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ADALAT RETARD 20 MG MODIFIED- RELEASE TABLETS

Active substance(s): NIFEDIPINE

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Package leaflet: Information for the user



Adalat® retard 20 mg



If your liver is not working properly. Your doctor may need
to do some blood tests. You may also be given a lower dose of
Adalat retard.
Talk to your doctor before you take Adalat retard if any of
these apply to you.

Modified-release tablets
(nifedipine)

Tell your doctor:

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.



Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Adalat retard 20 mg Modifiedrelease tablets, but will be referred to as Adalat retard in this
leaflet.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Adalat retard is and what it is used for
What you need to know before you take
Adalat retard
How to take Adalat retard
Possible side effects
How to store Adalat retard
Contents of the pack and other information

1. What Adalat retard is and what it is used
for



















If you have had a heart attack within the last month.
If you get a sudden angina attack. Adalat retard will not help
relieve symptoms of angina quickly.

If you are giving a urine sample. Adalat retard may interfere
with the results of certain urine tests.
If you are a man who has been unable to father a child by
in vitro fertilisation. Drugs like Adalat retard have been shown
to impair sperm function.

Tell your doctor if you are taking, have recently taken or might
take any other medicines.
Some medicines may affect the way Adalat retard works. Tell
your doctor if you are taking:












Do not take Adalat retard:

If you notice swelling of the ankles.

Other medicines and Adalat retard

Adalat retard is used to treat high blood
pressure or angina (chest pain).

2. What you need to know before you take
Adalat retard

If you notice increased breathlessness.

Also tell your doctor:



For angina: Adalat retard works by relaxing and expanding the
arteries supplying the heart. This allows more blood and oxygen to
reach the heart and decreases the strain on it. Your angina attacks
will be less severe and less frequent if there is less strain on the
heart.

If you have chest pains after taking your first dose of
Adalat retard. Your doctor may wish to change your treatment.

Tell your doctor before you take the next dose if any of
these apply to you.

Adalat retard contains nifedipine, which belongs to a group of
medicines called calcium antagonists.

For high blood pressure: Adalat retard works by relaxing and
expanding the blood vessels. This makes the blood flow more
easily and lowers blood pressure. Lower blood pressure reduces
the strain on your heart.

If your chest pain (angina) gets worse (comes on more often
or more severely) over a matter of hours or days. You may be
advised not to take Adalat retard.






Other medicines to treat high blood pressure.
Rifampicin (an antibiotic).
Cimetidine (to treat stomach ulcers).
Digoxin, diltiazem, quinidine or beta-blockers (to treat heart
conditions).
Quinupristin/dalfopristin (a combination antibiotic).
Phenytoin, carbamazepine or valproic acid (to treat
epilepsy).
Cisapride (to treat reduced movements of the gullet and
stomach).
Magnesium sulphate injections during pregnancy (may
cause a severe fall in blood pressure).
Erythromycin (an antibiotic).
Ketoconazole, itraconazole or fluconazole (anti-fungal
medicines).
Indinavir, nelfifinavir, ritonavir, saquinavir or amprenavir
(to treat HIV).
Fluoxetine or nefazodone (to treat depression).
Tacrolimus (to prevent the rejection of transplanted organs).
Phenobarbital (usually used to treat insomnia or anxiety).

Adalat retard with Food and drink
You can take Adalat retard either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking
Adalat retard.
Do not start taking Adalat retard within 3 days of drinking grapefruit
juice or eating grapefruit. Tell your doctor if you have had
grapefruit or grapefruit juice in this time. Also, do not drink
grapefruit juice or eat grapefruit whilst taking Adalat retard.
Grapefruit juice is known to increase the blood levels of the active
ingredient, nifedipine. This effect can last for at least 3 days.

If you have unstable angina.

Pregnancy and breast-feeding

If you are allergic to nifedipine, any other similar medicines
(known as dihydropyridines) or any of the other ingredients of
this medicine (listed in section 6).

If you are pregnant, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this
medicine.

If you are taking rifampicin, an antibiotic.

You may be able to use Adalat retard but only after special
consideration and agreement by your doctor.
Do not take Adalat retard if you are breast-feeding. If you need
to take Adalat retard, you should stop breast-feeding before you
start taking this medicine.

If you have been told that you have a narrowing of the
aortic heart valve (stenosis).
If you have ever had a collapse caused by a heart problem
(cardiogenic shock), during which you became breathless, pale
and had a cold sweat and dry mouth.
If your blood pressure continues to rise despite treatment
(malignant hypertension).
If you have been told to avoid lactose, that you have a
hereditary condition called Lapp lactase deficiency or
glucose-galactose malabsorption.
Tell your doctor and do not take Adalat retard if any of
these apply to you.

Warnings and precautions

Driving and using machines
Adalat retard may make you feel dizzy, faint, extremely tired or
have visual disturbances. Do not drive or operate machinery if you
are affected in this way.
This may be more likely when you first start treatment, if you
change tablets, or if you have drunk alcohol.

Adalat retard contains lactose monohydrate
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.

Talk to your doctor before taking Adalat retard








If you have low blood pressure and you were prescribed
Adalat retard for your angina. Your blood pressure may be
decreased further by this treatment.
If you have a heart condition where your heart cannot cope
with increased strain (poor cardiac reserve).
If you are pregnant.
If you are breast-feeding. If you need to take Adalat retard,
you should stop breast-feeding before you start to take this
medicine.
If you are a diabetic. The treatment for your diabetes may
need to be adjusted. If you have any questions about this, ask
your doctor.
If you are on kidney dialysis. If you have a very high blood
pressure and a low blood volume, you might experience a
sudden drop in blood pressure when you take Adalat retard.

3. How to take Adalat retard
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.



To start with, you may be given a lower strength (10 mg)
tablet called Adalat retard 10 mg. This allows your doctor to
monitor how you are responding so that the best long-term dose
can be identified.



The usual maintenance dose of Adalat retard (20 mg
strength) is 1 tablet, every 12 hours (i.e. twice per day), but your
doctor may increase or decrease the dose depending on how well
your blood pressure or angina is being controlled. The maximum
dose is 2 tablets (40 mg) every 12 hours.



Lower doses may be prescribed for older people.



If you have problems with your liver you are likely to be
given Adalat retard 10 mg, at least to begin with.




Swallow the tablets whole with a little water.

Continue to take the tablets for as long as your doctor has
told you to.
Do not take them with grapefruit juice.
You can take Adalat retard either with or without food.
Use in children and adolescents: Adalat retard is not
recommended for use in children and adolescents below
18 years of age, because there are only limited data on the safety
and efficacy in this population.

If you take more Adalat retard than you should
Get medical help immediately. If possible, take your tablets
or the box with you to show the doctor.
Taking too many tablets may cause your blood pressure to
become too low and your heartbeats to speed up or slow down. It
may also lead to an increase in your blood sugar level or an
increase in the acidity of your blood, swelling in the lungs, low
blood oxygen levels and disturbances in consciousness, possibly
leading to unconsciousness.

If you forget to take Adalat retard
Take your normal dose immediately and continue taking your
tablets as prescribed, waiting 12 hours before taking your next
dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask
your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Serious side effects
If you notice:








Severe, sudden generalised allergic reaction including very
rarely life-threatening shock (e.g. difficulty in breathing, drop of
blood pressure, fast pulse), swelling (including potentially lifethreatening swelling of the airway)
other allergic reactions causing swelling under the skin
(possibly severe and including swelling of the larynx that may
result in a life-threatening outcome)
fast heart beat (tachycardia)

painful or difficult urination
inability to achieve or maintain an erection (impotence)
blurred vision
temporary increase in certain liver enzymes

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




pins and needles
inflammation of the gums, tender or swollen gums, bleeding
gums

Other side effects
(Frequency not known: frequency cannot be estimated from the
available data)
















vomiting
reduction in the number of white blood cells (leucopenia)
a more severe decrease in a specific class of white blood cell
(agranulocytosis)
increased blood sugar (hyperglycaemia)
decreased skin sensitivity (hypoaesthesia)
drowsiness (somnolence)
eye pain
chest pain (angina pectoris)
heartburn or indigestion (gastroesophageal sphincter
insufficiency)
yellowing of the whites of the eyes or skin (jaundice)
sensitivity to light (photosensitivity allergic reaction)
small, raised areas of bleeding in the skin (palpable purpura)
joint pain
muscle pain

All of these symptoms usually go away when treatment with Adalat
retard is stopped.

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.

shortness of breath or difficulty breathing
mild to moderate allergic reactions

5. How to store Adalat retard

itching (possibly severe), a rash or hives
Contact your doctor immediately and do not take the next
dose as these may be the first signs of allergic reaction which
may become severe.

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

If you develop:








a skin reaction or blistering/peeling of the skin and/or mucosal
reactions (in the mouth/nose or at the penis/vagina) (Toxic
Epidermal Necrolysis)
Contact your doctor immediately before you continue
treatment as these may be signs of a severe reaction.

Store your medicine in its original package. Do not store above
25°C. Protect from moisture. Protect from strong light and only
remove the tablet from the blister strip when you are about to take
it.
Do not use after the expiry date which is marked on both the outer
carton and on each blister strip of tablets.
Do not dispose of medicines in household rubbish. Any unused
Adalat retard tablets should be returned to a pharmacist (chemist)
who will dispose of them properly. This helps the environment.

Less serious side effects
Apart from the side effects listed above, these are the other side
effects of Adalat retard, starting with the more common ones:

6. Contents of the pack and other information

Common side effects

Adalat retard tablets contain the active ingredient, nifedipine.

(These may affect up to 1 in 10 people)







headache
flushing
general feeling of being unwell
constipation
swelling, particularly of the ankles and legs

Uncommon side effects
(These may affect up to 1 in 100 people)
























stomach pain (abdominal pain)
unspecific pain

What Adalat retard contains
Adalat retard tablets also contain microcrystalline cellulose, maize
starch, lactose, polysorbate 80, magnesium stearate,
hypromellose, macrogol 4000, titanium dioxide (E171) and iron
oxide red (E172).
Also contains sodium chloride (salt). To be taken into
consideration by patients on a controlled sodium diet.

What’s in the pack
Each modified-release tablet contains 20 mg of nifedipine.
Each tablet is pink and round embossed with a ‘BAYER’ cross on
one side and ‘A20’ on the other.
Each pack contains 60 tablets.

chills

Manufacturer:

low blood pressure when standing up (symptoms include
fainting, dizziness, light headedness, occasional palpitations,
blurred vision and sometimes confusion)

Bayer Pharma AG, D-51368 Leverkusen, Germany.

fainting
irregular heartbeat (palpitations)
dry mouth
indigestion or upset stomach
wind (flatulence)

Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, Slough, SL1 4NL.
®
Adalat retard 20 mg Modified-release Tablets, POM
PL: 39352/0069

feeling sick (nausea)

Adalat® is a registered trademark of Bayer AG, Germany.

muscle cramps

Leaflet date: 02.10.2015

joint swelling
sleep disorders
anxiety or nervousness
reddening of the skin
nose bleeds
nasal congestion
sensation of spinning or whirling motion (vertigo)
migraine
dizziness
trembling
increase in the need to pass water (urinate)

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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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