In this manual :
1. WHAT IS LIDOCAINE TITANOREIN 2 PER CENT, cream AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING LIDOCAINE TITANOREIN 2 PER CENT, cream
3. HOW DO I USE LIDOCAINE TITANOREINE 2 PER CENT, Cream?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW DO I USE LIDOCAINE TITANOREINE 2 PER CENT, Cream?
6. ADDITIONAL INFORMATION
1. WHAT IS LIDOCAINE TITANOREINE 2 PER CENT CREAM AND WHAT IS IT USED FOR?
Pharmacotherapeutic Class
Local anaesthetic
Symptomatic treatment of pain, pruritus, and congestive sensations during hemorrhoidal flare-ups and other anal conditions.
2. WHAT YOU SHOULD KNOW BEFORE USING LIDOCAIN TITANOREIN 2 PER CENT, cream
List of information needed before taking the medicine
Not applicable.
Never use LIDOCAINE TITANOREINE 2 PER CENT, cream if you have a history of allergy to lidocaine or to any of the other components of this medicine (see section 6).
Precautions for use; special warnings
Use caution with TITANOREINE A LIDOCAINE 2 PER CENT, cream:
- If your symptoms (pain, itching, discomfort) persist beyond 15 days, you should consult your doctor.
- If you are pregnant, ask your doctor for advice; LIDOCAINE TITANOREINE 2 PER CENT, cream should only be used during pregnancy on the advice of your doctor.
- This medicine contains methyl propyl parahydroxybenzoate which may cause allergic reactions.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medications:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should be used with caution during pregnancy and breastfeeding.
In general, you should seek advice from your doctor or pharmacist before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some ingredients of TITANOREINE A LIDOCAINE 2 PER CENT, cream:
Methyl parahydroxybenzoate, propyl parahydroxybenzoate.
3. HOW TO USE TITANOREIN A LIDOCAINE 2 PER CENT, cream
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
1 to several applications per day.
Method and/or route(s) of administration
Rectal route.
Duration of treatment
Use should be for a short period of time.
Symptoms and instructions in case of overdose
If you have used more LIDOCAINE TITANOREINE 2 PER CENT, cream than you should have:
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. Symptomatic treatments should be applied.
If you have used more LIDOCAINE TITANOREINE 2 PER CENT cream than you should and you experience any adverse effects, please tell your doctor or pharmacist.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Not applicable.
5. HOW DO I USE TITANOREINE WITH LIDOCAINE 2 PER CENT, cream?
Keep out of the reach and sight of children.
Do not use LIDOCAINE TITANOREIN 2 PER CENT cream after the expiry date stated on the outer packaging.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does TITANOREINE A LIDOCAINE 2 PER CENT, cream contain?
The active ingredients are :
Carrageenan ................................................................................................................................... 2.50 g
Titanium dioxide ............................................................................................................................... 2.00 g
Zinc oxide ................................................................................................................................... 2.00 g
Lidocaine .......................................................................................................................................... 2.00 g
Per 100 g of cream
The other components are :
Macrogol palmitostearate, saturated polyglycol glycerides, dimeticone, microcrystalline cellulose, propylene glycol, methyl parahydroxybenzoate (E 219), propyl parahydroxybenzoate (E 217), potassium sorbate, purified water.
Pharmaceutical form and content
What TITANOREINE A LIDOCAINE 2 PER CENT cream is and what it contains
This medicinal product is in the form of a cream; 20 g tube.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY-LES-MOULINEAUX
Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY-LES-MOULINEAUX
Manufacturer
CREAPHARM BESSAY SAS
Zone d'Activite Le Comte
03340 BESSAY-SUR-ALLIER
or
MCNEIL IBERICA S.L.U.
Antigua Ctra National II
Km. 32,800
28805 Alcala de Henares
Madrid
Spain
Names of the medicinal product in the Member States of the European Economic Area