Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: FENOFIBRATE Capsules (2019)

Αναφορές

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

Περιεχόμενα

Name of the medicinal product

Fenofibrate 200 mg capsules.

Qualitative and quantitative composition

Each capsule contains 200 mg of micronised fenofibrate. Excipient with known effect: Each capsule contains 101mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Capsule, hard. Orange, hard gelatine capsule.

Therapeutic indications

Fenofibrate 200 mg capsules are indicated as an adjunct to diet and other non pharmacological treatment (e.g. exercise, weight reduction) for the following: Treatment of severe hypertriglyceridaemia with ...

Posology and method of administration

Posology Adults The recommended initial dose is one capsule taken daily during a main meal. In elderly patients without renal impairment, the normal adult dose is recommended. Since it is less well absorbed ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Fenofibrate 200 mg capsules are contraindicated in children, gallbladder disease, severe renal disorders and ...

Special warnings and precautions for use

Secondary causes of hyperlipidaemia Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological ...

Interaction with other medicinal products and other forms of interaction

Oral anti-coagulants Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. In patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range ...

Effects on ability to drive and use machines

Fenofibrate 200mg capsules has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The adverse drug reactions are stated in the table below using the following convention: Very common (>1/10); common (>1/100; <1/10); uncommon (>1/1,000; <1/100); rare (>1/10,000; <1/1,000); very rare ...

Overdose

No case of overdosage has been reported. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be ...

Pharmacodynamic properties

Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates ATC code: C10AB05 Fenofibrate 200 mg capsule is a formulation containing 200 mg of micronised fenofibrate: the administration ...

Pharmacokinetic properties

Absorption The unchanged compound is not recovered in the plasma. Fenofibric acid is the major plasma metabolite. Peak plasma concentration occurs after a mean period of 5 hours following dosing. Mean ...

Preclinical safety data

Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate. Studies on mutagenicity of fenofibrate have been negative. In rats and mice, liver tumours have been ...

List of excipients

Lactose monohydrate Pregelatinised starch Sodium lauryl sulfate Povidone Magnesium stearate Composition of the capsule shell: Gelatin Titanium dioxide (E171) Yellow iron oxide (E172) Ponceau 4R, cochineal ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 30 months.

Special precautions for storage

Do not store above 25°C. Store in the original package.

Nature and contents of container

Blister, PVC (250 μm)-PVDC (40 g/m²)/Alu (20 µm) and Blister, PVC (250 μm)-PVDC (60 g/m²)/Alu (20 µm) Pack sizes: 20, 28, 30. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS, United Kingdom

Marketing authorization number(s)

PL 00142/0552

Date of first authorization / renewal of the authorization

29 June 2004 / 03.08.2009

Date of revision of the text

15/03/2019

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 104,9 KB