Octosedan
Italy
Table of Contents
Package leaflet: Information for the user
OCTOSEDAN 50 mg/g rectal ointment
lidocaine
Read this entire leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- If you need more advice or information, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.
Contents of this leaflet:
- What OCTOSEDAN is and what it is used for
- What you need to know before using OCTOSEDAN
- How to use OCTOSEDAN
- Possible side effects
- How to store OCTOSEDAN
- Contents of the pack and other information
1. What OCTOSEDAN is and what it is used for
OCTOSEDAN contains lidocaine, an anesthetic, and is indicated for the short-term treatment of
itching and pain in the anal area caused by hemorrhoidal disorders.
Consult your doctor if you do not feel better or if you feel worse after 7 days.
2. What you should know before using OCTOSEDAN
Do not use OCTOSEDAN:
- if you are allergic to lidocaine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using OCTOSEDAN.
This product must be used with extreme caution in case of severely damaged mucosa or inflammation in the area to be treated, as excessive absorption of the active substance may occur under such conditions.
Caution is also required in case of infection in the area to be treated and in patients with diabetes.
Other medicines and OCTOSEDAN
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interaction studies with other medicines have been performed.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no data available on the passage of rectally administered lidocaine through the placenta or into breast milk.
Clinical data on risk during pregnancy and breastfeeding are not available.
The use of OCTOSEDAN during pregnancy and breastfeeding should be considered only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Driving and operating machinery
Not applicable.
OCTOSEDAN contains cetyl alcohol
It may cause localized skin reactions (e.g. contact dermatitis).
3. How to use OCTOSEDAN
Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Initially, apply OCTOSEDAN 2–3 times a day; subsequently, apply it twice daily. The amount of ointment to be applied depends on the size of the skin or mucosal area to be treated. Do not exceed the maximum dose of 2.5 g of ointment (125 mg of lidocaine) per single application, which corresponds to 5 finger tip units.
One finger tip unit is the amount squeezed from the tube onto the surface of the distal phalanx of the index finger.
The duration of treatment depends on the type and severity of the condition. The ointment must not be used for longer than 7 days without medical reassessment.
Paediatric population
There is no specific indication for the use of OCTOSEDAN in the paediatric population.
Method of administration
Apply the ointment in the morning and evening, preferably after bowel movement, to the affected skin areas and mucosa, and gently rub in with a finger.
An applicator with lateral openings is included in the package to facilitate insertion into the anal canal and delivery of the ointment.
Use of the ointment applicator:
Screw the applicator onto the tube and remove its tip. Pressing the tube, squeeze the ointment into the applicator until it emerges from the lateral openings. Then gently insert the applicator into the anus until fully in place.
Insertion may be facilitated by lubricating the applicator with a small amount of ointment.
Pressing the tube will deliver the ointment into the anal canal. To optimally distribute the ointment, gently rotate the tube. After use, clean the applicator by squeezing out any residual ointment through the lateral openings and wiping the surface with absorbent paper.
Unscrew the applicator and wash it with warm water after each application.
If you use more OCTOSEDAN than you should
There are no known cases of overdose with OCTOSEDAN.
Perioral (around the mouth) contact with the ointment may cause gastrointestinal disturbances such as abdominal pain and nausea. Following excessive perioral intake of lidocaine, symptoms such as disorientation, cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body), seizures (uncontrolled body movements), and respiratory failure (a condition in which the lungs fail to ensure adequate gas exchange and thus cannot maintain appropriate levels of oxygen and/or carbon dioxide in the blood) may occur.
If you forget to use OCTOSEDAN
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people)
Allergic reactions at the application site, for example itching and burning
Common (may affect up to 1 in 10 people)
Diarrhoea
Uncommon (may affect up to 1 in 100 people)
Discomfort and erythema (redness of the skin) at the application site.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store OCTOSEDAN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The
expiry date refers to the last day of that month.
Validity period after first opening: 6 months. Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What OCTOSEDAN contains
- The active substance is lidocaine.
- The other components are: cetyl alcohol, macrogol, purified water.
Description of the appearance of OCTOSEDAN and package contents
White rectal ointment in a 25 g aluminium tube.
An applicator with lateral openings is included in the package.
Marketing Authorization Holder
LABORATORI BALDACCI S.P.A.
Via San Michele degli Scalzi n. 73
56124 Pisa
Manufacturer
DR. KADE Pharmazeutische Fabrik GmbH
Opelstraße 2, 78467 Constance
Germany