Consumer medicine information

1. Why am I using SILDATIO PHT?

SILDATIO PHT contains the active ingredient sildenafil (present as sildenafil citrate). SILDATIO PHT is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs). SILDATIO PHT lowers the blood pressure by relaxing these blood vessels.
For more information, see Section 1. Why am I using SILDATIO PHT? in the full CMI.

2. What should I know before I use SILDATIO PHT?

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 SILDATIO PHT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sildenafil 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 SILDATIO PHT?

• The usual dose is one 20 mg tablet taken three times a day (taken 6-8 hours apart)

5. What should I know while using SILDATIO PHT?

6. Are there any side effects?

Tell your doctor or pharmacist if you notice headache, dizziness, flushing, indigestion, stuffy nose, muscle aches, back or limb pain, rash, diarrhoea or upset stomach, a numbness or tingling sensation, breathlessness or coughing, fever or flu like symptoms, nose bleeds, difficulty sleeping, hayfever, prolonged erection.
If you lose sight in one or both eyes or experience changes in vision such as blurring, a blue colour to your vision or great awareness of light while on SILDATIO PHT, seek medical attention urgently.
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 tablet contains 20 mg sildenafil (as citrate).
Sildenafil 20 mg, an oral therapy for pulmonary arterial hypertension, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5).
Sildenafil citrate is an off-white, crystalline powder. Its aqueous solubility is equivalent to 2.6 mg sildenafil per mL at 25°C.
Excipients with known effect. This product contains lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sildatio PHT are white to off white, round shaped, biconvex, film-coated tablets, debossed with '20' on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

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.
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 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 33- and 48-times, for male and female rats, respectively, the exposures observed in human males given the RHD of 20 mg three times a day. 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 RHD.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Sildenafil citrate is 1-[4-ethoxy-3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin5-yl)phenylsulphonyl]-4-methylpiperazine citrate.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSILDEN.gif Molecular formula: C₂₂H₃₀N₆O₄S.C₆H₈0₇.
Molecular weight: 666.7.
CAS number. 171599-83-0.

7 Medicine Schedule (Poisons Standard)

Schedule 4, Prescription Only Medicine.

Summary Table of Changes

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