NOTICE
ANSM - Updated on : 15/03/2021
Product name
KEAL 1 g, drinkable suspension in sachet
Sucralfate
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is KEAL 1 g, drinkable suspension in sachet and what is it used for?
2. What do I need to know before taking KEAL 1 g, drinkable suspension in sachet?
3. How do I take KEAL 1 g, drinkable suspension in sachet?
4. What are the possible side effects?
5. How should KEAL 1 g, Oral suspension in sachet, be stored?
6. Package contents and other information.
1. WHAT IS KEAL 1 g, drinkable suspension in sachet AND WHAT IS IT USED FOR?
ANTI-ULCEREAL (A: digestive system and metabolism)
This medicine is indicated for the treatment of gastric or duodenal ulcers and the prevention of duodenal ulcers.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING KEAL 1 g, drinkable suspension in sachet?
Never take KEAL 1 g, drinkable suspension in sachet
- if you are allergic to sucralfate or to any of the other ingredients listed in section 6;
- in premature and immature newborn infants.
IF IN DOUBT, ASK YOUR DOCTOR OR CHEMIST FOR ADVICE.
Warnings and precautions
Ask your doctor or pharmacist before taking KEAL.
A few cases of bezoars (obstructions of the digestive tract) have been reported in patients hospitalized in intensive care units, mainly in association with tube feeding, and in neonates, particularly premature and immature newborns.
Use with CAUTION in cases of :
- chronic renal failure (impaired kidney function);
- decrease in blood phosphorus levels.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
For proper use of this medicine, regular medical supervision is essential; this may include stomach examinations (fibroscopy).
Children and adolescents
Not applicable.
Other medicinal products and KEAL 1 g, drinkable suspension in sachet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Sucralfate may reduce the effect of certain drugs taken at the same time. Sucralfate should be taken within 2 hours of another medicine.
KEAL 1 g, oral suspension in sachet with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable not to use this medicine during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue.
The use of sucralfate during breast-feeding is not recommended.
Driving and using machines
Not applicable.
KEAL 1 g, suspension buvable en sachet contains sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium.
This medicine contains 0.75 g sorbitol per sachet.
This medicine contains 3.9 mg methyl parahydroxybenzoate and 1.99 mg propyl parahydroxybenzoate per sachet and may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol (23 mg) sodium per sachet, i.e. it is essentially "sodium-free".
3. HOW TO TAKE KEAL 1 g, drinkable suspension in sachet?
Dosage
Gastric ulcer healing
1 sachet 4 times a day:
- 1 sachet half an hour to 1 hour before each of the 3 main meals,
- 1 sachet at bedtime, approximately 2 hours after the evening meal.
Healing duodenal ulcers
Two treatment modalities are possible:
- 1 sachet 4 times a day, or :
o 1 sachet half an hour to 1 hour before each of the 3 main meals,
o 1 sachet at bedtime, approximately 2 hours after the evening meal.
- 2 sachets morning and evening:
o 2 sachets in the morning on waking, half an hour to 1 hour before breakfast,
o 2 sachets in the evening, approximately 2 hours after the evening meal.
Preventing duodenal ulcer relapses
Two treatment modalities are possible:
- 1 sachet 2 times a day, or :
o 1 sachet in the morning on waking, half an hour to 1 hour before breakfast,
o 1 sachet in the evening, either half an hour to 1 hour before the meal, or at bedtime, around 2 hours after the evening meal.
- 2 sachets in the evening, either half an hour to 1 hour before the meal, or at bedtime, approximately 2 hours after the evening meal.
Method and route of administration
Take by mouth.
To drink the contents of the sachet, open along the dotted line, then squeeze the sachet, holding the open end between the lips.
Duration of treatment
Healing of gastric or duodenal ulcers: 4 to 6 weeks.
If you have taken more KEAL 1 g, drinkable suspension in sachet than you should have
Not applicable.
If you forget to take KEAL 1 g, Oral suspension in sachet
Not applicable.
If you stop taking KEAL 1 g, Oral suspension in sachet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
- constipation;
- rarely: dry mouth, nausea, vomiting, rash, dizziness;
- in the case of long-term administration of high doses, there is a theoretical risk of a decrease in blood phosphorus levels;
- some cases of bezoars (obstructions of the digestive tract) have been reported in certain patients (see "Warnings and precautions").
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE KEAL 1 g, drinkable suspension in sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at temperatures not exceeding +25°C.
Do not dispose of any medicine in the drain with household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What KEAL 1 g, drinkable suspension in sachet, contains
- The active substance is :
sucralfate............................................................................................................................. 1 g
- The other components are :
Guar gum, 70% non-crystallizable sorbitol, sodium saccharin, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbic acid, 26G55 flavoring, purified water.
What KEAL 1 g, suspension buvable en sachet is and what it contains
Marketing authorization holder
EXOD
6 PARC DE MONTRETOUT
92210 SAINT CLOUD
Marketing authorization holder
E.G. LABO - LABORATOIRES EUROGENERICS
CENTRAL PARK
9-15 RUE MAURICE MALLET
92130 ISSY-LES-MOULINEAUX
Manufacturer
PHARMATIS
Z.I. LE FOSSÉ DE L'ETANG
BP 20
60190 ESTREES SAINT DENIS
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.