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ORAVERSE 400 MICROGRAMS/L.7 ML SOLUTION FOR INJECTION

Active substance(s): PHENTOLAMINE MESILATE

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Package leaflet: Information for the user
OraVerse® 400 micrograms / 1.7 ml solution for injection
Phentolamine mesilate
Read all of this leaflet carefully before being given this medicine because it contains important
information for you.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your dentist or doctor.
If you get any side effects, talk to your dentist or doctor. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1.
What OraVerse is and what it is used for
2.
What you need to know before you are given OraVerse
3.
How OraVerse is used
4.
Possible side effects
5.
How OraVerse is stored
6.
Contents of the pack and other information
1.

What OraVerse is and what it is used for

OraVerse contains the active substance phentolamine mesilate.
OraVerse is used to reverse the numbness in the lip and tongue caused by the injection of a local anaesthetic
associated with a vasoconstrictor (of catecholamine type) given for a routine dental procedure such as teeth
cleaning, scaling and planning, cavity filling, crowns.
OraVerse increases blood flow in the blood vessels at the injection site. This accelerates the return of normal
sensation in the lip and tongue enabling you to speak, drink liquids and avoid drooling.
OraVerse is for use in adults and in children 6 years of age and older and weighing at least 15 kg
2.

What you need to know before you are given OraVerse

OraVerse must not be used:
-

If you are allergic to phentolamine mesilate or any of the other ingredients of this medicine listed in
section 6.

Warnings and precautions
Talk to your dentist or doctor before being given OraVerse, especially:
- If you have, or if you have ever had any heart conditions.
- If you are at increased risk of bleeding.
- If you have any liver problems.
Notify your dentist or doctor immediately if you feel dizzy or have palpitations right after OraVerse injection.
Contact your dentist or doctor immediately if you experience important oral bleeding after the dental
procedure.
Children
OraVerse is not recommended for use in children under 6 years of age or weighing less than 15 kg.

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Other medicines and OraVerse
OraVerse is not known to affect, or be affected by any other medicines.
Tell your dentist or doctor if you are taking, have recently taken or might take any other medicines.
In particular, tell your dentist or doctor if you are taking anticoagulant medicines.
OraVerse with food and drink
Patients are advised not to eat or drink until oral feeling returns to normal.
Pregnancy and breast-feeding
OraVerse is not recommended during pregnancy. OraVerse should not be used during breast feeding unless
clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby ask your doctor or dentist for advice before taking this medicine.
Driving and using machines
Your dentist or doctor will advise you when it is safe to drive and/or use machines.
OraVerse contains sodium
OraVerse contains less than 1 mmol of sodium (23 mg) per cartridge, i.e. it is essentially “sodium-free”.
3.

How OraVerse is used

OraVerse should only be given to you by a dentist or a doctor. It will be given to you at the end of the dental
procedure, when the numbing effect of the anaesthesia is no longer needed. It is injected in the mouth at the
same location(s) and using the same technique(s) used for the injection of the local anaesthetic.
The recommended dose is based on a 1:1 ratio to the number of cartridges of local anaesthetic administered:
Amount of Local Anaesthetic Administered
½ Cartridge
1 Cartridge
2 Cartridges

Amount of OraVerse
½ Cartridge
1 Cartridge
2 Cartridges

The maximum dose is 2 cartridges of OraVerse.
Always use this medicine exactly as described in this leaflet
Use in children
OraVerse is not recommended for use in children under 6 years of age or weighing less than 15 kg.
As for adult patients, the recommended dose of OraVerse in children is based on a 1:1 ratio to the number of
cartridges of local anaesthetic administered.
The maximum dose to be administered depends on the age and weight of the children:
Age

Weight

Maximum amount of OraVerse

6-11 years
6-11 years
≥ 12 years

15-30 kg
> 30 kg
> 30 kg

½ Cartridge
1 Cartridge
2 Cartridges

Use in elderly patients
Use of OraVerse for elderly persons is not expected to be different when compared to use for adults less than
65 years of age.
If your dentist uses more OraVerse than he or she should
Your dentist or doctor will carefully calculate how much OraVerse you should receive.
It is unlikely that you will receive more OraVerse than you should.
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Signs of receiving too much OraVerse include: lowered blood pressure, abnormal heart rate, headache, being
overly excited, eyesight problems, sweating, diarrhoea, vomiting and low blood sugar.
If you have any further questions on the use of this medicine, ask your dentist or doctor.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common ( may affect up to 1 in 10 people)

Pain at the location of injection.

Pain at the location of the dental procedure.

Oral pain.

Slow heart rate.

Increased heart rate.

Headache.

High blood pressure.
Uncommon (may affect up to 1 in 100 people)

Unusual or decreased sensations such as numbness, tingling, prickling, burning in the mouth area
(paraesthesia).

Abdominal pain, diarrhoea, being sick (vomiting).

Pain in jaw.

Swelling of the face.

Itching.

Injection site reaction, tenderness.

Reporting of side effects
If you get any side effects, talk to your doctor or dentist. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system.

<[To be completed nationally]>
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How OraVerse is stored.

This medicine should be kept out of the sight and reach of children.
Your dentist will not use OraVerse after the expiry date which is stated on the carton and the cartridge after
EXP. The expiry date refers to the last day of that month.
Your dentist will not store it above 25C.
This medicine should not be refrigerated or frozen.
Your dentist will store it in the original carton in order to protect it from light.
This medicine must not be given to you if it is discoloured or if there are particles in it.
Medicines should not thrown away via wastewater or household waste. Your dentist or doctor knows how to
throw away medicines no longer used. These measures will help protect the environment.
6.

Contents of the pack and other information

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What OraVerse contains
The active substance is phentolamine mesilate. 1.7 ml of solution contains 400 micrograms
phentolamine mesilate (235 micrograms/ml).
The excipients are mannitol (E421), disodium edetate, sodium acetate trihydrate (E262i), acetic acid
(E260) or sodium hydroxide (for pH adjustment), and water for injections.
What OraVerse looks like and contents of the pack
The solution for injection should be clear and colourless. OraVerse comes in a glass cartridge, in pack-sizes
of 10 or 50 cartridges. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Manufacturer:
Septodont SAS
58 rue du Pont de Créteil
F-94100 Saint-Maur-des-fossés
France

Marketing Authorisation Holder:
<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom, Germany, France, Spain: OraVerse
Italy: Oraverse
This leaflet was last revised in September 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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