Product Details

What you need to know before you take Namuscla

Do not take Namuscla – if you are allergic to mexiletine or to any of the other ingredients of this medicine (listed in section 6) – if you are allergic to any local anaesthetic – if you have had heart attack – if your heart does not work well enough – if you have certain disorders of the heart rhythm – if your heart beats too fast – if the blood vessels of your heart are damaged – if you also take certain medicines to treat disorders of the heart rhythm (see Other medicines and Namuscla) – if you also take certain medicines which have a narrow therapeutic window (see Other medicines and Namuscla). If you have any doubt, ask your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist or nurse before taking Namuscla if you have: – heart problems Internal Doc Ref: v6.6 2 – liver problems – kidney problems – low or high potassium blood levels – low magnesium blood levels – epilepsy 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. Children and adolescents Namuscla should not be used in children and adolescents younger than 18 years old. Other medicines and Namuscla 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: • medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem), • certain other medicines: o timolol for treating high pressure in the eye (glaucoma), o certain antibiotics (ciprofloxacin, rifampicin), o certain antidepressants (fluvoxamine), o tizanidine (used to relax the muscles), o metformin (used against diabetes) o omeprazole (to treat stomach ulcer and gastric acid reflux). Smoking and 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. Internal Doc Ref: v6.6 3 Namuscla with drink 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. Pregnancy and breast-feeding 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. Driving and using machines Namuscla may in rare cases cause tiredness, confusion, blurred vision: If you have these effects do not drive, cycle and use machines.