148 mm

210 mm

Information Torthe user

Boots Stomach Comfort 10 mg Film Coated Tablets

l

(Domperidone)

'Read all o? this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice

You must contact a pharmacist or doctor if your symptoms worsen or do not improve If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

What this medicine is for

This medicine contains Domperidone which belongs to a group of medicines called anti-emetics, which can stop you feeling sick.

It can be used to treat feeling sick (nausea), being sick (vomiting), heartburn, indigestion or a feeling of discomfort or fullness in the stomach.

Before you take this medicine

This medicine can be taken by adults and children of 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

X Do not take:

If you are allergic to domperidone or any of the ingredients (see “What is in this medicine")

If you have heart problems including heart failure, a previous heart attack, angina (chest pains), problems with your heart rate or rhythm If you have had perforation or a bleeding stomach (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

If you have a blocked bowel (intestinal obstruction)

If you have a tumour of the pituitary gland (a

condition called prolactinoma)

If you have liver problems If you have an intolerance to some sugars,

unless your doctor tells you to (this medicine contains lactose)

If you are pregnant or planning to become pregnant, unless your doctor tells you to If you are breastfeeding

! Talk to your pharmacist or doctor:

•    If you have kidney problems

•    If you are on a low salt (sodium) diet (this medicine contains 0.042 mg of sodium per tablet)

Other important information

Driving and using machines: This medicine is not expected to affect your ability to drive or use machines. However, you may have less control over your movements whilst taking this medicine. You should not drive or use machines until you are sure you are not affected.

If you take other medicines

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Opioids (e.g. codeine or morphine used to treat pain)

•    Ketoconazole (for fungal infections)

•    Ritonavir (for virus infections)

•    Erythromycin (for bacterial infections)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

/ How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Swallow each tablet whole with water. Take the tablets before food.

Do not give to children under 16 years.

Do not take more than the amount recommended above.

If you forget to take a tablet, take it as soon as you remember. Do not make up for the missed tablet by taking more than 1 tablet at a time.

Do not take this medicine for more than 14 days unless your doctor tells you to.

If symptoms do not go away talk to your doctor, f If you take too many tablets: Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional, f If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

•    Other allergic reactions such as skin rash

•    Raised, red, itchy skin (symptoms of urticaria, which is often known as hives or nettle rash)

•    Fast, slow or irregular heart beat (palpitations), changes in the way the heart works (this may show up in ECG tests)

•    Dizziness, flushing or fainting

•    Rapid and uncontrollable movement of the eyes, face and body

•    In rare cases mild stomach cramps can occur, but these should go away quickly

If you get any of the following side effects see your pharmacist or doctor:

Uncommon side effects (affects less than 1 in 100 people)

•    Breast pain

Rare side effects (affects less than 1 in 1,000 people)

•    Unusual production of breast milk in men and women

•    Breast growth in men

•    Disruption of periods (menstrual flow)

Very rare side effects (affects less than 1 in 10,000 people)

•    Feeling agitated, nervousness

•    Fits, feeling sleepy, headache

•    Diarrhoea

•    Changes in the way the liver works (this may show up in blood tests)

Not known (cannot be estimated from available data)

•    Reduced sex drive

This medicine may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. This medicine should be used at the lowest effective amount in adults and adolescents.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Reporting of side effects

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 the Yellow Card Scheme at: www.mhra.aov.ukA/ellowcard. By reporting side effects you can help provide more information on the _ _safetyof th[sjmedicine._ _

Howto storethismed [cine"

Do not store above 25°C. Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.    [

Use by the date on the' end flap of the carton, j After this date return i any unused product toj your nearest pharmacy, for safe disposal.    '

What is in this medicine

Each tablet contains Domperidone Maleate equivalent to Domperidone 10 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain lactose, pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate Type A, magnesium stearate and Opadry white OY-S-28899 which consists of titanium dioxide (E171), hypromellose and macrogol.

The pack contains 10 white, round, film coated tablets marked with “DM” on one side and “10" on the other side.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by CP Pharmaceuticals Limited Ash Road North Wrexham LL13 9UF, UK. Marketing Authorisation held by Wockhardt UK Limited Ash Road North Wrexham LL13 9UF, UK. Leaflet prepared August 2013 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information: Product name: Boots Stomach Comfort 10 mg Film Coated Tablets

Reference number: PL 29831/0355

This is a service provided by the Royal National

Institute of Blind People.

ARTWORK 01NLY

Technical Ft Non Printing Items Cutter ^ Guides

ARTWORK TEXT SIZE

Colours

PACK MOCK OP

Product Name:    Stomach Comfort 10 mg Film Coated

Tablets

Product Licence No.: 29831/0355 Wording Ref:    5200.doc

Status:    Internally approved

Pack Details:    Carton of 10 tablets in blisters of FVC/

aluminium foil

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, EU7 3AP, England. T: +44(0) 1482 828100

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

Date Issued

Reason For Change

15/07/2013

UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

STUDIO USE ONLY Michelle Hays    vi.o

Sm»Art check results: 6=0; 0=0; R=0; - MH -16/08/13 15:17:07