LYRICA®

Pregabalin

What is in this leaflet

This leaflet answers some common questions about LYRICA.

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 LYRICA against the benefits they expect it will 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 LYRICA is used for

LYRICA is used to treat neuropathic pain.

LYRICA 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.

LYRICA belongs to a group of medicines called anticonvulsants. These drugs
are thought to work by controlling brain chemicals which send signals to
nerves so that seizures do not happen.

LYRICA also has analgesic effects.

Your doctor may prescribe LYRICA in addition to your current therapy when
your current treatment is no longer working as well as before.

Your doctor may have prescribed LYRICA for another reason. Ask your doctor
if you have any questions about why LYRICA has been prescribed for you.

There is no evidence that LYRICA is addictive.

This medicine is available only with a doctor's prescription.

LYRICA is not recommended for use in children under the age of 18 years as
its safety and effectiveness in that age group have not been established.

Before you take LYRICA

When you must not take it

Do not take LYRICA if you have an allergy to:

  • pregabalin, the active ingredient in LYRICA or any of the ingredients
    listed at the end of this leaflet.

Symptoms of an allergic reaction to LYRICA 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 LYRICA after the expiry date (EXP) printed on the pack.

Do not take LYRICA if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for
disposal.

If you are not sure whether you should start taking LYRICA, talk to your
doctor or pharmacist.

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
  • mixed seizure disorders.

Tell your doctor if you are pregnant or plan to become pregnant.

LYRICA 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 LYRICA, your doctor can help you decide
whether or not to take it during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed.

It is recommended that you do not breastfeed while taking LYRICA, as it is
not known whether it passes into breast milk.

If you have not told your doctor about any of the above, tell him/her
before you start taking LYRICA.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines,
including any that you get without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines when taken together with LYRICA may interfere with each
other. These include:

  • some pain relievers, such as oxycodone
  • benzodiazepines, medicines used as sedatives or to treat mental
    disorders such as anxiety or schizophrenia.

These medicines may be affected by LYRICA or may affect how well it works.
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 LYRICA.

How to take LYRICA

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 LYRICA and
slowly increase the dose to the lowest amount needed to control your
epilepsy/convulsions or neuropathic pain.

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 to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take LYRICA at about the same time each day.

Taking LYRICA 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 LYRICA before or after food.

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.

How long to take it

Continue taking LYRICA for as long as your doctor tells you.

LYRICA 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 LYRICA, or lower the dosage, without checking with
your doctor. Do not let yourself run out of medicine over the weekend or on
holidays.

Stopping LYRICA suddenly may cause unwanted effects or make your condition
worse. Your doctor will slowly reduce your dose before you can stop taking it
completely.

If you take too much (overdose)

Immediately telephone your Australian Poisons Information Centre
(telephone 13 11 26) or the New Zealand National Poisons Information Centre
(telephone 0800 POISON or 0800 764 766) or go to Accident and Emergency at the
nearest hospital, if you think that you or anyone else may have taken too much
LYRICA. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose with LYRICA may include feeling tired, confusion,
depression, agitation and restlessness.

While you are using LYRICA

Things you must do

Tell any other doctors, dentists, and pharmacists who treat you that you
are taking LYRICA.

If you are about to be started on any new medicine, tell your doctor,
dentist or pharmacist that you are taking LYRICA.

Before you have any surgery or emergency treatment, tell your doctor or
dentist that you are taking LYRICA.

Tell your doctor if you feel LYRICA is not helping your condition.

Your doctor may need to change your medicine.

Tell your doctor if, for any reason, you have not taken LYRICA exactly
as prescribed.


Otherwise, your doctor may change your treatment unnecessarily.

If you become pregnant while taking LYRICA, tell your doctor.

If you need to have any medical tests while you are taking LYRICA, tell
your doctor.


LYRICA may affect the results of some tests.

Be sure to keep all of your doctor's appointments so that your progress
can be checked.

Your doctor will check your progress and may want to take some tests from time
to time. This helps to prevent unwanted side effects.

Things you must not do

Do not give LYRICA to anyone else, even if their symptoms seem similar
to yours or they have the same condition as you.

Do not take LYRICA to treat any other complaints unless your doctor
tells you to.

Do not stop taking it unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how LYRICA
affects you.


As with other anticonvulsant medicines, LYRICA may cause dizziness and
drowsiness in some people and affect alertness. Make sure you know how you
react to LYRICA before you drive a car, operate machinery, or do anything else
that could be dangerous if you are dizzy or drowsy. If this occurs do not
drive. If you drink alcohol, dizziness or drowsiness may be worse.

Be careful when drinking alcohol while taking LYRICA.

Combining LYRICA and alcohol can make you more dizzy or drowsy. Your doctor
may suggest you avoid alcohol while you are being treated with LYRICA.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking LYRICA.

LYRICA 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. If you are over 65
years of age you may have an increased chance of getting side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop taking LYRICA without first
talking to your doctor or pharmacist.

Tell your doctor or pharmacist if you notice any of the following and
they worry you:

  • dizziness
  • feeling tired or drowsy
  • increase in appetite, weight
  • mood changes, such as feeling irritated or excited
  • forgetfulness, loss of concentration or confusion
  • sexual disturbances, such as change in sexual drive, impotence
  • unsteadiness when walking, reduced co-ordination, shaking or tremors
  • difficulty speaking
  • dry mouth
  • numbness or tingling in hands or feet
  • blurred or double vision
  • constipation or excessive gas in the stomach or bowel
  • vomiting
  • swelling of hands, ankles or feet
  • muscle pain, tenderness and weakness.

These are the more common side effects of LYRICA.

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
  • 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 .

These are 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 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 using LYRICA

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
25°C.

Do not store LYRICA 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 LYRICA or the capsules have passed
their expiry date, ask your pharmacist what to do with any medicine that is
left over.

Product Description

What it looks like

75 mg - White and orange hard gelatin capsule, marked Pfizer, PGN 75 with
black ink.

150 mg - White hard gelatin capsule, marked Pfizer, PGN 150 with black ink.

300 mg - White and orange hard gelatin capsule, marked Pfizer, PGN 300 with
black ink.

A pack contains 56 capsules, a starter pack contains 14 capsules.

Ingredients

Active Ingredients

75 mg capsules - 75 mg pregabalin

150 mg capsules - 150 mg pregabalin

300 mg capsules - 300 mg pregabalin

Other Ingredients

  • Lactose
  • Starch - maize
  • Talc- purified
  • Gelatin
  • Titanium dioxide
  • Sodium lauryl sulfate
  • Silica - colloidal anhydrous
  • Iron oxide red CI77491 (75 mg, and 300 mg capsules only)

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