Imolevia 100mg Capsules
Package leaflet: Information for the user ImoLevia 100 mg capsules racecadotril
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What ImoLevia is and what it is used for
2. What you need to know before you take ImoLevia
3. How to take ImoLevia
4. Possible side effects
5. How to store ImoLevia
6. Contents of the pack and other information
1. What ImoLevia is and what it is used for
ImoLevia is indicated for the treatment of symptoms of acute diarrhoea in adults, when the cause of the diarrhoea cannot be treated.
ImoLevia can be used as a complementary treatment when causal treatment is possible.
The capsule contains racecadotril which reduces the excessive release of fluids into the bowel associated with diarrhoea, and which results in a reduction of the loss of water and salts.
2. What you need to know before you take ImoLevia
Do not take ImoLevia
• if you are allergic to racecadotril or any of the other ingredients of this medicine listed in section 6.
Warnings and precautions
Please talk to your doctor or pharmacist before taking ImoLevia.
You should tell your doctor if you have:
• blood or pus in your stools and if you have fever. The cause of the diarrhoea may be a bacterial infection that should be treated by your doctor.
• chronic diarrhoea or diarrhoea caused by antibiotics.
• kidney disease or impaired liver function.
• prolonged or uncontrolled vomiting.
• intolerance to lactose (see “ImoLevia contains lactose”).
Other medicines and ImoLevia
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
ImoLevia is not recommended if you are pregnant, think you may be pregnant, are planning to become pregnant or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
ImoLevia has little or no effect on the ability to drive or use machinery.
ImoLevia contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine does not contain gluten.
3. How to take ImoLevia
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
ImoLevia is presented in the form of capsules. The capsules should be swallowed with a glass of water.
Day 1: Start with 1 capsule regardless of the time of day. You may take up to 3 capsules on the first day of treatment preferably before main meals.
Day 2 and after: You may take 1 capsule, 3 times daily, preferably before main meals with a glass of water. Continue the treatment until you have had two normal stools. Treatment should not exceed 7 days.
Elderly: A dosage adjustment is not necessary.
Use in children and adolescents: This medicine must not be given to children under 18 years of age.
To compensate for the loss of liquid due to your diarrhoea, this medicine should be used together with an adequate replacement of fluid and salts. The best replacement of fluid and salts is achieved with an oral rehydration solution (please ask your pharmacist if you are not sure).
If you take more ImoLevia than you should, please contact your doctor or pharmacist immediately. If you forget to take ImoLevia
Do not take a double dose to make up for a forgotten dose. Simply continue with the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOP taking ImoLevia and see your doctor immediately if you experience symptoms of an allergic reaction, such as:
• swollen face, tongue or throat
• difficulty in swallowing
• hives
• difficulty in breathing
The following side effects have been reported:
Common (may affect up to 1 in 10 people)
- headache.
Uncommon (may affect up to 1 in 100 people)
- rash and erythema (skin redness).
Not known (frequency cannot be estimated from the available data)
- erythema multiforme (pink lesions on the arms, legs and inside the mouth),
- inflammation of the tongue, face, lip, or eyelid,
- angioedema (swelling and inflammation under the skin in different parts of the body),
- urticaria (hives or nettle rash),
- erythema nodosum (inflammation in the form of a nodule under the skin),
- papular rash (eruption in the skin with small lesions, hard and nodulated),
- prurigo (itching skin lesions),
- pruritus (generalised itching),
- toxic skin eruption.
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.
5. How to store ImoLevia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and the blister pack. The expiry date refers to the last day of that month.
Store the blister in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away-medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What ImoLevia contains
- The active substance is racecadotril. Each capsule contains 100 mg of racecadotril.
- The other ingredients are lactose monohydrate, hydroxypropyl cellulose, microcrystalline cellulose, crospovidone (type A), magnesium stearate. The capsule contains gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171).
Contains lactose (see Section 2, “ ImoLevia contains lactose”).
What ImoLevia looks like and contents of the pack
ImoLevia is a peach banded capsule, hard containing a white to off white granulate.
Each pack contains 10 or 20 capsules, hard. Not all pack sizes may be marketed.
Marketing Authorisation Holder
McNeil Products Ltd
Maidenhead
Berkshire
SL6 3UG
UK
Manufacturer
Janssen Cilag Domaine de Maigremont 27100 Val De Reuil France