NORIMODE Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Norimode 2mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 2mg of Loperamide hydrochloride. <u>Excipients with known effect:</u> Each Norimode 2mg tablet contains 110.356 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, round, biconvex tablet of diameter 6.35mm, marked T3 on one side, scored on reverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. ...
4.1. Therapeutic indications
The symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to five days, in adults and children over nine years. The symptomatic ...
4.2. Posology and method of administration
Posology Acute Diarrhoea Adults and Children (9-17) years The initial dose is two tablets (4mg) for adults and one tablet (2mg) for children, followed by one tablet (2mg) after every subsequent loose stool ...
4.3. Contraindications
The medicine is contraindicated: Patients with a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In children under 9 years of age. When inhibition of peristalsis ...
4.4. Special warnings and precautions for use
In patients with diarrhoea, especially young children, fluid and electrolyte depletion may occur. Use of loperamide does not preclude the administration of appropriate fluid and electrolyte replacement ...
4.5. Interaction with other medicinal products and other forms of interaction
Non-clinical and clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine or ritonavir, which are P-glycoprotein ...
4.6. Pregnancy and lactation
Pregnancy Safety in human pregnancy has not been established, although studies in animals have not demonstrated any teratogenic or embryotoxic properties. As with other drugs, it is not advisable to administer ...
4.7. Effects on ability to drive and use machines
Loss of consciousness, depressed level of consciousness, tiredness, dizziness, or drowsiness may occur when diarrhoea is treated with loperamide. Therefore, it is advisable to use caution when driving ...
4.8. Undesirable effects
The safety of loperamide hydrochloride was evaluated in 3076 adults and children aged ≥12 years who participated in 31 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the ...
4.9. Overdose
Symptoms In cases of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia, and respiratory depression), ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antipropulsives <b>ATC code:</b> A07DA03 Loperamide binds to the opiate receptor in the gut wall, reducing propulsive peristalsis, increasing intestinal transit. Loperamide ...
5.2. Pharmacokinetic properties
<b>Absorption:</b> Most ingested loperamide is absorbed from the gut, but as a result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%. <b>Distribution:</b> Studies ...
5.3. Preclinical safety data
Acute and chronic studies on loperamide showed no specific toxicity. Results of in vivo and in vitro studies carried out indicated that loperamide is not genotoxic. In reproduction studies, very high doses ...
6.1. List of excipients
Lactose monohydrate Povidone Crospovidone Magnesium stearate
6.2. Incompatibilities
None Known.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Store below 25°C, store in the original package in order to protect from light and moisture.
6.5. Nature and contents of container
Blister Strip. PVC: 250 micron, colourless. Aluminium Foil: 20 micron. 3 such blister strips containing 10 tablets in an outer cardboard carton which also contains a Patient Information Leaflet.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Tillomed Laboratories Ltd, 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom
8. Marketing authorization number(s)
PL 11311/0016
9. Date of first authorization / renewal of the authorization
11/03/2009
10. Date of revision of the text
11/04/2022
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