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Active substance: NIFEDIPINE

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Adipine_MR_RET_GEN_UK_GI_154x420_Mock-up_1507.qxp_1 05.10.15 08:23 Seite 1

Nifedipine 10 / 20 mg

Responses to RFI

October 2015

Package leaflet: Information for the user


Adipine MR 10 and Adipine MR 20
modified release tablets


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. What Adipine™ MR is and what it is used for
2. What you need to know before you take
Adipine™ MR
3. How to take Adipine™ MR
4. Possible side effects
5. How to store Adipine™ MR
6. Contents of the pack and other information

1. What Adipine™ MR is and what it is
used for
Adipine™ MR contains the active substance
nifedipine, which belongs to a group of medicines
called calcium antagonists.
Adipine™ MR is used to treat high blood pressure or angina (chest pain).
For high blood pressure: Adipine™ MR 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: Adipine™ MR 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
Adipine™ MR
Do NOT take Adipine™ MR
• if you are allergic to the active substance, to
any other similar medicines (known as dihydropyridines) or to any of the other ingredients of
this medicine (listed in section 6).
• if you have had a heart attack within the last
• if you get a sudden angina attack. Adipine™
MR will not help relieve symptoms of angina
• if you have unstable angina.
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Adipine™ MR.
Your doctor will take special care:
• If you have low blood pressure and you were
prescribed Adipine™ MR for your angina. Your
blood pressure may be decreased further by this
• If you have a heart condition where your heart
cannot cope with increased strain (poor cardiac
• If you are pregnant.
• If you are breastfeeding. If you need to take
Adipine™ MR, 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 Adipine™ MR.
• 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 Adipine™ MR.
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
Adipine™ MR.
• If you have chest pains after taking your first
dose of Adipine™ MR. 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. Adipine™
MR 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
Adipine™ MR have been shown to impair sperm
Children and adolescents
Adipine™ MR. 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.
Other medicines and Adipine™ MR
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.
Some medicines may affect the way Adipine™ MR
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 (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).
Adipine™ MR with food and drink
You can take Adipine™ MR with or without food.
Do not drink grapefruit juice or eat grapefruit
while taking Adipine™ MR.
Do not start taking Adipine™ MR 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 Adipine™ MR.
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 or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
You may be able to use Adipine™ MR, but only
after special consideration and agreement by your
Do not take Adipine™ MR if you are breastfeeding. If you need to take Adipine™ MR, you
should stop breastfeeding before you start taking
the tablets.
Driving and using machines
Adipine™ MR, 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.
Adipine™ MR contains milk sugar (lactose)
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.



154 x 420 mm
6, 9, 10, 16 pt

5. Umlauf



3. How to take Adipine™ MR
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise specified, the recommended
starting dose is 10 mg Adipine™ MR every 12
hours. This may be increased to the maximum
dose of 40 mg every 12 hours if necessary. Your
doctor may increase or decrease the dose

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Adipine_MR_RET_GEN_UK_GI_154x420_Mock-up_1507.qxp_1 05.10.15 08:23 Seite 2

Nifedipine 10 / 20 mg
depending on how well your blood pressure or
angina is being controlled.
Older people
Lower doses may be prescribed for older people.
Hepatic impairment
If you have problems with your liver your doctor
will monitor you carefully. A reduction in your
nifedipine dose may be required
Use in children and adolescents
Adipine™ MR 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.
Method of administration
Swallow the tablets whole with a little water.
You can take Adipine™ MR either with or without
Do not take them with grapefruit juice.
Duration of treatment
Continue to take the tablets for as long as your
doctor has told you to.
If you take more Adipine™ MR than you should
Get medical help immediately. If possible, take
your tablets or the box with you to show the
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 Adipine™ MR
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.
If you stop taking Adipine™ MR
High blood pressure and angina pectoris require
longterm treatment. Your doctor will monitor your
progress and determine the duration of your treatment. If you wish to stop taking these tablets
temporarily or permanently, you should consult
your doctor. It is important to reduce the dose
gradually, especially if you have been taking high
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. For
the assessment of the side effects the following
frequency rating was used:
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
• 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
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 Nifedipine, starting with
the more common ones:
Common (may affect up to 1 in 10 people):
• headache
• flushing
• general feeling of being unwell
• constipation
• swelling, particularly of the ankles and legs
Uncommon (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


Responses to RFI

October 2015

• 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
• blurred vision
• temporary increase in certain liver enzymes
Rare (may affect up to 1 in 1,000 people):
• pins and needles
• inflammation of the gums, tender or swollen
gums, bleeding gums
Not known (frequency cannot be estimated from
the available data):
• vomiting
• a reduction in the number of white blood cells
• 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
• sensitivity to light (photosensitivity allergic
• small, raised areas of bleeding in the skin
(palpable purpura)
• joint pain
• muscle pain
All of these symptoms usually go away when
treatment with Adipine™ MR 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 YellowCard
Scheme at
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Adipine™ MR
Keep this medicine out of sight and reach of
Do not take this medicine after the expiry date
which is stated on the carton and blister after
“EXP”. The expiry date refers to the last day of
that month.
Store in the original package in a cool, dry place
below 25°C.
Nifedipine is light-sensitive. Once you remove the
tablets from the packaging, you should not expose
them to intensive light for prolonged periods of
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.

6. Contents of the pack and other information
What Adipine™ MR contains
• The active substance is nifedipine.
Each Adipine™ MR 10 tablet contains 10 mg of
Each Adipine™ MR 20 tablet contains 20 mg of
• The other ingredients are lactose, microcrystalline cellulose, macrogol 6000, magnesium
stearate, maize starch, hydroxypropylmethyl
cellulose, polysorbate 80 (tween 80), talc, titanium dioxide (E171), red iron oxide (E172).
What Adipine™ MR looks like and contents of
the pack
Adipine™ MR 10 and Adipine™ MR 20 modified
release tablets are pink-coated round, slightly
biconvex tablets with smooth surface.
Adipine™ MR 10 and Adipine™ MR 20 are
available in packs containing 10, 20, 30, 50, 56,
60 or 100 tablets.
Blister packages are made of aluminium foil and
PVC film.
Not all packaging sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG,
Stadastrasse 2–18, 61118 Bad Vilbel, Germany
Tel: +49 6101 603 0, fax: +49 6101 603 259,
Chiesi Limited,
333 Styal Road, Manchester, M22 5LG, UK.
This leaflet was last revised in July 2015.
1507 UK

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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.