Consumer medicine information

1. Why am I using Sildenafil Sandoz?

Sildenafil Sandoz contains the active ingredient sildenafil. Sildenafil Sandoz is used to d to treat erectile dysfunction, more commonly known as impotence, in men.
For more information, see Section 1. Why am I using Sildenafil Sandoz? in the full CMI.

2. What should I know before I use Sildenafil Sandoz?

Do not use if you have ever had an allergic reaction to sildenafil 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 Sildenafil Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sildenafil Sandoz 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 Sildenafil Sandoz?

• Take Sildenafil Sandoz exactly as your doctor has prescribed.

• Your doctor will decide the correct dose for you depending on your condition and response.

5. What should I know while using Sildenafil Sandoz?

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following and they worry you: headache, dizziness, flushing, hot flushes, indigestion, heartburn, nasal or sinus congestion, swelling of your nose, diarrhoea, rash, tightness in your throat, feeling hot or irritable, redness in your mouth or tongue. Tell your doctor or go straight to the Emergency Department if you notice any of the following: unusual heartbeat, persistent headache or fainting, bleeding from the nose, pain or tingling in your hands, toes or feet, red eye(s), swollen, puffy or pain in or around the eye(s), blood in the urine, sudden vision problems, changes to your normal vision, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, chest pain, increased heart rate, seizures, fits or convulsions or your erection is increased, painful or persists for longer than four hours.
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 (as citrate).

2 Qualitative and Quantitative Composition

Each Sildenafil Sandoz 25 mg tablets contains 25 mg Sildenafil (as citrate).
Each Sildenafil Sandoz 50 mg tablets contains 50 mg Sildenafil (as citrate).
Each Sildenafil Sandoz 100 mg tablets contains 100 mg Sildenafil (as citrate).
Sildenafil citrate is an off-white, crystalline powder. Its aqueous solubility is equivalent to 2.6 mg sildenafil per millilitre at 25°C.
For the full list of excipients, see Section 6.1 List of Excipients.
Not all presentations may be marketed in Australia.

3 Pharmaceutical Form

Sildenafil Sandoz 25 mg tablets. Light blue round slightly dotted tablets with breaking notch and embossment "25".
Sildenafil Sandoz 50 mg tablets. Light blue round slightly dotted tablets with cross breaking notch and embossment "50".
Sildenafil Sandoz 100 mg tablets. Light blue round slightly dotted tablets with cross breaking notch and embossment "100".

4 Clinical Particulars

4.9 Overdose

Symptoms. Overdose information is limited. 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 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 Poison Information Centre on 131126 (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 18-21 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

The chemical name of 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. Its empirical formula is C₂₂H₃₀N₆O₄S.C₆H₈O₇ (MW: 666.7).
Chemical structure. Its chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSILDEN.gif 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/SILSANST.gif