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NIFEDIPINE 10MG CAPSULES

Active substance(s): NIFEDIPINE / NIFEDIPINE

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TEVA UK Ref:

Version:

231-30-46614-F LEA NIFEDIPINE A/S CAP TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

02 August 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

Tell your doctor before you take the next dose
if any of these apply to you.

Package leaflet: Information for the user

Also tell your doctor:
• If you are giving a urine sample. Nifedipine
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 nifedipine have been shown to impair
sperm function.

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.

Pharma code 544

Tell your doctor or pharmacist if you are taking
have recently taken or might take any of the
following:
• erythromycin or quinupristin and dalfopristin
(antibacterial drugs)
What is in this leaflet:
• ketoconazole, itraconazole or fluconazole
1. What Nifedipine is and what it is used for
(anti-fungal drugs)
2. What you need to know before you take
• fluoxetine or nefazodone (antidepressants)
Nifedipine
• indinavir, nelfinavir, ritonavir, amprenavir or
3. How to take Nifedipine
saquinavir (drugs used to treat HIV)
4. Possible side effects
• tacrolimus (used following organ transplant)
5. How to store Nifedipine
• cisapride (to treat heartburn and
6. Contents of the pack and other information
inflammation of the gullet)
• cimetidine (for stomach ulcers)
Nifedipine is and what it is
1 What
• quinidine or digoxin (for the heart), diltiazem
used for
(a heart drug), or any other drugs to control
blood pressure
• Nifedipine is a selective calcium channel
• phenytoin, carbamazepine, valproic acid or
blocker. It slows the rate at which calcium
phenobarbitone (for epilepsy)
flows into cells, and thus modifies the
• magnesium sulphate injections during
contraction of muscles, particularly heart
pregnancy (may cause a severe fall in blood
muscle and causes a reduction in blood
pressure)
pressure.
• diuretics, β-blockers, ACE-inhibitors,
Nifedipine is used:
angiotensin 1(AT1) receptor antagonists,other
• to prevent angina attacks in patients
calcium antagonists, α-adrenergic blocking
suffering from chronic stable angina.
agents,PDE5 inhibitors, α-methyldopa (blood
• for the treatment of high blood pressure and
pressure lowering drugs)
to improve the circulation to the limbs e.g. in
the treatment of Raynaud’s phenomenon,
Please tell your doctor or pharmacist if you are
where poor blood circulation makes toes
taking or have recently taken any other
and fingers numb and pale.
medicines, including medicines obtained
without a prescription.
What you need to know before you

2

take Nifedipine

Do not take Nifedipine :
• If you are allergic to active substance(s) or
any of the other ingredients of this medicine
(listed in section 6) or other dihydropyridines
e.g. nicardipine, felodipine
• If you have significant aortic stenosis
(abnormal narrowing of the aortic valve in
the heart)
• If you have unstable angina pectoris(chest pain)
• If you have had a heart attack within the last
month
• If you are currently having an acute angina
(chest pain) attack
• If you are pregnant or able/planning to
become pregnant, or are breast-feeding
• If you are taking rifampicin (an antibiotic
used to treat tuberculosis)
• If you have suffered a collapse of your blood
circulation system (cardiovascular shock)
• If you experience increase in the blood
pressure despite treatment (malignant
hypertension)
Take special care with Nifedipine
Warnings and precautions
Talk to your doctor before taking Nifedipine if
you:
• are diabetic
• have severe high or low blood pressure
• have poor cardiac reserve (a reduction in the
ability of the heart to do work)
• are on dialysis and have very high blood
pressure and low blood volume
• have liver problems. Your doctor may need
to do some blood tests. You may also be
given a lower dose of nifedipine.
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 nifedipine
• If you have chest pains after taking your first
dose of nifedipine. Your doctor may wish to
change your treatment
• If you notice increased breathlessness
• If you notice swelling of the ankles

REG0048588

Other medicines and Nifedipine
Do not take Nifedipine if you are taking rifampicin
(an antibiotic used to treat tuberculosis).

Version 5.5

Important information about some of the
ingredients of Nifedipine
• Nifedipine capsules contain E110 (sunset
yellow) which may cause allergic reactions.
Nifedipine with food, drink and alcohol
Do not take Nifedipine capsules with grapefruit
juice, because this affects the amount of
nifedipine which enters the bloodstream.
Pregnancy , breast-feeding and fertility
If you are pregnant or breast-feeding, 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 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 recommended dose is:
• Adults
5 mg every 8 hours. The dose may be
adjusted according to response up to 20 mg
every 8 hours.
• Elderly
A lower maintenance dose of Nifedipine may
be required in the elderly.
• 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
Nifedipine

TEVA UK Ref:

Version:

231-30-46614-F LEA NIFEDIPINE A/S CAP TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

Colours Used:

02 August 2016

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.

Rare: (may affect up to 1 in 1,000 people)
• Itching, nettle rash
• pins and needles
• inflammation of the gums, tender or swollen
gums, bleeding gums.

Not known: (frequency cannot be estimated
from the available data)
• a more severe decrease in a specific class of
white blood cell (agranulocytosis)
• a reduction in the number of white blood
cells (leucopenia)
• sensitivity to light (photosensitivity allergic
reaction)
• small, raised areas of bleeding in the skin
(palpable purpura)
• increased blood sugar (hyperglycaemia)
If you forget to take Nifedipine
• decreased skin sensitivity (hypoaesthesia)
If you forget to take a capsule, take one as
soon as you remember, unless it is nearly time • drowsiness (somnolence)
to take the next one. Do not take a double dose • eye pain
• chest pain (angina pectoris)
to make up for a forgotten dose.
• shortness of breath (dyspnoea)
If you stop taking Nifedipine
• vomiting
Do not stop taking your medicine without
• heartburn or indigestion (gastroesophageal
talking to your doctor first even if you feel better.
sphincter insufficiency)
If you have any further questions on the use of • yellowing of the whites of the eyes or skin
this medicine, ask your doctor or pharmacist.
(jaundice)
• joint pain
Possible
side
effects
• muscle pain
4
• excess collection of watery fluid in the lungs
Like all medicines, this medicine can cause side
Reporting of side effects
effects, although not everybody gets them.
If you get any side effects, talk to your doctor
If the following happens, stop taking the capsules or pharmacist. This includes any possible side
and tell your doctor immediately or go to the
effects not listed in this leaflet. You can also
casualty department at your nearest hospital:
report side effects directly via the Yellow Card
• an allergic reaction (swelling of the lips, face Scheme at: www.mhra.gov.uk/yellowcard
or neck leading to severe difficulty in
By reporting side effects you can help provide
breathing; skin rash or nettle rash)
more information on the safety of this medicine.
• a skin reaction or blistering / peeling of the
skin and/or mucosal reactions (in the
5 How to store Nifedipine
mouth/nose or at the penis/vagina) (Toxic
Epidermal Necrolysis).
Keep this medicine out of the sight and reach
of children.
This is a very serious but rare side effect. You
may need urgent medical attention or
Store in the original package.
hospitalisation.
Do not store above 25°C. Do not use this
medicine after the expiry date which is stated
• Talk to your doctor immediately if you get
on the outer packaging. The expiry date refers
increasing chest pain shortly after taking
to the last 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
no longer use. These measures will help
Common: (may affect up to 1 in 10 people )
protect the environment.
• headache
• swelling of the hands , feet and ankles
of the pack and other
6 Contents
• widening of blood vessels (vasodilatation)
information
• constipation
What Nifedipine capsules contain:
• general feeling of being unwell
• The active ingredient is either 5 mg or 10 mg
Uncommon: (may affect up to 1 in 100 people)
of nifedipine.
• anxiety or nervousness
• The other ingredients are polyethylene
• sleep disorders
glycol 400, glycerol (E422), peppermint oil
• vertigo (a feeling of dizziness or “spinning”)
and sodium saccharin (E954). The capsule
• migraine
shell contains gelatin, glycerol (E422), and
• dizziness
the colours titanium dioxide (E171), sunset
• shaking
yellow (E110) and erythrosine (E127). The
• agitation
white printing ink contains propylene glycol,
• problems with sight
titanium dioxide (E171), polyvinyl acetate
• irregular heartbeats (palpitations)
phthalate and polyethylene glycol.
• low blood pressure on standing (symptoms
include fainting, dizziness, light headedness, What Nifedipine capsules look like and
contents of the pack:
occasional palpitation, blurred vision and
• Nifedipine 5 mg capsules are opaque, oval,
sometimes confusion)
soft gelatin capsules containing an orange
• fainting (syncope)
liquid. Overprinted 2L3 in white.
• nose bleeds
• Nifedipine 10 mg capsules are opaque,
• nasal congestion
oblong, soft gelatin capsules containing an
• stomach pain (abdominal pain)
orange liquid. Overprinted 2L4 in white.
• wind
• The products are available in packs of 7, 10,
• feeling sick (nausea)
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
• dry mouth
120, 150, 160 and 168. Not all pack sizes may
• indigestion or heartburn, diarrhoea or other
be marketed.
stomach problems
• temporary increase in certain liver enzymes Marketing Authorisation Holder and
• reddening of the skin
Manufacturer
• sweating
Marketing Authorisation Holder and company
• muscle cramps
responsible for manufacture is Teva UK
• joint swelling
Limited, Eastbourne, BN22 9AG.
• increase in the need to pass water (urinate)
This leaflet was last revised: July 2016
• painful or difficult urination
PL 00289/0745-6
• inability to achieve or maintain erection
(impotence)
• unspecific pain
• chills
• lethargy
46614-F
160 x 323

REG0048588

Version 5.5

Approved

Page 2 of 3

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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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