FINALGON

FINALGON Warming Ointment DUO 4 mg/g + 25 mg/g

Important notes (mandatory information)

Finalgon Wärmecreme DUO. Areas of application: for promoting skin circulation in the case of muscle and joint complaints.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Finalgon Wärmecreme DUO 1.7 mg, 10.8 mg/1 g cream for use in adults
Active ingredients: nonivamide, nicoboxil

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after a few days, contact your doctor

What this package leaflet contains

1. WHAT IS FINALGON WÄRMECREME DUO AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING FINALGON WÄRMECREME DUO
3. HOW TO USE FINALGON WÄRMECREME DUO
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE FINALGON WÄRMECREME DUO
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS FINALGON WÄRMECREME DUO AND WHAT IS IT USED FOR?

This is how Finalgon Wärmecreme DUO works. Finalgon Wärmecreme DUO is a circulation-boosting cream for heat-stimulus therapy. Finalgon Wärmecreme DUO is used to promote skin circulation in the case of muscle and joint complaints.

Children and adolescents

The safety and efficacy of Finalgon Wärmecreme DUO in children and adolescents under 18 years of age have not been proven.

2. WHAT YOU NEED TO KNOW BEFORE USING FINALGON WÄRMECREME DUO

Finalgon Wärmecreme DUO must not be used:

• if you are allergic to nonivamide, nicoboxil or any of the other ingredients of this medicine listed in section 6.
• if you have very sensitive skin.
• on wounds.
• on inflamed or diseased skin areas.

Temporary itching or burning may occur at the site of application. This may be more pronounced if too much Finalgon Wärmecreme DUO is applied. Finalgon Wärmecreme DUO that has been applied accidentally or in excess can be removed with skin cream or cooking oil (on the eye with Vaseline).

Special care must be taken when using Finalgon Wärmecreme DUO

Finalgon Wärmecreme DUO causes a local increase in skin circulation. This can lead to skin redness, a feeling of warmth, itching or burning at the site of application. These symptoms may be more pronounced if too much Finalgon is applied or if Finalgon Wärmecreme DUO is rubbed into the skin intensively. This can also lead to blistering. Caution: mucous membrane irritation!

Finalgon Wärmecreme DUO must not be used on the face, eyes, nose or mouth. This could lead to facial swelling, facial pain, conjunctival irritation, increased blood flow to the eye, burning, visual disturbances, discomfort in the mouth and inflammation of the oral mucosa. Sensitive skin areas such as the neck or the insides of the thighs should not be rubbed in at all or only sparingly or with a lower dose than recommended. The skin of fair-haired or sensitive people generally reacts more strongly, which is why the heat stimulus can be achieved with very little Finalgon Wärmecreme DUO.

Finalgon Wärmecreme DUO contains the excipients cetyl stearyl alcohol and sorbic acid, which can cause local skin reactions.

Using Finalgon Wärmecreme DUO together with other medicines

Interactions are not known to date. Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Pregnancy, breastfeeding and

fertility/childbearing potential

Pregnancy and breastfeeding

There are no sufficient data on the use of Finalgon Wärmecreme DUO during pregnancy and breastfeeding. Finalgon Wärmecreme DUO should therefore not be used during pregnancy and breastfeeding.

fertility/childbearing potential

There are no data on the effect on fertility and childbearing potential.

Driving and using machines

There is no experience regarding impairment of the ability to drive and use machines.

3. HOW TO USE FINALGON WÄRMECREME DUO

Always use Finalgon Wärmecreme DUO exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, take a pea-sized portion of cream (corresponding to 0.5 cm) for a palm-sized skin area. The effect of Finalgon Wärmecreme DUO is perceived differently by individuals. In the case of relatively insensitive skin, the heat effect may be weak or absent altogether; in the case of sensitive skin, even a very small amount can produce the desired heat effect. Therefore, treatment with a small amount of Finalgon Wärmecreme DUO should be started on a small area of skin. Rub into the skin if necessary. The heat stimulus lasts for approx. 3 - 6 hours. The effect often continues for days: muscle work, sweating or external heat application can trigger the heat stimulus again. A warm bath, a professional massage before rubbing in can intensify or prolong the effect. Patients with sensitive skin should not take hot baths or showers before or after Finalgon Wärmecreme DUO treatment. It is advisable to grease your hands with skin cream before rubbing in and to clean them thoroughly with soap and water after rubbing in. In the case of sensitive skin, it is advisable to wear a disposable glove. Care should be taken to ensure that Finalgon Wärmecreme DUO is not transferred to other areas of the skin or to other persons.

Please talk to your doctor or pharmacist if you have the impression that the effect of Finalgon Wärmecreme DUO is too strong or too weak. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

If you have used more Finalgon Wärmecreme DUO than you should

Excessive use of Finalgon Wärmecreme DUO can intensify the warming effect and the side effects described (see 4.). In particular, blistering may occur on the treated skin areas. Since the active ingredients of Finalgon Wärmecreme DUO are well absorbed through the skin, overdose can lead to general reactions, such as reddening of the skin on the upper body, increased body temperature, hot flushes, painfully increased blood flow and a drop in blood pressure. If too much Finalgon Wärmecreme DUO has been applied, it can be removed with skin cream or cooking oil (on the eye with Vaseline). If necessary, treat symptomatically, if necessary with corticosteroids locally.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 treated persons in 100
Uncommon:	1 to 10 treated persons in 1,000
Rare:	1 to 10 treated persons in 10,000
Very rare:	less than 1 treated person in 10,000
Not known:	frequency cannot be estimated from the available data.

Immune system disorders:

• Frequency not known: Anaphylactic reactions, hypersensitivity reactions

Nervous system disorders:

• Common: burning sensation on the skin
• Frequency not known: paraesthesia

Respiratory disorders:

• Frequency not known: cough, shortness of breath

Skin and subcutaneous tissue disorders:

• Common: skin redness, itching
• Uncommon: rash
• Frequency not known: blisters, facial swelling, hives, pustules in the area of application, local skin reaction

General disorders and administration site conditions:

• Common: feeling of heat

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE FINALGON WÄRMECREME DUO

Keep this medicine out of the reach of children! Do not use this medicine after the expiry date which is stated on the label and carton after "Use by". The expiry date refers to the last day of the month indicated. After opening the tube, the shelf life is 12 months. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Finalgon Wärmecreme DUO contains

The active ingredients are: nonivamide, nicoboxil. 1 g of non-greasy cream contains 1.7 mg of nonivamide and 10.8 mg of nicoboxil. The other ingredients are: Decyl oleate, Emulgade F [cetyl stearyl alcohol (Ph. Eur.), macrogolglycerol ricinoleate, sodium cetyl stearyl sulfate], Emulgade 1000 NI (macrogol cetyl stearyl ether), stearic acid, cetyl stearyl alcohol (Ph. Eur.), liquid paraffin, sorbic acid (Ph. Eur.), herbal perfume oil, purified water.

What Finalgon Wärmecreme DUO looks like and contents of the pack

Appearance: White to slightly beige cream. Finalgon Wärmecreme DUO is available as a 50 g tube.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main

Telephone: 0800 56 56 010
Telefax: 0800 56 56 011
www.finalgon.de

Manufacturer

C.P.M. ContractPharma GmbH & Co. KG
Frühlingstraße 7
83620 Feldkirchen-Westerham

This package leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 01/2020
Areas of application: for promoting skin circulation in the case of muscle and joint complaints.