RIVANOL

RIVANOL ointment

Important notes (mandatory information)

Rivanol Salbe 2 mg/g. Active ingredient: Ethacridine lactate monohydrate. Areas of application: For local use as an antiseptic.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Rivanol Salbe 2 mg/g, for germ reduction on the skin
Active ingredient: Ethacridine lactate monohydrate

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 directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS RIVANOL SALBE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING RIVANOL SALBE?
3. HOW TO USE RIVANOL SALBE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE RIVANOL SALBE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS RIVANOL SALBE AND WHAT IS IT USED FOR?

Rivanol Salbe contains the active ingredient ethacridine lactate. It is a medicine from the acridine derivative group with a broad antibacterial effect against wound infections (antiseptic). When applied locally, it inhibits the formation of the bacterial wall and thus leads to the rapid death of a variety of pathogens. Rivanol Salbe is used to reduce germs on the skin.

2. WHAT SHOULD YOU CONSIDER BEFORE USING RIVANOL SALBE?

Rivanol Salbe must not be used if you are allergic to ethacridine lactate, other acridine derivatives or any of the other ingredients of this medicine listed in section 6. Rivanol Salbe must not be used in the eye area.

Warnings and precautions

Please talk to your doctor or pharmacist before using Rivanol Salbe.

Special care should be taken when using Rivanol Salbe

Areas of skin to which Rivanol Salbe has been applied should not be exposed to sunlight for an extended period of time.

Using Rivanol Salbe with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Rivanol Salbe must not be mixed with another skin medicine or applied to the skin at the same time, as this can lead to incompatibilities between the two skin medicines. If in doubt, ask your doctor or pharmacist for advice.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Rivanol Salbe should not be used during pregnancy, as there are no studies on the effects of damage to the foetus. Rivanol Salbe should also not be used during breast-feeding, as it is not known exactly whether the medicine passes into breast milk.

Driving and using machines

There is no experience regarding impairment of the ability to drive and use machines.

3. HOW TO USE RIVANOL SALBE?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Apply Rivanol Salbe in a thin layer to the affected area of skin 3 times a day.

Type of application

Rivanol Salbe is for application to the skin. Rivanol Salbe should always be applied thinly to accelerate the drying process, avoid fluid congestion and, if possible, to avoid the use of dressings.

Duration of use

Do not use Rivanol Salbe for more than 7 days without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Rivanol Salbe is too strong or too weak.

If you have used more Rivanol Salbe than you should

You can continue treatment with the specified dosage. No adverse effects are to be expected in the event of a short-term overdose.

If you forget to use Rivanol Salbe

Do not use a double dose to make up for the missed dose.

If you stop using Rivanol Salbe

You could jeopardise the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment with Rivanol Salbe.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to assess side effects

Very common:	may affect more than 1 in 10 people
Common:	may affect up to 1 in 10 people
Uncommon:	may affect up to 1 in 100 people
Rare:	may affect up to 1 in 1,000 people
Very rare:	may affect up to 1 in 10,000 people
Not known:	frequency cannot be estimated from the available data

Possible side effects

Rarely, especially in conjunction with sunlight, allergic skin reactions may occur, but these disappear quickly after Rivanol Salbe is discontinued. Swelling of the face, itchy hives, headaches and mild cramps have been observed rarely. Inflammatory skin reactions may occur occasionally.

Reporting of side effects

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

5. HOW TO STORE RIVANOL SALBE?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and container after "Use by". The expiry date refers to the last day of the month indicated.

After first opening the tube, Rivanol Salbe can be stored for 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Rivanol Salbe contains

The active ingredient is ethacridine lactate monohydrate. 1 g of ointment contains 2 mg of ethacridine lactate monohydrate.

The other ingredients are zinc oxide, wheat starch, isopropyl myristate, white petrolatum, alpha-(hexadecyl, octadecyl)-omega-hydroxypoly(oxyethylene)-3.5 and purified water.

What Rivanol Salbe looks like and contents of the pack:
Rivanol Salbe is a yellow ointment and is available in packs of 25 g and 50 g.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089/641860
Fax: 089/64186130
E-mail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Phone: 034954/247-0
Fax: 034954/247-100
(a subsidiary of Dermapharm AG)

This leaflet was last revised in July 2022.

Source: Information from the package leaflet
Status: 12/2024
Active ingredient: Ethacridine lactate monohydrate. Areas of application: For local use as an antiseptic.