Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Finalgon Cream. It does not contain all available information, nor does it take the place of talking to your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware.

Keep this information with your Finalgon Cream. You may need to read it again.

To find out more about Finalgon Cream

You should ask your doctor or pharmacist if you have any questions about Finalgon Cream or if you have any trouble before, during or after using Finalgon Cream.

What Finalgon Cream is used for

Finalgon Cream is used for the temporary relief of pain of rheumatism, arthritis, lumbago, muscular aches, sprains and strains, sporting injuries and other conditions where local warmth is beneficial.

Finalgon Cream works by increasing blood circulation to the area of application, hence promoting localised warmth and heat to relieve pain.

The warming reaction to Finalgon Cream occurs within a few minutes after application and reaches its peak within 20-30 minutes.

Before you use Finalgon Cream

When you must not use Finalgon Cream

Do not use Finalgon Cream if you are allergic to nonivamide, butoxyethyl nicotinate or any of the other ingredients in Finalgon Cream.

All the ingredients of Finalgon Cream are listed in section Ingredients.

You must not apply Finalgon Cream to:

• very sensitive skin;
• any broken skin surface;
• inflamed skin;
• when skin disease is present.

You should not use Finalgon Cream after the EXPIRY DATE on the tube or carton.

Before you start to use Finalgon Cream

You should not take a hot bath or shower before using Finalgon.

Finalgon Cream generates a lot of heat. Patients, particularly with sensitive skin, may experience severe heat if Finalgon Cream is applied to a "warmed up" body.

Finalgon Cream contains the ingredients cetostearyl alcohol and sorbic acid. These ingredients may cause local skin reactions (for example, contact dermatitis).

Pregnancy and Breastfeeding

Ask for your doctor's advice if you are pregnant, or likely to become pregnant, or are breastfeeding during your course of medication.

Finalgon Cream should not be used during pregnancy or breastfeeding.

Children

Finalgon Cream is not recommended for use on children. For further advice check with your doctor or pharmacist.

Using Finalgon Cream

How to use Finalgon Cream

Follow the directions below for using Finalgon Cream:

Pierce the aluminium seal with the spike of the screw cap.

Finalgon Cream can be applied with your hands. However, if you prefer, a cloth or paper towels may be used.

Always test your personal reaction to the cream on a small area of your skin before use.

Some people may experience more heat from using Finalgon Cream than others.

Apply a very small amount of Finalgon Cream to your skin to test your own reaction to Finalgon Cream.

Wait for at least 5 minutes before using more Finalgon Cream to treat the affected area.

Once you know your own reaction to Finalgon Cream, smear Finalgon Cream thinly on to the skin over the affected area.

DO NOT RUB IN.

Excessive use or rubbing of Finalgon Cream may cause blisters of the skin. If you do, consult your doctor or pharmacist.

IMMEDIATELY wash your hands in soap and cold water after use.

If you rub in Finalgon Cream and experience severe heat or pain, follow the directions in section If you have used too much Finalgon Cream.

You will find that the warmth or heat provided persists for up to 6 hours. Covering the affected part increases the warmth produced. Often, as much as 12 hours later, a hot shower or bath will regenerate the warmth.

Do not apply to face, eyes or mouth. Keep away from other sensitive parts of your body.

If Finalgon Cream comes in contact with the face, eyes or mouth, you may feel temporary face swelling, facial pain, irritation of eye conjunctiva, redness of eye, eye burning, visual disturbance, mouth discomfort and sore mouth. If Finalgon Cream comes in contact with other sensitive areas, you may feel an uncomfortable burning sensation.

If you experience severe heat or pain, then follow the directions in section If you have used too much Finalgon Cream.If contact is with eyes, ask for medical advice from your doctor or pharmacist as soon as possible.

If you have used a cloth or paper towels to apply Finalgon Cream, then dispose of these items in the garbage after use.

How much Finalgon Cream to use

Use not more than 5mm for an area the size of your hand. You may need to adjust this amount, depending on your personal reaction to Finalgon Cream.

If you have used too much Finalgon Cream

Immediately telephone your doctor or Poisons Information Centre (telephone 131126) if you think you or anyone else may have used too much Finalgon Cream.

Do this even if there are no signs of discomfort or poisoning.

If you have applied too much Finalgon Cream, wipe the excess off with cotton wool soaked with a cooking oil (eg. olive oil, peanut oil) or margarine.

Do not wash the affected area with water, as this may spread the cream.

If you experience severe heat or pain, apply ice packs or local anaesthetics to relieve the symptoms.

Ask for medical advice if symptoms persist.

Advice can be provided by a doctor or pharmacist.

While you are using Finalgon Cream

Things to be careful of

The extent and duration of Finalgon Cream's effect can be increased by extra heat, such as a hot bath, warm bed, hot water bottle or exercise, either before or after using Finalgon.

You should not take a hot bath or shower after using Finalgon.

Effects on Ability to Drive or Operate Machinery

There are no studies on the effects of Finalgon Cream on the ability to drive or operate machinery.

Side effects

You should be aware that all medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing.

Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of using Finalgon Cream.

Finalgon Cream may cause the following side effects:

• intense local heat
• redness of skin
• skin burning sensation
• tingling sensation
• cough
• difficulty breathing
• blistering
• local skin reaction
• itching of skin
• rashes
• swelling of face
• hives (urticaria)
• pustules at the site of application

Allergic (hypersensitivity) reactions to Finalgon Cream have been reported. These reactions include symptoms such as swelling of the face and localised skin reactions - tingling, rashes, pain or blistering.

If the above occurs, you should:

• wipe the cream off with cotton wool soaked with a cooking oil (eg. olive oil, peanut oil) or margarine.
• apply ice packs or local anaesthetics to relieve symptoms.
• do not re-apply Finalgon Cream
• ask for medical advice if symptoms persist. Advice can be provided by a doctor or pharmacist.

Do not wash the affected area with water, as this may spread the cream.

Finalgon Cream may also cause sudden life-threatening allergic (anaphylactic) reactions. These reactions include symptoms such as wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting.

If these occur, seek medical attention immediately.

After using Finalgon Cream

Storage

Finalgon Cream should be kept in a cool dry place where the temperature stays below 25°C.

Do not store in direct sunlight or heat. For example, do not leave it in the car on hot days.

Keep your Finalgon Cream where children cannot reach it.

Disposal

Unused Finalgon Cream should be returned to your pharmacist so that it can be disposed of safely.

Product Description

What is Finalgon Cream

Finalgon is the brand name of your medicine. It is available in a cream base (Finalgon Cream).

Finalgon Cream is identified by the Australian Registration Number, AUST R 49505 and this appears on the pack. Finalgon Cream is available from your local chemist without prescription.

Ingredients

Each gram of Finalgon Cream contains nonivamide 1.7 mg and butoxyethyl nicotinate 10.8 mg in a cream base containing decyl oleate, ceteareth-6, cetostearyl alcohol, stearic acid, liquid paraffin, emulgade f, fragrance kraeuter 0/065242, and purified water. Sorbic acid is used as a preservative.

Manufacturer

Finalgon Cream is made in Germany.

It is supplied in Australia by:

Sanofi Consumer Healthcare,
87 Yarraman Place, Virginia,
Qld 4014 Australia.
Toll-free: 1800 818 806

Date of preparation: 5 September 2017

finalgon-ccds0082-02-cmiv4-05sep17

Published by MIMS February 2019

Name of the medicine

Nonivamide 1.7 mg/g, butoxyethyl nicotinate 10.8 mg/g.

Excipients.

Description

The rubefacient Finalgon Cream will provide all the local warmth and create the necessary increased blood circulation to provide relief. The cream base is cosmetically acceptable, being without offensive odour and nonstaining.

Pharmacology

Nonivamide is a synthetic capsaicin analogue with analgesic properties, which are assumed to result from depletion of substance P in the peripheral nociceptive C-fibres and A-delta nerve fibres upon repetitive application on the skin. By stimulating the afferent nerve endings in the skin, nonivamide has a dilatatory effect on the surrounding blood vessels accompanied by an intense, long lasting feeling of warmth.
Butoxyethyl nicotinate is a B-vitamin which has vasodilating properties mediated by prostaglandin. The hyperaemic effect of butoxyethyl nicotinate has an earlier onset and it is more intense than the nonivamide hyperaemic effect
The combination of these two agents has complementary vasodilatory properties reducing the time to a hyperaemic skin reaction upon application.

Phamacokinetics.

Indications

For the temporary relief of the pain of rheumatism, arthritis, lumbago, muscular aches, sprains and strains, sporting injuries and other conditions where local warmth is beneficial.

Contraindications

Finalgon Cream is contraindicated in patients with known hypersensitivity to the active ingredients or excipients in the cream, or with very sensitive skin. Do not apply to wounds (including broken skin surfaces), to inflamed skin or when skin disease is present.

Precautions

Due to local skin hyperaemia induced by Finalgon, redness, feeling of warmth, itching and burning sensation at the application site is to be expected. These symptoms may be particularly marked if the amount applied is excessive or Finalgon is intensively rubbed on the skin area. Excessive use or rubbing of Finalgon may cause blisters of the skin. Hands should be washed immediately after application and care should be taken to avoid transferring to unintended areas or to other people.
Finalgon should not be applied to the face, eyes or mouth. This may result in transient face swelling, facial pain, conjunctival irritation, ocular hyperaemia, eye burning, visual disturbance, oral discomfort and stomatitis. Patients should not take a hot bath or shower before or after applying Finalgon Cream. Even hours after Finalgon application, redness of skin and an intensive feeling of warmth can be induced by sweating or application of warming effects.
Finalgon cream contains the excipients cetostearyl alcohol and sorbic acid, which all may cause local skin reactions (e.g. contact dermatitis).

Use in pregnancy.

Use in lactation.

Interactions

There are no known drug interactions with Finalgon Cream.

Effects on ability to drive or operate machinery.

Adverse Effects

Based on postmarketing experience with Finalgon, the following side effects may occur.

Immune system disorders.

Nervous system disorders.

Respiratory, thoracic and mediastinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Dosage and Administration

Treatment should always commence with a very small quantity of Finalgon Cream to test personal reaction. Individual response to Finalgon Cream varies greatly and some people need only the slightest smear to generate all the heat required.
No more than 5 mm should be used to cover an area the size of a hand.
The warming reaction to Finalgon Cream occurs within a few minutes after application and reaches its peak within 20 to 30 minutes. The warmth or heat promoted can persist for up to six hours.
Covering the affected area increases the warmth produced. The application of additional heat, such as by a hot bath, warm bed, hot water bottle or exercise, either before or after application of Finalgon Cream, increases the warming effect both in extent and duration. Often as much as 12 hours later, a hot shower or bath will regenerate the warmth.
Apply thinly onto the skin over the affected area.
Do not rub in.
Hands should be washed thoroughly in soap and cold water after use.
Due to a lack of information, Finalgon is not recommended for use on children.
If too much Finalgon Cream is applied, the excess may be wiped off with cotton wool soaked with a cooking oil (e.g. olive oil, peanut oil) or margarine.

Overdosage

In case of overdose, immediately call the Poisons Information Centre (telephone 131 126).

Symptoms.

Therapy.

Presentation

Cream: 50 g.

Poison Schedule

Unscheduled.