POSTERISAN

POSTERISAN acute 50 mg/g rectal ointment

Important notes (mandatory information)

Posterisan akut 50 mg/g rectal ointment. Active ingredient: Lidocaine. Areas of application: for the relief of pain in the anal area before proctological examination and for the relief of itching in the anal area.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Posterisan akut 50 mg/g rectal ointment and Posterisan akut 50 mg/g rectal ointment with anal dilator
Active ingredient: Lidocaine

Read the entire package leaflet carefully before you start using this medicine, as 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 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS POSTERISAN AKUT 50 MG/G RECTAL OINTMENT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING POSTERISAN AKUT 50 MG/G RECTAL OINTMENT?
3. HOW IS POSTERISAN AKUT 50 MG/G RECTAL OINTMENT USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD POSTERISAN AKUT 50 MG/G RECTAL OINTMENT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS POSTERISAN AKUT 50 MG/G RECTAL OINTMENT AND WHAT IS IT USED FOR?

Posterisan akut 50 mg/g rectal ointment contains a locally effective pain reliever (local anesthetic) and is used to relieve painful and itchy discomfort in the anal area. Posterisan akut 50 mg/g rectal ointment is used to relieve pain in the anal area before proctological examination and to relieve itching in the anal area.

2. What should you consider before using Posterisan akut 50 mg/g rectal ointment?

Posterisan akut 50 mg/g rectal ointment must not be used if you are allergic to lidocaine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Posterisan akut 50 mg/g rectal ointment. Posterisan akut 50 mg/g rectal ointment is used to relieve pain before medical examination and itching in the anal area. Please note that the use of this medicine cannot replace a medical examination and consult your family doctor, a proctologically experienced dermatologist or proctologist (doctor for rectal diseases) as soon as possible. Under no circumstances should Posterisan akut 50 mg/g rectal ointment be used for a longer period of time (see also section 3 How to use Posterisan akut 50 mg/g rectal ointment?). In case of a fungal infection, the additional use of a locally effective agent against fungal infections is necessary.

Use of Posterisan akut 50 mg/g rectal ointment together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. No interactions with other medicines are known.

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. Lidocaine, the active ingredient in this medicine, should only be used during pregnancy if strictly indicated. A risk to the infant when using Posterisan akut 50 mg/g rectal ointment during breast-feeding seems unlikely.

Driving and using machines

Posterisan akut 50 mg/g rectal ointment has no or negligible influence on the ability to drive and use machines.

Posterisan akut 50 mg/g rectal ointment contains cetyl alcohol

Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE POSTERISAN AKUT 50 MG/G RECTAL OINTMENT?

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: Usually the ointment is applied 2 to 3 times a day. The amount depends on the size of the skin and mucous membrane areas to be treated. Posterisan akut 50 mg/g rectal ointment contains a fast and effective pain reliever. It is therefore sufficient to apply the ointment sparingly. The maximum dose of 2.5 g ointment (125 mg lidocaine) per single application should not be exceeded.

Type of application

The ointment is applied thinly to the skin and mucous membrane areas to be treated in the morning and evening and, if possible, before (approx. 30 min) and after bowel movements and gently rubbed in with a finger. For easier handling, it is recommended to store the ointment at room temperature (18°C to 25°C). To insert the rectal ointment into the anal canal, follow the application instructions below: The pack contains an applicator with lateral outlet openings, which helps to distribute the ointment evenly and in sufficient quantity in the anal canal and adjacent rectal area.

Using the applicator

To use, screw the applicator onto the tube and remove the cap. By pressing on the tube, the ointment is pressed into the applicator until it emerges from the side openings. Then the applicator is carefully inserted into the anus until it is clearly felt to stop. The lubricity can be increased by applying some ointment to the applicator. By pressing the tube again, the ointment is then released into the anal canal. Sufficient distribution of the ointment is achieved by carefully turning the tube. The applicator is best cleaned after use by squeezing out some ointment at the side openings, wiping the surface with absorbent paper and putting on the cap to prevent the ointment from drying out in the applicator. If the ointment is not used for a longer period of time, the applicator should be unscrewed and cleaned with warm water. To avoid sharp kinks, it is advisable to roll up the tube from the end after each use so that the front part is always full. The pack of Posterisan akut 50 mg/g rectal ointment with anal dilator also contains a so-called anal dilator for the gradual stretching of the cramped sphincter muscle or to prevent sphincter muscle cramps, which can be used in addition to treatment with Posterisan akut 50 mg/g rectal ointment.

Using the anal dilator

For better lubricity, the anal dilator is thinly coated with ointment before it is inserted into the anal canal and an approx. 1 cm long ointment strand is also placed on the tip of the anal dilator. This makes insertion much easier and avoids additional pain. When using it, it is advisable to adopt a relaxed body position, either in a squatting position or lying on your side. The anal dilator is carefully inserted with a rotating movement as far as possible without pain. This loosens the cramp and at the same time massages the ointment into the finest cracks and folds of the anal canal. After use, please clean the anal dilator with toilet paper and warm water. Normally, the anal dilator should be used about 2 times a day for 2 minutes each time. In the course of treatment, an attempt should be made to insert the anal dilator gradually further into the anal canal. Please discuss the use of the anal dilator with your doctor.

Note

Since the use of creams, ointments and suppositories in the anal area can lead to contamination of the laundry, an anal pad is recommended as laundry protection.

Duration of use

The ointment may be used for a maximum of 3 days until the doctor's visit without medical advice. Please adhere to the recommended duration of treatment even if you feel better sooner.

If you have used more Posterisan akut 50 mg/g rectal ointment than you should

No overdosages are known when used as directed. If the ointment is taken, e.g. by children, no serious poisoning symptoms are to be expected. However, symptoms such as abdominal pain and nausea may occur. Only if very large amounts of lidocaine are ingested can clouding of consciousness, shock, convulsions and respiratory distress occur. Please inform a doctor in any case. If you have accidentally used Posterisan akut 50 mg/g rectal ointment once or several times more often than intended, no increased side effects are to be expected. In this case, reduce the application to the intended dosage.

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.

Very common side effects (may affect more than 1 in 10 people)

Itching and burning in the anal area. This may be a hypersensitivity reaction (e.g. contact allergy).

Common side effects (may affect up to 1 in 10 people)

Diarrhea

Uncommon side effects (may affect up to 1 in 100 people)

Mild pain, redness in the anal area

If your symptoms worsen during treatment with Posterisan akut 50 mg/g rectal ointment, treatment should be discontinued and a doctor should be consulted.

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, Dept. of Pharmacovigilance, 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 SHOULD POSTERISAN AKUT 50 MG/G RECTAL OINTMENT BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton/tube after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C. Note on shelf life after opening: After opening, Posterisan akut 50 mg/g rectal ointment may be used for a maximum of 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Posterisan akut 50 mg/g rectal ointment contains

The active ingredient is lidocaine. 1 g rectal ointment contains 50 mg lidocaine. The other ingredients are: Cetyl alcohol, macrogols, purified water.

What Posterisan akut 50 mg/g rectal ointment looks like and contents of the pack

Posterisan akut 50 mg/g rectal ointment is a white, homogeneous ointment.

The following pack sizes are available

25 g rectal ointment and 25 g rectal ointment with anal dilator.

Pharmaceutical entrepreneur

DR. KADE Pharmazeutische Fabrik GmbH
Rigistraße 2
12277 Berlin
Tel.: 0 30 / 7 20 82-0
Fax: 0 30 / 7 20 82-200
E-mail: info@kade.de
www.kade.de

Manufacturer

DR. KADE Pharmazeutische Fabrik GmbH
Opelstraße 2
78467 Konstanz

This package leaflet was last revised in August 2014.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Lidocaine. Areas of application: for the relief of pain in the anal area before proctological examination and for the relief of itching in the anal area.