SILDENAFIL LUPIN sildenafil (as citrate) 50 mg tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

sildenafil citrate, Quantity: 70.24 mg (Equivalent: sildenafil, Qty 50 mg)

Disponible depuis:

Generic Health Pty Ltd

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: calcium hydrogen phosphate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; hypromellose; indigo carmine aluminium lake; lactose monohydrate; titanium dioxide; triacetin

Mode d'administration:

Oral

Unités en paquet:

4, 8, 12

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Sildenafil Lupin is indicated for the treatment of erectile dysfunction in adult males. Sildenafil Lupin is not indicated for use by women.

Descriptif du produit:

Visual Identification: Pale blue to blue, capsule shaped film-coated tablet, debossed with SL50 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2022-01-13

Notice patient

SILDENAFIL LUPIN V1
Page 1 of 5
SILDENAFIL LUPIN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SILDENAFIL LUPIN?
This product contains the active ingredient sildenafil, which belongs
to a group of medicines called phosphodiesterase type 5
inhibitors. Sildenafil Lupin is used to treat erectile dysfunction,
more commonly known as impotence, in adult males.
For more information, see Section 1. Why am I using Sildenafil Lupin?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SILDENAFIL LUPIN?
Do not use if you have ever had an allergic reaction or
hypersensitivity to sildenafil or any of the ingredients listed at the
end of
the CMI.
Do not take Sildenafil Lupin if you have heart or blood vessel, liver,
kidney, or eye problem.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, OR TAKE
ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
Sildenafil Lupin? 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 SILDENAFIL LUPIN?
Your doctor will decide the correct dose for you depending on your
condition and response.
Do not take more than one dose of Sildenafil Lupin a day.
More instructions can be found in Section 4. How do I use Sildenafil
Lupin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SILDENAFIL LUPIN?
THINGS YOU
SHOULD DO
Remind any doctor, dentist, or pharmacist you visit that you are using
Sildenafil Lupin.
Stop taking this medicine if you have a loss of eyesight in one or
both eyes, experience loss of hearing or
have an erection that persists more than 4 hours; seek medical
attention urgently.
THINGS YOU
SHOULD NOT DO
Do not use drugs containing amyl nitrite (sometimes called "poppers")
while you are taking Sildenafil
Lupin. Do

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION – SILDENAFIL LUPIN
(SILDENAFIL CITRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Sildenafil citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildenafil Lupin 50 mg tablets contain 50 mg sildenafil (as citrate).
Sildenafil Lupin 100 mg tablets contain 100 mg sildenafil (as
citrate).
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The 50 mg tablets are pale blue to blue, capsule shaped film-coated
tablet, debossed with ‘SL50’ on one
side and plain on the other side.
The 100 mg tablets are pale blue to blue, capsule shaped film-coated
tablet, debossed with ‘SL100’ on
one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil Lupin is indicated for the treatment of erectile
dysfunction in adult males.
Sildenafil Lupin is not indicated for use by women.
4.2 DOSE AND METHOD OF ADMINISTRATION
_Sildenafil Lupin 25 mg film-coated tablets are unavailable. Where
correct dosing requires sildenafil 25 mg _
_film-coated tablets, other brands should be used. _
Sildenafil Lupin tablets are for oral administration.
DOSAGE
Use in Adults
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity. Based
on the efficacy and toleration, the dose may be increased to 100 mg or
decreased to 25 mg. The
Sildenafil Lupin v1
Page 2 of 16
(sildenafil citrate) film-coated tablets
maximum recommended dose is 100 mg. The maximum recommended dosing
frequency is once per
day.
Use in Children
Sildenafil Lupin is not indicated for use in children.
DOSAGE ADJUSTMENT
Dosage Adjustment in Renal Impairment
The dosing recommendations for USE IN ADULTS should be followed for
patients with mild to moderate
renal impairment (Cl
cr
= 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (Cl
cr
<30 mL/min) a 25 mg
starting dose should be considered. Based on efficacy and toleration,
the dose may be in