GSK LOC is responsible to approve the change documentation, artwork brief

and final artwork, ensuring that it is accurate, consistent and complete.

GSK Market is responsible to advise SDC when changes

GSK SDC is responsible for site technical requirements

Storage conditions and Shelf Life
Formulation, Tablet embossing,

IMPORTANT
required impact the following:

and pre-press suitability.

Local approvers must ensure that trade mark and

NOTE TO MARKET
copyright statements included in the brief
comply with guidance provided by
Legal: Global Trade 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, 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.
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 kidney problems, including alcoholic liver disease, are
This medicine is available without prescription, but you still need to use underweight or malnourished or regularly drink alcohol. 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:
1. What Panadol Night does • deep, rapid, difficult breathing
• 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_2017 - Harmony - Version 2
licence to GSK.
may require the supplier to produce evidence of such
declare that they do not use unlicensed fonts / software and
The GSK certification / audit process requires suppliers to
intellectual property rights by printed component suppliers.
not accept any liability for the breach of third party
constitutes an intellectual property infringement. GSK will
The distribution and use of fonts / software without a licence
conjunction with GSK artwork.
they have a licence for all fonts / software used in
printed components of any description must ensure that
of Companies. All suppliers providing a service to GSK for
Artwork copyright is the property of the GSK Group

N/A
Additional Info (3):
SGS 5769162
Additional Info (2):
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OTC.LT.002
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Base / Advance / Actifast / Extra Advance / Night
Variant:
Panadol
Sub Brand:
PANADOL CONCEPT (ANALGESICS)
Brand:
GSK_Dungarvan_IRELAND | Omega Pharma_Herrenberg_GERMANY

Manufacturing Site(s):
DFT-01034-3299996
AMS Document Number:
Artwork Information Panel
Harmony AMS
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SUBSTRATE
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AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

Colour Standard Reference:
Total Special Finishes: 0
Design 1:

Material Type:
BLACK

N/A
If an e-banner DOES NOT appear on the top of this document, THEN this document has NOT been printed from the Harmony system.

175 mm Measuring Bar

Technical Drawing (Do NOT include version number):

The distribution and use of fonts / software without a licence

declare that they do not use unlicensed fonts / software and

of Companies. All suppliers providing a service to GSK for
Base / Advance / Actifast / Extra Advance / Night

intellectual property rights by printed component suppliers.

Material Spec. (Do NOT include version number):

The GSK certification / audit process requires suppliers to

GSK_Dungarvan_IRELAND | Omega Pharma_Herrenberg_GERMANY

constitutes an intellectual property infringement. GSK will

printed components of any description must ensure that
Artwork copyright is the property of the GSK Group

AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

PANADOL CONCEPT (ANALGESICS)

may require the supplier to produce evidence of such

Artwork Information Panel

not accept any liability for the breach of third party

they have a licence for all fonts / software used in
AMS Document Number:

Manufacturing Site(s):

Approving Market(s):
DFT-01034-3299996

Smallest Text Size:

Additional Info (1):

Additional Info (2):

Additional Info (3):

Offset - Lithography

conjunction with GSK artwork.

Horizontal Scale:
3
Harmony AMS

Body Text Size:

Print Process:

SGS 5769162
Sub Brand:

OTC.LT.002

Microtext:

licence to GSK.
Leading:
Panadol
Variant:
Brand:

7.0pt

7.0pt

7.2pt

90%
N/A

N/A

N/A
GB

• Breathing problems. These are more likely if you have experienced them before when
If you are taking other medicines taking other painkillers (such as ibuprofen and aspirin)
• 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 • Unexplained bruising or bleeding
prescribed medicines; particularly monoamine oxidase inhibitors (MAOIs) in the last • Reoccurring fevers or infections
2 weeks or tricyclic antidepressants (prescribed for depression); atropine; beta • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
blockers (to treat heart problems); metoclopramide or domperidone (for nausea or
vomiting); metoprolol or venlafaxine; colestyramine (to lower blood cholesterol); When using this product you may experience:
medicines for stomach cramps (e.g. dicycloverine) or travel sickness (e.g. hyoscine); • Drowsiness, sedation, unsteadiness, dizziness, tiredness, blurred vision, or difficulty
medicines to treat anxiety or to help you sleep; medicines that make you drowsy or give concentrating
you a dry mouth; blood thinning drugs (anticoagulants e.g.warfarin) or painkillers • Dry mouth
(e.g. codeine). • Feeling restless or excitable, confusion
• Tingling sensation in the skin
• Muscle twitching.
Pregnancy and breast feeding Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Do not take Panadol Night if you are pregnant or breast feeding. possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow
3. How to take Panadol Night Card in the Google Play or Apple App Store. By reporting side effects, you can help
Adults (including the elderly) and children aged 16 years and over: provide more information on the safety of this medicine.
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 becomes
persistent, see your doctor. The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK)
Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this
4. Possible side effects address.
Like all medicines, Panadol Night can have side effects, but not everybody gets them. The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or Omega
If you are a carer of an elderly patient with confusion, this medicine should not be given. Pharma Manufacturing GmbH & Co. KG, Benzstraße 25, 71083, Herrenberg, Germany.
Very rare cases of serious skin reactions have been reported.
This leaflet was last revised in September 2019. Trade marks are owned by or licensed to
Stop taking this medicine and tell your doctor immediately if you experience:
the GSK group of companies.
• 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
• Upset stomach, nausea or vomiting DFT-01034-3299996
Local approvers must ensure that trade mark and
NOTE TO MARKET
copyright statements included in the brief
comply with guidance provided by
Legal: Global Trade Marks.
GSK LOC is responsible to approve the change documentation, artwork brief
and final artwork, ensuring that it is accurate, consistent and complete.

GSK Market is responsible to advise SDC when changes

GSK SDC is responsible for site technical requirements

Storage conditions and Shelf Life

Formulation, Tablet embossing,
IMPORTANT

required impact the following:

and pre-press suitability.