Tadalafil Teva Pharma B.V. 20 mg Filmdragerad tablett

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

tadalafil

Disponible depuis:

Teva Pharma BV

Code ATC:

G04BE08

DCI (Dénomination commune internationale):

tadalafil

Dosage:

20 mg

forme pharmaceutique:

Filmdragerad tablett

Composition:

laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne; tadalafil 20 mg Aktiv substans

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

Förpacknings: Blister, 28 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 120 tabletter

Statut de autorisation:

Avregistrerad

Date de l'autorisation:

2019-01-18

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL TEVA PHARMA B.V. 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 Tadalafil Teva Pharma B.V. is and what it is used for
2.
What you need to know before you take Tadalafil Teva Pharma B.V.
3.
How to take Tadalafil Teva Pharma B.V.
4.
Possible side effects
5
How to store Tadalafil Teva Pharma B.V.
6.
Contents of the pack and other information
1.
WHAT TADALAFIL TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR
Tadalafil Teva Pharma B.V. contains the active substance tadalafil.
Tadalafil Teva Pharma B.V. is a treatment for pulmonary arterial
hypertension in adults.
It belongs to a group of medicines called phosphodiesterase type 5
(PDE5) inhibitors which work by helping
the blood vessels around your lungs relax, improving the flow of blood
into your lungs. The result of this is
an improved ability to do physical activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL TEVA PHARMA B.V.
DO NOT TAKE TADALAFIL TEVA PHARMA B.V.
-
if you are allergic to tadalafil or any of the other ingredients of
this medicine (listed in section 6).
-
if you have had a heart attack in the last 3 months.
-
if you have low blood pressure.
-
if you are taking any form of nitrates such as amyl nitrite, used in
the treatment of chest pain.
Tadalafil Teva Pharma B.V. has been shown to increase the effects of
these medicines. If you are
taking any form of nitrate or are unsure tell your doctor.
-
if you are taking riociguat. This drug is u

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Teva Pharma B.V. 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg tadalafil.
Excipient with known effect
Each film-coated tablet contains 250 mg lactose (monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
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 4.60-5.20 mm in thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tadalafil Teva Pharma B.V. is indicated in adults for the treatment of
pulmonary arterial hypertension (PAH)
classified as WHO functional class II and III, to improve exercise
capacity (see section 5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to
collagen vascular disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of PAH.
Posology
The recommended dose is 40 mg (2 x 20 mg) taken once daily with or
without food.
_Elderly patients_
Dose adjustments are not required in elderly patients.
_Renal impairment_
In patients with mild to moderate renal impairment a starting dose of
20 mg once per day is recommended.
The dose may be increased to 40 mg once per day, based on individual
efficacy and tolerability. In patients
with severe renal impairment the use of tadalafil is not recommended
(see sections 4.4 and 5.2).
_Hepatic impairment_
Due to limited clinical experience in patients with mild to moderate
hepatic cirrhosis (Child-Pugh Class A
and B), following single doses of 10 mg, a starting dose of 20 mg once
per day may be considered. If
tadalafil is prescribed, a careful individual benefit/risk evaluation
should be undertaken by the prescribing
physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C)
have not been studied and therefore
dosing of tadalafil i