Dymavig 20 mg Filmdragerad tablett

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

tadalafil

Disponible depuis:

Sigillata Ltd

Code ATC:

G04BE08

DCI (Dénomination commune internationale):

tadalafil

Dosage:

20 mg

forme pharmaceutique:

Filmdragerad tablett

Composition:

laktosmonohydrat Hjälpämne; tadalafil 20 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 8 tabletter

Statut de autorisation:

Avregistrerad

Date de l'autorisation:

2017-07-13

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
DYMAVIG 20 MG FILM-COATED TABLETS
_ _
tadalafil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dymavig is and what it is used for
2.
What you need to know before you take Dymavig
3.
How to take Dymavig
4.
Possible side effects
5.
How to store Dymavig
6.
Contents of the pack and other information
1.
WHAT DYMAVIG IS AND WHAT IT IS USED FOR
Dymavig is a treatment for adult men with erectile dysfunction. This
is when a man cannot get, or
keep a hard, erect penis suitable for sexual activity. Dymavig has
been shown to significantly improve
the ability of obtaining a hard erect penis suitable for sexual
activity.
Dymavig contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
Dymavig works by helping the
blood vessels in your penis to relax, allowing the flow of blood into
your penis. The result of this is
improved erectile function. Dymavig will not help you if you do not
have erectile dysfunction.
It is important to note that Dymavig does not work if there is no
sexual stimulation. You and your
partner will need to engage in foreplay, just as you would if you were
not taking a medicine for
erectile dysfunction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DYMAVIG
DO NOT TAKE DYMAVIG:
-
if you are allergic to tadalafil or any of the other ingredients of
this medicine (listed in section
6).
-
if you are taking any form of organic nitrate or nitric oxide donors
such as a

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dymavig 20 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 250 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
20 mg film-coated tablets are: Pale yellow, oval shape, film-coated
tablets, debossed with “20” on one
side and plain on the other side. The tablet is 12 mm x 7.4 mm in
diameter and 4.6 – 5.2 mm in
thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is
required.
Dymavig 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 adequate effect, 20 mg
might be tried. It may be taken at least 30 minutes prior to sexual
activity.
The maximum dose frequency is once per day.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual
activity and it is not
recommended for continuous daily use.
In patients who anticipate a frequent use of Dymavig (i.e., at least
twice weekly) a once daily regimen
with the lowest doses of Dymavig might be considered suitable, based
on patient choice and the
physician’s judgement.
In these patients the recommended dose is 5 mg taken once a day at
approximately the same time of
day. The dose may be decreased to 2.5 mg once a day based on
individual tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
Special populations
_Elderly men_
Dose adjustments are not required in elderly patients.
_Men with renal impairment_
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients
with s