1. NAME OF THE MEDICINAL PRODUCT
SMECTALIA 3 g, drinkable suspension in sachet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Diosmectite ................................... 3,000 g per sachet. Notable excipient: ethanol. For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension in sachet.
4. CLINICAL DATA
4.1 Therapeutic indications Short-term treatment of acute diarrhoea in adults and children over 15 years of age. This treatment is a complement to dietary measures. 4.2. Dosage and administration Dosage 1 sachet (3 g) then 1 sachet after each new unformed stool, up to a maximum of 6 sachets per day. The maximum duration of treatment is 3 days. Method of administration Oral administration To thin the suspension, knead the sachet between your fingers before opening. The contents of the sachet may be swallowed undiluted or diluted in a little water before use. Administer preferably at mealtimes. 4.3. Contraindications Back to top Hypersensitivity to diosmectite or to one of the excipients. 4.4 Special warnings and precautions for use Diosmectite should be used with caution in patients with a history of severe chronic constipation. Treatment does not dispense with rehydration if this proves necessary. The extent of rehydration by oral or intravenous rehydration solution should be adapted according to the severity of the diarrhoea, the age and particular characteristics of the patient. Patients should be informed of the need to : - rehydrate with plenty of salty or sweet drinks to compensate for fluid losses due to diarrhoea (the average daily water intake for adults is 2 litres); - maintain their diet during the period of diarrhoea: o by excluding certain foods, particularly raw vegetables, fruit, green vegetables, spicy dishes and iced foods or drinks; o by giving preference to grilled meats and rice. This medicine contains small quantities of ethanol (alcohol), less than 100 mg per daily dose. 4.5. Interactions with other medicinal products and other forms of interaction As the adsorptive properties of this product may interfere with the time and/or rate of absorption of another substance, it is recommended that any other medicinal product be administered at a distance from SMECTALIA. 4.6. Pregnancy and breast-feeding There are no reliable data on teratogenesis in animals. Clinically, no particular malformative or foetotoxic effects have been observed to date. However, the follow-up of pregnancies exposed to SMECTALIA is insufficient to exclude any risk. Consequently, taking into account that SMECTALIA is not absorbed, its use during pregnancy should be considered only if necessary. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Adverse reactions The following adverse reactions have been reported in clinical trials in children and adults. These adverse reactions are generally minor and transient and mainly concern the digestive system. The frequencies of adverse reactions are classified as follows: frequent (³1/100, <1/10), infrequent (³1/1000, £1/100). Gastrointestinal disorders: - Common: constipation usually yielding to dosage reduction but may in rare cases lead to discontinuation of treatment. - Uncommon: flatulence, vomiting. During marketing, cases of hypersensitivity reactions (frequency unknown) including urticaria, rash, pruritus and angioedema have been reported. Cases of aggravation of constipation have also been reported. Reporting suspected adverse reactions It is important to report suspected adverse reactions once the drug has been authorised. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr. 4.9. Overdose Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties Pharmacotherapeutic class: Other intestinal adsorbents ATC code: A07BC05 (A: digestive system and metabolism) Diosmectite is a double silicate of aluminium and magnesium. Due to its layered structure and high plastic viscosity, diosmectite provides excellent coverage of the digestive mucosa. By interacting with mucus glycoproteins, diosmectite increases the resistance of the adherent mucosal gel to aggressors. Through its action on the digestive mucosal barrier and its high binding capacity, diosmectite protects the digestive mucosa. Diosmectite is radiolucent, does not colour the stools and, at the usual doses, does not alter the physiological intestinal transit time. 5.2. Pharmacokinetic properties Due to the structure of diosmectite, SMECTALIA is neither absorbed nor metabolised. 5.3. Preclinical safety data Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients Xanthan gum, citric acid monohydrate, ascorbic acid, potassium sorbate, sucralose, caramel-cocoa flavour*, purified water. * Composition of the caramel-cocoa flavour: blend of natural and synthetic flavours, caramel colouring (E 150d), caramelised sugar syrup, propylene glycol, water, ethanol, caffeine. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Special precautions for storage This medicinal product does not require special precautions for storage. 6.5. Nature and contents of packaging 10 g in sachet (polyethylene terephthalate/aluminium/polyethylene terephthalate/polyethylene). Boxes of 12 and 18 sachets. 6.6. Special precautions for disposal and handling/b> No special requirements. Any unused product or waste must be disposed of in accordance with current regulations.
7. MARKETING AUTHORISATION HOLDER
IPSEN PHARMA 65 QUAI GEORGES GORSE 92100 BOULOGNE BILLANCOURT, FRANCE
8. MARKETING AUTHORISATION NUMBER(S)
- 34009 300 078 7 7: 10 g in sachet (polyethylene terephthalate/aluminium/polyethylene terephthalate/polyethylene), box of 12. - 34009 300 078 8 4 : 10 g in sachet (polyethylene terephthalate/aluminium/polyethylene terephthalate/polyethylene), box of 18.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
[To be completed later by the holder].
10. DATE OF UPDATE OF THE TEXT
[To be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicinal product not subject to medical prescription.
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