PREGABALIN

Main information

  • Trade name:
  • PREGABALIN SANDOZ pregabalin 300mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PREGABALIN SANDOZ pregabalin 300mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210050
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210050

PREGABALIN SANDOZ pregabalin 300mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

1/12/2015

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. PREGABALIN SANDOZ pregabalin 300mg capsule blister pack

Product Type

Single Medicine Product

Effective date

2/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

PREGABALIN SANDOZ is indicated for the treatment of neuropathic pain in adults.

PREGABALIN SANDOZ is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

56 capsules

(S4) Prescription Only Medicine

Components

1. PREGABALIN SANDOZ pregabalin 300mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

hard gelatin capsule with red cap and skin coloured body

Active Ingredients

Pregabalin

300 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 27.11.2017 at 10:03:40 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

PREGABALIN

SANDOZ

®

pregabalin capsules

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Pregabalin Sandoz.

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 you taking Pregabalin

Sandoz against the benefits it is

expected to have for you.

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 Pregabalin

Sandoz is used for

Pregabalin Sandoz is used to treat

neuropathic pain, which is pain

caused by an abnormality of, or

damage to, the nerves.

Pregabalin Sandoz is also used to

control epilepsy. Epilepsy is a

condition where you have repeated

seizures (fits). There are many

different types of seizures, ranging

from mild to severe.

Pregabalin Sandoz belongs to a

group of medicines called

anticonvulsants. These medicines are

thought to work by controlling brain

chemicals which send signals to

nerves so that seizures do not

happen.

Pregabalin Sandoz also has analgesic

effects (relieves pain).

Pregabalin Sandoz may be used

alone, or in combination with other

medicines, to treat your condition.

Your doctor may prescribe

Pregabalin Sandoz in addition to

your current therapy when your

current treatment is no longer

working as well as before.

Ask your doctor if you have any

questions about why Pregabalin

Sandoz has been prescribed for

you.

Your doctor may have prescribed it

for another reason.

This medicine is available only with

a doctor's prescription.

Use in Children

There is not enough information to

recommend the use of this medicine

in children under the age of 18 years.

Before you take

Pregabalin Sandoz

When you must not take it

Do not take Pregabalin Sandoz if

you have an allergy to:

pregabalin, the active ingredient

in Pregabalin Sandoz or

any of the ingredients listed at the

end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If the capsules have expired or the

pack is damaged, return to your

pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines, especially

barbiturates or any other

anticonvulsant medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

congestive heart failure

hereditary problems with

galactose metabolism

kidney problems

diabetes

a history of substance abuse

depression.

Tell your doctor if you have a

history of substance abuse.

There have been reported cases of

misuse and abuse with Lyrica.

Tell your doctor if you are

pregnant or plan to become

pregnant.

PREGABALIN SANDOZ

Pregabalin Sandoz is not

recommended for use during

pregnancy. However, if you have

epilepsy, it is very important to

control your fits while you are

pregnant. If it is necessary for you to

take Pregabalin Sandoz, your doctor

can help you decide whether or not to

take it during pregnancy.

Tell your doctor if you are

breastfeeding or plan to breast-

feed.

The active ingredient in Pregabalin

Sandoz passes into breast milk and

its safety in infants is unknown.It is

recommended that you do not breast-

feed while taking Pregabalin Sandoz.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Pregabalin Sandoz.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Pregabalin Sandoz or may affect how

well it works. You may need

different amounts of your medicines,

or you may need to take different

medicines. Your doctor will advise

you.

Tell your doctor or pharmacist if

you are taking any of the

following:

oxycodone, morphine or codeine,

pain relievers called opioid

analgesics

lorazepam, a medicine used to

treat anxiety

medicines used to treat allergies

(antihistamines)

medicines used to treat certain

psychiatric disorders.

Taking these medicines together with

Pregabalin Sandoz may increase your

chance of experiencing side effects.

You may need different amounts of

your medicine, or you may need to

take different medicines. Your doctor

or pharmacist will advise you.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

Pregabalin Sandoz.

How to take

Pregabalin Sandoz

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Your doctor will tell you how many

capsules you need to take each day.

This may depend on your age, your

condition and whether or not you are

taking any other medicines.

Your doctor may recommend that

you start with a low dose of

Pregabalin Sandoz and slowly

increase the dose to the lowest

amount needed to control your

epilepsy/convulsions or neuropathic

pain.

The usual dose range is 150 mg per

day to 600 mg per day given in two

divided doses.

How to take it

Swallow the capsules whole with a

full glass of water.

When to take it

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

It does not matter if you take this

medicine before or after food.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine, even if you feel well.

Do not stop taking Pregabalin

Sandoz, or lower the dosage,

without checking with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

Stopping Pregabalin Sandoz

suddenly may worsen your condition

or cause unwanted effects such as

sleeplessness, headache, nausea

(feeling sick), anxiety, excessive

sweating or diarrhoea (runny stools).

If appropriate, your doctor will

slowly reduce your dose before you

can stop taking it completely.

If you forget to take it

If it is almost time for your next

dose (within 4 hours), skip the dose

you missed and take your next dose

when you are meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Australian Poisons

Information Centre (telephone 13

11 26) or the New Zealand

National Poisons Information

Centre (telephone 0800 POISON

or 0800 764 766) for advice, or go

to Accident and Emergency at the

nearest hospital, if you think that

PREGABALIN SANDOZ

you or anyone else may have taken

too much Pregabalin Sandoz. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose with

Pregabalin Sandoz may include

mood changes, feeling tired,

confusion, depression, agitation,

restlessness or seizures.

While you are taking

Pregabalin Sandoz

Things you must do

If you are about to be started on

any new medicine, remind your

doctor, dentist or pharmacist that

you are taking Pregabalin Sandoz.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

Tell your doctor immediately if

you experience any changes in

your vision.

Pregabalin Sandoz may cause

blurring or other changes in eyesight.

Your doctor may ask you to stop

taking Pregabalin Sandoz to improve

these symptoms.

Tell your doctor immediately if

you have any thoughts of suicide or

self-harm, any unusual changes in

mood or behaviour, or show signs

of depression.

Some people taking medicines to

treat convulsions, such as Pregabalin

Sandoz have had thoughts of

harming themselves or taking their

life.

Patients and caregivers should be

alert and monitor for these effects.

Signs and symptoms of suicidal

risk include:

thoughts or talk of death or

suicide

thoughts or talk of self-harm or

harm to others

any recent attempts of self-harm

new or an increase in aggressive

behaviour, irritability or agitation

new or worsening depression.

Mention of suicide or violence must

be taken seriously.

If you or someone you know is

demonstrating these warning signs

of suicide while taking Pregabalin

Sandoz, contact your doctor or a

mental health professional right

away.

Tell your doctor if you feel

Pregabalin Sandoz is not helping

your condition.

Your doctor may need to change

your medicine.

Tell your doctor if, for any reason,

you have not taken Pregabalin

Sandoz exactly as prescribed.

Otherwise, your doctor may change

your treatment unnecessarily.

If you become pregnant while

taking Pregabalin Sandoz, tell your

doctor immediately.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Things you must not do

Do not take Pregabalin Sandoz to

treat any other complaints unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if their symptoms

seem similar to yours or they have

the same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor

Things to be careful of

Be careful driving or operating

machinery until you know how

Pregabalin Sandoz affects you.

As with other anticonvulsant

medicines, Pregabalin Sandoz may

cause dizziness and drowsiness in

some people. If you have any of

these symptoms, do not drive,

operate machinery or do anything

else that could be dangerous.

Be careful when drinking alcohol

while you are taking this medicine.

If you drink alcohol, symptoms such

as dizziness and drowsiness may be

worse.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Pregabalin Sandoz.

Pregabalin Sandoz helps most people

with neuropathic pain or epilepsy,

but it may have unwanted side effects

in a few people. All medicines can

have side effects. Sometimes they are

serious, most of the time they are not.

You may need medical attention if

you get some of the side effects.

It can be difficult to tell whether side

effects are the result of taking

Pregabalin Sandoz, effects of your

condition or side effects of other

medicines you may be taking. For

this reason it is important to tell your

doctor of any change in your

condition.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the list of

side effects.

You may not experience any of them.

If you get any side effects, do not

stop taking Pregabalin Sandoz

without first talking to your doctor

or pharmacist.

PREGABALIN SANDOZ

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if...

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

dizziness

feeling tired or drowsy

constipation

diarrhoea

nausea

headache

increase in weight

unsteadiness when walking,

reduced co-ordination, shaking or

tremors

dry mouth

blurred or double vision

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as

possible if...

Tell your doctor as soon as possible

if you notice any of the following:

unusual changes in mood or

behaviour

signs of new or increased

irritability or agitation

signs of depression

swelling of the hands, ankles or

feet

enlargement of breasts

unexplained muscle pain,

tenderness and weakness

passing little to no urine..

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

Go to hospital if...

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

shortness of breath, swelling of

the feet and legs, weight increase

due to fluid build-up

irritated red eyes that are sensitive

to light

more frequent or more severe

seizures (fits)

sudden signs of allergy such as

rash, itching or hives, swelling of

the face, lips, tongue or other

parts of the body, shortness of

breath, wheezing or difficulty

breathing.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects (for

example, changes in blood pressure)

can only be found when your doctor

does tests from time to time to check

your progress.

After taking

Pregabalin Sandoz

Storage

Keep your capsules in the pack

until it is time to take them.

If you take the capsules out of the

pack they may not keep well.

Keep your capsules in a cool dry

place where the temperature stays

below 30°C.

Do not store Pregabalin Sandoz or

any other medicine in the

bathroom or near a sink. Do not

leave it on a windowsill or in the

car on hot days.

Heat and dampness can destroy some

medicines.

Keep it 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.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product Description

What it looks like

25 mg - skin coloured hard gelatin

capsule

75 mg - hard gelatin capsule with red

cap and white body

150 mg - white hard gelatin capsule

300 mg - hard gelatin capsule with

red cap and skin coloured body

Each pack contains 56 capsules.

Ingredients

Active Ingredients:

Pregabalin Sandoz 25 mg - 25 mg

pregabalin

Pregabalin Sandoz 75 mg - 75 mg

pregabalin

Pregabalin Sandoz 150 mg - 150 mg

pregabalin

Pregabalin Sandoz 300 mg - 300 mg

pregabalin

Inactive ingredients:

Starch - pregelatinised maize

Starch - maize

Talc - purified

Gelatin

Titanium dioxide

Iron oxide red CI77491 (25 mg

and 75 mg capsules only).

Iron oxide yellow CI77492 (75

mg and 300 mg capsules only)

Iron oxide black CI77499 (25 mg

and 300 mg capsules only)

PREGABALIN SANDOZ

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 634 500

This leaflet was revised in May 2017.

Australian Register

Numbers

25 mg capsules: AUST R 210049

(blisters)

75 mg capsules: AUST R 210043

(blisters)

150 mg capsules: AUST R 210046

(blisters)

300 mg capsules: AUST R 210050

(blisters

PREGABALIN SANDOZ

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

1-8-2018

Lyrica (Pfizer Europe MA EEIG)

Lyrica (Pfizer Europe MA EEIG)

Lyrica (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5223 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/546/T/95

Europe -DG Health and Food Safety

1-8-2018

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5234 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/T/24

Europe -DG Health and Food Safety