Naramig 2.5mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Naratriptan hydrochloride
Available from:
CST Pharma Ltd
ATC code:
N02CC02
INN (International Name):
Naratriptan hydrochloride
Dosage:
2.5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070401; GTIN: 5055946800974

PATIENT INFORMATION LEAFLET

Naramig® 2.5mg tablets

(naratriptan hydrochloride)

Your tablets are available using the name Naramig 2.5mg tablets, but

will be referred to as Naramig throughout this leaflet.

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

What is in this leaflet

1. What Naramig is and what it is used for

2. What you need to know before you take Naramig

3. How to take Naramig

4. Possible side effects

5. How to store Naramig

6. Contents of the pack and other information

1. WHAT NARAMIG IS AND WHAT IT IS USED FOR

Naramig contains naratriptan (hydrochloride), which belongs to a

group of medicines called triptans (also known as 5-HT

1

receptor

agonists).

Naramig is used to treat migraine.

Migraine symptoms may be caused by the temporary widening of

blood vessels in the head. Naramig is believed to reduce the widening

of these blood vessels. This in turn helps to take away the headache

and relieve other symptoms of a migraine attack, such as feeling or

being sick (nausea or vomiting) and sensitivity to light and sound.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

NARAMIG

Do not take Naramig:

If you are allergic to naratriptan, or any of the other ingredients of

this medicine (listed in section 6)

If you have a heart problem such as heart failure or chest pains

(angina), or have already had a heart attack

If you have circulation problems in your legs that cause cramp-

like pains when you walk (peripheral vascular disease)

If you have had a stroke or a mini-stroke (also called a transient

ischaemic attack or TIA)

If you have high blood pressure. You may be able to take

Naramig if your high blood pressure is mild and is being treated

If you have kidney or liver disease

With other migraine medicines, including those which contain

ergotamine, or with similar medicines such as methysergide, or with

other 5-HT

receptor agonists, such as sumatriptan.

If any of these apply to you:

Tell your doctor, and don’t take Naramig.

Warnings and precautions

Talk to your doctor or pharmacist before taking Naramig.

If you have any extra risk factors

If you are a heavy smoker or are using nicotine replacement

therapy, and especially

If you are a man over 40, or

If you are a woman who has been through the menopause.

In very rare cases, people have developed serious heart conditions

after taking Naramig, even though they had no signs of heart disease

before.

If any of the points in the list applies to you, it could mean you have a

greater risk of developing heart disease – so:

Tell your doctor so that your heart function can be checked

before Naramig is prescribed for you.

S0277-GE-PIL-18.07.2019

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Naramig. If you know you are allergic

to an antibiotic but you are not sure whether it is a sulphonamide:

Tell your doctor or pharmacist before taking Naramig.

If you take Naramig frequently

Taking Naramig too often may make your headaches worse.

Tell your doctor if this applies to you. He or she may

recommend you stop taking Naramig.

If you feel pain or tightness in your chest after you take Naramig

These effects may be intense but they usually pass quickly. If they

don’t pass quickly, or they become severe:

Get medical help immediately. Section 4 of this leaflet has more

information about these possible side effects.

Not for older people or children under 18

Naramig is not recommended for people aged over 65, or for

children under the age of 18.

Other medicines and Naramig

Tell your doctor if you’re taking, have recently taken or might take

any other medicines.

Some medicines must not be taken with Naramig and others may

cause adverse effects if they’re taken with Naramig. You must tell

your doctor if you are taking:

any medicines for your migraine which contain any triptan/5HT

1

agonist (such as sumatriptan or zolmitriptan). Don’t take Naramig at

the same time as these medicines. Stop taking these medicines at

least 24 hours before taking Naramig.

ergotamine also used to treat migraine, or similar medicines such

as methysergide. Don’t take Naramig at the same time as these

medicines. Stop taking these medicines at least 24 hours before

taking Naramig.

any antidepressants classed as selective serotonin reuptake

inhibitors (SSRIs), such as citalopram, fluoxetine or paroxetine, or

serotonin noradrenaline reuptake inhibitors (SNRIs) such as

venlafaxine. If you are not sure, talk to your doctor or pharmacist.

St John’s Wort (Hypericum perforatum). Using herbal remedies

that contain St John’s Wort while you are taking Naramig may make

side effects more likely.

Pregnancy and breast-feeding

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. There is only limited information about the safety of

Naramig for pregnant women, though up till now there is no

evidence of any increased risk of birth defects. Your doctor may

recommend that you do not take Naramig while you are pregnant.

Don’t breast-feed your baby for 24 hours after taking Naramig.

If you express any breast milk during this time, discard the milk and

don’t give it to your baby.

Driving and using machines

Either the symptoms of migraine or your medicine may make you

drowsy. If you are affected, don’t drive or operate machinery.

Naramig contains lactose

Naramig contains a small amount of a sugar called lactose.

If you have an intolerance to lactose or any other sugars:

Ask your doctor for advice about taking Naramig.

3. HOW TO TAKE NARAMIG

Only take Naramig after your migraine headache begins.

Don’t take Naramig to try to prevent an attack.

Always take this medicine exactly as your doctor has told you. Check

with your doctor or pharmacist if you are not sure.

How much to take

The usual dose for adults aged 18 to 65 is one Naramig 2.5mg

tablet, swallowed whole with water.

Naramig is not recommended for children under 18 and adults over 65.

When to take Naramig

It’s best to take Naramig as soon as you feel a migraine coming

on, although it can be taken at any time during an attack.

If your symptoms start to come back

You can take a second Naramig after 4 hours, unless you have

kidney or liver damage.

If you have kidney or liver damage don’t take more than one

tablet in 24 hours.

No one should take more than two tablets in 24 hours.

If the first tablet has no effect

Don’t take a second tablet for the same attack.

If Naramig doesn’t give you any relief:

Ask your doctor or pharmacist for advice.

If you take more Naramig than you should

Don’t take more than two Naramig tablets in 24 hours. Taking

too much Naramig could make you ill. If you have taken more than

two tablets in 24 hours:

Contact your doctor for advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

Tell your doctor straight away if you notice any of the

following serious side effects – you may need urgent medical

treatment:

Heartbeat may go faster, slower or change rhythm (affects up to 1

in 100 people).

Pain in the lower left side of the stomach and bloody diarrhoea

(ischaemic colitis) – affects up to 1 in 1,000 people.

Allergic reaction (affects up to 1 in 1,000 people). The signs of

allergy include rash; hives; itching; wheezing; swollen eyelids,

face or lips; complete collapse.

If you get any of these symptoms soon after taking Naramig:

Don’t take any more. Contact a doctor straight away.

Heaviness, pressure, tightness or pain in the chest, throat or

other parts of the body (affects up to 1 in 100 people).

These effects may be intense but generally pass quickly.

If these effects continue or become severe (especially the chest

pain):

Get medical help urgently. In a very small number of people

these symptoms can be caused by a heart attack.

Common:

may affect up to 1 in 10 people

Feeling sick (nausea) or being sick (vomiting), although this may

be due to the migraine itself.

Tiredness, drowsiness or sleepiness (somnolence), or generally

feeling unwell.

Dizziness, tingling feelings or getting hot flushes.

If you get any of these effects:

Tell your doctor or pharmacist.

Uncommon:

may affect up to 1 in 100 people

Visual disturbances (although these may be due to the migraine

attack itself).

Slight increase in blood pressure which may occur up to 12 hours

after taking Naramig.

If you get any of these effects:

Tell your doctor or pharmacist.

Very rare:

may affect up to 1 in 10,000 people

Heart problems, including chest pains (angina) and heart attack.

Poor blood circulation to the arms and legs, causing pain and

discomfort.

If you get these symptoms:

Tell your doctor or pharmacist.

If you get side effects

If you notice any unwanted effects, even ones not listed in this

leaflet or if any of the side effects becomes troublesome:

Tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed on this leaflet. You

can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the

safety of this medicine.

5. HOW TO STORE NARAMIG

Keep out of sight and reach of children.

Do not store above 30°C.

Don’t take Naramig after the expiry date shown on the carton. The

expiry date refers to last day of that month.

If you have any unwanted Naramig, don’t dispose of it in your waste

water or household rubbish. Take it back to your pharmacist who

will dispose of it in a way that won’t harm the environment.

If your medicine becomes discoloured or show any signs of

deterioration, you should seek the advice of your pharmacist.

6. FURTHER INFORMATION

What Naramig contains

Each film-coated tablet contains 2.5mg of naratriptan (as naratriptan

hydrochloride).

The other ingredients in the tablet core are lactose (anhydrous),

microcrystalline cellulose, croscarmellose sodium, magnesium

stearate, methylhydroxypropylcellulose, titanium dioxide (E171),

triacetin, iron oxide yellow (E172), and indigo carmine aluminium lake

(E132).

What Naramig looks like and contents of the pack

Half-moon green tablet with "GXCE5" engraved on one side and plain

on the other. Tablets are supplied in blister packs of 6 or 12 tablets

Additional information

This leaflet does not contain all the information about your medicine. If

you have any questions or are not sure about anything, ask your

doctor or pharmacist who have the information you need, and will

advise you.

Manufacturer

GlaxoSmithKline Pharmaceuticals S.A, 60-322 Poznan, Poland.

Procured from within the EU and repackaged: Amimed Direct Ltd,

Hendon, London, NW9 6AQ.

Product licence holder: Sam Pharma Ltd, Unit 20, Garrick industrial

Estate, Irving way, Hendon, London, NW9 6AQ.

PL No: 33902/0277

Leaflet revision date: 18/07/2019

Naramig® is a registered trademark of the GlaxoSmithKline group of

companies.

Blind or partially sighted? Is this

leaflet hard to see or read? Call

02082033203 to obtain the leaflet

in a format suitable for you.

S0277-GE-PIL-18.07.2019

POM

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Naramig 2.5 mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Tablets containing 2.5 mg of naratriptan as naratriptan hydrochloride.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Naramig Tablets are indicated for the acute treatment of migraine attacks with

or without aura.

4.2

Posology and method of administration

Naramig tablets should be taken as early as possible after the onset of a

migraine headache but they are effective if taken at a later stage.

Naramig Tablets are recommended as monotherapy for the acute treatment of

a migraine attack.

Naramig Tablets should not be used prophylactically.

Posology

Adults (18-65 years of age)

The recommended dose of Naramig Tablets is a single 2.5mg tablet.

The total dose should not exceed two 2.5mg tablets in any 24 hour period.

If symptoms of migraine should recur, following an initial response, a second

dose may be taken provided that there is a minimum interval of four hours

between the two doses.

If a patient does not respond to a first dose of Naramig Tablets a second dose

should not be taken for the same attack, as it is unlikely to be of benefit.

However Naramig Tablets may be used for subsequent migraine attacks.

Adolescents (12-17 years of age)

Efficacy of Naramig Tablets at single doses of 0.25, 1.0 and 2.5mg was not

demonstrated to be greater than placebo in a placebo-controlled study in

adolescents (12 to 17 years). Therefore, the use of Naramig Tablets in patients

under 18 years of age is not recommended.

Children (under 12 years of age)

There are no data available on the use of naratriptan in children under 12 years

of age therefore its use in this age group is not recommended.

Elderly (over 65 years of age)

The safety and effectiveness of naratriptan in individuals over age 65 have not

been evaluated and therefore, its use in this age group can not be

recommended. There is a moderate decrease in clearance with age (see

Pharmacokinetics).

Renal

Impairment

Naramig should be used with caution in patients with renal impairment. The

maximum dose in any 24 hour treatment period is a single 2.5mg tablet. The

use of Naramig is contraindicated in patients with severe renal impairment

(creatinine clearance < 15mL/min)

(See Contraindications and Pharmacokinetics).

Hepatic Impairment

Naramig should be used with caution in patients with hepatic impairment. The

maximum dose in any 24 hour treatment period is a single 2.5mg tablet. The

use of Naramig is contraindicated in patients with severe hepatic impairment

(Child-Pugh grade C)

(See Contraindications and Pharmacokinetics).

Method of administration

Naramig Tablets should be swallowed whole with water.

4.3

Contraindications

Hypersensitivity to naratriptan or to any of the excipients listed in section 6.1.

As with other 5-hydroxytryptamine1 (5-HT1) receptor agonists naratriptan

should not be used in patients who have had a myocardial infarction or have

ischaemic heart disease, or Prinzmetal's angina/coronary vasospasm,

peripheral vascular disease or patients who have symptoms or signs consistent

with ischaemic heart disease.

Naratriptan should not be administered to patients with a history of

cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

The use of naratriptan in patients with moderate or severe hypertension, and

mild uncontrolled hypertension is contraindicated.

The concomitant administration of ergotamine, derivatives or ergotamine

(including methysergide) or/and any triptan/5-hydroxytryptamine

(5-HT

receptor agonist with naratriptan is contraindicated (see Section 4.5).

Naratriptan is contraindicated in patients with severely impaired renal

(creatinine clearance <15 ml/min) or hepatic function (Child-Pugh grade C).

4.4

Special warnings and precautions for use

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

Naratriptan 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. It should be noted that migraineurs may be at risk of

certain cerebrovascular events (eg. CVA or TIA).

The safety and efficacy of naratriptan when administered during the aura

phase, prior to the onset of migraine headache, has yet to be established.

As with other 5-HT1 receptor agonists, naratriptan 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 therapy 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 when 5-HT1 agonists have been

administered.

Following administration, naratriptan can be associated with transient

symptoms including chest pain andtightness 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 naratriptan should be taken and

appropriate evaluation should be carried out (see section 4.8).

Serotonin syndrome (including altered mental status, autonomic instability and

neuromuscular abnormalities) has been reported following concomitant

treatment with triptans and selective serotonin reuptake inhibitors

(SSRIs)/serotonin noradrenaline reuptake inhibitors (SNRIs). If concomitant

treatment with naratriptan and an SSRI/SNRI is clinically warranted,

appropriate observation of the patient is advised, particularly during treatment

initiation, with dose increases, or with addition of another serotonergic

medication (see Section 4.5).

Naratriptan contains a sulphonamide component therefore there is a theoretical

risk of a hypersensitivity reaction in patients with known hypersensitivity to

sulphonamides.

The recommended dose of naratriptan should not be exceeded.

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 MOH should be

suspected in patients who have frequent or daily headaches despite (or because

of) the regular use of headache medications.

Undesirable effects may be more common during concomitant use of triptans

and herbal preparations containing St John’s Wort (Hypericum perforatum).

This medicinal product contains anhydrous lactose, patients with rare

hereditary problems of galactose intolerance, the Lapp lactase deficiency or

glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Serotonin syndrome (including altered mental status, autonomic instability and

neuromuscular abnormalities) has been reported following concomitant

treatment with triptans and SSRIs/SNRIs (see Section 4.4).

There is no evidence of a pharmacokinetic interaction with

-blockers,

tricyclic antidepressants, selective serotonin reuptake inhibitors, alcohol or

food.

Co-administration of naratriptan with ergotamine, dihydroergotamine, or

sumatriptan did not result in clinically significant effects on blood pressure,

heart rate or ECG or affect naratriptan exposure. However, an increased risk

of coronary vasospasm is a theoretical possibility and concomitant

administration with preparations containing ergotamine or another triptan/5-

HT1 receptor agonist is contraindicated (see section 4.3).

At least 24 hours should elapse after the administration of naratriptan before

an ergotamine-containing preparation or any triptan/5-HT

receptor agonist is

given. Conversely, at least 24 hours should elapse after the administration of

an ergotamine-containing preparation before naratriptan is given.

Naratriptan does not inhibit monoamine oxidase enzymes; therefore

interactions with monoamine oxidase inhibitors are not anticipated. In

addition, the limited metabolism of naratriptan and the wide range of

cytochrome P450 isoenzymes involved suggest that significant drug

interactions with naratriptan are unlikely (see Pharmacokinetics).

Oral contraceptives decrease the total clearance of naratriptan by 30%, and

smoking increases total clearance by 30%. But no dosing adjustments are

required.

Since 60% of naratriptan is excreted renally with active renal secretion

representing approximately 30% of total clearance, interactions might be

possible with other drugs that are also renally secreted. However due to the

safety profile of naratriptan, inhibition of naratriptan secretion is probably of

minor importance, while the possibility of naratriptan to inhibit other drugs

actively secreted should be considered

4.6

Fertility, pregnancy and Lactation

Pregnancy

Evaluation

experimental

animal

studies

does

indicate

direct

teratogenic effects or harmful effects on peri- and postnatal development.

However, delays in foetal ossification and possible effects on embryo viability

have been observed in the rabbit.

Post-marketing data from prospective pregnancy registries have documented

the pregnancy outcomes in less than 60 women exposed to naratriptan. Due to

a small sample size no definitive conclusion can be drawn regarding the risk of

birth defects following exposure to naratriptan.

Because animal reproduction studies are not always predictive of human

response

administration

naratriptan

should

only

considered

expected benefit to the mother is greater than any possible risk to the foetus.

Breast-feeding

Naratriptan and/or drug related metabolites are secreted into the milk of

lactating rats.

Transient effects in the pre and post-natal development of neonatal rats were

observed only at maternal exposures sufficiently in excess of maximum human

exposure.

studies

have

been

conducted

determine

level

transference

naratriptan

into

breast

milk

nursing

women.

recommended that infant exposure be minimised by avoiding breast-feeding

for 24 hours after treatment.

4.7

Effects on ability to drive and use machines

Drowsiness may occur as a result of migraine or its treatment with naratriptan.

Caution is recommended when skilled tasks are to be performed (e.g. driving or

operating machinery).

4.8

Undesirable effects

At therapeutic doses of naratriptan the incidence of side effects reported in

clinical trials was similar to placebo. Some of the symptoms may be part of

the migraine attack.

Undesirable

effects

ranked

under

headings

frequency

using

following convention: Very common (

1/10), common (

1/100 and <1/10),

uncommon (

1/1,000 and <1/100), rare (

1/10,000 and <1/1,000) and very

rare (<1/10,000).

Immune system disorders

Rare:

Hypersensitivity

reactions

ranging

from

cutaneous

hypersensitivity to rare cases of anaphylaxis.

Nervous system disorders

Common:

Tingling. This is usually of short duration, may be severe and

may affect any part of the body including the chest or throat.

Dizziness and somnolence.

Eye disorders

Uncommon:

Visual disturbance.

Cardiac disorders

Uncommon:

Bradycardia, tachycardia, palpitations.

Very Rare:

Coronary artery vasospasm, transient ischaemic ECG changes,

angina and myocardial infarction (see sections 4.3 and 4.4).

Vascular disorders

Very rare:

Peripheral vascular ischaemia.

Gastrointestinal

Common:

Nausea and vomiting.

Rare:

Ischaemic colitis.

Skin and subcutaneous tissue disorders

Rare:

Rash, Urticaria, Pruritis, facial oedema

General disorders and administration site conditions:

The following symptoms are usually of short duration, may be severe and may

affect any part of the body including the chest or throat:

Common:

Sensations of heat, malaise/fatigue.

Uncommon:

Pain, sensations of heaviness, pressure or tightness.

Investigations

Uncommon:

Increase in blood pressure of approximately 5mmHg (systolic)

and 3 mmHg (diastolic) in a period of upto 12 hours after administration.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

product is important. It allows continued monitoring of the benefit/risk balance

of the medicinal product. Healthcare professionals are asked to report any

suspected

adverse

reactions

Yellow

Card

Scheme

www.mhra.gov.uk/yellowcard.

4.9

Overdose

Administration of a high dose of 25 mg naratriptan in one healthy male subject

increased blood pressure by up to 71 mmHg and resulted in adverse events

including light-headedness, tension in the neck, tiredness and a loss of co-

ordination. Blood pressure returned to baseline by 8 hours after dosing without

other pharmacological intervention.

It is unknown what effect haemodialysis or peritoneal dialysis has on the

plasma concentrations of naratriptan.

Treatment

If overdosage with naratriptan occurs, the patient should be monitored for at

least 24 hours and standard supportive treatment applied as required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Mechanism of action

Naratriptan has been shown to be a selective agonist for 5 hydroxytryptamine1

(5-HT

) receptors mediating vascular contraction. This receptor is found

predominantly in intracranial (cerebral and dural) blood vessels. Naratriptan

has high affinity for human cloned 5-HT

and 5-HT

receptors, the human

5-HT

receptor is thought to correspond to the vascular 5-HT

receptor

mediating contraction of intracranial blood vessels. Naratriptan has little or no

effect at other 5-HT receptor (5-HT

, 5-HT

, 5-HT

and 5-HT

) subtypes.

Pharmacodynamic effect

In animals, naratriptan selectively constricts the carotid arterial circulation.

This circulation supplies blood to the extracranial and intracranial tissues such

as the meninges, and dilatation and/or oedema formation in these vessels is

thought to be the underlying mechanism of migraine in man. In addition,

experimental evidence suggests that naratriptan inhibits trigeminal nerve

activity. Both these actions may contribute to the anti-migraine action of

naratriptan in humans.

Clinical efficacy and safety

In man, a meta-analysis of BP recordings in 15 studies showed that the

population average maximum increases in systolic and diastolic blood pressure

after a 2.5mg dose of naratriptan tablets would be less than 5mmHg and

3mmHg respectively. The blood pressure response was unaffected by age,

weight, hepatic or renal impairment.

5.2

Pharmacokinetic properties

Absorption

Following oral administration, naratriptan is rapidly absorbed with maximum

plasma concentrations observed at 2-3 hours. After administration of a 2.5mg

naratriptan tablet Cmax is approximately 8.3ng/mL (95% Cl: 6.5 to

10.5ng/mL) in women and 5.4ng/mL (95% Cl: 4.7 to 6.1ng/mL) in men.

The oral bioavailability is 74% in women and 63% in men with no differences

in efficacy and tolerability in clinical use. Therefore a gender related dose

adjustment is not required.

Distribution

Naratriptan is distributed in a volume of 170L. Plasma protein binding is low

(29%).

Biotransformation

Mean clearance after intravenous administration was 470mL/min in men and

380mL/min in women. Renal clearance is similar in men and women at

220mL/min and is higher than the glomerular filtration rate suggesting that

naratriptan is actively secreted in the renal tubules. Naratriptan is

predominantly excreted in the urine with 50% of the dose recovered as

unchanged naratriptan and 30% recovered as inactive metabolites. In vitro

naratriptan was metabolised by a wide range of cytochrome P450 isoenzymes.

Consequently significant metabolic drug interactions with naratriptan are not

anticipated (see section 4.5).

Elimination

The mean elimination half-life (t

) is 6 hours.

Special Patient Populations

Elderly

In healthy elderly subjects (n=12), clearance was decreased by 26% when

compared to healthy young subjects (n=12) in the same study (See Posology

and method of administration).

Gender

The naratriptan AUC and Cmax were approximately 35% lower in males

compared to females however, with no differences in efficacy and tolerability

in clinical use.

Therefore a gender related dose adjustment is not required (see Posology and

method of administration).

Renal impairment

Renal excretion is the major route for the elimination of naratriptan.

Accordingly exposure to naratriptan may be increased in patients with renal

disease.

In a study in male and female renally impaired patients (creatinine clearance

18 to 115mL/min; n=15) matched for sex, age and weight with healthy

subjects (n=8), renally impaired patients had an approximately 80% increase

in t

and an approximately 50% reduction in clearance (See Posology and

method of administration).

Hepatic impairment

The liver plays a lesser role in the clearance of orally administered naratriptan.

In a study in male and female hepatically impaired patients (Child-Pugh grade

A or B n=8) matched for sex, age and weight with healthy subjects who

received oral naratriptan, hepatically impaired patients had an approximately

40% increase in t

and an approximately 30% reduction in clearance (See

Posology and method of administration).

5.3

Preclinical safety data

No clinically relevant findings were observed in preclinical studies.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core

Microcrystalline cellulose

Anhydrous lactose

Croscarmellose sodium

Magnesium stearate

Film-coat

Methylhydroxypropylcellulose

Titanium dioxide (E171)

Triacetin

Iron oxide yellow (E172)

Indigo carmine aluminium lake (E132)

6.2

Incompatibilities

None reported

6.3

Shelf life

36 months

6.4

Special precautions for storage

Store below 30

6.5

Nature and contents of container

2, 4, 6 or 12 tablets in a double foil blister pack or child-resistant foil blister

pack.

Not all pack sizes may be marketed

6.6

Special precautions for disposal

No special requirements for disposal.

7

MARKETING AUTHORISATION HOLDER

Glaxo Wellcome UK Ltd.

Trading as GlaxoSmithKline UK

980 Great West Road

Brentford

Middlesex

TW8 9GS

8

MARKETING AUTHORISATION NUMBER(S)

PL 10949/0273

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

28/04/2007 / 26/03/2002

10

DATE OF REVISION OF THE TEXT

27/11/2019

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