Gielism 60 Mg Hard Capsules
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Alverine citrate
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.
What is in this leaflet:
1. What GIELISM is and what it is used for
2. What you need to know before you take GIELISM
3. How to take GIELISM
4. Possible side effects
5. How to store GIELISM
6. Contents of the pack and other information
1. What GIELISM is and what it is used for
GIELISM is an anti-spasmodic medicine. It relaxes the muscles in the intestine (gut) and uterus (womb). This helps stop the pain you feel when the muscles become tense.
GIELISM is used:
• to help people who have Irritable Bowel Syndrome (IBS). Some of the symptoms of IBS are:
- abdominal pains like cramp which come and go,
- diarrhoea,
- constipation,
- feeling full and bloated,
- wanting to go to the toilet urgently.
Sometimes these symptoms are worse if you are worried or under stress.
• for a condition of the large intestine called painful diverticular disease of the colon.
• to relieve period pains.
GIELISM is intended for adults and adolescents over 12 years old.
2. What you need to know before you take GIELISM Do not take GIELISM
• If you are allergic to the active substance (alverine citrate) or any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have obstruction of the gut or that your small bowel is not working properly.
Precautions and warnings
If any of the following apply to you, you should not take GIELISM, as it may not be the right treatment for you. See your doctor as soon as possible if:
• you are aged 40 years or over.
• you have passed blood from the bowel.
• you are feeling sick or vomiting.
• you have lost your appetite or lost weight.
• you are looking pale and feeling tired.
• you are suffering from severe constipation.
• you have a fever.
• you have recently travelled abroad
• you have abnormal vaginal bleeding or discharge.
• you have difficulty or pain passing urine.
Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.
Children
GIELISM is not suitable for children under 12 years old.
Other medicines and GIELISM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking GIELISM with food
It does not matter if you take GIELISM with or without food.
Pregnancy, breast-feeding and fertility
You should not use this medicine if you are pregnant or if you are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
If you feel dizzy while taking GIELISM you should avoid driving or operating machinery.
3. How to take GIELISM Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 or 2 capsules taken up to 3 times a day.
Method of administration
Swallow the capsule with a glass of water.
Duration of treatment
Consult your doctor if your symptoms do not improve after 2 weeks treatment.
If you take more GIELISM than you should, contact a doctor.
If you forget to take GIELISM, take it when you remember. If you forget for more than 4 hours, just take the next dose when you remember it is due.
Do not take a double dose to make up for a forgotten dose.
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.
Stop taking GIELISM and see your doctor as soon as possible if you notice:
• Difficulties in breathing, shortness of breath, wheezing, swelling of your face or other parts of your body, as serious allergic reactions have been known to occur.
• Yellowing of the whites of the eyes and the skin, as inflammation of the liver has been known to occur.
Other side effects may include:
• a feeling of sickness or dizziness,
• headache,
• allergic reactions, which may include itching or skin rash.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If tou 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 GIELISM
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 blister pack and on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 protect the environment.
6. Contents of the pack and other information What GIELISM contains
• The active substance is: 60 mg alverine citrate.
• The other ingredients are: pregelatinised starch, magnesium stearate.
Composition of the capsule shell: gelatin, titanium dioxide (E171).
What GIELISM looks like and contents of the pack
GIELISM is available in PVC/Aluminium blisters.
Each pack contains 3, 10, 12, 20, 30, 60, 90 or 100 hard capsules in blisters. The hard capsules are white and oblong.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Laboratoires Mayoly Spindler 6 avenue de l’Europe B.P.51
78401 Chatou Cedex France
Manufacturer SOPHARTEX 21, rue du Pressoir F-28500 Vernouillet France
Health tips for you
Try to make your everyday life a bit healthier:
• Allow plenty of time to do things, and avoid stress
• Do not rush meals
• Try to eat a balanced diet with high fibre foods
• Do not eat foods which seem to make your IBS worse
This medicinal product is authorised in the Member States of the EEA under the following names:
Ireland: Gielism
This leaflet was last revised in {MM/YYYY}.
To request a copy of this leaflet in Braille, large print or audio format, please contact licence holder at the address above.