Namuscla 167 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Namuscla 167 mg hard capsules

mexiletine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

There is an Information Card provided with Namuscla to remind you and healthcare professionals of the risk of cardiac arrhythmias. Read the Information Card together with this leaflet and carry the card with you at all times.

Contents of this leaflet

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

1. What Namuscla is and what it is used for

Namuscla is a medicine that contains the active substance mexiletine.

Namuscla is used to treat symptoms of myotonia (when muscles relax slowly and with difficulty after use) in adults with non-dystrophic myotonic disorders caused by genetic effects that affect muscle function.

2. What you need to know before taking Namuscla

Do not take Namuscla

• if you are allergic to mexiletine or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to any local anaesthetic
• if you have had a heart attack
• if your heart is not functioning adequately
• if you have certain heart rhythm disorders
• if your heart beats too fast
• if you have damaged blood vessels of the heart
• if you are also taking certain medicines used to treat heart rhythm disorders (see Other medicines and Namuscla)
• if you are also taking certain medicines that have a narrow therapeutic index (see Other medicines and Namuscla).

If in doubt, ask your doctor or pharmacist.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Namuscla if you have:

• heart problems
• liver problems
• kidney problems
• low or high potassium levels
• low magnesium levels
• epilepsy

Heart function

Before starting treatment with Namuscla, you will undergo tests to check your heart function, including an ECG (electrocardiogram). These tests will also be performed periodically during treatment with Namuscla, and before and after any dose adjustment of Namuscla. The frequency of these tests depends on your heart function.

If you or your doctor notice any changes in your heart rhythm or any of the conditions listed in the section “Do not take Namuscla”, your doctor will stop your treatment with Namuscla.

If you notice changes in your heart rhythm (if it beats faster or slower), if you feel fluttering or chest pain, if you have difficulty breathing, feel dizzy, sweat excessively, or faint, you must contact an emergency medical service immediately.

Some patients may have higher blood levels of Namuscla due to slower metabolism in the liver, and dose adjustment may therefore be necessary.

Children and adolescents

Namuscla must not be used in children and adolescents under 18 years of age.

Other medicines and Namuscla

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

Do not take Namuscla with certain medicines used to treat heart rhythm disorders (quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant). See section “Do not take Namuscla”. Taking Namuscla together with any of these medicines increases the risk of a serious heart rhythm disturbance called torsades de pointes.

Do not take Namuscla with certain medicines that have what is known as a narrow therapeutic index (medicines in which small differences in dose or blood concentration can affect the medicine’s efficacy or side effects). Examples of such medicines are digoxin (for heart problems), lithium (a mood stabilizer), phenytoin (for treating epilepsy), theophylline (for asthma), and warfarin (for blood clots).

Inform your doctor or pharmacist if you are taking any of the following medicines, as they may interact with or be affected by Namuscla:

• medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem),
• some other medicines:

o timolol for the treatment of ocular hypertension (glaucoma),

o certain antibiotics (ciprofloxacin, rifampicin),

o some antidepressants (fluvoxamine),

o tizanidine (used to relax muscles),

o metformin (used for diabetes),

o omeprazole (for treating stomach ulcers and gastric acid reflux).

Tobacco and Namuscla

Inform your doctor or pharmacist if you start or stop smoking while taking Namuscla, as smoking affects the blood levels of Namuscla and your dose may need to be adjusted accordingly.

Use of Namuscla with beverages

It is recommended to reduce caffeine intake by half during treatment with mexiletine, as this medicine may increase caffeine levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. If you become pregnant while taking Namuscla, see your doctor immediately, as it is preferable not to take Namuscla during pregnancy.

Mexiletine passes into breast milk. You should discuss this with your doctor and jointly decide whether to avoid breastfeeding or to discontinue or refrain from treatment with mexiletine.

Driving and using machines

Namuscla may, in rare cases, cause fatigue, confusion, and blurred vision: if you experience these effects, do not drive, ride a bicycle, or operate machinery.

3. How to take Namuscla

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 1 capsule per day. Your doctor will gradually increase the dose depending on how the medicine is working. The maintenance dose is 1 to 3 capsules per day taken at regular intervals throughout the day.

Do not take more than 3 capsules per day.

Cardiac function monitoring

Before starting treatment with Namuscla and regularly during treatment, you will have tests to check how your heart is working. Depending on how your heart functions, you may also need tests before and after any dose adjustment. See section “Warnings and precautions”. Your doctor will also regularly re-evaluate your treatment to ensure that Namuscla remains the most appropriate medicine for you.

Method of administration

Namuscla is for oral use.

Swallow the capsule with a glass of water while standing or sitting. You may take Namuscla with a meal to avoid stomach discomfort (see section “Possible side effects”).

If you take more Namuscla than you should

If you have taken more Namuscla than the recommended dose, contact your doctor immediately. It may be very harmful to your health. You or your partner should contact your doctor immediately if you experience tingling in the arms and legs, if you are unable to think clearly or concentrate, if you have hallucinations or seizures, if you notice your heart beating more slowly, if you feel dizzy or faint, if you lose consciousness, or if your heart stops beating.

If you forget to take Namuscla

If you forget a dose, do not take a double dose. Take the next dose as scheduled.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

The most serious adverse effects are:

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

• Severe allergic reaction to mexiletine (with symptoms such as severe rash accompanied by fever); this is a very rare adverse effect, affecting up to 1 in 10,000 people.
• Heart rhythm disorders – see the section “Warnings and precautions” for symptoms and further information; this is a common adverse effect, affecting up to 1 in 10 people.

Other adverse effects that may occur:

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

• Abdominal pain (in the stomach)
• Insomnia (difficulty sleeping)

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

• Drowsiness
• Headache
• Tingling in arms and legs
• Blurred vision
• Dizziness (sensation of loss of balance)
• Fast heartbeat
• Hot flush
• Low blood pressure (which may cause dizziness or feeling faint)
• Nausea
• Acne
• Pain in arms and legs
• Tiredness
• Weakness
• Chest discomfort
• General malaise (feeling of general discomfort and illness)

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

• Seizures (fits)
• Speech disorders
• Slow heartbeat

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

• Abnormal liver function (observed in blood tests)

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

• Liver damage, including inflammation (hepatitis)
• Severe reaction to the medicine (with rash and fever)

Frequency not known (cannot be estimated from available data):

• Decrease in the number of white blood cells or platelets
• Lupus syndrome (an immune system disease)
• Redness and peeling of the skin
• Stevens-Johnson syndrome: severe allergic reaction with skin rash, often blistering and sores in the mouth and eyes and other mucous membranes
• Skin blisters, general malaise, fever in the context of a condition called DRESS
• Hallucinations (seeing or hearing things that are not real)
• Transient confusion (temporary inability to think clearly or concentrate)
• Double vision
• Disturbance of taste sensation
• Heart rhythm disorders
• Loss of consciousness
• Hot flushes
• Pulmonary fibrosis (lung disease)
• Diarrhoea
• Vomiting
• Injury to the oesophagus (the tube carrying food)

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Namuscla

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Store below 30 °C. Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Namuscla

Each hard capsule contains:

• Mexiletine hydrochloride corresponding to 166.62 mg of mexiletine (active substance)
• Other components (corn starch, colloidal anhydrous silica, magnesium stearate, gelatin, iron oxide [E 172] and titanium dioxide [E 171]).

Appearance of Namuscla and contents of the pack

Namuscla capsules are reddish hard gelatin capsules filled with white powder. Namuscla is available in blister packs containing 30, 50, 100 or 200 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Lupin Europe GmbH

Hanauer Landstraße 139-143,

60314 Frankfurt am Main

Germany

Manufacturer

Hormosan Pharma GmbH

Hanauer Landstraße 139-143,

60314 Frankfurt am Main

Germany

Lupin Healthcare (UK) Ltd

The Urban Building, second floor, 3-9 Albert Street

SL1 2BE Slough, Berkshire,

United Kingdom

Etablissement Pharmaceutique de l’AP-HP (Assistance Publique-Hôpitaux de Paris) AGEPS

11-13 rue Lavoisier,

92000 Nanterre, France

Etablissement Pharmaceutique de l’AP-HP (Assistance Publique-Hôpitaux de Paris) AGEPS

7 rue du Fer à Moulin,

75005 Paris, France

Date of the most recent review of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.