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NIFEDIPINE CAPSULES 5MG

Active substance(s): NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NIFEDIPINE CAPSULES
5mg and 10mg
[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,
pharmacist or nurse.
 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
or nurse. This includes any side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Nifedipine Capsules are and what they are used for
2. What you need to know before you take Nifedipine
Capsules
3. How to take Nifedipine Capsules
4. Possible side effects
5. How to store Nifedipine Capsules
6. Contents of the pack and other information
1. WHAT NIFEDIPINE CAPSULES ARE AND WHAT THEY
ARE USED FOR
The active ingredient, nifedipine, is one of a group of
medicines called calcium antagonists. These relax and
expand blood vessels.
Nifedipine Capsules are used for:
 High blood pressure
 To reduce the frequency of angina attacks
 Raynaud’s phenomenon, a condition in which the
circulation of blood to fingers and toes is reduced.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NIFEDIPINE CAPSULES
Do not take Nifedipine
 If you are allergic to nifedipine or any of the other
ingredients of this medicine (listed in section 6)
 If you have previously had an allergic reaction to the active
ingredient nifedipine or to any other similar drugs (known
as dihydropyridines). If you are unsure about this, ask your
doctor
 If you are taking the antibiotic, rifampicin
 If you have been told that you have a narrowing (stenosis)
of the aortic valve of the heart or have experience a
collapse which was caused by a heart problem
 For the treatment of a heart attack or within one month of a
heart attack
 To treat an angina attack
 If your blood pressure is continuing to rise despite
treatment. This is a condition known as malignant
hypertension.
If the severity or frequency of your angina has rapidly
worsened over a matter of hours or days, you must contact a
doctor. You may be advised not to take Nifedipine Capsules.
If you are unsure whether you might have any of these
conditions, please ask your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Nifedipine Capsules:
 If you experience chest pains within 30-60 minutes of
taking your FIRST dose of nifedipine, contact your doctor
BEFORE YOU TAKE THE NEXT DOSE as he may change
your treatment
 If you suffer with angina you may notice an increase in the
number and severity of the angina attacks at the start of
treatment with nifedipine
 If you are taking other medicines that affect the way your
body metabolises nifedipine (see section: Other medicines
and Nifedipine Capsules)
 If you have impaired liver function
 If you are pregnant
 If you are breast-feeding
 If you are pregnant and have to have intravenous
magnesium sulphate as there may be a sudden fall in
blood pressure.
Please tell your doctor if you:
 Suffer from low blood pressure and have nifedipine
prescribed for angina or Raynaud’s syndrome

 Heart condition where your heart cannot cope with
increased strain (poor cardiac reserve), or your heart
condition gets worse
 Have increased breathlessness or swelling of the ankles
 Are a diabetic as your treatment may need to be adjusted
 Are having dialysis and have a very high blood pressure as
you may experience a sudden drop in blood pressure.
Your doctor may want to monitor your blood pressure during
treatment with Nifedipine Capsules.
Also tell your doctor:
 If you are giving a urine sample as nifedipine may interfere
with the results of certain urine tests
 If you are a man who has been unable to father a child
by IVF. Drugs like nifedipine have been shown to impair
sperm function
Other medicines and Nifedipine Capsules:
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. In particular, tell your
doctor or pharmacist if you are taking:
 Other drugs to treat high blood pressure
 Cimetidine, to treat stomach ulcers
 The medicines digoxin, diltiazem, quinidine or
beta-blockers, which are used to treat heart conditions
 The antibiotics rifampicin and combination treatment
quinupristin/dalfopristin
 The anti-epileptic drugs phenytoin, carbamazepine or
valproic acid
 Cisapride, a drug used to treat reduced movements of the
gullet and stomach.
The effect of the following drugs on nifedipine is uncertain.
Therefore, as an additional precaution, please tell your doctor
or pharmacist if you are taking:
 The antibiotic erythromycin
 The antifungals ketoconazole, itraconazole or fluconazole
 The HIV protease inhibitors indinavir, nelfinavir, ritonavir,
saquinavir or amprenavir
 The antidepressant drugs fluoxetine and nefazodone
 Tacrolimus, an immunosuppressant used to prevent the
rejection of transplant organs
 The barbiturate phenobarbital, used primarily to treat
insomnia and anxiety
 Magnesium sulphate injections during pregnancy
(may cause a severe fall in blood pressure).
Nifedipine Capsules with food and drink:
You should not start taking Nifedipine Capsules within three
days of drinking grapefruit juice. If you have, speak to your
doctor. In addition you should not drink grapefruit juice whilst
taking Nifedipine Capsules. This is because grapefruit juice
is known to increase the blood levels of the active ingredient,
nifedipine. This effect can last for at least three days after the
last ingestion of grapefruit juice.
Pregnancy and breast-feeding:
Do not take this medicine if you are pregnant or breastfeeding. If you are taking it and think that you may be
pregnant or are planning a family, consult your doctor.
Driving and using machines:
It is possible that you may react to nifedipine. Reactions may
be dizziness, lethargy and visual disturbances but can vary
in intensity from individual to individual and may impair your
ability to drive or operate machinery. This applies particularly
at the start of treatment, on changing the medication and in
combination with alcohol.
Nifedipine Capsules contain sunset yellow (E110)
May cause allergic reactions.
3. HOW TO TAKE NIFEDIPINE CAPSULES
Always take Nifedipine Capsules exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
The capsules should be swallowed with a little water.
You should not take your capsule(s) with grapefruit juice.
 The recommended dose is 5mg every 8 hours. The dose
may be increased to a maximum dose of 20mg every
8 hours.
 If you suffer from a liver disorder, your doctor may want
to start your treatment on a low dose and increase it with
careful monitoring of your blood pressure or angina.

180 x 300 mm

Front Side

Nifedipine Capsules
Co-Pharma

Pack Insert
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Front & Back Side printing. To be supplied in the Unfolded size.
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PRINTING CLARITY TO BE CLEAR AND SHARP.

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Children
Nifedipine Capsules 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.
DO NOT EXCEED THE PRESCRIBED DOSE
If you take more Nifedipine Capsules than you should:
Exceeding the correct dosage or taking an overdose may
cause your blood pressure to become too low and your heart
beats to become irregular. Also, it may lead to dizziness,
confusion, visual disturbances, low blood oxygen levels and
possibly unconsciousness.
If you take more than the prescribed dose, or in the event of
an overdose, seek medical advice immediately and, if possible
take your capsules or the box with you to show the doctor.
If you forget to take Nifedipine Capsules:
You should take your normal dose immediately and then
continue taking your capsules as prescribed, waiting 8 hours
before taking your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Nifedipine Capsules:
You should take Nifedipine Capsules for as long as your
doctor tells you to. It may be dangerous to stop taking
Nifedipine Capsules before talking to your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Allergic reactions:
All medicines can cause allergic reactions, although serious
allergic reactions are very rare. Tell your doctor straight away
if you get any sudden wheeziness, difficulty in breathing
swelling of the eye lids, face or lips, rash, reddening of the
skin or itching (especially affecting your whole body).
Serious side effects:
 Liver problems including jaundice (yellowing of the skin or
whites of the eyes)
 As with similar drugs, which act on blood vessels, chest
pain may occur at the start of treatment with Nifedipine
Capsules. Because of the nature of coronary artery
disease, heart attacks have occurred in patients treated
with the active ingredient, nifedipine. It has not been
shown that these heart attacks were due to treatment with
nifedipine
 A skin reaction or blistering/peeling of the skin and/or
mucosal reactions (in the mouth/nose or penis/vagina)
(Toxic Epidermal Necrolysis)
If you experience any of the above side effects, contact
your doctor immediately.
Common: may affect up to 1 in 10 people:
 Headache
 Swelling of the ankles and legs
 Flushing
 Constipation
 Generally feeling unwell
Uncommon: may affect up to 1 in 100 people:
 Dizziness
 Feeling tired
 Feeling sick (nausea
 Rash
 Itching
 Muscle pain and cramps
 Shaking
 Problems with your eyesight
 Needing to pass water more often
 Joint swelling
 Migraine
 Nose bleeds
 Nasal congestion
 Sleep disturbances
 Low blood pressure
 Fainting
 Indigestion
 Dry mouth
 Stomach discomfort
 Feeling cold

 Impotence
 Feeling anxious
 Vertigo
 General pains
 Red or purple discolouration of the skin
Rare: may affect up to 1 in 1,000 people:
 Gum disease
 Enlargement of breast in males
 Mood changes
 Sensitivity to light
 Pins and needles
 Flaking skin
 Pruritus
 Rash
 Vomiting
 Shortness of breath
Not known: frequency cannot be estimated from the
available data:
 Low white blood cell count
 High blood sugar
 Loss of sensation
 Eye pain
 Chest pain
 Jaundice
 Muscle aches and pains
All of the symptoms above usually go away when treatment
with nifedipine is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 NIFEDIPINE CAPSULES
Keep out of the sight and reach of children.
Store in the original container.
Do not store above 25°C.
The capsules should be protected from strong light, so only
remove the capsule from the container or blister strip when
you are about to take it.
Do not use Nifedipine Capsules after the expiry date which
is stated on the label. The expiry refers to the last day of that
month.
Do not use Nifedipine Capsules if you notice visible signs of
deterioration.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nifepidine Capsules contain:
The active substance(s) is Nifedipine BP/PH.Eur.
The capsules contain either 5mg or 10mg of nifedipine.
The other ingredients are: Macrogols (Polyethylene glycol
400), Propylene glycol, Peppermint oil, Saccharin sodium.
Ingredients of shell: Gelatin, Glycerol, Titanium dioxide,
Sunset yellow supra (Colorant), Andrisorb 85/70.
What Nifedipine Capsules look like and contents of the
pack:
Nifedipine 5mg Capsules:
Description: Orange oval, soft gelatine capsules containing a
clear liquid fill material.
Nifedipine 10mg Capsules:
Description: Orange oblong, soft gelatine capsules containing
a clear liquid fill material.
Contents of pack: Blister pack.
14 capsules in a blister, 6 blisters in a carton
Marketing Authorisation Holder
Co-pharma Limited
Unit 4, Metro Centre, Tolpits Lane
Watford, Herts, UK, WD18 9SS
Tel: 01923 255580
Fax: 01923 255581
This leaflet was last revised 09/2015

180 x 300 mm

1026850

Elderly: lower doses of this medicine may be prescribed by
your doctor.
It is possible that you may have to take these capsules
indefinitely. You may want to discuss this with your doctor.

Back Side

Nifedipine Capsules
Co-Pharma

Pack Insert
----

180 x 300 mm
1026850
Black

***
Front & Back Side printing. To be supplied in the Unfolded size.
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.

1009720
ONE
1.0

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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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