Tadalafil 10 mg 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:

10mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Pack sizes of 4 or 28 film-coated tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

TEVA UK Limited

Therapeutic group:

Urologicals, Drugs used in erectile dysfunction

Therapeutic indications:

Treatment of erectile dysfunction in adult males.

Authorization status:

Authorised

Authorization date:

2015-05-13

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

TADALAFIL 2.5 MG, 5 MG, 10 MG AND 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.

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 is used for treatment of erectile dysfucntion and /or
urinary symptoms associated with benign 
prostatic hyperplasia. Tadalafil contains the active substance
tadalafil which belongs to a group of medicines 
called phosphodiesterase type 5 inhibitors. 

ERECTILE DYSFUNCTION 
Tadalafil 2.5mg, 5 mg, 10 mg and 20 mg 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. Tadalafil has been shown to 
significantly improve the ability of obtaining a hard erect penis
suitable for sexual activity. Following sexual 
stimulation Tadalafil 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.
Tadalafil will not help you if you do not have 
erectile dysfunction. 

IT IS IMPORTANT TO NOTE THAT TADALAFIL DOES NOT WORK IF THERE IS NO
SEXUAL STIMULATION. You and your 
partner will need to engage i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Tadalafil 10 mg Film-coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 10 mg tadalafil. 

Excipients with known effect: 
Each 10 mg film-coated tablet contains approximately 177 mg of
lactose (as 
monohydrate) 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Film-coated tablet 

Ochre to yellow, oval shaped film coated tablet. On
one side scored and 
debossed with “1” 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: 11.1 mm,
width: 6.4 
mm. 

The tablet can be divided into equal doses. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Treatment of erectile dysfunction in adult males. 

In order for tadalafil to be effective for the treatment of
erectile dysfunction, 
sexual stimulation is required. 

Tadalafil is not indicated for use by women. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

_Erectile dysfunction in 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 mg 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 Tadalafil (i.e.,
at least twice 
weekly) a once daily regimen with the lowest doses of Tadalafil
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 t