Package leaflet: Information for the patient. Scandonest 3% w/v, Solution for Injection Mepivacaine hydrochloride

Transcription

1 Package leaflet: Information for the patient Scandonest 3% w/v, Solution for Injection Mepivacaine hydrochloride Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Please read this leaflet carefully before you start using this medicine. It tells you the important points you should know about SCANDONEST 3% w/v. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your dentist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Scandonest 3% w/v is and what it is used for 2. What you need to know before you use Scandonest 3% w/v 3. How to use Scandonest 3% w/v 4. Possible side effects 5. How to store Scandonest 3% w/v 6. Contents of the pack and other information 1. What Scandonest 3% w/v is and what it is used for Scandonest 3% w/v is given by injection to cause loss of feeling before and during dental procedures. It contains one active ingredient: Mepivacaine hydrochloride which is a local anaesthetic allowing to prevent the pain. 2. What you need to know before you use Scandonest 3% w/v Do not use Scandonest 3% w/v - In children under 4 years old - If you are allergic to Mepivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6) - If you have heart problems not compensated by pacemaker - If you have epilepsy that is not controlled by treatment - If you have porphyria (group of disorders caused by deficiencies of enzymes) Warnings and precautions Before using Scandonest 3% w/v, tell your dentist if:. - You have problems with your heart - You have problems with your kidneys - You have problems with your liver - You have breathing problems - You have abnormal blood levels - You have severe infection or an inflammation in the area where the injection will be done - You have epilepsy - You are taking blood thinning medication (e.g. warfarin) - You are pregnant or breast feeding. The dentist should have available resuscitation equipment for effects on heart.

2 Children and adolescent Do not use in children below 4 years of age (i.e. weighing at least 20 kg). Other medicines and Scandonest 3% w/v Tell your dentist if you are taking, have recently taken or might take any other medicines. Your dentist should take special attention if you are taking the following medicines: - blood-thinning medication (e.g. warfarin) - H2 antihistaminics used to treat heartburns and peptic ulcers (e.g. cimetidine) - medicines used to reduce patient apprehension (e.g. sedatives). In that case, the dosage of anesthetic should be reduced. Scandonest 3% w/v with food and drink Avoid chewing gums or any type of food as long as the anaesthesia persists, as there is a risk of biting. Pregnancy and breast-feeding If you are pregnant or breast-feeding, ask your dentist for advice before taking this medicine. Driving and using machines Mepivacaine hydrochloride may have a minor influence on the ability to drive and use machines. Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of mepivacaine hydrochloride. You should not leave the dental office until any such symptoms have completely resolved. Scandonest 3% w/v and athletes Scandonest 3% w/v can induce positive results on doping tests. Scandonest 3% w/v contains Sodium (<1mmol/ml). 3. How to use Scandonest 3% w/v Your dentist will explain to you why you are being treated with SCANDONEST 3% w/v and tell you what dose you will be administered. The recommended dose is one cartridge. This dose is sufficient but your dentist may give you a greater quantity. He or she adjusts the dosage according to your age, to your health and to the dental work. If you use more Scandonest 3%w/v than you should If you think you may have been given too much of the injection and feel unwell (see section 4. Possible side effects), tell your dentist who will promptly take appropriate action. 4. Possible side effects Like all medicines, Scandonest 3% w/v can cause side effects, although not everybody gets them. The administration of Scandonest 3% w/v may cause high plasma levels in active substance (Mepivacaine hydrochloride), especially overdose or unintended injection in a blood vessel. The following common side effects affect between 1 and 10 of every 100 patients treated: Headache

3 The following rare side effects affect between 1 and 10 of every 10,000 patients treated: Effects on your immune defences resulting in: severe allergic reactions (anaphylactoid reactions) characterized by swelling of the face, tongue, lips, throat, puffy eyes difficulty breathing, hives. Effects on your nerves characterized by pain, burning, pricking, itching, tingling, sensation of heat or cold with no apparent physical cause, numbness, loss of sensitivity, distortion in sensation including distorted or metallic taste, absence of taste, dizziness (lightheadedness), trembling, loss of consciousness, coma, convulsion, confusion, disorientation, vertigo, speech disorders (e.g. difficulty in articulating or excessive talkativeness), restlessness, agitation, loss of balance, drowsiness. Effects on your eyes characterized by visual impairment, blurred vision and inability of the eye to change focus from seeing at a distance to seeing at near. Effects on your heart characterized by slow or rapid heartbeats, irregular pulsation of heart, chest pain and cardiac arrest Effects on your blood vessels characterized by low blood pressure Effects on your lungs characterized by slow or shallow breathing, shortness of breath, yawning and respiratory arrest Effects on your stomach, intestines or mouth characterized by nausea, vomiting, sloughing of the mucous tissue of the mouth, canker sore, and swelling of the tongue, lips, gums Effects on your skin characterized by rash, itching and facial swelling Effects on your muscles characterized by muscle twithing, shivering General effects characterized by local swelling, swelling at the injection site The following very rare side effects affect 1 of every 10,000 patients treated: Effects on your blood vessels characterized by high blood pressure The following side effects may also be observed but frequencies are unknown: Effects on your mind or behaviour characterized by an exaggerated feeling of well-being, or feeling nervous or worried Effects on your nerves characterized by uncontrolled eye movements Effects on your eyes characterized by drooping of the upper eyelid, constriction or dilatation of the pupil, recession of the eyeball in the orbit, double vision, blindness Effects on your ears characterized by ear discomfort, buzzing in the ears, abnormally acute hearing Effects on your blood vessels characterized by widening of blood vessels

4 Effects on your lungs characterized by a deficiency in the amount of oxygen reaching body tissues resulting in a deterioration of motor functions and reasoning abilities sometimes accompanied by an euphoric state; excessive carbon dioxide in the blood; hoarseness Effects on your mouth characterized by an inflammation of the mucous tissues of the mouth (cheeks, gums, tongue, lips, roof or floor of the mouth) General effects characterized by swelling, fatigue, weakness, feeling hot, and pain at the injection site Other complications such as nerve injury. If you get any side effects, talk to your dentist, doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5. How to store Scandonest 3% w/v Your dentist will keep this medicine in a safe place out of the sight and reach of children. Your dentist will not store Scandonest 3% w/v above 25 C. He or she will not use this medicine after the expiry date printed on the package. 6. Contents of the pack and other information What Scandonest 3% w/v contains - The active substance is Mepivacaine hydrochloride. - The other ingredients are sodium chloride, sodium hydroxide and water for injections. Your dentist should use a new cartridge for you at each session. If only part is used, he or she should discard the remainder. What Scandonest 3% w/v looks like and contents of the pack Scandonest 3% w/v is a solution containing mg of Mepivacaine hydrochloride per ml. It is a clear and colourless solution for injection. Scandonest 3% w/v is avaible in boxes containing 50 cartridges of 1.8 ml or 2.2 ml. Marketing Authorisation Holder and Manufacturer Septodont 58 rue du Pont de Créteil Saint-Maur-des-Fossés France

5 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: SEPTODONT Ltd Unit R & S - Orchard Business Centre St Barnabas Close ALLINGTON, Maidstone KENT ME16 OJZ UNITED KINGDOM Contact: Mr Martin FOAD Tel.: This leaflet was last approved on: {MM/YYYY} The following information is intended for healthcare professionals only: Posology and method of administration Administration: Local injection (block or infiltration). Adults: Use 1 to a maximum of 3 cartridges. Pediatric population: Children from 4 years of age (ca. 20kg body weight) and older (see 4.3) Recommended therapeutic dose: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The average dosage is 0.75mg/kg=0.025ml of mepivacaine solution per kg body weight. Maximum recommended dosage: Do not exceed the equivalent of 3mg mepivacaine/kg (0.1ml mepivacaine/kg) of body weight