Juneflecad 100 Mg Prolonged Release Capsules Hard
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Juneflecad 50 mg, prolonged-release capsule, hard Juneflecad 100 mg, prolonged-release capsule, hard Juneflecad 150 mg, prolonged-release capsule,hard Juneflecad 200 mg, prolonged-release capsule, hard
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Juneflecad, prolonged-release capsule is and what it is used for
2. Before you take Juneflecad, prolonged-release capsule
3. How to take Juneflecad prolonged-release capsule
4. Possible side-effects
5. How to store Juneflecad, prolonged-release capsule
6. Contents of the pack and other information
1. What Juneflecad, prolonged-release capsule is and what it is used for
Flecainide prolonged-release capsules belongs to the group of medicines that work against cardiac arrhythmia (known as anti-arrhythmics). It inhibits stimulus conduction in the heart and extends the time during which the heart is at rest, causing the heart to pump normally again.
Flecainide prolonged-release capsules is used
-for certain serious cardiac arrhythmias, which are often expressed as serious palpitations of the heart or tachycardia.
-for serious cardiac arrhythmias that did not respond well to treatment with other medicines, or when other treatments cannot be tolerated.
2. What you need to know before you take Juneflecad 50 mg, prolonged-release capsule
Do not useJuneflecad, prolonged-release capsule:
if you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6) if you suffer from another heart condition, different from the heart condition for which you are taking this medicine. If you are unsure, or if you would like additional information, consult your doctor or pharmacist if you are taking certain other antiarrhythmics (sodium channel blockers) if you suffer from Brugada syndrome (a genetic cardiac disease).
Warnings and precautions
Talk to your doctor or pharmacist before using Flecainide prolonged-release capsules.
- if you suffer from a reduced liver function and/or reduced kidney function, since the concentration of flecainide in the blood may increase. In that event, your doctor may regularly have the concentration of flecainide in the blood checked,
- if you are elderly, since the concentration of flecainide in the blood may increase,
- if you have a permanent pacemaker or temporary pacing electrodes,
- if you have suffered from cardiac arrhythmias after heart surgery,
- if you suffer from severe bradycardia or pronounced hypotension. These conditions should be corrected before using Flecainide prolonged-release capsules,
- if you have experienced a heart attack.
A lowered or elevated level of potassium in the blood may influence the effect of Flecainide prolonged-release capsules. Diuretics, medicines that stimulate bowel movement (laxatives) and adrenal cortex hormones (corticosteroids) may lower the level of potassium in the blood. In that event, your doctor may have the amount of potassium in your blood checked.
Other medicines and Flecainide prolonged-release capsules
If you use certain other medicines along with Flecainide prolonged-release capsules, the medicines can sometimes affect the way each other work and/or their side effects (i.e. there may be interactions).
Interactions may occur when using this medicine with for example:
-digoxin (a medicine to stimulate the heart); Flecainide prolonged-release capsules may raise the level of digoxin in your blood,
-medicines that reduce the heart’s pumping function, such as those known as beta blockers,
-certain medicines against epilepsy (e.g. phenytoin, phenobarbital and carbamazepine): the breakdown of flecainide may be accelerated by these substances;
-cimetidine (an antacid); this may increase the effect of Flecainide prolonged-release capsules,
-amiodarone (for heart conditions); the dose of flecainide must be reduced for some patients,
-medicines against depression (paroxetine, fluoxetine and some other antidepressants),
-clozapine (medicine used to treat schizophrenia),
-mizolastine, astemizole and terfenadine (medicines against allergies),
-quinine and halofantrine (medicines against malaria),
-verapamil (lowers the blood pressure),
- quinidine,
- medicines to treat HIV -infections (ritonavir, lopinavar and indinavir),
-thiazides and loop diuretics,
-disopyramide (an anti-arrhythmic); do not use Flecainide prolonged-release capsules if you are also using disopyramide.
-terbinafine (to treat fungal infections),
-bupropion (anti-smoking drug).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Flecainide prolonged-release capsules with food and drink
Flecainide prolonged-release capsules should be taken on an empty stomach or at least one hour before a meal.
Pregnancy and breast-feeding
During pregnancy Flecainide prolonged-release capsules should only be used if the benefit outweighs the risks since flecainide has been shown to cross the placenta in patients taking flecainide during pregnancy. If Flecainide prolonged-release capsules is used during pregnancy maternal flecainide plasma levels should be monitored. You must consult your doctor as soon as you suspect you are pregnant, or if you want to have children.
Flecainide is secreted in the mothers milk. Flecainide prolonged-release capsules should only be used during breast-feeding if the benefit outweighs the risks.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
If you suffer from side effects such as dizziness, double vision or blurred vision, or if you feel light in the head, then your ability to react may have been reduced. This may be dangerous in situations that demand concentration and attentiveness, such as using the road, handling dangerous machinery or working at heights. If you are unsure whether Flecainide prolonged-release capsules is having a negative effect on your ability to drive, discuss this with your doctor.
3. How to takeJuneflecad prolonged-release capsule Posology
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will prescribe a personalised dose, adjusted to fit your complaints. Treatment with Flecainide prolonged-release capsules will normally be started under medical supervision (if necessary, in the hospital). Follow your doctor’s advice closely when taking Flecainide prolonged-release capsules. Check with your doctor or pharmacist if you are not sure.
When and how should the capsules be taken?
Take the capsules by swallowing them with sufficient fluid (e.g. water). The daily dose is usually taken split up over the day, on an empty stomach, or at least one hour before meals.
The general dose is just a guideline and is as follows:
the usual starting dose lies between 100 and 200 mg. The dose may be increased by your doctor to a maximum of 400 mg a day.
More elderly patients
Your doctor may prescribe a lower dose for you. The dose for elderly patients should not exceed 300mg daily Children
These capsules should not be taken by children under the age of 12 years.
Patients with a reduced kidney or liver function Your doctor may prescribe a lower dose for you.
Patients with a permanent pacemaker The daily dose must not exceed 200 mg daily.
Patients who are simultaneously being treated with cimetidine (medicine against gastric disorders) or amiodarone (medicine against cardiac arrhythmia)
The doctor will check you regularly, and a lower dose will be prescribed for some patients.
During treatment, your doctor will regularly determine the level of flecainide in the blood and what is known as an electrocardiogram (ECG) of the heart will be taken. A simple ECG must be taken once a month and a more
extensive ECG once every three months. An ECG will be taken every 2 to 4 days at the start of the treatment and when the dose is raised.
An ECG must be taken more frequently for patients who are receiving a smaller dose than is usually prescribed. The doctor can adjust the doses at intervals of 6 to 8 days. An ECG will be taken for these patients at weeks 2 and 3 after the start of the treatment.
If you take more Flecainide prolonged-release capsules than you should
If you suspect an overdose, you must alert a doctor immediately.
If you forget to take Flecainide prolonged-release capsules
Take the dose when you discover that you have forgotten to take it, unless you only discover this when it is almost time to take your next dose. In the latter case, you must not take the dose that you forgot as an addition but should continue to follow your schedule. It is important to take the capsules according to the schedule. Consult your doctor if you have any doubts.
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Flecainide prolonged-release capsules
If you suddenly stop taking Flecainide prolonged-release capsules you will not get withdrawal symptoms. However, the cardiac arrhythmia will no longer be being controlled as intended. So never stop using it without your doctor knowing.
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.
Like other anti-arrhythmics flecainide can have the effect of inducing arrhythmia. The existing arrhythmia may worsen or a new arrhythmia may occur. The risk of pro-arrhythmic effects is most likely in patients with a structural heart disease and / or significant impairment of the heart function.
Concerning the heart, the most commonly occurring adverse effects are decrease or increase of the heart rate (bradycardia, tachycardia), palpitations, cardiac arrest, cardiac failure, chest pain, heart attack and lowering of blood pressure (hypotension).
Other side effects that may occur include the following:
very commonly (in more than 1 in 10 patients):
dizziness, light-headedness, problems with vision, such as double vision, blurred vision and difficulties to focus
commonly (in more than 1 in 100 patients, but in fewer than 1 in 10):
shortness of breath, weakness, tiredness (fatigue), fever, built up of fluid in the tissue (oedema) and discomfort
uncommonly (in more than 1 in 1000 patients, but in fewer than 1 in 100):
nausea, vomiting, constipation, abdominal pain, anorexia, diarrhoea, dyspepsia (pain in upper abdomen, fullness), flatulence, decrease in red and white blood cells and platelets, allergic skin reactions such as rash and hair loss
rarely (in more than 1 in 10,000 patients, but in fewer than 1 in 1000):
lung inflammation (pneumonia), tingling of the skin (“as if ants are walking over it”), coordination problems, difficulties in movement (tics), decrease of sensitivity, increased sweating, temporary loss of consciousness, ringing in the ears, tremor, spinning sensation (vertigo), flushing, sleepiness, severe depression, anxiety, insomnia, headache, nervous disorders e.g. in the arms and legs, convulsions, confusion, seeing things that are not there (hallucinations), amnesia, hives, elevated liver enzymes with or without jaundice (yellow eyes or skin)
very rarely (in fewer than 1 in 10,000 patients):
elevated levels of certain antibodies, corneal deposits, sensitivity to light
frequency not known (cannot be estimated from the available data):
certain changes in the electrocardiogram (increase in PR and QRS intervals), increase in pacing threshold in patients with pacemakers or temporary pacing electrodes, impairment of the conduction between the atria and ventricles of the heart (second or third degree atrioventricular block), stopped heart beat, slower or faster heart beat, loss of the heart’s ability to pump enough blood to the body's tissues, chest pain, low blood pressure, heart attack, feeling your heart beat, a pause in the normal cardiac rhythm (sinus arrest), appearance of a certain pre-existing heart disease (Brugada syndrome) which was not seen before the treatment with Flecainide prolonged-release capsules, scarring of the lungs or lung diseases (pulmonary fibrosis and interstitial lung disease), hepatic dysfunction
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to storeJuneflecad, prolonged-release capsule
Keep out of the sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this medicineafter the expiry date stated on the. package after “Do not use after” or “Exp”. The expiry date refers to the last day of that month. Consult your pharmacist about the shelf life if you have any doubts.
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.
6. Contents of the pack and other information
What Flecainide prolonged-release capsules contains
The active substance is flecainide acetate.
- Flecainide 50 mg prolonged-release capsules: Each capsule contains 50 mg flecainide acetate
- Flecainide 100 mg prolonged-release capsules: Each capsule contains 100 mg flecainide acetate
- Flecainide 150 mg prolonged-release capsules: Each capsule contains 150 mg flecainde acetate
- Flecainide 200 mg prolonged-release capsules: Each capsule contains 200 mg flecainde acetate
-The other ingredients are; povidone,
cellulose microcrystalline, crospovidone, collodial silicon dioxide, magnesium stearate,
methacrylic acid-methyl methacrylate (1:2) copolymer,
polyethylene glycol,
talc.
- The capsule shells of the various capsules contain the following ingredients:
50 mg: gelatin, titanium dioxide.
100 mg: gelatin, titanium dioxide, black iron oxide.
150 mg: gelatin, titanium dioxide, black iron oxide.
200 mg: gelatin, titanium dioxide, black iron oxide and red iron oxide.
What Flecainide prolonged-release capsules looks like and contents of the pack
Flecainide 50 mg prolonged-release capsules are gelatine opaque capsules with white body and white cap containing white or almost white round micro-tablets.
Flecainide 100 mg prolonged-release capsules are gelatine opaque capsules with grey body and white cap containing white or almost white round micro-tablets.
Flecainide 150 mg prolonged-release capsules are gelatine opaque capsules with grey body and grey cap containing white or almost white round micro-tablets.
Flecainide 200 mg prolonged-release capsules are gelatine opaque capsules with grey body and pink cap containing white or almost white round micro-tablets.
Pack sizes:
Blister: 28, 30, 60 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratorios Liconsa, S.A.
Gran Via Carlos III, 98 7°
08028 Barcelona Spain
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands
Belgium
Germany
Grecee
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard
Flecainide Sandoz 50 mg prolonged-release capsule, hard Flecainide Sandoz 100 mg prolonged-release capsule, hard Flecainide Sandoz 150 mg prolonged-release capsule, hard Flecainide Sandoz 200 mg prolonged-release capsule, hard
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard
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Italy |
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard |
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Portugal |
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard |
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Rumania |
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard |
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United Kingdom |
Juneflecad 50 mg prolonged-release capsule, hard Juneflecad 100 mg prolonged-release capsule, hard Juneflecad 150 mg prolonged-release capsule, hard Juneflecad 200 mg prolonged-release capsule, hard |
This leaflet was last revised in June 2013
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