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CARDILATE MR 10MG TABLETS

Active substance(s): NIFEDIPINE / NIFEDIPINE / NIFEDIPINE

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Package leaflet: Information for the user

Cardilate MR 10mg 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 Cardilate MR is and what it is used for
2. What you need to know before you take Cardilate MR
3. How to take Cardilate MR
4. Possible side effects
5. How to store Cardilate MR
6. Contents of the pack and other information

1. What Cardilate MR is and what it is used for
Your tablets are called Cardilate MR Tablets. The common name for your tablets is nifedipine.
They are part of a group of drugs known as calcium channel blockers which interfere with the
movement of calcium in heart muscle cells.
Cardilate MR Tablets are used to treat high blood pressure (hypertension) and to prevent the
condition called angina pectoris (pain in the centre of your chest which is brought on by
exercise).
For high blood pressure: Cardilate 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: Cardilate 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 Cardilate MR

Do not take Cardilate MR Tablets if you:
• If you have had a heart attack within the last month.
• If you get a sudden angina attack. Cardilate MR will not help relieve symptoms of
angina quickly.
• If you have unstable angina.
• If you are allergic to nifedipine, any other similar medicines (known as
dihydropyridines) or any of the other ingredients of this medicine (listed in section 6).
• 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 your blood pressure continues to rise despite treatment (malignant hypertension).
• If you have a “Kock pouch” (a surgically constructed intestinal reservoir with an opening
through the abdominal wall) in your gut.
 Tell your doctor and do not take Cardilate MR if any of these apply to you.

Warnings and precautions
Talk to your doctor before taking Cardilate MR
• If you have low blood pressure and you were prescribed Cardilate 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 Cardilate MR, you should stop breastfeeding
before you start to take this medicine.
• If you are a 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 very high blood pressure and a low blood
volume, you might experience a sudden drop in blood pressure when you take Cardilate 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 Cardilate MR.
 Talk to your doctor before you take Cardilate MR if any of these apply to you.

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 Cardilate MR.
• If you have chest pains after taking your first dose of Cardilate 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. Cardilate MR may interfere with the results of certain
urine tests.
• If you are a man who has been unable to father a child by in vitro fertilisation.
Drugs like Cardilate MR have been shown to impair sperm function.

Other medicines and Cardilate MR
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the way Cardilate 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 (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 sulphate 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).

Cardilate MR with food and drink
You can take Cardilate MR either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Cardilate MR.
Do not start taking Cardilate 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 Cardilate 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 your doctor
for advice before taking this medicine.

You may be able to use Cardilate MR but only after special consideration and agreement by your
doctor.
Do not take Cardilate MR if you are breast-feeding. If you need to take Cardilate MR, you
should stop breast-feeding before you start taking this medicine.

Driving and using machines
Cardilate 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.
3. HOW TO TAKE CARDILATE MR
Always take this medicine exactly as your doctor has told you. Check with your doctor if you
are not sure.
• To start with, your doctor will monitor you carefully to see how you are responding so that
the best long-term dose can be identified.
• After a while, you may be given a higher strength (20 mg) Cardilate MR tablet.
• The usual maintenance dose is 1 tablet, every 12 hours (i.e. twice per day), but your doctor
may increase or decrease the dose depending on how well your blood pressure or angina is
being controlled. The maximum dose is 40 mg every 12 hours.
• Lower doses may be prescribed for older people.
• If you have problems with your liver your doctor will monitor you carefully. A reduction
in your nifedipine dose may be required.
• 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 them with grapefruit juice.
You can take Cardilate MR either with or without food.
Use in children and adolescents: Cardilate 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 Cardilate MR than you should

 Get medical help immediately. If possible, take your tablets or the box with you to show

the doctor.
Taking too many tablets may cause your blood pressure to become too low and your
heartbeats to 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 Cardilate MR
Take your normal dose immediately and continue taking your tablets as prescribed, waiting
12 hours before taking your next dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor.

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 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)
• fast heart beat (tachycardia)
• shortness of breath (frequency not known) or difficulty breathing
• mild to moderate allergic reactions
• itching (possibly severe), a rash or hives
 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 Cardilate MR, starting
with the more common ones:

Common side effects
(These may affect up to 1 in 10 people)
• headache
• flushing




general feeling of being unwell

constipation
swelling, particularly of the ankles and legs

Uncommon side effects
(These may affect up to 1 in 100 people)
• 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
• 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

Rare side effects
(These may affect up to 1 in 1,000 people)
• pins and needles
• inflammation of the gums, tender or swollen gums, bleeding gums

Other side effects
(Frequency not known: frequency cannot be estimated from the available data)
• 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
• chest pain (angina pectoris)
• heartburn or indigestion (gastroesophageal sphincter insufficiency)
• yellowing of the whites of the eyes or skin (jaundice)
• sensitivity to light (photosensitivity allergic reaction)
• small, raised areas of bleeding in the skin (palpable purpura)
• joint pain
• muscle pain
• excess collection of watery fluid in the lungs
All of these symptoms usually go away when treatment with Cardilate MR is stopped.

Reporting of side effects
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 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 Cardilate MR
Keep this medicine out of the sight and reach of children.
You should keep your tablets in a dry place, below 25°C and away from light.
Keep them in the pack they came in. Do not put them into another container.
Do not take the tablets after the after the expiry date. 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 protect the
environment.

These tablets are only for you. Only a doctor can prescribe them for you. Never give them to
anyone else.

6. Contents of the pack and other information
What Cardilate MR contains
Each tablet contains:
• Nifedipine Ph Eur 10 milligrams (mg); and
• Microcrystalline cellulose, carboxymethyl sodium starch,mannitol, colloidal anhydrous silica,
povidone, magnesium stearate, sodium lauryl sulphate, methyl hydroxyl propyl cellulose,
polyoxyethylene glycol 400 and 6000, talc and colours E171 and E172 (inactive ingredients).

What Cardilate MR looks like and contents of the pack
Cardilate MR 10mg Tablets are pink modified release tablets.
Cardilate MR Tablets come in packs of 56 and 100.

Marketing Authorisation Holder and Manufacturer
IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10
5HX

This leaflet was last revised in May 2017.
PL 0530/0517

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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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