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BETA ADALAT CAPSULES

Active substance(s): ATENOLOL / NIFEDIPINE / ATENOLOL / NIFEDIPINE / ATENOLOL / NIFEDIPINE

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Package Leaflet - Information for the user



(nifedipine and atenolol)



This medicine is available using the above name but will be referred to as Beta-Adalat
throughout the following leaflet.



Read all of this leaflet carefully before you start taking this medicine.



Beta-Adalat Capsules

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:
■ 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. BetaAdalat 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 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 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.
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.
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.
→ 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)




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.
If you get side effects
→ If you experience any of these side effects or any other effects that are not listed, tell
your doctor immediately. Your doctor will give you advice.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Beta-Adalat




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



Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Protect from light and moisture.
Do not use capsules after the expiry date which is marked on both the outer carton and on
each blister strip of capsules. The expiry date refers to the last day of that month.
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.
If the capsules become discoloured or show any other signs of deterioration, you should
seek the advice or your pharmacist.

6. Further information
What Beta-Adalat contains
Each brown-reddish opaque gelatin capsule contains 20 mg of the active ingredient nifedipine
and 50 mg of the active ingredient atenolol. Each capsule is marked “Beta-Adalat” on the body
and the Bayer logo on the cap in white.
Beta-Adalat also contain the following inactive ingredients: microcrystalline cellulose,
polysorbate 80, hypromellose, lactose, maize starch, macrogol 4000, gelatin, magnesium
carbonate, sodium lauryl sulphate, shellac, magnesium stearate, titanium dioxide (E171) and
red iron oxide (E172).
Beta-Adalat is available in calendar blister packs of 28 capsules.
PL No: 17805/0091

®

Beta-Adalat Capsules

POM

This product is manufactured by Bayer Pharma AG, Leverkusen, Germany. Procured from
within the EU by the Product Licence holder Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O.
Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd,
Watford, Herts WD24 4PR.
Beta-Adalat is a registered Trade Mark of Bayer AG, Germany.
Leaflet revision and issue date (ref.): 30.04.2015
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Package Leaflet - Information for the user



(nifedipine and atenolol)



This medicine is available using the above name but will be referred to as Beta-Adalat
throughout the following leaflet.



Read all of this leaflet carefully before you start taking this medicine.



Beta-Adalat Capsules

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:
■ 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. BetaAdalat 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 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 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.
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.
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.
→ 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)




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.
If you get side effects
→ If you experience any of these side effects or any other effects that are not listed, tell
your doctor immediately. Your doctor will give you advice.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Beta-Adalat




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



Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Protect from light and moisture.
Do not use capsules after the expiry date which is marked on both the outer carton and on
each blister strip of capsules. The expiry date refers to the last day of that month.
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.
If the capsules become discoloured or show any other signs of deterioration, you should
seek the advice or your pharmacist.

6. Further information
What Beta-Adalat contains
Each brown-reddish opaque gelatin capsule contains 20 mg of the active ingredient nifedipine
and 50 mg of the active ingredient atenolol. Each capsule is marked “Beta-Adalat” on the body
and the Bayer logo on the cap in white.
Beta-Adalat also contain the following inactive ingredients: microcrystalline cellulose,
polysorbate 80, hypromellose, lactose, maize starch, macrogol 4000, gelatin, magnesium
carbonate, sodium lauryl sulphate, shellac, magnesium stearate, titanium dioxide (E171) and
red iron oxide (E172).
Beta-Adalat is available in calendar blister packs of 28 capsules.
PL No: 17805/0091

®

Beta-Adalat Capsules

POM

This product is manufactured by Bayer Schering Pharma AG, Leverkusen, Germany. Procured
from within the EU by the Product Licence holder Delta Pharma (Europe) Ltd, 1 Colonial Way,
P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd,
Watford, Herts WD24 4PR.
Beta-Adalat is a registered Trade Mark of Bayer AG, Germany.
Leaflet revision and issue date (ref.): 30.04.2015.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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