Lamotrigine Sandoz Chewable tablets

Lamotrigine Sandoz 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.

Lamotrigine Sandoz®

lamotrigine dispersible/chewable tablets


Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Lamotrigine 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 this medicine 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.

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WHAT LAMOTRIGINE SANDOZ IS USED FOR

This medicine is used to treat epilepsy in adults and children. Usually Lamotrigine Sandoz is initially used in addition to other medicines for the treatment of epilepsy.

It contains the active ingredient lamotrigine. Lamotrigine belongs to a group of medicines called anti-epileptic medicines.

It works by altering the levels of some of the chemicals causing seizures.

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

This medicine is not addictive.

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BEFORE YOU TAKE LAMOTRIGINE SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:

  • lamotrigine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
  • any other similar medicines.

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 it has expired or is damaged, return it 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 if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • history of allergies to other anti-epileptic medicines
  • kidney or liver disorders
  • Parkinson’s disease.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

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

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 and Lamotrigine Sandoz may interfere with each other. These include:

  • other medicines used to treat epilepsy, e.g. sodium valproate, phenytoin, carbamazepine, oxcarbazepine, phenobarbitone or primidone
  • rifampicin, a medicine used to treat infections, including tuberculosis
  • a combination of lopinavir and ritonavir, medicines used to treat HIV infection
  • any form of hormonal contraceptive (e.g. the “pill”)
  • Hormone Replacement Therapy (HRT).

These medicines may be affected by Lamotrigine Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

If you are female and are using a hormonal contraceptive, your doctor might suggest that you use a contraception without a pill-free week instead, e.g. a continuous hormonal contraceptive or a non-hormonal method.

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

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HOW TO TAKE LAMOTRIGINE SANDOZ

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

Take Lamotrigine Sandoz tablets as directed by your doctor or pharmacist. It is usual to start at a low dose of Lamotrigine Sandoz and to then slowly increase it during the first few weeks of treatment. The dose prescribed by your doctor will generally depend on any other anti-epileptic medications you are taking for the treatment of epilepsy and your response to Lamotrigine Sandoz.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you. If you take the wrong dose, Lamotrigine Sandoz may not work as well and your problem may not improve.

If you start or stop taking hormonal contraceptives (e.g. the “pill”) while taking Lamotrigine Sandoz your doctor may need to adjust the dose of Lamotrigine Sandoz depending on how well your condition is being treated.

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

The use of this medicine in children depends upon the child’s age and weight. The dose must be reviewed as weight changes occur.

How to take it

Lamotrigine Sandoz tablets may be swallowed whole, chewed or dispersed in a glass of water (use at least enough water to cover the whole tablet).

When to take Lamotrigine Sandoz

Your doctor will advise you when to take this medicine.

How long to take Lamotrigine Sandoz

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.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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 Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Lamotrigine Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

  • nausea, vomiting
  • tiredness, drowsiness
  • problems with eyesight
  • twitching
  • impaired consciousness or coma.

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WHILE YOU ARE TAKING LAMOTRIGINE SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Lamotrigine Sandoz.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine. Always follow your doctor’s instructions carefully.

Tell your doctor if you have not taken your medicine as prescribed.

Otherwise your doctor may think that Lamotrigine Sandoz was not effective and may change your treatment unnecessarily.

If you develop any skin rash (e.g. spots or “hives”) during Lamotrigine Sandoz treatment contact your doctor immediately. There are reports of skin rash associated with this medicine. Some of these may be serious and can cause severe illness.

If you become pregnant or are trying to become pregnant while taking this medicine tell your doctor immediately.

Things you must not do

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

Do not give your medicine to anyone else, even if they have the same condition as you. Do not stop taking your medicine without checking with your doctor.

If you stop taking this medicine your epilepsy may suddenly come back or become worse. This is known as “rebound seizures”. Your doctor will advise you if you need to stop taking Lamotrigine Sandoz and how.

Things to be careful of

Be careful driving or operating machinery until you know how Lamotrigine Sandoz affects you. This medicine may affect alertness and may cause dizziness/drowsiness and blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.

See your doctor if these effects continue.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or drowsiness may be worse.

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SIDE EFFECTS

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

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

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

  • dizziness, unsteadiness, drowsiness
  • headache
  • nausea, vomiting, feeling weak
  • diarrhoea
  • double vision or blurred vision
  • tremor or movement problems such as tics, unsteadiness and jerkiness
  • trouble sleeping
  • loss of memory, confusion
  • irritability, aggression, agitation
  • increased activity in children
  • joint or back pain.

These are the more common side effects of Lamotrigine Sandoz. Mostly, these are mild and short-lived.

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
  • fever
  • swollen glands in neck, armpit or groin
  • hallucinations
  • easy bruising or unusual bleeding
  • yellowing of the skin and/or eyes (jaundice)
  • fever together with pain in the joints and general ill-health (“lupus-like reactions”)
  • temporary paralysis and weakness of muscles.

The above list includes side effects of Lamotrigine Sandoz that may be serious. You may need urgent medical attention. Serious side effects are rare.

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. A very rare side effect is meningitis, an infection around the brain or spinal cord. It may present as a group of symptoms consisting of fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light.

If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • suicidal thoughts or suicide attempts. You need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behaviour, or the emergence of suicidal thoughts/behaviour, or thoughts about self-harm.
  • swelling of the lips, mouth or throat, which may cause difficulty in swallowing or breathing, wheezing, lumpy rash (“hives”) or fainting. These are symptoms of an allergic reaction.

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

If you are female, tell your doctor if there are any changes to your menstrual pattern, such as breakthrough bleeding.

Using Lamotrigine Sandoz for the first time

You may notice that you feel dizzy, tired or unsteady during the first few weeks of treatment with this medicine. 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.

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.

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AFTER TAKING LAMOTRIGINE SANDOZ

Storage

Keep your medicine in the original container. If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Lamotrigine Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. 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.

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PRODUCT DESCRIPTION

What it looks like

Lamotrigine Sandoz comes in four types of tablets:

  • Lamotrigine Sandoz 25mg - white to off-white, modified square shape, engraved with “L” and “25” on one side, plain on the other side.
  • Lamotrigine Sandoz 50mg - white to off-white, modified square shape, engraved with “L” and “50” on one side, plain on the other side.
  • Lamotrigine Sandoz 100mg - white to off-white, modified square shape, engraved with “L” and “100” on one side, plain on the other side.
  • Lamotrigine Sandoz 200mg - white to off-white, modified square shape, engraved with “L” and “200” on one side, plain on the other side.

Available in blister packs of 56 tablets.

Ingredients

Active ingredients:

  • Lamotrigine Sandoz 25mg - 25mg lamotrigine
  • Lamotrigine Sandoz 50mg - 50mg lamotrigine
  • Lamotrigine Sandoz 100mg - 100mg lamotrigine
  • Lamotrigine Sandoz 200mg - 200mg lamotrigine

Inactive ingredients:

  • calcium carbonate
  • sorbitol
  • colloidal silicon dioxide
  • microcrystalline cellulose
  • crospovidone
  • maize starch
  • talc
  • saccharin sodium
  • sodium stearylfumarate
  • blackcurrant flavour.

Supplier/Distributor

Lamotrigine Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 2, 19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500

This leaflet was revised in January 2012

Australian Register Numbers
25mg dispersible/chewable tablets: AUST R 143556
50mg dispersible/chewable tablets: AUST R 143559
100mg dispersible/chewable tablets: AUST R 143569
200mg dispersible/chewable tablets: AUST R 143570

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CMI provided by MIMS Australia, September 2016  

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