FYBOGEL - Patient leaflet, side effects, dosage

2. what you need to know before you take fybogel

Do not take if:

• You are allergic to Ispaghula husk or any of the other ingredients (see section 6)
• You have a sudden change in bowel habit that has persisted for more than two weeks
• You are suffering from a blockage of the bowel (intestinal obstruction, faecal impaction)
• If you have a weakness of the bowel wall (colonic atony)
• The speed in which material moves through your gut has always been slow (naturally occurring reduced gut motility).
• You have difficulty in swallowing or any throat problems

Tell your doctor, pharmacist or nurse if:

• You have phenylketonuria (an inherited genetic disorder) as this product contains aspartame, a source of phenylalanine.
• You are suffering from an undiagnosed rectal bleeding and unable to pass stools following the use of laxatives.
• Your symptoms worsen or do not improve after 3 days
• You have difficulty in swallowing or any throat problems.

Take special care:

• If you are a healthcare worker or care giver as allergic sensitisation may occur due to inhalation
• If not taken with enough liquid, can cause chest pain, vomiting or difficulty swallowing
• Elderly and debilitated (weak) patients may require medical supervision Other medicines and Fybogel:
• You must not take this medicine if you are taking other medicines which may cause constipation (e.g. codeine or morphine).

Do not take Fybogel within 1/a to 1 hour before or after the following medicines.

• Insulin – if you are diabetic and use insulin, you may need to reduce your dose of insulin if you take Fybogel with meals.
• medicines for thyroid problems – your doctor may need to change the dose of the thyroid hormones you are taking.

3. how to take fybogel

For Oral use. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Fill a glass with approximately 150ml cold water. Pour in the required amount (see dosage below). Stir well and drink straight away, preferably after meals.

Do not take without water. This product should be taken at least 30 mins before or after taking other medicines and should not be taken immediately before going to sleep.

Adults and children over 12 years : Take one sachet in the morning and one in the evening, preferably after meals.

Children aged 6 to 12 years: Take half to one level 5 ml spoonful depending on size and age, morning and evening, preferably after meals.

Children under 6 years: Not recommended for children under 6 years of age. If symptoms worsen or if there is no bowel movement after 3 days of treatment, consult a doctor.

If you take more Fybogel than you should

Do not take more than directed, if you accidently take more than you should, drink plenty of water.

If you forget to take Fybogel

Ifa dose is missed, do not take a double dose; just carry on with the next recommended dose.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This product can cause allergic reactions with symptoms including difficulty in breathing, wheezing or coughing, skin rash, itching and a sudden life-threatening allergic reaction. This product contains allergens and it is possible to come into contact with them via skin, inhalation or when taking the product by mouth and may cause red or itchy eyes, runny or blocked nose and a skin rash. If symptoms appear, you should immediately contact your doctor or pharmacist. Due to the increased fibre intake of your diet you may experience wind (flatulence) or bloating during the first few days of taking this product, which should lessen as you continue to take it. If you have any other symptoms after taking this product, tell your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store fybogel

Keep this medicine out of the sight and reach of children.

Store below 30°C in a dry place. Do not use after the expiry date stated on the carton.

6. contents of the pack and other information

What Fybogel contains

Each single dose sachet contains 3.5g Ispaghula Husk. Other ingredients are potassium bicarbonate, sodium bicarbonate, citric acid, riboflavin sodium phosphate, beta-carotene, aspartame (E951), saccharin sodium, polysorbate 80 and silica colloidal anhydrous.

Marketing Authorisation Holder and Manufacturer

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

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

Marketing Authorisation Number

PL 00063/0023

Fybogel and Q) are trademarks.

Leafletlastrevised August 2021