Consumer medicine information

1. Why am I using Vasafil?

Vasafil contains the active ingredient sildenafil citrate. Vasafil is used to treat erectile dysfunction also commonly called impotence in men.
For more information, see Section 1. Why am I using Vasafil? in the full CMI.

2. What should I know before I use Vasafil?

Do not use if you have ever had an allergic reaction to sildenafil citrate or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Vasafil? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with sildenafil citrate and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Vasafil?

• The dose varies from patient to patient. Your doctor will decide the correct dose for you depending on your condition and response.

• Your doctor may instruct you to take one 25mg tablet a day or one 50mg tablet a day or one 100mg tablet a day.

5. What should I know while using Vasafil?

6. Are there any side effects?

The common side effects include headache, dizziness, flushing, indigestion, nasal congestion, diarrhoea, rash, dry mouth, throat, nose, or eye. Other side effects include unusual heartbeat, urinary tract infection (stinging or burning urine, more frequent need to pass urine), blood in the urine, changes in vision such as blurring, a blue color to your vision or a greater awareness of light, persistent headache or fainting, bleeding from nose, pain or tingling in your hands, toes or feet, decreased sensitivity or numbness in your mouth, Irritation or pain in or around eyes, signs of allergy such as shortness of breath
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Sildenafil citrate.

2 Qualitative and Quantitative Composition

Vasafil tablets come in three strengths and contain 25 mg, 50 mg or 100 mg of sildenafil (as sildenafil citrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Vasafil 25. Green coloured, round shape, convex film coated tablet break line on one side and plain on the other side.
Vasafil 50. Green coloured, round shape, convex film coated tablet with cross break line on one side and plain on the other side.
Vasafil 100. Green coloured, round shape, convex film coated tablet with cross break line on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Overdose information is limited.
Symptoms. In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates and severities were increased.
Treatment. In cases of overdose, standard supportive measures should be adopted as required. Sildenafil blood levels are not clinically useful. Monitor electrocardiogram (ECG) and blood pressure in symptomatic patients. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity.
Carcinogenicity. Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUC) for unbound sildenafil and its major metabolite of 35 and 39 times, for male and female rats, respectively, the exposures observed in human males given the maximum recommended human dose (MRHD) of 100 mg. Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the maximum tolerated dose of 10 mg/kg/day, but resulting in total systemic drug exposure for unbound sildenafil and its major metabolite of less than the exposures observed in human males given the MRHD.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Sildenafil citrate is an off white, crystalline powder. Its aqueous solubility is equivalent to sildenafil 2.6 mg/mL at 25°C. The chemical name for sildenafil citrate is 1-[4-ethoxy- 3-(6,7-dihydro-1-methyl- 7-oxo-3-propyl-1H-pyrazolo [4,3-d]pyrimidin-5-yl) phenylsulfonyl]- 4-methylpiperazine citrate.
Chemical structure. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSILDEN.gif C₂₂H₃₀N₆O₄S.C₆H₈O₇. Molecular weight: 666.7.
CAS number. 171599-83-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VASAFIST.gif