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BETA ADALAT CAPSULES

Active substance: NIFEDIPINE

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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
2
3
4
5
6

What Beta-Adalat is



Before you take Beta-Adalat
How to take Beta-Adalat
Possible side effects
How to store Beta-Adalat



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 BetaAdalat

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. BetaAdalat 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 alphablockers.
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 BetaAdalat 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 BetaAdalat 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:








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 BetaAdalat:
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
July
and procainamide or betaadrenoceptor stimulants
such as isoprenaline
REVISED
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

2012





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.

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.

81098832

PMR 81098832 (93/01/MU-0201204543) Pantone: SCHWARZ, ORANGE 021

296x315-07508

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.

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 life-threatening
outcome)
• a serious skin disorder (potentially lifethreatening) 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)
(
k
• 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)

5

Side effects known to occur with
nifedipine:

This medicine does not require any special
storage conditions.

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

How to store Beta-Adalat

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

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, Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA
Manufacturer: Bayer Pharma AG, Leverkusen,
Germany
This leaflet was last revised: 07/2012
Product licence number: PL 00010/0155

U

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.

If you get side effects
If you experience any of these sideeffects or any other effects that are not
listed, tell your doctor immediately. Your
doctor will give you advice.

81098832

PMR 81098832 (93/01/MU-0201204543) Pantone: SCHWARZ, ORANGE 021

296x315-07508

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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