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Fybogel Mebeverine

Ispaghula husk Mebeverine hydrochloride

Pharmacode Reads This Way

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you are not sure about anything, ask your doctor or pharmacist.

You must consult a doctor if you develop new symptoms, or if your symptoms worsen or do not improve after two weeks of treatment.

WHAT IS FYBOGEL MEBEVERINE?

Fybogel Mebeverine contains ispaghula husk, which is a natural plant material which is high in fibre. It works by increasing the bulk of the contents of the gut passing through the digestive system, helping your body to work normally. Mebeverine is an antispasmodic drug which relieves spasms and cramps, which occur in the gut causing pain.

WHAT IS FYBOGEL MEBEVERINE USED FOR?

This product is to relieve the symptoms of irritable bowel syndrome. If you have irritable bowel syndrome, you are likely to suffer from painful spasms of the gut and irregular bowel habits. Fybogel Mebeverine is effective in relaxing the spasms of the gut, relieving pain. At the same time Fybogel Mebeverine will help you to restore and maintain bowel regularity.

BEFORE TAKING FYBOGEL MEBEVERINE

Do not take Fybogel Mebeverine if your doctor has told you that you

*    are suffering from a blockage of the bowel (intestinal obstruction or faecal impaction)

*    have decreased activity of the bowel known as paralytic ileus

*    have muscle weakness of the bowel wall (colonic atony)

*    have an inherited condition called phenylketonuria, because the product is sweetened with aspartame E951, which is a source of phenylalanine. This may be harmful for people with phenylketonuria.

*    are allergic to any of the ingredients (see over page).

Fybogel Mebeverine should not be taken by children under 12 years.

If this is the first time you have had these symptoms

Consult your doctor before using Fybogel Mebeverine, as this may not be the right treatment for you.

Check with your doctor before taking Fybogel Mebeverine if you are aged 40 years or over have passed blood from the bowel are feeling sick or vomiting have lost your appetite or lost weight are looking pale and feeling tired are suffering from severe constipation have a fever

have recently travelled abroad are or may be pregnant have abnormal vaginal bleeding or discharge have difficulty or pain passing urine

have been prescribed diuretic medicine are on a controlled sodium or potassium diet (as each sachet contains 2.37mmol of sodium and 2.50 mmol of potassium).

■ Have acute porphyria (metabolic disorder affecting the production of heme)

RB004777

Pharmacode Reads This Way

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HOW SHOULD I TAKE FYBOGEL"MEBEVERINE?"

Stir the contents of a sachet into a glass of cold water (approximately 1/4 pint or 150ml) and drink immediately.

Fybogel Mebeverine must be taken with an adequate amount of liquid, as directed. Blockage of the gut may occur if the granules are not prepared with enough liquid. Do not take Fybogel Mebeverine without water.

Dosage: Adults and children over 12: should take Fybogel Mebeverine half an hour before a meal, one sachet in the morning and one in the evening, or as prescribed by your doctor. If necessary, an additional sachet may be taken before the midday meal.

Fybogel Mebeverine should not be taken by children under 12years. Length of treatment

Consult a doctor if you develop new symptoms or if your symptoms worsen or do not improve after two weeks of treatment.

If you miss a dose

Simply continue with your treatment when the next dose is due.

If you take more than you should

If you have taken too much Fybogel Mebeverine, drink plenty of water. POSSIBLE SIDE EFFECTS

You may experience allergic skin reaction including skin rash with itching e.g. “hives” or “nettle rash”. If you start to itch or get rash, STOP taking Fybogel Mebeverine and tell your doctor at once.

Hypersensitivity or severe allergic reaction including swollen face or breathing problems. Tell your doctor straight away if you notice any of these symptoms and STOP taking Fybogel Mebeverine.

You may experience flatulence or bloating for the first few days after starting this medicine, but these effects should lessen as you continue treatment.

If you have any other unwanted side effects after taking this product, tell your doctor or pharmacist.

HOW TO STORE

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the pack (EXP month/year). Store below 30°C. Store in the original package to protect from moisture. FURTHER INFORMATION

What Fybogel Mebeverine contains

Each single dose of granules contains

•    3.5 g ispaghula husk and 135 mg mebeverine hydrochloride. These are the active ingredients (which make the product work).

•    potassium hydrogen carbonate, sodium hydrogen carbonate, microcrystalline cellulose, basic butylated methacrylate copolymer, sterilised talc, polyethylene glycol 6000, citric acid, polysorbate 80, silica colloidal anhydrous, saccharin sodium, aspartame E951, orange flavour and beta-carotene, riboflavine sodium phosphate and apo-carotenal colouring.

What Fybogel Mebeverine looks like and contents of the pack Fybogel Mebeverine comes in a carton containing ten sachets of orange flavoured granules.

Fybogel and are trademarks.

Manufacturer and Product Licence Holder in the UK:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS, UK.

Leaflet last revised December 2011.

RB004777

RBH Contact:    Samantha Bradley

Artwork Type: Submission Only

Component Code (2D if applicable):    RB004777

Parent Technical Packaging    ....

Specification:    '

Bulk Code (if applicable):    N/A

CAD Cam Ref: Fyb~Lft-D0268244- 130x255mm Printer:    Contego Packaging (Bradford, UK) Nampak

Substrate:    Paper - White

Edgemark Position:    N/A

Pharmacode No/NE: N/A

Print and Technical Colours

COLOURS TO MATCH RECOGNISED STANDARDS

BARCODE INFO

All other aspects of the bar code to conform to the current GSl Operating Manual or other agreed commercial standard.

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 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.

STUDIO USE ONLY Rebecca Milner    vi.o

Sm«Art check results: G=0;0=0; R=0; - RM - 22/12/11 14:29:43

ARTWORK APPROVAL

Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________

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CUSTOMER INFO: Minimum Point Size = 9 pt

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