iMedi.co.uk

Gastricalm Tablets

Informations for option: Gastricalm Tablets, show other option
Document: label-leaflet MAH BRAND 2_PL 00014-0287 change

Yellow Card Submission Page 1

Carton for Gastricalm Tablets (PL 00014/0287)

FRONT OF PACK (follow brand principles and readability guidelines)

Gastricalm Tablets

Aluminium Hydroxide, Magnesium Hydroxide, Simeticone

GENTLE ACTION X Fast effective relief

X For the pain and discomfort of trapped wind, bloating, fullness after food and indigestion

36

BACK OF PACK (follow readability guidelines)

Read all of this carton for full instructions.

What this medicine is for

This medicine contains a wind reliever and antacids, which can be used to relieve bloating and the pain of trapped wind.

It can also be used to relieve the symptoms of indigestion, heartburn and excess acid.

Before you take this medicine

X Do not take:

   If you are allergic to any of the ingredients

   If you have low levels of phosphate in your blood

   If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sorbitol and sucrose)

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

! Talk to your pharmacist or doctor:

•    If you have kidney problems

•    If you take other medicines - tetracycline antibiotics, chloroquine (to prevent malaria), quinolone antibiotics (e.g. ciprofloxacin), penicillamine (for rheumatoid arthritis), phenothiazines (e.g. chlorpromazine for mental problems)

X How to take this medicine

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

Age

How many to take

How often to take

Adults and children of 12 years and over

One or two tablets

After meals, at bedtime, or when you need to.

Children of 5 to 11 years

One tablet

After meals, at bedtime, or when you need to.

Suck or chew the tablets.

Do not give to children under 5 years.

If symptoms do not go away within 5 days talk to your doctor.

If you take too many tablets: You may feel sick or be sick. Talk to a pharmacist or doctor if

Carton for Gastricalm Tablets (PL 00014/0287) this happens.

Possible side effects

Most people will not have problems, but some may get some of these:

• Occasionally diarrhoea or constipation 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 on this carton. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each tablet contains Dried Aluminium Hydroxide Gel (calculated as Aluminium Oxide)

170 mg, Magnesium Hydroxide 164 mg, Simeticone 25 mg.

Also contains: sucrose, sorbitol (E420), maize starch, povidone, microcrystalline cellulose, magnesium stearate, peppermint oil.

PL 00014/0287 Text prepared 05/15

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA by Famar SA Anthoussa Attiki 15344 Greece

If you need more advice ask your pharmacist.

Lot:

Use By:

Bar code Item code Component code

BRAILLE NAME

Gastricalm Tablets

PACK MOCK UP BOX

Product Name: Gastricalm Tablets Product Licence No: 00014/0287 Wording Ref: A4 text Status: Internal Draft PROPOSED

Pack details: 20 microns hard temper-aluminium foil an 250 PVC/40 PVdC Clear Pack sizes 36.

Version No: 1

Date issued: June 2015

Reason for change: Yellow Card submission