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Bayer Limited

The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 18/12/2017
SPC Nimotop 0.02% w/v Concentrate for Solution for Infusion.

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Dec-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 6.1
Old Version                 New Version             
Ethanol                         Ethanol
Macrogol                      Macrogol
Sodium citrate              Sodium citrate
Citric acid anhydrous   Citric acid
Water for injections      Water for injections


Section 10(Date of revision of text)
Old Version
November 2014

New Version
December 2017
Updated on 21/11/2014 and displayed until 18/12/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Nov-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In section 4.2 the following was inserted

Special populations

Paediatric population

Safety and efficacy of nimodipine in patients under 18 years of age have not been established.”


In section 4.8 information on Reporting of suspected adverse reactions was introduced.

The date of revision was updated

Updated on 31/05/2013 and displayed until 21/11/2014
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Apr-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



(Inserted text; Deleted text)

 

4.3       Contraindications

 

            Nimodipine solution for infusion must not be used in cases of hypersensitivity to nimodipine or to any of the excipients. Known hypersensitivity to Nimodipine or any of the excipients.

Nimodipine should not be administered to patients during or within one month of a myocardial infarction of an episode of unstable angina.

4.4       Special warnings and precautions for use

 

            Nimotop solution should be used with care when cerebral oedema or severely raised intracranial pressure are present. Although treatment with Nimotop nimodipine has not been shown to be associated with increases in intracranial pressure, close monitoring is recommended in these cases or when the water content of the brain tissue is elevated (generalised cerebral oedema).

Caution is required in patients with hypotension (systolic blood pressure lower than 100mg Hg). Nimotop solution must be used with caution in hypotensive patients.

In patients with unstable angina or within the first 4 weeks after acute myocardial infarction, physicians should consider the potential risk (e.g. reduced coronary artery perfusion and myocardial ischemia) versus the benefit (e.g. improvement of brain perfusion).

Patients with known renal disease and/or receiving nephrotoxic drugs should have renal function monitored closely during intravenous treatment with Nimotop solution.

...

The amount of alcohol in this medicine may alter the effects of other medicines (See Section 4.5 Interaction with other medicinal products and other forms of interactions).

This medicinal product contains 1 mmol (23mg) sodium per 50ml bottle. To be taken into consideration by patients on a controlled sodium diet.

 

Renal function can deteriorate if potentially nephrotoxic drugs (e.g. aminoglycosides, cephalosporins, furosemide) are given simultaneously, and also in patients whose renal function is already impaired. Renal function must be monitored carefully in such cases, and if a deterioration is found discontinuation of the treatment should be considered (see “Interaction with other medicinal products and other forms of interaction”). This medicinal product contains 2 mmol sodium per daily dose. This should be taken into consideration for patients on a controlled sodium diet.

 

4.5       Interaction with other medicinal products and other forms of interaction

Fluoxetine

Concomitant administration of nimodipine with the antidepressant fluoxetine, once steady state has been achieved has led to approximately 50% higher plasma nimodipine levels.  Fluoxetine plasma levels were exposure was markedly decreased, however the while its active metabolite, norfluoxetine was not affected.

 

Nortryptyline

The steady-state concomitant administration of nimodipine and nortriptyline led to a slight decrease in nimodipine plasma concentrations exposure with unaffected nortriptyline plasma concentrations.

 

Blood pressure lowering drugs:

However, iIf a combination of this type proves unavoidable particularly careful monitoring of the patient is necessary.

Renal function must be monitored carefully in such cases and if deterioration is found discontinuation of the treatment should be considered (See Section 4.4 Special warnings and precautions for use).

 

Zidovudine

In a monkey study simultaneous administration of anti-HIV drug zidovudine i.v. and nimodipine bolus i.v. resulted for zidovudine in significantly higher AUC, whereas the distribution volume and clearance were significantly reduced.

Animal studies have shown that when nimodipine and zidovudine are administered concomitantly, the AUC for zidovudine was increased, and the volume of distribution and clearance rate decreased.

 

Other forms of interaction:

Since Nimotop nimodipine solution for infusion contains 23.7 vol % ethanol (alcohol), patients should be monitored for any possible interactions with alcohol-incompatible drugs should be taken into consideration (see Section 4.4 Special warnings and precautions for use).

 

 

4.6       Pregnancy and lactation

Pregnancy:

...

Reproductive toxicology studies in animals after oral administration showed no teratogenic effect.  Therefore, if Nimotop solution nimodipine solution for infusion is to be administered during pregnancy, the benefits and the potential risks must be carefully weighed according to the severity of the clinical picture.

...

In vitro fertilisationFertility:

            In single cases of in-vitro fertilisation calcium antagonists have been associated with reversible biochemical changes in the spermatozoa’s head section that may result in impaired sperm function. The relevance of this finding in short-term treatment is unknown.

4.8       Undesirable effects

 

The frequencies of ADRs reported with nimodipine summarized in the tables below are based on clinical trials with nimodipine in the indication aSAH sorted by CIOMS III categories of frequency (placebo-controlled studies: nimodipine N = 703; placebo N = 692; uncontrolled studies: nimodipine N = 2496; status: 31 Aug 2005). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

Frequencies are defined as:

Very common (1/10),

Common (1/100 to <1/10),

Uncommon (1/1,000 to <1/100),

Rare (1/10,000 to <1/1,000),

Very rare (<1/10,000).

Table 01: ADR

System Organ Class
          (MedDRA)

Uncommon

Rare

Blood and the lymphatic system disorders

Thrombocytopenia

 

Immune system disorders

Allergic reaction

Rash

 

Nervous system disorders

Headache

 

Cardiac disorders

Tachycardia

Bradycardia

Vascular disorders

Hypotension

Vasodilatation

 

Gastrointestinal disorders

Nausea

Ileus

Hepatobiliary disorders

 

Transient increase in liver enzymes

General disorders and administration site conditions

 

 

Injection and infusion site

reactions

Infusion site (thrombo-)

phlebitis

 

Adverse drug reactions (ADRs) based on clinical trials with nimodipine in the indication aSAH sorted by CIOMS III categories of frequency (placebo controlled studies nimodipine N = 703; placebo N = 692; uncontrolled studies: nimodipine N = 2496; status: 31 Aug 2005) are listed below:

 

Clinical Description

Common >1% to <10%

Uncommon ≥0.1% to <1%

Rare ≥0.01% to <0.1%

Very Rare <0.01%

Blood and Lymphatic System Disorders

Changes in blood cell counts

 

Thrombocytopenia

 

 

Immune System Disorders

Acute hypersensitivity reactions

 

Allergic reaction (rash skin hypersensitivity reaction)

Rash

 

 

Nervous System Disorders

Unspecific cerebrovascular symptoms

 

Headache

 

 

Cardiac Disorders

Unspecific arrhythmias

 

Tachycardia

Bradycardia

 

Vascular Disorders

Unspecific cardiovascular symptoms

 

Hypotension

Vasodilatation (sweating, flushing and feeling of warmth)

 

 

Gastrointestinal Disorders

Gastro intestinal symptoms

 

Nausea

Ileus

 

Hepatobiliary Disorders

Mild to moderate hepatic reactions

 

 

Transient increase in liver enzymes

 

General Disorders and Administration Site Conditions

 

 

 

 

Infusion site reactions

 

 

Injection and infusion site reactions

Infusion site (thrombo-) phlebitis

 

 

4.9       Overdose

...

 

In the event of acute overdosage, treatment with Nimotop nimodipine must be discontinued immediately. Emergency measures should be governed by the symptoms. Gastric If the substance was ingested orally, gastric lavage with addition of charcoal should be considered as an emergency therapeutic measure. If there is a marked fall in blood pressure, dopamine or noradrenaline can be administered intravenously. As Since no specific antidote is known, subsequent treatment for other side effects should be aimed at governed by the most prominent symptoms.

 

10.       DATE OF REVISION OF THE TEXT

June 2010 April 2013

 

Updated on 01/07/2010 and displayed until 31/05/2013
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Please note where new text has been inserted into a sentence the text has been highlighted  in red:

 

1.         NAME OF THE MEDICINAL PRODUCT

 

Nimotop 0.02% w/v Concentrate for Solution for Infusion.

 

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Addition of:

“Each 50ml vial also contains 10g of ethanol (0.2g/ml) and 2.3mg of sodium (as sodium citrate dihydrate).”

 

For a full list of excipients, see 6.1.

 

 

3.         PHARMACEUTICAL FORM

 

            Concentrate for solution for infusion (Sterile concentrate).

 

            A clear, yellow solution.

 

 

4.2       Posology and method of administration

 

Therapeutic administration

 

Subsection: Route of administration

“Nimotop solution must not be added to an infusion bag or bottle and msut not be moixed with other drugs.”  has been changed to:

 

“Nimotop must not be mixed with other drugs so it should not be added to an infusion bag or bottle which contains other drugs.” 

 

 

4.4       Special warnings and precautions for use

 

At the end of this section addition of “Nimotop should not be used in concentrated form.”

 

 

6.2              Incompatibilities

 

Addition of “Nimotop must not be mixed with other drugs so it should not be added to an infusion bag or bottle which contains other drugs.”

 

 

6.4       Special precautions for storage

 

            Do not store above 25°C.  Keep the vial in the outer carton to protect from light.

 

 

9.         DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

 

Date of first authorisation:          15 February 1994

Date of last renewal:     15 Feburary 2009

 

 

10.       DATE OF REVISION OF THE TEXT

Changed to “June 2010”

Updated on 16/10/2008 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/1007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to MA Holder, MA Number and date of revision of text.
Updated on 17/05/2007 and displayed until 16/10/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Sections 4.2, 5.1, 5.2, 5.3 and 6.6 where updated following internal review.

Updated on 23/05/2005 and displayed until 17/05/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/12/2004 and displayed until 23/05/2005
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 03/12/2004 and displayed until 06/12/2004
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 29/05/2003 and displayed until 03/12/2004
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Nimodipine