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Nimodrel PIL ZP0013-5:INITIAL.QXD 10/04/2

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ZURICH

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nimodrel® XL 30 mg & 60 mg Prolonged Release 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 Nimodrel is and what it is used for

2.    What you need to know before you take Nimodrel

3.    How to take Nimodrel

4.    Possible side effects

5.    How to store Nimodrel

6.    Contents of the pack and other information

1. What Nimodrel is and what it is used for

Nimodrel XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). Nimodrel has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. They are called prolonged release tablets because they are manufactured in a way that allows the nifedipine to be released and slowly absorbed by your body over a period of several hours.

In high blood pressure, nifedipine works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.

In angina, nifedipine works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occurring when extra strain is placed upon the heart.

2. What you need to know before you take Nimodrel

Do not take Nimodrel:

   if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine) or any of the other ingredients in Nimodrel

   if you are pregnant, likely to become pregnant or are breast-feeding

   if    you    have been told that you have a narrowing (stenosis) of the aortic valve in your    heart

   if    you    have experienced a collapse which was caused by a heart problem (cardiogenic    shock)

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

   to treat an angina attack as it occurs, but rather to reduce the frequency of the angina you experience over time

   if you suffer from inflammation of the bowel or intestines (such as Crohn's disease), oesophageal (gullet) obstruction or have in the past had an obstruction or narrowing of the intestine

   if    you    have a liver disease

   if    you    have had a heart attack during the last month or to treat a heart attack

   if    you    are taking the antibiotic rifampicin (used to treat tuberculosis)

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

•    if you have a Kock pouch (a type of ileostomy)

Take special care with Nimodrel and always tell your doctor if:

   you suffer from low blood pressure

   you experience chest pains when you first start taking Nimodrel, contact your doctor immediately

   you are diabetic, the treatment for your diabetes may need to be adjusted

   you are receiving kidney dialysis and have very high blood pressure with low blood volume

   you are taking other drugs to treat high blood pressure (e.g. beta-blockers). If you are changing from a beta-blocker to nifedipine, you should gradually reduce your beta-blocker after discussion with your doctor

   you have to give a urine sample, have an barium contrast x-ray or undergo surgery

   you are male and have been unsuccessful in fathering a child by in vitro fertilisation. Medicines like Nimodrel have been shown to impair sperm function.

Your doctor may, under certain conditions, think it necessary to keep you on Nimodrel whilst you are pregnant. If this is the case particular care must be taken if you are also having magnesium sulfate injections.

Taking other medicines

Before starting treatment, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Nimodrel. This is especially important if you are likely to have an anaesthetic or an operation.

In particular, tell your doctor if you are taking:

   other drugs to treat high blood pressure

   cimetidine, to treat stomach ulcers

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

   the anti-epileptic drug phenytoin

   the antibiotic rifampicin

   combination treatment quinupristin/dalfopristin

   cisapride, a drug used to speed up the movement of food through the gullet and stomach

The effect of the following drugs on Nimodrel is uncertain. Therefore, as an additional precaution, please tell your doctor if you are taking:

   the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole

   indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infection

   the antidepressant drugs fluoxetine and nefazodone

   tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs

   carbamazepine and valproic acid, used for the treatment of epilepsy

   the barbiturate phenobarbital, used primarily to treat insomnia and anxiety

Taking Nimodrel with food and drink

Do not drink grapefruit juice at the same time or soon after taking Nimodrel because grapefruit juice can increase the blood levels of nifedipine.

Pregnancy, breast-feeding and fertility

Do not take Nimodrel if you are pregnant, trying to become pregnant or are breast-feeding.

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

Driving and using machines:

If you feel dizzy or extremely tired after taking Nimodrel, then do not drive or operate machinery.

Important information about some of the ingredients of Nimodrel

Nimodrel contains lactose monohydrate. 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 —

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3. How to take Nimodrel

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

Nimodrel is formulated so that you only have to take your tablets once a day. It is important that you take your tablets at the same time each day, preferably in the morning. Your tablet must be swallowed whole with a glass of water and not with grapefruit juice. Do not break or chew your tablets.

Adults:

The usual adult dose for treating high blood pressure or preventing angina is 30 mg or 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 90 mg of Nimodrel once a day.

If you are elderly, lower doses of this medicine may be prescribed by your doctor.

Do not stop taking your medicine until your doctor tells you.

Children:

Nimodrel 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 Nimodrel than you should

If you accidentally take more Nimodrel than you should, contact your nearest casualty department immediately. Remember to take the pack and any remaining tablets with you.

If you forget to take Nimodrel

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nimodrel can cause side effects, although not everyone gets them.

Allergic reactions, although serious, have been reported in rare cases. If you experience any of the following, contact your doctor or casualty department immediately:

•    rash or skin redness affecting • wheezing or breathing    • yellowing of the skin and

your whole body    difficulties    whites of the eyes

•    swelling of the face, lips and • fever tongue

If you experience chest pains when you first start taking Nimodrel, contact your doctor immediately.

The following side effects have also been reported, if you do experience any of these side effects they will usually go away when treatment is stopped.

Very rare (affecting less than 1

•    severe allergic reaction (described above)

•    a mass of foreign material found in the stomach

•    difficulty swallowing

•    inflammation of the gullet

•    problems with the gums

•    obstruction of the gut

•    ulcers in the gut


in 10,000 people):

•    yellowing of the skin or whites of the eyes caused by liver or blood problems

•    signs of infection e.g. unexplained fever due to low levels of white blood cells

•    weight loss

•    muscle cramps

•    skin flaking


•    red or purple discolourations on the skin

•    blistering of the skin when exposed to sunlight

•    too much sugar in the blood, resulting in increased thirst, frequent urination, weight loss and tiredness.

•    blurred vision


Common (affecting less than 1

in 10 people):

• headache

• general weakness or loss of

• dizziness

• an irregular heartbeat

strength and energy

• swelling, particularly of the

• flushing

• constipation

ankles and legs.

Uncommon (affecting less than

1 in 100 people):

• pain, particularly in the

• diarrhoea

• drowsiness

stomach area, chest and legs

• a dry mouth

• pins and needles

• general feeling of being

• indigestion

• dizziness

unwell

• wind

• difficulty in breathing

• low blood pressure when

• feeling sick

• itching

rising to the standing position

• leg cramps

• rash

• fainting

• sleep disorders

• passing large volumes of urine

• a fast heart beat

• nervousness

• an increased need to urinate at

Rare (affecting less than 1 in 1,000 people):

night

• allergic reactions (described

• belching

• trembling

above)

• problems with your gut

• mood changes

• an allergic inflammation of the

• inflammation of the gums

• nose bleeds

liver causing rash, fever or

• tender or swollen gums which

• lumpy, itchy red rash that

yellowing of the skin and

may bleed

appears on the body, lips, eyes,

whites of the eyes

• blood tests which show changes

or tongue

• chills

in the way the liver is working

• sweating

• chest pains

• vomiting

• problems with the eyes that

• swelling of the face, lips and

• problems with your joints that

may be painful or cause blurred

tongue

may be painful

vision

• fever

• muscle pain

• pain, discomfort or burning

• problems with your circulatory

• increased sensitivity

sensation when passing urine

system

of the skin (particularly to

• failure to achieve or maintain

• loss of appetite

touch)

an erection

The development of breast tissue in older men on long term therapy and heart attacks have also been reported.

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.

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 YellowCard 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 Nimodrel

   Keep this medicine out of the sight and reach of children.

   Do not store above 25°C. Keep the blister in the outer carton.

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

   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.    Contents of the pack and other information

What Nimodrel contains:

   The active substance is nifedipine.

   The other ingredients are povidone K30, lactose monohydrate, talc, hypromellose (E464), magnesium stearate, carbomer 974P, colloidal anhydrous silica, macrogol 4000, dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate copolymer, red iron oxide (E172) and titanium dioixide (E171).

What Nimodrel look like and the contents of the pack:

Nimodrel XL 30mg and 60 mg Prolonged Release Tablets are pale red with a round and biconvex shape, marked on one side with "30" or "60" respectively. They are available in calendar blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer.

The Marketing Authorisation holder and manufacturer is Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK.

Is this leaflet hard to see or read? Phone 0161488 5555 for help.

This leaflet was last revised in 02/2015


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