Betnovate Scalp Application 0.1% w/v Cutaneous Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Betamethasone
Available from:
GlaxoSmithKline (Ireland) Limited
ATC code:
D07AC; D07AC01
INN (International Name):
Betamethasone
Dosage:
0.1 percent weight/volume
Pharmaceutical form:
Cutaneous solution
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Corticosteroids, potent (group III); betamethasone
Authorization status:
Marketed
Authorization number:
PA1077/001/003
Authorization date:
1984-03-05

Package leaflet: Information for the user

Betnovate Scalp Application 0.1% w/v Cutaneous Solution

betamethasone (as valerate)

Read all of this leaflet carefully before you start using 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 4.

In this leaflet, Betnovate Scalp Application 0.1% w/v Cutaneous Solution will be

called Betnovate.

What is in this leaflet

What Betnovate is and what it is used for

What you need to know before you use Betnovate

How to use Betnovate

Possible side effects

How to store Betnovate

Contents of the pack and other information

1

What Betnovate is and what it is used for

Betnovate contains the active substance betamethasone valerate which belongs to a

group of medicines called corticosteroids that help to reduce redness, swelling and

irritation of the skin. These should not be confused with “anabolic steroids” misused

by some body builders and taken as tablets or injections.

Betnovate is used to help reduce the redness and itchiness of certain scalp problems,

such as psoriasis (thickened patches of inflamed, red skin, often covered by silvery

scales), an inflamed scalp due to severe dandruff, and dermatitis in adults and children

over the age of 1 year.

Betnovate also contains an alcohol which has an antiseptic effect.

2

What you need to know before you use Betnovate

Do not use Betnovate:

if you are allergic (hypersensitive) to betamethasone valerate or any of the other

ingredients of this medicine (listed in section 6).

if you have a skin infection on your scalp.

on a child under the age of 1 year.

Do not use Betnovate if any of the above applies to you. If you are not sure, talk to

your doctor or pharmacist before using Betnovate.

Stop using Betnovate and tell your doctor as soon as possible if:

you find that you develop an allergic reaction, the area being treated becomes infected,

or if you are being treated for psoriasis and you get raised bumps with pus under the

skin (pustular psoriasis).

Warnings and precautions

Talk to your doctor or pharmacist before using Betnovate.

If you are allergic (hypersensitive) to any corticosteroids.

Only use Betnovate for as long as your doctor recommends.

Only use an airtight dressing over this medicine if your doctor has told you to. If

you are applying the liquid under an airtight dressing, make sure that the skin is

cleansed before a fresh dressing is applied to prevent infections. These

dressings make it easier for the active ingredient to pass through the skin. It is

possible to accidentally end up using too much.

Prolonged use with occlusive dressings can cause the body to produce lower

levels of the hormone cortisol than normal.

If you have psoriasis, your doctor will want to see you more often.

If you are using this for a prolonged period of time there is a possibility you may

develop a cataract (clouding of the eye's lens).

Contact your doctor if you experience blurred vision or other visual disturbances

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist

before using this medicine.

Children

Do not use this medicine on a child under the age of 1 year.

Avoid continuous treatment for a long period of time in infants and children under

the age of 12 years as adrenocortical suppression (where the body produces lower

levels of the hormone cortisol than normal) and growth retardation may occur.

Other medicines and Betnovate

Tell your doctor or pharmacist if you are taking, have recently taken or might take

any other medicines.

Some medicines may affect how Betnovate Scalp Application works or make it more

likely that you’ll have side effects. Examples of these medicines include:

ritonavir and itraconazole

Tell your doctor or pharmacist if you are taking any of these. There are other

medicines which may have a similar effect. It is therefore very important to tell your

doctor or pharmacist if you’re taking any other medicines, if you’ve taken any

recently, or if you start taking a new one. This includes medicines bought without a

prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use this medicine if you are pregnant or breast-feeding unless your

doctor has recommended you to do so.

If you do use Betnovate when breast-feeding, do not use it on your breast area to

ensure that the baby does not accidentally get Betnovate in their mouth.

3

How to use Betnovate

Always use this medicine exactly as your doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not sure.

Using this medicine

You usually put Betnovate on your scalp in the morning and at night. This may be

reduced as your scalp problem begins to get better.

For use on your skin of your scalp only.

Do not use Betnovate more often than prescribed.

Do not use it for a long time (such as every day for many weeks or months) - unless

your doctor tells you to.

This medicine should not be used every day for more than 4 weeks at a time.

Be very careful not to get the liquid in your eyes. Do not touch your eyes until you

have washed your hands.

If you wash or shampoo your hair it should be dried before applying the liquid.

If you are applying Betnovate on someone else make sure you wash your hands

after use or wear disposable plastic gloves.

If your scalp problem does not improve tell your doctor.

Due to the flammable nature of Betnovate, you should avoid smoking or being near

an open flame while you are applying it and immediately after you’ve used it.

Guidance on how to apply the liquid

Wash your hands.

Unscrew the bottle cap and place the nozzle on the scalp that needs treating.

Gently squeeze the bottle to cover the area with a thin and even layer of liquid.

You can rub this liquid in, but you don’t have to.

Your scalp will feel cool until the liquid has dried.

Wash your hands again.

As soon as the scalp problem looks better use once a day or less.

Use in children

Do not use this medicine on children under the age of 1 year.

Avoid continuous treatment for a long period of time in infants and children under

the age of 12 years.

If you use more Betnovate than you should

If, by mistake on a few occasions you use more than you should, do not worry.

If you continue to use too much over a period of time you may develop symptoms such

as: stretch marks, the appearance of blood vessels under the surface of your skin,

increased body hair, changes to the colour of your skin, skin thinning, weight gain,

moon face/rounding of the face.

If any of these symptoms occur or you think you have used too much of this medicine

talk to your doctor or go to hospital as soon as possible.

If you accidentally swallow Betnovate, it could make you ill. Rinse your mouth out

with plenty of water and contact your doctor or pharmacist for advice.

If you forget to use Betnovate

If you forget to apply Betnovate, apply it as soon as you remember. If it is close to the

time you are next meant to apply it, wait until this time. Do not apply extra Betnovate

to make up for missed doses.

If you stop using Betnovate

If you use Betnovate regularly make sure you talk to your doctor before you stop using

If you have any further questions on the use of this medicine, ask your doctor or

pharmacist.

4

Possible side effects

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

them.

Stop using Betnovate and tell your doctor as soon as possible if:

you find that your skin condition gets worse or becomes swollen during treatment.

You may be allergic to the Betnovate, have an infection or need other treatment.

you have psoriasis and you get raised bumps with pus under the skin. This can

happen very rarely during or after treatment and is known as pustular psoriasis.

Other side effects you may notice when using Betnovate include:

Common: may affect up to 1 in 10 people

local skin burning or pain

itchy skin

Very rare: may affect up to 1 in 10,000 people

Use of Betnovate for a long period of time, or use under an airtight dressing, may

cause the following symptoms:

increased weight

rounding of the face/moon face

obesity

thinning of your skin, this may cause stretch marks and it may also damage more

easily

skin wrinkling

skin dryness

the appearance of blood vessels under the surface of your skin

changes to the colour of your skin

increased body hair

hair loss/lack of hair growth/damaged looking hair

Other very rare skin reactions that may occur are:

allergic reaction at the site of application

worsening of condition

application site irritation / pain

redness

rash or hives

skin infection

In children also look out for the following symptoms:

delayed weight gain

slow growth

Very rare side effects that may show up in blood tests or when your doctor gives you

a medical examination:

a 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)

weakening of the bones through gradual loss of mineral (osteoporosis);

additional tests may be needed after your medical examination to confirm if you

have this condition

Not Known: frequency cannot be estimated from the available data

blurred vision

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 in this leaflet. You can also report side effects directly

via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1

6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this

medicine.

5

How to store Betnovate

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label or

carton after (EXP). The expiry date refers to the last day of that month.

Do not store above 25

C. Store in the original package.

Keep the container tightly closed when not in use.

Contents are flammable. Keep away from all sources of fire, flame and heat. Do

not leave in direct sunlight.

Do not throw away any medicines via wastewater or household waste. Ask your

pharmacist how to throw away medicines you no longer use. These measures will

help protect the environment.

6

Contents of the pack and other information

What Betnovate contains

The active substance is betamethasone (as valerate). Each 10 ml contains 0.01 g

of betamethasone(0.1 % w/v) as valerate.

The other ingredients are: carbomer, isopropyl alcohol, sodium hydroxide and

purified water.

What Betnovate looks like and contents of the pack

Betnovate is a colourless, hazy and slightly sticky solution. Within each carton is a

specially designed plastic bottle with a nozzle and cap that contains 30 ml or 100 ml

of a sticky liquid.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline (Ireland) Ltd, 12 Riverwalk, Citywest Business Campus, Dublin 24,

Ireland.

Manufacturer

Aspen, Bad Oldesloe GmbH, Industriestrasse 32 – 36, 23843 Bad Oldesloe,

Germany.

This leaflet was last revised in September 2017.

Other sources of information

This package leaflet is available in formats that are suitable for the blind or partially

sighted. Such formats are available on request.

Trade marks are owned by or licensed to the GSK group of companies.

© 2017 GSK group of companies or its licensor.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Betnovate Scalp Application 0.1% w/v Cutaneous Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 10ml of cutaneous solution contains 0.01g betamethasone (0.1% w/v) as

betamethasone valerate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cutaneous Solution

A colourless, hazy, slightly viscous liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Betnovate Scalp Application is a topical corticosteroid used in the management of

steroid-responsive dermatoses of the scalp, such as psoriasis, seborrhoea capitis and

inflammation associated with severe dandruff.

4.2 Posology and method of administration

Posology

Adults, Elderly and Children over 1 year

A small quantity of Betnovate Scalp Application should be applied to the scalp night

and morning until improvement is noticeable for up to 4 weeks. It may then be

possible to sustain improvement by applying once a day, or even less frequently.

Due to the flammable nature of Betnovate Scalp Application, patients should avoid

smoking or being near an open flame during application and immediately after use.

Administration in Children

Betamethasone valerate is contraindicated in children under 1 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.

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

applied is the minimum that provides therapeutic benefit.

Administration in the Elderly

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

younger patients. Since renal and hepatic dysfunctions are more common in the

elderly population, elimination could be reduced in the case of systemic absorption.

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

the desired clinical benefit.

Administration in Renal/Hepatic Impairment

In case of systemic absorption (when 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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1.

Infections of the scalp.

Betamethasone valerate is contraindicated in dermatoses in infants under 1 year of

age, including dermatitis.

4.4 Special warnings and precautions for use

Betamethasone valerate should be used with caution in patients with a history of

local hypersensitivity to corticosteroids or to any of the excipients in the preparation.

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 drug gradually by reducing the

frequency of application, or by substituting a less potent corticosteroid. Abrupt

withdrawal of treatment may result in glucocorticosteroid insufficiency (see section

4.8).

Risk factors for increased systemic effects are:

Potency and formulation of topical steroid

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Duration of exposure

Application to a large surface area

Use on occluded areas of skin (e.g. on intertriginous areas or under

occlusive dressings) (in infants the nappy may act as an occlusive dressing)

Increasing hydration of the stratum corneum

Use on thin skin areas such as the face

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, long-term continuous topical

corticosteroid therapy should be avoided where possible, as adrenal suppression can

occur.

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 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.

Care must be taken to keep the preparation away from the eyes.

There have been a few reports in the literature of the development of cataracts in

patients who have been using corticosteroids for prolonged periods of time.

Although it is not possible to rule out systemic corticosteroids as a known factor,

prescribers should be aware of the possible role of corticosteroids in cataract

development.

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

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central serous chorioretinopathy (CSCR) which have been reported after use of

systemic and topical corticosteroids.

4.5 Interaction with other medicinal products and other forms of interactions

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and 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

Breast-feeding

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.

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.

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4.8 Undesirable effects

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

Frequencies are defined as: very common (³1/10), common (³1/100 to <1/10),

uncommon (³1/1000 to <1/100), rare (³1/10,000 to <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 Local hypersensitivity

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

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

adrenal (HPA) axis suppression.

General Disorders and Administration Site Conditions

Very rare Application site irritation/pain

Eye disorders

Not known Vision, blurred (see also section 4.4)

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 via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1

6764971; Fax: +353 1 6762517.

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Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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).

Management

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 centre, where available.

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.

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5.2 Pharmacokinetic properties

Absorption

Topical corticosteroids can be systemically absorbed from l 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

Because circulating levels of topical corticosteroids are well below the level of

detection, it is necessary to use endpoints that assess signs of drug effect to evaluate

systemic exposure.

Metabolism

Once absorbed through the skin, topical corticosteroids are handled through

pharmacokinetic pathways similar to systematically administered corticosteroids.

They are metabolised primarily in the liver.

Elimination

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

and their metabolites are also excreted in the bile.

5.3 Preclinical safety data

Carcinogenesis/Mutagenesis

Carcinogenesis

Long-term animal studies have not been performed to evaluate the carcinogenic

potential of betamethasone valerate.

Genotoxicity

No specific studies have been conducted to investigate the genotoxic potential of

betamethasone valerate.

Reproductive Toxicology

Fertility

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

Pregnancy

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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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer

Isopropyl alcohol

Sodium hydroxide (for pH adjustment)

Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25º C.

Store in the original package.

Keep container tightly closed when not in use. Contents are flammable.

Keep away from fire, flame or heat. Do not leave in direct sunlight.

6.5 Nature and contents of container

Betnovate Scalp Application is supplied in polyethylene bottles and nozzles with caps

of 30 ml and 100 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

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8 MARKETING AUTHORISATION NUMBER

PA1077/001/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 05 March 1984

Date of last renewal: 05 March 2009

10 DATE OF REVISION OF THE TEXT

December 2018

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