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Panadol Nightpain

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Document: leaflet MAH BRAND 2_PL 00071-0423 change

Panadol Night

Paracetamol + Diphenhydramine

Please read right through this leaflet before you start using this medicine.

This medicine is available without prescription, but you still need to use Panadol Night carefully to get the best results from them.

•    Keep this leaflet you may need to read it again.

•    If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leaflet:

1.    What Panadol Night does

2.    Check before you take Panadol Night

3.    How to take Panadol Night

4.    Possible side effects

5.    How to store Panadol Night

6.    Further information

1. What Panadol Night does

Panadol Night is used for the relief of bedtime pain. It is suitable for pain such as headache, migraine, backache, rheumatic and muscle pain, neuralgia, toothache or period pain.

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.

2. Check before you take Panadol Night

[X symbol] Do not take Panadol Night:

   if you have ever had an allergic reaction to paracetamol, diphenhydramine 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.

Do not take with any other antihistamine-containing products.

[! Symbol] Ask your doctor before you take this medicine:

•    if you have liver or kidney disease, including alcoholic liver disease

•    if you have epilepsy, or seizure disorders

•    if you have an obstruction in your stomach or gut (for example, because of an ulcer)

•    if you experience difficulty passing urine

•    if you have narrow-angle glaucoma (raised pressure in the eye)

•    if you have an enlarged prostate

•    if you have myasthenia gravis

•    if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)

•    if you have been told by your doctor that you have an intolerance to some sugars.

[! Symbol] 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.

[! Symbol] If you are taking other medicines

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly monoamine oxidase inhibitors (MAOIs) in the last 2 weeks or tricyclic antidepressants (prescribed for depression); atropine; metoclopramide or domperidone (for nausea or vomiting); colestyramine (to lower blood cholesterol); medicines for stomach cramps (e.g. dicycloverine) or travel sickness (e.g. hyoscine); medicines to treat anxiety or to help you sleep; medicines that make you drowsy or give you a dry mouth; or blood thinning drugs (anticoagulants e.g.warfarin).

[! Symbol] Pregnancy and breast feeding

Do not take Panadol Night if you are pregnant or breast feeding.

3.    How to take Panadol Night

[tick Symbol alongside points below ]

Adults and children aged 12 years and over:

Swallow 2 tablets with water, 20 minutes before you go to bed.

[! Symbol alongside below bullet points]

   Do not take Panadol Night if you have already taken 4 doses of a paracetamol-containing product during the day.

   Do not take more than 2 tablets in 24 hours.

   Do not take more than the recommended dose.

   Do not take if you are under 12 years.

If you take too many tablets

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Do not take Panadol Night for more than one week

If your bedtime pain carries on for more than one week, or if your headache becomes persistent, see your doctor.

4.    Possible side effects

Like all medicines, Panadol Night can have side effects, but not everybody gets them.

Older people are more prone to these side effects.

When using this product you may experience:

•    Drowsiness, dizziness, tiredness, blurred vision, or difficulty concentrating

•    Dry mouth.

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

   Skin rash or peeling or mouth ulcers

   Upset Stomach

   Breathing problems. These are more likely if you have experienced them before when taking other painkillers (such as ibuprofen and aspirin)

   Seizures or difficulty of muscle coordination

•    Changes in heart rhythm

•    Unexplained bruising or bleeding.

These reactions are rare.

If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.

5.    How to store Panadol Night

Keep out of the reach and sight of children.

Do not use this medicine after the 'EXP' date shown on the pack.

Store below 25°C in a dry place.

6.    Further information

Active ingredients; Each tablet contains Paracetamol 500 mg and Diphenhydramine Hydrochloride 25 mg. Other ingredients Maize starch, starch pre-gelatinised, potassium sorbate (E 202), povidone, purified talc, stearic acid, hypromellose (E 464), titanium dioxide (E 171), lactose monohydrate, macrogol 400, triacetin, brilliant blue FCF (E 133), indigo carmine (E 132) and carnauba wax.

Packs of Panadol Night contain 20 film-coated tablets.

The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare,

Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or Omega Pharma Manufacturing GmbH & Co. KG, BenzstraBe 25, 71083,

Herrenberg, Germany.

This leaflet was last revised in July 2012.

Panadol is a registered trade mark of the GlaxoSmithKline group of companies.

[GSK logo]