• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your product is Mexiletine hydrochloride 50 mg, 100 mg or 200 mg Hard Capsules, but it will be referred to as Mexiletine Hard Capsules throughout this leaflet.

There is an Alert Card distributed with Mexiletine Hard Capsules, to remind you and medical staff of the risk of cardiac arrhythmias. Read the Alert Card in conjunction with this leaflet and keep the card with you at all times.

1. What Mexiletine Hard Capsules is and what it is used for
2. What you need to know before you take Mexiletine Hard Capsules
3. How to take Mexiletine Hard Capsules
4. Possible side effects
5. How to store Mexiletine Hard Capsules
6. Contents of the pack and other information

• If you are allergic to mexiletine hydrochloride or any of the other ingredients of this medicine (listed in Section 6)
• If you are allergic to any local anaesthetics (drugs or agents used to decrease the feeling of pain or by numbing an area of your body, without putting you to sleep)
• If you have a heart rhythm disorder called “sinus syndrome” (unless you have a pacemaker fitted)
• If you have any other heart problems which may cause slow heartbeat and do not have a pacemaker fitted
• If you suffer from severe heart failure (including cardiac shock, which can cause shortness of breath, ankle swelling, or sudden heart rhythm disorders).

Talk to your doctor or pharmacist or nurse before taking Mexiletine Hard Capsules:

• If you have heart problems
• If you have liver problems
• If you have kidney problems
• If you know you have low or high electrolyte blood levels
• If you suffer from seizures (fits)
• If you know you have abnormal blood counts
• If you have been told that you have a genetic problem with an enzyme in your body called CYP2D6 which breaks down (metabolizes) certain medicines in your body too slowly, because a different dose may be applicable to you.

Mexiletine Hard Capsules should not be used in children and adolescents younger than 18 years old.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following since these medicines may affect or be affected by Mexiletine Hard Capsules:

• Medicines for heart problems (quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant, lidocaine, tocainide, propranolol, esmolol, timolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem, propafenone, quinidine, dofetilide)
• Certain other medicines
  • Opioids (for the treatment of severe pain)
  • Antacids (for the relief of the symptoms of gastroesophageal reflux disease)
  • Atropine (to treat certain types of nerve agent and pesticide poisonings)
  • Metoclopramide (to prevent and treat nausea and vomiting)
  • Drugs that make urine more or less acid
  • Ciprofloxacin (for bacterial infections)
  • Fluvoxamine (antidepressant)
  • Omeprazole (for the treatment of stomach ulcer and gastric acid reflux)
  • Phenytoin (used to treat fits)
  • Rifampicin (for several types of bacterial infections)
  • Theophylline (for treating asthma)
  • Caffeine
  • Tizanidine (muscle relaxant)
  • Metformin (used to treat diabetes)
  • Warfarin (used to treat and prevent blood clots)

Tell your doctor or pharmacist if you start to smoke or quit smoking while taking Mexiletine Hard Capsules because smoking impacts the Mexiletine blood levels and your dose may need to be adjusted accordingly.

It is recommended to take mexiletine after food in order to reduce the incidence of gastrointestinal adverse effects.

It is recommended to reduce your caffeine intake by half while on treatment with mexiletine because the medicine can increase caffeine levels in your blood.

Limit the amount of alcohol you drink while taking this medicine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking any medicine.

As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy. Mexiletine appears in human milk, if your doctor decides to give you Mexiletine you will need to consider an alternative method of feeding your baby.

The effects of mexiletine on fertility in humans have not been studied.

This medicine can affect your ability to drive and operate machinery. Do not drive or operate machinery while taking this medicine, until you know how it affects you. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

These medicines contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Mexiletine capsules should not be given to children and adolescents.

Mexiletine should be used with caution in patients with mild or moderate liver dysfunction. In those patients, a minimum of two weeks between dose adjustments is recommended. Mexiletine should not be used in patients with severe liver disease.

In patients with mild-to-moderate kidney disease no adjustment of the starting dose is required. Mexiletine should not be used in patients with severe kidney disease.

Dose adjustments may be needed if you have a genetic problem with an enzyme in your body called CYP2D6. A minimum of one week between dose adjustments is recommended.

Contact your doctor if you take more than the recommended dose of Mexiletine Hard Capsules. This could be very harmful to your health. You or your companion should contact the doctor immediately if you have nausea, hypotension (low blood pressure), bradycardia (slow heartbeat), paraesthesia (tingling of the extremities), if you have hallucinations (seeing or hearing something that is not present), convulsions (fits), if you feel that your heart beats irregularly (slower or faster), if you collapse or if your heart stops beating.

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

If you suddenly stop taking Mexiletine you may experience side effects. Speak to your doctor first before stopping this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Contact your doctor or go to your nearest emergency center immediately if you experience any of the following side effects:

• severe allergy to mexiletine (with symptoms such as severe rash with fever); this is a very rare side effect, may affect up to 1 in 10,000 people.
• disorders of heart rhythm (with symptoms such as: faster or slower heart beats, feeling fluttering or pain in your chest, difficulty in breathing, dizziness, sweating or fainting); this is a common side effect, may affect up to 1 in 10 people.

Contact your doctor or pharmacist if you experience any of the following side effects:

Very common side effects (may affect more than 1 in 10 people):

• Abdominal (belly) pain
• Dyspepsia (difficulty to digest)
• Insomnia (difficulty sleeping)
• Dizziness
• Involuntary shaking (tremor)

Common side effects (may affect up to 1 in 10 people):

• Somnolence (sleepiness)
• Headache
• Tingling in the arms and legs
• Blurred vision
• Vertigo (sensation of feeling off balance)
• Numbness
• Ringing in the ears (tinnitus)
• Rapid heart rate
• Palpitations (when you feel your heart beating)
• Chest pain (angina pain)
• Abnormal heart rhythm (atrial fibrillation)
• Flushing
• Low blood pressure (which can cause dizziness and feeling faint)
• Nausea (feeling sick)
• Constipation (decreased number of or difficulty making bowel movements)
• Dry mouth
• Acne
• Pain in the arms and legs
• Tiredness
• Weakness
• Chest discomfort
• Malaise (a feeling of general discomfort and illness)
• Rash
• Ataxia (difficulty in coordinating your movements)

Uncommon side effects (may affect up to 1 in 100 people):

• Convulsions (fits)
• Speech disorders
• Slow heart rate
• Memory loss (amnesia)
• Lost consciousness
• Hiccups
• Loss of hair (alopecia)
• Joint pain (arthralgia)
• Dry skin
• Abnormal liver function tests
• Erectile dysfunction (difficulties in getting or keeping an erection)

Rare side effects (may affect up to 1 in 1,000 people):

• Abnormal functioning of the liver (observed after blood analysis)
• Very low white blood cell count (agranulocytosis and neutropenia)
• Heart failure

Very rare side effects (may affect up to 1 in 10,000 people):

• Liver injury including inflammation (hepatitis)
• Blisters of the skin, malaise and fever in the context of a condition called DRESS

Not known (frequency cannot be estimated from the available data):

• Decrease in white blood cells or in platelets
• Lupus like syndrome (an immune system condition)
• Redness and peeling of the skin
• Stevens-Johnson syndrome: a severe allergic reaction with skin rashes, often in the form of blisters and sores in the mouth and eyes, and other mucous membranes
• Hallucinations (seeing or hearing something that is not present)
• Transient confusion (a temporary inability to think clearly or concentrate)
• Double vision
• Altered sense of taste
• Disorders of heart rhythm
• Collapse (severe drop in blood pressure)
• Hot flushes
• Pulmonary fibrosis (scarring of the lungs which causes shortness of breath)
• Diarrhoea
• Vomiting
• Injury of the oesophagus

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Mexiletine hydrochloride 50 mg Hard Capsules

• Each capsule contains 50 mg of the active substance mexiletine hydrochloride, equivalent to 41.55 mg of mexiletine.
• The other ingredients are maize starch, silica colloidal anhydrous and magnesium stearate (E572).
• Mexiletine hydrochloride 50 mg capsule shell contains: titanium dioxide (E171) and gelatin.

Mexiletine hydrochloride 100 mg Hard Capsules

• Each capsule contains 100 mg of the active substance mexiletine hydrochloride, equivalent to 83.10 mg of mexiletine.
• The other ingredients are maize starch, silica colloidal anhydrous and magnesium stearate (E572).
• Mexiletine hydrochloride 100 mg capsule shell contains: indigotine – FD&C blue 2 (E132) (including traces of sodium), titanium dioxide (E171) and gelatin.

Mexiletine hydrochloride 200 mg Hard Capsules

• Each capsule contains 200 mg of the active substance mexiletine hydrochloride, equivalent to 166.20 mg of mexiletine.
• The other ingredients are maize starch, silica colloidal anhydrous and magnesium stearate (E572).
• Mexiletine hydrochloride 200 mg capsule shell contains: indigotine – FD&C blue 2 (E132) (including traces of sodium), titanium dioxide (E171) and gelatin.

Mexiletine hydrochloride 50 mg Hard Capsules are size 4, opaque hard gelatin capsules of white body and white cap.

Mexiletine hydrochloride 100 mg Hard Capsules are size 3, opaque hard gelatin capsules of white body and light blue cap.

Mexiletine hydrochloride 200 mg Hard Capsules are size 1, opaque hard gelatin capsules of light blue body and light blue cap.

They are packed in PVC/PVDC/aluminium blisters. Each blister contains 10 or 14 capsules.

Pack sizes: 30, 50, 56, 84, 100, 200 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer