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Cetirizine 10 mg film-coated tablets (Cetirizine hydrochloride)

Read all of this leaflet carefully before you taking or have recently taken or might take any other start taking this medicine because it contains medicines, including medicines obtained without a important information for you. prescription. This medicine is available without prescription. However, you still need to use Cetirizine 10 mg Due to the profile of cetirizine, no interactions with Tablets carefully to get the best results from it. other drugs are expected. - Keep this leaflet. You may need to read it again. Taking Cetirizine 10 mg Tablets with food and - If you have any further questions, ask your doctor drink or pharmacist. Food does not noticeably affect the absorption of - You must contact a doctor if your symptoms worsen cetirizine. or do not improve after 3 days. - If you get any side effects, talk to your doctor or No interactions having a noticeable impact have pharmacist. This includes any possible side effects been observed between (at the blood level not listed in this leaflet. See section 4. of 0.5 per mille (g/l) corresponding to one glass of - In this leaflet Cetirizine 10 mg film-coated tablets will wine) and cetirizine used at the recommended doses. be called Cetirizine 10 mg Tablets However, as it is the case with all , it is recommended to avoid consumption of alcohol while What is in this leaflet: taking this medicine. 1. What Cetirizine 10 mg Tablets are and what they are used for and breast-feeding 2. What you need to know before you take Cetirizine If you are pregnant or breast-feeding, think you may 10 mg Tablets be pregnant or are planning to have a baby, ask your 3. How to take Cetirizine 10 mg Tablets doctor for advice before taking this medicine. 4. Possible side effects Cetirizine 10mg Tablets should be avoided in 5. How to store Cetirizine 10 mg Tablets pregnant women. 6. Contents of the pack and other information Accidental use of the drug by a pregnant woman should not produce any harmful effects on the 1. WHAT CETIRIZINE 10 MG TABLETS ARE AND foetus. Nevertheless, the medicine should only be WHAT THEY ARE USED FOR administered if necessary and after medical advice. Cetirizine passes into breast milk. Side effects Cetirizine hydrochloride is the active ingredient of associated with cetirizine may be seen in breastfed Cetirizine 10 mg Tablets. infants. Therefore, you should not take Cetirizine 10 Cetirizine 10 mg Tablets is an antiallergic medication. mg Tablets during breast-feeding unless you have In adults and children aged 6 year and above, contacted a doctor. Cetirizine 10 mg Tablets are indicated Allergy skin test - for the relief of symptoms of hay fever (seasonal If you are going to have an allergy skin test stop ) and allergies such as dust or taking Cetirizine 10 mg Tablets for three days before pet allergies (perennial allergic rhinitis), such as the test. This medicine may affect your allergy test sneezing, itchy, runny and blocked nose, itchy, red results. and watery eyes. - for the relief of swelling, redness and itchiness of Driving and using machines the skin (symptoms of chronic idiopathic urticaria, Clinical studies have produced no evidence of which is also known as chronic nettle rash). impaired attention, alertness and driving capabilities after taking Cetirizine 10 mg Tablets at the 2. WHAT YOU NEED TO KNOW BEFORE YOU recommended dose. TAKE CETIRIZINE 10 MG TABLETS You should closely observe your response to the drug after you have taken Cetirizine 10 mg Tablets Do not take Cetirizine 10 mg Tablets if you are intending to drive, engage in potentially - if you have a severe kidney disease (severe renal hazardous activities or operate machinery. You should failure with creatinine clearance below 10 ml/min). not exceed the recommended dose. If you are a - if you are known to be allergic (hypersensitive) to sensitive patient, you may find that the simultaneous the active substance of Cetirizine 10 mg Tablets or use of alcohol or other nervous depressant agents any of the other ingredients of these tablets (these may additionally affect your attention and ability to are listed below, in section 6 “Further information”). react. - if you are known to be allergic (hypersensitive) to (closely related active substances of Cetirizine 10 mg Tablets contains lactose other medicines). Cetirizine 10 mg Tablets contain lactose; if you have - if you are known to be allergic (hypersensitive) been told by your doctor that you have an intolerance to drugs from the family, for example to some sugars, please contact your doctor before , , meclozine, . taking this medicinal product. Warnings and precautions 3. HOW TO TAKE CETIRIZINE 10 MG TABLETS Talk to your doctor or pharmacist before taking Cetirizine 10 mg Tablets. Always take Cetirizine 10 mg Tablets exactly as If you have kidney problems, please ask your doctor your doctor has told you. Check with your doctor for advice; if necessary, you may have to take a if you are not sure. lower dose. The new dose will be determined by your doctor. Tablets need to be swallowed with a glass of liquid. If you have predisposition factors of urinary retention Children aged 6 to 12 years (eg: spinal cord lesion, prostatic hyperplasia) as The recommended dose is 5 mg twice daily as half a cetirizine increases the risk of urinary retention, twice a day. please ask your doctor for advice. Adults and children aged 12 years and over: If you are an epileptic patient or a patient at risk of The recommended dose is 10 mg once daily as one convulsions, you should ask your doctor for advice. tablet. Children Patients with moderate to severe renal Do not give this medicine to children below the age of impairment: 6 years because the tablet formulation does not allow Patients with moderate renal impairment are the necessary dose adjustments. recommended to take 5 mg once daily as a half tablet. If you suffer from severe kidney disease, please Other medicines and Cetirizine 10 mg Tablets contact your doctor or pharmacist who may adjust Please tell your doctor or pharmacist if you are the dose accordingly. If your child suffers from kidney disease, please - Convulsions contact your doctor or pharmacist who may adjust - Weight increased the dose according to your child’s needs. - Aggression, confusion, depression, hallucination If you feel that the effect of Cetirizine 10 mg Tablets (hearing or seeing things), insomnia (difficulty is too weak or too strong, please consult your doctor. sleeping) - Urticaria (swelling,redness and itchiness of the Duration of treatment skin) The duration of treatment depends on the type, duration and course of your complaints. Very rare side effects (may affect up to 1 in 10,000 Please ask your doctor or pharmacist for advice. patients) - Thrombocytopenia (low level of blood platelets), If you take more Cetirizine 10 mg Tablets than you which increases risk of bleeding or bruising should - Accommodation disorder (impaired ability of the If you think you have taken an overdose of Cetirizine eye to focus), blurred vision, oculogyration (eyes 10 mg Tablets, please inform your doctor. Your doctor moving in an uncontrolled circular manner) will then decide what measures, if any, should be - Syncope (fainting), dyskinesia (involuntary taken. movements), dystonia (abnormal prolonged After an overdose, the side effects described below muscular contractions),tremor, dysgeusia (altered may occur with increased intensity. taste) Adverse effects such as confusion, diarrhoea, - Tics (sudden abnormal repetitive muscle movement) dizziness, tiredness, , ailing, dilating - Fixed drug eruption (may look like round or oval (widening) of the pupil, itching, restlessness, sedation, patches of redness and swelling of the skin) , stupor (lowered consciousness), - Abnormal elimination of urine (bed wetting, pain abnormal rapid heart rate, tremors and urinary and/or difficulty passing water) retention have been reported. Not known frequency of side effects (frequency If you forget to take Cetirizine 10 mg Tablets cannot be estimated from the available data) If you forget to take a tablet, take it as soon as you - Increased appetite remember, but wait at least 24 hours before taking - Suicidal ideation (recurring thoughts of or the next tablet. Do not take a double dose to make up preoccupation with suicide), nightmare for a forgotten dose. - Amnesia (loss of memory), memory impairment If you stop taking Cetirizine 10 mg Tablets - Vertigo (sensation of rotation or movement) Rarely, pruritus (intense itching) and/or urticaria may - Urinary retention (inability to completely empty the return if you stop taking Cetirizine 10 mg Tablets. urinary bladder) - Pruritus (intense itching) and /or urticaria upon If you have any further questions on the use of this discontinuation product, ask your doctor or pharmacist. - Joint pain - Rash with blisters containing pus 4. POSSIBLE SIDE EFFECTS - Hepatitis (inflammation of the liver) Like all medicines, Cetirizine 10 mg Tablets can cause side effects, although not everybody gets them. Reporting of suspected adverse reactions If you think you have any side effects not In very rare cases people have thought about mentioned in this leaflet, please inform your committing suicide and if you feel this way then doctor or pharmacist. stop taking the tablets and see your doctor This includes any possible side effects not listed immediately. in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www. If you develop one of the very rare side effects mhra.gov.uk/yellowcard or search for MHRA described below, please inform your doctor Yellow Card in the Google Play or Apple App straight away. Store. At the first signs of a severe allergic By reporting side effects you can help provide (hypersensitivity) reaction (symptoms include: more information on the safety of this medicine. rash, itchiness and fever, difficulty breathing, swelling of the neck, throat, tongue, face, eyelids 5. HOW TO STORE CETIRIZINE 10 MG TABLETS or lips) stop taking the tables and contact your doctor immediately. Keep out of the sight and reach of children. This reaction may start soon after you first take the medicine or it might start later. Do not use Cetirizine 10 mg Tablets after the expiry Your doctor will then assess the severity and date which is stated on the box and blister. decide on any further measures that may be This medicine does not require any special storage necessary. conditions. The following side effects have also been reported. 6. CONTENTS OF THE PACK AND OTHER INFORMATION Common side effects (may affect up to 1 in 10 patients) What Cetirizine 10 mg Tablets contain - , somnolence (sleepiness) - The active substance of Cetirizine 10 mg Tablets - Dizziness, headache, is cetirizine hydrochloride. One film coated tablet - Dry mouth, nausea (feeling sick), diarrhoea (children contains 10 mg cetirizine hydrochloride. only) - The other ingredients are: pregelatinized starch, - Pharyngitis (sore throat), rhinitis (swelling and lactose, maize starch, povidone, magnesium irritation inside the nose (children only)) stearate, macrogol 6000, basic polymethacrylate, titanium dioxide (E171), talc. Uncommon side effects (may affect up to 1 in 100 patients) What Cetirizine 10 mg Tablets look like and - Pruritus (itching), rash contents of the pack - Abdominal pain White, capsule shaped film-coated tablets with a - Agitation score on one side. - Asthenia (feeling of weakness), malaise (feeling of There are 7, 10 or 30 tablets in a pack. being generally unwell) - Paraesthesia (abnormal feelings of the skin), tingling Not all pack sizes may be marketed. in the hands and feet Marketing Authorization Holder and / Manufacturer: Dexcel®-Pharma Ltd., Dexcel®-Pharma Ltd., Rare side effects (may affect up to 1 in 1,000 7 Sopwith Way, Drayton Fields, Daventry, patients) Northamptonshire, NN11 8PB,UK. - (heart beating fast) - Oedema (generalised swelling due to water This leaflet was last revised in June 2019. retention) - Liver function abnormal