Document: leaflet MAH BRAND_PL 15760-0004 change

• label-leaflet MAH BRAND_PL 15760-0004
• leaflet MAH BRAND_PL 15760-0004

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SPECIFICATION DETAILS
Previous Version	n/a
Datamatrix code	Supplied
Material	60gsm Opaque
Flat Size	210x 145
Fold Size	145 x 35
View Panel	TITLE & DATA MATRIX TO VIEW
Fold Detail	PARALLEL
Packing Details	Shrinkwrapped in trays
Colours Front	BLACK
Colours Back	BLACK

NOTE: Artwork Revised - 29th June 2015

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PATIENT INFORMATION LEAFLET

KOLANTICON® GE L Oral Suspension

Dicycloverine Hydrochloride, Aluminium Hydroxide Gel, Light Magnesium Oxide, Simeticone

In this leaflet:

3. What Kolanticon Gel i® and what it i® used for

2.    Before you take Kolanticon Gel

3.    How to sake Kolanticon Gel

4.    Possible slide effects

5.    How to store Kolanticon Gel

4. Further information

1 . WHAT KOLANTICON GEL IS AND WHAT IT IS USED FOR

•    Kolanticon Gel contains an antispasmodic (relieves muscle spasm), an antiflatulent (relievee wind) and antacids.

• Kolanticon Gel ie used to treat stom ach com plaints, such as irritable toov\/el syndrome, where there ate problems such as painful cramps, indigestion and flatulence (wind).

•    It helss to relieve painbjl cramps by rela xing the mdscles of the intestine. It helps to relieve indigestion by reducing acidity, and relieve flatulence by bringing together all the small bubbles of gas to form a large bubble which can be expelled.

2. bofore you take kolanticon gel

Do not take Kolanticon Gnl if:

• You are a llergic to a ny of the ingredients (see Section 6)

•    You finae difficulty passing urine because of an enlarged prostate or other condition

•    You have ulcasatiee aolitis or ot her conditious affecting movement of food through the gastrointestinal tract

•    You have myasthenia gravis (a very rare muscle disease)

• You have glaucoma (a condition involvingincreased pressu re within the eye resulting in poor vision!.

Before takmg Kolanticon Gel telt your doctor / pharmacist if:

•    You have ar have had kidney problems

•    You have a low phosphorus diet

•    You have a hiatus hernia (a condition with symptoms such as acid or food regurgitation)

Taking other medicines:

Tell your (doctor or pharmacist if you are; talking any other medicine s, i n particular antib i otics (e.g. tetracycline, ciprofloxacin, rifampicin), ACE inhibitors, anticoagulante, digoxin, ketoconnzole, penicillamine or biphosphonates,

This; is because Kolanticon Gel may affefci the absorption of other medicines taken at the same time.

Pregnancy and breast feeding:

Tell your doctor or pharmacist if you are or may be pregnant or if you are breast feeding .

3.    HOW TO TAKE KOeANTICON GEL Adults and Children over 1 2 years old:

• The usual dose of Kolanticon Gel is two to four 5ml spoonfuls (10-20ml) every four hours if needed.

• Pou should shake the bottle before use to mix the ingredients properly. Then mhasure out the amount you need onto a 5ml spoon and swallow the liquid.

If you take more t lthn you should:

• If you accidentally take too much medicine yy u should consult your doctor c^r^- go to your^- nearest hospital casualty department.

If you forget to take Kolanticon Gel:

•    If you forget to take yyur medicine at the correct time, don't worry. Do not take twice as much next time. Just take your medicine as soon as you remember and carry on as before.

4.    POSSIBLE SICE EFFECTS

Like all medicines, Kolanticon Gel can cause side effects, although not evvrybody gets them.

Some people may get a dr]/ mouth, blurred vision, constipation or^- difticu lty passing urine .

Re port ing of side effects: fy ou get sny sid e effects, ta lk to your eocitor, pharmacist or nurse.

This iec^es any possible oide effectt notlisted in this leaflet. Pou can also report side effects directly via the Pellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE KOLANTICON GEL Keep out of¹ t he reach and sight of¹ children.

Do not use your medidne after the expiry date on the labee or^- if the medicine has (deteriorated in _a^anⁿyf^yw^fwa^ay.^yf^.f

Keep your medidnein the original bottle; and store below 25°C.

6.    FURTHER INFORMATION What Kolanticon Gel Contains:

The active ingredients are:

Each 5ml spoonful of Kolanticon Gel contains: 2.5mg dic^yloverine hydrochloride, 200mg aluminium hydroxide, 100mg magnesium oxide and 20mg simeticone.

The otheeingredients are: Magnesium sulphate, methylcellulose 450, bbnzyl alcohol, ,0(111x01 lauryl sulphate, saccharin sodium, alcohol 95%, methiyri pprahydroxybcnooate| foropo /ic| parahydroxybenzoate, butyl parahy/roxybenzoate, citric: acid, oil of cinnamon, peppermint oili oil of spearmint, oil of cedar lea! oil of nutmeg, eucalyptol, menthol and demineralised water.

What Kolanticon Gel looks l ike:

Kolanticon Gel is a thici, white liquid available in bottlees off 200ml und 500ml.

Markkting Authorisation Holder:

Peci<forton Pharmaccuticals Ltd., Crewe Halll Crewe, Cheshire, CW1 6UL, England.

Manufastured by:

Fleet Laboratories Ltd., 94 Rickmansworth Road, Watford, |f|^rtford^ii irel WD18 7JJ, Englaod.

Date of revision: J une 2015

LTFxxxx