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What you need to know before you use Depo-Medrone with Lidocaine

Do not use Depo-Medrone with Lidocaine: • If you think you have ever suffered an allergic reaction, or any other type of reaction after being given Depo-Medrone with Lidocaine, or any other medicine containing a corticosteroid or local anaesthetic or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath. • If you get a rash, or another symptom of an infection. • If you have recently had, or are about to have any vaccination. • In premature babies or neonates. See your doctor immediately if any of the above applies to you. Do not inject this medicine: • into the Achilles tendon (which is located behind the ankle joint) • directly into a vein (intravenous), the spinal cord (intrathecal), into the nostrils (intranasal), in the eye (intraocular). Warnings and precautions Talk to your doctor or nurse before taking Depo-Medrone with Lidocaine if you have any of the following conditions. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine. • Acute adrenal insufficiency (when your body cannot produce enough corticosteroid due to problems with your adrenal glands). • Acute pancreatitis (inflammation of the pancreas). • Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them. • Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Depo-Medrone with Lidocaine, or having a family history of these illnesses. • Cushing’s disease (condition caused by an excess of cortisol hormone in your body). • Diabetes (or if there is a family history of diabetes). • Epilepsy, fits or seizures. • Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma. • Contact your doctor if you experience blurred vision or other visual disturbances. • You have recently suffered a heart attack. • Heart problems, including heart failure or infections. • Hypertension (high blood pressure). • Hypotension (low blood pressure). • Hypothyroidism (an under-active thyroid). • Joint infection – which is active and so requires treatment. • Kidney or liver disease. • Scleroderma (also known as systemic sclerosis, an autoimmune disorder), because the risk of a serious complication called scleroderma renal crisis may be increased. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. • Muscle problems (pain or weakness) have happened while taking steroid medicines in the past. • Myasthenia gravis (a condition causing tired and weak muscles). • If you have recently had an operation. Page 3 of 12 • Osteoporosis (brittle bones). • Peritonitis (Inflammation of the thin lining (peritoneum) around the gut and stomach). • Pheochromocytoma (a rare tumour of adrenal gland tissue. The adrenal glands are located above the kidneys). • Skin abscess or other disorders of the skin. • Stomach ulcer or other serious stomach or intestinal problems (ulcerative colitis). • Unusual stress. • Thrombophlebitis – vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins). • Tuberculosis (TB) or if you have suffered tuberculosis in the past. • Traumatic brain injury You must tell your doctor before you take this medicine if you have any of the conditions listed above. Other medicines and Depo-Medrone with Lidocaine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should tell your doctor if you are taking any of the following medicines which can affect the way Depo-Medrone with Lidocaine or the other medicine works: • Acetazolamide – used to treat glaucoma and epilepsy. • Aminoglutethimide and cyclophosphamide – used for treating cancer. • Antibacterials (such as isoniazid, erythromycin, clarithromycin and troleandomycin). • Antivirals (such as ritonavir, indinavir) and pharmacokinetic enhancers (such as cobicistat) used to treat HIV infections. • Anticoagulants – used to ‘thin’ the blood such as acenocoumarol, phenindione and warfarin. • Anticholinesterases – used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine. • Antidiabetics – medicines used to treat high blood sugar. • Antiemetics (such as aprepitant and fosaprepitant). • Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain. • Barbiturates, carbamazepine, phenytoin and primidone – used to treat epilepsy. • Carbenoxolone – used for heartburn and acid indigestion. • Ciclosporin – used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant. • Digoxin – used for heart failure and/or an irregular heartbeat. • Diltiazem – used for heart problems or high blood pressure. • Ethinylestradiol and norethindrone – oral contraceptives. • Indinavir and ritonavir – used to treat HIV infections. • Ketoconazole or itraconazole – used to treat fungal infections. • Pancuronium and vecuronium – or other medicines called neuromuscular blocking agents which are used in some surgical procedures. • Potassium depleting agents – such as diuretics (sometimes called water tablets), amphotericin B, xanthenes or beta2 agonists (e.g. medicines used to treat asthma). • Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB). • Tacrolimus – used following an organ transplant to prevent rejection of the organ. Page 4 of 12 • Vaccines – tell your doctor or nurse if you have recently had, or are about to have any vaccination. You must not have ‘live’ vaccines while using this medicine. Other vaccines may be less effective. If you are taking long term medication(s) If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions. Before you have any operation, tell your doctor, dentist or anaesthetist that you are taking this medicine. If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Depo-Medrone with Lidocaine. This medicine can affect the results of some tests. Depo-Medrone with Lidocaine with drink Do not drink grapefruit juice while taking this medicine. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as this medicine could slow the baby’s growth. There is a risk associated with low birth weight of the baby; this risk can be reduced by administering a lower dose of the medicine. Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy. Depo-Medrone with Lidocaine contains benzyl alcohol (see section 2 Depo-Medrone with Lidocaine contains benzyl alcohol and sodium). If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine, since lidocaine as well as small amounts of corticosteroid medicines are excreted into breast milk. If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine. Depo-Medrone with Lidocaine contains benzyl alcohol (see section 2 Depo-Medrone with Lidocaine contains benzyl alcohol and sodium). Driving and using machines Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids. If you are affected do not drive or operate machinery. Depo-Medrone with Lidocaine contains benzyl alcohol and sodium. Depo-Medrone with Lidocaine contains 8.7 mg and 17.4 mg of benzyl alcohol in each 1 ml and 2 ml of solution respectively, which is equivalent to 8.7 mg/ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not use medicines containing benzyl alcohol in newborn babies (up to 4 weeks old), and do not use these medicines for more than a week in young children (less than 3 years old), unless advised by the doctor. Ask your doctor or pharmacist for advice if you have a liver or kidney disease, or if you are pregnant or breast‑feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects such as an increased amount of acid in your blood (called “metabolic acidosis”). Page 5 of 12 Depo-Medrone with Lidocaine contains less than 1 mmol sodium (23 mg) in each vial, that is to say essentially ‘sodium-free’.