FYBOGEL MEBEVERINE - patient leaflet, side effects, dosage

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.

Ispaghula husk contains substances which may lead to allergic reactions after use of the product by the oral route, contact with the skin or, in case of powder formulations, also by inhalation. The allergic symptoms may include running nose, redness of the eye, difficulty in breathing, skin reactions, itching, and in some cases anaphylaxis (a sudden, generalised allergic reaction that may lead to life-threatening shock). Individuals manipulating the powder formulations routinely are more prone to these reactions (see section “Before taking Fybogel Mebeverine” above).

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

You may experience difficulty swallowing and/or blockage of the bowel, especially if swallowed with insufficient water.

The frequency of these side effects is unknown.

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: , or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

HOW TO STORE

Keep out of the sight and reach 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

Each single dose of Fybogel Mebeverine contains:

• 3.5g ispaghula husk and 135mg 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, 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 PL Holder: Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS, UK.

Manufacturer: RB NL Brands B.V. WTC Schiphol Airport, Schiphol Boulevard 207, 1118 BH Schiphol, Netherlands

Marketing Authorisation number: PL 00063/0025 !

'Leaflet last revised August 2021 |

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