Lidoposterin

Package Leaflet: Information for the Patient

LIDOPOSTERIN

50 mg/g, ointment

Lidocaine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is LIDOPOSTERIN and what is it used for

LIDOPOSTERIN is an ointment containing lidocaine, a local anesthetic agent.
LIDOPOSTERIN ointment is used to:

• reduce pain in the anal area in patients with hemorrhoids,
• relieve anal itching,
• support anesthesia before and after rectal examination.

2. Important information before using LIDOPOSTERIN

When not to use LIDOPOSTERIN

• if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use LIDOPOSTERIN, discuss it with your doctor or pharmacist.
If you have heart problems, consult your doctor before using this medicine. Such patients should be carefully monitored for signs of additional, unwanted effects on the heart.
Applying the medicine to damaged skin and/or mucous membrane of the anal area may result in the absorption of a larger amount of lidocaine into the bloodstream and cause systemic side effects.
In the case of fungal infections, simultaneous use of locally acting antifungal medicines is required.

Children

The safety of using LIDOPOSTERIN in children under 18 years of age has not been established. There are no available data.

LIDOPOSTERIN and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
LIDOPOSTERIN may affect the action of certain medicines containing the following active substances or be affected by these medicines:

• other local anesthetics,
• medicines used to treat irregular heartbeat (so-called antiarrhythmic medicines),
• medicines used to treat high blood pressure (so-called beta-adrenolytics),
• a medicine containing the active substance cimetidine used to treat heartburn and stomach ulcers.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Pregnancy
Lidocaine crosses the placenta. The potential risk to humans is not known. Before using LIDOPOSTERIN during pregnancy, discuss it with your doctor.
Breastfeeding
The active substance in LIDOPOSTERIN passes into breast milk, but it is unlikely to affect the breastfed child. However, consult your doctor before using LIDOPOSTERIN during breastfeeding.

Driving and using machines

LIDOPOSTERIN has no or negligible influence on the ability to drive and use machines.

LIDOPOSTERIN contains cetyl alcohol

The medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use LIDOPOSTERIN

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

At the beginning of treatment, the ointment should be used 2 to 3 times a day, then twice a day. The amount of ointment used depends on the size of the skin and mucous membrane area to be treated.
LIDOPOSTERIN ointment contains a fast-acting pain reliever. Therefore, it is recommended to use only small amounts of ointment. Do not exceed the maximum dose of 2.5 g of ointment (125 mg of lidocaine) per application. The length of the strip squeezed out of the tube is about 2 cm.

How and when to use LIDOPOSTERIN?

The ointment should be used in the morning and evening after bowel movements.
The ointment should be carefully rubbed into the skin and mucous membranes to be treated.
The ointment applied to the anal area can be covered with a gauze dressing.
To avoid sharp bends in the ointment tube, it is recommended to roll up the tube from the end after each use, so that the top part is always completely filled with ointment.
To apply the ointment to the anal canal, use the applicator provided with the packaging.

Using the applicator

Screw the applicator onto the ointment tube and remove its top part. After pressing the tube, the ointment enters the applicator and appears in its side holes. Then, carefully insert the applicator into the anus.
Moistening the applicator with ointment may facilitate its insertion into the anus. Re-pressing the tube causes the ointment to enter the anal canal. Careful rotation of the tube leads to the proper distribution of the ointment. After use, clean the applicator by squeezing out a small amount of ointment through the side holes, wiping the surface with absorbent paper, and then screwing the top part of the applicator back on. This protects the ointment from drying out.
If the ointment has not been used for a longer period, unscrew the applicator and then rinse it with warm water.
Note:
Due to body temperature, using the ointment in the anal area may cause soiling of underwear.

How long to use LIDOPOSTERIN

The treatment period is determined by your doctor. The medicine should not be used for more than 7 days. In case of recurrence of disease symptoms, the medicine can be used again.
Do not stop using the medicine before the planned end of the treatment period without consulting your doctor.

In case of accidental oral ingestion of the ointment

In case of accidental oral ingestion of the ointment, gastrointestinal disorders, such as abdominal pain and nausea, may occur. Disorientation, cardiogenic shock, seizures, and respiratory disorders may occur only after oral ingestion of very large doses of lidocaine. In such a case, consult your doctor or pharmacist immediately.

Using a higher dose of LIDOPOSTERIN than recommended

In case of using a higher dose than recommended, no side effects should occur.
Continue using the recommended dose and follow the treatment schedule.

Missing a dose of LIDOPOSTERIN

Do not use a double dose to make up for a missed dose.
If you have any further questions about using 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.

Side effects

Very common (may affect more than 1 in 10 people)
Itching and burning in the anal area
This may be an allergic reaction (e.g., contact allergy).
Common (may affect up to 1 in 10 people)
Diarrhea
Uncommon (may affect up to 1 in 100 people)
Discomfort, redness around the anus

Reporting side effects

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

5. How to store LIDOPOSTERIN

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 after "Expiry date". The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What LIDOPOSTERIN contains

• The active substance is lidocaine. 1 gram of ointment contains 50 mg of lidocaine.
• The other ingredients are: cetyl alcohol, macrogol 1500, macrogol 3000, macrogol 400, purified water.

What LIDOPOSTERIN looks like and contents of the pack

White, homogeneous ointment in an aluminum tube internally coated with epoxy resin, sealed at the end with a latex or heat-sealable coating, closed with a cap in a cardboard box.
The box contains an aluminum tube containing 25 g of ointment and a PE cannula (applicator).

Marketing authorization holder and manufacturer

DR. KADE Pharmazeutische Fabrik GmbH
Rigistraße 2
12277 Berlin
Germany
For more detailed information, please contact the representative of the marketing authorization holder:
Kadefarm Sp. z o.o.
Sierosław, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Phone: +48 61 862 99 43
e-mail: [email protected]

Date of last revision of the leaflet: