SILDENAFIL AJANTA PHARMA 50 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SILDENAFIL CITRATE

Available from:

Ajanta Pharma UK Limited

INN (International Name):

SILDENAFIL CITRATE

Dosage:

50 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

    Sildenafil Ajanta Pharma 50 mg film-coated tablets 
 Sildenafil Ajanta Pharma 100 mg film-coated tablets 
Sildenafil  

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, pharmacist or
nurse. 
- 
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 Sildenafil Ajanta Pharma is and what it is used for 
2.  
What you need to know before you take Sildenafil Ajanta Pharma 
3.  
How to take Sildenafil Ajanta Pharma 
4.  
Possible side effects 
5.  
How to store Sildenafil Ajanta Pharma 
6.  
Contents of the pack and other information 

1.  
WHAT SILDENAFIL AJANTA PHARMA IS AND WHAT IT IS USED FOR 

Sildenafil Ajanta Pharma contains the active substance sildenafil
which belongs to a group of 
medicines called phosphodiesterase type 5 (PDE 5) inhibitors. It works
by helping to relax the blood 
vessels in your penis, allowing blood to flow into your penis when
you get sexually excited.  
Sildenafil Ajanta Pharma will only help you to get an erection if you
are sexually stimulated.  

Sildenafil Ajanta Pharma is a treatment for adult men with erectile
dysfunction, sometimes known as 
impotence. This is when a man cannot get, or keep a hard, erect penis
suitable for sexual activity. 

2.  
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILDENAFIL AJANTA PHARMA 

DO NOT TAKE SILDENAFIL AJANTA PHARMA�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Ajanta Pharma 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of sildenafil (as citrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Green coloured oval shaped film coated tablets engraved with ‘ap’ logo on one side and ‘50’ on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for
satisfactory sexual performance.
In order for Sildenafil Ajanta Pharma to be effective, sexual stimulation is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
_Use in adults:_
The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Based on efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg. The maximum
recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If Sildenafil Ajanta
Pharma is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
_Use in the elderly:_
Dosage adjustments are not required in elderly patients. (>65 years old).
_Use in patients with impaired renal function:_
The dosing recommendations described in ‘Use in adults’ apply to patients with mild to moderate renal impairment
(creatinine clearance = 30 - 80 ml/min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25
mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.
_Use in patients with impaired hepatic function:_