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NIFOPRESS RETARD TABLETS 20MG

Active substance(s): NIFEDIPINE / NIFEDIPINE / NIFEDIPINE

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Package leaflet: Information for the patient
Nifopress Retard® 20mg 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.

What is in this leaflet
1.
What Nifopress Retard® Tablets are and what they are used for
2.
What you need to know before you take Nifopress Retard® Tablets
3.
How to take Nifopress Retard® Tablets
4.
Possible side effects
5.
How to store Nifopress Retard® Tablets
6.
Contents of the pack and other information
1.

What Nifopress Retard® Tablets are and what they are used for

The full name of your medicine is Nifopress Retard® 20mg Modified-release tablets, but within the
leaflet it will be referred to as Nifopress Retard® Tablets.
Nifopress Retard® Tablets contain nifedipine, which belongs to a group of medicines known as calcium
antagonists.
Nifopress Retard® Tablets are used to treat high blood pressure or angina (chest pain).
For high blood pressure: Nifopress Retard® Tablets 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: Nifopress Retard® Tablets 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.

2.

What you need to know before you take Nifopress Retard® Tablets

DO NOT take Nifopress Retard® Tablets:

If you have had a heart attack within the last month.

If you get a sudden angina attack. Nifopress Retard® Tablets will not help to relieve the
symptoms of angina quickly.

If you have unstable angina.

If you are allergic to nifedipine, any other similar medicines (known as dihydropyridines) or to
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).

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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 Nifopress Retard® Tablets if any of these applies to you.
Warning and precautions
Talk to your doctor before taking Nifopress Retard® Tablets:

If you have low blood pressure and you were prescribed Nifopress Retard® Tablets 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 Nifopress Retard® Tablets, 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 very high blood pressure and a low blood volume, you
might experience a sudden drop in blood pressure when you take Nifopress Retard® Tablets.

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 Nifopress Retard® Tablets.
Talk to your doctor before you take Nifopress Retard® Tablets 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 Nifopress Retard® Tablets.

If you have chest pain after taking your first dose of Nifopress Retard® Tablets. Your doctor
may wish to change your treatment.

If you notice increased difficulty in breathing.

If you notice swelling of the ankles.
Tell your doctor before you take the next dose if any of these applies to you.
Also tell your doctor:

If you are giving a urine sample. Nifopress Retard® Tablets may interfere with the results of
certain urine tests.

If you are a man who has not been able to father a child by in vitro fertilisation. Drugs like
Nifopress Retard® Tablets have been shown to impair sperm function.
Other medicines and Nifopress Retard® Tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription.
Some medicines may affect the way Nifopress Retard® Tablets work. Tell your doctor if you are
taking:

Other medicines used 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)
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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)

Nifopress Retard® Tablets with food and drink
You can take Nifopress Retard® Tablets either with or without food.
DO NOT drink grapefruit juice or eat grapefruit while taking Nifopress Retard® Tablets.
DO NOT start taking Nifopress Retard® Tablets 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 Nifopress Retard® Tablets. 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 Nifopress Retard® Tablets but only after special consideration and agreement
by your doctor.
DO NOT take Nifopress Retard® Tablets if you are breast-feeding. If you need to take Nifopress
Retard® Tablets , you should stop breast-feeding before you start taking this medicine.
Driving and using machines
Nifopress Retard® Tablets 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.
Nifopress Retard® Tablets contain lactose
This medicine contains lactose which is a form of sugar. 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 Nifopress Retard® Tablets

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 of nifedipine (10mg). This allows your doctor
to monitor how you are responding so that the best long-term dose can be identified.

The usual maintenance dose of Nifopress Retard® Tablets 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 2 tablets (40mg) every 12 hours.

Lower doses may be prescribed for older people.

If you have problems with your liver you are likely to be given a lower strength of nifedipine
(10mg), at least to begin with.

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.
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You can take Nifopress Retard® Tablets either with or without food.
Use in children and adolescents: Nifopress Retard® Tablets 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 Nifopress Retard® Tablets 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 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 counsciousness, possibily
leading to unconsciousness.
If you forget to take Nifopress Retard® Tablets
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 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 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 outcome)

fast heart beat (tachycardia)

itching (possibly severe), a rash or hives

shortness of breath (frequency not known) or difficulty breathing

mild to moderate allergic reactions
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

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Apart from the side effects listed above, these are the other side effects of Nifopress Retard® Tablets,
starting with the more common ones:
Common side effects
(These may affect up to 1 in 10 people)

headache

general feeling of being unwell

swelling, particularly of the ankles and legs.

flushing

constipation
Uncommon side effects
(These may affect up to 1 in 100 people)

stomach pain (abdominal pain)

unspecific pain

chills

fainting

irregular heartbeat (palpitations)

dry mouth

indigestion or upset stomach

feeling sick (nausea)

joint swelling

anxiety or nervousness

nose bleeds

sensation of spinning or whirling motion (vertigo)

dizziness

increase in the need to pass water (urinate)

inability to achieve or maintain an erection (impotence)

low blood pressure when standing up (symptoms include fainting, dizziness, light headedness,
occasional palpitations, blurred vision and sometimes confusion)

wind (flatulence)

muscle cramps

sleep disorders

reddening of the skin

nasal congestion

migraine

trembling

painful or difficult urination

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
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)
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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 Nifopress Retard® Tablets 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.

5.

How to store Nifopress Retard® Tablets

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
DO NOT use Nifopress Retard® Tablets after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.



Store in the original package in order to protect from light.
DO NOT store above 25°C.

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.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give this
medicine to someone else, it could harm them, even if their symptoms seem the same as yours.

6.

Contents of the pack and other information

What Nifopress Retard® Tablets contain

The active substance is nifedipine.

The other ingredients are polysorbate 80, maize starch, microcrystalline cellulose, lactose,
magnesium stearate, red iron oxide (E172), polyethylene glycol 4000, hydroxypropylmethyl
cellulose and titanium dioxide (E171).
What Nifopress Retard® Tablets look like and contents of the pack
Nifopress Retard® are circular biconvex coated tablets, pink-brownish in colour and embossed with
“NR” on one face and “20” on the other.
Nifopress Retard® Tablets 20mg come in pack sizes of 56, 100 or 112.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
6

Crescent Pharma Limited,
Units 3 & 4 Quidhampton Business Units,
Polhampton Lane, Overton,
Hampshire,
RG25 3ED
UK
This leaflet was last revised in 09/2016.

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Expand Transcript

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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