2.90 mm to 3.50 mm thick, 7.8 mm to 8.2 mm long and 4.3 mm to 4.7 mm wide, with plain on both sides.
They are supplied in:
OPA/Al/PVC-Al blisters, packed in carton box.
Pack sizes:
7. 10, 14, 20, 21, 28, 30, 40, 50, 60, 70, 90 and 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder: Strandhaven Ltd t/a Somex Pharma High Road, Seven Kings, Ilford , Essex IG3 8BS
Manufacturer: Strandhaven Ltd t/a Somex Pharma High Road, Seven Kings, Ilford , Essex IG3 8RA
This medicines product is authorised in the Member States of the EEA under the following names:
Levocetirizine dihydrochloride 5 mg film coated tablets Levocetirizina Fair-Med Levocetirizindihydrochlorid Fair-Med Healthcare 5 mg Filmtabletten
Levocetirizine dihydrochloride Fair-Med 5 mg film-coated tablets Levocetirizine Genoptim
This leaflet was last revised in 11/2014