NOTICE
ANSM - Updated on : 20/05/2025
Product name
TITANOREINE WITH LIDOCAINE 2 PER CENT, cream
Carrageenates / Titanium dioxide / Zinc oxide / Lidocaine
Cover
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 7 days.
What does this leaflet contain?
1. What is TITANOREINE WITH LIDOCAINE 2 PER CENT, cream and what is it used for?
2. What do I need to know before using TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream?
3. How do I use TITANOREINE WITH LIDOCAINE 2 PER CENT, cream?
4. What are the possible side effects?
5. How should TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream be stored?
6. Package contents and other information.
1. WHAT IS LIDOCAINE TITANOREINE 2 PER CENT, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DRUGS FOR THE TOPICAL TREATMENT OF EMORRHOIDS AND ANAL BRANCHES - LOCAL ANESTHETICS - ATC code: C05AD
Local treatment of symptoms (pruritus, pain) associated with hemorrhoidal crisis.
2. WHAT DO I HAVE TO KNOW BEFORE USING TITANOREINE WITH LIDOCAINE 2 PER CENT, cream?
Never use TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream:
- if you are allergic to carrageenates, titanium dioxide, zinc oxide, lidocaine or any of the other ingredients listed in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using TITANOREINE A LA LIDOCAINE 2 POUR CENT, crème.
- If your symptoms (pain, itching, discomfort) persist beyond 7 days, you should consult your doctor.
- Medical advice should be sought before use in children.
- If you are pregnant, ask your doctor for advice; TITANOREINE A LA LIDOCAINE 2 POUR CENT, crème should only be used during pregnancy on the advice of your doctor.
- Because of the presence of lidocaine, repeated or prolonged use of TITANOREINE WITH LIDOCAINE 2 PER CENT, cream on the mucous membrane should be avoided.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children
Not applicable.
Other medicinal products and TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LIDOCAINE TITANOREINE 2 PER CENT, cream with food and drink
Not applicable.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy or while breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving vehicles and operating machinery
This medicine has no or negligible effect on the ability to drive vehicles and use machines.
TITANOREINE A LA LIDOCAINE 2 POUR CENT, crème contains propylene glycol, methyl parahydroxybenzoate and propyl parahydroxybenzoate.
This medicine contains 500 mg propylene glycol per 100 g of cream and may cause skin irritation.
This product contains methyl and propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
3. HOW TO USE TITANOREINE WITH LIDOCAINE 2 PER CENT, cream?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Medical advice is required before use in children.
Adults and children over 6: 1 application (0.5 to 2 g), renewable as needed, with a minimum interval of 3 hours between applications.
Rectal route.
Treatment must not exceed 7 days.
If you have used more TITANOREINE WITH LIDOCAINE 2 PER CENT, cream than you should have
Consult your doctor or pharmacist immediately.
Exceptional cases of anal ulceration have been reported with prolonged treatment. The application of extremely large doses could lead to overdosage; in this case, specialized monitoring should be maintained. Overdosage with local anesthetics may induce systemic symptoms such as central nervous system and cardiac effects. Symptomatic treatments should be applied.
If you forget to use TITANOREINE WITH LIDOCAINE 2 PER CENT, cream
Do not take a double dose to make up for the single dose you forgot to take.
If you stop using TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
The following effects may occur:
- Application site reactions such as burning, redness, irritation, pain, itching and rash.
- Hypersensitivity reactions.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE TITANOREINE WITH LIDOCAINE 2 PER CENT, cream?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream contains
- The active ingredients are :
Carrageenates........................................................................................................................2.50 g
Titanium dioxide...................................................................................................................2.00 g
Zinc oxide........................................................................................................................2.00 g
Lidocaine...............................................................................................................................2.00 g
For 100 g of cream.
- Other ingredients include: macrogol palmitostearate, saturated polyglycosylated glycerides, dimeticone, microcrystalline cellulose, propylene glycol, methyl parahydroxybenzoate (E219), propyl parahydroxybenzoate (E217), potassium sorbate, purified water.
What TITANOREINE A LA LIDOCAINE 2 POUR CENT, cream is and what it contains
This medicine is available as a cream in 20 g or 40 g tubes.
Marketing authorization holder
KENVUE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX, FRANCE
Marketing authorization holder
KENVUE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Manufacturer
MCNEIL IBERICA, S.L.U.
ANTIGUA CENTRA NACIONAL II
KM. 32,800
28805 ALCALA DE HENARES (MADRID)
SPAIN
Or
CREAPHARM BESSAY S.A.S.
ZONE DACTIVITE LE COMTE
03340 BESSAY-SUR-ALLIER
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice:
What are hemorrhoids and hemorrhoidal crisis?
Hemorrhoids are veins located in the anal area (anus, rectum and surrounding tissue). They are normal, painless anatomical structures that only become pathological when they develop into hemorrhoidal disease.
Problems arise when a hemorrhoidal crisis occurs, caused by abnormal dilation of these veins.
These dilated hemorrhoids can then protrude to form a kind of "ball" in the anus. This hemorrhoidal crisis results in varying degrees of discomfort. Itching, irritation and bleeding during or after bowel movements (found on toilet paper or underwear) are the usual trio of symptoms of hemorrhoids. Hemorrhoidal attacks are generally not serious, and should subside within a few days.
Caution:
If symptoms persist, you should seek medical advice. Pain and bleeding may be signs of complications, or even of a more serious disease that only your doctor will be able to diagnose and treat.
What to avoid
In general, excessive pressure on hemorrhoidal veins can lead to congestion. For this reason, avoid the following
- intestinal transit disorders: constipation leads to repeated pushing; diarrhea or irritating laxatives irritate the mucous membranes;
- foods that can promote congestion of the hemorrhoid veins and thus the onset of an attack: alcohol, spices.