Juneflecad 150 Mg Prolonged Release Capsules Hard
Out of date information, search anotherINFORMATION FOR THE USER
Juneflecad 50 mg, prolonged-release capsules, hard Juneflecad 100 mg, prolonged-release capsules, hard Juneflecad 150 mg, prolonged-release capsules, hard Juneflecad 200 mg, prolonged-release capsules, hard Flecainide acetate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Juneflecad prolonged-release capsules are and what they are used for
2. What you need to know before you take Juneflecad prolonged-release capsules
3. How to take Juneflecad prolonged-release capsules
4. Possible side effects
5. How to store Juneflecad prolonged-release capsules
6. Contents of the pack and other information
Flecainide belongs to a group of medicines that work against heart rhythm problems (known as anti-arrhythmics). Anti-arrhythmics work by controlling the rate and rhythm of the heart.
Juneflecad prolonged-release capsules are used
- for certain serious heart rhythm problems, which are often expressed as serious palpitations of the heart or fast heart beat (tachycardia).
- for serious heart rhythm problems that did not respond well to treatment with other medicines, or when other treatments cannot be tolerated.
Do not take Juneflecad prolonged-release capsules:
• 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 anti-arrhythmics (sodium channel blockers) if you suffer from Brugada syndrome (a genetic heart disease).
Warnings and precautions
Talk to your doctor or pharmacist before taking Juneflecad 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,
- are elderly, since the concentration of flecainide in the blood may increase,
- have a permanent pacemaker or temporary pacing electrodes,
- have suffered from heart rhythm problems after heart surgery,
- suffer from severe slow heart beat (bradycardia) or pronounced low blood pressure (hypotension). These conditions should be corrected before using Juneflecad prolonged-release capsules,
- have experienced a heart attack.
A low or high level of potassium in the blood may influence the effect of these capsules. Diuretics, medicines that stimulate bowel movement (laxatives) and steroids (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 Juneflecad prolonged-release capsules
If you take certain other medicines along with Juneflecad prolonged-release capsules, the medicines can sometimes affect the way each other works 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); these 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 increased by these substances;
- cimetidine (a medicine to treat stomach disorders); this may increase the effect of these capsules,
- amiodarone (a medicine for heart conditions); the dose of flecainide must be reduced for some patients,
- medicines against depression (paroxetine, fluoxetine and some other antidepressants),
- clozapine (a medicine used to treat schizophrenia),
- medicines against allergies (mizolastine, astemizole and terfenadine),
- medicines against malaria (quinine and halofantrine ),
- verapamil (a medicine which lowers the blood pressure),
- quinidine (an anti-arrhythmic),
- medicines to treat HIV (such as ritonavir, lopinavir and indinavir),
- water tablets (diuretics) such as thiazides and loop diuretics,
- disopyramide (an anti-arrhythmic); do not use Juneflecad prolonged-release capsules if you are also using disopyramide.
- terbinafine (a medicine used to treat fungal infections),
- bupropion (an anti-smoking drug).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Juneflecad prolonged-release capsules with food and drink
Juneflecad prolonged-release capsules should be taken on an empty stomach or at least one hour before a meal.
Pregnancy and breast-feeding
During pregnancy Juneflecad 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. 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 mother’s milk. Juneflecad 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 lightheaded, 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 Juneflecad prolonged-release capsules are having a negative effect on your ability to drive, discuss this with your doctor.
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 Juneflecad prolonged-release capsules will normally be started under medical supervision (if necessary, in the hospital). Follow your doctor’s advice closely when taking Juneflecad 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 usual starting dose is 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 300 mg 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 also taking cimetidine (medicine against stomach disorders) or amiodarone (medicine against heart rhythm problems)
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 Juneflecad prolonged-release capsules than you should
If you accidentally take too much, you must contact your nearest casualty department or alert a doctor immediately.
If you forget to take Juneflecad prolonged-release capsules
Take the dose when you remember, unless it is almost time to take your next dose. Do not take a double dose to make up for a forgotten capsule. It is important to take the capsules according to the schedule. Consult your doctor if you have any doubts.
If you stop taking Juneflecad prolonged-release capsules
If you suddenly stop taking Juneflecad prolonged-release capsules you will not get withdrawal symptoms. However, the heart rhythm problem will no longer be 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical help immediately if you have any of the following symptoms:
- Your heart beat changes; it starts to pound, or it gets faster or slower
- You have chest pain
- You become breathless or have other breathing or lung problems
- You faint or you feel faint
- You have ringing in your ears
- Your skin and eyes begin to go yellow (jaundice)
- You have a fever, become flushed or sweat
- You have fits (convulsions)
Other side effects that may occur include the following:
Very common (may affect more than 1 in 10 people):
- Dizziness
- Light-headedness
- Problems with vision, such as double vision, blurred vision and difficulties in focusing
Common (may affect up to 1 in 10 people):
- Shortness of breath
- Weakness
- Tiredness (fatigue)
- Build up of fluid in the tissues (oedema) and discomfort
Uncommon (may affect up to 1 in 100 people):
- Nausea
- Vomiting
- Constipation
- Abdominal pain
- Anorexia (eating disorder)
- Diarrhoea
- Dyspepsia (pain in upper abdomen, fullness)
- Flatulence
- Decrease in red blood cells (which may make the skin pale and cause weakness or breathlessness)
- Decrease in white blood cells (which makes you prone to infections)
- Decrease in platelets (which can make you bleed or bruise more easily than normal)
- Allergic skin reactions such as rash and hair loss
Rare (may affect up to 1 in 1,000 people):
- Lung inflammation (pneumonitis)
- Tingling of the skin ("pins and needles”)
- Coordination problems
- Difficulties in movement (tics)
- Decrease of sensitivity
- Increased sweating
- Tremor
- Spinning sensation (vertigo)
- Sleepiness
- Severe depression
- Anxiety
- Insomnia (difficulty in going to sleep)
- Headache
- Nervous disorders e.g. in the arms and legs
- Confusion
- Seeing, hearing or feeling things that are not there (hallucinations)
- Loss of memory
- Hives
- Increased liver enzymes (shown in blood tests)
Very rare (may affect up to 1 in 10,000 people):
- High levels of certain antibodies (shown in blood tests)
- Corneal deposits
- Sensitivity to light
Not known (frequency cannot be estimated from the available data):
- Certain changes in the ECG (increase in PR and QRS intervals)
- Increase in pacing threshold in patients with pacemakers or temporary pacing electrodes
- Impairment of conduction between the upper (atria) and lower (ventricles) chambers of the heart (second or third degree atrioventricular block)
- Stopped heart beat
- Feeling your heart beat (palpitations)
- A pause in the normal heart rhythm (sinus arrest)
- Appearance of a certain pre-existing heart disease (Brugada syndrome) which was not seen before treatment with these capsules
- Scarring of the lungs or lung diseases (pulmonary fibrosis and interstitial lung disease)
- Liver dysfunction
Reporting of side effects
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 the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). 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 store above 30OC.
Do not use this medicine after 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.
What Juneflecad prolonged-release capsules contains
The active substance is flecainide acetate.
- Juneflecad 50 mg prolonged-release capsules: Each capsule contains 50 mg flecainide acetate
- Juneflecad 100 mg prolonged-release capsules: Each capsule contains 100 mg flecainide acetate
- Juneflecad 150 mg prolonged-release capsules: Each capsule contains 150 mg flecainide acetate
- Juneflecad 200 mg prolonged-release capsules: Each capsule contains 200 mg flecainide acetate
The other ingredients are:
povidone, cellulose microcrystalline, crospovidone, colloidal 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 Juneflecad prolonged-release capsules looks like and contents of the pack
Juneflecad 50 mg prolonged-release capsules are gelatine opaque capsules with white body and white cap containing white or almost white round micro-tablets.
Juneflecad 100 mg prolonged-release capsules are gelatine opaque capsules with grey body and white cap containing white or almost white round micro-tablets.
Juneflecad 150 mg prolonged-release capsules are gelatine opaque capsules with grey body and grey cap containing white or almost white round micro-tablets.
Juneflecad 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
Marketing authorisation holder:
DB Ashbourne Limited The Rectory, Braybrooke Road Arthingworth, Market Harborough LE16 8JT, United Kingdom Telephone: (01858) 525643 Fax: (01858) 525383 Email: enquiries@medinformation.co.uk
Manufacturer:
Laboratorios Liconsa, S.A.
Gran Via Carlos III 98 7° 08028 Barcelona Spain
This leaflet was last revised in December 2014
Juneflecad 50 mg, 100 mg, 150 mg, 200 mg prolonged-release capsules, PIL - UK Dimensions: 140mm x 540mm - folded - Drawing #231 - Proof Date: 18/12/14