PRODUCT LEAFLET: USER INFORMATION HYDROCORTISONE ERFA 20 MG TABLETS. Hydrocortisone

Transcription

1 PRODUCT LEAFLET: USER INFORMATION HYDROCORTISONE ERFA 20 MG TABLETS Hydrocortisone Read this leaflet carefully before you start taking this medicine; it contains important information. - Keep this leaflet. You may need to read it again. - If you have other questions, contact your doctor or pharmacist. - This medicine has been prescribed for you only. Do not let other people take it. It could be harmful for them, even if the symptoms of their illness are identical to yours. - If you suffer any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Contents of this leaflet: 1. What are Hydrocortisone Erfa 20 mg tablets and what are they used for? 2. Information you need to know before taking Hydrocortisone Erfa 20 mg tablets. 3. How to take Hydrocortisone Erfa 20 mg tablets. 4. Possible side effects. 5. How to store Hydrocortisone Erfa 20 mg tablets. 6. Content of the packaging and other information. 1. WHAT ARE HYDROCORTISONE ERFA 20 MG TABLETS AND WHAT ARE THEY USED FOR? Physiological glucocorticoid hormone. This medicine is used as a maintenance treatment to make up for an insufficiency in natural secretion of hydrocortisone by the adrenal glands. 2. INFORMATION YOU NEED TO KNOW BEFORE TAKING HYDROCORTISONE ERFA 20 MG TABLETS Never take Hydrocortisone Erfa: If you are allergic to hydrocortisone or one of the other ingredients contained in this medicine (mentioned in section 6). There are no contra-indications in the case of natural insufficiency treatment. Warnings and precautions Contact your doctor or pharmacist before using Hydrocortisone Erfa 20 mg tablets. Never abruptly stop your treatment without first consulting a doctor. Inform your doctor immediately of any unusual stressing agent, in particular fever, illness, surgical procedure, significant stress or heat, because it may be necessary in such cases to temporarily increase the doses of this medicine. In case of diabetes: you must inform your doctor. In case of vaccination: it is imperative that you inform the doctor of your hydrocortisone treatment. If you practice a sport: this medicine may produce a positive reaction in anti-doping tests. For your information: it is not necessary to modify the salt content of your normal diet. Children Not applicable. 1

2 Other medicines and Hydrocortisone Erfa Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicine. The following combinations may cause problems in the case of too high doses: Inadvisable combinations: Erythromycin I.V. (antibiotic), sultopride (neuroleptic), vincamine (medicine for vascular disorders), due to the risk of wave burst arrhythmia (very fast heart-beat that halts spontaneously). Combinations requiring precautionary measures: - Bepridil, bretylium, disopyramide, sotalol, amiodarone (antiarrhythmics) which cause wave burst arrhythmia. - Digitalis (a medicine for heart disorders), because a low level of potassium in the blood (hypokalemia) caused by hydrocortisone can enhance the toxic effects of digitalins. - Other hypokalemics because an increased risk of hypokalemia may occur following an additive effect. Monitoring by your doctor is necessary in order to check the level of potassium in the blood, to possibly carry out an ECG and, if necessary, a correction of the hypokalemic state. - Acetylsalicylic acid (pain relief and anti-pyretic): o This medicine decreases the concentration of acetylsalicylic acid in the blood. An adjustment of the dose is necessary during combined intake of this medicine and after the treatment. - Oral and heparin anti-coagulants (parenteral route): o Aggravation of the risk of bleeding specific to corticosteroid therapy (digestive mucosa, vascular fragility), at high doses or during prolonged treatment lasting more than 10 days. If taken with other medicines, medical monitoring is necessary. - Insulin (anti-diabetic), metformin (anti-diabetic), sulpha-based hypoglycaemic: o The rise in glycaemia sometimes with ketosis (a decrease in tolerance of sugars due to the corticoids) is possible and you must pay extra attention to monitoring your blood and urine. o It is possible that your doctor may adapt the dose of anti-diabetics during treatment with this medicine and after treatment has finished. - Phenobarbital, phenytoin and primidone (anti-epileptics), rifampicin (anti-bacterial, anti-tubercolotic) (enzyme-inducing agents): o A decrease in the efficacy of this medicine is possible. Your doctor will monitor your clinical and biological signs. He or she may adapt the dose of this medicine during combination with and enzyme-inducing agent and once its use is halted. Combinations to be monitored: - Anti-hypertensive drugs, because a decrease in the anti-hypertensive effect is possible. 2

3 - Alpha interferon (immunosuppressive drug), because a risk of interferon action inhibition may occur. - Live attenuated vaccines, because a risk of generalised and possibly mortal illness may occur. This risk is aggravated in patients who are already immuno-depressed by the underlying illness. Hydrocortisone Erfa interactions with food Swallow the tablets with a small amount of water during meals. Pregnancy and breast-feeding If you are pregnant or breast-feeding, if you think that you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. You must imperatively inform your doctor if you are pregnant. Breast-feeding is highly inadvisable during the treatment. Driving and using machines Not applicable. Hydrocortisone Erfa contains lactose If your doctor has informed you that you are intolerant to certain sugars, contact him or her before taking this medicine. 3. HOW TO TAKE HYDROCORTISONE ERFA, 20 MG TABLETS Make sure that you always take this medicine exactly as you have been instructed by your doctor or pharmacist. Check with your doctor or pharmacist in case of doubt. If there is no improvement, please consult your doctor again. The recommended dose for adults is 1 tablet in the morning and ½ a tablet in the evening. Swallow the tablets with a small amount of water during meals. In certain cases, the doctor may deem that it is necessary to adapt this dose to the personal status of the patient. Never abruptly stop the treatment (see the "Warnings and precautions" section). Your doctor will instruct you on how long you must use Hydrocortisone Erfa. Do not stop taking your treatment prematurely. If you have used more Hydrocortisone Erfa than is recommended If you take too much of this medicine over a prolonged period, Cushing s syndrome (a syndrome caused by too much glucocorticoids in the body) may occur. If you have used or taken too much Hydrocortisone Erfa, immediately contact your doctor, your pharmacist or your local poison control centre. If you have forgotten to take Hydrocortisone Erfa It is important to take this medicine each day as prescribed. However, should you forget, take the forgotten dose as soon as possible; the following dose should be taken at the normal time. Do not take a double dose to compensate for the tablet that you have forgotten to take. If you stop taking Hydrocortisone Erfa Never abruptly stop the treatment (see the "Warnings and precautions" section). 3

4 Always consult your doctor if you are planning on stopping the treatment. If you have any other questions on the use of this medicine, ask your doctor or pharmacist for more information. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although they do not occur systematically in all patients. They are only observed in cases of overdose or in the case of prolonged treatment. The side effects are classified by system organ class with indication of frequency evaluation: Very frequent ( 1/10), frequent ( 1/100, < 1/10), not frequent ( 1/1000, < 1/100), rare ( 1/10000, < 1/1000), very rare (<1/10000), including isolated reports. Endocrinal disorders & metabolic and nutritional disorders: Iatrogenic Cushing s syndrome (a syndrome caused by too much glucocorticoids in the body), decrease in the tolerance of glucose (reversible), reversible diabetes in case of normalisation of doses, stunting of growth in children, irregular menstruation, fluid and electrolyte disorders, in particular potassium levels in the blood that are too low with a loss of acid in the body (hypokalaemia with alkalaemia), water and salt retention (sodium and water retention) with sometimes an increase in blood pressure (high blood pressure). Cardiac disorders: Congestive heart failure due to fluid and electrolyte disorders. Gastro-intestinal disorders: Peptic ulcers (possibly with bleeding or perforations). Very rare: acute inflammation of the pancreas. Skin and subcutaneous tissue disorders: Acne, abnormally excessive hair growth (hypertrichosis), haematoma (bruising), small blue haemorrhagic blotches (purpura), delayed healing. Musculoskeletal and systemic disorders: Muscular weakness and atrophy, loss of bone mass density (osteoporosis), pathological fractures, in particular vertebral collapse, aseptic necrosis of the femoral heads. If you suffer any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5 HOW TO STORE HYDROCORTISONE ERFA, 20 MG TABLETS Keep out of the reach and sight of children. Store at room temperature, between 15 and 25 C. Do not use this medicine after the expiry date featured on the packaging after the wording Do not use after or exp.. The expiry date refers to the last day of the month mentioned. Do not dispose of this medicine via sewer systems or in household waste. Ask your pharmacist to eliminate the medicine that you do not use. These measures will help to protect the environment. 4

5 6. CONTENT OF THE PACKAGING AND OTHER INFORMATION Composition of Hydrocortisone Erfa - The active ingredient is hydrocortisone. Each tablet contains 20 mg of hydrocortisone. - The other ingredients are: lactose, gelatin, potato starch, talc, magnesium stearate. Appearance of Hydrocortisone Erfa and content of the external packaging This medicine is a white, biconvex, round, breakable tablet available in boxes of 20 tablets in a type III brown glass bottle, sealed by a white low-density polyethylene cap. Marketing Authorisation Holder and manufacturer Marketing Authorisation Holder BePharBel Manufacturing S.A. Rue du Luxembourg 13 B-6180 Courcelles Belgium Manufacturer BePharBel Manufacturing S.A. Rue des Cultivateurs Brussels Belgium Marketing Authorisation Number: BE Mode of delivery Available on medical prescription. The most recent date on which this leaflet was revised was March The most recent date on which this leaflet was approved is: 5