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Adalat Retard 20mg

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Document: label-and-leafletMAH BRAND_PLPI 33902-0356 change

ASSESSED AGAINST UK PIL DATED MAY 2015

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S0356-60-SP-PIL-07.09.2015

Package leaflet - information for the user

Adalat® retard 20mg modified-release tablets

Nifedipine

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

The name of your medicine is Adalat retard 20mg modified-release tablets but will be referred to as Adalat retard throughout the remainder of this leaflet.

This product is also available in lower strength: 10mg.

   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 Adalat retard is and what it is used for

2.    What you need to know before you take Adalat retard

3.    How to take Adalat retard

4.    Possible side effects

5.    How to store Adalat retard

6.    Contents of the pack and other information

1.    WHAT ADALAT RETARD IS AND WHAT IT IS USED FOR

Adalat retard contains nifedipine, which belongs to a group of medicines called calcium antagonists.

Adalat retard is used to treat high blood pressure or angina (chest pain).

For high blood pressure: Adalat retard 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: Adalat retard 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.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT RETARD

Do not take Adalat retard:

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

   If you get a sudden angina attack. Adalat retard will not help relieve symptoms of angina quickly.

•    If you have unstable angina.

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

   If you are taking rifampicin, an antibiotic.

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

   If you have been told to avoid lactose, that you have a hereditary condition called Lapp lactase deficiency or glucose-galactose malabsorption.

Tell your doctor and do not take Adalat retard if any of these apply to you.

Warnings and precautions

Talk to your doctor before taking Adalat retard

   If you have low blood pressure and you were prescribed Adalat retard 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 pregnant.

   If you are breast-feeding. If you need to take Adalat retard, you should stop breast-feeding before you start to take this medicine.

   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 Adalat retard.

   If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Adalat retard.

•    Talk to your doctor before you take Adalat retard 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 Adalat retard.

•    If you have chest pains after taking your first dose of Adalat retard. 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. Adalat retard may interfere with the results of certain urine tests.

•    If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Adalat retard have been shown to impair sperm function.

Other medicines and Adalat retard

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way Adalat retard 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 (antifungal 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).

Adalat retard with food and drink

You can take Adalat retard either with or without food.

Do not drink grapefruit juice or eat grapefruit while taking Adalat retard.

Do not start taking Adalat retard 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 Adalat retard. 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 may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You may be able to use Adalat retard but only after special consideration and agreement by your doctor.

Do not take Adalat retard if you are breast-feeding.

If you need to take Adalat retard, you should stop breast-feeding before you start taking this medicine.

Driving and using machines

Adalat retard 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.

Adalat retard contains lactose monohydrate

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 ADALAT RETARD

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

•    To start with, you may be given a lower strength (10 mg) tablet called Adalat retard 10 mg. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.

   The usual maintenance dose of Adalat retard (20 mg strength) is 1 tablet, every 12 hours (i.e. twice per day), but your doctor may increase or decrease the dose depending on how well your blood pressure or angina is being controlled. The maximum dose is 2 tablets (40 mg) every 12 hours.

   Lower doses may be prescribed for older people.

   If you have problems with your liver you are likely to be given Adalat retard 10 mg, at least to begin with.

•    Swallow the tablets whole with a little water.

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

Do not take them with grapefruit juice.

You can take Adalat retard either with or without food.

Use in children and adolescents: Adalat retard is not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.

POM


If you take more Adalat retard than you should

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 Adalat retard

Take your normal dose immediately and continue taking your tablets as prescribed, waiting 12 hours before taking your next dose.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 Adalat retard, 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

   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 not known: frequency cannot be estimated from the available data)

   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 Adalat retard is stopped.

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 (see details below). By reporting side effects

you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE ADALAT RETARD

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

Store your medicine in its original container. Protect from strong light and only remove the tablet from the blister strip when you are about to take it.

Protect from moisture.

Do not store above 25°C.

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

Do not dispose of medicines in household rubbish. Any unused Adalat retard tablets should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Adalat retard contains

Each tablet contains 20mg of the active ingredient, nifedipine.

Adalat retard tablets also contain: microcrystalline cellulose, maize starch, lactose, polysorbate 80, magnesium stearate, hypromellose, macrogol 4000, red iron oxide (E172) and titanium dioxide (E171).

What's in the pack

Each tablet is grey-pink and round, marked with ‘A20' on one side and Bayer logo on the reverse.

Each pack contains 60 tablets.

Manufacturer: Bayer Pharma AG, D-51368 Leverkusen, Germany.

Procured from within the EU and repackaged by: Amimed Direct Ltd, Hendon, London, NW9 6AQ.

Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.

PL No: 33902/0356

This leaflet was last revised: 07/09/2015

Adalat® is a registered trademark of Bayer AG, Germany

S0356-60-SP-PIL-07.09.2015