GSK LOCisresponsibletoapprovethechangedocumentation, artworkbrief and finalartwork,ensuringthatitisaccurate,consistent complete. GSK MarketisresponsibletoadviseSDCwhenchanges GSK SDCisresponsibleforsitetechnicalrequirements Storage conditions andShelfLife Formulation, Tablet embossing, IMPORTANT required impactthefollowing: and pre-presssuitability. Local approversmustensurethattrademarkand NOTE TO MARKET copyright statementsincludedinthebrief comply withguidanceprovidedby Legal: GlobalTrade Marks.

PATIENT INFORMATION LEAFLET 2. Check before you take Panadol Night

Do not take Panadol Night:

• if you have ever had an allergic reaction to paracetamol, hydrochloride or to any of the other ingredients (listed in Section 6) • if you have porphyria (too much of the pigment called porphyrin which may discolour the urine) • if you have taken another medicine containing paracetamol in the last 4 hours. Contains paracetamol. Do not take with any other antihistamine-containing products, including those used Night on your skin or in cough and cold medicines. Paracetamol + Diphenhydramine Ask your doctor before you take this medicine:

Please read right through this leaflet before you start using this medicine. • if you have liver or kidneyproblems, including alcoholic liver disease, are This medicine is available without prescription, but you still need to use underweight or malnourished or regularly drink . You may need to avoid Panadol Night carefully to get the best results from them. using this product altogether or limit the amount of paracetamol that you take. • Keep this leaflet you may need to read it again. • if you have epilepsy, or seizure disorders • If you have any questions, or if there is anything you do not understand, • if you have an obstruction in your stomach or gut (for example, because of an ulcer) ask your pharmacist. • if you experience difficulty passing urine • if you have narrow-angle glaucoma (raised pressure in the eye) In this leaflet: • if you have an enlarged prostate 1. What Panadol Night does • if you have myasthenia gravis 2. Check before you take Panadol Night • if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD) 3. How to take Panadol Night • if you have been told by your doctor that you have an intolerance to some sugars. 4. Possible side effects • if you have a severe infection, are severely malnourished, severely underweight or are 5. How to store Panadol Night a chronic heavy alcohol user as this may increase the risk of metabolic acidosis. 6. Further information Signs of metabolic acidosis include: • deep, rapid, difficult breathing 1. What Panadol Night does • feeling sick (nausea), being sick (vomiting) Panadol Night is used for the relief of bedtime pain. It is suitable for pain such as headache, migraine, backache, rheumatic and muscle pain, toothache or period pain. • loss of appetite Contact a doctor immediately if you get a combination of these symptoms. The active ingredients are paracetamol and diphenhydramine hydrochloride. Paracetamol is a painkiller and diphenhydramine hydrochloride is an antihistamine that causes sleepiness or drowsiness making it useful when pain is keeping you awake. Take special care with Panadol Night

• Do not drive or operate machinery. Panadol Night is intended to produce sleepiness or drowsiness soon after the dose is taken. • Do not drink alcohol while using Panadol Night

DFT-01034-3299996 AIP_Template_V_INDD -04_2017HarmonyVersion 2 licence toGSK. may requirethesuppliertoproduceevidenceofsuch declare thattheydonotuseunlicensedfonts/softwareand The GSKcertification/auditprocessrequiressuppliersto intellectual propertyrightsbyprintedcomponentsuppliers. not acceptanyliabilityforthebreachofthirdparty constitutes anintellectualpropertyinfringement.GSKwill The distributionanduseoffonts/softwarewithoutalicence conjunction withGSKartwork. they havealicenceforallfonts/softwareusedin printed componentsofanydescriptionmustensurethat of Companies. Artwork copyrightisthepropertyofGSKGroup Technical Drawing Offset -Lithography Print Process: GB Approving Market(s): Base / Advance / Actifast /Extra Advance /Night Variant: Panadol Sub Brand: PANADOL CONCEPT (ANALGESICS) Brand: GSK_Dungarvan_IRELAND |OmegaPharma_Herrenberg_GERMANY Manufacturing Site(s): DFT-01034-3299996 AMS DocumentNumber: Artwork InformationPanel Harmony AMS N/A Additional Info(3): SGS 5769162 Additional Info(2): N/A Additional Info(1): N Microtext: 90% Horizontal Scale: 7.2pt Leading: 7.0pt Smallest Text Size: 7.0pt Body Text Size: N/A Material Spec. OTC.LT.002 All suppliersprovidingaservicetoGSKfor (DoNOTincludeversionnumber): 3

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• Breathing problems. These are more likely if you have experienced them before when taking other painkillers (such as ibuprofen and aspirin) If you are taking other medicines • Seizures or difficulty of muscle coordination • Changes in heart rhythm Talk to your doctor or pharmacist before taking these tablets if you are taking any • Unexplainedbruising or bleeding prescribed medicines; particularly monoamine oxidase inhibitors (MAOIs) in the last• Reoccurringfevers or infections 2 weeks or tricyclic antidepressants (prescribed for depressionatropine;); beta • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin. blockers(to treat heart problems); or (for nausea orWhen using this product you may experience: vomiting);metoprolol or venlafaxine; colestyramine (to lower blood cholesterol); • Drowsiness, sedation, unsteadiness, dizziness, tiredness, blurred vision, or difficulty medicines for stomach cramps (e.g. dicycloverine) or travel sickness (e.g. hyoscine); concentrating medicines to treat anxiety or to help you sleep; medicines that make you ordrowsy give • Dry mouth you a dry mouth;blood thinning drugs (anticoagulantswarfarin) e.g. or painkillers • Feeling restless or excitable, confusion (e.g. codeine). • Tingling sensation in the skin • Muscle twitching. Reporting of side effects and breast feeding If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Do not take Panadol Night if you are pregnant or breast feeding. the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help 3. How to take Panadol Night provide more information on the safety of this medicine. Adults (including the elderly) and children aged 16 years and over: Swallow 2 tablets with water, 20 minutes before you go to bed. Do not take more than 2 tablets in 24 hours. 5. How to store Panadol Night Keep out of the sight and reach of children. • Do not take Panadol Night if you have already taken 4 doses of Do not use this medicine after the ‘EXP’ date shown on the pack. a paracetamol-containing product during the day. Store below 25°C in a dry place. • Do not take more than the recommended dose. • Do not take if you are under 16 years. 6. Further information Active ingredients; Each tablet contains Paracetamol 500 mg and Diphenhydramine If you take too many tablets Hydrochloride 25 mg. Other ingredients Maize starch, starch pre-gelatinised, potassium Talk to a doctor at once if you take too much of this medicine even if you feel well. sorbate (E 202), povidone, purified talc, stearic acid, hypromellose (E 464), titanium This is because too much paracetamol can cause delayed, dioxide (E 171), lactose monohydrate, macrogol 400, triacetin, brilliant blue FCF (E 133), serious liver damage. indigo carmine (E 132) and carnauba wax. Do not take Panadol Night for more than one week Packs of Panadol Night contain 20 film-coated tablets. If your bedtime pain carries on for more than one week, or if your headache becomesThe marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK) persistent,see your doctor. Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address. 4. Possible side effects The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or Omega Like all medicines, Panadol Night can have side effects, but not everybody gets them.Pharma Manufacturing GmbH & Co. KG, Benzstraße 25, 71083, Herrenberg, Germany. If you are a carer of an elderly patient with confusion, this medicine should not be given.This leaflet was last revised in September 2019. Trade marks are owned by or licensed to Very rare cases of serious skin reactions have been reported. the GSK group of companies. Stop taking this medicine and tell your doctor immediately if you experience: • Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath • Chest tightness or thickening of phlegm • Difficulty in passing urine, headaches or • Upset stomach, nausea vomiting DFT-01034-3299996

Legal: Global Trade Marks. Legal: Global Trade comply with guidance provided by copyright statements included in the brief NOTE TO MARKET NOTE TO Local approvers must ensure that trade mark and and pre-press suitability. required impact the following: IMPORTANT Formulation, Tablet embossing, Formulation, Tablet Storage conditions and Shelf Life GSK SDC is responsible for site technical requirements GSK Market is responsible to advise SDC when changes and final artwork, ensuring that it is accurate, consistent and complete. GSK LOC is responsible to approve the change documentation, artwork brief