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Package leaflet: Information for the user

ENFED XL 30 mg Prolonged-release Tablets {Nifedipine}

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your 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 this medicine is and what it is used for.

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

ENFED XL 30 mg Prolonged-release Tablet contains Nifedipine, which belongs to a group of medicines called calcium antagonists.

ENFED XL 30 mg Prolonged-release Tablet is used to treat high blood pressure or angina (chest pain).

For high blood pressure: ENFED XL 30 mg Prolonged-release Tablet works by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.

For angina: ENFED XL 30 mg Prolonged-release Tablet works by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart. Your doctor might prescribe you this medicine alone or in combination with another medicine called as beta blocker medicines.

Do not take this medicine:

•    If you have had a heart attack within the last month.

•    If you get a sudden angina attack. ENFED XL 30 mg Prolonged-release Tablet will not help relieve symptoms of angina quickly.

•    If you have unstable angina.

•    If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients or to any of the other ingredients of this medicine (listed in section 6).

•    If you are pregnant (at least during first 3 months of pregnancy).

•    If you are breastfeeding. If you need to take ENFED XL 30 mg Prolonged-release Tablet, you should stop breastfeeding before you start to take this medicine.

•    If you are taking rifampicin, an antibiotic.

•    If you have ever had an obstruction in the gullet (the oesophagus - the tube connecting the throat to the stomach).

•    If you have been told that you have a narrowing of the aortic heart valve (stenosis).

•    If you have ever had a collapse caused by a heart problem (cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.

•    If you have a “Kock pouch” (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut.

^ Tell your doctor and do not take ENFED XL 30 mg Prolonged-release Tablet if any of theseapply to you.

Take special care with this medicine:

•    If you have low blood pressure and you were prescribed ENFED XL 30 mg Prolonged-release Tablet for your angina. Your blood pressure may be decreased further by this treatment.

•    If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).

•    If you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.

•    If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take ENFED Xl 30 mg Prolonged-release Tablet.

•    If you have a liver disease that prevents your liver from working properly.

•    If you are taking beta-blocking medicines and other drugs that reduce the high blood pressure, you might experience sudden drop in blood pressure on changing the posture or standing up (postural hypotension).

•    If your blood pressure continues to rise despite treatment (malignant hypertension).

•    If you have an obstruction or narrowing in your intestines, or have had this in the past.

•    Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine.

•    If you are pregnant and receiving nifedipine with a medicine called magnesium sulphate, this might result in excessive drop in your blood pressure which will be harmful to you as well as your baby.

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•    Nifedipine is not recommended for use during breast-feeding.

^ Talk to your doctor before you take ENFED XL 30 mg Prolonged-release Tablet if any of these apply to you.

Tell your doctor:

•    If your chest pain (angina) gets worse (comes on more often or more severely) over a matter of hours or days. You may be advised not to take ENFED XL 30 mg Prolonged-release Tablet

•    If you have chest pains after taking your first dose of ENFED XL 30 mg Prolonged-release Tablet. Your doctor may wish to change your treatment.

•    If you notice increased breathlessness.

•    If you notice swelling of the ankles.

^ Tell your doctor before you take the next dose if any of these apply to you.

Also tell your doctor:

•    If you are giving a urine sample. ENFED XL 30 mg Prolonged-release Tablet may interfere with the results of certain urine tests.

•    If you are to have a barium contrast x-ray (barium meal). These tablets may affect the results of the test.

•    If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like ENFED XL 30 mg Prolonged-release Tablet have been shown to impair sperm function.

Children and adolescents:

ENFED XL 30 mg Prolonged-release Tablet should not be given in children as the safety and efficacy of ENFED XL 30 mg Prolonged-release Tablet in children below 18 years has not been established.

Other medicines and ENFED XL 30 mg Prolonged-release Tablet:

Tell your doctor or pharmacist about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.

Some medicines may affect the way ENFED XL 30 mg Prolonged-release Tablet works. Tell your doctor if you are taking:

•    Other medicines to treat high blood pressure.

•    Rifampicin (an antibiotic).

•    Cimetidine (to treat stomach ulcers).

•    Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).

•    Quinupristin/dalfopristin (a combination antibiotic).

•    Phenytoin, carbamazepine or valproic acid (to treat epilepsy).

•    Cisapride (to treat reduced movements of the gullet and stomach).

•    Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).

•    Erythromycin (an antibiotic).

•    Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).

•    Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).

•    Fluoxetine or nefazodone (to treat depression).

•    Tacrolimus (to prevent the rejection of transplanted organs).

•    Phenobarbital (usually used to treat insomnia or anxiety).

•    St John's Wort (used to treat depression).

ENFED XL 30 mg Prolonged-release Tablet with Food and drink:

You can take ENFED XL 30 mg Prolonged-release Tablet with or without food.

Do not drink grapefruit juice or eat grapefruit while taking ENFED XL 30 mg Prolonged-release Tablet.

Do not start taking ENFED XL 30 mg Prolonged-release Tablet within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking ENFED XL 30 mg Prolonged-release Tablet. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

Pregnancy and breast-feeding:

If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking ENFED XL 30 mg Prolonged-release Tablet. You may be able to use ENFED XL 30 mg Prolonged-release Tablet during pregnancy, but only after special consideration and agreement by your doctor.

Do not take ENFED XL 30 mg Prolonged-release Tablet if you are breastfeeding. If you need to take ENFED XL 30 mg Prolonged-release Tablet, you should stop breastfeeding before you start taking the tablets.

Driving and using machines:

ENFED XL 30 mg Prolonged-release Tablet may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.

This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.

Take the tablets as prescribed by your doctor.

ENFED XL 30 mg Prolonged-release Tablet is specially formulated so that you only have to take one dose each day.

•    Dose for high blood pressure: the usual dose is 1 tablet, once a day.

•    Dose for angina: the dose depends on your individual requirements. Your doctor will decide how much you should take.

•    Swallow the tablets whole. Do not bite, chew or break them - if you do they will j not work properly. If you have difficulty swallowing tablets, consult your doctor as

he or she may wish to change your medicine.    p -

• Continue to take these tablets for as long as your doctor has told you to.

Take your dose at the same time each day, preferably in the morning.

Take your tablets with a glass of water. Do not take them with grapefruit juice.

You can take ENFED XL 30 mg Prolonged-release Tablet with or without food.

You may see what looks like a complete tablet in the toilet or in your stools. This is normal - it's the outer shell of the tablet which is not digested by the body.

Use in children and adolescents:

ENFED XL 30 mg Prolonged-release Tablet is not recommended for use in children.

If you take too many tablets

^ Get medical help immediately. If possible, take your tablets or the box with you to show the doctor.

Taking too many tablets may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.

If you forget to take the tablets:

Take your normal dose immediately and continue taking your tablets at the usual time of day, waiting at least 12 hours before taking the next dose.

Do not take a double dose to make up for the missed dose.

If you have any further questions on the use of ENFED XL 30 mg Prolonged-release Tablet, ask your doctor or pharmacist.

Like all medicines, ENFED XL 30 mg Prolonged-release Tablet can cause side effects, although not everybody gets them.

Serious side effects:

If you notice:

•    Severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (including potentially life-threatening swelling of the airway)

•    other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life-threatening outcome)

•    fast heart beat (tachycardia)

•    shortness of breath or difficulty breathing

•    mild to moderate allergic reactions

•    itching (possibly severe), a rash or hives

^ Contact your doctor immediately and do not take the next dose as these may be the first signs of allergic reaction which may become severe.

If you develop:

•    a skin reaction or blistering / peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis)

^ Contact your doctor immediately before you continue treatment as these may be signs of a severe reaction.

Less serious side effects:

Apart from the side effects listed above, these are the other side effects of ENFED XL 30 mg Prolonged-release Tablet, starting with the more common ones:

Common side effects

(These may affect up to 1 in 10 people)

•    headache

•    flushing

•    general feeling of being unwell

•    constipation

•    swelling, particularly of the ankles and legs Uncommon side effects

(These may affect up to 1 in 100 people)

•    stomach pain (abdominal pain)

•    unspecific pain

•    chills

•    low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)

•    fainting

•    irregular heartbeat (palpitations)

•    dry mouth

•    indigestion or upset stomach

•    wind (flatulence)

•    feeling sick (nausea)

•    muscle cramps

•    joint swelling

•    sleep disorders

•    anxiety or nervousness

•    reddening of the skin

•    nose bleeds

•    nasal congestion

•    sensation of spinning or whirling motion (vertigo)

•    migraine

•    dizziness

•    trembling

•    increase in the need to pass water (urinate)

•    painful or difficult urination    Page 3

•    inability to achieve or maintain an erection (impotence)

•    blurred vision

•    temporary increase in certain liver enzymes Rare side effects

(These may affect up to 1 in 1,000 people)

•    pins and needles

•    inflammation of the gums, tender or swollen gums, bleeding gums Other side effects (Frequency unknown)

•    stomach pain or distress caused by a mass of foreign material found in the stomach which may require surgery for removal

•    difficulty swallowing

•    abdominal pain caused by obstruction of the gut or ulcers in the gut

•    vomiting

•    a reduction in the number of white blood cells (leucopenia)

•    a more severe decrease in a specific class of white blood cell (agranulocytosis)

•    increased blood sugar (hyperglycaemia)

•    decreased skin sensitivity (hypoaesthesia)

•    drowsiness (somnolence)

•    eye pain

•    chest pain (angina pectoris)

•    heartburn or indigestion (gastroesophageal sphincter insufficiency)

•    yellowing of the whites of the eyes or skin (jaundice)

•    sensitivity to light (photosensitivity allergic reaction)

•    small, raised areas of bleeding in the skin (palpable purpura)

•    joint pain

•    muscle pain

All of these symptoms usually go away when treatment with ENFED XL 30 mg Prolonged-release Tablet is stopped.

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 the national reporting system Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store this medicine

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is marked on both the outer carton and on each blister of tablets.

This medicinal product does not require any special storage conditions.

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 this medicine contains

Each prolonged release tablet contains 30 mg of Nifedipine.

ENFED XL 30 mg Prolonged-release Tablets also contain: Polyethylene Oxide, hydroxy-propyl methylcellulose (E464), sodium chloride, magnesium stearate, iron oxide (E172), cellulose acetate, polyethylene glycol, hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), iron oxide red (E172).

What this medicine looks like and contents of the pack

Each tablet is Pink Coloured, film coated circular biconvex tablet, having orifice on one side and plain on other side.

This medicine is available in the following pack sizes

Blister pack with an outer carton 28's, 30's, 90's, and 98's Not all pack sizes may be marketed Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW,

United Kingdom

Manufacturer

Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta Cipla (EU) Limited, 4^th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom Focus Farma B.V., Lagedijk 1-3, Koog Aan De Zaan, 1541 KA, Netherlands.

This medicinal product is authorised in the Member States of the EEA under the following names:

DE    Nifedipin Cipla 30 mg, Retardtabletten

DK    Nifedipin Sandoz

ES    Nifedipino Cipla 30 mg comprimidos de liberacion prolongada

NL    Nifedipine Cipla 30 mg, tabletten met verlengde afgifte    _x

NO    Nifedoz

PT    Nifedipina Cipla

SE    Nifedipin Cipla 30 mg depottabletter

UK    ENFED XL 30 mg Prolonged-release Tablets

This leaflet was last revised in 05/2015.    Page 4