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Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml

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Document: label-leaflet ALMUS PHARMACEUTICALS_PL 00014-0615 change

Label-leaflet for Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml

(Yellow Card October 2014)

Page 1

[Base Label]

® A ®

AI^IVIUS* •

•••

Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg / 30ml

Relief of nausea, upset stomach, diarrhoea, indigestion and heartburn

[P] Pharmacy Medicine

300ml e

Read all of this label for full instructions.

Before you take this medicine

X Do not take:

•    If you are allergic to any of the ingredients in the medicine, aspirin or any other nonsteroidal anti-inflammatory medicines.

•    If you are taking medicines containing aspirin

•    If you have kidney problems or gout

•    If you have intolerance to some sugars unless your doctor tells you to (this medicine contains maltitol liquid)

•    If you are pregnant or breastfeeding ! Talk to your pharmacist or doctor:

• If you are on a low salt (sodium) diet (each 30 ml contains 63 mg of sodium)

• If you take other medicines - warfarin or other blood thinners, tablets for diabetes (e.g. chlorpropamide, glibenclamide), medicines to treat gout (e.g. probenecid)

There is a possible association between salicylates and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason salicylates should not be given to children under 16 years, unless on the advice of a doctor.

This medicines contains maltitol liquid which may have a mild laxative effect. Each 30 ml contains 8 g of maltitol. This provides 18 kcal per 30 ml.

Glycerol may cause headache, stomach upset and diarrhoea. The colour (E122) in this medicine may cause allergic reactions.

S How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Shake the bottle.

Use the measuring cup provided.

Adults and children of 16 years and over: Swallow 30 ml every 30 to 60 minutes if you need to, up to a maximum of 8 times in 24 hours.

Do not give to children under 16 years.

Do not exceed the stated dose.

If symptoms are severe, talk to your pharmacist or doctor.

If symptoms do not go away within 2 days, talk to your pharmacist or doctor.

Do not store above 25°C.

! If you take too much: Talk to a doctor straight away.

Possible side effects

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

•    Feeling sick and being sick

•    Darkening or blackening of the stools and tongue 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 label. 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

Do not store above 25°C.

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

Use by the date on the label edge.

What is in this medicine

Active ingredient: Each 30ml ml of oral suspension contains Bismuth Subsalicylate 525.6 mg

Also contains: purified wate, glycerol, maltitol liquid (E965), microcrystalline cellulose, xanthan gum, citric acid monohydrate, carmellose sodium, sodium citrate, sodium benzoate (211), carmoisine (E122), root beer flavour (containing propylene glycol).

PL 00014/0615    [P]

Text prepared 10/14 MA holder: BCM, Nottingham, NG2 3AA Manufacturer: BCM Ltd., Nottingham, NG2 3AA If you need more advice ask a pharmacist

Almus® is a registered trademark

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BRAILLE NAME (on label)

Almus Pepti-Calm Suspension Bismuth Subsalicylate #525.6mg/#30ml

ALMUS ARTWORK STATUS BOX

Product Name: Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml

Product Licence Number: PL00014/0615

Reason for change: MHRA Yellow Card Warning, October 2014