INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SMECTA®, powder for oral suspension

PROPRIETARY NAME
(and dosage form):

SMECTA®, powder for oral suspension

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

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