NOTICE
ANSM - Updated: 21/09/2017
Name of the drug
TITANOREINE, suppository
Carrageenan / Titanium Dioxide / Zinc Oxide
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel worse after 7 days.
What does this booklet contain ?
1. What is TITANOREINE, suppository and in what cases is it used?
2. What information do you need to know before using TITANOREINE, suppository?
3. How to use TITANOREINE, suppository?
4. What are the possible side effects?
5. How to keep TITANOREINE, suppository?
6. Contents of the package and other information.
1. WHAT IS TITANOREIN, suppository AND WHAT IT IS USED FOR
Pharmacotherapeutic group: CICATRISANT - ATC code: C: cardiovascular system.
TITANOREINE is an anti-hemorrhoidal medicine that acts locally.
This medicine is indicated for the symptomatic treatment of pain, pruritus and congestive sensation during hemorrhoids and other anal disorders.
You should talk to your doctor if you do not feel better or feel worse after 7 days.
2. WHAT YOU SHOULD KNOW BEFORE USING TITANOREINE, suppository?
Never use TITANOREINE, suppository:
· if you are allergic to the active substances 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 TITANOREINE, suppository .
· If your symptoms (pain, itching, discomfort) persist beyond 7 days, you should consult your doctor;
· If you have rectal bleeding or blood in the stool, talk to your doctor before using TITANOREINE.
· If you are pregnant, ask your doctor for advice; TITANOREINE will be used during pregnancy only on the advice of your doctor.
Children and adolescents
Not applicable.
Other medicines and TITANOREINE, suppository
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
TITANOREINE, suppository with food and drinks
Not applicable.
Pregnancy and breast feeding
This medicine will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Under normal conditions of use, there is no evidence that TITANOREINE affects the ability to drive or use machinery.
3. HOW TO USE TITANOREINE, suppository?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 to 2 suppositories a day.
Rectal way. Do not use orally.
The duration of treatment should not exceed 7 days.
If you have used more TITANOREINE, suppository than you should
Immediately consult your doctor or pharmacist.
If swallowed, consult your doctor or pharmacist immediately or call a poison control center.
If you forget to use TITANOREINE, suppository
Do not take a double dose to make up for the dose you forgot to take.
If you stop using TITANOREINE, suppository
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects of unknown frequency (can not be estimated from the available data).
· Itching and rashes.
· Hypersensitivity reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE TITANOREINE, suppository?
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 carton. The expiry date refers to the last day of this month.
Keep away from heat.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What TITANOREINE contains, suppository
· The active substances are:
Carragheenates ................................................. .................................................. ............. 300 mg
Titanium dioxide............................................... .................................................. .......... 200 mg
Zinc oxide............................................... .................................................. ............... 400 mg
For a suppository.
· The other components are:
Talc, semi-synthetic glycerides.
What TITANOREINE, suppository and contents of the pack
This medicine comes in the form of suppositories. Box of 12 suppositories.
Marketing Authorization Holder
JOHNSON & JOHNSON HEALTH BEAUTY FRANCE
1 STREET CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Operator of the marketing authorization
JOHNSON & JOHNSON HEALTH BEAUTY FRANCE
1 STREET CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
UNITHER LIQUID MANUFACTURING
1-3 ALLEE OF THE NEST
ZI IN SIGAL
31770 COLOMIERS
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
What is hemorrhoids and the hemorrhoidal crisis?
Hemorrhoids are veins located in the anal area (anus, rectum, and tissue surrounding them). They are normal, painless anatomical structures that only look pathological when they progress to hemorrhoidal disease.
Problems arise when a hemorrhoidal crisis occurs, caused by abnormal dilatation of these veins.
These dilated hemorrhoids can then be externalized to form a kind of "ball" in the anus. This hemorrhoidal crisis results in more or less discomfort. Itching, irritation, and small bleeding during or after stool (found on toilet paper or undergarments) are the trio of usual symptoms of hemorrhoids. Generally, the haemorrhoidal crisis is not serious and should be reduced in a few days.
Warning :
If the symptoms persist, it is necessary to consult. Pain and bleeding can be signs of complications or even more serious illness that only your doctor will be able to diagnose and treat.
To avoid :
In general, any excessive pressure exerted on the haemorrhoidal veins can cause congestion. Therefore, avoid:
· intestinal transit disorders: constipation leads to repeated thrusting efforts; diarrhea or the taking of irritating laxatives causes irritation of the mucous membranes;
· foods that can promote congestion of veins hemorrhoids and therefore the onset of the crisis: alcohol, spices.