TRIPAN 20mg Film-coated tablet (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
Tripan 20 mg Film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 20 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 308 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Light pink, oblong, biconvex, film-coated tablets, with score line on one side.
The score line is not intended for breaking the tablet.
4.1. Therapeutic indications
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is required.
Tripan is not indicated for use by women.
4.2. Posology and method of administration
Posology
Adult men
In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.
In those patients in whom tadalafil 10 mg does not produce an adequ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought ...
4.4. Special warnings and precautions for use
Before treatment with Tripan
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treat...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant ...
4.6. Fertility, pregnancy and lactation
Tripan is not indicated for use by women.
Pregnancy
There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respec...
4.7. Effects on ability to drive and use machines
Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients sho...
4.8. Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dysp...
4.9. Overdose
Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cas...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Urologicals, Drugs used in erectile dysfunction
ATC Code:
G04BE08
Mechanism of action
Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate ...
5.2. Pharmacokinetic properties
Absorption
Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (C
max
) is achieved at a median time of 2 hours after dosing. Absolute bioavai...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproductio...
6.1. List of excipients
Tablet core:
Lactose monohydrate
Microcrystalline cellulose
Povidone K-30
Poloxamer type 188
Sodium lauryl sulfate
Croscarmellose sodium
Silica colloidal anhydrous
Magnesium stearate
Film-co...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Aluminium/PVC/PVDC blisters in cartons of 2, 4 and 8 film-coated tablets.
Not all packs sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Delorbis Pharmaceuticals ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
8. Marketing authorization number(s)
M.L.: 022616
9. Date of first authorization / renewal of the authorization
21/08/2017 / 07/12/2021
10. Date of revision of the text
07/12/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
