Package leaflet: information for the patient

Rivel, 5 mg/g, gel
Ethacridini lactas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Rivel is and what it is used for

Rivel is a topical gel. The active substance in the medicine is ethacridine lactate. When applied to the skin, the medicine exerts a strong antibacterial effect and simultaneously relieves pain and inflammation.
Indications
Rivel is used topically:

for disinfection of the skin and mucous membranes;
as supportive treatment of skin infections mainly caused by Gram-positive bacteria (e.g. boils, furunculosis, abscesses), and mixed skin infections (bacterial and fungal);
after insect bites.

2. Important information before using Rivel

When not to use Rivel

if the patient is allergic to ethacridine lactate, other acridine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before using Rivel, discuss it with your doctor or pharmacist.
If symptoms of irritation or skin changes occur, discontinue use of the medicine. If
these symptoms persist, consult a doctor.
Consult your doctor even if the above warnings relate to conditions that occurred
in the past.
Avoid contact of the medicine with the eyes. If the gel gets into the eyes, remove it
by thoroughly rinsing with water.
Do not use on large areas of damaged skin.
Do not apply to the mucous membranes of the oral cavity.
If the medicine is accidentally ingested, contact a doctor immediately. Avoid
contact of the medicine with clothing (risk of staining or discoloration). To remove
stains formed, use alcohol or a solution of 6% vinegar mixed with hot water in a ratio of 1.5 to 1.
For stains difficult to remove, add one tablespoon of 3% hydrogen peroxide to the solution described
above.
Children and adolescents
Do not use this medicine in children under 2 years of age.
Rivel and other medicines
There is no data available regarding interactions with other medicines. Avoid simultaneous use of this
medicine with other topical medicines.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Rivel may be used in pregnant or breastfeeding women only if the doctor decides it is necessary.
Driving and operating machinery
Rivel has no effect on the ability to drive or operate machinery.
Rivel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate,
which may cause allergic reactions (including delayed-type reactions).
Rivel contains 100 mg of propylene glycol in 1 g of gel, i.e. 50 mg of propylene glycol in
each dosage unit (in 0.5 g of medicine, i.e. in approximately 2.5 cm of gel squeezed from the tube). Propylene glycol may cause skin irritation.
Due to the presence of propylene glycol, the medicine should not be applied to open wounds or large
areas of injured or damaged skin (e.g. burned skin) 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 dosage
unit (in 0.5 g of medicine, i.e. in approximately 2.5 cm of gel squeezed from the tube). It may cause stinging on damaged skin.

3. How to use Rivel

This medicine should always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin or mucous membranes.
A thin layer of the medicine should be applied to the affected skin or mucous membranes 2–3 times daily (more frequently if necessary). The medicine may be used under a dressing.
After applying the medicine, hands should be washed unless they are the area being treated.
The duration of treatment depends on the type and severity of the lesions. If there is no improvement or if the patient feels worse, medical advice should be sought.
Use of more medicine than recommended
There are no known cases of overdose with this medicinal product when used topically.
Missed dose
If a dose is missed, continue treatment as recommended (see section 3).
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Local skin irritation (redness, burning, itching, rash) and local allergic reactions may occur rarely (in fewer than 1 in 1,000 people).
If adverse reactions occur, use of the medicine should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Rivel

Keep this medicine out of 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 stated month.
Do not use this medicine if you notice any change in its external appearance or odour.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Rivel contains

The active substance is etacridine lactate 5 mg/g.
The other ingredients are: ethanol 96%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, hydroxyethylcellulose, propylene glycol, purified water.

What Rivel looks like and contents of the pack
Rivel is a gel.
Pack
Aluminium tube containing 30 g or 100 g of gel, placed in a cardboard box.
Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Manufacturer
EMO-FARM Sp. z o.o.
Łódzka Street 52
95-054 Ksawerów