PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER. Prilotekal 20 mg/ml solution for injection prilocaine hydrochloride

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1 Page 1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER Prilotekal 20 mg/ml solution for injection prilocaine hydrochloride Read all of this leaflet carefully before you are 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 doctor or pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Prilotekal is and what it is used for 2. What you need to know before Prilotekal is given to you 3. How to use Prilotekal 4. Possible side effects 5. How to store Prilotekal 6. Contents of the pack and other information 1. What Prilotekal is and what it is used for Prilotekal solution for injection 20 mg/ml is a type of medicine called local anaesthetic, belonging to the category of the amides, contains a medicine called prilocaine hydrochloride and is a solution for injection. Prilotekal solution for injection is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery in adults. Prilotekal is injected into the lower part of your spine. This quickly stops pain from your waist down for a limited period of time (short-term surgical procedures). 2. What you need to know before Prilotekal is given to you You must not be given Prilotekal - if you are allergic (hypersensitive) to prilocaine hydrochloride, other amide-type local anaesthetics or any of the other ingredients of this medicine (listed in section 6) - if you have serious problems with cardiac conduction, - if you suffer from severe anaemia, - if you have a decompensated cardiac insufficiency, - if you have cardiogenic and hypovolemic shock, - if you suffer from congenital or acquired methemoglobinemia - if you have general or specific contraindications for the technique of subarachnoid anaesthesia

2 Page 2 You must not be given Prilotekal in a blood vessel. Prilotekal must not be used in children younger than 6 months. Warnings and precautions If you suffer of any of these, you should discuss it with your doctor before being given this medicine. - if you have ever had a bad reaction to an anaesthetic in the past - if you have a skin infection at or near the proposed site of the injection - if you are suffering from any of the following: - diseases of the central nervous system such as meningitis, polio and problems with your spinal cord due to anaemia - a severe headache - brain, spine or any other tumours - tuberculosis of the spine - recent trauma to your spine - very low blood pressure or low blood volume - problems with clotting of your blood - acute porphyria - fluid in your lungs - septicaemia (blood poisoning) - if you have a heart condition (e.g. total or partial heart block, cardiac decompensation, arrhythmia) - if you have any liver or kidney problems - if you suffer from neurological disorder, such as multiple scleroris, hemiplegia, paraplegia or neuromuscular disorders - if you are in reduced general condition. Spinal anaesthesia must only be administered by a doctor with the necessary knowledge and experience. The doctor in charge is responsible for taking the measures needed to avoid injection in a blood vessel and to know how to recognize and treat undesirable effects. Children and adolescents Prilotekal is not recommended for the use in children and adolescents. The safety and efficacy of Prilotekal in paediatric population have not been established. No data are available. The use of Prilotekal in children younger than 6 months is contraindicated due to a higher risk of of developing methemoglobinemia. Other medicines and Prilotekal Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular if you are taking any medicines for an irregular heartbeat (class III antiarrhythmics agents) and for pain relief. 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 who will decide whether or not you should be given prilocaine injection. Prilocaine should not be a administered for local or regional anaesthesia during childbirth. It is not known whether prilocaine passes into breast milk. Breast-feeding can be resumed approximately 24 hours after treatment.

3 Page 3 Driving and using machines Do not drive and do not use any tools or machines as Prilotekal may temporarily interfere with your reactions and muscular coordination. Prilotekal contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose (maximum dose equal to 4 ml of Prilotekal solution for injection), so it is essentially sodium-free. 3. How to use Prilotekal This medicine will be given to you by your doctor who will decide what dose is right for you. The usual dose in adults is mg of prilocaine hydrochloride (2-3 ml of Prilotekal); the maximal dose is 80 mg of prilocaine hydrochloride (4 ml of Prilotekal). The doctor will give you Prilotekal into the lower part of your spine while you are in a seated position or lying down. Prilocaine hydrochloride hyperbar is not recommended for the use in children and adolescents. The safety and efficacy of Prilotekal in paediatric population have not been established. The use of Prilotekal in children younger than 6 months is contraindicated due to a higher risk of developing methemoglobinemia. For patients in a compromised general condition and with established concomitant disorders (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy and compromised liver and kidney function), a reduced dose is indicated. In the case of compromised liver or kidney function a lower dosage range is recommended. Prilocaine hydrochloride hyperbar is injected via spinal route. Equipment, drugs and personnel capable of dealing with an emergency, must be immediately available. Rare cases of severe reactions have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient s case history. If you have been given too much Prilotekal The doctor giving you Prilotekal will be experienced in the use of spinal local anaesthetics, so it is unlikely that you will be given an overdose. However, if the dose is accidently injected directly in to blood, you may develop problems for a short time with your sight or hearing, twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness. Whenever you are given Prilotekal, equipment will be available to care for you if an overdose happens. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Prilotekal can cause side effects, although not everybody gets them. As with all local anaesthetics, a drop in arterial pressure may occur and cardiac frequency may decrease. You may feel sick, have lowered blood pressure or a slow heart beat. Other possible effects are headache after surgery, vomiting and difficulty in passing urine.

4 Page 4 These are the possible side effects: Very common: may affect more than 1 in 10 people Lowered blood pressure, feeling sick (nausea) Common: may affect up to 1 in 10 people Paresthesia, dizziness, vomiting Uncommon: may affect up to 1 in 100 people Convulsions, circumoral paresthesia, loss of consciousness, shaking, feeling of numbness affecting the tongue, speech problems, hearing problems, tinnitus, visual problems, back pain, temporary muscle weakness. Slow heart beat, elevated blood pressure. Rare: may affect up to 1 in 1,000 people Methemoglobinemia, cyanosis. Anaphylactic shock, anaphylactic reactions, allergic reactions, itching. Arachnoiditis, neuropathy, lesions of peripheral nerves. Diplopia. Cardiac arrest, irregular heartbeat. Respiratory depression. Prilotekal solution for injection is unlikely to cause serious side effects unless it is accidentally injected in the wrong way or used together with other local anaesthetics. If this happens, numbness of the tongue, lightheadedness, dizziness, shakiness and fits may occur. In extremely rare cases, prilocaine has been associated with heart attack, breathing difficulties, loss of feeling in your lower body and allergic reactions, which may cause rashes, swelling or very low blood pressure. A rare, but serious undesiderable effects of spinal anaesthesia is a high or total spinal block, with consequent cardiovascular and respiratory depression. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Prilotekal Keep out of the reach and sight of children. Do not use Prilotekal after the expiry date which is stated on the ampoules and the outer carton. The expiry date refers to the last day of that month. Do not store Prilotekal above 25 C. Do not refrigerate. Store in original package in order to protect from light. Use immediately after first opening. Do not use Prilotekal if you notice that the solution is not clear and free from particles. Any remaining product must be disposed of. As it is limited to hospital use the waste drug elimination is carried out directly by the hospital. These measures will help to protect the environment. 6. Contents of the pack and other information What Prilotekal contains The active substance is prilocaine hydrochloride. 1 ml of solution for injection contains 20 mg of prilocaine hydrochloride (equivalent to 2%). 1 ampoule with 5 ml solution, contains 100 mg of prilocaine hydrochloride.

5 Page 5 The other ingredients are: Glucose anhydrous Sodium hydroxide 1N (for ph adjustment) Water for injection What Prilotekal looks like and contents of the pack Solution for injection. Clear, colourless solution. Prilotekal comes in Type I clear colourless glass ampoules. Box of 10 ampoules each containing 5 ml of solution for injection. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sintetica Limited 30th Floor 40 Bank Street Canary Wharf London E14 5NR United Kingdom Manufacturer Sirton Pharmaceuticals SpA Piazza XX Settembre, 2 Villa Guardia (CO) Italy This medicinal product is authorised in the Member States of the EEA under the following names Member State Austria Product Name Takipril hyperbar 2% Injektionslösung Germany Takipril Italy Spain United Kingdom Prilotekal Takipril hiperbárica 20mg/ml solución inyectable Prilotekal 20mg/ml solution for injection

6 Page 6 Member State Product Name Belgium Bulgaria Tachipri Hyperbar 20 mg/ml Oplossing voor injectie Tachipri Hyperbar 20 mg/ml Solution injectable Tachipri Hyperbar 20mg/ml Injektionslösung Takipril 20mg/ml Инжекционен разтвор Czech Republic Takiprin 20mg/ml Injekční roztok Denmark Takipril 20mg/ml Injektionsvæske, opløsning Finland Takipril 20mg/ml Injektioneste, liuos France Baritekal 20mg/ml Solution injectable Hungary Luxemburg Prilotekal 20mg/ml oldatos injekció Tachipri Hyperbar 20 mg/ml Solution injectable The Netherlands Prilotekal 20mg/ml Oplossing voor injectie Norway Takipril 20 mg/ml injeksjonsvæske, oppløsning Poland Prilotekal Romania Prilotekal 20mg/ml Soluţie injectabilă Slovakia Prilotekal 20mg/ml Injekčný roztok Sweden Takipril 20mg/ml Injektionsvätska, lösning This leaflet was last revised in February 2017