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NIDEF 60 MG PROLONGED RELEASE TABLETS

Active substance(s): NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nidef

60mg Prolonged Release Tablets

Nifedipine

Read all of this leaflet carefully before you start
using 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 Nidef Tablets are and what they are used for
2. What do you need to know before you take Nidef Tablets
3. How to take Nidef Tablets
4. Possible side effects
5. How to store Nidef Tablets
6. Contents of the pack and other information
1. What Nidef Tablets are and what they are used for
Nidef Tablets contain nifedipine, which belongs to a group
of medicines called calcium antagonists.
Nidef Tablets are used to treat high blood pressure or
angina (chest pain).
For high blood pressure: Nidef 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: Nidef Tablets 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 do you need to know before you take Nidef
Tablets
Do not take Nidef Tablets:
• if you have had a heart attack within the last month.
• if you get a sudden angina attack. Nidef will not help
relieve symptoms of angina quickly.
• if you have unstable angina.
• if you are allergic to the nifedipine to any other similar
medicines (known as dihydropyridines) or to any of the
other ingredients (listed in section 6), if you are taking
rifampicin, an antibiotic,
• if you have a liver disease that prevents your liver
from working properly.
• if you have inflammation of the bowel or intestines,
such as Crohn’s disease.
• if you have an obstruction or narrowing in your
intestines, or have had this in the past.
• if you have ever had an obstruction in the gullet
(the oesophagus - the tube connecting the throat to
the stomach).
• 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 you have a “Kock pouch” (a surgically constructed
intestinal reservoir with an opening through the
abdominal wall) in your gut.
• if your blood pressure continues to rise despite
treatment (malignant hypertension).
Tell your doctor and do not take Nidef if any of these
apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nidef
Tablets.
• If you have low blood pressure and you were
prescribed Nidef 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 Nidef,
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 a very high
blood pressure and a low blood volume, you might
experience a sudden drop in blood pressure when you
take Nidef.
• 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 Nidef.
Tell your doctor and do not take Nidef Tablets if any of
these apply to you.
Tell your doctor:
• if you notice severe pulmonary complaints, such as
shortness of breath or difficulty breathing.

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. Nidef Tablets may
interfere with the results of certain urine tests,
• if you are to have a barium contrast x-ray (barium
meal). These tablets may affect the results of the test,
• if you are a man who has been unable to father a
child by in vitro fertilisation. Drugs like Nidef Tablets
have been shown to impair sperm function.
Other medicines and Nidef Tablets
Tell your doctor if you are taking, have recently taken or
might take any other medicines. This includes any products
you bought without a prescription.
Some medicines may affect the way Nidef Tablets work.
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 phenobarbital 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).
Nidef Tablets with food and drink
You can take Nidef Tablets with or without food.
Do not drink grapefruit juice or eat grapefruit while
taking Nidef Tablets.
Do not start taking Nidef 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.
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
Pregnancy
Do not take Nidef Tablets if you are pregnant. If you are
pregnant, think you might be pregnant or are planning a
family, ask your doctor for advice before taking Nidef
Tablets. You may be able to use Nidef but only after
special consideration and agreement by your doctor.
Breast-feeding
Do not take Nidef Tablets if you are breast-feeding.
If you need to take Nidef, you should stop breast-feeding
before you start taking this medicine.
Driving and using machines
Nidef 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.
3. How to take Nidef Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Nidef Tablets are specially formulated so that you only
have to take one dose each day.
Nidef Tablets are not recommended for use in children.
Take the tablets as prescribed by your doctor.
• Dose for high blood pressure: the usual dose is
1 tablet, once a day.
• Dose for angina: the dose depends on your individual
requirements. Your doctor will decide how much you
should take.
• Swallow the tablets whole. Do not bite, chew or
break them – if you do they will not work properly.
If you have difficulty swallowing tablets, consult
your doctor as he or she may wish to change your
medicine.
• Continue to take these tablets for as long as your
doctor has told you to.
Take your dose at the same time each day, preferably in
the morning. Take your tablets with a glass of water. Do not
take them with grapefruit juice.
You can take Nidef Tablets with or without food.
You may see what looks like a complete tablet in the toilet
or in your stools. This is normal – it’s the outer shell of the
tablet which is not digested by the body.

Use in children and adolescents: Nidef 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 Nidef 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 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 Nidef Tablets
Take your normal dose immediately and continue taking
your tablets at the usual time of day, waiting at least
12 hours before taking the next dose.
Do not take a double dose to make up for the missed 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 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 (frequency not known) 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.
Less serious side effects
Apart from the side effects listed above, these are the
other side effects of Nidef Tablets, 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,
• 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 abnormal liver function.
Rare
(may affect up to 1 in 1,000 people)
• pins and needles,
• inflammation of the gums, tender or swollen gums,
bleeding gums.
Other
(Frequency unknown: frequency cannot be estimated
from the available data)
• stomach pain or distress caused by a mass of foreign
material found in the stomach which may require
surgery for removal,
• difficulty swallowing,

• abdominal pain, caused by obstruction of the gut or
ulcers in the gut,
• 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),
• yellowing of the whites of the eyes or skin,
• 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 Nidef 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store Nidef Tablets
Keep this medicine out of the reach and sight of children.
Store in the original container.
Do not use after the expiry date which is stated on both the
outer carton and on each blister strip of tablets. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater. 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 Nidef Tablets contain
- The active substance is nifedipine.
- The other excipients are polyethylene oxide,
hydroxypropyl methylcellulose (E464), sodium chloride,
magnesium stearate (E572), ferric oxide (E172),
magnesium stearate, cellulose acetate, polyethylene
glycol (E1521), hydroxypropyl cellulose (E463),
hypromellose (E464), titanium dioxide (E171), talc
(E553b), iron oxide red (E172).
What Nidef Tablets look like and contents of the pack
Each prolonged-release tablet contains 60 mg of
nifedipine.
Each tablet is pink coloured, film coated, circular and
biconvex, having an orifice on one side and plain on the
other side.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way
Loughborough
LE11 5GW
UK
This leaflet was last revised in January 2018.

M0229LAMUKNAB1-S-001

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