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Beta-Adalat Capsules

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Document: leaflet MAH BRAND_PL 00010-0155 change


•    If you notice you have an enlarged thyroid and problems with your eyes.

Beta-Adalat may block the signs of an overactive thyroid. If you have any questions about this, ask your doctor.

Check with your doctor:

•    If you are male and have been unsuccessful in fathering a child by in vitro fertilisation. Drugs like Beta-Adalat that contain the active ingredient nifedipine have been shown in laboratory experiments to impair sperm function.

•    If you are about to have an operation, tell the anaesthetist or medical staff that you are taking Beta-Adalat. This is particularly important if you are also taking strong painkillers (narcotics) or drugs that affect your heart rhythm (antiarrhythmics).

•    Beta-Adalat may interfere with the results of certain urine tests. If you are giving a urine sample, inform the person responsible that you are taking this medicine.

•    If you may be subjected to drug testing for any reason, since Beta-Adalat may lead to positive test results in doping tests.

•*► If you develop symptoms which your doctor thinks are due to a slow heart rate, he or she may ask you to stop taking this medicine.


Other medicines and Beta-Adalat:

Before taking Beta-Adalat tell your doctor if you are taking any other medicines, whether bought or prescribed, since some medicines can interfere with your treatment. In particular, tell your doctor if you are taking:

•    digoxin (or any other type of cardiac glycoside). theophylline, verapamil, disopyramide, or quinidine which are used to treat heart conditions

   cimetidine to treat stomach ulcers

•    clonidine (for hypertension or migraine). You must not stop taking clonidine unless your doctor tells you to. Your doctor will give you instructions should you need to stop taking clonidine

•    the antibiotics rifampicin and combination treatment quinupristin/dalfopristin

•    the anti-epileptic drug phenytoin

•    ibuprofen or indomethacin. Other drugs that may cause similar effects are: reserpine, alpha-methyldopa, guanethidine or guanfacine

•    other blood pressure lowering drugs such as beta-blockers, verapamil or diltiazem

•    drugs that correct an irregular heartbeat (antiarrhythmics) such as lidocaine, amiodarone or sotalol

•    chloroform, lignocaine and procainamide or beta-adrenoceptor stimulants such as isoprenaline

   noradrenaline, adrenaline or monoamine oxidase inhibitors such as phenelzine or isocarboxazid

•    cisapride, a drug used to treat reduced movements of the gullet and stomach

•    baclofen, a type of muscle relaxant used to relieve muscle spasms

If you suffer with a hypoglycaemic metabolic disorder, tell your doctor if you are taking insulin or drugs called oral antidiabetics.

Your doctor may, under certain conditions, think it necessary to keep you on Beta-Adalat whilst you are pregnant. If this is the case, particular care should be exercised if you are also having magnesium sulphate injections.

You should also tell your doctor if you are taking:

•    the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole

•    the HIV protease inhibitors indinavir, nelfinavir, ritonavir, saquinavir or amprenavir

•    the antidepressant drugs fluoxetine and nefazodone

   tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs

   carbamazepine and valproic acid, which are both used for the treatment of epilepsy

•    the barbiturate phenobarbital, used primarily to treat insomnia and anxiety

If you are taking any of these drugs, your doctor may want to monitor your blood pressure and might reduce your dose of Beta-Adalat.


Package leaflet - information for the user

0) Beta-Adalat®

Capsules containing 20 mg nifedipine and 50 mg atenolol

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 Beta-Adalat is

2

Before you take Beta-Adalat

3

How to take Beta-Adalat

4

Possible side effects

5

How to store Beta-Adalat

6

Further information

1 What Beta-Adalat is

Beta-Adalat contains two active ingredients: nifedipine and atenolol.

Nifedipine belongs to a group of medicines called calcium antagonists. Atenolol belongs to a group of medicines called beta-blockers.

Beta-Adalat is used to treat high blood pressure or angina.

For high blood pressure: Beta-Adalat works by 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: Beta-Adalat works by 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.

Before you take Beta-Adalat

Do not take Beta-Adalat:

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

To prevent another heart attack, if you have a history of previous heart attack. Beta-Adalat will not help to prevent another heart attack.

If you get a sudden angina attack. Beta-Adalat will not help relieve symptoms of angina quickly If you are allergic to the active ingredients (atenolol and nifedipine), to any other similar medicines (known as beta-blockers and dihydropyridines) or to any of the other ingredients. The ingredients of Beta-Adalat are listed in section 6.

If you are pregnant or breastfeeding. If you think that you may be pregnant or are planning to have a family, consult your doctor and do not take Beta-Adalat.

If you have a history of wheezing or asthma.

Consult your doctor or pharmacist first.

If you are taking rifampicin, an antibiotic.

If you are taking monoamine oxidase inhibitors

such as phenelzine or isocarboxazid. Please consult with your doctor if you think you may be taking such medication.

If you have been told that you have an unusually slow heart rate (your heart’s electrical signals move more slowly through the heart than is normal (second or third degree heart block)).

If you have been told that your heart fails to pump your blood properly around the body (heart failure).

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

If you have been told that you have sick sinus syndrome or sino-atrial block (an irregularly slow or fast heartbeat).

If you have experienced a collapse which was caused by a heart problem (cardiogenic shock), during which you would have become breathless, pale and had a cold sweat and dry mouth.

If your blood pressure is continuing to rise despite treatment. This is a condition known as malignant hypertension.

If you are also taking other drugs which lower your heart’s workload, for example a drug called verapamil.

If you have severe problems with the circulation

in your hands and feet.

If you have metabolic acidosis (a decline in blood pH value). Symptoms of acidosis may include a marked decline in conscious level with confusion and irritability. In addition your breathing may be deep, sighing and rapid (Kussmaul’s respiration).

If you have a condition called phaeochromocytoma (a rare cancer of the adrenal gland). In these circumstances Beta-Adalat must only be used after you have been treated with drugs called alpha-blockers.

If your kidneys do not work properly. If you are

unsure about this and require further information, please consult with your doctor.

If your liver does not work properly. If you are

unsure about this and require further information, please consult your doctor.

Tell your doctor and do not take Beta-Adalat if

any of these apply to you.

Your doctor will take special care:

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

•    If you have a heart condition where there is a split-second delay in the time that it takes electrical impulses to move through a specific section of your heart muscle (first degree heart block).

•    If you suffer from low blood pressure and he or

she prescribes Beta-Adalat for your angina.

•    If you suffer from Prinzmetal’s angina. Tell your doctor if you have this condition.

•    If you are a diabetic. The treatment for your diabetes may need to be adjusted. This medicine may alter the fast heart rate that can occur with a low blood sugar level (hypoglycaemia).

   If your liver or kidneys do not work properly.

Tell your doctor before you take Beta-Adalat if

any of these apply to you.

Tell your doctor:

•    If you are allergic to any of the other ingredients of this medicine.

•    If you get chest pain for the first time at the start of treatment. Contact your doctor immediately and do not take the next dose. He or she will give you advice.

•    If your angina pain gets rapidly worse at the start of treatment or the frequency of attacks increases. Contact your doctor immediately and do not take the next dose. He or she will give you advice.

•    If you notice increased breathlessness or swelling of the ankles, or if your heart condition gets worse whilst taking your medicine.

Food and drink with Beta-Adalat

Do not drink grapefruit juice or eat grapefruit while taking Beta-Adalat.

Pregnancy and breastfeeding

Do not take Beta-Adalat if you are pregnant or breastfeeding. If you are taking it and think that you may be pregnant or are planning a family, consult your doctor.

Beta-Adalat contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Beta-Adalat.

4 Possible side effects

Like all medicines, Beta-Adalat can have side effects, although not everybody gets them.

Side effects occur mainly at the start of treatment and are generally mild. These will settle down with continued treatment.


You should not start taking Beta-Adalat within three days of drinking grapefruit juice or eating grapefruit. If you have, speak to your doctor. In addition, you should not drink grapefruit juice or eat grapefruit whilst taking Beta-Adalat. This is because grapefruit and grapefruit juice are known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least three days.


Driving and using machines

Dizziness or tiredness may occasionally occur after taking Beta-Adalat. Beta-Adalat could affect your ability to drive and use machines. Do not drive or operate machinery if you are affected. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.


3 How to take Beta-Adalat

Take the capsules as prescribed by your doctor.

•    For high blood pressure: the usual dose is 1 capsule, once a day. Your doctor may increase this to 1 capsule every 12 hours depending on how well your blood pressure is being controlled.

•    For angina: the usual dose is 1 capsule, every 12 hours.

•    The maximum dose is 2 capsules every 24 hours. Do not exceed the prescribed dose.

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

If you suffer from a liver disorder, your doctor may want to start your treatment on a low dose and increase it with careful monitoring of your blood pressure.

If you are elderly, lower doses of this medicine may be prescribed by your doctor.

This medicine is not recommended for use in children.

If you take too many capsules

Exceeding the correct dosage or taking an overdose may cause your blood pressure to become too low and your heart beats to become irregular.

If you take more than the prescribed dose, or in the event of an overdose, seek medical advice immediately and, if possible, take your capsules or the box with you to show the doctor.

If you forget to take the capsules

Take your normal dose immediately and then continue taking your capsules as prescribed, waiting at least 12 hours before taking your next dose.


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Serious side effects

If you experience the following:

• chest pain (angina pectoris) for the first time or your angina pain gets worse

•    an irregular heart beat (palpitations) or fast heart beat (tachycardia)

•    breathing difficulties

•    a serious allergic reaction which causes difficulty in breathing, an itchy rash, swelling of the face or throat, or dizziness

•    allergic reactions including itching or blistering of the skin, hives, or swelling under the skin (possibly severe and including swelling of the larynx that may result in a life-threatening outcome)

•    a serious skin disorder (potentially life-threatening) that causes severe blistering, reddening and peeling of the skin (toxic epidermal necrolysis)

•    a serious condition causing inflammation of the skin with widespread scaling, reddening, itching and shedding of the skin (exfoliative dermatitis)

"$> Contact your doctor immediately and do not take the next dose.

Less serious side effects

Apart from the side effects listed above, the other side effects of Beta-Adalat are listed below, starting with the more common ones.

Side effects known to occur with Beta-Adalat:

Common side effects

(These may affect up to 1 in 10 people)

•    headache

•    changes in your heart beat that may lead to a slowing of the heart rate

•    cold limbs, hands or feet

•    flushing

•    problems with your stomach or intestines

•    constipation

•    feeling tired or a loss of energy (fatigue)

® feeling unwell

•    general fluid retention causing swelling Rare side effects

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

•    worsening of psoriasis in people already suffering from this condition

Other side effects (Frequency unknown)

•    purplish spots or patches caused by bleeding under the skin

•    dizziness

•    failure to achieve or maintain an erection (impotence/ erectile dysfunction)

Side effects known to occur with atenolol:

Uncommon side effects

(These may affect up to 1 in 100 people)

® sleep disturbances (of the type noted with other beta-blockers)

•    an increase in the level of certain liver enzymes Rare side effects

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

•    a reduction in the number of blood clotting agents (platelets) that increases the risk of bleeding into the skin or bruising

•    increased risk of heart failure

•    an irregular heart beat due to electrical signals moving through your heart more slowly than normal (heart block)

•    a fall in blood pressure on standing up which causes dizziness and lightheadedness that may be associated with fainting

•    an increase in leg pain that comes and goes (intermittent claudication) in people already suffering from spasms in the fingers (Raynaud's phenomenon)

•    a narrowing of the air passages that may occur in patients with asthma or a history of asthma

•    problems with your liver including inflammation

(hepatitis) and blockage that causes bile and fat to build-up in your blood stream

•    nightmares

•    mood changes (including depression)

® confusion

•    mental disorders including hallucinations

•    dizziness

•    abnormal sensations or pins and needles

•    eye problems including dry eyes

•    a dry mouth

•    hair loss

•    skin rashes including a condition that may resemble psoriasis

•    failure to achieve or maintain an erection (impotence/ erectile dysfunction)

Very rare side effects

(These may affect up to 1 in 10,000 people)

•    an increase in the level of a certain type of antibody (Antinuclear Antibodies)

Side effects known to occur with nifedipine:

Uncommon side effects

(These may affect up to 1 in 100 people)

•    reddening of the skin

•    low blood pressure

•    nervousness

•    sleep disorders

•    a sensation of spinning or whirling motion (vertigo)

•    migraine

•    dizziness

•    shaking

•    fainting

•    chills

•    eye problems

•    nose bleed or a stuffy, blocked nose (nasal congestion)

•    pain in the stomach, intestines or abdomen

•    muscle cramps

•    swelling of the joints

•    general pain with no obvious cause

•    feeling sick

•    indigestion or a feeling of fullness that may be painful or uncomfortable

•    wind

® painful or difficult urination, or the production of large amounts of urine with an increased need to pass water

•    failure to achieve or maintain an erection (impotence/ erectile dysfunction)

•    dry mouth

•    a temporary increase in the level of certain liver enzymes

Rare side effects

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

•    abnormal sensations or pins and needles

•    skin reactions such as a rash, itching or hives

•    swollen gums that may bleed Other side effects (Frequency unknown)

•    a decrease in the number of white blood cells that may be severe and which may make infections more likely

•    too much sugar in the blood (hyperglycaemia)

•    decreased skin sensitivity

•    skin sensitivity to light

•    small, raised areas of bleeding in the skin ® eye pain

•    drowsiness

® being sick (vomiting)

•    heartburn, indigestion or difficulty swallowing

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

•    joint pain

® muscle pain

Heart attacks have occurred in patients treated with nifedipine. It has not been shown that these heart attacks were due to treatment with nifedipine.

All of the side-effects above usually go away when treatment with Beta-Adalat 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 via the 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.


How to store Beta-Adalat

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

This medicine does not require any special storage conditions.

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

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


6 Further information

What Beta-Adalat contains

Beta-Adalat capsules contain the active ingredients nifedipine and atenolol.

Each capsule contains 20 mg of nifedipine and 50 mg of atenolol.

Beta-Adalat capsules also contain microcrystalline cellulose, polysorbate 80, hypromellose, lactose, maize starch, macrogol 4000, gelatin, magnesium carbonate, sodium lauryl sulphate, and magnesium stearate. Titanium dioxide (E171) and iron oxide (E172) are included as colouring agents.

What’s in the pack

Each capsule is brown-reddish and is marked “BETA-ADALAT" on one side with the Bayer symbol on the other side.

Your medicine comes in packs of 28 capsules.

Marketing authorisation holder:

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

Manufacturer: Bayer Pharma AG, Leverkusen, Germany This leaflet was last revised in 05/2015.

Product licence number: PL 00010/0155


Bayer


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