Fybogel Mebeverine
Ref: 1326/171214/1/F
Fybogel ® Mebeverine
(ispaghula husk / mebeverine hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start 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.
In this leaflet:
Q WHAT IS FYBOGEL MEBEVERINE?
Q WHAT IS FYBOGEL MEBEVERINE USED FOR?
Q BEFORE TAKING FYBOGEL MEBEVERINE O HOW SHOULD I TAKE FYBOGEL MEBEVERINE?
Q POSSIBLE SIDE EFFECTS Q HOW TO STORE O FURTHER INFORMATION
O 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.
Q WHAT IS FYBOGEL MEBEVERINE USED FOR?
The 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.
O 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 know as paralytic ileus
* have muscle weakness of the bowel wall (colonic atony)
* have 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 Further Information)
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 2.37 mmol of sodium and 2.50 mmol of potassium)
* Have acute porphyria (metabolic disorder affecting the production of heme)
O 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.
PL 15184/1326
P
Fybogel Mebeverine
(ispaghula husk / mebeverine hydrochloride)
Patient Information Leaflet (continued)
Fybogel Mebeverine must be taken with an adequate amount if 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 12 years.
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.
Q 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 a 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 unwanted side effects after taking this product, tell your doctor or pharmacist.
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.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
Q HOW TO STORE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Store in the original package to protect from moisture.
Do not take Fybogel Mebeverine after the expiry date shown on the carton or sachet label. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Q FURTHER INFORMATION
What Fybogel Mebeverine contains
Each single dose of granules contains
* 3.5g 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, eudragit, sterilised talc, macrogol, citric acid, polysorbat 80, colloidal anhydrous silica, saccharin sodium, aspartame E951, orange flavour, beta-carotene E160a 10%CWS/S, riboflavine sodium phosphate, apo-carotenal colouring.
What Fybogel Mebeverine looks like and contents of the pack
Fybogel Mebeverine is buff coloured and orange coloured granules with an
orange flavour for oral suspension in a unit dose sachet.
Each pack contains 10 sachets.
This medicine is manufactured by Reckitt Benckiser Healthcare (UK) Ltd., Dansom Lane, Hull, HU8 7DS, UK and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Fybogel Mebeverine
Fybogel is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.
Revision date: 17/12/14