Nifedipress Mr 20
Out of date information, search anotherPACKAGE LEAFLET - INFORMATION FOR THE USER
NIFEDIPRESS® MR 10 NIFEDIPRESS® MR 20
(Nifedipine)
Font size 9pt 155x480
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 your 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.
What is in this leaflet:
1. What Nifedipress MR Tablets are and what they are used for
2. What you need to know before you take Nifedipress MR Tablets
3. How to take Nifedipress MR Tablets
4. Possible side effects
5. How to store Nifedipress MR Tablets
6. Contents of the pack and other information
1. What Nifedipress MR Tablets are and what they are used for
Nifedipress MR 10 & 20 Tablets (referred to as ‘Nifedipress MR' throughout this leaflet) are modified release tablets containing the active substance nifedipine 10 mg and 20 mg respectively.
The active substance, nifedipine is one of a group of medicines called calcium-channel blockers. Nifedipress MR is used to treat high blood pressure (hypertension) and to prevent the condition called chronic stable angina pectoris (chest pain coming from the heart).
• For high blood pressure: Nifedipress MR works by widening the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
• For angina: Nifedipress MR works by widening the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
2. What you need know before you take Nifedipress MR Tablets
Do not take Nifedipress MR if:
• you are allergic to the active ingredient (nifedipine), to any other similar medicines (e.g. amlodipine, felodipine and nimodipine) or to any of the other ingredients of this medicine (See section 6).
• you have had a heart attack within the last month
• you get a sudden angina attack. Nifedipress MR will not help relieve symptoms of angina quickly
• you have unstable angina
• you are pregnant
• you are breast-feeding. If you need to take this medicine, you should stop breastfeeding before you start taking it (see section below ‘Pregnancy Breast-feeding and fertility')
• you are taking rifampicin, an antibiotic
• you have been told that you have a narrowing of the aortic heart valve (stenosis)
• you have ever had a collapse caused by a heart problem (cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth
• your blood pressure continues to rise despite treatment (malignant hypertension)
• you have acute porphyria
Tell your doctor and do not take this medicine if any of these apply to you. If you are unsure whether you might have any of these conditions, please ask your doctor.
Warnings and precautions Take special care with Nifedipress MR and check with your doctor or pharmacist before taking your medicine if:
• you have low blood pressure (may cause dizziness or fainting on standing up) and your doctor prescribed Nifedipress MR for your angina. Your blood pressure may be decreased further by this treatment
• you have a heart condition where your heart cannot cope with increased stress such as exercise (poor cardiac reserve)
• you have heart problems which can cause shortness of breath or ankle swelling
• you are pregnant
• you are breastfeeding. If you need to take Nifedipress MR, you should stop breastfeeding before you start to take this medicine.
• you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor
• you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in your blood pressure when you take Nifedipress MR
• your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of the medicine
• you are male and have not been successful in fathering a child by in vitro fertilisation, as this medicine may reduce sperm function
• you are giving a urine sample. Nifedipress MR may interfere with the results of certain urine tests
• 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 Nifedipress MR
• you have chest pains after taking your first dose of Nifedipress MR. Your doctor may wish to change your treatment
Talk to your doctor before you take the medicine if any of these apply to you.
Other medicines and Nifedipress MR:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those bought without a prescription. In particular, tell your doctor if you are taking any of the following:
• other medications for angina and/or high blood pressure
• drugs containing cimetidine (used to reduce stomach acidity and treatment of stomach ulcers)
• any other drugs for the treatment of heart problems (especially digoxin, diltiazem, quinidine or beta-blockers)
• the antibiotic, rifampicin
• combination antibiotic 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
• Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure)
The effect of the following drugs on Nifedipress MR is uncertain. Therefore, as an additional precaution, please tell your doctor if you are taking:
• the antibiotic, erythromycin
• Ketoconazole, itraconazole or fluconazole (antifungal medicines)
• Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV)
• Fluoxetine or nefazodone (to treat depression)
• Tacrolimus and ciclosporin, immunosuppressants used to prevent the rejection of transplant organs
• the barbiturate phenobarbital, used primarily to treat insomnia and anxiety
• drugs used to relieve anxiety (anxiolytics) and medicines used to help you sleep (hypnotics)
• drugs used to treat high blood pressure (adrenergic neurone blockers, moxonidine, sodium nitroprusside and hydralazine)
• Antipsychotics (used to treat severe mental illness such as schizophrenia)
• Anaesthesia/isoflurane and non-depolarizing muscle-relaxants e.g. rocuronium (used during surgery)
• Aldesleukin (works as part of the body's defense mechanism in fighting illness)
• Baclofen (used to treat multiple sclerosis)
• Cilostazol (used to reduce leg pain by encouraging blood flow)
• Clonidine (used to treat high blood pressure and migraine headache)
• Corticosteroids (used for inflammation and controlling body water and salt)
• Diazoxide (used to lower insulin levels in the blood and in the emergency treatment of high blood pressure)
• Insulin, used by diabetics
• Levodopa, used to treat Parkinson's disease
• Monoamine Oxidase Inhibitors (MAOIs), a group of antidepressants, e.g., phenelzine and tranylcypromine
• Minoxidil (used orally to treat high blood pressure and as a cream to promote hair regrowth)
• Moxisylyte and vardenafil, used for erectile dysfunction (impotence in men)
• Mefloquine (used for the prevention and treatment of malaria)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen used to control pain and inflammation
• Oestrogen (female sex hormone)
• Primidone (used to control epileptic fits)
• Tizanidine (used as a muscle relaxant)
• Theophylline (used for breathing problems)
• Vincristine (used in cancer chemotherapy)
Taking Nifedipress MR with food and drink:
The tablets can be taken with or without food. Do not drink grapefruit juice or eat grapefruit while taking Nifedipress MR. You should not start taking the tablets within three days of drinking grapefruit juice or eating grapefruit. If you have, speak to your doctor. 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. Avoid drinking alcohol while taking this product as it may worsen the side effects.
Pregnancy, breast-feeding and fertility: Nifedipress MR should not be taken if you are pregnant. If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Nifedipress MR. You may be able to use this medicine but only after special consideration and agreement by your doctor. Particular care should be exercised if you are also having magnesium sulphate injections.
Do not take this medicine if you are breastfeeding. If you need to take it, you should stop breast-feeding before you start taking the tablets.
Fertility
Drugs like Nifedipress MR have been shown to impair sperm function. Talk to your doctor if you are a man who has been unable to father a child by in vitro fertilisation.
general feeling of being unwell
Driving and using machines:
Nifedipress MR 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 applies particularly at the start of treatment, on changing the medication and in combination with alcohol.
Important information about some of the ingredients of Nifedipress MR
This medicine contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking the medicine.
3. How to take Nifedipress MR Tablets
Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You can take Nifedipress MR Tablets with or without food. The tablets may be taken whole with a little water. Do not take them with grapefruit juice. Do not chew or break them - if you do they will not work properly. Tell your doctor if you have difficulty swallowing tablets.
• To start with, you may be given Nifedipress MR 10 mg. This allows your doctor to monitor how you are responding so that the best longterm dose can be identified.
• The usual maintenance dose of Nifedipress MR 20 mg is one tablet, every 12 hours (i.e. twice per day). Your doctor may increase or decrease the dose depending on how well your blood pressure or angina is being controlled. The maximum dose is 2 tablets (40 mg) every 12 hours.
• Lower doses of this medicine may be prescribed by your doctor if you are elderly.
• If you have liver problem you are likely to be given Nifedipress MR 10 mg, at least to begin with
• Continue to take the tablets for as long as your doctor has told you to.
Use in children and adolescents:
Nifedipress MR 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.
If you take more Nifedipress MR tablets than you should:
If you take more tablets than you should, get medical help immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken.
The most likely effects you will notice on taking too many tablets are severe drop in blood pressure causing dizziness particularly on standing and your heart beat may 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 Nifedipress MR:
If you forgot to take a tablet, take it if you remember within 12 hours of your usual time. If more than 12 hours have passed, do not take the missed tablet but take your next tablet at the normal time when it is due.
Do not take a double dose to make up for the missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nifedipress MR can have side effects, although not everybody gets them.
Serious side effects
Stop taking Nifedipress MR and tell your doctor immediately if you experience:
• severe, sudden generalized allergic reaction including very rarely life-threatening shock (e.g. difficulties in breathing, drop of blood pressure, fast pulse), swelling (including potentially life-threatening swelling of the airway)
• signs of other allergic reaction such as swelling under the skin (possibly severe and including swelling of the throat that may result in a life-threatening outcome)
• fast heart beat (tachycardia)
• shortness of breath or difficulty breathing (dyspnoea )
• mild to moderate allergic reactions (including swollen lips)
• skin rash, itching (possibly severe) or hives
• chest pain occurring within 1 to 4 hours of taking the first dose of these tablets.
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 your medicine, starting with the more common ones:
Common side-effects (These may affect up to 1 in 10 people):
• headache
• general swelling and swelling of the ankles and legs
• flushing
• constipation
Uncommon side-effects (These may affect up
to 1 in 100 people)
• pain particularly in the stomach area (abdomen)
• general unspecified pain
• chills
• low blood pressure when rising to the standing position (causing dizziness or fainting, light headedness, irregular heartbeat, blurred vision and sometimes confusion)
• irregular heartbeat (palpitations)
• dry mouth
• indigestion or an upset stomach
• wind (flatulence)
• feeling sick (nausea)
• muscle cramps
• joint swelling
• anxiety or nervousness
• reddening of the skin
• nose bleeds
• blocked or stuffy nose
• feeling of dizziness or “spinning" (vertigo)
• migraine
• trembling
• difficulty sleeping
• 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 the levels of certain liver enzymes (shown on blood test).
Rare side-effects (These may affect up to 1 per 1,000 people)
• inflammation of the gums, tender or swollen gums, bleeding gums
• increased sensitivity particularly of the skin (e.g. sensitivity to touch, heat etc.)
• pins and needles
Other side-effects (Unknown frequency)
• vomiting
• a reduction in the number of white blood cells (leucopenia)
• severe reduction in the number of a specific class of white blood cells which makes infections more likely (agranulocytosis)
• decreased skin sensitivity (hypoaesthesia)
• eye pain
• chest pain (angina pectoris)
• heartburn or indigestion (gastroesophageal sphincter insufficiency)
• yellowing of the whites of the eyes or skin (jaundice)
• anorexia (loss of appetite)
• asthenia (feeling of weakness or loss of strength)
• gynaecomastia (breast enlargement in men)
• hyperglycaemia (too much sugar in the blood)
• abdominal pain, caused by obstruction of the gut or ulcers in the gut
• feeling drowsy (somnolence)
• abnormally sensitive or reactive to light
• small, raised areas of bleeding in the skin (palpable purpura)
• joint pain
• muscle pain
All of the symptoms above usually go away when treatment with this medicine is stopped.
If any of the side effects gets serious, or if you
notice any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Nifedipress MR Tablets Keep this medicine out of the reach and sight of children.
Do not store above 25°C.
Store your medicine in the original package in order to protect from strong light and only remove the tablet from the blister strip when you are about to take it.
Do not use this medicine after the expiry date which is stated on the outer carton and on each blister strip after Exp. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Nifedipress MR contains Nifedipress MR 10 & 20 are modified release tablets containing the active substance nifedipine 10mg and 20mg respectively.
The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, lactose, polysorbate 80, starch pregelatinized, magnesium stearate, hypromellose 2910, macrogol 6000, titanium dioxide E-171, purified talc, iron oxide red E-172, purified water and carnauba wax.
What Nifedipress MR Tablets look like and contents of the pack
Nifedipress MR 10 and 20 tablets are modified release, brownish pink, round, film-coated tablets which come in two different tablet sizes. Nifedipress MR 10 is the smaller tablet of the two. Nifedipress MR 10 and Nifedipress MR 20 are available in packs of: 28 tablets in foil blister strips; 30 tablets in foil blister strips; 56 tablets in foil blister strips.
Not all pack size may be marketed.
The holder of the marketing authorization / Manufacturer is:
Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
This leaflet was last revised in May 2014.
1255510112-H/V1078
A B C D E F G H