. If you have a phaeochromocytoma (a tumour which . Stimulants or appetite suppressants and drugs Package leaflet: Information for the user affects your heart rate and blood pressure). used to treat congestion and asthma . If you have an overactive thyroid. (sympathomimetic drugs). Non-drowsy Sinutab® Tablets . If you have glaucoma (increased pressure in the eye). . Anticoagulants (to thin the blood such as ( 500mg . If you have severe kidney problems. warfarin). hydrochloride 30mg) . If you have lung disease or breathing difficulties. . Oral contraceptives (“the pill”). . If you are taking, or have taken in the last two weeks, . Anticonvulsants (drugs used to treat epilepsy). Your medicine is available using the above name but will be drugs for depression known as . Anticholinergic drugs (drugs used to treat cramps referred to as 'Sinutab' throughout this leaflet. Monoamine Oxidase Inhibitors (MAOIs) or or spasms such as atropine). Reversible Inhibitors of Monoamine Oxidase (RIMAs). Read all of this leaflet carefully before you . If you are taking any other cough and cold If you are not sure about any of the medicines you are start using this medicine because it contains medicines. taking, show the bottle or pack to your pharmacist. If any of these bullet points apply to you now or in the past, important information for you. . If you are taking beta blockers (used to treat high blood pressure). talk to a doctor or pharmacist. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. . In children under 12 years. Pregnancy and Breast-feeding . Keep this leaflet. You may need to read it again. If any of these apply to you, get advice from a doctor or . If you are pregnant or breast-feeding, think you may be . Ask your pharmacist if you need more information or pharmacist without using Sinutab. pregnant or planning to have a baby, ask your doctor or advice. pharmacist for advice before using this medicine. . If you get any side-effects, talk to your doctor or Warnings and Precautions pharmacist. This includes any possible side-effects not Talk to your doctor or pharmacist… Sinutab with drink listed in this leaflet. See section 4. . If you are taking any other medicines containing . Avoid alcoholic drink. Alcohol can increase the liver . You must talk to a doctor if you do not feel better or if paracetamol. damage of a paracetamol overdose. you feel worse after 5 days . If you have prostate problems (difficulty passing water or needing to pass water often). Driving and Using Machines What is in this leaflet . If you have epilepsy. . This medicine may cause dizziness. If affected, do not 1. What Sinutab is and what it is used for . If you have liver or kidney problems. drive or operate machinery. 2. What you need to know before you use Sinutab . If you have blocked arteries or veins (occlusive 3. How to use Sinutab vascular disease). Anti-doping tests 4. Possible side-effects . If you have the type of anaemia where your red blood . This medicine contains pseudoephedrine hydrochloride, 5. How to store Sinutab cells get broken down (haemolytic anaemia) or any which may produce positive results in anti-doping tests.

6. Contents of the pack and other information risk factors for this condition. . If you are being treated for a thyroid disorder. 3. How to use Sinutab

1. What Sinutab is and what it is used for . If you have alcohol dependence. Check the tables that follow to see how much . If you weigh less than 50kg, suffer from Sinutab relieves the symptoms of colds and flus including medicine to take chronic malnutrition or are dehydrated aches, pains, fever, nasal and sinus congestion. . For oral use only. Other medicines and Sinutab . Do not take more than the stated dose shown in the The tablets contain paracetamol, an analgesic and antipyretic . Tell your doctor or pharmacist if you are taking any tables. to relieve pain and fever, and pseudoephedrine, other medicines, including: . Take with a glass of water. a decongestant to clear nasal congestion and blocked sinuses. . Antihypertensives (drugs to treat high blood Children under 12 years pressure such as guanethidine, methyldopa, This medicine is for use in adults and children aged 12 years This medicine should not be given to children under 12 years adrenergic neurone blockers, debrisoquine, and over. old. bretylium, reserpine and betanidine).

2. What you need to know before you use . Oxytocin (drug used to help contractions during Adults and children aged 16 years and over childbirth). Sinutab Age Dose . Moclobemide (used to treat mood disorders). Adults and children 2 tablets every 4-6 hours . Cardiac glycosides (drugs used to control heart This medicine is suitable for most people but a few people aged 16 years and over as needed rhythms or contractions e.g. digoxin). should not use it. If you are in any doubt, talk to your doctor or pharmacist. . Ergot alkaloids (used to treat migraine such as . Leave at least 4 hours between doses. ergotamine and methysergide). . Do not take more than 8 tablets (4 doses) in 24 hours. Do not use this medicine... . Tricyclic antidepressants (used to treat mood . Do not take for more than 5 days. . If you have ever had a bad reaction (allergic disorders). . If symptoms persist or worsen talk to your doctor or reaction) to paracetamol or pseudoephedrine or . Cholestyramine (to lower blood cholesterol). pharmacist. any of the other ingredients (listed in section 6). . Metoclopramide and (to treat . If you have high blood pressure or heart disease. nausea and vomiting). . If you have diabetes.

Page 1 of 2 Children aged 12 to 15 years Other effects which may occur but it is not known What the medicine looks like and contents of the Age Dose how often: pack Children aged 12 to 15 1 tablet every 4 to 6 hours . Agitation, anxiety, irritability, feeling jittery or feelings of Sinutab Tablets are white, round, biconvex, plain on both years as needed extreme happiness sides. . Leave at least 4 hours between doses. . Drowsiness . Do not take more than 4 tablets (4 doses) in 24 hours. . High blood pressure Sinutab Tablets are available in blister packs containing . Do not take for more than 5 days. . Vomiting 15 tablets.

. If symptoms persist or worsen talk to your doctor or . Pain when passing water Manufacturer pharmacist. . Tremors . Very high fever Manufactured by: Janssen , Domaine de Maigremont, If you use more Sinutab than you should . Stomach pain or discomfort or diarrhoea. 27100 Val de Reuil, France.

Immediate medical advice should be sought in the event of Procured from within the EU and repackaged by: an overdose, even if you feel well, because of the risk of Long-term use Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, delayed, serious liver damage. . People who use medicines containing paracetamol every Doncaster, DN3 1QR, UK. day for a long time (several months or more) could get

If you forget to use Sinutab certain side-effects including liver and kidney damage. PPA holder: Imbat Ltd., Unit L2, North Ring Business Park, If you forget to take a dose, take the next dose when needed People taking paracetamol in the usual way for shorter Santry, Dublin 9. provided that the last dose was taken at least 4 hours ago. periods have not had these problems. Do not take a double dose. Distributed by: Eurodrug Ltd., Unit L2, Reporting of side-effects North Ring Business Park, Santry, Dublin 9. 4. Possible side-effects If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this PPA1151/114/001 Like all medicines, Sinutab can have side-effects, although leaflet. You can also report side-effects directly via not everybody gets them. HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. Leaflet issue and revision date (ref): 07.06.18 Tel: +353 1 6764971 Fax: +353 1 6762517 ® If you experience any of the following, stop using Website: www.hpra.ie e-mail: [email protected] Sinutab is a registered trademark of Janssen-Cilag Ltd this medicine and seek immediate medical help: . Swelling of the face, lips, mouth, tongue or throat which By reporting side-effects you can help provide more may cause difficulty swallowing or breathing. information on the safety of this medicine. Blind or partially sighted? . Allergic reactions including skin rashes such as hives (which may be severe and include blistering and peeling 5. How to store Sinutab Is this leaflet hard to see or of the skin) and itching. . Hallucinations, paranoid delusions or fits. . Do not store above 25ºC. Store in the original read? packaging. If you experience any of the following, stop using . Keep this medicine out of the sight and of Call +44 (0) 1302 365000 this medicine and talk to your doctor: children. . Restlessness or sleep disturbances. . Do not use this medicine after the expiry date (EXP) which is stated on the carton and blister strips. The (Regulatory) . Trouble passing water (especially men with prostate problems). expiry date refers to the last day of that month. . Unusual tiredness, unexpected bruising or bleeding and . Do not throw away any medicines via wastewater or getting more infections (such as colds) than normal. household waste. Ask your pharmacist how to throw . A fast or irregular heartbeat or an increased awareness away any medicines you no longer use. These measures of your heartbeat (palpitations). will help protect the environment.

Other effects which may occur include: 6. Contents of the pack and other Very common (may affect more than 1 in 10 information people) . Headache What Sinutab contains Each tablet contains 500mg paracetamol and Common (may affect up to 1 in 10 people) 30mg pseudoephedrine hydrochloride as the active . Dry mouth or nausea ingredients. . Difficulty sleeping, nervousness or dizziness The other ingredients are: pregelatinised maize starch, crospovidone, povidone, stearic acid, microcrystalline cellulose, sodium starch glycolate (Type A)

and magnesium stearate.

Page 2 of 2