TADALAFIL 20mg FILM-COATED TABLETS

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

tadalafil

Available from:

TEVA UK Limited

ATC code:

G04BE08

INN (International Name):

tadalafil

Dosage:

20mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Pack sizes of 2, 4, 5, 8, 10, 12, 14, 15, 28, 30, 56, 60 or 84 film-coated tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

TEVA UK Limited

Therapeutic group:

Urologicals, Drugs used in erectile dysfunction

Therapeutic indications:

is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Authorization status:

Authorised

Authorization date:

2015-05-13

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

TADALAFIL 20 MG FILM-COATED TABLETS 

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 or
nurse.

This includes any possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 
1. 
What Tadalafil is and what it is used for 
2. 
What you need to know before you  take Tadalafil 
3. 
How to take Tadalafil 
4. 
Possible side effects 
5. 
How to store Tadalafil 
6. 
Contents of the pack and other information 

1. 
WHAT TADALAFIL IS AND WHAT IT IS USED FOR 

Tadalafil contains the active substance tadalafil.  
Tadalafil 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 

DO NOT TAKE TADALAFIL IF YOU: 
- 
are allergic to tadalafil or any of the other ingredients of this
medicine (see section 6).  
- 
are taking any form of nitrates such as amyl nitrite, used in the
treatment of chest pain. [Invented    
    name] 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 - NAI

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Tadalafil 20 mg Film-coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 20 mg tadalafil. 

Excipients with known effect: 
Each 20 mg film-coated tablet contains 353 mg of lactose (as
monohydrate) 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Film-coated tablet (tablet) 

Ochre to yellow, oval shaped film coated tablet. On
one side scored and 
debossed with “2” on the left side of the score and with
“0” on the right side of 
the score. The other side of the tablet is plain. Length: 14.0 mm,
width: 8.0 
mm. 

The tablet can be divided into equal doses. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Tadalafil 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), follo