Patient Leaflet Updated 02-Oct-2024 | Lupin Healthcare (UK) Ltd
Namuscla 167 mg hard capsules
Namuscla 167 mg hard capsules
mexiletine
There is an Alert Card distributed with Namuscla, to remind you and medical staff of the risk of cardiac arrythmias. Read the Alert Card in conjunction with this leaflet and keep the card it with you at all times.
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
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 they are used) in adults with non-dystrophic myotonic disorders, which are caused by genetic defects that affect muscle function.
If you have any doubt, ask your doctor or pharmacist.
Talk to your doctor or pharmacist or nurse before taking Namuscla if you have:
Heart function
Before starting treatment with Namuscla, you will have tests to check how well your heart is working, including ECG (Electrocardiogram). These tests will also be performed regularly during treatment with Namuscla, and before and after your dose of Namuscla is modified. How often these tests will be performed depends on your heart function.
If you or your doctor detects any heart rhythm disturbances or any of the conditions stated in section “Do not take Namuscla”, your doctor will stop your treatment with Namuscla.
If you notice that the rhythm of your heart changes (the heart beats faster or slower), if you feel fluttering or pain in your chest, if you have difficulty breathing, if you feel dizzy, if you sweat or if you faint, you have to contact an emergency centre immediately.
Some patients may have higher blood levels of Namuscla because of slower break down in the liver and the dose may need to be adjusted accordingly.
Namuscla 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.
Do not take Namuscla with certain medicines for treating 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 which have a so called narrow therapeutic window (these are medicines where small differences in dose or blood concentration may impact the effect of the medicine or side effects). Examples of such medicines are digoxin (for heart problems), lithium (mood stabiliser), phenytoin (for treating epilepsy), theophylline (against asthma) and warfarin (against blood clots).
Tell your doctor or pharmacist if you are taking any of the following since these medicines may affect or be affected by Namuscla:
Tell your doctor or pharmacist if you start to smoke or quit smoking while taking Namuscla because smoking impacts the Namuscla blood levels and your dose may need to be adjusted accordingly .
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you become pregnant while taking Namuscla, see your doctor immediately as it is preferable not to take Namuscla while you are pregnant. If you become pregnant while taking Namuscla, see your doctor immediately.
Mexiletine passes into human milk. You should talk to your doctor about this, together you will make a decision whether to abstain breast-feeding or to discontinue/abstain from mexiletine therapy.
Namuscla may in rare cases cause tiredness, confusion, blurred vision: If you have these effects do not drive, cycle and use machines.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended starting dose is 1 capsule per day. The doctor will increase the dose gradually depending on how well the medicine is working. The maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day.
Do not take more than 3 capsules a day.
Check of heart function
Before starting treatment with Namuscla and regularly during treatment, you will have tests to check how well your heart is working,. Depending on your heart function you may also need testing before and after any dose adjustment. See section “Warnings and precautions”. Your doctor will also regularly reassess your treatment to make sure Namuscla is still the best medicine for you.
Method of administration
Namuscla is for oral use.
Swallow the capsule with a glass of water, while standing or sitting up. You may take Namuscla during a meal to avoid belly pain (see section “Possible side effects”).
Contact your doctor if you take more than the recommended dose of Namuscla. This could be very harmful to your health. You or your companion should contact the doctor immediately if you have tingling in the arms and legs, if you feel unable to think clearly or concentrate, if you have hallucinations, convulsions, if you feel that your heart beats slower, if you feel dizzy and faint, if you collapse or if your heart stops beating.
If you have forgotten a dose, do not take a double dose and take the next dose at your regular schedule.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
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 your nearest emergency center immediately if you experience any of the following side effects:
Other side effects that may occur:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Very rare side effects (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
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.
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 carton and blister. The expiry date refers to the last day of that month.
Store below 30°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each hard capsule contains:
Namuscla hard capsules are reddish hard gelatin capsules filled with white powder.
Namuscla is available in blister packs containing 30, 50, 100 or 200 capsules.
Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in July 2021.
The Urban Building, 2nd Floor, 3-9 Albert Street, Slough, SL1 2BE
+44 (0)1565 751 378
+44 (0)1565 751 378 Option 1
+44 (0)1565 751 378
+44 (0)1565 751 378
www.lupinhealthcare.co.uk
+44 (0)1565 751 379
+44(0) 1565 751 379
