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Package leaflet - information for the user

0 Adalat retard 10 mg

Modified-release tablets Nifedipine

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 more 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet

1	What Adalat retard is
2	Before you take Adalat retard
3	How to take Adalat retard
4	Possible side effects
5	How to store Adalat retard
6	Further information

1 What Adalat retard is

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 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 the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Adalat retard are 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.

Your doctor will take special care:

_• 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 breastfeeding. If you need to take Adalat retard, you should stop breastfeeding 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 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 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).

Food and drink with Adalat retard

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 breastfeeding

If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Adalat retard.

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 breastfeeding.

If you need to take Adalat retard, you should stop breastfeeding before you start taking the tablets.

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.

3 How to take Adalat retard

Take the tablets as prescribed by your doctor.

•    To start with, your doctor will monitor you carefully to see how you are responding so that the best long-term dose can be identified.

•    After a while, you may be given a higher strength (20 mg) Adalat retard tablet.

•    The usual maintenance dose 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 40 mg every 12 hours.

•    Lower doses may be prescribed for elderly patients.

•    If you have problems with your liver your doctor will monitor you carefully. A reduction in your nifedipine dose may be required.

•    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: 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.

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 as prescribed, waiting 12 hours before taking your next dose.

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

4 Possible side effects

Like all medicines, Adalat retard can have 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

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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)

•    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.

If you get side effects

•    Tell your doctor if any side effect gets serious, or

if you get any effects not listed in this leaflet.

6 Further information

What Adalat retard contains

Adalat retard tablets contain the active ingredient, nifedipine.

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

What’s in the pack

Each modified-release tablet contains 10 mg of nifedipine. Each tablet is grey-pink and round with A10 on one side and a Bayer cross on the reverse.

Each pack contains 56 tablets.

Marketing authorisation holder:

Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA

Manufacturer:

Bayer Pharma AG, Leverkusen, Germany This leaflet was last revised: November 2013 Product licence number: PL 00010/0151

Bayer

PMR 81942447 (O8/01/MU-0201312086) Pantone: Schwarz, Orange 021 180x610-11483 11423