Nifedipress MR 10 Modified-release tablets

• 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. See section 4.

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

• if you are allergic to the active ingredient (nifedipine), to any other similar medicines known as dihydropyridines (e.g. amlodipine, felodipine, isradipine, nisolidipine or nimodipine) or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, or likely to become pregnant
• if you have narrowing (stenosis) of the aortic heart valve (one of the valves of the heart)
• if you have unstable angina (heart pain)
• if you have suffered a heart attack within the last month
• if you have collapse of the circulation (cardiogenic shock)
• if you get a sudden angina attack. Nifedipress MR will not help relieve symptoms of angina quickly
• if you have taken nifedipine before and found your heart pain got worse
• if you have very high blood pressure (malignant hypertension)
• if you have Porphyria
• if you have a “Knock pouch” (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut.
• if you are taking rifampicin, an antibiotic (for tuberculosis treatment for example)

Tell your doctor and do not take Nifedipress MR if any of these apply to you. If you are unsure whether you might have any of these conditions, please ask your doctor.

Talk to your doctor or pharmacist before taking Nifedipress MR

• if you have low blood pressure (may cause dizziness or fainting on standing up). Your blood pressure may be decreased further by this treatment
• if you have heart problems other than chronic stable angina (heart failure)
• if you have diabetes. The treatment for your diabetes may need to be adjusted
• if 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
• if you are breastfeeding. If you need to take Nifedipress MR, you should stop breastfeeding before you start to take this medicine.
• if 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

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 Nifedipress MR.
• If you have chest pains after taking your first dose of Nifedipress MR. 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. Nifedipress MR may interfere with the results of certain urine tests.

Nifedipress MR is not recommended for use in children and adolescence below 18 years of age, because there are only limited data on the safety and efficacy in this population.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way Nifedipress MR works. Tell your doctor if you are taking any of the following medicines:

• 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 sulfate 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 to treat insomnia or anxiety).
• St John’s Wort (herbal medicine).

If you are unsure about your other medication, please talk to your doctor or pharmacist before taking Nifedipress MR. They may need to alter your treatment or give you some special advice.

Nifedipress MR may be taken with or without food. As a safety precaution, do not take with alcohol.

Do not drink grapefruit juice or eat grapefruit while taking Nifedipress MR.

Do not start taking Nifedipress MR 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 Nifedipress MR. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

Do not take Nifedipress MR if you are pregnant or breastfeeding.

Medicines like Nifedipress MR have been shown in laboratory experiments to impair sperm function. If you are male and have been unsuccessful in fathering a child please consult your doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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 may become more likely when you first start treatment, if you change medication or if you have drunk alcohol.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 tablets than you should go straight to your casualty department. Take any remaining tablets, box and this leaflet with you so the medical staff know exactly what you have taken.

Taking too many tablets may cause your blood pressure to become too low causing dizziness particularly on standing and your heartbeats 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.

Do not worry. Take the missed dose as soon as you remember, waiting 12 hours before taking your next dose.

Do not take a double dose to make up for a forgotten dose.

• An increase in chest pain at the start of treatment
• An allergic reaction and experience difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat which may cause difficulty in swallowing.

• Start shaking or experience a loss of eyesight caused by a sudden drop in blood pressure
• Notice a fast heart beat (tachycardia)
• Notice a shortness of breath or difficulty breathing (dyspnoea)
• Notice a yellowing of the skin and eyes caused by liver problems such as allergic hepatitis, intra-hepatic cholestasis
• Notice flaking or purple blotching of the skin caused by exfoliative dermatitis, erythema multiform or pemphigoid reactions
• 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)
• Notice itching (possibly severe), a rash or hives

Apart from the side effects listed above, these are the other side effects of Nifedipress MR, starting with the more common ones:

Common may affect up to 1 in 10 people

• headache
• 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)
• unspecified 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)
• dry mouth
• indigestion or upset stomach
• wind (flatulence)
• feeling sick (nausea)
• muscle cramps
• joint swelling
• sleep disorders
• anxiety or nervousness
• reddening of the skin
• nosebleeds
• 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 (shown on blood test).

Rare may affect up to 1 in 1,000 people

• pins and needles
• change in mood
• inflammation of the gums, tender or swollen gums, bleeding gums

Not known: frequency cannot be estimated from the available data

• a reduction in the number of white blood cells (leucopenia)
• a more severe decrease in a specific class of white blood cells (agranulocytosis)
• depression
• increased blood sugar (hyperglycaemia)
• decreased skin sensitivity (hypoaesthesia)
• sleepiness
• lethargy
• insufficient blood flow to the brain
• eye pain
• chest pain (angina pectoris)
• decreased blood flow to your heart
• flushing
• vomiting
• heartburn or indigestion (gastroesophageal sphincter insufficiency)
• diarrhoea
• sensitivity to light (photosensitivity allergic reaction)
• small, raised areas of bleeding in the skin (palpable purpura)
• spider veins
• joint pain
• muscle pain
• muscle weakness
• fever
• worsening of myasthenia gravis
• development of breast tissue in older men on long term therapy has been reported

Because of the nature of coronary heart 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.

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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.

The active substance is nifedipine. Nifedipress MR 10 & 20 are modified-release tablets. Each tablet contains either 10 mg or 20 mg nifedipine respectively.

The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, 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.

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 sizes may be marketed.