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TENSIPINE MR 10

Active substance(s): NIFEDIPINE / NIFEDIPINE / 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 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 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.
What is in this leaflet:
1. What Tensipine MR is and what it is used for
2. What you need to know before you take Tensipine MR
3. How to take Tensipine MR
4. Possible side-effects
5. How to store Tensipine MR
6. Contents of the pack and other information
1. WHAT TENSIPINE MR IS AND WHAT IT IS USED FOR
Tensipine MR contains nifedipine, which belongs to a group of medicines called calcium antagonists.
Tensipine MR is used to treat high blood pressure or angina (chest pain).
For high blood pressure: Tensipine MR works by relaxing and expanding 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: Tensipine MR works by relaxing and expanding 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 TO KNOW BEFORE YOU TAKE TENSIPINE MR
DO NOT take Tensipine MR:
• if you are allergic (hypersensitive) to nifedipine, any other similar medicines (known as
dihydropyridines) or any of the other ingredients of Tensipine MR (listed in Section 6).
• if you have had a heart attack within the last month or if you suspect that you are having a heart
attack.
• if you get a sudden angina attack. Tensipine MR will not help to relieve the symptoms of angina
quickly.
• if you have unstable angina.
• if you are pregnant, think you may be pregnant, are planning to become pregnant or are breastfeeding.
• if you are taking rifampicin, an antibiotic.
• if you have been told that you have a narrowing of the aortic heart valve (stenosis).
• if 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.
• if the severity or frequency of your angina has rapidly worsened over a matter of hours or if your
blood pressure continues to rise despite treatment (malignant hypertension).
• if 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tensipine MR:
• if you have low blood pressure and you were prescribed Tensipine MR for your angina. Your blood
pressure may be decreased further by this treatment.
• if you have a heart condition where your heart cannot cope with increased strain (poor cardiac
reserve).
• if you are pregnant.
• if you are breast-feeding. If you need to take Tensipine MR, you should stop breast-feeding before
you start to take this medicine.
• if you are diabetic. The treatment for your diabetes may need to be adjusted. If you have any
questions about this, ask your doctor.
• if you are on kidney dialysis. If you have a high blood pressure and a low blood volume, you might
experience a sudden drop in blood pressure when you take Tensipine MR.
• 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 Tensipine MR.
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 Tensipine MR.
• 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.
• if you suffer from a severe form of high blood pressure (malignant hypertension), Tensipine MR may
not be suitable for you.
• if you notice increased breathlessness.
• if you notice swelling of the ankles.
Also tell your doctor:
• if 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.
• if you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Tensipine
MR have been shown to impair sperm function.
Other medicines and Tensipine MR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the way Tensipine MR works. 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 (used 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 used to treat insomnia or anxiety).
Taking Tensipine MR with food or drink
Tensipine MR can be taken with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Tensipine MR.
Do not start taking Tensipine 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 Tensipine MR. 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
If you are pregnant, think you may be pregnant or are planning to have a baby, ask you doctor for advice
before taking this medicine.
You may be able to use Tensipine MR after week 20 of your pregnancy, but only after special
consideration and agreement by your doctor.
Do not take Tensipine MR if you are breast-feeding. If you need to take Tensipine MR, you should 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.
Please read the back of this leaflet.

*Trademark

25214802

GEN/TNS/PIL/349_06
12/09/2016

3. HOW TO TAKE TENSIPINE MR
Always take this medicine exactly as your doctor or pharmacist has told you. 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 recommended 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.
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, this medicine can cause 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 (e.g.
• shortness of breath or difficulty breathing
difficulty in breathing, drop of blood pressure,
• mild to moderate allergic reactions
fast pulse), swelling (including potentially life• itching (possibly severe), a rash or hives
threatening swelling of the airway)
• chest pain (angina attacks) at the start of
• other allergic reactions causing swelling under
treatment.
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 (may affect up to 1 in 10 people)
• headache
• constipation
• flushing
• swelling, particularly of the ankles and legs.
• general feeling of being unwell
Uncommon (may affect up to 1 in 100 people)
• 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)
vision and sometimes confusion)
• migraine
• fainting
• dizziness
• irregular heartbeat (palpitations)
• trembling
• dry mouth
• increase in the need to pass water (urinate)
• indigestion or upset stomach
• painful or difficult urination
• wind (flatulence)
• inability to achieve or maintain an erection
• feeling sick (nausea)
(impotence)
• muscle cramps
• blurred vision
• joint swelling
• temporary increase in certain liver enzymes.
Rare (may affect 1 in 1,000 people)
• pins and needles
• itching on one particular location on the body
• inflammation of the gums, tender or swollen
• loss of sensitivity or feeling in the hands.
gums, bleeding gums
Other side-effects (Frequency unknown)
• vomiting
• heartburn or indigestion (gaestoesophageal
• a reduction in the number of white blood cells
sphincter insufficiency)
(leucopenia)
• yellowing of the whites of the eyes or skin
• a more severe decrease in a specific class of
(jaundice)
white blood cell (agranulocytosis)
• sensitivity to light (photosensitivity allergic
• increased blood sugar (hyperglycaemia)
reaction)
• decreased skin sensitivity (hypoaesthesia)
• small, raised areas of bleeding in the skin
• drowsiness (somnolence)
(palpable purpura)
• eye pain
• joint pain
• chest pain (angina pectoris)
• 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 September 2016.

*Trademark
25214802

GEN/TNS/PIL/349_06
12/09/2016

Expand Transcript

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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