Cetirizine 10 mg film-coated tablets (Cetirizine hydrochloride)

Read all of this leaflet carefully before you the necessary dose adjustments. start taking this medicine because it contains important information for you. Other medicines and Cetirizine 10 mg Tablets This medicine is available without prescription. Please tell your doctor or pharmacist if you are taking However, you still need to use Cetirizine 10 mg or have recently taken any other medicines, including Tablets carefully to get the best results from it. medicines obtained without a prescription. - Keep this leaflet. You may need to read it again. Due to the profile of cetirizine, no interactions with - If you have any further questions, ask your doctor other drugs are expected. or pharmacist. - You must contact a doctor if your symptoms worsen Taking Cetirizine 10 mg Tablets with food and or do not improve after 3 days. drink - If you get any side effects, talk to your doctor or Food does not noticeably affect the absorption of pharmacist. This includes any possible side effects cetirizine. not listed in this leaflet. See section 4. No interactions having a noticeable impact have been - In this leaflet Cetirizine 10 mg film-coated tablets will observed between alcohol (at the blood level of 0.5 be called Cetirizine 10 mg Tablets per millilitre corresponding to one glass of wine) and What is in this leaflet: cetirizine used at the normal doses. However, as it is 1. What Cetirizine 10 mg Tablets are and what they the case with all antihistamines, it is recommended are used for to avoid consumption of alcohol while taking this 2. What you need to know before you take Cetirizine medicine. 10 mg Tablets Pregnancy and breast-feeding 3. How to take Cetirizine 10 mg Tablets If you are pregnant or breast-feeding, think you may 4. Possible side effects be pregnant or are planning to have a baby, ask your 5. How to store Cetirizine 10 mg Tablets doctor for advice before taking this medicine. 6. Contents of the pack and other information Cetirizine 10mg Tablets should be avoided in pregnant women. 1. WHAT CETIRIZINE 10 MG TABLETS ARE AND Accidental use of the drug by a pregnant woman WHAT THEY ARE USED FOR should not produce any harmful effects on the Cetirizine hydrochloride is the active ingredient of foetus. Nevertheless, the medicine should only be Cetirizine 10 mg Tablets. administered if necessary and after medical advice. Cetirizine 10 mg Tablets is an antiallergic medication. Cetirizine passes into breast milk. Therefore, you should not take Cetirizine 10 mg Tablets during In adults and children aged 6 year and above, breast-feeding unless you have contacted a doctor. Cetirizine 10 mg Tablets are indicated - for the relief of symptoms of hay fever (seasonal Allergy skin test allergic rhinitis) and allergies such as dust or If you are going to have an allergy skin test stop pet allergies (perennial allergic rhinitis), such as taking Cetirizine 10 mg Tablets for three days before sneezing, itchy, runny and blocked nose, red and the test. This medicine may affect your allergy test watery eyes. results. - 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 If you intend to drive, operate machinery, or perform Do not take Cetirizine 10 mg Tablets other tasks that need your full attention, you should - if you have a severe kidney disease (severe renal not exceed the recommended dose and you should failure with creatinine clearance below 10 ml/min). closely observe your response to the drug. 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 Cetirizine 10 mg Tablets contains lactose hydroxyzine (closely related active substances of Cetirizine 10 mg Tablets contain lactose; if you have other medicines). been told by your doctor that you have an intolerance - if you are known to be allergic (hypersensitive) to some sugars, please contact your doctor before to drugs from the piperazine family, for example taking this medicinal product. buclizine, cyclizine, meclozine, levocetirizine. Warnings and precautions 3. HOW TO TAKE CETIRIZINE 10 MG TABLETS Check with your doctor before taking Cetirizine 10 mg Always take Cetirizine 10 mg Tablets exactly as Tablets: your doctor has told you. Check with your doctor - if you have problems with your kidneys if you are not sure. - if you have predisposition factors of urinary retention (eg: spinalcord lesion, prostatic hyperplasia) as Tablets need to be swallowed with a glass of liquid. cetirizine increases the risk of urinary retention Children aged 6 to 12 years - you suffer from epilepsy or are at risk of convulsions The recommended dose is 5 mg twice daily as half a tablet twice a day. Take special care with Cetirizine 10 mg Tablets If you have kidney problems, please ask your doctor Adults and children aged 12 years and over: for advice; if necessary, you may have to take a The recommended dose is 10 mg once daily as one lower dose. The new dose will be determined by your tablet. doctor. Patients with moderate to severe renal impairment: If you are an epileptic patient or a patient at risk of Patients with moderate renal impairment are convulsions, you should ask your doctor for advice. recommended to take 5 mg once daily as a half tablet. Children If you suffer from severe kidney disease, please Do not give this medicine to children below the age of contact your doctor or pharmacist who may adjust 6 years because the tablet formulation does not allow 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 skin) Duration of treatment The duration of treatment depends on the type, Very rare side effects (may affect up to 1 in 10,000 duration and course of your complaints. patients) Please ask your doctor or pharmacist for advice. - Thrombocytopenia (low level of blood platelets), which increases risk of bleeding or bruising If you take more Cetirizine 10 mg Tablets than you - Accommodation disorder (impaired ability of the should eye to focus), blurred vision, oculogyration (eyes If you think you have taken an overdose of Cetirizine moving in an uncontrolled circular manner) 10 mg Tablets, please inform your doctor. Your doctor - Syncope (fainting), dyskinesia (involuntary will then decide what measures, if any, should be movements), dystonia (abnormal prolonged taken. muscular contractions),tremor, dysgeusia (altered After an overdose, the side effects described below taste) may occur with increased intensity. - Tics (sudden abnormal repetitive muscle movement) Adverse effects such as confusion, diarrhoea, - Swelling of the skin particularly around the face, dizziness, tiredness, headache, ailing, dilating fixed drug eruption (may look like round or oval (widening) of the pupil, itching, restlessness, patches of redness and swelling of the skin) sedation, somnolence, stupor, abnormal rapid - Abnormal elimination of urine (bed wetting, pain heart rate, tremors and urinary retention have been and/or difficulty passing water) 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 - Amnesia (loss of memory), memory impairment the next tablet. Do not take a double dose to make up - Vertigo (sensation of rotation or movement) for a forgotten dose. - Urinary retention (inability to completely empty the If you stop taking Cetirizine 10 mg Tablets urinary bladder) Rarely, pruritus (intense itching) and/or urticaria may - Pruritus (intense itching) and /or urticaria upon return if you stop taking Cetirizine 10 mg Tablets. discontinuation If you have any further questions on the use of this Reporting of suspected adverse reactions product, ask your doctor or pharmacist. If you think you have any side effects not mentioned in this leaflet, please inform your 4. POSSIBLE SIDE EFFECTS doctor or pharmacist. Like all medicines, Cetirizine 10 mg Tablets can cause This includes any possible side effects not listed side effects, although not everybody gets them. in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: In very rare cases people have thought about www.mhra.gov.uk/yellowcard committing suicide and if you feel this way then By reporting side effects you can help provide stop taking the tablets and see your doctor. more information on the safety of this medicine. If you develop one of the very rare side effects 5. HOW TO STORE CETIRIZINE 10 MG TABLETS described below, please inform your doctor straight away. Keep out of the sight and reach of children. At the first signs of a severe allergic (hypersensitivity) reaction (symptoms include: Do not use Cetirizine 10 mg Tablets after the expiry rash, itchiness and fever, difficulty breathing, date which is stated on the box and blister. swelling of the neck, throat, tongue, face, eyelids or lips) stop taking the tables and contact your This medicine does not require any special storage doctor immediately. conditions. This reaction may start soon after you first take the medicine or it might start later. 6. CONTENTS OF THE PACK AND OTHER Your doctor will then assess the severity and INFORMATION decide on any further measures that may be What Cetirizine 10 mg Tablets contain necessary. - The active substance of Cetirizine 10 mg Tablets The following side effects have also been is cetirizine hydrochloride. One film coated tablet reported. contains 10 mg cetirizine hydrochloride. - The other ingredients are: pregelatinized starch, Common side effects (may affect up to 1 in 10 lactose, maize starch, povidone, magnesium patients) stearate, macrogol 6000, basic polymethacrylate, - Fatigue, somnolence (sleepiness) titanium dioxide (E171), talc. - Dizziness, headache, - Dry mouth, nausea (feeling sick), diarrhoea (children What Cetirizine 10 mg Tablets look like and only) contents of the pack - Pharyngitis (sore throat), rhinitis (swelling and White, capsule shaped film-coated tablets with a irritation inside the nose (children only)) score on one side. Uncommon side effects (may affect up to 1 in 100 There are 7, 10 or 30 tablets in a pack. patients) Not all pack sizes may be marketed. - Pruritus (itching), rash - Abdominal pain Marketing Authorization Holder and / Manufacturer: - Agitation Dexcel®-Pharma Ltd., Dexcel®-Pharma - Asthenia (feeling of weakness), malaise (feeling of Ltd.,7 Sopwith Way, Drayton Fields, Daventry, being generally unwell) Northamptonshire, NN11 8PB,UK. - Paraesthesia (abnormal feelings of the skin), tingling This leaflet was last revised in January 2017. in the hands and feet Rare side effects (may affect up to 1 in 1,000 patients) - Tachycardia (heart beating fast) - Oedema (generalised swelling due to water retention) - Liver function abnormal (your doctor will know what to do)