Imigran 20 Nasal Spray

  • Name:

    Imigran 20 Nasal Spray

  • Company:
    info
  • Active Ingredients:

    Sumatriptan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/15

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Summary of Product Characteristics last updated on medicines.ie: 21/7/2015
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 items.Total: Infinity pages

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 21 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 July 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Update to MA holder contact details - Address change

Updated on 20 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 19 March 2015 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 Addition of do not exceed recommended dose. Administrative changes.
Section 4.3 Administrative changes.
Section 4.4 Further clarity in before treatment with Sumatriptan. Addition of child pugh information.
Section 4.8 Addition of HPRA reporting details
Section 4.9 Administrative changes.
Section 5.2 Addition of information on hepatic impairment.

Updated on 18 March 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to how the medicine works
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 March 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.2 - Posology and method of administration,
Section 4.4 - Special warnings and precautions for use,
Section 4.8 - Undesirable effects,
Section 5.1 - Pharmacodynamic properties

 

Updated on 13 March 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 1 February 2013 PIL

Reasons for updating

  • Change to storage instructions
  • Change to dosage and administration

Updated on 1 February 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration

 

Imigran is indicated for the acute intermittent treatment of migraine. Imigran Nasal Spray should not be used prophylactically.

 

Imigran is recommended as monotherapy for the acute treatment of a migraine and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3)other acute migraine therapies. If a patient fails to respond to a single dose of Imigran there are no reasons, either on theoretical grounds or from limited clinical experience, to withhold products containing aspirin or non-steroidal anti-inflammatory drugs for further treatment of the attack.

 

It is advisable that Imigran be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.

 

Adults only:

The optimal dose of Imigran Nasal Spray is 20 mg for administration into one nostril. HoweverAlthough, due to inter/intra patient variability of both the migraine attacks and the absorption of sumatriptan, 10 mg may be effective in some patients.

 

If a patient does not respond to the first dose of Imigran, a second dose should not be taken for the same attack. . In these cases the attack can be treated with paracetamol, aspirin or non-steroidal anti-inflammatory drugs.However the attack can be treated with simple analgesics, e.g. paracetamol, or non-steroidal anti-inflammatory drugs. Imigran may be taken for subsequent attacks.

 

If the patient has responded to the first dose, but the symptoms recur, a second dose may be given in the next 24 hours, provided that there is a minimum interval of two 2 hours between the two doses.

 

No more than two Imigran 20 mg Nasal Sprays to be used in any 24 hour period.

 

Adolescents (12-17 years of age)

Imigran 20 mg Nasal Spray is not recommended for use in adolescents.

 

Children (under 12 years of age):

Imigran Nasal Spray is not recommended for use in children under 12 years of age due to insufficient data on safety and  efficacy.The safety and effectiveness of Imigran Nasal Spray in children has not yet been established.

 

Elderly (over 65):

There is no experience of the use of Imigran Nasal Spray in patients over 65. Experience of the use of Imigran in patients aged over 65 years is limited. The pharmacokinetics in elderly patients have not been sufficiently studied. Therefore the use of sumatriptan is not recommended until further data are available.The pharmacokinetics of sumatriptan given orally do not differ significantly from a younger population but, until further clinical data are available, the use of Imigran in patients aged over 65 years is not recommended.

 

Patients with Hepatic Impairment:

Impairment of hepatic function gives rise to an 80% increase in plasma sumatriptan levels after an oral dose of 100mg. The drug should therefore be used with extreme caution and at reduced dosage in these patients.

 

Patients with Renal Impairment:

There is no information on the effect of renal impairment.

 

4.3 Contra-indications

 

Hypersensitivity to sumatriptan or to any of the excipientsany component of the preparation.

 

Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal’s angina), peripheral vascular disease or patients who have symptoms or signs consistent with ischaemic heart disease.

 

Sumatriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

 

Sumatriptan should not be administered to patients with severe hepatic impairment.

 

The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contra-indicated.

 

The concomitant administration of ergotamine, or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist, is contra-indicated (See Interaction with Other Medicinal Products and Other Forms of Interactionsection 4.5).

 

Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan or within 2 weeks of discontinuation of MAOI therapy is contra-indicated.

 

Imigran must not be used within 2 weeks of discontinuation of therapy with monoamine oxidase inhibitors.

Imigran Nasal Spray should not be given to diabetic patients.

 

4.4 Special Warnings and Special Precautions for Use

 

Imigran Nasal Spray should only be used where there is a clear diagnosis of migraine.

 

Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.

 

As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

 

There have been a number of reports of CVA (stroke, paresis), where a temporal association with sumatriptan intake was seen. It should be noted that migraineurs may be at increased risk of certain cerebrovascular events (e.g. CVA, TIA).

 

Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat (see section 4.8). Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and an appropriate evaluation should be carried out.

 

Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are heavy smokers or users of nicotine substitution therapies, without prior cardiovascular evaluation (see Section 4.3).Special consideration should be given to postmenopausal women and males over 40 with these risk factors. These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease and in adolescents (see section 4.8).

 

Imigran should not be used in patients with underlying cardiac disorders and in patients who, although asymptomatic, have significant risk factors predisposing to coronary artery disease.

 

Therefore a careful history to exclude pre-existing cardiac disease should be taken before sumatriptan is prescribed. Evaluations may not identify every patient who has cardiac diseases and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease and in the absence of known risk factors.

 

Patients in whom undiagnosed coronary artery disease is a possibility on the basis of age or the presence of other risk factors, such as family history of coronary artery disease, tobacco smoking, diabetes, hypercholesterolaemia, should receive the product only with great caution and if the benefit of treatment is judged to outweigh the possible risk. Use of sumatriptan should be carefully considered in patients who may be at risk of thrombotic episodes. There have been rare reports of patients on hormone replacement therapy who have had cardiac ischaemic events.

 

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).

 

If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised (see section 4.5)

 

Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat and arms. These symptoms may mimic angina pectoris but, in patients in whom cardiac investigations have been performed, they have only rarely been found to have been the result of coronary vasospasm. Although rare, the vasospasm may result in arrhythmia including ventricular fibrillation/ischaemia or myocardial infarction. If the patient experiences symptoms which are severe or persistent or are consistent with angina, further doses should not be taken until appropriate investigations have been carried out to check for the possibility of ischaemic changes.

 

There have been a number of fatalities from ventricular fibrillation and myocardial infarction.

 

Sumatriptan should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.

 

Sumatriptan should be administered with caution to patients with conditions, which may affect significantly the absorption, metabolism or excretion of the drug, e.g. impaired hepatic or renal function.

 

Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan (see section 4.8).

 

Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan. Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients.

 

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St. John’s Wort (Hypericum perforatum).

 

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

 

The recommended dose of Imigran should not be exceeded.

 

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).

 

If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised (see Interactions).

 

The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.

 

Overuse of acute migraine treatments has been associated with the exacerbation of headache (Medication Overuse Headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.

 

4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

 

There is no evidence of interactions Studies in healthy subjects show that Imigran does not interact with propranolol, flunarizine, pizotifen or alcohol.

 

There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT1 receptor agonistcontaining preparations. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contra-indicated (see section 4.3).

 

The period of time that should elapse between the use of sumatriptan and ergotamine containing preparations or another triptan/5-HT1 receptor agonist is not known. This will also depend on the doses and type of ergotamine containing products used. The effects may be additive. It is advised to wait at least 24 hours following the use of ergotamine containing preparations or another triptan/5-HT1 receptor agonist before administering sumatriptan. Conversely, it is advised to wait at least six 6 hours following use of sumatriptan before administering an ergotamine containing product and at least 24 hours before administering another triptan/5-HT1 receptor agonist.(see Contra-indications).

 

An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicated There is a risk of CNS toxicity when both MAOI’s and SSRI’s are given with Imigran; hence concomitant use is contraindicated (see section 4.3).

 

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs (see section 4.4Warnings and Precautions).

 

4.6 Pregnancy and Lactation

 

Pregnancy:

Post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, they do not point to an increased risk of congenital defects. Experience with the use of sumatriptan in the second and third trimester is limited.Caution should be exercised by considering the expected benefit to the mother against possible risk to the foetus

 

Post-marketing data from multiple prospective pregnancy registries have documented the pregnancy outcomes in over 1,000 women exposed to sumatriptan. Although there is insufficient information to draw definitive conclusions, the findings have not detected an increase in the frequency of birth defects nor a consistent pattern of birth defects, amongst women exposed to sumatriptan compared with the general population.

 

Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development. However, embryo-foetal viability might be affected in the rabbit (see section 5.3). Administration of sumatriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

 

Lactation:

It has been demonstrated that following subcutaneous administration sumatriptan is secreted into breast milk. Infant exposure can be minimised by avoiding breast-feeding for 12 hours after treatment, during which time any breast milk expressed should be discarded.Sumatriptan is excreted in breast milk in animals. No data exist in humans therefore administration of Imigran to a nursing woman is not recommended.

 

4.7 Effects on the Ability to Drive and Operate Machinery

 

No studies on the effects on the ability to drive and use machines have been performed. No data are available. Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.

 

4.8 Undesirable Effects

 

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) , not known (cannot be estimated from the available data).  Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.including isolated reports. The data from clinical trials are estimates. It should be noted that the background rate in comparator groups was not taken into account. Post-marketing data refer to reporting rate rather than true frequency.

 

Adverse events reported in adults have also been observed in adolescents. These include very rare reports of coronary artery vasospasm and myocardial infarction (see section 4.4)

 

Clinical Trial Data

 

Immune system disorders

Not known:                   Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.

 

Nervous System system Disordersdisorders

Very common:              Dysgeusia/unpleasant taste.

 

Common:                      Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

 

Not known:                   Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent; Tremor, dystonia, nystagmus, scotoma.

 

Eye disorders

Not known:                   Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself.

 

Cardiac disorders

Not known:                   Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see sections 4.3 and 4.4).

 

Vascular disorders

Common:                      Transient increases in blood pressure arising soon after treatment. Flushing.

 

Not known:                   Hypotension, Raynaud’s phenomenon.

 

Respiratory, Thoracic thoracic and Mediastinal mediastinal Disordersdisorders

Common:                      Following administration of sumatriptan nasal spray mild, transient irritation or burning sensation in the nose or throat or epistaxis have been reported. Dyspnoea

 

Gastrointestinal Disordersdisorders

Common:                      Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.but the relationship to sumatriptan is not clear.

 

Not known:                   Ischaemic colitis.

 

Not known:                   Diarrhoea.

 

Musculoskeletal and Connective connective Tissue tissue Disordersdisorders

The following symptom is usually transient and may be intense and can affect any part of the body including the chest and throat:

Common:                      Sensations of heaviness. (usually transient and may be intense and can affect any part of the body including the chest and throat). Myalgia.

 

Not known:                   Neck stiffness.

 

Not known:                   Arthralgia.

 

General Disorders disorders and Administration administration Site site Conditionsconditions

The following symptoms are usually transient and may be intense and can affect any part of the body including the chest and throat:

Common:                      Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat); feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).

 

The following symptoms are mostly mild to moderate in intensity and transient:

Common:        Feelings of weakness, fatigue.

 

Investigations

Very rare:                      Minor disturbances in liver function tests have occasionally been observed.

 

Psychiatric disorders

Not known:                   Anxiety.

 

Skin and subcutaneous tissue disorders

Not known:                   Hyperhidrosis.

 

Injection:

The most common side effects associated with treatment with sumatriptan administered subcutaneously are:

 

General Disorders and Administration Site Conditions

Very common:   Transient injection site pain. Injection site stinging/burning, swelling, erythema, bruising and bleeding have also been reported.

 

Although direct comparisons are not available, flushing and sensations of tingling, heat, pressure, and heaviness may be more common after sumatriptan injection.

 

Conversely, nausea, vomiting and fatigue appear to be less frequent with subcutaneous administration of sumatriptan injection than with tablets.

 

Nasal spray:

Respiratory, Thoracic and Mediastinal Disorders

Common:        Following administration of sumatriptan nasal spray mild, transient irritation or burning sensation in the nose or throat or epistaxis have been reported.

 

Post-Marketing Data

 

Immune System Disorders

Very rare:        Hypersensitivity reactions ranging from cutaneous hypersensitivity to rare cases of anaphylaxis.

 

Nervous System Disorders

Very rare:        Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures there are also reports in patients where no such predisposing factors are apparent. Tremor, dystonia, nystagmus, scotoma.

 

Eye disorders

Very rare:        Flickering, diplopia, reduced vision. Loss of vision (usually transient). However, visual disorders may also occur during a migraine attack itself.

 

Visual disorders may also occur during a migraine attack itself. Patients treated with Imigran rarely exhibit visual disorders like flickering and diplopia. Additionally cases of nystagmus, scotoma, reduced vision and retinal vascular occlusions have been observed. Very rarely loss of vision has occurred, which although usually transient, has included isolated irreversible cases.

 

Cardiac disorders

Very rare:        Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see Contraindications, Warnings and Precautions).

 

Vascular disorders

Very rare:        Hypotension, Raynaud’s phenomenon.

 

Gastrointestinal Disorders

Very rare:        Ischaemic colitis.

 

4.9 Overdose

 

Single doses, of sumatriptan, up to 40 mg intranasally and in excess of 16 mg subcutaneously and 400 mg orally have not been associated with side effects other than those mentioned.

 

In clinical studies volunteers have received 20 mg of sumatriptan by the intranasal route three times a day for a period of 4 days without significant adverse effects.

 

If overdosage occurs, the patient should be monitored for at least ten 10 hours and standard supportive treatment applied as required. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.

 

 

6.4 Special Precautions for Storage

 

Do not store above 30°C.

Do not freeze.

Store in the original package in order to protect from light.

 

 

Updated on 31 March 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • 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

Section 1

Name updated to include ‘Solution’

 

Section 2

Statement regarding excipients updated to read: ‘For a full list of excipients, see section 6.1’

 

Section 6.1

Name of excipient updated from ‘Dibasic sodium Phosphate anhydrous’ to ‘Disodium Phosphate anhydrous’

 

Section 6.5

Description of product presentation updated to include description of individually sealed blisters, i.e.

‘Unit dose spray device containing 0.1ml solution is presented in an individually sealed blister.’

 

Section 6.6

Updated to read ‘Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product’

 

Section 8

PA number updated to new format, e.g. from PA 1077/8/3 to PA 1077/008/003

 

Section 9

Included the date of first authorisation and date of last renewal

 

Section 10

Updated to February 2010

 

PACKAGE LEAFLET UPDATES

 

·         Name updated to include ‘Solution’

·         Manufacturer’s details updated to include full name and address

·         Storage instructions updated to the standard terms: ‘Do not store above 30°C. Store in the original package in order to protect from light’ and ‘Keep out of the reach and sight of children’

·         Included the standard statement regarding expiry date: ‘Do not use Imigran Nasal Spray Solution after the expiry date which is stated on the carton, blister or nasal spray after EXP. The expiry date refers to the last day of that month’

·         Corrected the name of excipient from ‘dibasic sodium phosphate’ to ‘disodium phosphate, anhydrous’

·         Deleted pack-shot image

Updated on 29 March 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change of manufacturer
  • Change to storage instructions

Updated on 30 October 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 29 October 2008 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use

Updated on 15 September 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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. 3

The following lines were  deleted “

Until further data are available the use of Imigran is contra-indicated in patients receiving concurrent treatment with certain antidepressants e.g. selective 5-HT reuptake inhibitors (see Interaction with other Medicinal Products and Other Forms of Interaction) and lithium.”

Updated on 4 March 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 19 February 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

4.4       Special Warnings and Precautions for Use

 

Imigran Ftab should only be used where there is a clear diagnosis of migraine.

 

Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.

           

            …………………………………………………………………………………

…………………………………………………………………………………..      ………………………..

 

The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.

 

Overuse of acute migraine treatments has been associated with the exacerbation of headache (Medication Overuse Headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.

 

 

4.8       Undesirable effects

 

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports. The data from clinical trials are estimates. It should be noted that the background rate in comparator groups was not taken into account. Post-marketing data refer to reporting rate rather than true frequency.

Clinical Trial Data:

Nervous System Disorders

Common:        Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia..

 

Vascular disorders

Common:        Transient increases in blood pressure arising soon after treatment. Flushing.

 

Respiratory, Thoracic and Mediastinal Disorders

Common:         Dyspnoea

 

Gastrointestinal Disorders

Common:        Nausea and vomiting occurred in some patients but the relationship to sumatriptan is not clear.

 

…………………………………………………………………………………………………………………………………………………………………………

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

            June 2006July 2007

Updated on 8 February 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 2 February 2007 PIL

Reasons for updating

  • Change to side-effects

Updated on 2 February 2007 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.4......

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).

If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised (see Interactions).

The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.

 

4.5...............There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs (see Warnings and Precautions)...........................

                4.8                   Undesirable effects

 

Adverse events are listed below by system organ class and frequency.  Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports. The data from clinical trials are estimates. It should be noted that the background rate in comparator groups was not taken into account. Post-marketing data refer to reporting rate rather than true frequency.

Clinical Trial Data:

Nervous System Disorders

Common:       Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

 

Vascular disorders

Common:       Transient increases in blood pressure arising soon after treatment.  Flushing.

 

Gastrointestinal Disorders

Common:       Nausea and vomiting occurred in some patients but the relationship to sumatriptan is not clear.

 

Musculoskeletal and Connective Tissue Disorders

The following symptom is usually transient and may be intense and can affect any part of the body including the chest and throat:

Common:                 Sensations of heaviness.

 

General Disorders and Administration Site Conditions

The following symptoms are usually transient and may be intense and can affect any part of the body including the chest and throat:

Common:       Pain, sensations of heat or cold,, pressure or tightness.

The following symptoms are mostly mild to moderate in intensity and transient:

Common:       Feelings of weakness, fatigue.

 

Investigations

Very rare:       Minor disturbances in liver function tests have occasionally been observed.

Post-Marketing Data:

Immune System Disorders

Very rare:       Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.

 

Nervous System Disorders

Very rare:                  Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures there are also reports in patients where no such predisposing factors are apparent. Tremor, dystonia, nystagmus, scotoma.

 

Eye disorders

Very rare:       Flickering, diplopia, reduced vision.         Loss of vision (usually transient). However, visual disorders may also occur during a migraine attack itself.

 

Cardiac disorders

Very rare:       Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see Section 4.3 Contraindications, Section 4.4 Special warnings and precautions).

 

Vascular disorders

Very rare:       Hypotension, Raynaud’s phenomenon.

 

Gastrointestinal Disorders

Very rare:       Ischaemic colitis.

 

Updated on 30 May 2006 SmPC

Reasons for updating

  • 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 5.3 - Preclinical safety data

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

Updated on 24 May 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 February 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 June 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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