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NIDEF 30 MG PROLONGED RELEASE TABLETS

Active substance(s): NIFEDIPINE / NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

If you take more Nidef Tablets than you should
!
painful or difficult urination,
Get medical help immediately. If possible, take your tablets or
!
inability to achieve or maintain an erection,
the box with you to show the doctor. Taking too many tablets
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blurred vision,
Nidef 30mg Prolonged Release Tablets
may cause your blood pressure to become too low and your
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temporary abnormal liver function.
Nifedipine
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
Rare
Read all of this leaflet carefully before you start using this
Some medicines may affect the way Nidef Tablets work. Tell your
your blood, swelling in the lungs, low blood oxygen levels and
(may affect up to 1 in 1,000 people)
medicine because it contains important information for you.
doctor if you are taking:
disturbances in consciousness, possibly leading to
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pins and needles,
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Keep this leaflet. You may need to read it again.
!
Beta-blockers (to treat heart conditions or high blood
unconsciousness.
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inflammation of the gums, tender or swollen gums, bleeding
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If you have any further questions, ask your doctor or
pressure),
gums.
pharmacist.
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Other medicines to treat high blood pressure,
If you forget to take Nidef Tablets
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This medicine has been prescribed for you only. Do not pass
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Rifampicin (an antibiotic),
Take your normal dose immediately and continue taking your
Other
it on to others. It may harm them, even if their signs of illness
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Cimetidine (to treat stomach ulcers),
tablets at the usual time of day, waiting at least 12 hours before
(Frequency unknown)
are the same as yours.
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Digoxin (to treat heart conditions),
taking the next dose.
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stomach pain or distress caused by a mass of foreign
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If you get any side effects, talk to your doctor or pharmacist.
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Quinupristin/dalfopristin (a combination antibiotic),
material found in the stomach which may require surgery for
This includes any possible side effects not listed in this
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Phenytoin, carbamazepine phenobarbital or valproic acid (to
Do not take a double dose to make up for the missed dose.
removal,
leaflet. See section 4.
treat epilepsy),
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difficulty swallowing,
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Cisapride (to treat reduced movements of the gullet and
4. Possible side effects
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abdominal pain, caused by obstruction of the gut or ulcers in
What is in this leaflet
stomach),
the gut,
1. What Nidef Tablets are and what they are used for
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Magnesium sulphate injections during pregnancy (may cause
Like all medicines, this medicine can cause side effects,
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vomiting,
2. What do you need to know before you take Nidef Tablets
a severe fall in blood pressure),
although not everybody gets them.
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a reduction in the number of white blood cells,
3. How to take Nidef Tablets
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Erythromycin (an antibiotic),
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a more severe decrease in a specific class of white blood
4. Possible side effects
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Ketoconazole, itraconazole or fluconazole (anti-fungal
Serious side effects
cell,
5. How to store Nidef Tablets
medicines),
If you notice:
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increased blood sugar,
6. Contents of the pack and other information
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Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to
severe, sudden generalised allergic reaction including very
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decreased skin sensitivity,
treat HIV),
rarely life-threatening shock (e.g. difficulty in breathing, drop
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drowsiness,
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Fluoxetine or nefazodone (to treat depression),
1. What Nidef Tablets are and what they are used for
of blood pressure, fast pulse), swelling (including potentially
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eye pain,
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Tacrolimus (to prevent the rejection of transplanted organs).
life-threatening swelling of the airway),
chest pain,
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Nidef Tablets contain nifedipine, which belongs to a group of
other allergic reactions causing swelling under the skin
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yellowing of the whites of the eyes or skin,
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medicines called calcium antagonists.
Nidef Tablets with food and drink
(possibly severe and including swelling of the larynx that may
sensitivity to light,
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You can take Nidef Tablets with or without food.
result in a life-threatening outcome),
small, raised areas of bleeding in the skin,
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Nidef Tablets are used to treat high blood pressure or angina
shortness of breath or difficulty breathing,
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joint pain,
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(chest pain).
Do not drink grapefruit juice or eat grapefruit while taking Nidef
itching (possibly severe), a rash or hives.
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muscle pain.
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For high blood pressure: Nidef Tablets work by relaxing and
Tablets.
expanding the blood vessels. This makes the blood flow more
Contact your doctor immediately and do not take the next
All of these symptoms usually go away when treatment with
easily and lowers blood pressure. Lower blood pressure reduces
Do not start taking Nidef Tablets within 3 days of drinking
dose as these may be the first signs of allergic reaction which
Nidef Tablets is stopped.
the strain on your heart.
grapefruit juice or eating grapefruit. Tell your doctor if you have
may become severe.
For angina: Nidef Tablets work by relaxing and expanding the
had grapefruit or grapefruit juice in this time. Grapefruit juice is
Reporting of side effects
arteries supplying the heart. This allows more blood and oxygen
known to increase the blood levels of the active ingredient,
If you develop:
If you get any side effects, talk to your doctor or pharmacist. This
to reach the heart and decreases the strain on it. Your angina
nifedipine. This effect can last for at least 3 days.
a skin reaction or blistering / peeling of the skin and/or
!
includes any possible side effects not listed in this leaflet. You
attacks will be less severe and less frequent if there is less strain
mucosal reactions (in the mouth/nose or at the penis/vagina).
can also report side effects directly via Yellow Card Scheme at:
on the heart.
Pregnancy and Breast-feeding
www.mhra.gov.uk/yellowcard
You must talk to a doctor if you do not feel better or if you feel
Pregnancy
Contact your doctor immediately before you continue
By reporting side effects you can help provide more information
worse.
Do not take Nidef Tablets if you are pregnant. If you are
treatment as these may be signs of a severe reaction.
on the safety of this medicine.
pregnant, think you might be pregnant or are planning a family,
tell your doctor before taking Nidef Tablets.
2. What do you need to know before you take Nidef Tablets
Tell your doctor if:
5. How to store Nidef Tablets
your chest pain (angina) gets worse (comes on more often or
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Do not take Nidef Tablets:
Breast-feeding
more severely) over a matter of hours or days. You may be
Keep this medicine out of the sight and reach of children.
if you are allergic to the active ingredient (nifedipine), to any
Do not take Nidef Tablets if you are breast-feeding as nifedipine
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advised not to take Nidef Tablets,
other similar medicines (known as dihydropyridines) or to any
is passed into the mother's milk.
you have chest pains after taking your first dose of Nidef
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Store in the original container.
of the other ingredients of this medicine (listed in section 6),
Tablets. Your doctor may wish to change your treatment,
if you have inadequate blood circulation due to a poor heart,
Driving and using machines
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you notice increased breathlessness,
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Do not use after the expiry date which is stated on both the outer
Nidef Tablets may make you feel dizzy, faint, extremely tired or
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if you are taking rifampicin, an antibiotic,
you notice swelling of the ankles.
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carton and on each blister strip of tablets. The expiry date refers
have visual disturbances. Do not drive or operate machinery if
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if you have an obstruction or narrowing in your intestines, or
to the last day of that month.
you are affected in this way. This may be more likely when you
have had this in the past.
Tell your doctor before you take the next dose if any of these
first start treatment, if you change tablets, or if you have drunk
apply to you.
Do not throw away any medicines via wastewater. Ask your
alcohol.
Warnings and precuations
pharmacist how to throw away medicines you no longer use.
Talk to your doctor or pharmacist before taking Nidef Tablets.
Less serious side effects
These measures will help protect the environment.
3. How to take Nidef Tablets
Apart from the side effects listed above, these are the other side
Tell your doctor and do not take Nidef Tablets if any of these
effects of Nidef Tablets, starting with the more common ones:
6. Contents of the pack and other information
Always take this medicine exactly as your doctor or pharmacist
apply to you.
has told you. Check with your doctor or pharmacist if you are not
Common
What Nidef Tablets contain
sure.
Special precautions
(may affect up to 1 in 10 people)
!
The active substance is nifedipine
Take special care with Nidef Tablets:
headache,
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The other excipients are polyethylene oxide, hydroxypropyl
Nidef Tablets are specially formulated so that you only have to
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if you have low blood pressure,
flushing,
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methylcellulose (E464), sodium chloride, magnesium stearate
take one dose each day.
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if you have been told that you have a narrowing of the aortic
general feeling of being unwell,
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(E572), ferric oxide (E172), magnesium stearate, cellulose
Nidef Tablets are not recommended for use in children. Take the
heart valve (stenosis),
constipation,
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acetate, polyethylene glycol (E1521), hydroxypropyl cellulose
tablets as prescribed by your doctor.
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if you suffer from heart failure,
swelling, particularly of the ankles and legs.
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(E463), hypromellose (E464), titanium dioxide (E171), talc
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Dose for high blood pressure: the usual dose is 1 tablet,
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if you are breastfeeding,
(E553b), iron oxide red (E172).
once a day.
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if you have a liver disease that prevents your liver from
Uncommon
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Dose for angina: the dose depends on your individual
working properly,
(may affect up to 1 in 100 people)
What Nidef Tablets look like and contents of the pack
requirements. Your doctor will decide how much you should
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if you have a “Kock pouch” (a surgically constructed intestinal
stomach pain (abdominal pain),
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Each prolonged release tablet contains 30 mg of nifedipine.
take.
reservoir with an opening through the abdominal wall) in your
unspecific pain,
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Each tablet is pink coloured, film coated, circular and biconvex,
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Swallow the tablets whole. Do not bite, chew or break
gut.
chills,
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having an orifice on one side and plain on the other side.
them if you do they will not work properly. If you have
low blood pressure when standing up (symptoms include
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difficulty swallowing tablets, consult your doctor as he or she
Talk to your doctor before you take Nidef Tablets if any of these
fainting, dizziness, light headedness, occasional palpitations,
Marketing Authorisation Holder
may wish to change your medicine.
apply to you.
blurred vision and sometimes confusion),
Morningside Healthcare Ltd
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Continue to take these tablets for as long as your doctor
fainting,
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115 Narborough Road
has told you to.
Tell your doctor:
irregular heartbeat,
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Leicester
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if you notice severe pulmonary complaints, such as
dry mouth,
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LE3 0PA
Take your dose at the same time each day, preferably in the
shortness of breath or difficulty breathing.
indigestion or upset stomach,
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UK
morning.
wind,
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Take your tablets with a glass of water. Do not take them with
Also tell your doctor:
feeling sick,
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Manufacturer
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grapefruit juice.
if you are giving a urine sample. Nidef Tablets may interfere
muscle cramps,
!
Morningside Pharmaceuticals Ltd.
You can take Nidef Tablets with or without food.
with the results of certain urine tests,
joint swelling,
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5 Pavilion Way
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You may see what looks like a complete tablet in the toilet or in
if you are to have a barium contrast x-ray (barium meal).
sleep disorders,
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Loughborough
your stools. This is normal it's the outer shell of the tablet which
These tablets may affect the results of the test,
!
anxiety or nervousness,
LE11 5GW
is not digested by the body.
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if you are a man who has been unable to father a child by in
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reddening of the skin,
UK
vitro fertilisation. Drugs like Nidef Tablets have been shown
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nose bleeds,
Use in children and adolescents: Nidef tablets are not
to impair sperm function.
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nasal congestion,
This leaflet was last revised in August 2016.
recommended for use in children and adolescents below 18
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sensation of spinning or whirling motion,
years of age, because there are only limited data on the safety
Other medicines and Nidef Tablets
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migraine,
and efficacy in this population.
Tell your doctor about any other medicines that you are taking,
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dizziness,
or have recently taken or might take any other medicines. This
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trembling,
includes any products you bought without a prescription.
!
increase in the need to pass water,

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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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