Tadalafil Aristo PAH 20mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany

ATC code:

G04BE08

INN (International Name):

TADALAFIL 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 20 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-01-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL ARISTO PAH 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 of the 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 Aristo PAH is and what it is used for
2.
What you need to know before you take Tadalafil Aristo PAH
3.
How to take Tadalafil Aristo PAH
4.
Possible side effects
5.
How to store Tadalafil Aristo PAH
6.
Contents of the pack and other information
1.
WHAT TADALAFIL ARISTO PAH IS AND WHAT IT IS USED FOR
Tadalafil Aristo PAH contains the active substance tadalafil.
Tadalafil Aristo PAH 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 ARISTO PAH
DO NOT TAKE TADALAFIL ARISTO PAH IF YOU:
-
are allergic to tadalafil or any of the other ingredients (see section
6).
-
are taking any form of nitrates such as amyl nitrite, used in the
treatment of chest pain.
Tadalafil Aristo PAH has been shown to increase the effects of these
medicines. If you are
taking any form of nitrate or are unsure tell your doctor.
-
have ever had loss of vision – a condition described as “stroke of
the eye” (non-arteritic
anterior ischemic optic neuropathy - NAION).
-
have had a heart attack in the last 3 months.
-
have low blood pressu

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Aristo PAH 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 265 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow coloured, oval shaped, one side scored and other side debossed
with “T 20” biconvex
film-coated tablet of 13.90 x 7.20 mm. The tablet can be divided into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tadalafil Aristo PAH 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).
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_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 dosin