NIFEDIPINE CAPSULES 10 MG

Active substance: NIFEDIPINE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.

WHAT'S IN YOUR 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
(E171).
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.

ABOUT YOUR MEDICINE
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)
BEFORE TAKING YOUR MEDICINE
Do not take Nifedipine if you:
• have ever had an allergic reaction to Nifedipine or to 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.
• have had a recent heart attack. Nifedipine should not be used within one month of
a heart attack.
• have ever collapsed due to a heart problem (cardiovascular 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) .
are taking an antibiotic called rifampicin.

Check with your doctor or pharmacist before taking if you:
• have a narrowing (stenosis) of the aorta
• suffer from chest pain (angina)
• suffer from low blood pressure (hypotension)
• have heart failure
• have liver problems (your doctor will monitor your condition and may want to
reduce your dose)
• are giving a urine sample (your results may be affected)
Check with your doctor or pharmacist if you are taking any of the following:
• Medicines to treat high blood pressure such as methyldopa, diuretics, betablockers, ACE-inhibitors, Angiotensin 1 (AT1) receptor-antagonists, other
calcium antagonists, adrenergic blocking agents, PDE5 inhibitors

• Ritonavir, used to treat HIV
• Cisapride, used to increase the emptying time of the stomach
• Digoxin or quinidine for heart problems
• Fluoxetine or nefazodone used to treat depression
• Magnesium sulphate injections during pregnancy
• Phenytoin, carbamazepine, valproic acid or phenobarbital to treat epilepsy
• Rifampicin, erythromycin, ketoconazole or quinupristin with dalfopristin used to
treat infections
• Tacrolimus used to prevent organ rejection following transplantation
• Cimetidine for stomach ulcers
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:
If you are pregnant, planning to become pregnant or are breast-feeding, ask your
doctor or pharmacist for advice before taking this medicine. Nifedipine may affect 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, on changing
the medication or in combination with alcohol.

TAKING YOUR MEDICINE
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:
Indication
Dosage
Adults:
Initially 5mg every 8 hours, then according to your response.
Dosage may be adjusted to a maximum of 20mg every 8
hours.
Elderly:
A lower maintenance dose compared to younger patients may
be given.
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.
Liver problems:
If you have liver problems, your doctor will monitor your
condition and may want to reduce your dose.
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 a severe overdose occurs, there may be
signs such as low blood pressure, a fast or slow heartbeat, heart rhythm disturbances,
an increase in blood sugars, metabolic acidosis (abnormal chemical levels in the
blood), hypoxia (tissue oxygen deficiency), cardiogenic shock (where you become
breathless, pale and experience a cold sweat and dry mouth), fluid on the lung.
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.

AFTER TAKING YOUR MEDICINE
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, severe burn-like rash
involving reddening, peeling and swelling of the skin (Toxic Epidermal

Necrolysis). This is a very serious side effect. You may need urgent medical
attention or hospitalisation.
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, swollen ankles and legs, widening of blood vessels causing flushing ,
constipation, a general unwell feeling.
Uncommon (occurs in between 1 in 100 and 1 in 1,000 people)
anxiety, sleep disorders, vertigo, migraine, dizziness, trembling, visual disturbances,
fast heart beat, palpitations, low blood pressure, fainting, nosebleeds, nasal
congestion, stomach pain, feeling sick, indigestion, wind, dry mouth, increase in liver
enzymes, skin redness, muscle cramps, joint swelling needing to pass urine more
frequently or pain when urinating, reduced sexual potency (impotence), unspecific
pain, chills.
Rare (occurs in between 1 in 1000 and 1 in 10,000 people)
‘pins and needles’(paraesthesia), abnormal sensation when skin is touched
(dysaesthesia), inflamed, bleeding, tender or swollen gums.
Not Known (frequency cannot be determined from the data)
a large decrease in the numbers of neutrophil blood cells (agranulocytosis), a large
decrease in numbers of white blood cells (leukopenia), increase in blood sugars
(hyperglycaemia), reduced sense of touch or sensation (hypoaesthesia), drowsiness,
eye pain, chest pain, difficulty breathing, being sick, gastroesophageal sphincter
insufficiency (causing symptoms such as heart burn or indigestion), disease of the
liver causing yellowing of the skin or whites of the eyes (jaundice), raised blood
spots, bruising or discolouration of the skin (palpable purpura), joint or muscle pain.
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.
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.

STORING YOUR MEDICINE
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
packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN
CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU
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 385257.
This leaflet was last revised in February 2014.

Expand view ⇕

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.

Hide
(web1)