SILEREC 50 sildenafil (as citrate) 50 mg film-coated tablets blister pack

Main information

  • Trade name:
  • SILEREC 50 sildenafil (as citrate) 50 mg film-coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SILEREC 50 sildenafil (as citrate) 50 mg film-coated tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 188703
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188703

SILEREC 50 sildenafil (as citrate) 50 mg film-coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

10/09/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SILEREC 50 sildenafil (as citrate) 50 mg film-coated tablets blister pack

Product Type

Single Medicine Product

Effective date

10/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Indicated for the treatment of erectile dysfunction in adult males. Sildenafil Citrate 50 mg tablets is not indicated for use by women.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

4 Tablets in blister pack

(S4) Prescription Only Medicine

12 Tablets in blister pack

(S4) Prescription Only Medicine

8 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. SILEREC 50 sildenafil (as citrate) 50 mg film-coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Blue, almond shaped, biconvex, film-coated tablets, debossed with '50' on

one side and plain on other side.

Active Ingredients

Sildenafil citrate

70.25 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 01:04:02 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SILEREC 25, 50, 100

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2012- Page 1 of 4

Silerec 25, 50, 100

(Sildenafil (as citrate) 25 mg, 50 mg, 100 mg film-coated Tablets)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Silerec.

It does not contain all the available

information.

It does not take the place of talking

to your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of your taking Silerec

tablets against the benefits they

expect it will have for you.

It should be used only under strict

medical supervision.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Silerec is used for

Silerec tablet is used to treat erectile

dysfunction, more commonly known

as impotence, in men. This is when a

man cannot get, or keep, a hard erect

penis suitable for sexual activity.

Silerec tablet belongs to a group of

medicines called phosphodiesterase

type 5 inhibitors.

It works by relaxing the blood

vessels in your penis when you are

sexually excited. This allows blood

to flow into your penis, allowing you

to get an erection in the natural way.

Silerec tablet will work only if you

are sexually excited.

Silerec tablet will not increase your

sex drive.

Silerec tablet is not for use in

women.

This medicine is available only with

a doctor's prescription.

Before you take Silerec

YOU MUST NOT TAKE

SILEREC TABLET IF YOU ARE

TAKING ANY NITRATE

MEDICATION.

IT MAY LEAD TO A SEVERE

DROP IN YOUR BLOOD

PRESSURE, WHICH MAY BE

DIFFICULT TO TREAT.

BECAUSE SEXUAL ACTIVITY

MAY PLACE A STRAIN ON

YOUR HEART, YOUR DOCTOR

WILL NEED TO CHECK

WHETHER YOU ARE FIT

ENOUGH TO TAKE SILEREC

TABLET.

When you must not take it

Do not take Silerec tablet if:

1. you are being treated for

angina (chest pain), or other

heart conditions, with certain

medicines called nitrates

Nitrate medicines include glyceryl

trinitrate (also called nitroglycerin).

Common tradenames include tablets;

such as Anginine, Lycinate and

Nitrostat; patches such as Nitro-Dur,

Transiderm-Nitro, Nitroderm TTS

and Minitran; sprays such as

Nitrolingual and Glytrin and

injections such as Gliceryl trinitrate

concentrate.

Common tradenames for other

nitrate preparations include tablets

such as Imdur Durules, Monodur

durules, Sorbidin, Isordil, Corangin,

ISMO 20, Imtrate, Duride, Isomonit,

Ikorel and Sodium Nitroprusside.

There may be other tradenames not

listed here.

2. you are using amyl nitrite

3. you have heart or blood vessel

problems that make sexual

intercourse inadvisable

4. you have suffered a heart attack

or stroke in the last 6 months

5. you have severe liver problems

6. your blood pressure is unusually

high or low or is not effectively

treated

7. you have loss of vision in one or

both eyes from an eye disease

called non-arteritic anterior

ischaemic optic neuropathy

(NAION)

8. you have an eye disease called

retinitis pigmentosa

9. you have an allergy to:

* sildenafil or similar medicines

* any of the ingredients listed at the

end of this leaflet

An allergic reaction can include:

* hives, itching or skin rash

* swelling of the face, lips or tongue

which may lead to difficulty

swallowing or breathing

10. the packaging is torn or shows

signs of tampering, or does not

look quite right even if the

tablets may look alright

11. the expiry date on the pack has

passed

If it has expired or is damaged,

return it to your pharmacist for

disposal.

Before you start to take it

SILEREC 25, 50, 100

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2012- Page 2 of 4

Tell your doctor if:

You have any allergies to any

other medicines or any other

substances such as foods,

preservatives or dyes

You have any other heart or blood

vessel problems

You have previously had sudden

loss of eyesight in one or both eyes

You have any of the following

medical conditions:

diabetes, especially if you also

have eye problems

kidney or liver problems

leukaemia (cancer of the blood

cells)

multiple myeloma (a cancer of the

bone marrow)

any disease or deformity of your

penis

any bleeding disorder such as

haemophilia

stomach ulcer

a disease of the blood called sickle

cell anaemia

colour vision problems

previously experienced sudden

decrease or loss of hearing

You are receiving any other

treatment for impotence

You have any other medical

conditions

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

Silerec tablets.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines you

buy without a prescription from a

pharmacy, supermarket or health

food shop.

Do not take Silerec tablets if you

are using nitrate medicines for

angina.

Some medicines and Silerec tablets

may interfere with each other. These

include:

cimetidine, a medicine used to

treat ulcers

some medicines used to treat

fungal infections including

ketoconazole and itraconazole

some antibiotics including

erythromycin and rifampicin

some protease inhibitors such as

ritonavir and saquinavir for the

treatment of HIV infection

medicines called alpha-blockers.

These are used treat high blood

pressure or prostate problems.

You may need different amounts of

your medicine or you may need to

take different medicines. Your

doctor or pharmacist can tell you

what to do if you are taking any of

these medicines. They also have a

more complete list of medicines to

be careful with or avoid while taking

Silerec tablets.

Ask your doctor or pharmacist, if

you are not sure if you are taking

any of these medicines.

How to take Silerec

Take Silerec tablet exactly as your

doctor has prescribed.

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the pack, ask your

doctor or pharmacist for help.

How much to take

Your doctor will decide the correct

dose for you depending on your

condition and response.

This can be one 25 mg tablet a day

or one 50 mg tablet a day or one 100

mg tablet a day.

Do not take more than one dose of

Silerec tablets a day.

When to take it

Take your dose of Silerec tablets

about one hour before you intend to

have sex.

Swallow the tablet whole with a full

glass of water.

The amount of time Silerec tablets

takes to start working varies from

person to person, but it normally

takes between half an hour and one

hour.

You may find Silerec tablets takes

longer to work if you take it with a

heavy meal.

Silerec tablets will work only if you

are sexually excited.

If you take too much

(Overdose)

If you take too much, you are more

likely to experience side effects.

Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26) for

advice if you think that you or

anyone else may have taken too

much Silerec tablet. Do this even if

there are no signs of discomfort.

While you are using it

Things you must do

Stop using Silerec tablet if you have

a loss of eyesight in one or both

eyes, experienced loss of hearing or

have an erection that persists more

than 4 hours. Seek medical attention

urgently.

If Silerec tablets does not help you

get an erection or if your erection

does not last long enough to

SILEREC 25, 50, 100

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2012- Page 3 of 4

complete sexual intercourse, tell

your doctor.

In these cases, your doctor may

decide that you need a higher dose.

If you are about to start taking any

new medicines, especially nitrates,

tell your doctor and pharmacist

that you are taking Silerec tablets.

See "Before you take Silerec

tablet" for a list of common nitrate

medications.

Tell any other doctors, dentists

and pharmacists who are treating

you that you are taking Silerec

tablet.

Things you must not do

Do not use the drug amyl nitrite

(sometimes called "poppers")

while you are taking Silerec tablet.

If you get an angina attack do not

take nitrate medicines to relieve

the pain but tell your doctor

immediately. Make sure your

doctor knows you are taking

Silerec tablet.

Do not give Silerec tablet to

anyone else, even if they have the

same condition as you.

Things to be careful of

Be careful drinking alcohol while

taking Silerec tablets.

Drinking alcohol can temporarily

impair the ability to get an erection.

Do not drink large amounts of

alcohol before sexual activity.

If you experience changes in

vision, or dizziness, when taking

Silerec tablet, you should not drive

or operate machinery.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Silerec

tablet.

While Silerec tablet helps most

people it can cause some unwanted

side effects in a few people. All

medicines have side effects. If

unwanted effects occur, most are

likely to be minor and temporary.

However, some may be serious and

need medical attention.

Do not be alarmed by this list of

possible side effects.

You may not get any of them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

* headache, dizziness

* flushing

* indigestion

* nasal congestion

* diarrhoea

* rash

Tell your doctor as soon as

possible if you notice any of the

following:

unusual heart beat

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 colour to your vision or a

greater awareness of light

persistent headache or fainting

bleeding from the nose

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

signs of allergy such as shortness

of breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue or other parts

chest pain

sudden decrease or loss of hearing

seizures, fits or convulsions

Very rarely your erection may

persist for longer than usual. If

your erection continues for four

hours, or sooner if there is pain,

you should seek medical attention

urgently.

Rarely men have lost eyesight

some time after taking drugs to

treat erectile dysfunction (known

as impotence). It is not known at

this time if Silerec tablet causes

this. If you lose eyesight in one or

more eyes, seek medical attention

urgently.

This is not a complete list of all

possible side effects. Others may

occur in some people and there may

be side effects not yet known.

If you notice any other symptoms

that worry you, check with your

doctor.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

After using Silerec

Storage

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Keep Silerec tablets in a dry place

where the temperature stays below

25°C. Do not store it or any other

medicine in the bathroom or near

a sink.

Do not leave it in the car or on

windowsills.

SILEREC 25, 50, 100

CONSUMER MEDICINE INFORMATION

Version: 1.0

-2012- Page 4 of 4

Heat and dampness can destroy some

medicines.

Keep the tablets in their pack until

it is time to take them. If you take

your tablets out of the pack they

will not keep as well.

Disposal

If your doctor tells you to stop

taking Silerec tablet, or the tablets

have passed their expiry date, ask

your pharmacist what to do with

any left over.

Product description

What it looks like

Silerec Tablets are available in three

strengths:

Silerec 25 is blue, almond shaped,

biconvex, film-coated tablets,

debossed with ‘25’ on one side and

plain on other side.

Silerec 50 is blue, almond shaped,

biconvex, film-coated tablets,

debossed with ‘50’ on one side and

plain on other side.

Silerec 100 is blue, almond shaped,

biconvex, film-coated tablets,

debossed with ‘100’ on one side and

plain on other side.

All strengths come in a box of 4

tablets. The 100 mg strength also

comes in a box of 12 tablets.

Ingredients

Active ingredients

* Silerec 25- sildenafil 25 mg

* Silerec 50- sildenafil 50 mg

* Silerec 100 - sildenafil 100 mg

Other ingredients

* cellulose microcrystalline

* calcium hydrogen phosphate

anhydrous

* croscarmellose sodium

* hypromellose

* magnesium stearate

* Opadry II -31K80865

Blue

(hypromellose, titanium dioxide,

lactose, glycerol triacetate, indigo

carmine aluminium lake) [ARTG

No. 107653]

Name and Address of the Sponsor

Accord Healthcare Pty Ltd.

Unit 702/23,

Queens Road,

Melbourne, Victoria, 3004

Australia

Silerec 25:

AUST R No. 188694

Silerec 50:

AUST R No. 188703

Silerec 100:

AUST R No. 188698

Date of first inclusion in the

ARTG:

September 2012