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ADALAT RETARD 20 MG MODIFIED- RELEASE TABLETS

Active substance: NIFEDIPINE

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Package leaflet - information for the user

Tell your doctor:

Adalat® retard 20 mg



Modified-release tablets
(nifedipine)
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.
The name of your medicine is Adalat retard 20 mg Modifiedrelease tablets, but will be referred to as Adalat retard in this
leaflet.

In this leaflet

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

What Adalat retard is
Before you take Adalat retard
How to take Adalat retard
Possible side effects
How to store Adalat retard
Further information


























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 have unstable angina.
If you are allergic to the active ingredient (nifedipine), to any
other similar medicines (known as dihydropyridines) or to any
of the other ingredients. The ingredients of Adalat retard are
listed in section 6.
If you are taking rifampicin, an antibiotic.












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, nelfinavir, 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).

Food and drink with Adalat retard
You can take Adalat retard 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.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning a
family, tell your doctor before taking Adalat retard.
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 breastfeeding. If you need
to take Adalat retard, you should stop breastfeeding before you
start taking the tablets.

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.

Driving and using machines

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.

Your doctor will take special care:





Other medicines to treat high blood pressure.

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

Tell your doctor and do not take Adalat retard if any of
these apply to you.



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.

Some medicines may affect the way Adalat retard works.
Tell your doctor if you are taking:

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




If you are giving a urine sample. Adalat retard may interfere
with the results of certain urine tests.

Tell your doctor about any other medicines that you are taking,
or took recently. This includes any products you bought without a
prescription.



Do not take Adalat retard:

If you notice swelling of the ankles.

Other medicines and Adalat retard

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

2. 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.

1. What Adalat retard is

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.

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 breastfeeding. If you need to take Adalat retard,
you should stop breastfeeding 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.
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.

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.

3. How to take Adalat retard
Take the tablets as prescribed by your doctor.


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 elderly patients.

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: 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 too many tablets
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 the tablets
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 the missed dose.

4. Possible side effects
Like all medicines, Adalat retard can have 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)
shortness of breath or difficulty breathing
mild to moderate allergic reactions
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.

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.

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:

Common side effects
(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
chills
















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, 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 Adalat retard
Keep this medicine out of the sight and reach of children.
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.

6. Further information
What Adalat retard contains
Adalat retard tablets contain the active ingredient, nifedipine.
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.

Manufacturer:
Bayer Pharma AG, D-51368 Leverkusen, Germany.

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

Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Ltd., 956 Buckingham

fainting

Avenue, Slough Trading Estate, Slough, SL1 4NL.

irregular heartbeat (palpitations)

®
Adalat retard 20 mg Modified-release Tablets, POM
PL: 39352/0069

dry mouth
indigestion or upset stomach
wind (flatulence)
feeling sick (nausea)
muscle cramps
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)
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)




(Frequency unknown)

fast heart beat (tachycardia)

If you develop:



Other side effects

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

Adalat® is a registered trademark of Bayer AG, Germany.
Leaflet date: 05.03.2014

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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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