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NIFEDIPINE 10MG CAPSULES

Active substance(s): NIFEDIPINE

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TEVA UK Ref:

Version:

231-30-46614-E LEA NIFEDIPINE A/S CAP TUK

1

09 JUNE 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
again.
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
doctor or pharmacist.
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
s )FANYSIDEEFFECTSTALKTOYOURDOCTOROR
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:

1. What Nifedipine is and what it is used for
2. What you need to know before you take
Nifedipine
3. How to take Nifedipine
4. Possible side effects
5. How to store Nifedipine
6. Contents of the pack and other information
Pharma code 544

1

WHAT NIFEDIPINE IS AND WHAT IT IS
USED FOR

s .IFEDIPINEISASELECTIVECALCIUMCHANNEL
blocker. It slows the rate at which calcium
flows into cells, and thus modifies the
contraction of muscles, particularly heart
muscle and causes a reduction in blood
pressure.
s .IFEDIPINEISUSED
s TOPREVENTANGINAATTACKSINPATIENTS
suffering from chronic stable angina
s FORTHETREATMENTOFHIGHBLOODPRESSURE
and to improve the circulation to the
limbs e.g. in the treatment of Raynaud’s
phenomenon, where poor blood circulation
makes toes and fingers numb and pale.

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NIFEDIPINE

Do NOT take Nifedipine:
s IFYOUAREALLERGICHYPERSENSITIVE TO
nifedipine or any of the other ingredients of
this medicine or other dihydropyridines e.g.
nicardipine, felodipine
s IFYOUHAVESIGNIFICANTAORTICSTENOSIS
(abnormal narrowing of the aortic valve in
the heart)
s IFYOUHAVEUNSTABLEANGINAPECTORISCHEST
pain)
s IFYOUHAVEHADAHEARTATTACKWITHINTHELAST
month
s IFYOUARECURRENTLYHAVINGANACUTEANGINA
(chest pain) attack
s IFYOUAREPREGNANTORABLEPLANNINGTO
become pregnant, or are breast-feeding
s IFYOUARETAKINGRIFAMPICINANANTIBIOTIC
used to treat tuberculosis)
s if you have suffered a collapse of your blood
circulation system (cardiovascular shock)
s IFYOUEXPERIENCEINCREASEINTHEBLOOD
pressure despite treatment (malignant
hypertension).
Take special care with Nifedipine
Warnings and precautions
Talk to your doctor before taking Nifedipine if
you:
s AREDIABETIC
s HAVESEVEREHIGHORLOWBLOODPRESSURE
s HAVEPOORCARDIACRESERVEAREDUCTIONIN
the ability of the heart to do work)
s AREONDIALYSISANDHAVEVERYHIGHBLOOD
pressure and low blood volume
s HAVELIVERPROBLEMS9OURDOCTORMAYNEED
to do some blood tests. You may also be
given a lower dose of nifedipine.
Tell your doctor:
s IFYOURCHESTPAINANGINA GETSWORSE
(comes on more often or more severely)
over a matter of hours or days. You may be
advised not to take nifedipine.
s IFYOUHAVECHESTPAINSAFTERTAKINGYOURFIRST
dose of nifedipine. Your doctor may wish to
change your treatment.
s IFYOUNOTICEINCREASEDBREATHLESSNESS
s IFYOUNOTICESWELLINGOFTHEANKLES

REG0048588

Version 4.2

Tell your doctor before you take the next dose
if any of these apply to you.
Also tell your doctor:
s if you are giving a urine sample. Nifedipine
may interfere with the results of certain
urine tests.
s IFYOUAREAMANWHOHASBEENUNABLETO
father a child by in vitro fertilisation.
Drugs like nifedipine have been shown to
impair sperm function.
Other medicines and Nifedipine
Do NOT take Nifedipine if you are taking
rifampicin (an antibiotic used to treat
tuberculosis).
Tell your doctor or pharmacist if you are taking
have recently taken or might take any of the
following:
s ERYTHROMYCINORQUINUPRISTINAND
dalfopristin (antibacterial drugs)
s KETOCONAZOLE ITRACONAZOLEORFLUCONAZOLE
(anti-fungal drugs)
s FLUOXETINEORNEFAZODONEANTIDEPRESSANTS
s INDINAVIR NELFINAVIR RITONAVIR AMPRENAVIROR
saquinavir (drugs used to treat HIV)
s QUINUPRISTINDALFOPRISTINANTIBIOTICS
s tacrolimus (used following organ transplant)
s CISAPRIDETOTREATHEARTBURNAND
inflammation of the gullet)
s CIMETIDINEFORSTOMACHULCERS
s QUINIDINEORDIGOXINFORTHEHEART
diltiazem (a heart drug), or any other drugs
to control blood pressure
s PHENYTOIN CARBAMAZEPINE VALPROICACIDOR
phenobarbitone (for epilepsy)
s MAGNESIUMSULPHATEINJECTIONSDURING
pregnancy (may cause a severe fall in blood
pressure)
s DIURETICS β-blockers, ACE-inhibitors,
angiotensin 1(AT1) receptor antagonists,
other calcium antagonists, α-adrenergic
blocking agents, PDE5 inhibitors,
α-methyldopa (blood pressure lowering
drugs).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Important information about some of the
ingredients of Nifedipine
s .IFEDIPINECAPSULESCONTAIN%SUNSET
yellow) which may cause allergic reactions.
Nifedipine with food, drink and alcohol
Do NOT take Nifedipine capsules with
GRAPEFRUITJUICE BECAUSETHISAFFECTSTHEAMOUNT
of nifedipine which enters the bloodstream.
Pregnancy , breast-feeding and fertility
Do NOT take Nifedipine if you are pregnant or
breast-feeding, think you maybe pregnant or
are planning to have a baby, ask your doctor
for advice before taking any medicine.
You may be able to use nifedipine capsules after
week 20 of your pregnancy, but only after special
consideration and agreement by your doctor.
Driving and using machines
Nifedipine may cause effects such as visual
disturbances, drowsiness and low blood
pressure particularly at the start of treatment,
on changing from another medication, or if
taken in combination with alcohol; these
effects can affect your ability to drive or
operate machinery. If affected, do NOT drive or
operate machinery.

3

HOW TO TAKE NIFEDIPINE

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The capsules should be swallowed preferably
with a glass of water.
The usual dose is:
s Adults
5 mg every 8 hours. The dose may be
ADJUSTEDACCORDINGTORESPONSEUPTO
20 mg every 8 hours.
s Elderly
A lower maintenance dose of Nifedipine
may be required in the elderly.
s Children
Nifedipine 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.

Approved

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

NIFEDIPINE 5 mg AND
10 mg CAPSULES

TEVA UK Ref:

Version:

231-30-46614-E LEA NIFEDIPINE A/S CAP TUK

1

09 JUNE 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Rare (affecting fewer than one person in 1000
but more than one person in 10,000)
s ITCHING NETTLERASH
s PINSANDNEEDLES
s INFLAMMATIONOFTHEGUMS TENDEROR
swollen gums, bleeding gums.
Other side effects (Frequency unknown)
s AMORESEVEREDECREASEINASPECIFICCLASSOF
white blood cell (agranulocytosis)
s AREDUCTIONINTHENUMBEROFWHITEBLOOD
cells (leucopenia)
s SENSITIVITYTOLIGHTPHOTOSENSITIVITYALLERGIC
reaction)
s SMALL RAISEDAREASOFBLEEDINGINTHESKIN
(palpable purpura)
s INCREASEDBLOODSUGARHYPERGLYCAEMIA
s DECREASEDSKINSENSITIVITYHYPOAESTHESIA
s DROWSINESSSOMNOLENCE
s EYEPAIN
s CHESTPAINANGINAPECTORIS
s SHORTNESSOFBREATHDYSPNOEA
s VOMITING
s HEARTBURNORINDIGESTIONGASTROESOPHAGEAL
sphincter insufficiency)
s YELLOWINGOFTHEWHITESOFTHEEYESORSKIN
JAUNDICE
s JOINTPAIN
4 POSSIBLE SIDE EFFECTS
s MUSCLEPAIN
Like all medicines, this medicine can cause
Reporting of side effects
side effects, although not everybody gets them. If you get any side effects, talk to your doctor,
If the following happens, stop taking the
pharmacist or nurse. This includes any possible
capsules and tell your doctor immediately or
side effects not listed in this leaflet. You can
go to the casualty department at your nearest also report side effects directly via the Yellow
hospital:
#ARD3CHEMEATWWWMHRAGOVUKYELLOWCARD
s ANALLERGICREACTIONSWELLINGOFTHELIPS FACE By reporting side effects you can help provide
or neck leading to severe difficulty in
more information on the safety of this
breathing; skin rash or nettle rash)
medicine.
s ASKINREACTIONORBLISTERINGPEELINGOFTHE
SKINANDORMUCOSALREACTIONSINTHE
5 HOW TO STORE NIFEDIPINE
MOUTHNOSEORTHEPENISVAGINA (Toxic
Keep this medicine out of the sight and reach
Epidermal Necrolysis).
of children.
This is a very serious but rare side effect. You
Store in the original package.
may need urgent medical attention or
Do not store above 25°C. Do not use Nifedipine
hospitalisation.
after the expiry date that is stated on the outer
s 4ALKTOYOURDOCTORIMMEDIATELYIFYOUGET
packaging. The expiry date refers to the last
increasing chest pain shortly after taking
day of that month.
Nifedipine.
Do not throw away any medicines via
The following side effects have been reported
wastewater or household waste. Ask your
at the approximate frequencies shown:
pharmacist how to throw away medicines you
Common (affecting fewer than one person in
no longer use. These measures will help
ten but more than one person in 100)
protect the environment.
s HEADACHE
s SWELLINGOFTHEHANDS FEETANDANKLES
OF THE PACK AND OTHER
6 CONTENTS
s widening of blood vessels (vasodilatation)
INFORMATION
s CONSTIPATION
What Nifedipine capsules contain:
s GENERALFEELINGOFBEINGUNWELL
s 4HEACTIVEINGREDIENTISEITHERMGOR
Uncommon (affecting fewer than one person
10 mg of nifedipine
in 100 but more than one person in 1000)
s 4HEOTHERINGREDIENTSAREPOLYETHYLENE
s ANXIETYORNERVOUSNESS
glycol 400, glycerol (E422), peppermint oil
s SLEEPDISORDERS
and sodium saccharin (E954). The capsule
s vertigo (a feeling of dizziness or “spinning”)
shell contains gelatin, glycerol (E422), and
s MIGRAINE
the colours titanium dioxide (E171), sunset
s DIZZINESS
yellow (E110) and erythrosine (E127). The
s SHAKING
white printing ink contains propylene
s AGITATION
glycol, titanium dioxide (E171), polyvinyl
s PROBLEMSWITHSIGHT
acetate phthalate and polyethylene glycol.
s IRREGULARHEARTBEATSPALPITATIONS
s LOWBLOODPRESSUREONSTANDINGSYMPTOMS What Nifedipine capsules look like and
include fainting, dizziness, light headedness, contents of the pack:
s .IFEDIPINEMGCAPSULESAREOPAQUE OVAL
occasional palpitation, blurred vision and
soft gelatin capsules containing an orange
sometimes confusion)
liquid. Overprinted 2L3 in white.
s FAINTINGSYNCOPE
s .IFEDIPINEMGCAPSULESAREOPAQUE
s NOSEBLEEDS
oblong, soft gelatin capsules containing an
s NASALCONGESTION
orange liquid. Overprinted 2L4 in white.
s STOMACHPAINABDOMINALPAIN
s 4HEPRODUCTSAREAVAILABLEINPACKSOF 
s WIND
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
s FEELINGSICKNAUSEA
120, 150, 160 and 168.
s DRYMOUTH
s INDIGESTIONORHEARTBURN DIARRHOEAOROTHER Not all pack sizes may be marketed.
Marketing Authorisation Holder and
stomach problems
s TEMPORARYINCREASEINCERTAINLIVERENZYMES Manufacturer
Marketing Authorisation Holder and company
s REDDENINGOFTHESKIN
responsible for manufacture is TEVA UK
s SWEATING
Limited, Eastbourne, BN22 9AG.
s MUSCLECRAMPS
s JOINTSWELLING
This leaflet was last revised: 04/2014.
s INCREASEINTHENEEDTOPASSWATERURINATE PL 00289/0745-6
s PAINFULORDIFFICULTURINATION
s INABILITYTOACHIEVEORMAINTAINERECTION
(impotence)
s UNSPECIFICPAIN
s CHILLS
s LETHARGY
If you take more Nifedipine than you should
If you (or someone else) swallow a lot of the
capsules all together, or if you think a child has
swallowed any of the capsules, contact your
nearest hospital casualty department or your
doctor immediately. An overdose is likely to
cause severe low blood pressure and very fast
heart rate or very slow heart rate. Additional
signs include nausea, vomiting, drowsiness,
dizziness, confusion, tiredness, flushing and
unconsciousness. Please take this leaflet, any
remaining capsules and the container with you
to the hospital or doctor so that they know
which capsules were consumed.
If you forget to take Nifedipine
If you forget to take a capsule, take one as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Nifedipine
Do not stop taking your medicine without
talking to your doctor first even if you feel
better.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

46614-E
160 x 323

REG0048588

Version 4.2

Approved

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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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