Patient leaflet - NIFEDIPINE 60 MG PROLONGED-RELEASE TABLETS, NIDEF 60 MG PROLONGED-RELEASE TABLETS
MORNINGSIDE
HEALTHCARE
Talk to your doctor before you take Nifedipine PR Tablets if any of these apply to you.
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 PR Tablets
- if you have chest pain after taking your first dose of Nifedipien PR Tablets. Your doctor may wish to change your treatment
- if you notice increased breathlessness
- if you notice swelling of the ankles
Tell your doctor before you take the next dose if any of these apply to you.
Also tell your doctor:
- if you are giving a urine sample. Nifedipine PR Tablets may interfere with the results of certain urine tests,
- if you are to have a barium contrast x-ray (barium meal). These tablets may affect the results of the test,
- if you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Nifedipine PR Tablets have been shown to impair sperm function.
Other medicines and Nifedipine PR Tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the way Nifedipine PR Tablets work. Tell your doctor if you are taking:
- Other medicines to treat high blood pressure,
- Rifampicin (an antibiotic),
- Cimetidine (to treat stomach ulcers),
- Digoxin, diltiazem, quinidine or Beta-blockers (to treat heart conditions),
- Quinupristin/dalfopristin (a combination antibiotic),
- Phenytoin, carbamazepine or valproic acid (to treat epilepsy),
- Cisapride (to treat reduced movements of the gullet and stomach),
- Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure),
- Erythromycin (an antibiotic),
- Ketoconazole, itraconazole or fluconazole (anti-fungal medicines),
- Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV),
- Fluoxetine or nefazodone (to treat depression),
- Tacrolimus (to prevent the rejection of transplanted organs).
- Phenobarbital (usually used to treat insomnia or anxiety).
Nifedipine PR Tablets with food and drink
You can take Nifedipine PR Tablets with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Nifedipine PR Tablets.
Do not start taking Nifedipine PR Tablets within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Nifedipine PR Tablets. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Pregnancy and Breast-feeding
Pregnancy
If you are pregnant, 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 but only after special consideration and agreement by your doctor.
Breast-feeding
Do not take Nifedipine PR Tablets if you are breastfeeding. If you need to take Nifedipine, you should stop breast-feeding before you start taking this medicine.
Driving and using machines
Nifedipine PR Tablets may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way. This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
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3. Howto take Nifedipine PR Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Nifedipine PR Tablets are specially formulated so that you only have to take one dose each day.
- Dose for high blood pressure: the usual dose is
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1 tablet, once a day.
- Dose for angina: the dose depends on your individual requirements. Your doctor will decide how much you should take.
- Swallow the tablets whole. Do not bite, chew or break them – if you do they will not work properly. If you have difficulty swallowing tablets, consult your doctor as he or she may wish to change your medicine.
- Continue to take these tablets for as long as your doctor has told you to.
Take your dose at the same time each day, preferably in the morning. Take your tablets with a glass of water. Do not take them with grapefruit juice.
You can take Nifedipine PR Tablets with or without food.
You may see what looks like a complete tablet in the toilet or in your stools. This is normal – it’s the outer shell of the tablet which is not digested by the body.
Use in children and adolescents: Nifedipine PR Tablets 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.
If you take more Nifedipine PR Tablets than you should
Get medical help immediately. If possible, take your tablets or the box with you to show the doctor.
Taking too many tablets may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.
If you forget to take Nifedipine PR Tablets
Take your normal dose immediately and continue taking your tablets at the usual time of day, waiting at least 12 hours before taking the next dose.
Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you notice:
- severe, sudden generalised allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (including potentially life-threatening swelling of the airway),
- other allergic reactions causing swelling under the skin (possibly severe and including swelling of the larynx that may result in a life-threatening outcome),
- fast heart beat (Tachycardia)
- shortness of breath (frequency not known) or difficulty breathing,
- mild to moderate allergic reactions
- itching (possibly severe), a rash or hives.
Contact your doctor immediately and do not take
the next dose as these may be the first signs of allergic reaction which may become severe.
If you develop:
- a skin reaction or blistering / peeling of the skin and/or mucosal reactions (in the mouth/nose or at the penis/ vagina) (Toxic Epidermal Necrolysis).
Contact your doctor immediately before you continue treatment as these may be signs of a severe reaction.
Less serious side effects
Apart from the side effects listed above, these are the other side effects of Nifedipine PR Tablets, starting with the more common ones:
Common
(may affect up to 1 in 10 people)
- headache,
- flushing,
- general feeling of being unwell,
- constipation,
- swelling, particularly of the ankles and legs.
Uncommon
(may affect up to 1 in 100 people)
- stomach pain (abdominal pain),
- unspecific pain,
- chills,
- low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion),
- fainting,
- irregular heartbeat (palpitations),
- drymouth,
- indigestion or upset stomach,
- wind (flatulence),
- feeling sick (nausea),
- muscle cramps,
- joint swelling,
- sleep disorders,
- anxiety or nervousness,
- reddening of the skin,
- nose bleeds,
- nasal congestion,
- sensation of spinning or whirling motion (vertigo),
- migraine,
- dizziness,
- trembling,
- increase in the need to pass water (urinate),
- painful or difficult urination,
- inability to achieve or maintain an erection (impotence),
- blurred vision,
- temporary increase in certain liver enzymes
Rare
(may affect up to 1 in 1,000 people)
- pins and needles,
- inflammation of the gums, tender or swollen gums, bleeding gums.
Other
(Frequency unknown: frequency cannot be estimated from the available data)
- stomach pain or distress caused by a mass of foreign material found in the stomach which may require surgery for removal,
- difficulty swallowing,
- abdominal pain, caused by obstruction of the gut or ulcers in the gut,
- vomiting,
- a reduction in the number of white blood cells (leucopenia),
- a more severe decrease in a specific class of white blood cell (agranulocytosis),
- increased blood sugar (hyperglycaemia),
- decreased skin sensitivity (hypoaesthesia),
- drowsiness (somnolence),
- eyepain,
- chest pain (angina pectoris),
- yellowing of the whites of the eyes or skin,
- sensitivity to light (photosensitivity allergic reaction),
- small, raised areas of bleeding in the skin (palpable purpura),
- joint pain,
- muscle pain.
All of these symptoms usually go away when treatment with Nifedipine PR Tablets is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store nifedipine pr tablets
Keep this medicine out of the sight and reach of children.
Store in the original container.
Do not use after the expiry date which is stated on both the outer carton and on each blister strip of tablets. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Nifedipine PR Tablets contain
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– The active substance is nifedipine
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– The other excipients in 30mg tablets are polyethylene oxide, hydroxypropyl methylcellulose (E464), sodium chloride, magnesium stearate (E572), ferric oxide (E172), magnesium stearate, cellulose acetate, polyethylene glycol (E1521), hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), talc (E553b), iron oxide red (E172).
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– The other excipients in 60mg tablets are polyethylene oxide, hydroxypropyl methylcellulose (E464), sodium chloride, magnesium stearate (E572), ferric oxide (E172), cellulose acetate, polyethylene glycol (E1521), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), iron oxide red (E172), shellac (E904), iron oxide black (E172) and propylene glycol (E1520).