Active substance: NIFEDIPINE

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Nifedipine Capsules 5mg and 10mg
Please read this leaflet carefully before you start to take your medicine.
It gives you important information about your medicine.
If you want to know more, or you are not sure about anything, ask your
pharmacist or doctor.
Keep the leaflet until you have finished the medicine.
Nifedipine Capsules come in two strengths. Each capsule contains either 5mg or
10mg of the active ingredient Nifedipine.
The capsule contents also contain polyethylene glycol, glycerol, peppermint oil.
The capsule shell contains glycerol, gelatin, sunset yellow (E110), titanium dioxide
The printing ink contains propylene glycol, iron oxide black (E172), polyvinyl acetate
phthalate, macrogol 400, ammonium hydroxide.
Nifedipine Capsules are available in pack sizes of 28s, 30s, 50s, 56s, 60s, 84s, 90s,
100s, 112s, 120s, 168s, 180s, 250's, 500's, 1000's.*
*Only the marketed pack sizes will be stated
Nifedipine is one of a group of medicines called calcium channel blockers. These
capsules reduce the pain (angina pectoris) which occurs when the heart is starved of
oxygen, by improving oxygen supply to the heart muscle. Nifedipine also relaxes the
muscle lining of small blood vessels throughout the body and in this way brings high
blood pressure down to normal.
MA holder: Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer: Cardinal Health UK 414 Limited, Swindon, SN5 8YS, UK.

The name of your medicine is Nifedipine which is the generic (common) name. Your
doctor may have given you this medicine before from another company and it may
have looked slightly different. Either brand will have the same effect.
Nifedipine Capsules are used for:
the treatment of high blood pressure (hypertension)
the treatment of Raynaud’s phenomenon (attacks of pain, numbness, coldness and
blueness of the fingers)
the prevention of angina (chest pain)
Do not take Nifedipine if you:
have ever had an allergic reaction to Nifedipine, any of the other
dihydropyridines-type calcium channel blockers e.g nicardipine or isradipine or
any of the ingredients in the capsule. An allergic reaction may include a rash,
itching, difficulty breathing or swelling of the face, lips, throat or tongue)
are pregnant or breast-feeding. If you think you are pregnant or planning a family
consult your doctor
have a narrowing (stenosis) of the aortic heart valve
have had a recent heart attack. Nifedipine should not be used to treat a heart attack
or within one month of a heart attack

have ever collapsed due to a heart problem (cardiogenic shock) where you became
breathless, pale and experienced a cold sweat and dry mouth
get more severe or frequent chest pains over a matter of hours or days (unstable
angina) you must contact your doctor. Nifedipine is intended to reduce the
frequency of angina attacks and must not be used to treat an angina attack at the
time when it occurs
suffer from very high blood pressure (malignant hypertension) which is often
associated with kidney damage
are taking an antibiotic called rifampicin
Check with your doctor or pharmacist before taking if you:
experience chest pains within four hours of taking your first dose of Nifedipine
suffer from low blood pressure (hypotension)
have a heart condition where your heart cannot cope with increased strain (poor
cardiac reserve)
suffer from liver disease or are receiving kidney dialysis
are a diabetic. Nifedipine may cause temporary high blood sugar levels. Your
doctor may need to alter the dosages of medicines you are taking
Check with your doctor or pharmacist if you are taking any of the following:
Antiarrhythmics (e.g quinidine)
Antidiabetics (e.g. tolbutamide, glibenclamide, metformin)
Antifungals (e.g. ketoconazole, itraconazole, fluconazole)
Antihypertensives (e.g. diltiazem, atenolol)
Beta-blockers (to treat heart conditions)
Phenobarbital (usually used to treat insomnia or anxiety)
Antivirals (indinavir, nelinavir, ritonavir, saquinavir)
Cisapride use to increase the emptying time of the stomach
Digoxin and quinidine for heart problems
Fluoxetine and nefazodone used to treat depression
Magnesium salts (e.g. magnesium sulphate)
Phenytoin, carbamazepine or sodium valporate to treat epilepsy
Rifampicin, erythromycin and quinupristin with dalfopristin used to treat
Tacrolimus used to prevent organ rejection following transplantation
Ulcer healing medicines cimetidine
Taking Nifedipine with food and drink:
Do NOT eat or drink products containing grapefruit juice whilst taking this medicine.
Avoid alcohol whist taking this medicine.
Pregnancy and Breast-feeding:
Nifedipine should not be taken if you are pregnant, or are planning to become
pregnant as there is a risk of damage to the unborn. Nursing mothers should not take
nifedipine as it is found in breast milk.
Nifedipine may effect the sperm function in men.
Driving and using machines:

Nifedipine may make you feel drowsy, dizzy, agitated and nervous affecting your
ability to concentrate. If you do not have enough sleep you may be less alert. Your
vision can also be affect. Make sure you are not affected before you drive or operate
machinery. This may be a particular problem at the start of the treatment.
Other precautions you should take:
If you see another doctor or go into hospital, let them know what medicines you are
Follow your doctor’s instructions. Check the pharmacy label to see how many
capsules to take and how often to take them. If you are still unsure ask your
pharmacist or doctor.
The usual dosage(s) are described below:
Initially 5mg every 8 hours, then according to your response.
Dosage may
be adjusted to a maximum of 20mg every 8 hours.
A lower maintenance dose compared to younger patients may
be given.
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.
These capsules should be taken as instructed - swallowed with a glass of water during
or after food. Continue to take them for as long as your doctor tells you to, it may be
dangerous to stop without their advice.
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. If an overdose has been taken there may be
signs such as feeling and being sick, drowsiness, dizziness and confusion.
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. Never take two doses together. Take the remaining doses at
the correct time.
Like all medicines, Nifedipine can sometimes cause unwanted side effects. Most of
them are due to the effect of nifedipine on widening blood vessels and usually
disappear on stopping treatment.
If the following happens, stop taking Nifedipine and tell your doctor immediately or
contact the casualty department at your nearest hospital:
An allergic reaction: swelling of the face, lips, tongue or throat, or difficulty
breathing or swallowing.
Fast heart beat

Itching (possible severe), a rash or hives, sensitivity to light, or skin peeling
This is a very serious but rare side effect. You may need urgent medical attention or
Tell your doctor if you notice any of the following side effects or notice any other
effects not listed:
Common (occurs in between 1 in 10 and 1 in 100 people)
headache, dizziness, feeling sick, palpitations, widening of blood vessels causing
flushing at start of treatment, a general unwell feeling, tiredness, constipation, swollen
ankles and legs.
Uncommon (occurs in between 1 in 100 and 1 in 1,000 people)
stomach pain, unspecific pain, chills, chest pain, fainting or feeling faint on changing
posture due to low blood pressure, dry mouth, being sick, indigestion, wind, muscle
cramps or pain, joint swelling or pain, sleep disorders, insomnia, drowsiness, anxiety
or nervousness, nose bleeds, nasal congestion, vertigo, migraine, trembling, numbness
in the arms and legs, needing to pass urine more frequently generally or at night,
reduced sexual potency (impotence), visual disturbances, blurred vision, diarrhoea,
sweating, increase in liver enzymes.
Rare (occurs in between 1 in 1000 and 1 in 10,000 people)
inflamed, bleeding, tender or swollen gums, ‘pins and needles’, mood changes, poor
eyesight, bloating, changes in levels of a certain digestive enzyme called GGTP, liver
function and liver function test results, low blood pressure, jaundice (yellowing of the
skin and whites of the eyes), sensitivity of the skin to light, purpura (seen as blood
spots, bruising and discolouration of the skin),.
Very rare (occurs in less than 1 in 10,000 people)
throbbing and burning pain brought on by exertion or heat, felt in the hands or feet
with a reddening of the skin of those parts (erythromelalgia), enlarged breasts in older
men on long term treatment, a large decrease in numbers of neutrophil blood cells
Other (frequency cannot be determined from the data)
Stomach pain or distress caused by ulcers or by a mass of foreign material found in
the stomach which may require surgery for removal, a large decrease in numbers of
white blood cells (leucopenia) leading possibly to mouth ulcers and fever, increase in
blood sugars (hyperglycaemia), eye pain, gastroesophageal sphincter insufficiency
(causing symptoms such as heart burn or indigestion).
Tell your doctor if you notice or are worried by any of the side effects listed. Tell your
doctor or pharmacist if you notice any other effects not listed.
Do not use the capsules after the expiry date shown on the product packaging. Keep
the capsules below 30°C in a dry place, protected from light, and in the original

only. NEVER give it to anyone else. It may harm them, even if their symptoms are
the same as yours. Unless your doctor tells you to, do not keep medicines that you no
longer need - give them back to your pharmacist for safe disposal.

If you would like a leaflet with larger text, please
contact 01271 311257.
Date of last revision: July 2012

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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.