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NIFEDIPRESS MR 20

Active substance(s): NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NIFEDIPRESS® MR 10
NIFEDIPRESS® MR 20
(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 your 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 Nifedipress MR Tablets are and
what they are used for
2. What you need to know before you take
Nifedipress MR Tablets
3. How to take Nifedipress MR Tablets
4. Possible side effects
5. How to store Nifedipress MR Tablets
6. Contents of the pack and other
information
1. What Nifedipress MR Tablets are and
what they are used for
Nifedipress MR 10 & 20 Tablets (referred to
as ‘Nifedipress MR’ throughout this leaflet)
are modified release tablets containing the
active substance nifedipine 10 mg and 20 mg
respectively.
Nifedipine MR Tablets contains nifedipine,
which belongs to a group of medicines called
calcium antagonists.
Nifedipress MR is used to treat high blood
pressure (hypertension) and to prevent the
condition called chronic stable angina pectoris
(chest pain coming from the heart).
• For high blood pressure: Nifedipress 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: Nifedipress 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
Nifedipress MR Tablets
Do not take Nifedipress MR if:
• you have had a heart attack within the last
month
• you get a sudden angina attack. Nifedipress
MR will not help relieve symptoms of angina
quickly.
• you have unstable angina
• you are allergic to the active ingredient
(nifedipine), to any other similar medicines
known as dihydropyridines (e.g. amlodipine,
felodipine and nimodipine) or to any of the
other ingredients of this medicine (See
section 6).
• you are taking rifampicin, an antibiotic
• you have been told that you have a narrowing
of the aortic heart valve (stenosis)
• 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
• your blood pressure continues to rise despite
treatment (malignant hypertension)
• 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 Nifedipress
MR if any of these apply to you. If you are
unsure whether you might have any of these
conditions, please ask your doctor.
Warnings and precautions
Take special care with Nifedipress MR
and check with your doctor or pharmacist
before taking your medicine if:
• you have low blood pressure (may cause
dizziness or fainting on standing up) and
your doctor prescribed Nifedipress MR for
your angina. Your blood pressure may be
decreased further by this treatment
• you have a heart condition where your heart
cannot cope with increased stress such as
exercise (poor cardiac reserve)
• you are pregnant
• you are breastfeeding. If you need to
take Nifedipress MR, you should stop
breastfeeding before you start to take this
medicine.
• you are a diabetic. The treatment for your
diabetes may need to be adjusted. If you
have any questions about this, ask your
doctor
• 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 your
blood pressure when you take Nifedipress
MR
• your liver is not working properly. Your doctor
may need to do some blood tests. You may

also be given a lower dose of the medicine
Talk to your doctor before you take
Nifedipress MR 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 Nifedipress MR.
• If you have chest pains after taking your first
dose of Nifedipress 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. Nifedipress
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 Nifedipress MR have been shown to
impair sperm function.
Other medicines and Nifedipress MR:
Tell your doctor if you are taking, have
recently taken or might take any other
medicines.
Some medicines may affect the way Nifedipress
MR works. Tell your doctor if you are taking:
• other medicines to treat high blood pressure
• Rifampicin (an antiobiotic)
• 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 sulfate 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 to treat insomnia or
anxiety).
Nifedipress MR with food and drink:
You can take Nifedipress MR either with or
without food.
Do not drink grapefruit juice or eat
grapefruit while taking Nifedipress MR.
Do not start taking Nifedipress 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 Nifedipress 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, 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 Nifedipress MR
but only after special consideration and
agreement by your doctor.
Do not take Nifedipress MR if you
are breast-feeding. If you need to take
Nifedipress MR, you should stop breastfeeding before you start taking this medicine.
Driving and using machines:
Nifedipress 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 applies particularly at the start of
treatment, on changing the medication and in
combination with alcohol.
Important information about some of the
ingredients of Nifedipress MR
This medicine contains lactose (a sugar). If
you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking the medicine.
3. How to take Nifedipress MR Tablets
Always take your medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
• To 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) Nifedipress MR tablet.
• The usual maintenance dose of Nifedipress
MR 20 mg is one tablet, every 12 hours (i.e.
twice per day). 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 of this medicine may be
prescribed by your doctor 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.
• 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 Nifedipress MR either with or
without food.
Use in children and adolescents:
Nifedipress 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.
If you take more Nifedipress MR tablets
than you should:
If you take more tablets than you should
get medical help immediately. Take any
remaining tablets or this leaflet with you so
the medical staff know exactly what you have
taken.
The most likely effects you will notice on taking
too many tablets are severe drop in blood
pressure causing dizziness particularly on
standing and your heart beat may 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 Nifedipress MR:
If you forgot to take a tablet, take it if you
remember within 12 hours of your usual
time. If more than 12 hours have passed, do
not take the missed tablet but take your next
tablet at the normal time when it is due.
Do not take a double dose to make up for the
missed dose.
If you have any further questions about this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nifedipress MR can have
side effects, although not everybody gets
them.
Serious side effects
Stop taking Nifedipress MR and tell your
doctor immediately if you experience:
• severe, sudden generalized allergic reaction
including very rarely life-threatening shock
(e.g. difficulties in breathing, drop of blood
pressure, fast pulse), swelling (including
potentially life-threatening swelling of the
airway)
• other allergic reactions such as swelling
under the skin (possibly severe and including
swelling of the throat that may result in a lifethreatening outcome)
• fast heart beat (tachycardia)
• shortness of breath or difficulty breathing
(dyspnoea)
• mild to moderate allergic reactions (including
swollen lips)
• 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 Nifedipress MR,
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)
• unspecified 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 an 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
(shown on blood test).
Rare side-effects (These may affect up to 1
per 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 cells (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
• shortness of breath
All of the symptoms above usually go away
when treatment with Nifedipress MR is
stopped.
If any of the side effects gets serious, or if
you notice any side effects, including those not
listed in this leaflet, please tell your doctor or
pharmacist.
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.

5. How to store Nifedipress MR Tablets
Keep this medicine out of the reach and
sight of children.
Do not store above 25°C.
Store your medicine in the original package
in order to 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 the outer carton and on
each blister strip 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 to
protect the environment.
6. Contents of
information

the

pack

and

other

What Nifedipress MR contains
Nifedipress MR 10 & 20 are modified release
tablets containing the active substance
nifedipine 10mg and 20mg respectively.
The other ingredients are: colloidal anhydrous
silica, microcrystalline cellulose, lactose,
polysorbate 80, starch pregelatinized,
magnesium stearate, hypromellose 2910,
macrogol 6000, titanium dioxide E-171,
purified talc, iron oxide red E-172, purified
water and carnauba wax.
What Nifedipress MR Tablets look like and
contents of the pack
Nifedipress MR 10 and 20 tablets are modified
release, brownish pink, round, film-coated
tablets which come in two different tablet
sizes. Nifedipress MR 10 is the smaller tablet
of the two.
Nifedipress MR 10 and Nifedipress MR 20 are
available in packs of: 28 tablets in foil blister
strips; 30 tablets in foil blister strips; 56 tablets
in foil blister strips.
Not all pack sizes may be marketed.
The holder of the marketing authorization/
Manufacturer is:
Dexcel® - Pharma Ltd., 7 Sopwith Way,
Drayton Fields, Daventry, Northamptonshire,
NN11 8PB, UK
This leaflet was last revised in July 2016.

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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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