INZITAN. Quantitative composition The active substances are: dexamethasone, lidocaine (hydrochloride), thiamine (hydrochloride) and cyanocobalamin.

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1 Read all of this leaflet carefully before you start taking this medicine - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What is Inzitan and what it is used for 2. Before you take Inzitan 3. How to take Inzitan 4. Possible side effects 5. Storing Inzitan INZITAN Quantitative composition The active substances are: dexamethasone, lidocaine (hydrochloride), thiamine (hydrochloride) and cyanocobalamin. Each ampoule contains: Dexamethasone... 4 mg Lidocaine (hydrochloride) mg Thiamine (hydrochloride) mg Cyanocobalamin micrograms The other ingredients (excipients) are: polysorbate 80, sodium hydroxide and water for injection. Holder and manufacturer: Kern Pharma, S.L. Venus, 72 - Pol. Ind. Colón II Terrassa - Barcelona Spain 1. What is INZITAN and what it is used for Inzitan is a solution for injection packed in 2 ml ampoules. Each pack contains 6 ampoules. Inzitan belongs to the anti-inflammatory and anti-rheumatic group associated with corticoids. Dexamethasone is a corticosuprarrenal hormone with anti-inflammatory activity and little mineralcorticoid effect.

2 Vitamin B 1 (thiamine) is involved in the glucidic metabolism in the energy process generation. Vitamin B 12 (cyanocobalamin) is involved in the synthesis of nucleic acid. Therefore it is essential for cell replication and myelination of nerve fibre sheaths. Lidocaine, as local anaesthetic, allows for a nearly painless injection. Inzitan is indicated for pain relief due to lumbago, sciatica, lumbalgosciatica, neuritis and polyneuritis. 2. Before you use INZITAN Do not use Inzitan : - History of allergies to corticoids or to any of the components. - If you are allergic to amide local anaesthetic (articaine, mepivacaine, prilocaine). - If you are allergic to cobalt or have hereditary atrophy of the optic nerve (Leber disease). - If you have an important infection (tuberculosis, herpes, chickenpox, systemic fungus). - If you have recently received a vaccine with live virus. Take special care with Inzitan : - If hypersensitivity reactions are observed, the treatment must be interrupted. - In case of symptoms of acute infectious diseases, digestive or psychic alterations. - In case of renal or hepatic insufficiency, hyperlipidaemia, hypothyroidism, glaucoma, Cushing s disease, gout, polycythaemia and diabetes. - In the event you suffer gastriduodenal ulcer, osteoporosis, serious hypertension, serious myasthenia gravis, congestive cardiac disease, epilepsy, porphyria. - During the treatment in the elderly (over 70 years), because of osteoporosis, liquid retention and increase of arterial tension. - Do not use for the treatment of chronic pain (only in acute attacks for a maximum of 12 days). - The injection in infected or inflamed areas should be avoided. Pregnancy Ask your doctor or pharmacist for advice before taking any medicine. Studies in animals have shown the appearance of congenital malformations with the use of corticosteroids. Therefore its administration is not recommended during pregnancy. Breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Breast-feeding is not recommended for mothers treated with corticosteroids, as this medicine is excreted in human milk.

3 Driving and using machines: It is not likely that Inzitan will have an effect on the ability to drive or use dangerous machinery. However, during treatment, blurred vision or neurological effects may present, which could reduce response capacity. Use in athletes: Athletes are informed that this medication contains components which may lead to a positive analytical result in a drug test. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. The principal interactions are: - Changes in response to anticoagulants and anti-diabetics. - Decrease in the therapeutic action of Inzitan by barbiturates (phenobarbital), phenytoin, carbamazepine, rifampicin, ephedrine, antacids. - Decrease in the therapeutic action of salicylates and albendazole. - Cardiac glycosides may cause a decrease in potassium levels and an increase in cardiac toxicity. - Thiazide diuretics may lead to hypokalaemia. - Decreased responsiveness to vaccines. - The concomitant administration of non-steroidal anti-inflammatory drugs and alcohol may increase the severity of gastroduodenal ulcers. - The intramuscular injection of lidocaine may alter acute myocardial infarction diagnostic tests. 3. How to use INZITAN Follow these instructions unless otherwise instructed by your doctor. Remember to use your medication. If you think that the action of the Inzitan is too strong or weak, please tell your doctor or pharmacist. Inzitan must be administered intramuscularly, one ampoule daily. In order to avoid a possible local irritation, it should be injected very slowly, in aseptic conditions. If the injection has to be repeated, it is recommended to change the site of injection. Your doctor will indicate the duration of the treatment with Inzitan. Do not stop the treatment before, as your condition would deteriorate.

4 The usual treatment lasts 6 days (one ampoule daily). If it is needed, one ampoule on alternate days could be administered over a maximum of 12 days. This treatment cannot be repeated before 6 months have elapsed. If you use more Inzitan than you should: If you use more Inzitan than you should, immediately notify your doctor or pharmacist. The symptoms of intoxication associated with large doses of Inzitan are anxiety, depression, mental confusion, spasms, gastrointestinal bleeding, hyperglycaemia, hypertension and oedema. If allergic reactions appear they must be treated with adrenaline (epinephrine), artificial respiration y aminophylline. There is no specific antidote. Symptomatic and support treatment includes oxygen therapy, maintaining body temperature, adequate fluid intake, and monitoring of electrolytes in serum and urine, with special attention to sodium and potassium balance. Gastrointestinal bleeding symptoms should be treated in a similar way to a peptic ulcer. If you forget to take Inzitan : Do not take a double dose to make up for a forgotten dose. Take your dose as soon as you remember and continue the treatment as before. 4. Possible side effects Like all medications, Inzitan can cause side effects. The following side effects have been reported as being more common with high doses and in prolonged treatments: Common (less than 1 in 10, but more than 1 in 100 patients): General: Digestive system: Metabolism and nutrition disorders: Blood and lymphatic system: Allergic reactions (hives, exanthema), pain at the injection site. With high doses: gastric ulcers, intermittent diarrhoea. Hyperglycaemia, increase in appetite. With prolonged treatments: adrenal hormone deficit. With high doses: signs of adrenal hyperactivity (excessive production of corticosteroid hormones by the adrenal glands) with acneiform eruptions. Delay in the healing of wounds, susceptibility to infections (oropharyngeal candidiasis).

5 Nervous System: Musculoskeletal system: Skin and subcutaneous tissue: With high doses: hot flushes. Excitation, agitation, dizziness, ringing in the ears, nausea, vomiting, tremors and convulsions. Osteoporosis (mainly in post-menopausal women and in men over 70), bone fragility and necrosis (in particular, femoral and humeral head necrosis, more common in people under 50). With high doses: excessive hair growth, hyperpigmentation of the skin, scleroderma. Uncommon (less than 1 in 100 but more than 1 in 1,000 patients): Cardiovascular system: Metabolism and nutrition disorders: Blood and lymphatic system: Respiratory system: Musculoskeletal system: Nervous system: Skin and subcutaneous tissue: Urogenital system: Oedema, hypertension, heart failure, intracranial hypertension Low potassium levels in the blood, acute pancreatitis Thromboembolism, anaphylactic shock Pulmonary oedema Muscle weakness Neurological disorders Sweating Amenorrhoea Not known (frequency cannot be estimated from the available data): General: Hiccup If you notice any other side effect not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store INZITAN Store protected from moisture and not above 25ºC. Keep Inzitan out of the reach and sight of children. Do not use Inzitan if you notice that the solution is not transparent, is cloudy or has precipitates. Expiration Do not use Inzitan after the expiry date which is stated on the container.