ALSIOZ Sildenafil (as citrate) 20 mg film coated tablet blister pack

Main information

  • Trade name:
  • ALSIOZ Sildenafil (as citrate) 20 mg film coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALSIOZ Sildenafil (as citrate) 20 mg film coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186289
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186289

ALSIOZ Sildenafil (as citrate) 20 mg film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

24/09/2012

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. ALSIOZ Sildenafil (as citrate) 20 mg film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

6/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ò To treat patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity.

ò Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

ò The efficacy of sildenafil has not been evaluated in patients currently on bosentan therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

90 Tablets

(S4) Prescription Only Medicine

Components

1. ALSIOZ Sildenafil (as citrate) 20 mg film coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Blue coloured, round film coated tablets with "R" debossed on one side and

'372' debossed on the other side

Active Ingredients

Sildenafil citrate

28.096 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 03:09:00 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

ALSIOZ 20mg Tablet

Consumer Medicine Information

Dr Reddy’s Laboratories Australia Pty Ltd

v2 Feb, 2012

ALSIOZ

Sildenafil Citrate

Consumer Medicine Information

ALSIOZ CMI

Page 1 of 5

What is in this leaflet

This leaflet answers some common

questions about ALSIOZ.

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

ALSIOZ

against

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 ALSIOZ is used

For

ALSIOZ is used to treat pulmonary

arterial

hypertension

(high

blood

pressure in the blood vessels in the

lungs).

ALSIOZ

brings

down

blood

pressure

relaxing

these

vessels. ALSIOZ tablets contain

active ingredient sildenafil

(present

sildenafil citrate) which belongs to a

group

medicines

called

phosphodiesterase type 5 inhibitors.

Ask your doctor if you have any

questions about why ALSIOZ has

been prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you take

ALSIOZ

When you must not take it

Do not take ALSIOZ 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 and Tridil; patches

such

Nitro-Dur,

Nitradisc,

Transiderm-Nitro, Nitrocor,

Nitroderm TTS and Minitran; sprays

such

Nitrolingual

injections

such as Nitronal.

Common tradenames for other nitrate

preparations

include

tablets

such

Imdur

Durule,

Sorbidin,

Isordil,

Carvasin,

Corangin,

ISMO

Imtrate, Coronex, Duride, Ikorel and

Sodium Nitroprusside.

There may be other tradenames not

listed here.

2. you are using amyl nitrite

3. you have suffered a heart attack

or stroke in the last 6 months

4. you have severe liver problems

5. your blood pressure is unusually

low and is not effectively treated

6. you have an eye disease called

retinitis pigmentosa

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 are taking certain medicines

used

to

treat

fungal

infections

including

ketoconazole

and

itraconazole

9.

you

are

taking

ritonavir

a

treatment for HIV infection

10. 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

ALSIOZ 20mg tablet

Consumer Medicine Information

Dr Reddy’s Laboratories Australia Pty Ltd

v2 Feb 2012

ALSIOZ CMI

Page 2 of 5

11. the packaging is torn or shows

signs of tampering, or does not

look quite right even if the

tablets may look all right

12. 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

Tell your doctor if:

You have any allergies to any other

medicines or any other substances

such as foods, preservatives or dyes

You have previously had sudden

loss of eyesight in one or both eyes

You have any of the following

medical conditions:

have

heart

blood

vessel problems

you have high blood pressure

diabetes,

especially

also have eye problems

leukaemia

(cancer

blood cells)

multiple myeloma (a cancer

of the bone marrow)

any bleeding disorder such as

haemophilia

problems

with nose bleeds

stomach ulcer

a disease of the blood called

sickle cell anaemia

pulmonary veno occlusive

disease (blockage or narrow

vein in the lung)

any disease or deformity of your

penis

you are receiving any treatment

male

erectile

dysfunction

(impotence)

including

Viagra

which contains the same medicine

ALSIOZ.

Other

medicines

used to treat impotence include

Cialis and Levitra

you are receiving other treatments

for your condition

previously

experienced

sudden

decrease or loss of hearing

You

are

pregnant

or

planning

to

become pregnant.

ALSIOZ should not be used during

pregnancy. Your doctor will discuss

the risks with you.

You are breastfeeding.

should

breastfeed

while

taking ALSIOZ.

If you have not told your doctor or

pharmacist about any of the above,

tell

them

before

you

start

taking

ALSIOZ.

Taking other medicines

Do

not

take

ALSIOZ

if

you

are

using nitrate medicines for angina.

Tell your doctor if you are taking

any other medicines for pulmonary

arterial hypertension.

These medicines include Tracleer

(bosentan), Flolan (epoprostenol) or

Ventavis (Iloprost).

You may need to take different

medicines or take different amounts

of your medicine.

Also 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.

Some

medicines

ALSIOZ

interfere

with

each

other.

These

include:

medicines

called

alpha-blockers.

These are used to treat high blood

pressure or prostate problems.

some

medicines

used

treat

epilepsy

such

phenytoin,

carbamazepine and phenobarbital

St John's Wort that may be used

to treat mild anxiety

Rifampicin used to treat leprosy

or tuberculosis

antiobiotic

called

erythromyicin

Saquinavir

medicine

used

treat HIV infection

Cimetidine for stomach ulcers

You may need to take different

medicines or different amounts of

your medicine. 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

ALSIOZ.

Ask your doctor or pharmacist, if

you are not sure if you are taking

any of these medicines.

Avoid drinking grapefruit juice. It

may increase the level of sildenafil in

your blood.

You may feel lightheaded if you

drink alcohol while you are taking

ALSIOZ.

ALSIOZ 20mg tablet

Consumer Medicine Information

Dr Reddy’s Laboratories Australia Pty Ltd

v2 Feb 2012

ALSIOZ CMI

Page 3 of 5

How to take ALSIOZ

Take

ALSIOZ

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

The usual dose is one 20 mg tablet

taken three times a day (taken 6-8

hours apart).

How to take it

Swallow

ALSIOZ

tablet

whole

with a full glass of water.

When to take it

Take

ALSIOZ

at

the

same

times

each day.

Taking

ALSIOZ

at the same times

each day will have the best effect. It

will also help you to remember when

to take it. ALSIOZ can be taken with

or without food.

How long to take it

You must take ALSIOZ every day.

Continue taking your medicine for as

long as your doctor tells you.

If you forget to take it

If you forget to take ALSIOZ tablets,

take a dose as soon as you remember,

then continue to take your tablets at

the usual times.

Do not take a double dose to make up

for missed tablets.

However, tell your doctor or nurse if

think

that

dose

been

forgotten.

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 in Australia 13 11 26;)

for advice if you think that you or

anyone

else

may

have

taken

too

much ALSIOZ. Do this even if there

are no signs of discomfort.

While you are using

ALSIOZ

Things you must do

Stop using ALSIOZ if you have a

loss of eyesight in one or both eyes.

Seek medical attention urgently. If

you are about to start taking any

new

medicines,

especially

nitrates,

tell your doctor and pharmacist that

you are taking ALSIOZ.

See "Before you take ALSIOZ" for

a list of common nitrate

medications.

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking ALSIOZ.

Things you must not do

Do not use the drug amyl nitrite

(sometimes called "poppers")

while you are taking ALSIOZ.

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

ALSIOZ.

Do not take ALSIOZ to treat any

other conditions unless your doctor

says so.

Do not give ALSIOZ to anyone else,

even if they have the same condition

as you.

Things to be careful of

ALSIOZ

cause

dizziness

effects on vision. You should be aware

of how you react to ALSIOZ before

you drive or operate machinery.

If you experience changes in vision,

or dizziness, when taking ALSIOZ,

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 ALSIOZ.

While ALSIOZ helps most people it

can cause some unwanted side effects

in a few people. All medicines have

side effects. If unwanted effects occur,

most

likely

minor

temporary.

However,

some

ALSIOZ 20mg tablet

Consumer Medicine Information

Dr Reddy’s Laboratories Australia Pty Ltd

v2 Feb 2012

ALSIOZ CMI

Page 4 of 5

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

stuffy nose

changes in vision such as

blurring, a blue colour to your

vision or a greater awareness of

light

muscle aches, back or limb pain

rash

diarrhoea or upset stomach

a numbness or tingling skin

sensation

breathlessness or coughing

fever or flu like symptoms

nose bleeds

difficulty sleeping

hayfever

Rarely men have lost vision in one

or both eyes some time after taking

drugs

such

as

Viagra,

Cialis

or

Levitra to treat impotence (known

as

erectile

dysfunction).

It

is

not

known

at

this

time

if

these

medicines can cause vision loss. If

you lose sight in one or more eyes

while taking ALSIOZ, seek medical

attention urgently.

A small number of people have

reported a loss of hearing, which

may include a ringing or other

persistent noise in the ears and

dizziness, while taking ALSIOZ.

It

is not known whether hearing loss is

related to ALSIOZ. If you

experience any loss of hearing, tell

your doctor as soon as possible.

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 ALSIOZ

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 ALSIOZ in a cool, 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.

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 ALSIOZ, or the tablets have

passed their expiry date, ask your

pharmacist what to do with any left

over.

Product description

What it looks like

ALSIOZ

Tablets

blue

coloured,

round film-coated debossed with ‘SC’

on one side and ‘20’ on other side

The tablets are available in blister

packs containing 90 tablets in each

box.

Ingredients

Active ingredients

ALSIOZ

tablet

contains

sildenafil citrate equivalent to 20mg

sildenafil

Other ingredients

cellulose- microcrystalline

calcium hydrogen phosphate

croscarmellose sodium

hydroxypropylcellulose

magnesium stearate

hypromellose

lactose

glycerol triacetate

ALSIOZ 20mg tablet

Consumer Medicine Information

Dr Reddy’s Laboratories Australia Pty Ltd

v2 Feb 2012

ALSIOZ CMI

Page 5 of 5

titanium dioxide

indigo carmine aluminium lake (CI

73015).

Supplier

ALSIOZ is supplied in Australia by:

Dr Reddy’s Laboratories

(Australia) Pty Ltd

Level 1, 181 Bay Street

Brighton

Victoria 3186

Australia

Australian Registration

Numbers

ALSIOZ 20 mg tablet–

AUST R 186289

This leaflet was prepared in Feb, 2012