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BETA-ADALAT

Active substance(s): ATENOLOL / NIFEDIPINE

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Package leaflet – information for the user

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.

2 Before you take Beta-Adalat
Do not take Beta-Adalat:

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



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:

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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.
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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:

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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
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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.

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

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.

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.

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.

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.
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 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.

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.

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 lifethreatening 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)

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headache



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



cold limbs, hands or feet
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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)

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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
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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)

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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
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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.
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5 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 plc, 400 South Oak Way, Reading, RG2 6AD
Manufacturer: Bayer Pharma AG, Leverkusen, Germany
This leaflet was last revised in 08/2017.
Product licence number: PL 00010/0155

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Further information

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