PACKAGE LEAFLET: INFORMATION FOR THE USER

Tensipine MR 10mg and 20mg Tablets Nifedipine

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Tensipine MR is and what it is used for

2.    Before you take Tensipine MR

3.    How to take Tensipine MR

4.    Possible side-effects

5.    How to store Tensipine MR

6.    Further information

1. WHAT TENSIPINE MR IS AND WHAT IT IS USED FOR

Nifedipine, the active ingredient in Tensipine MR Tablets is one of a group of medicines called calcium antagonists. Calcium antagonists work by relaxing blood vessels. This makes the blood flow more easily. Tensipine MR is used to:

•    treat high blood pressure

•    reduce the frequency of chest pains (angina).

2. BEFORE YOU TAKE TENSIPINE MR

DO NOT take Tensipine MR if:

•    you are allergic (hypersensitive) to nifedipine, other medicines of this type or any of the other ingredients of Tensipine MR (see section 6 - Further information for details)

•    you have had a heart attack within the last month or if you suspect that you are having a heart attack

•    you have unstable angina

•    you are pregnant, think you may be pregnant, are planning to become pregnant or are breast-feeding

•    you are taking the antibiotic rifampicin

•    you have been told that you have a narrowing (stenosis) of the aortic valve of the heart

•    you have experienced a collapse of your blood circulation system (cardiogenic shock), during which you would have become breathless, pale and had a cold sweat and dry mouth

•    the severity or frequency of your angina has rapidly worsened over a matter of hours or days.

Do not take Tensipine MR to treat an angina attack when it occurs

•    your blood pressure continues to rise despite treatment (malignant hypertension)

•    you suffer from porphyria, a blood disorder

•    you have been told to avoid lactose, that you have a hereditary condition called Lapp lactase deficiency or glucose-galactose malabsorption.

If you are unsure whether you may have any of these conditions, please ask your doctor.

Tensipine MR should not be given to children.

Take special care with Tensipine MR

Check with your doctor if:

•    you experience chest pains within 1-4 hours of taking your first dose of Tensipine MR.

Contact your doctor before you take the next dose. Your treatment may be changed

•    you suffer from a severe form of high blood pressure (malignant hypertension), Tensipine MR may not be suitable for you

•    you are diabetic. The treatment for your diabetes may need to be adjusted

•    you suffer from low blood pressure and your doctor prescribes Tensipine MR for chest pains (angina)

•    you notice increased breathlessness whilst taking Tensipine MR

•    you are receiving kidney dialysis and have a very high blood pressure and a low blood volume. You may experience a sudden drop in blood pressure when you take Tensipine MR. Consult your doctor before taking this medicine

•    you are having your urine tested. Inform the healthcare professional responsible that you are taking this medicine. It may interfere with the results of certain tests

•    you notice that the severity or frequency of your chest pains (angina) has rapidly worsened over a matter of days or hours

•    you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve)

•    you suffer from liver disease. Your dose may need to be reduced.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following:

•    other medicines to treat high blood pressure

•    digoxin, beta-blockers, diltiazem or quinidine (used to treat heart conditions)

•    cimetidine (used to treat stomach ulcers or heartburn)

•    rifampicin (an antibiotic)

•    intravenous magnesium sulphate (used to treat magnesium deficiency - a lack of magnesium).

An excessive fall in blood pressure may occur

•    tacrolimus (used during organ transplantation).

The following drugs may increase the amount of nifedipine (the active ingredient) in the body, so your dose may have to be adjusted:

•    erythromycin and quinupristin/dalfopristin (antibiotics)

•    indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (used to treat HIV)

•    ketoconazole, itraconazole or fluconazole (used to treat anti-fungal infections)

•    fluoxetine and nefazodone (used to treat depression)

•    cisapride (used to treat heartburn)

•    valproic acid (used to treat depression or epilepsy).

The following drugs may decrease the amount of nifedipine (the active ingredient) in the body, so your dose may have to be adjusted:

•    phenytoin (used to treat irregular heartbeats or epilepsy)

•    carbamazepine and phenobarbital (used to treat epilepsy).

Taking Tensipine MR with food or drink

Tensipine MR can be taken with or without food.

Do not take Tensipine MR within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice within this time.

Do not take Tensipine MR with grapefruit juice or at the same time as eating a grapefruit. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not use Tensipine MR if you are pregnant, think you may be pregnant, are planning to get pregnant or are breast-feeding.

You may be able to use Tensipine MR after week 20 of your pregnancy, but only after special consideration and agreement by your doctor.

If you need to take Tensipine MR and you are breast-feeding, stop breast-feeding before you start taking the tablets.

Driving and operating machinery

Tensipine 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 be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.

Important information about some of the ingredients of Tensipine MR

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE TENSIPINE MR

Always take Tensipine MR exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

How to take:

•    Swallow the tablets whole with a little water

•    Continue to take the tablets for as long as your doctor has told you to

•    Do not take this medicine with grapefruit juice.

Adults

The usual dose is one 10mg tablet every 12 hours, but your doctor may want to increase your dose if your blood pressure or angina is not being controlled. If so, they will prescribe a 20mg tablet.

The maximum dose is 40mg every 12 hours.    .

Please read the back of this leaflet.

GENUS PHARMACEUTICALS

*Trademark    25214801

GEN/TNS/PIL/268_02

Elderly and adults with liver disease

Your doctor may want to prescribe a lower dose. Take the tablets as prescribed by your doctor.

Use in children and adolescents below 18 years of age

Tensipine 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 Tensipine MR than you should

If you have taken more Tensipine MR than prescribed tell your doctor or go to the nearest hospital casualty department immediately and take your tablets or the box with you to show the doctor.

Taking more Tensipine MR tablets than prescribed may cause your blood pressure to become too low and your heartbeats to become irregular. It may also lead to nausea (feeling sick) and vomiting, a lack of energy, drowsiness, dizziness, confusion, flushing and possibly, even unconsciousness.

If you forget to take Tensipine MR

If you forget to take a dose at the right time, take it as soon as you remember and then go on as before. However, allow at least 12 hours before taking your next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Tensipine MR

Your doctor will monitor your progress and determine the duration of treatment. If you wish to stop taking these tablets temporarily or permanently, you should consult your doctor. It is important to reduce the dose gradually, especially if you have been taking high doses.

If you have any further questions about these tablets, ask your doctor or pharmacist.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Tensipine MR can have 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)

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

Other side-effects include:

Common (affects 1 to 10 users in 100)

•    headache

•    flushing

•    general feeling of being unwell Uncommon (affects 1 to 10 users in 1,000)

•    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)

•    dry mouth

•    indigestion or upset stomach

•    wind (flatulence)

•    feeling sick (nausea)

•    muscle cramps

•    joint swelling

Rare (affects 1 to 10 users in 10,000)

•    pins and needles

•    inflammation of the gums, tender or swollen gums, bleeding gums

Other side-effects (Frequency unknown)

•    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)

•    eye pain

All of these symptoms usually go away when treatment with Tensipine MR is stopped.

Tell your doctor if any side-effects get serious, or if you notice any effects not listed in this leaflet. 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.

•    fast heart beat (tachycardia)

•    shortness of breath or difficulty breathing

•    mild to moderate allergic reactions

•    itching (possibly severe), a rash or hives

•    chest pain (angina attacks) at the start of treatment.

•    constipation

•    swelling, particularly of the ankles and legs.

•    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.

•    itching on one particular location on the body

•    loss of sensitivity or feeling in the hands.

•    chest pain (angina pectoris)

•    heartburn or indigestion (gaestoesophageal sphincter insufficiency)

•    yellowing of the whites of the eyes or skin (jaundice)

•    small, raised areas of bleeding in the skin (palpable purpura)

•    joint pain

•    muscle pain.

5. HOW TO STORE TENSIPINE MR

Keep out of the sight and reach of children.

Do not use Tensipine MR after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Store in the original container and carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Tensipine MR contains

•    The active substance in Tensipine MR is nifedipine. Tensipine MR 10 Tablets contain 10mg of nifedipine. Tensipine MR 20 Tablets contain 20mg of nifedipine.

•    The other ingredients are microcrystalline cellulose, polysorbate 80, hydroxypropyl methylcellulose, lactose, maize starch, polyethylene glycol and magnesium stearate. Titanium dioxide (E171) and iron oxide (E172) are included as colouring agents.

What Tensipine MR looks like and contents of the pack

Tensipine MR are pink-grey coloured tablets with ‘TMR’ marked on one side and ‘10’ or ‘20’ marked on the other. They are supplied in calendar packs of 56 tablets. The foil has the days of the week printed on it to remind you when to take the tablets.

POM

PL 06831/0048    Tensipine MR 10

PL 06831/0049    Tensipine MR 20

Marketing Authorisation Holder and Manufacturer:

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Manufacturer:

Bluepharma Industria Farmaceutica SA, Coimbra, Portugal.

This leaflet was last revised in August 2014.

*Trademark 25214801

GENUS PHARMACEUTICALS

GEN/TNS/PIL/268_02