Reedos Chewable Tablets

Reedos Chewable Tablets is a brand of medicine containing the active ingredient lamotrigine.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

REEDOS 5, 25, 50, 100 & 200

Lamotrigine


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you take REEDOS tablets.

This leaflet answers some common questions about REEDOS tablets. 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 risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking REEDOS tablets against the risks this medicine could 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.

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What REEDOS used for

REEDOS tablets are used for the treatment of epilepsy in adults and children aged 2 years and older.

Lamotrigine (the active ingredient in REEDOS tablets) belongs to a group of medicines called "anti-epileptic drugs".

Epilepsy: Usually REEDOS tablets are initially used in addition to other medicines for the treatment of epilepsy. REEDOS is used in partial or generalized seizures including Lennox-Gastaut Syndrome.

It is thought that REEDOS tablets work by changing the levels of some chemicals associated with seizures.

Your doctor may have prescribed REEDOS tablets for another reason.

REEDOS tablets are not addictive.

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Before you take REEDOS

Do not take if:

You must not take REEDOS tablets if:

  • you have ever had an allergic reaction to REEDOS tablets (See "Side-Effects") or any of the ingredients listed toward the end of this leaflet. (See "Ingredients")
  • the expiry date printed on the pack has passed.
  • the packaging is torn or shows signs of tampering

Tell your doctor if:

You must tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines.
  • you have a history of allergy or rash to other antiepileptic drugs.
  • you are suffering, or have ever suffered, from any liver or kidney disorders.
  • you have Parkinson's disease.
  • you are taking any other medicines. This is particularly important for sodium valproate ("Epilim", "Valpro"). You are taking any form of hormonal contraceptive (e.g. "the pill") or HRT, other anti epileptic drugs (e.g. carbamazepine or phenobarbitone) or medicines you buy without a prescription.
  • you are taking rifampicin, which is used to treat infections, including tuberculosis.
  • you are taking medicine which is used to treat Human Immunodeficiency Virus (HIV) infection.
    Tell your doctor if you are taking risperidone, a medicine used to treat bipolar disorder. You may be more likely to feel sleepy or drowsy when you take risperidone and lamotrigine together.
  • you are pregnant or trying to become pregnant.
    REEDOS may affect your unborn baby if you take it during pregnancy but it is still important that you control your fits while you are pregnant. Your doctor will discuss the risks and benefits of taking REEDOS during pregnancy and help you decide whether or not you should take REEDOS.
    It is recommended that women on antiepileptic drugs, such as REEDOS, receive pre-pregnancy counseling with regard to the risk on their unborn child.
    Studies have shown a decrease in the levels of folic acid during pregnancy with REEDOS. It is therefore recommended that you take a folate supplement, eg 5mg folate daily, before becoming pregnant and during the first 12 weeks of your pregnancy.
  • you are breastfeeding.
    REEDOS is thought to pass into breast milk.
    Your doctor will discuss the risks and benefits of using REEDOS tablets if you are breastfeeding.

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How to take REEDOS

Using REEDOS Tablets for the first time

You may notice that you feel dizzy, tired, or unsteady in the first few weeks of treatment with REEDOS tablets. During this period you may also notice that you have slight problems with your vision. As your reactions may be slower during this period you should not operate any machinery or appliances and you should not drive a car. If any of these effects do not go away or are troublesome you should see your doctor.

If you develop any skin rash (eg. spots or 'hives') during REEDOS treatment contact your doctor immediately. There are reports of skin rash associated with REEDOS treatment. Some of these may be serious and cause severe illness.

If you have any questions about taking REEDOS tablets ask your doctor or pharmacist.

How much to take

Take REEDOS tablets as directed by your doctor or pharmacist. Never change the dose yourself. Do not increase the dose more quickly than you have been told.

Your doctor and pharmacist will be able to tell you:

  • how many tablets to take at each dose.
  • how many doses to take each day
  • when to take each of your doses.

The label on the container that the tablets were supplied in will give the same information. If there is something that you do not understand ask either your doctor or pharmacist.

It is usual for the dose of REEDOS tablets to start at quite a low level and be slowly increased during the first few weeks of treatment. The doses that your doctor prescribes will generally depend on any other antiepileptic medications you are taking for the treatment of epilepsy and your response to REEDOS tablets.

Hormonal contraceptives (such as the birth control pill) and REEDOS tablets: Most people need a higher maintenance dose of REEDOS tablets when they take hormonal contraceptives, so if you are taking these, your doctor may increase your dose. Your doctor will usually decrease your dose once you stop taking hormonal contraceptives.

You should tell your doctor if there are any changes in your menstrual pattern, such as breakthrough bleeding.

Your doctor may need to change the dose of REEDOS during your pregnancy.

How to take REEDOS

REEDOS tablets may be swallowed whole, chewed or dispersed in a small volume of water (at least enough to cover the whole tablet).

How long to take it for

Do not stop taking REEDOS tablets, or change the dose without first checking with your doctor.

Use in children

REEDOS is not recommended for treatment of epilepsy in children under 2 years of age.

Epilepsy:
Children's weight should be checked and the dose reviewed as weight changes occur.

What do I do if I take too much? (Overdose)

Immediately telephone your doctor or Poisons Information Centre for advice, or go to Accident or Emergency department at your nearest hospital, if you think you or anyone else may have taken too many REEDOS tablets, even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

In Australia call 13 11 26 for Poisons Information Centres. In New Zealand call 0800 POISON (0800 764 766).

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

If too many REEDOS tablets have been taken it is likely that the following symptoms will be experienced: nausea, vomiting, tiredness/drowsiness and problems with eyesight, twitching, impaired consciousness and coma.

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While you are taking REEDOS

Your doctor or pharmacist will be able to tell you whether there are any special instructions while you are taking REEDOS tablets.

Things you must do

If you develop any skin rash (eg. spots or 'hives') during REEDOS treatment contact your doctor immediately. There are reports of serious skin rash with REEDOS that may need hospital treatment or drug withdrawal; rarely serious skin rash may cause death.

Tell your doctor or pharmacist that you are taking REEDOS tablets if you are about to be started on any new medicines.

REEDOS may interfere with some laboratory tests to detect other drugs. If you require a laboratory test, tell your doctor or hospital that you are taking REEDOS.

Pregnancy and Breastfeeding

Talk to your doctor as soon as possible if you are pregnant, or if you are planning to become pregnant. There may be an increased risk of babies developing a cleft lip or cleft palate if REEDOS tablets are taken during the first few months of pregnancy.

Talk to your doctor if you're breast feeding or planning to breast feed. The active ingredient of REEDOS passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while you're taking REEDOS.

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

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

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Things you must not do

Do not stop taking REEDOS tablets just because you feel better. Epilepsy: If you stop taking REEDOS tablets suddenly your epilepsy may come back or become worse. This is known as "rebound seizures".

Your doctor will advise you if you need to stop taking REEDOS tablets and how.

If you are unsure whether you should stop taking REEDOS tablets talk to your doctor or pharmacist.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use REEDOS tablets to treat any other complaints unless your doctor says to.

Things to be careful of

Be careful driving or operating machinery until you know how REEDOS tablets affect you. As with other anticonvulsant medicines for the treatment of epilepsy REEDOS may cause dizziness and drowsiness in some people, and affect alertness.

Make sure you know how you react to REEDOS before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol, dizziness or lightheadedness may be worse.

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

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Side Effects

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking REEDOS tablets, even if the problem is not listed below.

Like other medicines, REEDOS tablets can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side effects are:

  • dizziness/unsteadiness
  • rash
  • headache
  • drowsiness
  • feeling sick, also called nausea
  • vomiting
  • feeling weak
  • double vision, blurred vision
  • tremor (shakiness)
  • trouble sleeping
  • loss of memory
  • confusion
  • irritability/aggression
  • agitation
  • increased activity in children
  • joint or back pain

Other reported side effects include:

  • diarrhoea
  • liver problems
  • tiredness or feeling sleepy
  • movement problems such as tics, unsteadiness and jerkiness
  • hallucinations

Some people may have changes in their blood count, which may make them feel tired, short of breath and more susceptible to infections. They may also bleed or bruise very easily or have mouth ulcers or a sore throat.

In general these side effects usually happen only during the first few weeks of treatment with REEDOS. If any of these side effects persist, or are troublesome, see your doctor.

Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. Information from a large number of studies in patients being treated with anti-epileptic medicines such as REEDOS has shown a small number of reports of suicidal behaviour (including suicidal thoughts and suicide attempts).

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

  • Suicidal thoughts
  • Suicide attempts

Tell your Doctor immediately or go to the Accident and Emergency department of your nearest hospital if you have any thoughts of harming yourself or committing suicide.

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

  • Any skin reaction (e.g. rash or 'hives').
  • Swelling of the face, lips or tongue.
  • Sore mouth or sore eyes.
  • A high temperature (fever).
  • Swollen glands.
  • Drowsiness.
  • Easy bruising or unusual bleeding.
  • Yellow skin (jaundice).

If you are taking REEDOS for epilepsy, rarely, you may start to experience more seizures than usual. Tell your doctor as soon as possible if your seizures get worse or if you have a new type of seizure

These are all very serious side effects and you may need urgent medical attention or hospitalisation.

Serious side effects are rare.

Another rare side effect is "Lupus-like reactions" which may present as a collection of symptoms consisting of fever, pain in the joints and general ill-health.

A very rare side effect is meningitis which may present as a group of symptoms consisting of fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord.

If you think you are having an allergic reaction to REEDOS tablets, TELL YOUR DOCTOR IMMEDIATELY or go to the Accident or Emergency department at your nearest hospital. Symptoms usually include some or all of the following:

  • wheezing
  • swelling of the lips/mouth
  • difficulty in breathing
  • hay fever
  • lumpy rash ("hives")
  • fainting

Tell your doctor if you are female and your menstrual periods change.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Ask your doctor or pharmacist if you don't understand anything in this list.

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

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After Taking REEDOS

Storage

Keep REEDOS tablets where children cannot reach them such as in a locked cupboard.

Keep REEDOS tablets in the container that they were supplied in until time to take them.

Keep REEDOS tablets in a cool dry place where the temperature stays below 25°C and protect from moisture.

Do not leave in a car, on a window sill or in the bathroom. Return any unused or expired medicine to your pharmacist.

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Product Description

What REEDOS looks like

  • REEDOS 5
    REEDOS 5 dispersible/chewable tablets are white to off-white capsule shaped uncoated tablets debossed with ‘H’ on one side and ‘81’ on other side.
  • REEDOS 25
    REEDOS 25 dispersible/chewable tablets are white to off-white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘80’ on flat side.
  • REEDOS 50
    REEDOS 50 dispersible/chewable tablets are white to off-white rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘79’ on flat side.
  • REEDOS 100
    REEDOS 100 dispersible/chewable tablets are white to off-white rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘78’ on flat side.
  • REEDOS 200
    REEDOS 200 dispersible/chewable tablets 200 mg are white to off-white rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘77’ on flat side.

All strengths of tablets are presented in pack size of 56 tablets in blisters, and 30 tablets & 56 tablets in bottle.

Ingredients

Active Ingredient:
Lamotrigine

Each tablet may contain either 5 mg, 25 mg, 50 mg, 100 mg, 200 mg of lamotrigine.

Other Ingredients:

  • Microcrystalline cellulose (PH-101)
  • Microcrystalline cellulose (PH-102) [Only for 25 mg, 50 mg, 100 mg & 200 mg strengths]
  • Heavy magnesium carbonate
  • Polacrilin potassium
  • Sucralose
  • Povidone
  • Magnesium Stearate
  • Black currant flavour 501017 AP0551 (PI-ARTG No.106513)

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd
Unit 3, North Rydelink
277-283 Lane Cove Road,
Macquarie Park
NSW 2113
Australia

Date of Approval
18 April 2012

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CMI provided by MIMS Australia, June 2013  

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