Beta Scalp Application

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Betamethasone valerate 0.127% equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency; Betamethasone valerate 0.127% w/w equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency
Available from:
Mylan New Zealand Ltd
INN (International Name):
Betamethasone valerate 0.127% (=Betamethasone 0.105%. Plus 5% overage to ensure potency)
Dosage:
0.1 %
Pharmaceutical form:
Scalp lotion
Composition:
Active: Betamethasone valerate 0.127% equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency Excipient: Carbomer Isopropyl alcohol Purified water Sodium hydroxide Active: Betamethasone valerate 0.127% w/w equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency Excipient: Carbomer Isopropyl alcohol Purified water Sodium hydroxide
Units in package:
Bottle, plastic, 1x100ml, 100 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Sicor (Societa Italiana Corticosteroidi) Srl
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, - 100 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 250 mL - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-3147
Authorization date:
1986-01-22

Page 1 of 4

NEW ZEALAND CONSUMER MEDICINE INFORMATION

BETA SCALP APPLICATION

Betamethasone valerate scalp lotion 0.1% w/w

What is in this leaflet

Please read this leaflet carefully

before you start using BETA SCALP

APPLICATION.

This leaflet answers some common

questions about BETA SCALP

APPLICATION.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking BETA

SCALP APPLICATION against the

benefits they expect it will have for

you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What BETA SCALP

APPLICATION is

used for

BETA SCALP APPLICATION is

used to treat conditions of the

scalp, such as psoriasis and the

inflammation associated with

severe dandruff.

BETA SCALP APPLICATION

contains the active ingredient

betamethasone valerate. It belongs

to a group of medicines called

topical corticosteroids. “Topical”

means that they are applied onto

the skin. Topical corticosteroids are

used to help reduce the

inflammation that causes the

redness and itchiness in a variety

of conditions (they are not

‘anabolic’ steroids which are

sometimes misused by athletes).

Your doctor may have prescribed

it for another reason.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

This medicine is available only with

a doctor’s prescription.

There is no evidence that BETA

SCALP APPLICATION is

addictive.

Before you use

BETA SCALP

APPLICATION

When you must not use

it

Do not use BETA SCALP

APPLICATION if you have an

allergy to:

any medicine containing

betamethasone valerate

any of the ingredients listed

at the end of this leaflet

Some of the symptoms of an

allergic reaction may include:

shortness of breath; wheezing

or difficulty breathing; swelling

of the face, lips, tongue or other

parts of the body; rash, itching

or hives on the skin.

Do not use BETA SCALP

APPLICATION if you have an

infection on your scalp.

Do not use BETA SCALP

APPLICATION on children under

the age of one year.

Safety and effectiveness on

children younger than one year old

have not been established.

Do not take this medicine after

the expiry date printed on the

pack or if the packaging is torn or

shows signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start using this medicine,

talk to your doctor.

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

liver disease

kidney disease

skin diseases such as

wounds or inflammations

conditions that require you

to wear dressings

Tell your doctor if you are

pregnant, plan to become

pregnant, or are breastfeeding.

Your doctor can discuss with you

the risks and benefits involved.

If you do use BETA SCALP

APPLICATION when breast-

feeding, do not use on your breast

area so that the baby does not

accidently get the medicine in their

mouth.

If you have not told your doctor

about any of the above, tell them

before you start using BETA

SCAP APPLICATION.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

You should also tell any health

professional who is prescribing a

new medication for you that you are

using BETA SCALP APPLICATION.

Page 2 of 4

Some medicines may interfere

with BETA SCALP

APPLICATION. These include:

ritonavir (a medicine

used for the treatment

of HIV)

itraconazole (a medicine

for the treatment of

fungal infections)

These medicines may be

affected by BETA SCALP

APPLICATION or may affect

how well it works. You may need

different amounts of your

medicines, or you may need to

take different medicines.

Your doctor or pharmacist has

more information on medicines to

be careful with or avoid while

using this medicine.

How to use BETA

SCALP

APPLICATION

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the bottle, ask

your doctor or pharmacist for

help.

How much to use

Your doctor will tell you how much

BETA SCALP APPLICATION you

need to apply each day. It is

important that you apply BETA

SCALP APPLICATION only as

directed by your doctor.

Do not use more than the

recommended amount.

Applying more than this may allow

the active ingredient in this

medication to pass through the

scalp and into the blood stream.

This could affect other parts of the

body and may result in unwanted

side effects.

How to use it

Wash your hands before and

after you have used BETA

SCALP APPLICATION.

When applying the application to

your scalp, be careful not to get

the liquid in your eyes. If you

wash or shampoo your hair, it

should be dried before applying

the liquid.

When to use it

For adults, BETA SCALP

APPLICATION is usually applied to

the scalp twice a day (once in the

morning and once at night). This

may be reduced as your scalp

problems get better.

Your doctor may tell you to apply

the scalp application differently

to this. If so, it is important you

follow their instructions.

Use your medicine about the

same times each day.

Using it at the same times each day

will have the best effect. It will also

help you remember when to use it.

How long to use it

Continue using your medicine for

as long as your doctor tells you.

Do not use BETA SCALP

APPLICATION for any longer than

your doctor has prescribed. Using

this type of medicine for a long time

may affect the normal production of

steroids in your body and be

harmful to your health.

Duration of treatment will depend on

your condition and can vary

between a few days to a longer

period of time. If your scalp

condition does not clear within a few

weeks, tell your doctor.

Use on children should be limited to

5 days and dressing or bandages

should not be used on children

where the scalp application is

applied.

If you forget to use it

If it almost time for your next

application, skip the

application you missed and

apply your next dose when you

are meant to.

Otherwise, use it as soon as

you remember, and then go

back to using your medicine

as you would normally.

Do not apply twice to make up

for the application that you

missed.

This may increase the chance of

you getting unwanted side effects.

If you are not sure what to do,

ask your doctor or

pharmacist.

If you have trouble remembering

to use your medicine, ask your

pharmacist for some hints.

While you are using

BETA SCALP

APPLICATION

Things you must do

Tell your doctor if, for any

reason, you have not used your

medicine exactly as directed.

Otherwise, your doctor may think

that it was not working as it

should and change your

treatment unnecessarily.

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are using BETA SCALP

APPLICATION.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are using this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

using this medicine, tell your

doctor immediately.

If you are about to have any

blood tests, tell your doctor that

you are using this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor’s

appointments so that your

progress can be checked,

especially if your doctor has

prescribed BETA SCALP

APPLICATION for psoriasis.

Your doctor may want to make sure

the medicine is working and to

prevent unwanted side effects.

Page 3 of 4

Things you must not do

Do not use BETA SCALP

APPLICATION to treat any other

complaints or skin conditions

unless your doctor tells you to.

Do not give this medicine to

anyone else, even if they have

the same condition as you.

Do not stop using your medicine

or lower the dosage without

checking with your doctor.

If you stop using it suddenly, your

condition may worsen or you may

have unwanted side effects.

If possible, your doctor will gradually

reduce the amount you use each

day before stopping the medicine

completely.

Do

not

allow

the

BETA

SCALP APPLICATION to run

into your eyes.

If the application does accidentally

enter your eyes, rinse your eye(s)

thoroughly with water. Do not touch

your eyes until you have washed

your hands.

Things to be careful of

Only use an airtight dressing

over this medicine if your doctor

has told you to.

If you are applying BETA SCALP

APPLICATION under an airtight

dressing, make sure that the skin is

cleansed before a fresh dressing is

applied to prevent infections.

BETA SCALP APPLICATION is

flammable so keep it away from

fire, flames and all sources of

ignition.

Avoid smoking whilst applying it to

the scalp and immediately after use.

Do not dry your hair with a hairdryer

after applying BETA SCALP

APPLICATION.

Be careful driving or operating

machinery until you know how

BETA SCALP APPLICATION

affects you.

This medicine may cause blurred

vision in some people. If you have

this symptom, do not drive, operate

machinery or do anything else that

could be dangerous.

In case of overdose

If you use too

much (overdose)

Immediately telephone your

doctor or the National Poisons

Information Centre (telephone

0800 POISON or 0800 764 766),

or go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else may have accidently

swallowed BETA SCALP

APPLICATION; or if you

or anyone else may have used

too much BETA SCALP

APPLICATION. Do this even if

there are no signs of discomfort

or poisoning. You may need

urgent medical attention.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are using

BETA SCALP APPLICATION.

This medicine helps most people

with scalp conditions, but it may

have unwanted side effects in a few

people.

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

skin rash or hives

hot burning sensation on

skin or pain

itching

redness

increased weight

moon face / rounding of

the face

obesity

skin wrinkling

skin dryness

hair loss / lack of hair

growth / damaged looking

hair

Tell your doctor as soon as

possible if you notice any of the

following:

increased hair growth

thinning of the skin and

appearance of stretch

marks

changes to the colour of

your skin

appearance of blood

vessels under the surface

of your skin

raised bumps with pus

under the skin (this can

happen during or after

treatment)

blurred vision

skin infection

irritation at the site of

application

If any of the following happen,

tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital:

your skin condition gets

worse or your skin

becomes swollen during

treatment

wheezing, swelling of the

lips/mouth, difficulty in

breathing, hay fever, lumpy

rash (hives) or fainting

allergic reaction at the site

of application

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people. Tell

your doctor if you notice any other

effects.

Some side effects (for example,

decrease in the level of the

hormone cortisol in your blood,

increased levels of sugar in your

blood or urine, high blood

pressure, cloudy lens in the eye

(cataract), increased pressure in

the eye (glaucoma)

a weakening of the bones through

gradual loss of mineral

(osteoporosis)) can only be found

when your doctor does tests from

time to time to check your progress.

Page 4 of 4

Do not be alarmed by these lists

of possible side effects. You may

not experience any of them.

After using BETA

SCALP

APPLICATION

Storage

Keep your BETA SCALP

APPLICATION in the container

until it is time to use it.

Keep your BETA SCALP

APPLICATION in a cool dry place

where the temperature stays

below 25°C. Avoid exposure to

heat, light and moisture.

Do not store BETA SCALP

APPLICATION or any other

medicine in the bathroom or near a

sink. Do not leave it on a window sill

or in the car.

Heat and dampness can destroy

some medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

using this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

BETA SCALP APPLICATION is an

almost clear, colourless liquid.

Ingredients

Active ingredient:

BETA SCALP APPLICATION

contains 0.1% w/w of

betamethasone valerate as

the active ingredient.

Inactive ingredients:

BETA SCALP APPLICATION also

contains:

isopropyl alcohol

sodium hydroxide

carbomer

purified water

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

BETA SCALP APPLICATION is

supplied in New Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland

NEW ZEALAND

Telephone: 0800 579 811

Date of Preparation

23 April 2020

(Based on datasheet dated 22 April

2020)

Page 1 of 7

NEW ZEALAND DATA SHEET

BETA SCALP APPLICATION

1. Product Name

Beta Scalp Application, 0.1% w/w, scalp lotion.

2. Qualitative and Quantitative Composition

Beta Scalp Application contains 0.1% w/w betamethasone as the valerate ester.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Beta Scalp Application is a transparent, slightly gelled solution containing 0.1% w/w betamethasone

as the valerate ester.

4. Clinical Particulars

4.1

Therapeutic indications

Steroid-responsive dermatoses

scalp,

such

psoriasis,

seborrhoea

capitis and the

inflammation associated with severe dandruff.

4.2

Dose and method of administration

Dose

A small quantity of Beta Scalp Application should be applied to the scalp night and morning until

improvement is noticeable. It may then be possible to sustain improvement by applying once a day,

or less frequently.

Special populations

Paediatric population

Betamethasone valerate is contraindicated in children under one year of age.

Children are more likely to develop local and systemic side effects of topical corticosteroids and, in

general, require shorter courses and less potent agents than adults; therefore, courses should be

limited to five days and occlusion should not be used.

Care should be taken when using betamethasone valerate to ensure the amount applied is the

minimum that provides beneficial effect.

Elderly

Clinical studies have not identified differences in responses between the elderly and younger

patients. The greater frequency of decreased hepatic or renal function in the elderly may delay

Page 2 of 7

elimination if systemic absorption occurs. Therefore, the minimum quantity should be used for the

shortest duration to achieve the desired clinical benefit.

Renal / hepatic impairment

In case of systemic absorption (where application is over a large surface area for a prolonged period)

metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity.

Therefore, the minimum quantity should be used for the shortest duration to achieve the desired

clinical benefit.

Method of administration

For topical application.

This product is flammable. Keep the liquid away from open fire and flames and all sources of ignition

including smoking during application and immediately after use.

4.3

Contraindications

Hypersensitivity to the active ingredient, betamethasone valerate, or any of the excipients listed in

section 6.1.

Dermatoses in children under one year of age, including dermatitis.

Infections of the scalp.

4.4

Special warnings and precautions for use

Betamethasone

valerate

should

used

with

caution

patients

with

history

local

hypersensitivity to other corticosteroids. Local hypersensitivity reactions (see section 4.8) may

resemble symptoms of the condition under treatment.

Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-

adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some

individuals as a result of increased systemic absorption of topical steroids. If either of the above are

observed, withdraw the medicine gradually by reducing the frequency of application, or by

substituting

less

potent

corticosteroid.

Abrupt

withdrawal

treatment

result

glucocorticosteroid insufficiency (see section 4.8).

Risk factors for increased systemic effects are:

Potency and formulation of topical steroid

Duration of exposure

Application to a large surface area

Increasing hydration of the stratum corneum

Use on occluded areas of the skin

Use on thin skin areas

Use on broken skin or other conditions where the skin barrier may be impaired.

In comparison with adults, children may absorb proportionally larger amounts of topical

corticosteroids and thus be more susceptible to systemic adverse effects. This is because

children have an immature skin barrier and a greater surface area to body weight ratio

compared with adults

Paediatric population

In infants and children under 12 years of age, treatment courses should be limited to five days and

occlusion should not be used; long-term continuous topical corticosteroid therapy should be avoided

where possible, as adrenal suppression can occur.

Page 3 of 7

Infection risk with occlusion

Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by

occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh

dressing is applied.

Use in psoriasis

Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development

of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due

to impaired barrier function of the skin have been reported in some cases. If used in psoriasis, careful

patient supervision is important.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents

with symptoms such as blurred vision or other visual disturbances, the patient should be considered

for referral to an ophthalmologist for evaluation of possible causes which may include cataract,

glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been

reported after use of systemic and topical corticosteroids.

Scalp application

Patients should be advised to:

keep the preparation away from the eyes

avoid smoking whilst applying Beta Scalp Application to the scalp

avoid fire, flame and heat including use of hair dryer after application

4.5

Interaction with other medicines and other forms of interaction

Co-administered medicines that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown

to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to

which this interaction is clinically relevant depends on the dose and route of administration of the

corticosteroids and the potency of the CYP3A4 inhibitor.

4.6

Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of betamethasone valerate in pregnant women.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal

development (see section 5.3).

The relevance of this finding to humans has not been established; however, administration of

betamethasone valerate during pregnancy should only be considered if the expected benefit to the

mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum

duration.

Lactation

The safe use of topical corticosteroids during lactation has not been established.

It is not known whether topical administration of corticosteroids could result in sufficient systemic

absorption to produce detectable amounts in breast milk. Administration of betamethasone valerate

during lactation should only be considered if the expected benefit to the mother outweighs the risk

to the infant.

If used during lactation betamethasone valerate should not be applied to the breasts to avoid

accidental ingestion by the infant.

Page 4 of 7

Fertility

There are no data in humans to evaluate the effect of topical corticosteroids on fertility.

4.7

Effects on ability to drive and use machines

There have been no studies to investigate the effect of betamethasone valerate on driving

performance or the ability to operate machinery. A detrimental effect on such activities would not be

anticipated from the adverse reaction profile of topical betamethasone valerate.

4.8

Undesirable effects

Adverse events are listed below by MedDRA system organ class and frequency. Frequencies are

defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100),

rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports.

Post-marketing data

Infections and infestations

Very rare:

Opportunistic infection

Immune system disorders

Very rare:

Hypersensitivity, generalised rash

Endocrine disorders

Very rare:

Hypothalamic-pituitary adrenal (HPA) axis suppression

Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth

retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract,

hypertension,

increased

weight/obesity,

decreased

endogenous

cortisol

levels,

alopecia, trichorrhexis

Skin and subcutaneous tissue disorders

Common:

Pruritus, local skin burning/skin pain

Very rare:

Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis,

skin thinning

/ skin atrophy

, skin wrinkling

, skin dryness

, striae

, telangiectasias

pigmentation changes, hypertrichosis, exacerbation of underlying symptoms

General disorders and administration site conditions

Very rare:

Application site irritation/pain

Eye disorders

Not known:

Vision, blurred (see section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked

to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal

(HPA) axis suppression

Page 5 of 7

4.9

Overdose

Symptoms and signs

Topically applied betamethasone valerate may be absorbed in sufficient amounts to produce

systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic

overdosage or misuse the features of hypercortisolism may occur (see section 4.8).

Treatment

In the event of overdose, betamethasone valerate should be withdrawn gradually by reducing the

frequency of application, or by substituting a less potent corticosteroid because of the risk of

glucocorticosteroid insufficiency. Further management should be as clinically indicated or as

recommended by the National Poisons Information Centre.

For further advice on management of overdose please contact the National Poisons Information

Centre (0800 POISON or 0800 764 766).

5. Pharmacological Properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, potent (group III),

ATC code:

D07AC01

Mechanism of action

Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase

allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and

activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and

eosinophils, and inhibiting the metabolism of arachidonic acid.

Pharmacodynamic effects

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties.

5.2

Pharmacokinetic properties

Absorption

Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of

percutaneous absorption of topical corticosteroids is determined by many factors, including the

vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease

processes in the skin may also increase percutaneous absorption.

Distribution

pharmacodynamic

endpoints

assessing

systemic

exposure

topical

corticosteroids is necessary because circulating levels are well below the level of detection.

Metabolism

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic

pathways similar to systemically administered corticosteroids. They are metabolised primarily by the

liver.

Elimination

Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their

metabolites are also excreted in the bile.

Page 6 of 7

5.3

Preclinical safety data

Reproductive toxicity

Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥ 0.1 mg/kg/day

or rabbits at doses ≥ 12 micrograms/kg/day during pregnancy produced foetal abnormalities

including cleft palate and intrauterine growth retardation.

The effect on fertility of betamethasone valerate has not been evaluated in animals.

6. Pharmaceutical Particulars

6.1

List of excipients

Beta Scalp Application also contains

isopropyl alcohol,

sodium hydroxide,

carbomer 934P and

purified water.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

2 years.

6.4

Special precautions for storage

Store below 25

Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame

or heat. Do not leave Betnovate Scalp Application in direct sunlight.

6.5

Nature and contents of container

White MDPE bottles with LDPE plug and white PP cap. Pack sizes of 100 mL or 250 mL.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Not applicable.

7. Medicines Schedule

Prescription Medicine

8. Sponsor Details

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

AUCKLAND

Customer Services Freephone: 0800 579 811

Page 7 of 7

9. Date of First Approval

22 November 1986

10. Date of Revision of the Text

22 April 2020

Summary table of changes

Section

Summary of new information

Minor editorial changes

Dosage for paediatric, elderly and renal/hepatic impairment are moved

here from section 4.4

Added method of administration

Added eye disorders

Added preclinical safety data

Revised storage conditions

More detailed description of the packaging

Revised sponsor phone number

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