Project Name / Design Non-Drowsy Sinutab Tablets 15s – 1 – 12 mm New Component / Item Code 360164C ArtWorks ID EMEA_2020_00005102_001 If any of these apply to you, get advice from Old Component / Item Code 360164B Languages English a doctor or pharmacist without using Non-Drowsy Sinutab. Product / Eurocode / Mat. ID Code 8166703 Job / Version No. 402061024_r1 Date 17-02-2021 , Talk to your doctor or pharmacist… n If you have kidney or severe liver problems. CHILD n This medicine is used to relieve the symptoms of n If you have alcohol dependence. Black PANTONE Reflex Blue C colds, flu and allergies including aches, pains, n If you have blocked arteries or veins fever, nasal and sinus congestion. (occlusive vascular disease). LITHO OFFSET LITHO OFFSET n This medicine is for use by adults and children n REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. If you are being treated for a thyroid aged 12 years and over. disorder. n Do not take this medicine: n If you have difficulty with passing water F_I_006 PC-0002781 n There are some people who should not take and / or an enlarged prostate (which may this medicine. To find out if you are one of mean you need to pass water more often). PAPER Westrock St Pierre des Corps them see section 2 ▶ n If you are taking any other medicines, 1003 n If you have ever had a bad reaction to any of including: the ingredients. For the list of ingredients see n Anticholinergic drugs (drugs used to treat section 6 ▶ cramps and spasms such as atropine). Leaflet Val De Reuil n Speak to your doctor: n Antihypertensives (drugs to treat high 145 x 250 mm JJSC_00023_V2 11-09-2020 n If you suffer from any of the conditions blood pressure such as guanethidine, mentioned in section 2. See section 2 ▶ methyldopa, adrenergic neurone blockers, n If you are taking any other medicines. See debrisoquine, bretylium and betanidine). section 2 ▶ n Tricyclic antidepressants (used to treat n Follow the dosage instructions carefully. See mood disorders). section 3 ▶ n Moclobemide (used to treat mood Now read this whole leaflet carefully before you disorders). use this medicine. Keep the leaflet: you might n Cardiac glycosides (drugs used to control need it again. heart rhythms or contractions such as digoxin). 1 What the medicine is for n Ergot alkaloids (drugs used to treat Non-Drowsy Sinutab relieves the symptoms of migraine such as ergotamine and colds, flu and allergies including aches, pains, methysergide). fever, nasal and sinus congestion. The tablets n Oxytocin (drug used to help contractions contain paracetamol, an analgesic and antipyretic during childbirth). to relieve pain and fever, and pseudoephedrine, a n Cholestyramine (used to lower blood decongestant to clear nasal congestion and blocked cholesterol). Helvetica World-Regular sinuses. n Metoclopramide and (used NimbusSansGlobal-Regular 5.0pt This medicine is for use in adults and children aged to treat nausea and vomiting). Times New Roman-Bold 12 years and over. n Anticoagulants (drugs used to thin the

Times New Roman-Italic blood such as warfarin). 250 mm 8.0pt Times New Roman-Regular 2 Before taking this n Oral contraceptives ("the pill"). Zapf Dingbats-Regular n Anticonvulsants (drugs used to treat 14.0pt medicine epilepsy). This medicine is suitable for most people but a few If you are not sure about any of the medicines people should not use it. If you are in any doubt, you are taking, show the bottle or pack to talk to your doctor or pharmacist. your pharmacist. Do not use this medicine… If any of these bullet points apply to you now n If you have ever had a bad reaction to any or in the past, talk to a doctor or of the ingredients in this medicine (listed in pharmacist. section 6). If you experience the following, stop taking n If you have high blood pressure or heart this medicine immediately and contact your disease. doctor: n If you have diabetes. n A feverish generalised redness of the skin n If you have a phaeochromocytoma (a rare (erythema) associated with pustules. See tumour that affects your heart rate and section 4. blood pressure). n Sudden severe headaches, nausea, vomiting, n If you have an overactive thyroid gland. confusion, fits, visual disturbances. n If you have glaucoma (increased pressure n Sudden abdominal pain or rectal bleeding in the eye). may occur with this medicine, due to n If you have severe kidney problems. inflammation of the colon (ischaemic 1 12 1 n If you are taking any other cough and cold colitis). If you develop these gastrointestinal medicines or medicines containing symptoms, stop taking this medicine and paracetamol. contact your doctor or seek medical

2 n If you are taking beta blockers (used to treat attention immediately. See section 4. high blood pressure). n Reduction of blood flow to your optic nerve n If you are taking, or have taken in the last may occur with this medicine. If you develop two weeks, drugs for depression known as sudden loss of vision, stop taking this Monoamine Oxidase Inhibitors (MAOIs) or medicine and contact your doctor or seek Reversible Inhibitors of Monoamine medical attention immediately. See section 4. Oxidase (RIMAs). If you are pregnant or breast-feeding n If you are taking stimulants or appetite n If you are pregnant, or breast-feeding, think suppressants or drugs used to treat you may be pregnant or are planning to congestion and asthma (sympathomimetic have a baby, ask your doctor or pharmacist drugs). for advice before taking this n For children under 12 years old. medicine. turn over ▶ 12 mm

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– 2 – 12 mm n Trouble passing water (especially in men with 3 How to take this prostate problems). medicine Other effects which may occur include: Check the table that follows to see how much Very Common (may affect more than medicine to take. 1 in 10 people) n For oral use only. n Headache n Do not take more medicine than the label tells Common (may affect up to 1 in 10 you to. people) n Take with a glass of water. n Difficulty sleeping, nervousness or dizziness Children under 12 years n Dry mouth or nausea Do not give to children under 12 years old. Other effects which may occur but it is unknown Adults and children aged 12 years and over how often n Anxiety, restlessness, irritability, feeling jittery or Age Dose feelings of extreme happiness n Adults and children 2 tablets every 4-6 Sleep disturbances n aged 16 years and hours, up to 4 times a A fast or irregular heartbeat or an increased over day awareness of the heartbeat (palpitations) n Drowsiness Children aged 12 1 tablet every 4-6 n High blood pressure years to 15 years hours, up to 4 times a n Stomach pain, diarrhoea or vomiting day n Pain when passing water n Tingling or numbness of the hands or feet (pins n Leave at least 4 hours between doses. and needles) n Do not take more than 4 doses in 24 hours. n A tremor or shakiness n If symptoms persist or worsen, stop use and n Reduced blood flow to the optic nerve talk to your doctor. (Ischaemic optic neuropathy) Very rare cases of serious skin reactions have been If anyone has too much reported with paracetamol. Talk to a doctor at once if you take too much Reporting of side effects of this medicine even if you feel well. This is If you get any side-effects, talk to your doctor, because too much paracetamol can cause pharmacist or nurse. This includes any possible delayed, serious liver damage. side-effects not listed in this leaflet. You can also If you forget to take the medicine report side-effects directly via the Yellow Card If you forget to take a dose, take the next dose Scheme at www.mhra.gov.uk/yellowcard or search when needed provided that the last dose was for MHRA Yellow Card in the Google Play or taken at least 4 hours ago. Do not take a Apple App Store. double dose. By reporting side-effects, you can help provide more information on the safety of this medicine. 4 Possible side-effects 250 mm Like all medicines, Non-Drowsy Sinutab can have 5 Storing this medicine side-effects, although not everybody gets them. Do not store above 25ºC. If you experience any of the following, stop using Store in the original packaging. this medicine and seek immediate medical help: Keep this medicine out of the sight and of n Reduced blood flow to the heart which can cause children. angina (discomfort or pain in the chest, neck, Do not use this medicine after the expiry date back, jaw, shoulders or arms), or heart attack. which is stated on the carton after ‘Expiry’. The n Stroke (weakness of the face, arms or legs, or expiry date refers to the last day of that month. speech problems). Medicines should not be disposed of via n Sudden onset of fever, reddening of the skin, wastewater or household waste. Ask your or many small pustules (possible symptoms of pharmacist how to dispose of medicines no longer Acute Generalized Exanthematous Pustulosis required. These measures will help to protect the - AGEP) may occur within the first 2 days of environment. treatment with this medicine (See section 2). n Sudden onset of severe headache, nausea, 6 Further information vomiting, confusion, fits, visual disturbances. What's in this medicine? n Swelling of the face, lips, mouth, tongue or The active ingredients in Non-Drowsy Sinutab throat which may cause difficulty in swallowing are: 500 mg Paracetamol and 30 mg or breathing. Pseudoephedrine hydrochloride per tablet. n Allergic reactions including skin rashes such Other ingredients are: Pregelatinised maize as hives (which may be severe and include starch, crospovidone, povidone K30, stearic acid, blistering and peeling of the skin) and itching. microcrystalline cellulose, sodium starch n Hallucinations or paranoid delusions (seeing glycollate, magnesium stearate. or hearing things that are not there, irrational What the medicine looks like thoughts or feelings). Non-Drowsy Sinutab tablets are white round n Inflammation of the colon due to insufficient 1 10 1 tablets, available in packs of 15 tablets. blood supply (ischaemic colitis). Symptoms may include sudden abdominal pain or rectal Marketing Authorisation holder: bleeding. McNeil Products Ltd, Maidenhead, Berkshire, SL6 n Feeling unusually tired, unexpected bruising or 3UG, UK. bleeding and getting more infections (such as Manufacturer: Janssen-, Domaine de colds) than normal. Maigremont, 27100 Val de Reuil, France. 1003 If you experience any of the following, stop This leaflet was last revised in January 2021. Sinutab is a registered trade mark. Read Direction using this medicine and talk to your doctor: 360164C Laetus Pharma Code aligned to LHS.

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