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ADALAT RETARD 10 MG MODIFIED-RELEASE TABLETS

Active substance(s): NIFEDIPINE

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Package leaflet: Information for the user

0 Adalat

®

retard 10 mg

Modified-release tablets
Nifedipine

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.

Do not drink grapefruit juice or eat
grapefruit while taking Adalat retard.

May

2015

Do not start taking Adalat retard within
3 days of drinking grapefruit juice or
REVISED
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 breast-feeding
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.
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.

Driving and using machines

What is in this leaflet
1 What Adalat retard is and what it is used for

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.

2

What you need to know before you take Adalat
retard

This may be more likely when you first start treatment, if
you change tablets, or if you have drunk alcohol.

3
4
5
6

How to take Adalat retard

Adalat retard contains lactose
monohydrate

1

What Adalat retard is and
what it is used for

Possible side ef
effects
How to store Adalat retard
Contents of the pack and other information

Adalat retard contains nifedipine, which belongs to a
group of medicines called calcium antagonists.
Adalat retard is used to treat high blood pressure or
angina (chest pain).
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.
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.

2

What you need to know before
you take Adalat retard

Do not take Adalat retard:











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 nifedipine, any other similar
medicines (known as dihydropyridines) or any of the
other ingredients of this medicine (listed in section 6).
If you are taking rifampicin, an antibiotic.
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
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.
• 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.

Tell your doctor:






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 chest pains after taking your first
dose of Adalat retard. Your doctor may wish to
change your treatment.
If you notice increased breathlessness.
If you notice swelling of the ankles.

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

Also tell your doctor:




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.

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

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.
• TTo start with, your doctor will monitor you carefully
to see how you are responding so that the best
long-term dose can be identified.
• After a while, you may be given a higher strength
(20 mg) Adalat retard tablet.
• The usual maintenance dose 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 40 mg every 12 hours.
• Lower doses may be prescribed for older people.
• If you have problems with your liver your doctor
will monitor you carefully. A reduction in your
nifedipine dose may be required.
water.
• 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 ef
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 life-threatening
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)
• 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.

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.

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

Other medicines and Adalat retard

Uncommon side effects

Tell your doctor if you are taking, have recently taken or
might take any other medicine.

(These may affect up to 1 in 100 people)
• stomach pain (abdominal pain)
• unspecific pain
• chills
• low blood pressure when standing up (symptoms
include fainting, dizziness, light headedness,
occasional palpitations, blurred vision and sometimes
confusion)
• fainting
• irregular heartbeat (palpitations)
• 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

Some medicines may affect the way Adalat retard works.
Tell your doctor if you are taking:
• 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
egnancy (may cause a severe fall in blood
pressure).
• Erythromycin (an antibiotic).
• Ketoconazole, itraconazole or fluconazole (antifungal medicines).
Indinavir, nelfinavir, ritonavir, saquinavir or
• Indinavir
amprenavir (to treat HIV).
• Fluoxetine or nefazodone (to treat depression).
T
(to prevent the rejection of transplanted
• Tacrolimus
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.

82128670

PMR 82128670 (69/04/MU-0201413183) Pantone: Schwarz, Orange 021

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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
• a 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

6

Contents of the pack and
other information

What Adalat retard contains
Adalat retard tablets contain the active ingredient,
nifedipine.
Adalat retard tablets also contain microcrystalline
cellulose, maize starch, lactose monohydrate,
polysorbate 80, magnesium stearate, hypromellose,
macrogol 4000, red iron oxide (E172) and titanium
dioxide (E171).

What Adalat retard looks like and
contents of the pack
Each modified-release tablet contains 10 mg of
nifedipine. Each tablet is grey-pink and round with A10
on one side and a Bayer cross on the reverse.
Each pack contains 56 tablets.

Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA
Manufacturer:
Bayer Pharma AG, Leverkusen, Germany
This leaflet was last revised in May 2015.
Product licence number: PL 00010/0151

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.

U

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 container. Protect from
strong light and only remove the tablet from the blister
strip when you are about to take it.
Do not use this medicine after the expiry date which is
stated on both the outer carton and on each blister strip
of tablets after EXP. The expiry date refers to the last day
of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

82128670

PMR 82128670 (69/04/MU-0201413183) Pantone: Schwarz, Orange 021

180x610-11483_11423

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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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