Patient leaflet - Rythmodan Retard 250 mg tablets
1. WHAT RYTHMODAN RETARD IS AND WHAT IT IS USED FOR
The name of your medicine is Rythmodan Retard 250mg Tablets (called Rythmodan Retard in this leaflet).
Rythmodan Retard contains a medicine called disopyramide. This belongs to a group of medicines called antiarrhythmic agents.
It works by controlling the uneven beating of your heart and returns it to the normal rhythm.
It is used for controlling your heartbeat in the following situations:
- Arrhythmias – where your heartbeats are uneven, or unusually fast or slow
- To keep your heart beating at a normal rhythm
- To stop unusual heartbeats (arrhythmias) happening after a heart attack
- To stop unusual heartbeats (arrhythmias) during an operation
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RYTHMODAN RETARD
Do not take Rythmodan Retard:
if you are allergic to disopyramide or any of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
if you have any other heart problems – apart from unusual heartbeats (arrhythmias).
- if you are taking other medicines to control your heart rhythm (see section below ‘Other medicines and Rythmodan Retard’).
- if you are taking other medicines which could cause unusual heartbeats (see section below ‘Other medicines and Rythmodan Retard’).
- if you have any kidney or liver problems.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rythmodan Retard.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rythmodan Retard:
- if you have low levels of potassium in your blood (called hypokalaemia).
- if you have low blood sugar levels. This can happen if you have diabetes, a low body weight, a poor diet or if you are elderly.
if you have glaucoma (an eye condition often caused by an abnormally high pressure in the eye) or if you or someone in your family have ever had glaucoma. Your doctor may perform an eye pressure test before
prescribing Rythmodan Retard.
- if you have an enlarged prostate.
- if you have a disease which causes muscle weakness (myasthenia gravis).
- if you are elderly and have problems with your memory or attention span, or sometimes have difficulty thinking clearly.
- if you have constipation or take any medication that causes constipation.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rythmodan Retard.
Other medicines and Rythmodan Retard
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rythmodan Retard can affect the way some other medicines work.
Also, some medicines can affect the way Rythmodan Retard works.
In particular, do not take this medicine, and tell your doctor:
If you are taking any of the following medicines for uneven heartbeats (arrhythmias):
- Beta-blockers such as propranolol, oxprenolol or acebutolol
- Verapamil – used for chest pain or high blood pressure
- Digoxin – also used for heart problems
If you are taking any of the following medicines that can increase the risk of unusual heartbeats (arrhythmias) when taken at the same time as Rythmodan Retard:
- Medicines for depression such as amitriptyline, imipramine or maprotiline
- Medicines for male sexual problems such as sildenafil, tadalafil or vardenafil
- Antibiotics such as erythromycin, clarithromycin, azithromycin or sparfloxacin
- Antihistamines such as astemizole or terfenadine
- Cisapride – used for heartburn
- Pentamidine – used for pneumonia
- Pimozide and thioridazine – used for schizophrenia
The following medicines may affect the way Rythmodan Retard works:
- Amphotericin B – used for fungal infections
- Tetracosactide – used to test some hormone problems
- Rifampicin – used for infections
- Atropine – used in eye drops and in cough and cold medicines
- Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or incontinence
- Medicines used to calm emotional or mental problems or stop you feeling sick or being sick such as chlorpromazine or prochlorperazine
- Water tablets (diuretics) such as furosemide
- Corticosteroids such as hydrocortisone, betamethasone or prednisolone
- Laxatives such as bisacodyl or senna
- Medicines for epilepsy such as phenobarbital, primidone or phenytoin
Rythmodan Retard may affect the way the following medicines work:
- Medicines for HIV infections such as ritonavir, indinavir, or saquinavir
- Theophylline – used for wheezing or difficulty in breathing
- Ciclosporin – used to help prevent rejection of transplants
- Warfarin – used to thin the blood
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine. This is because small amounts of this medicine may pass into the mothers’ milk.
Driving and using machines
Rythmodan Retard may affect your ability to concentrate and react quickly. You may have blurred vision or become dizzy or light-headed. If this happens, do not drive or use any tools or machines.
Rythmodan Retard contains sucrose and glucose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE RYTHMODAN RETARD
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take this medicine by mouth.
- Swallow the tablets with a drink of water.
- Do not break, crush or chew your tablets.
- If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
Adults
The usual starting dose is one to one and a half tablets (250 mg to 375 mg) twice a day.
Elderly
Your doctor may lower your dose if you have any kidney or liver problems.
Children
Rythmodan Retard is not suitable for use in children.
Blood tests
Your doctor may ask you to have regular blood tests to check your blood sugar levels.
If you take more Rythmodan Retard than you should
If you take more tablets than you should, talk to a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: dizziness, feeling tired, uneven heartbeat (palpitations), dry mouth, difficulty in passing water (urinating), feeling or being sick, stomach pain or fits (seizures).
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If you forget to take Rythmodan Retard
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Rythmodan Retard
Keep taking Rythmodan Retard until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Not known (frequency cannot be estimated from available data)
- If you have an allergic reaction. The signs may include: a skin rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Other side effects:
Tell your doctor as soon as possible if you have any of the following side effects:
Not known (frequency cannot be estimated from available data)
- Feeling faint, dizzy or light-headed
- Palpitations or an uneven, fast or slow heartbeat that you have not had before or that gets worse.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:
Rare (may affect up to 1 in 1,000 patients)
- Low blood sugar levels (hypoglycaemia). Signs include sweating, paleness, headache, feeling faint or drowsy.
Very rare (may affect up to 1 in 10,000 patients)
- Yellowing of your skin or eyes (jaundice)
- You get more infections than usual. This could be caused by a lowering in the number of white blood cells (called neutropenia).
- Rashes
- Headache
Not known (frequency cannot be estimated from the available data)
- A lack of white blood cells called agranulocytosis, which may cause sudden high fever, severe sore throat and mouth ulcers.
- Feeling sick (nausea) or being sick (vomiting), dry mouth, indigestion, diarrhoea, constipation, stomach pain, loss of appetite
- Difficulty in passing urine, especially in men with prostate problems.
- Difficulty in getting or maintaining an erection, or in ejaculating (impotence).
- Mood changes or mental problems
- Increased eye pressure in patients with glaucoma
- Blurred or double vision
- Worsening of myasthenia gravis (a disease which causes muscle weakness)
- Problems with memory or attention span, difficulty thinking clearly
- In certain situations, the bowel may become blocked, especially in the elderly, when Disopyramide Tablets are taken with other medicines that may cause constipation or when blood levels of disopyramide are raised due to kidney or liver problems.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:
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.
5. HOW TO STORE RYTHMODAN RETARD
- Keep out of the sight and reach of children.
- Do not store above 25oC. Protect from light.
- Do not use Rythmodan Retard after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
- Do not use Rythmodan Retard if you notice your tablets are crumbling, broken or discoloured.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Rythmodan Retard contains
Each tablet contains 250mg of the active ingredient disopyramide as disopyramide phosphate in a modified release formulation.
The other ingredients are glyceryl stearate, anhydrous glucose, povidone, magnesium stearate, hypromellose, propylene glycol and sucrose.
What Rythmodan Retard looks like and contents of the pack
Rythmodan Retard are white, round, biconvex tablets. One side has a break-line and is embossed '013' and ‘E’; the other side is embossed with the Roussel logo.
Rythmodan Retard are available in blister packs of 40 and 60 tablets.
Manufacturer and product licence holder
Manufactured by
- Opella Healthcare International SAS, 56 Route de Choisy, 60200 Compiegne, France.
- Erfa NV, Landbouwersstraat 25, B-1040, Brussel, Belgium.
Procured from within the EU and repackaged by the product licence holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlesex HA3 0HD.
Leaflet revision and issue date (Ref.) 30.01.25[21]
Rythmodan is a trademark of Cheplapharm Arzneimittel GmbH.
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