Package leaflet: Information for the user

REPARIL 1% + 5% gel, 2% + 5% gel

aescin + diethylamine salicylate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has advised.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What Reparil is and what it is used for
What you need to know before using Reparil
How to use Reparil
Possible side effects
How to store Reparil
Contents of the pack and other information

1. What Reparil is and what it is used for

Reparil is a topical anti-inflammatory medicinal product.
Reparil is used for minor trauma (joint and muscle pain resulting from injuries).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Reparil

Do not use Reparil

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
on open lesions (wounds), mucous membranes, or skin areas treated with radiation.

Warnings and precautions
Talk to your doctor or pharmacist before using Reparil.
This medicine does not carry any risk of tolerance (resistance to the medicine's effect) or dependence.
Since this is a topical medicine (for skin application), use it externally only.
If you are allergic (hypersensitive) to salicylates, consult your doctor or pharmacist before using this medicine,
as there is an increased risk of developing asthma attacks, local swelling of the skin and mucous membranes
(Quincke's edema), or hives compared to other patients.
Avoid contact with the eyes.
Do not use the medicine for prolonged periods. Topical skin medicines may cause sensitization reactions.
This medicine contains lavender oil and bitter orange flower oil as fragrances, with d-limonene, farnesol, and linalool.
These substances may cause allergic reactions.

Other medicines and Reparil
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines or foods are known.
This medicine should not be applied together with other topical (skin) medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Reparil is not recommended during pregnancy and breastfeeding. In particular, avoid using the medicine on large skin areas during pregnancy and avoid applying it to the breasts during breastfeeding.

3. How to use Reparil

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply and spread a thin layer of REPARIL to the skin in the affected area 1 to 3 times daily. Use only for short treatment periods.
Apply the gel directly to the affected area. After each application, wash your hands thoroughly.
The amount of gel to be applied per single dose depends on the size of the painful area to be treated.
The maximum amount of gel to be applied per single dose, up to three times daily, is approximately 6 g, corresponding to 195 mg of salicylate. A quantity of about 6 g corresponds to a strip of gel approximately 12 cm long.
The maximum daily dose is 20 g of gel, equivalent to approximately 650 mg of salicylate.
Leave the gel to dry on the skin for a few minutes before applying a dressing. The use of occlusive dressings is not recommended.
The maximum treatment duration is 5 days.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.

Use in Children
Use in children under 12 years of age is not recommended.

If you use more Reparil than you should
Cases of overdose are not known.
If you accidentally apply an excessive dose of REPARIL, wash the affected area thoroughly. In case of accidental ingestion/ingestion of REPARIL, contact your doctor immediately or go to the nearest hospital.

If you forget to use Reparil
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In rare cases, hypersensitivity reactions (allergy) may occur, such as flushing, desquamation (loss of the outer layer of skin), skin dehydration, rash, erythema, dermatitis, pruritus, urticaria.
Topical application of medicinal products containing salicylate, especially when applied over large skin areas, may cause systemic side effects affecting a specific organ (e.g. hepatic, renal or gastrointestinal adverse reactions) or the entire organism (e.g. hypersensitivity reactions).
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the Italian Medicines Agency – Website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Reparil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube.
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original packaging, correctly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Reparil contains
Reparil 1% + 5% gel:
The active substances are Escin and Diethylamine salicylate.
100 g of gel contain 1 g of Escin and 5 g of Diethylamine salicylate.

The other components are: Lavender essence, bitter orange flower essence, carbomers, macrogol 6 glycerol caprylocaprate, disodium edetate, tromethamine, isopropyl alcohol, purified water.

Reparil 2% + 5% gel:
The active substances are Escin and Diethylamine salicylate.
100 g of gel contain 2 g of Escin and 5 g of Diethylamine salicylate.

The other components are: Lavender essence, bitter orange flower essence, carbomers, macrogol 6 glycerol caprylocaprate, disodium edetate, tromethamine, isopropyl alcohol, purified water.

Description of the appearance of Reparil and package contents
Reparil 1% + 5% is a topical gel.
The pack contains 40 g of gel.
Reparil 2% + 5% is a topical gel.
The pack contains 40 g of gel.

Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)

Manufacturer
Madaus GmbH - Luetticher Strasse, 5 – Troisdorf (Germany)