Lidoposterin

Patient Information Leaflet

LIDOPOSTERIN
50 mg/g, ointment
Lidocaine
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What LIDOPOSTERIN is and what it is used for

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

• to reduce painful symptoms around the anus in patients with haemorrhoids,
• to relieve anal itching,
• as an adjunctive anaesthetic before and after rectal examination.

2. Important information before using LIDOPOSTERIN

When not to use LIDOPOSTERIN

• if the patient is 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 this with your doctor or pharmacist.
If the patient has heart problems, consult a doctor before using this medicine. Such patients should be carefully monitored for signs of additional, undesirable effects on the heart.
Application of the medicine to damaged skin and/or mucous membrane of the anal area may result in increased absorption of lidocaine into the bloodstream and may cause systemic adverse effects.
In case of fungal infections, concomitant use of locally acting antifungal medicines is required.

Children
The safety of LIDOPOSTERIN in children under 18 years of age has not been established. There is a lack of available data.

LIDOPOSTERIN with other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
LIDOPOSTERIN may affect the action of certain medicines containing the following active substances or may be affected by these medicines:

• other local anaesthetics,
• medicines used to treat irregular heartbeat (so-called antiarrhythmics),
• medicines used to treat high blood pressure (so-called beta-blockers),
• medicines containing the active substance cimetidine, used to treat heartburn and stomach ulcers.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
Lidocaine crosses the placenta. The potential risk in humans is unknown. Consult your doctor before using LIDOPOSTERIN during pregnancy.

Breastfeeding
The active substance in LIDOPOSTERIN passes into breast milk, but it probably does not affect the breastfed child. Nevertheless, consult your doctor before using LIDOPOSTERIN during breastfeeding.

Driving and operating machinery
LIDOPOSTERIN has no effect or negligible effect on the ability to drive and operate machinery.

LIDOPOSTERIN contains cetyl alcohol
This medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use LIDOPOSTERIN

This medicine should always be used as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Recommended dose
At the beginning of treatment, apply the ointment 2 to 3 times daily, then reduce to twice daily. The
amount of ointment used depends on the size of the area of skin or mucous membrane being treated.
LIDOPOSTERIN ointment contains a fast-acting analgesic. Therefore, only small amounts of the ointment
should be applied. The maximum dose of 2.5 g of ointment (125 mg lidocaine) per single application
should not be exceeded. This corresponds to a strip approximately 2 cm in length.
How and when to use LIDOPOSTERIN
Apply the ointment in the morning and evening, after bowel movement.
Gently rub the ointment into the skin and mucous membranes requiring treatment.
The ointment applied around the anus may be covered with a gauze dressing.
To prevent sharp creasing of the ointment tube, it is recommended to roll the tube from the end after
each use, so that the top part remains completely filled with ointment.
To apply the ointment inside the anal canal, use the applicator provided with the package.
Using the applicator
Screw the applicator onto the tube and remove its top cap. Squeeze the tube gently so that the ointment
fills the applicator and appears through its side openings. Then gently insert the applicator into the anus.
Moistening the applicator with ointment may facilitate insertion. Squeezing the tube again delivers the
ointment into the anal canal. Gently rotating the tube ensures proper distribution of the ointment. After
use, clean the applicator by squeezing a small amount of ointment through the side openings, wipe the
surface with absorbent paper, and then screw the top cap back on. This helps prevent the ointment from
drying out.
If the ointment has not been used for a prolonged period, disassemble the applicator and wash it with
hot water.
Note:
Due to body temperature, applying the ointment around the anus may cause soiling of clothing.
How long to use LIDOPOSTERIN
The duration of treatment should be determined by your doctor. This medicine should not be used for
longer than 7 days. If symptoms recur, the medicine may be used again.
Do not discontinue treatment before the planned end of treatment without consulting your doctor.
In case of accidental oral ingestion of the ointment
Accidental oral ingestion of the ointment may cause gastrointestinal symptoms such as abdominal
pain and nausea. Disorientation, cardiogenic shock, seizures, and respiratory disturbances may occur
only after ingestion of very large doses of lidocaine. In such a case, seek immediate medical advice from
a doctor or pharmacist.
Use of a higher than recommended dose of LIDOPOSTERIN
If more ointment than recommended is used, adverse effects are unlikely to occur. Continue using the
recommended dose and follow the prescribed treatment regimen.
Missed dose of LIDOPOSTERIN
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects
Very common (may occur in more than 1 in 10 people)
Itching and burning around the anus
This may be an allergic reaction (e.g. contact allergy).
Common (may occur in less than 1 in 10 people)
Diarrhea
Uncommon (may occur in less than 1 in 100 people)
Discomfort, redness around the anus
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions
of the 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
Adverse effects can also be reported directly to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store the medicine LIDOPOSTERIN

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube under "Expiry date". The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What LIDOPOSTERIN contains

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

What LIDOPOSTERIN looks like and contents of the pack
A white, homogeneous ointment in an aluminium tube internally coated with epoxy resin,
sealed at the end with latex or thermoseal lacquer, closed with a cap, packed in a cardboard box.
The box contains an aluminium tube with 25 g of ointment and a PE cannula (applicator).
Marketing Authorisation Holder and Manufacturer
DR. KADE Pharmazeutische Fabrik GmbH
Rigistraße 2
12277 Berlin
Germany
For further information, please contact the representative of the Marketing Authorisation Holder:
Kadefarm Sp. z o.o.
Sierosław, Gipsowa 18 Street
62-080 Tarnowo Podgórne, Poland
Tel. +48 61 862 99 43
e-mail: [email protected]