FYBOGEL Granules (2021)
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
Fybogel.
2. Qualitative and quantitative composition
Each single dose sachet contains 3.5g ispaghula husk EP. <u>Excipients with known effect:</u> Aspartame (E 951) 16 mg/sachet Potassium 9.76 mg/Sachet For the full list of excipients see section 6.1.
3. Pharmaceutical form
Granules.
4.1. Therapeutic indications
The treatment of patients requiring a high fibre regimen: for example, for the relief of constipation including constipation in pregnancy and the maintenance of regularity; for the management of bowel ...
4.2. Posology and method of administration
If there have been no bowel movements after 3 days of treatment a doctor or health care professional should be consulted. (See section 4.4 Special warnings and precautions for use) Posology Adults One ...
4.3. Contraindications
Hypersensitivity to the ispaghula husk or to any of the excipients listed in Section 6.1 (See Section 4.4 Special warnings and precautions for use). Patients with a sudden change in bowel habit that has ...
4.4. Special warnings and precautions for use
The product should not be taken dry and should always be taken mixed with fluid (5 fluid ounces or 150 mL of water or other liquid per sachet). Ispaghula husk should not be used by patients with faecal ...
4.5. Interaction with other medicinal products and other forms of interaction
Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed. For this reason the product ...
4.6. Pregnancy and lactation
Pregnancy There are limited amount of data (less than 300 pregnancy outcomes) from the use of ispaghula husk in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see ...
4.7. Effects on ability to drive and use machines
Fybogel has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Special attention should be given to individuals manipulating the powder formulations routinely (see 4.4 Special warnings and precautions for use). Adverse events which have been associated with ispaghula ...
4.9. Overdose
Symptoms Overdose with ispaghula husk may cause abdominal discomfort, flatulence, and intestinal obstruction. Management Attention should be paid to maintaining an adequate fluid intake, particularly if ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Drugs for constipation; Bulk-forming laxatives; Ispaghula (Psylla seeds) <b>ATC Code:</b> A06AC01 The active ingredient ispaghula husk consists of the episperm and collapsed ...
5.2. Pharmacokinetic properties
The material hydrates and swells to form a mucilage because it is only partially solubilised. Polysaccharides, such as those which dietary fibres are made of, must be hydrolysed to monosaccharides before ...
5.3. Preclinical safety data
In a study on fertility, embryo-foetal development and pre- and postnatal development (multigeneration study) ispaghula husk (0, 1, 2.5, or 5% (w/w) of the diet) was administered to rats continuously through ...
6.1. List of excipients
Potassium bicarbonate Ph Eur Sodium bicarbonate Ph Eur Citric acid Ph Eur Riboflavin sodium phosphate Ph Eur Beta-carotene 10% (E160a) HSE Aspartame Ph Eur Saccharin sodium Ph Eur Polysorbate 80 Ph Eur ...
6.2. Incompatibilities
None known.
6.3. Shelf life
Three years.
6.4. Special precautions for storage
Store below 30°C in a dry place.
6.5. Nature and contents of container
Sachets of paper/aluminium foil/polythene laminate enclosed in a cardboard outer carton. <u>Pack size(s):</u> Ten or thirty sachets (pack size printed in bold is currently sold).
6.6. Special precautions for disposal and other handling
No special instructions.
7. Marketing authorization holder
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
8. Marketing authorization number(s)
PL 00063/0023
9. Date of first authorization / renewal of the authorization
15/01/1990 / 09/06/2003
10. Date of revision of the text
05/03/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
