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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

Mexitil®

Mexiletine hydrochloride

This leaflet answers some common questions about Mexitil. It does not contain all available information. It does not take the place of talking to your doctor or pharmacist. Keep this information with your capsules. You may want to read it again later.

You should ask your doctor or pharmacist if you have any questions about your medicine or if you have any concerns about taking Mexitil.

What Mexitil is used for

Mexitil is used in the management of irregular heartbeats, a condition known as ventricular arrhythmia. Mexitil works by reducing the excitability of the heart. This helps return the heartbeat to normal.

Your doctor will have explained why you are being treated with Mexitil and told you what dose to take. Follow these directions carefully, they may differ from the information contained in this leaflet.

Before taking Mexitil

When not to take Mexitil

Only take Mexitil if it has been prescribed for you by a doctor. Never give it to someone else even if their symptoms seem to be the same as yours.

Do not take Mexitil if you are allergic to it or to any of the ingredients. These ingredients are listed in full at the end of this leaflet (see ingredients). If you are uncertain as to whether you have, or have had, any of these allergies you should raise those concerns with your doctor.

Do not take Mexitil if you have experienced the following conditions:

If you are uncertain as to whether you have, or have had, any of these conditions, you should raise those concerns with your doctor.

You should never use Mexitil after the expiry date on the carton or blister pack has passed. You should never use Mexitil if the packaging is torn or shows signs of tampering.

Before you start taking Mexitil

It is essential that your doctor knows your medical history before prescribing Mexitil. Before taking Mexitil, you must tell your doctor if you have, or have had, any of the following conditions:

If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor. Before taking Mexitil you must tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription. In particular you must tell your doctor if you are taking:

These medicines may be affected by Mexitil or may affect how well Mexitil works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while taking Mexitil.

Pregnancy

You must tell your doctor if you are pregnant, or are likely to become pregnant during the course of your medication. Your doctor will discuss the risks and benefits of taking Mexitil when pregnant.

Breastfeeding

Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication. As Mexitil enters the breast milk, your doctor may recommend an alternate method of feeding your child.

Taking Mexitil

Recommended dose

The dose of Mexitil may be different for each person and their medical condition. Your doctor will tell you how many capsules to take. The number of capsules that you take depends on the strength of the medicine. The initial dose is 400 mg of mexiletine. The maintenance dose is usually 200-250 mg of mexiletine 3 times daily, commencing 2 hours after the initial dose. The usual daily dose is between 600-800 mg in divided doses.

If your doctor has prescribed a different dose, you should ask for further information from your doctor or pharmacist.

If you forget to take a dose

It is important to take Mexitil as directed. If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time. Do not take a double dose to make up for the dose that you missed.

If you take too much (overdose)

Contact your doctor, pharmacist or Poisons Information Centre (telephone 0800 POISON or 0800 764766) immediately if you think that you or anyone else may have taken too much Mexitil, even if there are no signs of discomfort or poisoning. Go to your doctor or Casualty at the nearest hospital immediately if any signs of overdose are experienced. In addition to the symptoms listed under Side effects, cardiac arrest and convulsions may occur as a result of severe overdose.

While you are taking Mexitil

Things to be careful of

Avoid consuming alcohol while taking Mexitil. In case of doubt, seek medical advice prior to taking this medicine.

Effects on ability to drive or operate machinery

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

Mexitil may cause dizziness or drowsiness. Make sure you know how you react to Mexitil before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or drowsy. If you drink alcohol, dizziness or drowsiness may be worse.

Side effects

You should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. Your doctor has weighed the risks of you taking Mexitil against the benefits they expect it will have for you.

Ask for the advice of your doctor or other medical staff if you have any concerns about the effects of being treated with this medicine.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

However, check with your doctor if any of the following side effects continue or are bothersome:

Tell your doctor as soon as possible if you experience any side effects during or after treatment with Mexitil, so that these may be properly treated. In addition, unexpected effects, not listed above, can occur with any medicine. You should tell your doctor if you notice anything unusual, during or after treatment with Mexitil.

After taking Mexitil

Storage

Leave all capsules in the blister pack until it is time to take a dose. The blister packaging protects the capsules. Mexitil should be kept in a cool, dry place where the temperature stays below 30°C. For example, do not leave your capsules in a car or store them in the bathroom. Heat and dampness will damage the capsules.

Keep Mexitil capsules where children cannot reach them.

Disposal

If your doctor tells you to stop taking Mexitil, the unused medicine should be returned to your pharmacist so that it can be disposed of safely.

Product Description

What the capsules look like

Mexitil is the brand name of the capsules prescribed for you by your doctor. There are two different strengths.

Mexitil M 50 Capsules: Red/purple hard gelatin capsule, imprinted with '50 mg' and the company symbol. Available in packs of 100 capsules.

Mexitil 200 mg Capsules: Red/red hard gelatin capsule, imprinted with '200 mg' and the company symbol. Available in packs of 100 capsules.

Ingredients

The active ingredient in Mexitil capsules is mexiletine hydrochloride.

Mexitil M 50 contains maize starch, silica, magnesium stearate, gelatin, indigo carmine CI73015, erythrosine CI45430, iron oxide black CI77499 and titanium dioxide.

Mexitil 200 mg contains maize starch, silica, magnesium stearate, gelatin, indigo carmine CI73015, erythrosine CI45430 and titanium dioxide.

Distributor

Mexitil is supplied in New Zealand by:

BOEHRINGER INGELHEIM (N.Z.) LIMITED
PO Box 76-216
Manukau City
Auckland

Ph 0800 802461

This leaflet was prepared on 15 December 2006

© Boehringer Ingelheim 2009