NAMUSCLA 167 mg Kapsułki Twarde

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1. Namuscla 167 mg hard capsules
   1. What is Namuscla and what is it 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. Package Contents and Other Information

Namuscla 167 mg hard capsules

mexiletine

Read this leaflet carefully before taking this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

A Warning Cardis distributed with Namuscla to remind you and medical personnel of the
risk of cardiac arrhythmias. Read the Warning Card together with this leaflet and always
carry the card with you.
Contents of this leaflet

• 1. What Namuscla is and what it is used for
• 2. What you need to know before you take 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 is Namuscla and what is it used for

Namuscla is a medicine that contains the active substance mexiletine.
Namuscla is used to treat the symptoms of myotonia (when muscles relax slowly and
with difficulty after using them) in adults with non-dystrophic myotonic disorders, which are caused by
genetic defects that affect muscle function. Namuscla improves symptoms related to muscle stiffness
and helps patients to perform daily activities.

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 anesthetic
• If you have had a heart attack
• If your heart is not functioning well enough
• If you suffer from a heart condition that causes an irregular heartbeat
• If your heart beats too fast
• If the blood vessels of your heart are damaged
• If you are also taking certain medicines for the treatment of heart rhythm disorders (see “Other medicines and Namuscla”)
• If you are also taking certain medicines with a narrow therapeutic window (see “Other medicines and Namuscla”)

If you have any doubts, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Namuscla if you suffer from:

• Heart problems
• Liver problems
• Kidney problems
• Low or high blood levels of potassium
• Low levels of magnesium in the blood
• Epilepsy

Heart function
Before starting treatment with Namuscla, you will undergo a series of tests to check the
functioning of your heart, including an ECG (electrocardiogram). These tests will also be
performed regularly during treatment with Namuscla as well as before and after any changes
to your dose of Namuscla. The frequency with which these tests will be performed depends on your
heart function.
If you or your doctor should notice any heart rhythm disorder or any
of the conditions specified in the “Do not take Namuscla” section, your doctor will stop the
treatment with Namuscla.
If you notice changes in your heart rate (your heart beats faster or slower than usual),
if you experience palpitations or chest pain, if you have difficulty breathing, if you feel dizzy, if
you start to sweat or faint, you must immediately contact an emergency center.
Some patients may have higher blood levels of Namuscla due to slower
breakdown in the liver and it may be necessary to adjust the dose accordingly.
Before starting and during treatment with Namuscla, your doctor may
measure your blood levels of potassium and magnesium.
Drug reaction with eosinophilia and systemic symptoms (DRESS)
If you have an hypersensitivity to mexiletine or other ingredients of this product or to
any local anesthetic, do not take Namuscla and contact your doctor immediately. The symptoms of
hypersensitivity and DRESS include fever, rash and blisters, swelling of the face and
lymph nodes.

Children and adolescents
Namuscla should 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 take
any other medicine.
Do not take Namuscla with certain medicines for the treatment of heart rhythm disorders
(quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine,
amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant). See the “Do not
take Namuscla” section. Taking Namuscla together with any of these medicines increases
the risk of a serious heart rhythm disorder called torsade de pointes.
Do not take Namuscla with certain medicines that have a so-called narrow therapeutic
window (these are medicines in which small differences in dose or blood concentration
can affect the effect of the medicine or its side effects). Examples of such medicines
are digoxin (for heart problems), lithium (mood stabilizer), phenytoin (for the treatment
of epilepsy), theophylline (for asthma) and warfarin (for blood clots).
Tell your doctor or pharmacist if you are taking any of the following medicines as
these can affect or be affected by Namuscla:

• Medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem)
• Other specific medicines: o Timolol for the treatment of high blood pressure in the eye (glaucoma), o Some antibiotics (ciprofloxacin, rifampicin), o Some antidepressants (fluvoxamine), o Tizanidine (used to relax muscles), o Metformin (used for diabetes), o Omeprazole (to treat stomach ulcers and acid reflux).

Smoking and Namuscla
Tell your doctor or pharmacist if you start or stop smoking while taking Namuscla in
as smoking alters the blood levels of Namuscla and it may be necessary to adjust the dose accordingly.

Namuscla with drinks
It is recommended to reduce caffeine consumption by half during treatment with mexiletine in
as the medicine can increase caffeine levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. If you become pregnant while
taking Namuscla, contact your doctor immediately as it is preferable not to take
Namuscla during pregnancy.
Mexiletine passes into breast milk. You should talk to your doctor, together with whom you will decide
whether to avoid breastfeeding or stop/abstain from therapy with mexiletine.

Driving and using machines
In rare cases, Namuscla can cause fatigue, confusion, blurred vision: if you should
experience these effects, avoid driving, cycling and using machines.

3. How to take Namuscla

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
The recommended initial dose is 1 capsule per day. The doctor will gradually increase the dose based on
how the medicine is working. The maintenance dose is from 1 to 3 capsules per day to be taken at
regular intervals throughout the day, as prescribed.
Do not take more than 3 capsules per day.
In addition, the doctor will regularly re-evaluate the treatment you are taking to ensure
that Namuscla is still the most suitable medicine for you.
Method of administration
Namuscla is intended for oral use.
Swallow the capsule whole with a glass of water, while standing or sitting. You can take
Namuscla during a meal to avoid stomach upset (see section “Possible side effects”).

If you take more Namusclathan you should
Contact your doctor if you take more than the recommended dose of Namuscla. It may be
very dangerous to your health. You or your companion should contact your doctor immediately
if you experience tingling in your arms and legs, if you have difficulty thinking clearly or concentrating, if
you experience hallucinations, convulsions, if you feel a slowing of your heartbeat, dizziness and
fainting, if you collapse or if your heart stops beating.

If you forget to take Namuscla
If you forget to take a dose, do not take a double dose and take the next dose at the usual
time.
If you have doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are:
Contact your doctor or go to the nearest emergency room immediatelyif you experience any
of the following side effects:

• Stevens-Johnson syndrome (SJS): a severe allergic reaction with skin rashes, often in the form of blisters and ulcers in the mouth and eyes, as well as in other mucous membranes. This is a very rare side effect that can affect up to 1 in 10,000 people.
• A condition called DRESS with blisters on the skin, feeling unwell and fever. This is a very rare effect that can affect up to 1 in 1,000 people.
• Arrhythmia and other heart rhythm disorders (atrioventricular block, fast heart rate, ventricular fibrillation. These are common side effects that can affect up to 1 in 10 people; see section “Warnings and precautions” for symptoms and further information.
• Severe allergy to mexiletina (with symptoms such as severe rash with fever); this is a very rare side effect that can occur in up to 1 in 1,000 people.

Other side effects that may occur:

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

• Abdominal pain (stomach ache)
• Insomnia (difficulty sleeping)

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

• Drowsiness
• Headache
• Tingling in arms and legs
• Blurred vision
• Dizziness (feeling of loss of balance)
• Fast heartbeat
• Flushing
• Low blood pressure (which can cause dizziness and fainting)
• Nausea (feeling sick)
• Acne
• Pain in arms and legs
• Fatigue
• Weakness
• Chest discomfort
• Malaise (a general feeling of discomfort and illness)

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

• Convulsions (seizures)
• Speech disorders
• Slow heartbeat

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

• Abnormal liver function (observed after blood tests).

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

• Liver injury including inflammation (hepatitis)

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

• Reduction in the number of white blood cells or platelets
• Lupus-like syndrome (immune system disease)
• Redness and peeling of the skin
• Hallucinations (seeing or hearing things that do not exist)
• Transient confusion (temporary inability to think clearly or concentrate)
• Double vision
• Alteration of the sense of taste
• Collapse
• Hot flashes
• Pulmonary fibrosis (lung disease)
• Diarrhea
• Vomiting
• Injury to the esophagus (food pipe)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Namuscla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister. The expiry
date refers to the last day of that month.
Store at a temperature below 30 °C. Store in the original package to protect
the medicine from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Namuscla contains
Each hard capsule contains:

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

Description of the appearance of Namuscla and package contents
The hard capsules of Namuscla (capsules) are reddish-brown gelatin hard capsules filled with white
powder.
Namuscla 167 mg hard capsules are available in blisters containing 30, 50, 100 or 200 capsules
in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

AT, BE, BG, CZ, CY, DK, EE, EL, ES, FR,
FI, HR, IE, IS, IT, LV, LT, LU, HU, MT, NL,
NO, PL, PT, RO, SI, SK, SE
DE
Lupin Europe GmbH
Tel: +49 69 96759087
Email: [email protected]
Lupin Europe GmbH
Tel: +49 (0) 800 182 4160
Email: [email protected]

UK
Lupin Europe GmbH
Tel: +44 (0) 800-088-5969
Email: [email protected]
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .