Rivel

Package Leaflet: Information for the Patient

Rivel, 5 mg/g, Gel

Ethacridine Lactate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Rivel and what is it used for
• 2. Important information before using Rivel
• 3. How to use Rivel
• 4. Possible side effects
• 5. How to store Rivel
• 6. Contents of the pack and other information

1. What is Rivel and what is it used for

Rivel is a gel for topical use. The active substance of the medicine is ethacridine lactate. After application to the skin, the medicine exhibits strong antibacterial action, while also relieving pain and inflammation.

Indications for Use

Rivel is used topically:

• for skin and mucous membrane disinfection;
• as an adjunct in the treatment of skin infections caused mainly by Gram-positive bacteria (carbuncles, multiple carbuncles, abscesses), mixed skin inflammations (bacterial and fungal);
• after insect bites.

2. Important Information Before Using Rivel

When Not to Use Rivel

Warnings and Precautions

Before starting to use Rivel, discuss it with your doctor or pharmacist.
If signs of irritation or skin changes occur, stop using the medicine. If these symptoms persist, consult a doctor.
Consult a doctor even if the above warnings refer to past situations.
Avoid contact of the medicine with the eyes. If the gel gets into the eyes, rinse them abundantly with water.
Do not use on large areas of damaged skin.
Do not apply to the mucous membrane of the mouth.
If the medicine is accidentally ingested, contact a doctor immediately. Avoid contact of the medicine with clothing (may cause stains, discoloration). To remove stains, use alcohol or a 6% acetic acid solution with warm water mixed in a ratio of 1.5 to 1.
In case of difficult-to-remove stains, add 1 tablespoon of 3% hydrogen peroxide to the solution described above.
Childrenand adolescents
Do not use the medicine in children under 2 years of age.

Rivel and Other Medicines

No data are available on interactions with other medicines. Avoid using this medicine at the same time as other topical medicines.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

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.
Rivel may be used in pregnant or breast-feeding women only if the doctor decides it is necessary.

Driving and Using Machines

Rivel has no influence on the ability to drive and use machines.
Rivel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
Rivel contains 100 mg of propylene glycol in 1 g of gel, i.e., 50 mg of propylene glycol in each unit dose (in 0.5 g of medicine, i.e., in about 2.5 cm of gel squeezed from the tube). Propylene glycol may cause skin irritation.
Due to the content of propylene glycol, the medicine should not be used on open wounds or large areas of injured or damaged skin (e.g., burned) without consulting a doctor or pharmacist.
The medicine contains 80 mg of alcohol (ethanol) in 1 g of gel, i.e., 40 mg of ethanol in each unit dose (in 0.5 g of medicine, i.e., in about 2.5 cm of gel squeezed from the tube). It may cause a burning sensation on damaged skin.

3. How to Use Rivel

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The medicine is intended for topical use on the skin or mucous membranes.
Apply a thin layer of the medicine to the affected skin or mucous membranes 2-3 times a day (if necessary, more often). The medicine can be used under a dressing.
After using the medicine, wash your hands if they are not being treated.
The duration of treatment depends on the type and severity of the condition. If you do not feel better or if you feel worse, you should contact your doctor.

Using More Than the Recommended Dose of Rivel

No cases of overdose of the medicinal product have been reported when used topically.

Missing a Dose of Rivel

If you miss a dose, continue treatment as advised (see section 3).
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Rivel can cause side effects, although not everybody gets them.
Rarely (less often than 1 in 1,000 people), local skin irritation (redness, burning, itching, rash) and local allergic reactions may occur.
If you experience any side effects, stop using the medicine.

Reporting Side Effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to Store Rivel

Keep the medicine out of the sight and reach of children.
Do not store in the refrigerator or freeze. Protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use this medicine if you notice a change in its appearance or smell.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Rivel Contains

• The active substance of the medicine is ethacridine lactate 5 mg/g.
• The other ingredients are: ethanol 96%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, hydroxyethyl cellulose, propylene glycol, purified water.

What Rivel Looks Like and Contents of the Pack

Rivel is a gel.

Packaging

An aluminum tube containing 30 g or 100 g of the medicine, placed in a cardboard box.

Marketing Authorization Holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

EMO-FARM Sp. z o.o.
ul. Łódzka 52
95-054 Ksawerów

Date of Last Revision of the Leaflet: -