Nimotop 30mg film-coated tablets

  • Name:

    Nimotop 30mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Nimodipine

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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Summary of Product Characteristics last updated on medicines.ie: 20/12/2018

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Bayer Limited

Bayer Limited

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When a pharmaceutical company changes any document, 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 20 December 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 11 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 May 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 July 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 July 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Posology:
Unless otherwise prescribed the following dosage is recommended:
The recommended procedure is administration of Nimotop solution for infusion for 5 to 14 days followed by a total daily dose of 360 mg by taking6 x 2 Nimotop tablets at 4 hourly intervals, i.e. 6 times a day(total daily dose 360 mg).
Alternatively, prophylactic therapy may be initiated using Nimotop tablets. The recommended total daily dose is 360 mg by taking6 x 2 Nimotop tablets at 4 hourly intervals, i.e. 6 times a day(total daily dose 360 mg).
In patients who develop adverse reactions the dose should be reduced as necessary or the treatment discontinued.

Updated on 18 November 2014 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2

·         The subheading Special populations

·         The following was inserted

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 18 November 2014 PIL

Reasons for updating

  • Change of contraindications
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 7 June 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

(Inserted text; Deleted text)


Section 4.2: Posology and method of administration

 

Aneurysmal subarachnoid haemorrhage

Dosage: Posology:

…………….

Severely disturbed liver function, particularly liver cirrhosis, may result in an increased bioavailability of nimodipine due to a decreased first-pass capacity and a reduced metabolic clearance. The effects and side-effects, e.g. reduction in blood pressure, may be more pronounced in these patients.

 

In such cases the dose should be reduced (depending on the blood pressure) or, if necessary, discontinuation of the treatment should be considered.

 

Upon co-administration with cytochrome P450 3A4 inhibitors or inducers, a dose adaption may be necessary (see sections 4.4 and 4.5).

 

Administration: Method of administration:

…………….

Patients with hepatic impairment

Severely disturbed liver function, particularly liver cirrhosis, may result in an increased bioavailability of nimodipine due to a decreased first-pass capacity and a reduced metabolic clearance. The effects and side-effects, e.g. reduction in blood pressure, may be more pronounced in these patients.

In such cases the dose should be reduced (depending on the blood pressure) or, if necessary, discontinuation of the treatment should be considered.

 

Section 4.3 Contraindications

Known Nimodipine must not be used in case of hypersensitivity to Nimodipine the active

substance of or any of the excipients.

 

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

 

The use of nimodipine in combination with rifampicin is contraindicated as the efficacy of Nimotop tablets nimodipine could be significantly reduced when concomitantly administered. (See section 4.5 Interaction with other medicinal products and other forms of interaction).

 

The concomitant use of oral nimodipine and the antiepileptic drugs, phenobarbital, phenytoin or carbamazepine is contraindicated as the efficacy of Nimotop tablets nimodipine could be significantly reduced (see section 4.5 Interaction with other medicinal products and other forms of interaction).

 

Section 4.4: Special warnings and precautions for use

Nimotop tablets 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 100 mm Hg).

 

Decreased drug clearance may occur in cirrhotic patients receiving Nimotop and therefore close monitoring of blood pressure is recommended in these 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).

 

Nimodipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or induce this enzyme system may, therefore, alter the first pass or the clearance of nimodipine (see section 4.5 Interaction with other medicinal products and other forms of interaction and Section 4.2 Posology and method of administration / Patients with hepatic impairment).

 

Drugs which are known inhibitors of the cytochrome P450 3A4 system and, therefore, may lead to increased plasma concentrations of nimodipine are, e.g.:

·         macrolide antibiotics (e.g. erythromycin),

·         anti-HIV protease inhibitors (e.g. ritonavir),

·         azole antimycotics (e.g. ketoconazole),

·         the antidepressants nefazodone and fluoxetine,

·         quinupristin/dalfopristin, cimetidine and

·         valproic acid.

 

Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction in the nimodipine dose should be considered.

 

Section 4.5: Interaction with other medicinal products and other forms of interaction

Nimotop tablets should not be administered concomitantly with Nimotop solution.

 

Drugs that affect nimodipine:

 

Nimodipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or induce this enzyme system may, therefore, alter the first pass or the clearance of nimodipine (see section 4.2 Posology and method of administration / Patients with hepatic impairment).

 

The extent as well as the duration of interactions should be taken into account when administering nimodipine together with the following drugs:

 

Rifampicin

Ffrom experience with other calcium antagonists it has to be expected that rifampicin accelerates the metabolism of Nimotop tablets nimodipine due to enzyme induction. Thus efficacy of Nimotop tablets nimodipine could be significantly reduced when concomitantly administered with rifampicin. The use of nimodipine in combination with rifampicin is, therefore, contraindicated. (See section 4.3 contraindications).

 

Cytochrome P450 3A4 system-inducing antiepileptic drugs such as, phenobarbital, phenytoin or carbamazepine:

Pprevious chronic administration of these drugs markedly reduces the bioavailability of orally administered nimodipine. Therefore, the concomitant use of oral nimodipine and these antiepileptic drugs is contraindicated. (See section 4.3 contraindications).

 

Upon co-administration with the following inhibitors of the cytochrome P450 3A4 system the blood pressure should be monitored and, if necessary, an adaption in the nimodipine dose should be considered (see section 4.2 Posology and method of administration):

 

Macrolide antibiotics (e.g. erythromycin)

Nno interaction studies have been carried out between nimodipine and macrolide antibiotics. Certain macrolide antibiotics are known to inhibit the cytochrome P450 3A4 system and the potential for drug interaction cannot be ruled out at this stage. Therefore, macrolide antibiotics should not be used in combination with nimodipine (see section 4.4 Special warnings and precautions for use). Azithromycin, although structurally related to the class of macrolide antibiotics, is void of CYP3A4 inhibition.

 

Anti-HIV protease inhibitors (e.g. ritonavir)

Nno formal studies have been performed to investigate the potential interaction between nimodipine and anti-HIV protease inhibitors. Drugs of this class have been reported to be potent inhibitors of the cytochrome P450 3A4 system. Therefore, the potential for a marked and clinically relevant increase in nimodipine plasma concentrations upon co-administration with these protease inhibitors cannot be excluded. (See section 4.4 Special warnings and precautions for use).

 

Azole anti-mycotics (e.g. ketoconazole)

Aa formal interaction study investigating the potential interaction between nimodipine and ketoconazole has not been performed. Azole anti-mycotics are known to inhibit the cytochrome P450 3A4 system and various interactions have been reported for other dihydropyridine calcium antagonists. Therefore, when administered together with oral nimodipine, a substantial increase in systemic bioavailability of nimodipine due to a decreased first pass metabolism cannot be excluded. (See section 4.4 Special warnings and precautions for use).

 

Nefazodone

Nno formal studies have been performed to investigate the potential interaction between nimodipine and nefazodone. This antidepressant drug has been reported to be a potent inhibitor of the cytochrome P450 3A4 system. Therefore, the potential for an increase in nimodipine plasma concentrations upon co-administration with nefazodone cannot be excluded. (See section 4.4 Special warnings and precautions for use).

 

Fluoxetine

Cconcomitant 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 (See section 4.4 Special warnings and precautions for use).

 

Quinupristin/dalfopristin

Based on experience with the calcium-antagonist, nifedipine, co-administration of quinupristin/dalfopristin may lead to increased plasma concentrations of nimodipine (See section 4.4 Special warnings and precautions for use).

 

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

 

Cimetidine

The simultaneous administration of nimodipine with the anticonvulsant valproic acid or the H2-antagonist cimetidine can lead to an increase in the plasma nimodipine concentration of nimodipine (See section 4.4 Special warnings and precautions for use).

 

Valproic acid

The simultaneous administration of the anticonvulsant Valproic acid can lead to an increase in the plasma nimodipine concentration (See section 4.4 Special warnings and precautions for use).

 

Further drug interaction:

 

Nortriptyline

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

 

Based on experience with the calcium-antagonist, nifedipine, co-administration of quinupristin/dalfopristin may lead to increased plasma concentrations of nimodipine.

 

Effects of nimodipine on other drugs

 

Blood pressure lowering drugs:

Nimodipine may increase the blood pressure lowering effect of concomitant antihypertensives, such as

·                                               diuretics

·                                               beta-blockers

·                                               ACE inhibitors

·                                               A1-antagonists

·                                               other calcium antagonists

·                                               alpha-adrenergic blocking agents

·                                               PDE5 inhibitors

·                                               alpha-methyldopa

 

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

 

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.  The clinical relevance of this interaction is unknown, but since the side-effect profile of zidovudine is known to be dose-related, this interaction should be considered in patients receiving nimodipine and zidovudine concomitantly.

 

Drug-food interactions:

 

Grapefruit juice

Grapefruit juice inhibits the cytochrome P450 3A4 system. Administration of dyhydropyridine calcium antagonists together with grapefruit juice thus results in elevated plasma concentrations and prolonged action of nimodipine due to a decreased first pass metabolism or reduced clearance.

 

Other types of interaction

 

The intake of grapefruit juice is not recommended in combination with nimodipine as it can result in increased plasma nimodipine concentrations due to the inhibition of the oxidative metabolism of dihydropyridines. As a consequence, the blood pressure lowering effect may be increased. After intake of grapefruit juice this This effect may last for at least 4 days after the last ingestion of grapefruit juice.

Ingestion of grapefruit / grapefruit juice is therefore to be avoided while taking

nimodipine (see Section 4.2 Posology and method for administration).

 

Interactions shown not to exist

 

There is no evidence of a potential interaction between nimodipine and haloperidol.

 

Concomitant administration of oral nimodipine and diazepam, digoxin, glibenclamide, indometacin, ranitidine and warfarin did not reveal any potential for mutual interaction.

Section 4.6: Fertility, Pregnancy and lactation

Pregnancy:

There are no adequate and well controlled studies in pregnant women. The safety of this medicinal product for use in human pregnancy has not been established. An evaluation of experimental animal studies following oral administration does not indicate direct or indirect harmful effects with regard to reproduction, development of the embryo or foetus, the course of gestation, and peri- and post-natal development. If nimodipine is to be administered during pregnancy, the benefits and potential risks must be carefully weighed according to the severity of the clinical picture.

 

Lactation:

Nimodipine and its metabolites have been shown to appear in human milk at concentrations of the same order of magnitude as corresponding maternal plasma concentrations. Nursing mothers are advised not to breast-feed when taking this drug.

 

In-vitro fertilisation Fertility:

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

 

Section 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).

 

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:

            Table 01: ADR table aSAH

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

 

 

 

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

 

 

Section 4.9: Overdose

Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia, bradycardia and (after oral administration) gastro-intestinal complaints and nausea.

 

In the event of acute overdosage, treatment with Nimotop nimodipine must be discontinued immediately. Emergency measures should be governed by the symptoms. 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.

 

Section 10: Date of revision of the text

June 2010 April 2013

Updated on 31 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 9 April 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 22 February 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 29 June 2010 SmPC

Reasons for 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Note: New text highlighted in red.

 

1.         NAME OF THE MEDICINAL PRODUCT

 

            Change from “Nimotop 30 mg Tablets” to “Nimotop 30 mg Film-coated Tablets.”

 

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

            Each tablet contains 30 mg nimodipine.

 

            For a full list of excipients, see section 6.1.

 

3.         PHARMACEUTICAL FORM

 

            Film-coated tablet (Tablet).      

 

Yellow, film-coated tablet, about 10 mm in diameter, marked with the Bayer cross on one face and with “SK” on the reverse.

 

 

6.         PHARMACEUTICAL PARTICULARS

 

6.1       List of excipients

 

Change to formatting layout of this section.

 

6.5       Nature and contents of container

 

            PP/aluminium blister packs, contained in cardboard outer, containing 100 x 30mg tablets.

 

Not all pack sizes or types may be marketed.

 

9.         DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

 

            Date of first authorisation:          15 February 1994

Date of last renewal:     15 February 2009

 

10.       DATE OF REVISION OF THE TEXT

 

June 2010

Updated on 25 June 2010 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 18 August 2009 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 24 October 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change in MA holder, MA number and date of revision of text.

Updated on 24 October 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 March 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7. Marketing Authorisation Holder: Marketing authorisation transferred from Bayer plc to Bayer Limited
 
Section 8. Marketing Authorisation Number: Number was changed from PA 21/32/2 to PA 1410/30/1
 
Section 10. Date of the Revision of the Text: Date was changed from June 2007 to December 2007.

Updated on 7 August 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2: Wording has been adjusted to give clinicians the option of using either iv or tablets for prophylaxis
Section 10 : Revision date has been updated to June 2007

Updated on 17 May 2007 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may be renewed (B)

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 9 September 2005 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 September 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 December 2004 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)