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NIFEDIPINE 10 MG CAPSULES

Active substance(s): NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ADALAT® 10MG CAPSULES
(nifedipine)

Your medicine is called Adalat 10mg Capsules but will be
referred to as Adalat Capsules throughout this leaflet. Other
strength ‘5mg’ is also available.

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.

What is in this leaflet

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

What Adalat Capsules are and what they are used for
What you need to know before you take Adalat Capsules
How to take Adalat Capsules
Possible side effects
How to store Adalat Capsules
Contents of the pack and other information

1. What Adalat Capsules are and what they
are used for
Adalat Capsules contain nifedipine, which belongs to a group
of medicines called calcium antagonists.
Adalat Capsules are used to treat high blood pressure,
angina (chest pain) or a condition called Raynaud’s
phenomenon which causes discolouration (often whitening)
of the fingers and toes.
For high blood pressure: Adalat Capsules work 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 Capsules work 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.

Warnings and precautions

Talk to your doctor before taking Adalat capsules

If you have low blood pressure. 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 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 Capsules.

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 Capsules.


Tell your doctor:











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













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



Do not take Adalat Capsules:











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

If you are giving a urine sample. Adalat Capsules
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 Capsules
have been shown to impair sperm function.

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

For Raynaud’s phenomenon: Adalat Capsules work by
relaxing and expanding the blood vessels in the fingers and
toes. This helps ensure a good blood supply.




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

Other medicines and Adalat Capsules




If you have had a heart attack within the last month.
If you get a sudden angina attack. Adalat Capsules
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 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 Capsules.
If you have chest pains after taking your first dose
of Adalat Capsules. Your doctor may wish to change
your treatment.
If you notice increased breathlessness.
If you notice swelling of the ankles.

Also tell your doctor:

Adalat Capsules can increase the risk of serious heart
problems in patients with high blood pressure or angina.
Because of this, Adalat Capsules are only used in these
patients if no other treatments are appropriate.




Talk to your doctor before you take Adalat
Capsules if any of these apply to you.



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 (antifungal 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).

Adalat capsules with food and drink

You can take Adalat Capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while
taking Adalat Capsules.
Do not start taking Adalat Capsules 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
Capsules. 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 Capsules but only after special
consideration and agreement by your doctor.
Do not take Adalat Capsules if you are breast-feeding.
If you need to take Adalat Capsules while breast-feeding, tell
your doctor before taking this medicine.

Driving and using machines

Adalat Capsules 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 capsules contains sunset yellow (E110)
May cause allergic reactions.

3. How to take Adalat Capsules
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
(5mg) capsule every 8 hours. This allows your doctor to
monitor how you are responding so that the best longterm dose can be identified.

The dose can be increased to a maximum of 20mg every
8 hours.

Lower doses may be prescribed for older patients or
for patients who have liver problems.

Swallow the capsules whole with a little water.

Continue to take the capsules for as long as your
doctor has told you to.
Do not take them with grapefruit juice.
You can take Adalat Capsules either with or without food.

Use in children and adolescents: Adalat capsules are

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 Capsules than you should


Taking too many capsules 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 Capsules

Take your normal dose immediately and continue taking your
capsules as prescribed, waiting 8 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:










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Get medical help immediately. If possible, take your
capsules or the box with you to show the doctor.

severe, sudden generalised allergic reaction including
very rarely life-threatening shock (e.g. difficulty in
breathing, drop of blood pressure, fast pulse) or 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.

5. How to store Adalat Capsules




Less serious side effects

Apart from the side effects listed above, these are the other
side effects of Adalat Capsules, 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

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

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




Do not use after the expiry date printed on the carton
label or blister strip. If you find that you have capsules
after their expiry date, return them to your local
pharmacist (chemist) who will dispose of them properly.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original container
and protected from strong light, only remove the
capsule from the container or blister strip when you are
about to take it.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor decides to stop treatment, return any
leftover capsules to the pharmacist. Only keep them if
your doctor tells you to.
If the capsules become discoloured or show any other
signs of deterioration, you should seek the advice of
your pharmacist.
Do not dispose of medicines in household rubbish. Any
unused Adalat Capsules should be returned to a
pharmacist (chemist) who will dispose of them properly.
This will help to protect the environment.

6. Contents of the pack and other
information
What Adalat Capsules contain

Each soft capsule contains 10mg nifedipine.
Adalat Capsules also contain the following ingredients:
glycerol, purified water, sodium saccharine, macrogol 400,
gelatin, titanium dioxide (E171) oil of peppermint and
sunset yellow (E110).

What Adalat Capsules look like and contents of the
pack
Each orange soft capsule is filled with thick yellow liquid.
Adalat Capsules are available as blister packs of
50, 84 & 90 capsules.

Manufacturer

Manufactured by: Bayer Pharma AG, D-51368, Leverkusen,
Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0358

POM

Leaflet revision and issue date: 19.10.15
Adalat® is a registered trademark of Bayer AG.

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 Capsules 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.
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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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