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LEVOCETRIZINE DIHYDROCHLORIDE FILM COATED TABLETS 5 MG Package leaflet: Information for the patient Levocetirizine dihydrochloride 5mg Filmcoated 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
stored 6. Further Information
1. What Levocetirizine dihydrochloride is and what it is used for
Levocetirizine is an anti allergic agent. It is used to treat symptoms associated with allergic conditions, such as:
2. Before you are given Levocetirizine dihydrochloride Do not take Levocetirizine dihydrochloride if
What is in this leaflet 1. What Levocetirizine dihydrochloride is and what it is used for 2. Before you are given Levocetirizine dihydrochloride 3. How you will be given Levocetirizine dihydrochloride 4. Possible side effects 5. How Levocetirizine dihydrochloride is
hay fever year round allergies such as dust or pet allergies chronic nettle rash
you are allergic (hypersensitive) to levocetirizine, any other related substance, or any of the other ingredients of Levocetirizine dihydrochloride (see section 6 ‘What Levocetirizine dihydrochloride contains’). you suffer from severe kidney failure (less than 10 ml/min creatinine clearance) you have been told by your doctor that you have an intolerance to some sugars
Take special care with Levocetirizine dihydrochloride
If you suffer from epilepsy or are in any other way at risk of suffering 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.
Levocetirizine is not recommended in children less than 6 years since the currently available film-coated tablets do not allow dose adaptation. Taking other medicines Other medicines may be affected by levocetirizine. They, in turn, may affect how well levocetirizine works. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Levocetirizine dihydrochloride with food and drink Levocetirizine may be taken with or without food. You should be cautious if you take levocetirizine at the same time as alcohol In sensitive patients the effect of alcohol may be increased or different than expected. Pregnancy and breast-feeding No information is available on the safe use of levocetirizine during pregnancy or breastfeeding. When you are pregnant or breastfeeding you should only use levocetirizine if there is a clear benefit outweighing the
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possible risks. Your doctor will make this decision for you.
Your doctor or pharmacist will advise you on this.
Ask your doctor or pharmacist for advice before taking any medicine.
If you take more Levocetirizine dihydrochloride than you should
Driving and using machines
If you have taken more Levocetirizine than you should, you may experience the following symptoms: confusion, diarrhoea, dizziness, fatigue, headache, feeling unwell, dilation of the pupils, itching, restlessness, drowsiness, sleepiness, fast heart beat, shaking and difficulty passing urine. Contact your doctor or pharmacist immediately. They may empty your stomach or can take other measures to alleviate the symptoms.
In some patients levocetirizine may cause drowsiness, tiredness and exhaustion. If you experience any of these symptoms, then do not drive or operate any machines. Important information about some of the ingredients of Levocetirizine dihydrochloride These tablets contain lactose; if you have been told by your doctor that you have an intolerance to some sugars you must not take Levocetirizine dihydrochloride (see Section 2, Do not take).
3. How you will be given Levocetirizine dihydrochloride Always take levocetirizine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should swallow the tablet whole with water or another liquid. The usual dose for adults and children aged 6 years and over is one tablet daily. Children under 6 years of age should not take levocetirizine.
If you forget to take Levocetirizine dihydrochloride 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
Sleepiness Dizziness Headache Inflammation of the throat Swelling and irritation inside the nose (in children) Abdominal pain Dry mouth Feeling sick Tiredness
Uncommon side effects (occurring in more than 1 in 1000, but in less than 1 in 100 treated patients):
Sensation of tingling or numbness of the skin Diarrhoea Rash Itching Feeling of weakness Feeling unwell Agitation
If you stop the treatment with levocetirizine earlier than foreseen this should not cause any side effects. The symptoms you took levocetirizine for, may reappear however.
Rare side effects (occurring in more than 1 in 10,000 but in less than 1 in 1000 treated patients):
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible Side Effects
If you suffer from mild to moderate kidney failure, your doctor may prescribe a lower dose according to the severity of your kidney disease.
Like all medicines, levocetirizine can cause side effects, although not everybody gets them.
The duration of treatment depends on the type, duration and course of the complaints.
Common side effects (occurring in more than 1 in 100 treated patients):
Faster heart beat Fits Disorders of movement Hives Swelling of the skin Hypersensitivity (allergic reaction) Abnormal liver function Weight increase Aggression
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Confusion Depression Hallucinations Difficulty in sleeping
Very rare side effects (occurring in less than 1 in 10,000 treated patients):
Reduction in blood platelets, which increases risk of bleeding or bruising Changed or diminished taste sensation Fainting Blurry vision Painful urination Bedwetting Serious allergic reaction which causes swelling of the face or throat Local skin reaction Serious allergic reaction which causes difficulty in breathing or dizziness Shaking Muscle disorders Jerky movements Circular eye movements Tic
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The expiry date refers to the last day of that month.
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad 438225, Gujarat, INDIA
Store in the original package to protect from moisture
This leaflet was last revised in September 2019
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.
6. Further information What Levocetirizine dihydrochloride contains The active substance is levocetirizine. Each tablet contains 5 mg of levocetirizine dihydrochloride equivalent to 4. 2mg of levocetirizine. The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate (core) and hypromellose (E464), titanium dioxide (E171), and macrogol 400 (coating). What Levocetirizine dihydrochloride looks like and contents of the pack The film-coated tablets are white to offwhite, oval, biconvex tablets. They are supplied in blister packs of 30 tablets per box.
5. How Levocetirizine dihydrochloride is stored Keep out of the reach and sight of children. Do not use levocetirizine 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.
Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India