FORLAX Powder for solution (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
FORLAX Powder for solution.
2. Qualitative and quantitative composition
Each sachet contains 10 g of macrogol 4000. <u>Contains sugar:</u> sorbitol 1,7 mg per sachet. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution in sachet. A white or almost white powder having a reminiscent odour of orange and grapefruit.
4.1. Therapeutic indications
Symptomatic treatment of chronic functional constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment. FORLAX should remain ...
4.2. Posology and method of administration
Posology 1 to 2 sachets per day, preferably taken as a single dose in the morning. The effects of FORLAX becomes apparent within 24 to 48 hours after its administration. In children, treatment should not ...
4.3. Contraindications
Hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients of FORLAX (see section 6.1). Severe inflammatory bowel disease (such as ulcerative colitis, Crohns disease) or toxic megacolon, ...
4.4. Special warnings and precautions for use
The treatment of constipation with any medicine is only an adjuvant to a healthy lifestyle and diet, for example: increase intake of liquids and dietary fibre, advice on appropriate physical activity and ...
4.5. Interaction with other medicinal products and other forms of interaction
There is a possibility that the absorption of other medicines could be transiently reduced during use with FORLAX, particularly medicines with a narrow therapeutic index or short half-life such as digoxin, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). There is a limited amount of data (less than 300 pregnancy outcomes) ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Adverse Drug Reactions are listed under headings of frequency using the following categories: Adverse Drug Reaction Classification Terminology (frequency): Very common (≥1/10); common (≥1/100 to <1/10); ...
4.9. Overdose
Excessive doses may cause diarrhoea, generally stops when the dosage is reduced, or treatment temporarily interrupted. Diarrhoea, abdominal pain and vomiting have been reported. In cases of severe diarrhoea, ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 11.5 Laxatives <b>Pharmacotherapeutic group:</b> Osmotic laxative <b>ATC code:</b> A06AD15 (A: digestive system and metabolism) High molecular weight (4000) macrogols ...
5.2. Pharmacokinetic properties
The pharmacokinetic data confirm that macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.
6.1. List of excipients
Saccharin sodium (E954), orange-grapefruit flavour<sup>**</sup> ** Composition of the orange-grapefruit flavour: Orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalol, ethyl ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 30°C. For single use only. Discard unused solution.
6.5. Nature and contents of container
Single dose white sachets packed in cardboard cartons of 10 or 20. The sachet consists of paper/aluminium/polyethylene layers.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686
8. Marketing authorization number(s)
45/11.5/1129
9. Date of first authorization / renewal of the authorization
23 March 2015
10. Date of revision of the text
16 September 2022
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
