FINALGON UNG 20G

ATC code: M02AX10 

Active substances: Nonivamidum, Nicoboxilum

Vendor, principal: Boehringer Ingelheim Intern. G. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

FINALGON 25MG/+4MG/1G 20G

Package leaflet: Information for the user

FINALGON, 25 mg/4 mg/g ointment

Nicoboxil / nonivamide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What FINALGON is and what it is used for
2.   What you need to know before you use FINALGON
3.   How to use FINALGON
4.   Possible side effects
5.   How to store FINALGON
6.   Contents of the pack and other information

1. What FINALGON is and what it is used for

Nonivamide is a synthetic capsaicin analogue whose analgesic properties are caused by the reduction of a certain agent - substance P - in the nerve fibres after repeated administration of the medicine. Nicoboxil is an ester of nicotinic acid and 2-butoxyethanol. Nicotinic acid is a group B vitamin, which has blood vessel dilating properties intermediated by special agents (prostaglandins) in the organism.
Nonivamide and nicotinic acid promote mutually the blood vessel dilating effect reducing the development of skin redness after the administration of the medicine.
FINALGON is used externally for joint and muscle pain.

2. What you need to know before you use FINALGON Do not use FINALGON:

-   if you are allergic to nicoboxil, nonivamide or any of the other ingredients of FINALGON (listed in section 6).
-   if you have very sensitive skin.
-   the medicine should not be applied to wounds, inflamed skin or used in case of skin diseases. Tell your doctor if any of the above applies to you before using the medicine.

Warnings and precautions

Talk to your doctor or pharmacist before using FINALGON. The improvement of local blood supply in the skin caused by FINALGON may cause redness, warmth, itching and tingling in the region exposed to the ointment. These symptoms may be especially notable if the used amount of FINALGON was too big or when FINALGON was intensively rubbed on the skin. Extenssive use or rubbing of FINALGON may cause blisters on the skin.
After FINALGON use hands should be washed immediately to avoid the contact of the medicine with other body areas or transfer to other people.
Watch carefully that FINALGON does not come into contact with your face, eyes or mouth in any case. This could cause transient facial swelling, facial pain, irritation of the whites of the eyes, eye redness, eye stinging, vision disorders, mouth discomfort and stomatitis (inflammation of oral mucosa).
Do not take hot bath or shower before or after the application of FINALGON. Even several hours after FINALGON application skin redness or intense feeling of warmth may develop as a result of sweating or warming effects.

Other medicines and FINALGON

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Interactions with other medicines are not known.

Pregnancy, breast-feeding and fertility

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 using this medicine.
As there are no data on the use of FINALGON during pregnancy or breast-feeding, the medicine should not be used during these periods.

Driving and using machines

The effects of FINALGON on the ability to drive and use machines have not been studied.

FINALGON contains sorbic acid

FINALGON ointment contains sorbic acid as an excipient, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use FINALGON

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is not more than 0.5 cm (about pea-sized amount) for a palm-sized skin area. FINALGON ointment should be used as required, up to 3 times a day.
Always start treatment with FINALGON ointment with a very small amount and on a very small skin area to test your personal reaction to the medicine. Treatment response to FINALGON ointment has great individual variability and some people need only the slightest spreading to achieve the feeling of warmth, but the others may have very mild warming effect or it is completely absent.
The ointment is applied to skin with the provided applicator. After the use of FINALGON hands should be thoroughly washed with water and soap.

Use in children

There is no clinical data on using FINALGON in children and adolescents under 18 years of age.
If you have the impression that the effect of FINALGON is too strong or too weak, talk to your doctor or pharmacist.

If you use more FINALGON than you should

You should check with your doctor or pharmacist if you have used more FINALGON than you should.
When too large amount of FINALGON has been used the effect of the medicine can be reduced with a sponge
moistened with oil (for example cooking oil) or with nourishing cream.
After excessive use of FINALGON increased blood supply may deepen and the severity of described side effects may increase. The result of excessive use may be development of skin blisters in the region where FINALGON was administered.
FINALGON overdose may also result in redness of upper body, increased body temperature, hot flushes, painful increase of circulation and reduced blood pressure.

If you forget to use FINALGON

Do not use a double dose to make up for a forgotten dose. Use usual doses subsequently.

If you stop using FINALGON

FINALGON is used only when required and the use should be stopped when symptoms are relieved. 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.
Common (occurs in up to 1 user out of 10)
-   feeling of burning
-   skin redness (erythema)
-   pruritus
-   feeling of heat
Uncommon (occurs in up to 1 user out of 100)
-   rash
Unknown (cannot be estimated from the available data)
-   rapidly progressing life-threatening allergic (anaphylactic) reaction
-   hypersensitivity
-   feeling of pricking (paraesthesia)
-   cough
-   breathing difficulties
-   administration site pustules
-   localised skin reaction
-   facial swelling
-   urticaria
-   blisters

Reporting of side effects

If you get 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 via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FINALGON

Keep this medicine out of the sight and reach of children.
Store below 25°C.
After first opening of the tube use within 6 months.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
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 FINALGON contains

-   The active substances are 25 mg of nicoboxil and 4 mg of nonivamide per 1 g of ointment.
-   The other excipients are disopropyl adipate, silica colloidal anhydrous, white petroleum jelly, sorbic acid, citronella grass oil, purified water.

What FINALGON looks like and contents of the pack

20 g of clear colourless ointment in aluminium tube.

Marketing Authorisation Holder

sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2 11317 Tallinn Estonia

Manufacturer

Globopharm Pharmazeutische Produktions und Handelsgesellschaft m.b.H.
Breitenfurter Strasse 251
1230 Wien
Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2 11317 Tallinn Tel 627 3488

This leaflet was last revised in July 2018.

Other sources of information

Detailed information on this medicine is available on the State Agency of Medicine’s web site: http: //www .ravimiamet.ee.