1. NAME OF DRUG IMODIUMLINGUAL 2mg, oral lyophilisate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Loperamide hydrochloride: 2.00 mg Per oral lyophilisate. To see a complete list of dilutants, see section 6.1.
3. PHARMACEUTICAL FORM Oral lyophilisate.
4. CLINICAL DATA
4.1. Therapeutic Indications Short-term treatment for acute temporary diarrhoea for adults and children over 15 years. This is a supplementary treatment to dietetic measures.
4.2. Dosage and how to use Orally. Suitable for adults and children over the age of 15 years old. Initial dosage: 2 Oral lyophilisates then 1 extra Oral lyophilisate, to be taken after every non-soft stool but: - Do not exceed 6 Oral lyophilisates per day. - Do not exceed 2 days of treatment. - Place in mouth to melt or dilute in water and drink immediately.
4.3. Contraindications Acute outbreaks of ulcerative colitis (risk of colectasis). Hypersensitivity to one of its components in the capsule.
4.4. Special warnings and side effects Special warnings: This medication is not suitable for children younger than 15 years old. If the diarrhoea persists after 2 days of treatment , treatment needs to be revaluated and a rehydration solution will need to be prescribed. This drug contains lactose. This drug is not recommended for patients with a lactose intolerance. Precautions for use Loperamide should not be used as a first-line treatment in acute dysenteries with presence of blood in the stool and high fever. Loperamide should not be used for diarrhoea if also on a treatment with anti-biotic medication. In fact, pseudomembranous colitis with poisoning should be feared. In this case, any treatment resulting in faecal stasis should be avoided. In general, loperamide should not be used when inhibition of peristalsis should be avoided and administration should be discontinued in the event of constipation or abdominal distension. Hepatic insufficiency should be monitored for the important first-pass effect.
4.5. Interactions with other drugs Not applicable.
4.6. Pregnancy and breast feeding Pregnancy: Studies in animals have not shown a teratogen effect. In the absence of a teratogenic effect in animals, a malformative effect on the human species is not expected. To date the substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies on two species. The use of loperamide among a small number of pregnancies has not caused any malformations or foetal toxicity to this date. However, extra studies are required to evaluate the consequences during pregnancy. Given the data, the use of lopermaide is not recommended during pregnancy unless necessary. In case of prolonged treatment, take into account its opiate properties which can in particular affect the digestive functions of the newborn. Breast feeding: The passage of loperamide into human milk is very weak; therefore loperamide can be taken during pregnancy. In case of prolonged treatment, take into account its opiate properties.
4.7. Effects on the ability to drive and operate machinery This medication can sometimes cause light and temporary drowsiness. For drivers and users of machinery, be aware of the risk of drowsiness from taking this medication.
4.8. Side effects - constipation and/or abdominal pain combined with ileus in very rare cases. - abdominal pain, bloating, nausea, vomiting, dry mouth. - asthenia, drowsiness, vertigo. - rare allergic reactions including rash, urticaria and angioedema and extremely rare cases of anaphylactic shocks.
4.9. Overdose Symptoms Central nervous system depression (decrease in vigilence, drowsiness, mycosis, hypertonia, respiratory depression, coordination problems), urinary retention and ileus. Children are more sensitive to the effects of the central nervous system. Emergency procedure Naloxone can be used as an antidote. The duration of action of the speciality being longer than that of naloxone (1 to 3 hours), it may be necessary to renew the administration of the latter. As a result, the patient should be kept under medical supervision for at least 48 hours to detect any depression of the central nervous system.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmaco-dynamic properties ANTI-DIARRHOEA. (A: digestive and metabolism) Anti-diarrhoea , opiates structure. Anti-secretory activity by increasing the hydro-electrolyte flow of intestinal lumen to the enterocyte plasma pole and reduction of the reverse flow. Slower colonic transit with increased segmental contractions. Quick and lasting effects. Respects the bacteriological and parasitological characteristics of the stool.
5.2. Pharmacokinetics properties Loperamide is absorbed in the digestive tract. It undergoes a significant first-pass hepatic effect. Plasma concentrations are low (2 ng / ml after administration of approximately 8 mg loperamide per day). In humans, the plasma peak is between 2 and 4 hours. Loperamide is mainly metabolised by the liver, and its elimination half-life is 10 to 15 hours. Its elimination is mainly in faeces.
5.3. Preclinical safety data Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of dilutants Gelatine, aspartame (E951), mint flavoring (maltodextrin, peppermint essential oil, menthol, benzyl alcohol, vanillin, benzoin 50% AB, amyl alcohol, citronelic acid, cocoa extract, decanoic acid, octanoic acid, hexanoic acid 1-octene-3-ol, p-hydroxybenzylacetone, isopentanal, clove essential oil, 2-ethylhexanol, 2-methylbutyric acid, heliotropin, guaiacol, propionic acid, acetic acid, benzaldehyde, diacetyl, butyl acetate, ethyl decanoate, 1-butanol, ethyl acetate, triacetin, ethyl laurate, ethyl nonanoate), sodium bicarbonate, mannitol.
6.2. Incompatibilities Not applicable.
6.3. Shelf life 4 years.
6.4. Storage precautions No specific storage precautions.
6.5. Nature and contents of outside packaging 5, 6, 10 or 12 capsules in blister packs (PVC/Aluminium)
6.6. Precautions for handling and disposal No specific requirements.
7. THE MARKETING AUTHORISATION HOLDER JOHNSON & JOHNSON SANTE BEAUTE FRANCE 1, rue Camille Desmoulins 92130 ISSY-LES-MOULINEAUX
8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 359 598-5: 5 oral lyophilisates in blister packs (Aluminium/Aluminium). · 359 599-1: 6 oral lyophilisates in blister packs (Aluminium/Aluminium). · 359 601-6: 10 oral lyophilisates in blister packs (Aluminium/Aluminium). · 366 667-9: 12 oral lyophilisates in blister packs (Aluminium/Aluminium).
9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder]
10. DATE OF UPDATE OF TEXT [To be completed by holder]
11. DOSIMETRY Not applicable.
12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.
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