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NIMODREL XL 30MG TABLETS

Active substance(s): NIFEDIPINE

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567_FR01042_V3_MIMODREL_567_FR01042_V3 16/06/15 08:50 Page1

PHARMACEUTICALS

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



567_FR01042_V3_MIMODREL_567_FR01042_V3 16/06/15 08:50 Page2

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
whites of the eyes
difficulties
• 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.
Common (affecting less than 1 in 10 people):
• general weakness or loss of
• headache
strength and energy
• an irregular heartbeat
• constipation
• flushing
Uncommon (affecting less than
• pain, particularly in the
stomach area, chest and legs
• general feeling of being
unwell
• low blood pressure when
rising to the standing position
• fainting
• a fast heart beat

1 in 100 people):
• diarrhoea
• a dry mouth
• indigestion
• wind
• feeling sick
• leg cramps
• sleep disorders
• nervousness

• dizziness
• swelling, particularly of the
ankles and legs.









drowsiness
pins and needles
dizziness
difficulty in breathing
itching
rash
passing large volumes of urine
an increased need to urinate at
night

Rare (affecting less than 1 in 1,000 people):
• allergic reactions (described
• belching
above)
• problems with your gut
• an allergic inflammation of the • inflammation of the gums
liver causing rash, fever or
• tender or swollen gums which
yellowing of the skin and
may bleed
whites of the eyes
• blood tests which show changes
• chills
in the way the liver is working
• chest pains
• vomiting
• swelling of the face, lips and • problems with your joints that
tongue
may be painful
• fever
• muscle pain
• problems with your circulatory • increased sensitivity
system
of the skin (particularly to
• loss of appetite
touch)

trembling
mood changes
nose bleeds
lumpy, itchy red rash that
appears on the body, lips, eyes,
or tongue
• sweating
• problems with the eyes that
may be painful or cause blurred
vision
• pain, discomfort or burning
sensation when passing urine
• failure to achieve or maintain
an erection

Very rare (affecting less than 1 in 10,000 people):
• severe allergic reaction
• yellowing of the skin or whites
(described above)
of the eyes caused by liver or
• a mass of foreign material
blood problems
found in the stomach
• signs of infection e.g.
• difficulty swallowing
unexplained fever due to low
• inflammation of the gullet
levels of white blood cells
• problems with the gums
• weight loss
• obstruction of the gut
• muscle cramps
• ulcers in the gut
• 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






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, 333 Styal Road, Manchester,
M22 5LG, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in 07/2015

FR01042.V3 / ZP0013/6

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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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