Document: Scandonest solution for injection ENG PL change

• Scandonest solution for injection PL
• Scandonest solution for injection ENG PL

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Package leaflet: Information for the user

Scandonest 30 mg/ml, solution for injection

Mepivacaine hydrochloride

Read all of this leaflet carefully before you start receiving 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 doctor or dentist.

• If you get any side effects, talk to your doctor or dentist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Scandonest is and what it is used for

2. What you need to know before Scandonest is used

3. How Scandonest is used

4. Possible side effects

5. How to store Scandonest

6. Contents of the pack and other information

Scandonest is a local anaesthetic (agent which reduces or abolishes sensation, affecting a particular region). The medicine is used in local dental anaesthesia during minor procedures in dentistry.

Scandonest must not be used:

• if you are allergic to mepivacaine or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic to other local anaesthetics of the same group (e.g. bupivacaine, lidocaine)

• if you have heart rhythm disorder. Ask your doctor for advice, since Scandonest might not be suitable for you.

• if you suffer from epilepsy not controlled by any treatment,

• if you suffer from intermittent acute porphyria (inherited disease which affects the nervous system and results in neurological disorders).

• in children below 4 years of age (ca.20kg body weight).

Warnings and precautions

Talk to your doctor or dentist before Scandonest is used:

• If you suffer from severe or untreated hypertension (high blood pressure),

• If you have severe heart disease,

• If you have severe anaemia,

• If you have severe liver disease,

• If you have severely impaired renal function

• If you have poor blood circulation,

• If you have blood coagulation disorders or if you are taking anticoagulants (drugs which prevent blood clotting),

• If your general condition is impaired,

• If you suffer from heart rhythm disorder,

• If you suffer from inflamed or infected area in the mouth

• In sportsmen, there is a possibility of positive results on anti-doping controls.

Other medicines and Scandonest

Tell your doctor or dentist if you are taking, have recently taken or might take any other medicines.

Scandonest should be used with caution if you already receive some drugs for treatment of heart rhythm disorders (so called class IB antiarrhythmics, e.g. Lidocaine) as this will increase the risk of side effects.

Care should be taken, with a simultaneous use of Central Nervous System depressors, which could cause additive effects.

When used together with certain disinfectants, local irritation, swelling and oedema may occur.

Blood coagulation inhibitors (drugs which prevent blood clotting) and anti-inflammatory drugs, could increase risk of bleeding.

Scandonest with food, drink and alcohol

Avoid chewing-gum or any type of food as long as the anaesthesia persists. It is recommended not to take any food before you have recovered sensibility because of the risk of bites in your mouth (lips, jaws, tongue).

Excessive alcohol consumption could reduce sensibility to anaesthetics.

Pregnancy and breast-feeding

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.

There is limited clinical experience with the use of this medicine during pregnancy. Scandonest should only be used during pregnancy on the advice of your dentist.

Scandonest passes over to mother’s milk but, when used at the recommended doses, it seems unlikely that there would be any risk of effects on the nursing child.

Scandonest can be used during breast-feeding.

Driving and using machines

Scandonest has minor influence on the ability to drive and use machines.

Scandonest contains Sodium chloride and sodium hydroxide.

Scandonest contains less than 23 mg sodium per cartridge, meaning it is essentially "sodium free".

Scandonest will be given to you as an injection by your doctor or dentist.

The dentist will adjust the dosage according to your age, weight and general health.

If you are given more Scandonest than you should

In case of overdose, side effects on the heart or blood vessels or on the central nervous system may arise: agitation, a sensation of numbness in the lips and tongue, numbness around the mouth, dizziness, vision and hearing disturbances, and buzzing in the ears. Difficulty talking, muscle stiffness and twitching are more serious symptoms and precede seizures. If any of these effects is observed or if you notice changes your heart rhythm, inform the dentist immediately since the injection of Scandonest must immediately be stopped.

4. Possible side effects

Like all medicines, Scandonest can cause side effects, although not everybody gets them.

Rare side effects: may affect up to 1 in 1000 people

Allergic reactions including serious reactions (so called anaphylactic shock), that includes rash, difficulty breathing and swelling of the tongue and throat, eruption of itching wheals (urticaria), giant hives (angiooedema).

Heart disorders and heart attack (in cases of overdose).

Unconsciousness and seizures (in cases of overdose).

Methaemoglobinaemia: abnormality of haemoglobin (either congenital or as result of poisoning).

Neurological effects (e.g. residual effect of numbness and other sensory disturbances) may occur.

It has not been established for certain to what extent these symptoms are dependent on technical factors (e.g. injection in nerve) or on the anaesthetic.

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 (see details below).

By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Scandonest

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

The cartridges are for single use. Unused solution must be discarded.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or dentist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Scandonest contains

• The active substance is mepivacaine hydrochloride 30 mg/ml.

• The other ingredients are: sodium chloride, sodium hydroxide water for injections.

What Scandonest looks like and contents of the pack:

Scandonest is packaged in glass cartridges.

The marketed presentation is box containing 50 x 1.8 ml glass cartridges.

Marketing Authorisation Holder and Manufacturer:

SEPTODONT

58, rue du Pont de Créteil

94100 Saint Maur des Fossés

France

This medicinal product is authorised in the Member States of the EEA under the following names:

AUSTRIA, GERMANY: SCANDONEST 3% OHNE VASOKONSTRIKTOR

BELGIUM, LUXEMBOURG: SCANDONEST 3% SANS VASOCONSTRICTEUR

BULGARIA, ESTONIA, LITHUANIA, NORWAY, ROMANIA, UNITED KINGDOM: SCANDONEST 3% PLAIN

GREECE, IRELAND, SLOVAKIA: SCANDONEST 3%,

DENMARK: SCANDONEST

FINLAND, HUNGARY, MALTA, POLAND, PORTUGAL, SPAIN: SCANDONEST 30 mg/mL

FRANCE: SCANDONEST 30mg/mL

FRANCE: XECAINE 3 POUR CENT SANS VASOCONSTRICTEUR

ITALY: SCANDONEST 3% SENZA VASOCOSTRITTORE

LATVIA: SCANDONEST PLAIN 30 mg/ml

NETHERLANDS: SCANDONEST 3% ZONDER VASOCONSTRICTOR

SLOVENIA: SCANDICAINE 30 mg/ml

This leaflet was last revised in 2015-02-18.

The following information is intended for healthcare professionals only:

Method of administration:

Local injection (block or infiltration).

Precaution to be taken before administering the product

To avoid intravascular injection, aspiration control at least in two planes (rotation of the needle by 180º) must always be carefully undertaken, although a negative aspiration result does not safely rule out an unintentional and unnoticed intravascular injection.

The injection rate should not exceed 1 ml per minute.

Major systemic reactions as a result of accidental intravascular injection can be avoided in most cases by an injection technique – after aspiration slow injection of 0.1-0.2 ml and slow application of the rest- not earlier than 30 seconds to 1 minute after.