12 mm 12 mm spot = 12 x 2 centered in Distance between cutted the margin of 14 mm line/middel of the spot = 51.6 mm

UK_Sudafed Decongestant Tablets 12s_PIL_SNAS 3359_SNAS 3557 14 mm 29.07.2021 English rate and blood pressure). 402059927_r2 N/A Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you ■ If you have an overactive thyroid Brochure/Lea et/Insert 145 x 250 mm might need it again. gland. 360165B BL-Val de Reuil_France ■ If you have glaucoma (increased CHILD 360165A Multi Packaging Solutions St Pierre 1 What the medicine is for pressure in the eye). 953 Oset Printing Sudafed Decongestant Tablets is a medicine used ■ If you have severe kidney problems. 8169503 PAPER to provide relief from cold, flu and allergy ■ If you are taking beta blockers (used to EMEA_2020_00006767_001 PC-0002778 symptoms such as blocked sinuses, stuffy nose treat high blood pressure). and catarrh. ■ If you are taking, or have taken in the The tablets contain pseudoephedrine last two weeks, drugs for depression ■ This medicine is used to help clear cold, flu hydrochloride, which is a decongestant that known as Monoamine Oxidase and allergy symptoms such as blocked relieves nasal and sinus congestion. Inhibitors (MAOIs) or Reversible Black PANTONE sinuses, stuffy nose and catarrh. This medicine is for use by adults and children Inhibitors of Monoamine Oxidase 3005 C ■ This medicine is for use by adults and (RIMAs). LITHO OFFSET LITHO OFFSET aged 12 years and over.

children aged 12 years and over. 145 mm REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. ■ If you are taking stimulants or appetite ■ Do not take this medicine: 2 Before taking this medicine suppressants or drugs used to treat ■ There are some people who should not This medicine is suitable for most people but a congestion and asthma take this medicine. few people should not use it. If you are in any (Sympathomimetic drugs). To find out if you are one of them see doubt, talk to your doctor or pharmacist. ■ If you are taking any other cough and section 2 cold medicine. ■ If you have ever had a bad reaction to Do not use this medicine… ■ For children under 12 years old. any of the ingredients. For the list of If you have ever had a bad reaction to any If any of these apply to you, get advice ingredients see section 6 of the ingredients of this medicine from a doctor or pharmacist without BlissPro-Bold Smallest Text Size ■ Speak to your doctor: (see section 6). using Sudafed Decongestant Tablets. BlissPro-ExtraBold 7.5pt ■ If you suffer from any of the conditions ■ If you have high blood pressure or BlissPro-Italic Ave. Text Size heart disease. BlissPro-Regular mentioned in section 2. See section 2 Talk to your doctor or 10.0pt ZapfDingbatsITC ■ If you are taking any other medicines. ■ If you have diabetes. Largest Text Size ■ If you have a phaeochromocytoma pharmacist… See section 2 ■ If you have kidney or severe liver Fonts used Fonts 14.0pt (a rare tumour that affects your heart 2020-10-08 22:25:48 ■ Follow the dosage instructions problems. carefully. See section 3 - 1 - turn over 12 mm

250 mm 12 mm 12 mm 12 mm UK_Sudafed Decongestant Tablets 12s_PIL_SNAS 3359_SNAS 3557 29.07.2021 English ■ If you have blocked arteries or veins If you are not sure about any of the medicines you If you are pregnant or breastfeeding 402059927_r2 N/A (occlusive vascular disease). are taking, show the bottle or pack to your If you are pregnant, or breastfeeding, think Brochure/Lea et/Insert 145 x 250 mm ■ If you are being treated for a thyroid pharmacist. you may be pregnant or are planning to have 360165B BL-Val de Reuil_France disorder. If any of these bullet points apply to you now or in a baby, ask your doctor or pharmacist for

CHILD 360165A Multi Packaging Solutions St Pierre ■ If you have difficulty with passing the past, talk to a doctor or pharmacist. advice before taking this medicine. 953 Oset Printing water and / or an enlarged prostate If you experience the following, Some of the ingredients can cause 8169503 PAPER (which may mean you need to pass problems stop taking this medicine EMEA_2020_00006767_001 PC-0002778 water more often). This medicine contains lactose. If you have been ■ If you are taking any other medicines, immediately and contact your told by your doctor that you have an intolerance including: doctor: to some sugars, contact your doctor before ■ Antihypertensives (drugs used to ■ A feverish generalised erythema taking this medicine. treat high blood pressure such as associated with pustules (See section 4) ■ Sudden severe headaches, nausea, vomiting, 3 How to take this medicine Black PANTONE guanethidine, methyldopa, 3005 C adrenergic neurone blockers and confusion, fits, visual disturbances. Check the table that follows to see LITHO OFFSET LITHO OFFSET beta blockers, debrisoquine, ■ Sudden abdominal pain or rectal bleeding REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. how much medicine to take. bretylium and betanidine). may occur with this medicine, due to ■ For oral use only. ■ Tricyclic antidepressants (used to inflammation of the colon (ischaemic treat mood disorders). colitis). If you develop these gastrointestinal ■ Do not take more medicine than the label ■ Anticholinergic drugs (drugs used symptoms, stop taking this medicine and tells you to. ■ Take with a glass of water. to treat cramps or spasms) contact your doctor or seek medical ■ Moclobemide (used to treat mood attention immediately. (See section 4). Children under 12 years disorders). ■ Reduction of blood flow to your optic nerve Do not give to children under 12 years old. ■ Cardiac glycosides (drugs used to may occur with this medicine. If you develop BlissPro-Bold Smallest Text Size control heart rhythms or sudden loss of vision, stop taking this Adults and children aged BlissPro-ExtraBold 7.5pt contractions such as digoxin). medicine and contact your doctor or seek 12 years and over BlissPro-Italic Ave. Text Size ■ Ergot alkaloids (drugs used to treat medical attention immediately. BlissPro-Regular 10.0pt ZapfDingbatsITC migraine such as ergotamine and (See section 4). Largest Text Size methysergide).

Fonts used Fonts 14.0pt ■ Oxytocin (drug used to help 2020-10-08 22:25:48 contractions during childbirth). - 2 - 14 mm 12 mm 12 mm

UK_Sudafed Decongestant Tablets 12s_PIL_SNAS 3359_SNAS 3557 14 mm 29.07.2021 English Age Dose can cause angina (discomfort or pain in which may be due to reduced blood 402059927_r2 N/A the chest, neck, back, jaw, shoulders or flow to the optic nerve (ischaemic Brochure/Lea et/Insert 145 x 250 mm Adults and Swallow 1 tablet every arms), or heart attack. optic neuropathy). children aged 4-6 hours up to 4 times 360165B BL-Val de Reuil_France ■ 12 years and over a day Stroke (weakness of the face, arms or If you experience any of the CHILD 360165A Multi Packaging Solutions St Pierre legs, or speech problems). following, stop using the medicine 953 Oset Printing ■ Leave at least 4 hours between doses. ■ Sudden onset of fever, reddening of the 8169503 PAPER ■ Do not take more than 4 doses in 24 hours. skin, or many small pustules (possible and talk to your doctor: EMEA_2020_00006767_001 PC-0002778 ■ If symptoms persist or worsen stop use symptoms of Acute Generalized ■ Trouble passing water (especially in and talk to your doctor. Exanthematous Pustulosis - AGEP) may men with prostate problems). occur within the first 2 days of treatment Other effects which may occur include: If anyone has too much with this medicine (See section 2). Very Common (may affect more than 1 in 10 If anyone has too much contact a doctor ■ Sudden onset of severe headache, nausea, people) Black PANTONE vomiting, confusion, fits, visual disturbances. 3005 C or your nearest Accident & Emergency ■ Headache Department (Casualty) taking this leaflet LITHO OFFSET LITHO OFFSET ■ Swelling of the face, lips, mouth, tongue Common (may affect up to 1 in 10 people) REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. and pack with you. or throat which may cause difficulty in ■ swallowing or breathing. Difficulty sleeping, nervousness or If you forget to take the medicine dizziness If you forget to take a dose, take the next ■ Allergic reactions including skin rashes ■ dose when needed provided that the last such as hives (which may be severe and Dry mouth or nausea dose was taken at least 4 hours ago. Do include blistering and peeling of the skin) Other effects which may occur but it is not take a double dose. and itching. unknown how often: 4 Possible side-effects ■ Hallucinations or paranoid delusions ■ Vomiting ■ Anxiety, irritability, feeling jittery or Like all medicines, Sudafed Decongestant (seeing or hearing things that are not BlissPro-Bold Smallest Text Size feelings of extreme happiness Tablets can have side-effects, although not there, irrational thoughts or feelings). BlissPro-ExtraBold 7.5pt ■ Inflammation of the colon due to ■ Restlessness or sleep disturbances. BlissPro-Italic Ave. Text Size everybody gets them. BlissPro-Regular insufficient blood supply (ischaemic ■ A fast or irregular heartbeat or an 10.0pt If you experience any of the ZapfDingbatsITC colitis). Symptoms may include sudden Largest Text Size increased awareness of the heartbeat following, stop using the medicine abdominal pain or rectal bleeding. (palpitations).

Fonts used Fonts 14.0pt 2020-10-08 22:25:48 and seek immediate medical help: ■ Sudden loss or reduction of vision ■ Pain when passing water ■ Reduced blood flow to the heart which - 3 - ■ High blood pressure 12 mm 12 mm 12 mm 12 mm UK_Sudafed Decongestant Tablets 12s_PIL_SNAS 3359_SNAS 3557 29.07.2021 English ■ Drowsiness pharmacist how to dispose of medicines no 402059927_r2 N/A ■ Reduced blood flow to the optic nerve longer required. These measures will help to Brochure/Lea et/Insert 145 x 250 mm (Ischaemic optic neuropathy) protect the environment. 360165B BL-Val de Reuil_France ■ Pins and needles in your fingers and toes 6 Further information CHILD 360165A Multi Packaging Solutions St Pierre ■ A tremor 953 Oset Printing What’s in this medicine? 8169503 PAPER Reporting of side-effects The active ingredient in Sudafed Decongestant Tablets is: Pseudoephedrine EMEA_2020_00006767_001 PC-0002778 If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible hydrochloride 60 mg per tablet. side-effects not listed in this leaflet. You can Other ingredients are: Lactose, microcrystalline also report side-effects directly via the Yellow cellulose, maize starch, silica, magnesium Card Scheme at www.mhra.gov.uk/yellowcard stearate, hypromellose, polyethylene glycol, talc and red iron oxide (E172). Black PANTONE or search for MHRA Yellow Card in the Google 3005 C Play or Apple App Store. What the medicine looks like LITHO OFFSET LITHO OFFSET REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. By reporting side-effects you can help provide Sudafed Decongestant Tablets are reddish brown more information on the safety of this film-coated tablets, available in packs of 12 medicine. tablets. Marketing Authorisation holder: McNeil 5 Storing this medicine Products Ltd, 50 - 100 Holmers Farm Way, Store below 30° C in the original package to High Wycombe, Buckinghamshire, HP12 4EG, UK. protect from moisture. Manufacturer: Janssen-Cilag, Domaine de Keep this medicine out of the sight and reach Maigremont, 27100 Val de Reuil, France of children. This leaflet was last revised in August 2021 BlissPro-Bold Smallest Text Size Do not use this medicine after the expiry date BlissPro-ExtraBold 7.5pt which is stated on the carton after ‘Expiry’. The Sudafed is a registered trade mark. BlissPro-Italic Ave. Text Size BlissPro-Regular expiry date refers to the last day of that 10.0pt ZapfDingbatsITC month. Largest Text Size Medicines should not be disposed of via

Fonts used Fonts 14.0pt 2020-10-08 22:25:48 wastewater or household waste. Ask your - 4 - 360165B 14 mm