ADIPINE MR 10

Active substance: NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

AdipineTM MR 10 and
AdipineTM MR 20 modified release tablets
Active substance: 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 any further 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.

In this leaflet:
1. What Adipine™ MR is and what it is used for
2. Before you take Adipine™ MR
3. How to take Adipine™ MR
4. Possible side effects
5. How to store Adipine™ MR
6. Further information

Whilst taking Adipine™MR, you should have your
blood pressure checked regularly, as your treatment
may need to be adjusted.

Children and adolescents
Children and adolescents should not use Adipine™ MR.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
1. What Adipine™ MR is and what it is used for
Adipine™MR contains the active substance nifedipine, medicines, herbal remedies, health foods or supplements
which belongs to a group of medicines called calcium that you have obtained without a prescription.
channel blockers (calcium antagonists).
You must NOT take rifampicin (used to treat bacterial
Nifedipine lowers blood pressure by relaxing the blood infections) together with Adipine™MR.
vessels. It does this by blocking calcium channels in
the muscle cells of the heart and blood vessels, which Before starting treatment, you should remind your doctor
leads to less muscle contraction.
about any other medicines you may be taking, particularly:

• medicines to treat high blood pressure (such as
Adipine™ MR is used to:
beta-blockers)
• treat high blood pressure (hypertension)
• prevent angina pectoris (a heart condition due to a lack of • medicines to treat angina pectoris (such as nitrates)
• medicines to treat abnormal heart beats (including
blood and hence oxygen supply to the heart muscle).
amiodarone and quinidine)
2. Before you take Adipine™MR
• digoxin, also known as digitalis (to treat heart conditions)
DO NOT use Adipine™ MR
• tricyclic antidepressants, such as imipramine (to treat
• If you are allergic (hypersensitive) to
depression)
− the active substance nifedipine
• anti-asthma drugs (theophylline)
− any other medicine which belongs to the same group • anti-ulcer medicines (cimetidine and ranitidine)
called dihydropyridines (such as amlodipine,
Taking Adipine™MR with food and drink
felodipine, nicardipine, lercanidipine)
− any of the other ingredients of Adipine™MR (see section You should not drink grapefruit juice during treatment with
Adipine™MR. Grapefruit may enhance the effect of the
6. “Further information” at the end of this leaflet).
medicine by raising the blood levels of nifedipine.
• If you are pregnant
You should take the tablets before meals.
• If you are taking an antibiotic called rifampicin (to
treat bacterial infections).
Pregnancy and breast-feeding
• If you suffer from any of the following medical
Ask your doctor or pharmacist for advice before taking
conditions:
any medicine.
− severe narrowing of the aortic valve (one of the
Please tell your doctor if you are or think you may be
valves of the heart)
pregnant or if you are planning to become pregnant.
− angina attacks of increased frequency or severity
Pregnancy
− heart related shock or heart failure
You must not take Adipine™MR during pregnancy.
− very low blood pressure.
• If you have had a heart attack within the last month or Breast-feeding
if you suspect that you are having a heart attack.
Nifedipine is passed into the mother’s milk. You must not
Adipine™ MR should not be used to prevent a heart take Adipine™MR if you are breast-feeding. If treatment
with Adipine™MR is necessary during breast-feeding, you
attack or to treat acute attacks of angina.
should wean.
Take special care with Adipine™MR
Please tell your doctor if you have or have had any medical Driving and using machines
conditions or illnesses, especially any of the following: You should be very careful about driving or operating
machinery. Your ability to drive or use machines may
• liver problems
be impaired especially at the start of therapy, when
• diabetes: If you are diabetic, changes to your diabetic switching medications or in combination with alcohol.
medication may become necessary during the
treatment with Adipine™MR.
Important information about some of the
ingredients of Adipine™MR
The use of Adipine™ MR is not recommended if you
Adipine™MR contains milk sugar (lactose). If you have been
suffer from malignant hypertension (very high blood
told by your doctor that you have an intolerance to some
pressure followed by organ damage in the eyes, brain,
sugars, contact your doctor before taking this medicine.
lungs and/or kidneys). Ask your doctor for further
advice if this applies to you.

• gastrointestinal complaints such as diarrhoea, feeling
3. How to take Adipine™MR
Always take Adipine™MR exactly as your doctor has sick (nausea), a feeling of fullness
• allergic skin reactions (e.g. itching, hives, rashes),
told you. You should check with your doctor or
and in individual cases inflammation and peeling of
pharmacist if you are not sure.
the skin (exfoliative dermatitis)
You should swallow the tablets whole with some water • changes in the number of blood cells, the symptoms are:
(but NOT grapefruit juice) before meals if possible.
− fever or chills, sore throat, ulcers in the mouth or throat,
Do not bite, chew or break up the tablets. The length of
unusual tiredness or weakness. This can indicate a
treatment will be determined by your doctor.
reduction in the number of red (anaemia) and white
The interval between individual doses should be 4
(leucopenia) blood cells.
hours or more.
− unexplained bruises and unusual bleeding. Tell your
Adults
doctor if you notice any of these symptoms. This
Unless otherwise specified, the usual starting dose is 10 mg
can indicate a reduction in the number of platelets
Adipine™MR every 12 hours. This may be increased to
which help the blood to clot (thrombopenia,
40 mg every 12 hours if necessary. Your doctor may change
thrombocytic purpura).
the dose according to your response to the treatment. • swelling of the breasts, especially in elderly
• swelling of the gums
Elderly
Elderly patients may require lower doses of Adipine™MR. • impairment of the liver function, including:
− stoppage in the flow of bile (gall) from the liver to the gut
Please ask your doctor for advice.
− increase of some liver enzymes (transaminases)
Patients with impaired liver function
• stiffness, finger trembling (tremor)
If you suffer from any liver problems, your doctor should • minor temporary eye disturbances
monitor you carefully during treatment with Adipine™MR. • increase in the blood sugar (hyperglycaemia). This
should be taken into account in patients with diabetes.
Patients with impaired kidney function
In general, no dose adjustment is required for this patient Patients who are on haemodialysis and have a very high
group.
blood pressure (malignant hypertension) and a low blood

volume may have a marked drop in their blood pressure.
Children and adolescents
Adipine™ MR is not recommended for use in children and During the first weeks of therapy, daily urine volume
adolescents below 18 years of age, because there are only may be increased.
limited data on the safety and efficacy in this population.
In patients with kidney impairment, the kidney function
may temporarily worsen.
If you take more Adipine™MR than you should
If you take too many tablets, contact your doctor or nearest
If any of the side effects gets serious, or if you notice
hospital casualty department immediately for advice.
any side effects not listed in this leaflet, please tell
The symptoms of overdosage include for example:
your doctor or pharmacist.
• loss of awareness possibly leading to coma
5. How to store Adipine™MR
• a fall in blood pressure
Keep out of the reach and sight of children.
• fast heart beat (tachycardia)
• lower heart beat (bradycardia)
Store in the original package in a cool, dry place below
• high blood sugar level (hyperglycaemia)
25°C.
If you forget to take Adipine™MR
• more than 4 hours before the usual time of your next
dose: take the missed dose.
• less than 4 hours before the usual time of your next
dose: do not take the missed medicine and wait until
your next dose is due.

Never take a double dose to make up for the missed dose.

If you stop taking Adipine™MR
High blood pressure and angina pectoris require long
term 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 doses.

Nifedipine is light-sensitive. Once you remove the tablets
from the packaging, you should not expose them to
intensive light for prolonged periods of time.
Do not take Adipine™MR after the expiry date which is
stated on the package after EXP. The expiry date refers
to the last day of that month.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. Further information

What Adipine™MR contains
The active substance is nifedipine.
Each Adipine™ MR 10 tablet contains 10 mg of nifedipine.
If you have any further questions on the use of this product,
Each Adipine™ MR 20 tablet contains 20 mg of nifedipine.

ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, AdipineTM MR can cause side effects,
although not everybody gets them. For the assessment of
the side effects the following frequency rating was used:
The following side effects have been observed in patients
treated with nifedipine. The frequency cannot be
estimated from available data:
• worsening of angina pectoris
• headaches
• flushing or reddening of the skin associated with a feeling
of warmth (erythema, erythromelalgia)
• heart attack
• fast heart beat (tachycardia)
• feeling the heart beats (palpitations)
• tiredness (fatigue)
• dizziness (vertigo)
• swelling of the lower legs due to fluid retention (oedema)
• tingling sensation in the arms or legs (paraesthesia)
• a drop in blood pressure (hypotension)

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
Distributor
Chiesi Limited, Cheadle Royal Business Park, Highfield,
Cheadle, SK8 3GY, UK.
This leaflet was last revised in 02/2013
CP0031/2

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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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