Finalgon Warming Ointment Duo, 20 g

Finalgon Warming Cream DUO. Indications: to promote skin circulation in cases of muscle and joint pain.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Finalgon Warming Cream 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse after a few days, consult your doctor.

What this leaflet contains:

1. WHAT IS FINALGON HEAT CREAM DUO AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING FINALGON HEAT CREAM DUO?
3. HOW IS FINALGON HEAT CREAM DUO TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FINALGON HEAT CREAM DUO BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS FINALGON HEAT CREAM DUO AND WHAT IS IT USED FOR?

How Finalgon Heat Cream DUO works. Finalgon Heat Cream DUO is a circulation-enhancing cream for heat therapy. Finalgon Heat Cream DUO is used to promote skin circulation in cases of muscle and joint pain.

Children and adolescents:
The safety and efficacy of Finalgon Heat Cream DUO in children and adolescents under 18 years of age have not been established.

2. WHAT DO YOU NEED TO KNOW BEFORE USING FINALGON HEAT CREAM DUO?

Finalgon Heat Cream 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 areas of skin.

Temporary itching or burning may occur at the application site. This can be more pronounced if too much Finalgon Warming Cream DUO is applied. Accidentally or excessively applied Finalgon Warming Cream DUO can be removed with skin cream or cooking oil (petroleum jelly near the eye).

Special care is required when using Finalgon Warming Cream DUO:
Finalgon Warming Cream DUO causes a local increase in blood flow to the skin. This can lead to redness, a feeling of warmth, itching, or burning at the application site. These effects can be more pronounced if too much Finalgon is applied or if Finalgon Warming Cream DUO is rubbed intensively into the skin. This can also lead to blistering. Caution: Mucous membrane irritation!

Finalgon Warming Cream DUO must not be used on the face, eyes, nose, or in the 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 areas of skin, such as the neck or inner thighs, should not be treated, or only with a small amount or a lower dose than recommended. The skin of fair-haired or sensitive individuals generally reacts more strongly; therefore, the desired warming effect can be achieved with very little Finalgon Warming Cream DUO.

Finalgon Warming Cream DUO contains the excipients cetostearyl alcohol and sorbic acid, which may cause local skin reactions.

Use of Finalgon Warming Cream DUO with other medications:
No interactions are currently known. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medications, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility:
Pregnancy and breastfeeding:
There is insufficient data on the use of Finalgon Warming Cream DUO during pregnancy and breastfeeding. Therefore, Finalgon Warming Cream DUO should not be used during pregnancy and breastfeeding.

Fertility:
There are no data on the effects on fertility.

Driving ability and operating machinery:
There is no experience regarding impairment of driving ability and the ability to operate machinery.

3. HOW TO USE FINALGON HEAT CREAM DUO?

Always use Finalgon Warming Cream DUO exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, apply a pea-sized amount of cream (approximately 0.5 cm²) to an area of skin the size of your palm. The effect of Finalgon Warming Cream DUO is perceived differently by each individual. With relatively insensitive skin, the warming effect may be weak or absent altogether; with sensitive skin, even a very small amount can produce the desired warming effect. Therefore, treatment should begin with a small amount of Finalgon Warming Cream DUO on a small area of skin. Rub into the skin as needed. The warming sensation lasts for approximately 3–6 hours. The effect is often noticeable for several days: muscle activity, perspiration, or external heat application can reactivate the warming sensation. A warm bath or a professional massage before application can enhance or prolong the effect. Patients with sensitive skin should avoid hot baths or showers before or after applying Finalgon Warming Cream DUO. It is recommended to apply skin cream to your hands before rubbing in the cream and to wash them thoroughly with soap and water afterward. If you have sensitive skin, it is advisable to wear disposable gloves. Care should be taken to ensure that Finalgon Warming Cream DUO is not transferred to other areas of skin or to other people.

Please talk to your doctor or pharmacist if you feel that the effect of Finalgon Warming Cream DUO is too strong or too weak. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you have used more Finalgon Warming Cream DUO than you should:
Excessive use of Finalgon Warming Cream DUO can intensify the warming effect and the described side effects (see section 4). In particular, blisters may form on the treated areas of skin. Because the active ingredients of Finalgon Warming Cream DUO are readily absorbed through the skin, overdosing can lead to systemic reactions such as reddening of the upper body, increased body temperature, hot flashes, painful increased blood flow, and a drop in blood pressure. If too much Finalgon Warming Cream DUO has been applied, it can be removed with skin cream or cooking oil (with petroleum jelly if applied to the eye). If necessary, symptomatic treatment should be administered, possibly with topical corticosteroids.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Diseases of the immune system:

• Frequency not known: Anaphylactic reactions, hypersensitivity reactions

Diseases of the nervous system:

• Common: burning skin sensation
• Frequency not known: paresthesia

Respiratory diseases:

• Frequency not known: cough, shortness of breath

Diseases of the skin and subcutaneous tissue:

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

General diseases and conditions at the administration site:

• Common: Feeling of heat

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

5. HOW TO STORE FINALGON HEAT CREAM DUO?

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 label and carton after EXP. The expiry date refers to the last day of that month. Once opened, the tube can be used for 12 months. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Finalgon Warming Cream DUO contains:
The active ingredients are: Nonivamide, Nicoboxil. 1 g of non-greasy cream contains 1.7 mg nonivamide and 10.8 mg nicoboxil. The other ingredients are: Decyl oleate, Emulgade F [Cetylstearyl alcohol (Ph. Eur.), Macrogolglycerol ricinoleate, Sodium cetylstearyl sulfate], Emulgade 1000 NI (Macrogol cetylstearyl ether), stearic acid, cetylstearyl alcohol (Ph. Eur.), liquid paraffin, sorbic acid (Ph. Eur.), herbal perfume oil, purified water.

(Apo) Usually ship out within 3-5 business days