Paxam

Clonazepam 0.5 & 2mg tablets

What is in this leaflet

This leaflet answers some common questions about Paxam. It does not contain
all of the available information. It does not take the place of talking to your
doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of
you taking Paxam against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or
pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Paxam is used for

Paxam is used to treat epilepsy in adults and in children aged 2 years and
over.

Paxam contains the active ingredient clonazepam, which belongs to a group of
medicines called benzodiazepines. These medicines are thought to work by their
action on brain chemicals.

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

The use of benzodiazepines may lead to dependence on the medicine. If you
have any concerns, you should discuss these with your doctor.

Paxam is available only with a doctor's prescription.

Before you take Paxam

When you must not take it

Do not take Paxam if you are allergic to:

• medicines containing clonazepam or other benzodiazepines
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching
or hives; swelling of he face, lips or tongue, which may cause difficulty in
swallowing or breathing; wheezing or shortness of breath.

Do not take Paxam if you have:

• severe and chronic lung disease
• severe liver disease
• an addiction to drugs or alcohol.

Do not take Paxam if the expiry date (EXP) printed on the bottle has
passed.

If you take this medicine after the expiry date, it may not work as well.

Do not take Paxam if the packaging shows signs of tampering or the tablets
do not look quite right.

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 if you have, or have had, any medical conditions,
especially the following:

• liver problems
• lung problems
• myasthenia gravis, a condition characterised by severe muscle weakness
• depression, psychosis, schizophrenia
• spinal or cerebellar ataxia, condition of clumsiness or in co-ordination
  of the muscles
• history of addiction or drug dependence.

Your doctor may want to take special care if you have any of these
conditions.

Tell your doctor if you are allergic to any other medicines, foods, dyes
or preservatives.

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

It is not known whether Paxam is safe to use during pregnancy. However, there
have been reports of unwanted effects occurring in the newborn with the use of
medicines of this class when used during pregnancy. Therefore, if there is a
need to take Paxam during pregnancy, your doctor will discuss the risks and
benefits with you.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Paxam is not recommended for use during breastfeeding as it passes into the
breast milk, and may cause drowsiness and feeding difficulties in the infant.

Tell your doctor if you drink alcohol.

Alcohol may change the effects of Paxam and may even cause you to have
epileptic fits.

Tell your doctor if you plan to have surgery, including dental surgery.

If you have not told your doctor or pharmacist about any of the above, tell
them before you start taking Paxam.

Taking other medicines

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

Some medicines may be affected by Paxam or may affect how well Paxam
works. These include:

• other medicines for epilepsy, such as phenytoin, carbamazepine, sodium
  valproate
• sleeping tablets, sedatives, muscle relaxants
• medicines for depression such as tricyclic antidepressants, monoamine
  oxidase inhibitors and SSRI's.
• medicines for mental illness
• pain relievers
• anaesthetics
• cimetidine, a medicine used to treat reflux and stomach ulcers
• disulfiram, a medicine used to deter alcohol consumption
• lithium, a medicine used to treat mood swings and some types of
  depression.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with
your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking Paxam.

How to take Paxam

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 bottle, ask your doctor or
pharmacist.

How much to take

The dose varies from person to person.

Take Paxam exactly as directed by your doctor.

Your doctor will tell you how many tablets you need to take each day and when
to take them. The dose may depend on your age, your condition and whether or not
you are taking any other medicines.

Paxam is usually started using low doses. Your doctor may then gradually
increase this dose to the lowest amount needed to control your condition,
depending on how well you respond and tolerate the medicine.

The usual adult maintenance dose is between 3 mg and 6 mg per day.

Children, the elderly and people with liver or kidney problems may need
smaller doses.

How to take Paxam

Swallow the tablets with a glass of water.

Paxam tablets can be broken in half if your doctor has prescribed half a
tablet.

When to take Paxam

Paxam is usually taken twice a day (morning and evening). However, depending
on your dose, your doctor may recommend you take it three or four times a day.

Paxam can be taken with or without food.

Take Paxam at about the same time each day.

Taking your tablets the same time each day will have the best effect. It will
also help you remember when to take it.

How long to take Paxam

Keep taking Paxam for as long as your doctor recommends.

Paxam helps to control your condition but does not cure it, so it is
important to take it every day.

If you forget to take Paxam

If it is almost time for your next dose, 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
tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you miss more than one dose, or are not sure what to do, check with your
doctor or pharmacist.

If you take too much Paxam, you may feel drowsy, tired, confused, dizzy, have
difficulty breathing, feel weak or become unconscious.

While you are taking Paxam

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you
are taking Paxam.

Tell all the doctors, dentists and pharmacists who are treating you that
you are taking Paxam.

If you become pregnant while taking Paxam, tell your doctor immediately.

If you plan to have surgery (that requires an anaesthetic), including
dental surgery, tell your doctor or dentist that you are taking Paxam.

Tell your doctor if you feel that Paxam is not helping your condition.

If you continue to have seizures (fits) your doctor may need to adjust or
review your treatment.

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

Visit your doctor regularly so that they can check your progress.

Your doctor may ask you to have regular blood tests to check your blood
count, kidney and liver function.

Things you must not do

Do not drink alcohol while you are taking Paxam.

Combining Paxam and alcohol can make you more sleepy or dizzy.

Alcohol can also affect how well Paxam works and may even cause more seizures
(fits).

Do not drive or operate machinery until you know how Paxam affects you.

Paxam may cause drowsiness, dizziness or affect alertness in some people.
These effects may continue the following day.

Therefore, make sure you know how Paxam affects you before you drive a car,
operate machinery or do anything else that could be dangerous.

Children should not ride a bike, climb trees or do anything else that
could be dangerous if they are feeling drowsy or sleepy.

Paxam may cause drowsiness or dizziness in some people and affect alertness.

Do not take Paxam for a longer time than your doctor has prescribed.

Do not stop taking Paxam or change the dose without first checking with
your doctor.

Stopping this medicine suddenly may make your epilepsy worse and cause some
unwanted effects. Your doctor will tell you how to gradually reduce the amount
of Paxam you are taking before stopping completely.

Do not let yourself run out of Paxam over the weekend or on holidays.

Do not use Paxam to treat any other conditions unless your doctor tells
you to.

Do not give Paxam to anyone else, even if they have the same condition as
you.

Things to be careful of

If Paxam is being given to a small child, you should be especially careful
that they are breathing freely.

Paxam may increase the amount of saliva and fluid in the airways.

Be careful if you are elderly, unwell or taking other medicines.

Some people may experience side effects such as drowsiness, confusion,
dizziness and unsteadiness, which may increase the risk of a fall.

Side effects

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

Paxam helps most people with their epilepsy, but it may have unwanted side
effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

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

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

• drowsiness, tiredness
• dizziness, light-headedness
• unsteadiness when walking
• muscle weakness
• slurred speech
• slowed reactions
• increased saliva
• chest congestion
• headaches.

The above list includes the milder side effects of Paxam, some of which may
disappear with continued treatment.

Tell your doctor immediately if you notice any of the following:

• confusion
• behaviour changes such as aggression, agitation, irritability, depression,
  restlessness, nervousness, hostility, anxiety, sudden feelings of rage
• severe sleep disturbances, nightmares, vivid dreams
• loss of memory or difficulty remembering events, especially after taking
  the medicine
• bleeding or bruising more easily than normal
• signs of frequent infections such as fever, severe chills, sore throat,
  mouth ulcers.

The above list includes serious side effects, which may require medical
attention. These side effects are all rare.

Tell your doctor immediately or go to Accident and Emergency at the
nearest hospital if you notice any of the following:

• swelling of the face, lips, mouth, throat or neck, which may cause
  difficulty swallowing or breathing
• fainting
• more fits than usual
• difficulty breathing, shortness of breath
• chest pain
• thoughts of self-harm.

The above list includes very serious side effects. You may need urgent
medical attention or hospitalisation.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken PAXAM by mistake. Do this even if there are no signs of discomfort or
poisoning. You may need urgent medical attention. Take the pack of PAXAM
with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Storage

Keep Paxam 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 your tablets in the bottle until it is time to take them.

If you take the tablets out of the bottle they will not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25
degrees C.

Do not store Paxam or any other medicine in the bathroom or near a sink.

Do not leave Paxam in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Paxam, or your medicine has passed
its expiry date, ask your pharmacist what to do with any tablets that are left
over.

Product description

What it looks like

Paxam is available in 2 tablet strengths:

• Paxam 0.5mg: round, peach coloured tablet marked "CN" over "0.5" on one
  side and cross-scored on the other.
• Paxam 2mg: round, white tablet marked "CN" over "2" on one side and
  cross-scored on the other.

Ingredients

The active ingredient in Paxam is clonazepam.

• Each Paxam 0.5 tablet contains 0.5 mg of clonazepam.
• Each Paxam 2 tablet contains 2mg of clonazepam.

The tablets also contain the following inactive ingredients:

• lactose
• maize starch
• microcrystalline cellulose
• magnesium stearate
• sunset yellow [Paxam 0.5 tablet only].

Paxam tablets do not contain gluten.