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TENSIPINE MR 20

Active substance(s): NIFEDIPINE

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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
1.
2.
3.
4.
5.
6.

this leaflet:
What Tensipine MR is and what it is used for
Before you take Tensipine MR
How to take Tensipine MR
Possible side-effects
How to store Tensipine MR
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.
*Trademark

25214801

GEN/TNS/PIL/268_02
28/08/2014

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
• fast heart beat (tachycardia)
including very rarely life-threatening shock
• shortness of breath or difficulty breathing
(e.g. difficulty in breathing, drop of blood
• mild to moderate allergic reactions
pressure, fast pulse), swelling (including
• itching (possibly severe), a rash or hives
potentially life-threatening swelling of the
• chest pain (angina attacks) at the start of
airway)
treatment.
• other allergic reactions causing swelling
under the skin (possibly severe and including
swelling of the larynx that may result in a lifethreatening 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
• constipation
• flushing
• swelling, particularly of the ankles and legs.
• general feeling of being unwell
Uncommon (affects 1 to 10 users in 1,000)
• stomach pain (abdominal pain)
• sleep disorders
• unspecific pain
• anxiety or nervousness
• chills
• reddening of the skin
• low blood pressure when standing up
• nose bleeds
(symptoms include fainting, dizziness, light
• nasal congestion
headedness, occasional palpitations, blurred
• sensation of spinning or whirling motion (vertigo)
• migraine
vision and sometimes confusion)
• dizziness
• fainting
• trembling
• irregular heartbeat (palpitations)
• increase in the need to pass water (urinate)
• dry mouth
• painful or difficult urination
• indigestion or upset stomach
• inability to achieve or maintain an erection
• wind (flatulence)
(impotence)
• feeling sick (nausea)
• blurred vision
• muscle cramps
• temporary increase in certain liver enzymes.
• joint swelling
Rare (affects 1 to 10 users in 10,000)
• pins and needles
• itching on one particular location on the
• inflammation of the gums, tender or swollen
body
gums, bleeding gums
• loss of sensitivity or feeling in the hands.
Other side-effects (Frequency unknown)
• vomiting
• chest pain (angina pectoris)
• a reduction in the number of white blood
• heartburn or indigestion (gaestoesophageal
cells (leucopenia)
sphincter insufficiency)
• a more severe decrease in a specific class of
• yellowing of the whites of the eyes or skin
white blood cell (agranulocytosis)
(jaundice)
• increased blood sugar (hyperglycaemia)
• small, raised areas of bleeding in the skin
• decreased skin sensitivity (hypoaesthesia)
(palpable purpura)
• drowsiness (somnolence)
• joint pain
• eye pain
• muscle 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.
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

GEN/TNS/PIL/268_02
28/08/2014

MHRA Header Box
Product
Title

Tensipine MR 10mg and 20mg Tablets

Component

Leaflet

Pack Size

56's

IG code

25214801

Dimensions

154 x 420mm

Proof No.

02

Colours used
Black

Fonts used
Helvetica 55 Roman
Helvetica 75 Bold

Date

28/08/2014

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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.

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