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NIMOTOP 30MG TABLETS

Active substance(s): NIMODIPINE

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Package leaflet: Information for the user

0

Nimotop® 30 mg Tablets
Nimodipine

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 Nimotop tablets are and what they are
used for

2

What you need to know before you take Nimotop
tablets

3
4
5
6

How to take Nimotop tablets

1

What Nimotop tablets are and
what they are used for

Possible side effects
How to store Nimotop tablets
Contents of the pack and other information

Nimotop tablets contains nimodipine, which belongs to a
group of medicines called calcium antagonists.
Nimotop tablets are used to prevent changes in brain
function after bleeding around the brain (subarachnoid
haemorrhage).

 Tell your doctor before you take
Nimotop tablets, if any of these
apply to you.

Children and adolescents

August

2015
REVISED

Do not give Nimotop tablets to children under
the age of 18 as the safety and efficacy of Nimotop have
not been established.

Other medicines and Nimotop tablets
You will not be given Nimotop tablets if you are receiving
Nimotop Solution.
You are not to be given rifampcin (an antibiotic),
phenobarbital, phenytoin, or carbamazepine (antiepileptic drugs) if you are taking Nimotop tablets.
Tell your doctor if you are taking, have recently taken or
might take any other medicines.
Some medicines may affect the way Nimotop tablets
works. Tell your doctor if you are taking:
• High blood pressure tablets (including nifedipine,
diltiazem, verapamil, alpha-methyldopa, alphablockers or beta-blockers). Nimotop tablets may
increase the effect of these medicines.
• An anti-ulcer drug called cimetidine or an antiepilepsy drug called sodium valproate.
These medicines may increase the effect of Nimotop
tablets.
• The anti-depressant drugs fluoxetine or nefazodone.
• The anti-HIV drug zidovudine (AZT).
• The HIV protease inhibitor drugs indinavir, ritonavir,
nelfinavir or saquinavir.
• The antibiotic erythromycin or the anti-fungal drugs
ketoconazole, itraconazole or fluconazole.
• The antibiotic drug combination quinupristin /
dalfopristin.

Nimotop tablets with food and drink
You can take Nimotop tablets with or without food.
Do not drink grapefruit juice or eat grapefruit while
taking Nimotop tablets.

Do not take Nimotop tablets:

Do not start taking Nimotop tablets within 4 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 Nimotop tablets. Grapefruit juice is known
to increase the blood levels of the active ingredient,
nimodipine. This effect can last for at least four days.



Pregnancy, breast-feeding and fertility

2






What you need to know before
you take Nimotop tablets
At the same time as you are getting Nimotop
solution through a drip. The tablets have been
prescribed as a convenient way to continue your
treatment after the drip is stopped.
If you have had a heart attack within the last
month.
If you suffer from angina and notice an increase in
the frequency and severity of attacks.
If you are allergic to nimodipine or any of the
ingredients of this medicine (listed in section 6).
If you are taking rifampicin (an antibiotic),
phenobarbital, phenytoin or carbamazepine (three
medicines most commonly used to treat epilepsy).

 Tell your doctor and do not take Nimotop
tablets if any of these apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nimotop
tablets






If you had a head injury, which caused bleeding
around the brain (traumatic subarachnoid
haemorrhage).
If you have fluid in the brain or severely raised
pressure in your skull. Your doctor will be able to
advise you about this.
If you have low blood pressure.
If you have liver disease. You will probably need to
have your blood pressure measured regularly.

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. Follow his/her instructions carefully.
Do not breast-feed while taking Nimotop tablets.
If you are trying to father a child, talk to your doctor.
Medicines like Nimotop tablets can sometimes affect male
fertility.

Driving and using machines
Nimotop tablets may make you feel dizzy. Do not drive or
operate machinery if you are affected in this way.

3

How to take Nimotop tablets

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
• The recommended dose is 2 tablets, every four
hours, this gives a maximum daily dose of 12 tablets
(360 mg).
• Keep taking the tablets for as long as your doctor
has told you to. This may be for up to 21 days.
Swallow the tablets with a little water.
Do not take more than your doctor has prescribed.

82140581

PMR 82140581 (93/06/MU-0201500331) Pantone: Schwarz, Orange 021

180x315-07508

If you take more Nimotop tablets than
you should

5

 Get medical help immediately and, if possible, take

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

your tablets with you. Taking too much Nimotop tablets
may cause low blood pressure (you may feel faint),
heartbeats that are faster or slower than usual and
feeling sick.

If you forget to take Nimotop tablets
Take your normal dose immediately and carry on taking that
day’s tablets at 4-hour intervals. Do not take a double dose
to make up for the forgotten tablets.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

How to store Nimotop tablets

Do not store above 30°C.
Do not use this medicine after the expiry date which is
stated on both the outer carton and on each blister strip of
tablets after EXP. 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.

6

Contents of the pack and other
information

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

What Nimotop tablets contain

Potentially serious side effects

The active substance is nimodipine. Each film-coated tablet
contains 30 mg of nimodipine.

If you experience:
• signs of allergic reaction such as swelling of the face,
lips, tongue or throat, difficulty breathing, rash, itching,
nausea or vomiting
• low blood pressure (may cause dizziness)
• slow heartbeat
• easier bruising and bleeding caused by a reduced
number of blood platelets

The other ingredients are microcrystalline cellulose,
hypromellose, macrogol, maize starch, povidone,
crospovidone, magnesium stearate and the colourings
titanium dioxide (E171) and iron oxide yellow (E172).




Contact your doctor immediately as these side
effects can sometimes be serious.

What Nimotop tablets looks like and
contents of the pack



Nimotop tablets are film-coated tablets. The tablets
are yellow, round biconvex tablets with “SK” marked
on one side and the Bayer cross marked on the other
side.
Nimotop is available in a pack of 100 tablets.

Less serious side effects



In addition to the serious side effects listed above, these
are the other less serious side effects of Nimotop tablets:

The tablets come in boxes of 100, but your doctor will
prescribe as many as you need.

Uncommon side effects

Marketing Authorisation Holder and
Manufacturer

(These may affect less than 1 in 100 people)
• rash
• headache
• fast heartbeat
• flushing, sweating, feeling of warmth
• feeling sick (nausea)

Rare side effects
(These may affect less than 1 in 1,000 people)
• constipation (lack of bowel movement)
• slight rise in liver enzymes (this will show up in blood
tests)

Marketing authorisation holder:
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA

Manufacturer:
Bayer Pharma AG, Leverkusen, Germany
This leaflet was last revised in August 2015.
Product Licence Number: PL 00010/0137

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.

U

82140581

PMR 82140581 (93/06/MU-0201500331) Pantone: Schwarz, Orange 021

180x315-07508

Package leaflet: Information for the user

0

Nimotop® 30 mg Tablets
Nimodipine

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 Nimotop tablets are and what they are
used for

2

What you need to know before you take
Nimotop tablets

3
4
5
6

How to take Nimotop tablets

1

What Nimotop tablets are and
what they are used for

Possible side effects
How to store Nimotop tablets
Contents of the pack and other information

Nimotop tablets contains nimodipine, which belongs to a
group of medicines called calcium antagonists.
Nimotop tablets are used to prevent changes
in brain function after bleeding around the brain
(subarachnoid haemorrhage).

 Tell your doctor before you take
Nimotop tablets, if any of these
apply to you.

August

2015
REVISED

Children and adolescents
Do not give Nimotop tablets to children under
the age of 18 as the safety and efficacy of Nimotop have
not been established.

Other medicines and Nimotop tablets
You will not be given Nimotop tablets if you are receiving
Nimotop Solution.
You are not to be given rifampcin (an antibiotic),
phenobarbital, phenytoin, or carbamazepine (antiepileptic drugs) if you are taking Nimotop tablets.
Tell your doctor if you are taking, have recently taken or
might take any other medicines.
Some medicines may affect the way Nimotop tablets
works. Tell your doctor if you are taking:
• High blood pressure tablets (including nifedipine,
diltiazem, verapamil, alpha-methyldopa, alphablockers or beta-blockers). Nimotop tablets may
increase the effect of these medicines.
• An anti-ulcer drug called cimetidine or an antiepilepsy drug called sodium valproate.
These medicines may increase the effect of Nimotop
tablets.
• The anti-depressant drugs fluoxetine or nefazodone.
• The anti-HIV drug zidovudine (AZT).
• The HIV protease inhibitor drugs indinavir, ritonavir,
nelfinavir or saquinavir.
• The antibiotic erythromycin or the anti-fungal drugs
ketoconazole, itraconazole or fluconazole.
• The antibiotic drug combination quinupristin /
dalfopristin.

Nimotop tablets with food and drink
You can take Nimotop tablets with or without food.
Do not drink grapefruit juice or eat grapefruit while
taking Nimotop tablets.

Do not take Nimotop tablets:

Do not start taking Nimotop tablets within 4 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 Nimotop tablets. Grapefruit juice is known
to increase the blood levels of the active ingredient,
nimodipine. This effect can last for at least four days.



Pregnancy, breast-feeding and fertility

2






What you need to know before
you take Nimotop tablets
At the same time as you are getting Nimotop
solution through a drip. The tablets have been
prescribed as a convenient way to continue your
treatment after the drip is stopped.
If you have had a heart attack within the last
month.
If you suffer from angina and notice an increase in
the frequency and severity of attacks.
If you are allergic to nimodipine or any of the
ingredients of this medicine (listed in section 6).
If you are taking rifampicin (an antibiotic),
phenobarbital, phenytoin or carbamazepine
(three medicines most commonly used to treat
epilepsy).

 Tell your doctor and do not take Nimotop
tablets if any of these apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nimotop
tablets






If you had a head injury, which caused bleeding
around the brain (traumatic subarachnoid
haemorrhage).
If you have fluid in the brain or severely raised
pressure in your skull. Your doctor will be able to
advise you about this.
If you have low blood pressure.
If you have liver disease. You will probably need to
have your blood pressure measured regularly.

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. Follow his/her instructions carefully.
Do not breast-feed while taking Nimotop tablets.
If you are trying to father a child, talk to your doctor.
Medicines like Nimotop tablets can sometimes affect male
fertility.

Driving and using machines
Nimotop tablets may make you feel dizzy. Do not drive or
operate machinery if you are affected in this way.

3

How to take Nimotop tablets

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose is 2 tablets, every four
hours, this gives a maximum daily dose of 12 tablets
(360 mg).
• Keep taking the tablets for as long as your doctor
has told you to. This may be for up to 21 days.
Swallow the tablets with a little water.
Do not take more than your doctor has prescribed.

307724

82141987

PMR 82141987 (93/06/MU-0201500331) Pantone: Schwarz, Orange 021
180x315-17484

If you take more Nimotop tablets than
you should

5

 Get medical help immediately and, if possible,

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

take your tablets with you. Taking too much Nimotop
tablets may cause low blood pressure (you may feel
faint), heartbeats that are faster or slower than usual
and feeling sick.

If you forget to take Nimotop tablets
Take your normal dose immediately and carry on taking
that day’s tablets at 4-hour intervals. Do not take a double
dose to make up for the forgotten tablets.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

How to store Nimotop tablets

Do not store above 30°C.
Do not use this medicine after the expiry date which is
stated on both the outer carton and on each blister strip of
tablets after EXP. 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.

6

Contents of the pack and other
information

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

What Nimotop tablets contain

Potentially serious side effects

The active substance is nimodipine. Each film-coated
tablet contains 30 mg of nimodipine.

If you experience:
• signs of allergic reaction such as swelling of the face,
lips, tongue or throat, difficulty breathing, rash, itching,
nausea or vomiting
• low blood pressure (may cause dizziness)
• slow heartbeat
• easier bruising and bleeding caused by a reduced
number of blood platelets




Contact your doctor immediately as these side
effects can sometimes be serious.

Less serious side effects
In addition to the serious side effects listed above, these
are the other less serious side effects of Nimotop tablets:

Uncommon side effects
(These may affect less than 1 in 100 people)
• rash
• headache
• fast heartbeat
• flushing, sweating, feeling of warmth
• feeling sick (nausea)

Rare side effects
(These may affect less than 1 in 1,000 people)
• constipation (lack of bowel movement)
• slight rise in liver enzymes (this will show up in blood
tests)

The other ingredients are microcrystalline cellulose,
hypromellose, macrogol, maize starch, povidone,
crospovidone, magnesium stearate and the colourings
titanium dioxide (E171) and iron oxide yellow (E172).

What Nimotop tablets looks like and
contents of the pack




Nimotop tablets are film-coated tablets. The tablets
are yellow, round biconvex tablets with “SK” marked
on one side and the Bayer cross marked on the other
side.
Nimotop is available in a pack of 100 tablets.

The tablets come in boxes of 100, but your doctor will
prescribe as many as you need.

Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA

Manufacturer:
Bayer Pharma AG, Leverkusen, Germany
This leaflet was last revised in August 2015.
Product Licence Number: PL 00010/0137

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.

307724

U

82141987

PMR 82141987 (93/06/MU-0201500331) Pantone: Schwarz, Orange 021
180x315-17484

Expand view ⇕

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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