COMPOSITION: The active substance is: Diosmectite 3 g, in each sachet
The other ingredients are: Glucose monohydrate, saccharin sodium, orange-vanilla flavour (containing sucrose).
PHARMACEUTICAL FORM Powder for oral suspension. Box of 10 sachets.
PHARMACO-THERAPEUTIC CLASSIFICATION Antidiarrheal Gastro-intestinal protectant
(A: Alimentary tract and metabolism).
INDICATIONS This drug is indicated in the treatment of diarrhea and of painful symptoms associated with oesophageal-gastric and intestinal diseases.
PRECAUTIONS !
Special warnings If the symptoms do not improve within 7 days, consult your physician. If pain is associated with fever or vomiting, consult your physician. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. KEEP OUT OF CHILDREN’S REACH
DRUG INTERACTIONS As a precaution, this drug should not be taken at the same time with another drug. IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, YOU MUST SYSTEMATICALLY REPORT ANY OTHER ONGOING TREATMENT TO YOUR PHYSICIAN OR CHEMIST. IN CASE OF DOUBT , IT IS IMPERATIVE TO TAKE A MEDICAL OR A CHEMIST ADVICE.
PREGNANCY, BREAST FEEDING IN GENERAL, DURING PREGNANCY OR BREAST FEEDING, A MEDICAL OR A CHEMIST ADVICE SHOULD ALWAYS BE SOUGHT BEFORE TAKING ANY DRUG.
Excipients known to have a recognised effect: Glucose, sucrose.
HOW SHOULD THIS MEDICINE BE USED? DOSAGE AND DIRECTIONS FOR USE
Oral Route: Children:
•
Under 1 year:
1 sachet per day
•
Between 1 and
2 years: 1 to 2 sachets per day
•
Over 2 years:
2 to 3 sachets per day
Adult: An average of 3 sachets per day, mixed with half a glass of water. In case of acute diarrhea, the daily dosage can be doubled at the beginning of treatment.
Rectal Route: Retention enema: 1 to 3 enemas per day of 1 to 3 sachets diluted in 50 to 100 mL of lukewarm water. IN ALL CASES, FOLLOW STRICTLY YOUR PHYSICIAN’S PRESCRIPTION.
Administration
Oral route: Adults: Contents of one sachet should be suspended in half a glass of water. Children: Contents of sachet can be added to the baby’s bottle containing 50 mL of water to be given during the day or can be mixed with a semi liquid food: pap, compote, purée, baby food.
Rectal route: Contents of the sachets must be diluted in 50 to 100 mL lukewarm water, and be administered with a douche.
Rythm and time of administration Administer preferably:
- After meals in oesophagitis,
- Between meals in other indications.
Duration of treatment If the symptoms do not improve within 7 days, consult your physician.
SIDE EFFECTS Development or worsening of constipation
REPORT ANY SIDE EFFECT NOT DESCRIBED IN THIS NOTICE TO YOUR PHYSICIAN OR YOUR CHEMIST
STORAGE Do not exceed the expiry date indicated in clear on the packaging
LEAFLET UPDATE May 2007
DISTRIBUTOR BEAUFOUR IPSEN Pharma 24 rue Erlanger 75016 PARIS
MANUFACTURER BEAUFOUR IPSEN INDUSTRIE rue Ethe Virton 28100 DREUX
58 195-01 RV13.03.2008
PATIENT INFORMATION - ILLUSTRATED HERE:
BABIES
Under 1 year:
1 sachet per day In a baby's bottle containing 50 mL water to be given during the day.
CHILDREN
Between 1 and 2 years
1 to 2 sachets per day
Over 2 years
2 to 3 sachets per day To mix if necessary with a semi liquid food (pap, compote, purée, baby food).
ADULTS
3 sachets per day To dilute with half a glass water.
New addition to this site: January 2010
Source: Pharmaceutical Industry Pharmaplan Pty Ltd 106 - 16th Road, Midrand South Africa
Tel +27 (0)11 652 0950 Fax +27 (011) 652 0953 Cell +27 (0)83 443 7303 www.pharmaplan.co.za
SMECTA®, powder for oral suspension