VACONTIL Capsule, hard (2019)
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Περιεχόμενα
1. Name of the medicinal product
Vacontil 2 mg capsules.
2. Qualitative and quantitative composition
Each capsule contains loperamide hydrochloride 2 mg. <u>Excipient with known effect:</u> lactose monohydrate. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard. Dark green Grey gelatine capsules size 4.
4.1. Therapeutic indications
Symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. Symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years ...
4.2. Posology and method of administration
Posology Acute diarrhoea Adults and children 12 years and over Two capsules (4 mg) initially, and one capsule (2 mg) after each loose stool. The usual dose is 3-4 capsules (4-8 mg) per day. The total daily ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In children less than 12 years of age. In patients with acute dysentery, which is characterised by blood in stools ...
4.4. Special warnings and precautions for use
Treatment of diarrhoea with loperamide is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. The priority in acute diarrhoea is the ...
4.5. Interaction with other medicinal products and other forms of interaction
Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine or ritonavir, that are P-glycoprotein inhibitors, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Safety in human pregnancy has not been established, although from animal studies have not demonstrated any teratogenic or embryotoxic effects. 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, drowsiness and dizziness may occur when diarrhoea is treated with this medicine. Therefore, it is advisable to use caution when driving ...
4.8. Undesirable effects
Adults and children aged ≥12 years The safety of loperamide HCl was evaluated in 2755 adults and children aged ≥12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide ...
4.9. Overdose
Symptoms In case 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 time and ...
5.2. Pharmacokinetic properties
Absorption Most ingested loperamide is absorbed from the gut, but as a result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%. Distribution Studies on distribution ...
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
<u>Capsule core:</u> Lactose monohydrate Pregelatinized maize starch Talc Magnesium stearate <u>Capsule shell:</u> Gelatin Sunset yellow (E110) Brilliant blue (E133) Erythrosine (E127) Titanium dioxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25ºC, in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Blister boxes with 10 or 20 capsules. Blister boxes with 30 or 1000 capsules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Medochemie Ltd, 1-10 Constantinoupoleos Street 3011, Cyprus
8. Marketing authorization number(s)
8524
9. Date of first authorization / renewal of the authorization
First authorisation date: 22.10.1982 Renewal date: 15.06.2011
10. Date of revision of the text
30/08/2019
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