Package leaflet: Information for the User. ByMycin 50mg, 100mg Capsules Doxycycline (as hyclate)

Transcription

1 Package leaflet: Information for the User ByMycin 50mg, 100mg Capsules Doxycycline (as hyclate) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any of the 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 By-Mycin capsules are and what they are used for 2. What you need to know before you take By-Mycin Capsules 3. How to take By-Mycin Capsules 4. Possible side effects 5. How to store By-Mycin Capsules 6. Contents of the pack and other information 1. WHAT BYMYCIN CAPSULES ARE AND WHAT ARE THEY USED FOR The name of your medicine is ByMycin and the active substance is doxycycline present as doxycycline hyclate. It is available in two strengths: 50mg and 100mg capsules. By-Mycin Capsules is a tetracycline antibiotic which may be used to treat infections due to gram positive and gram negative bacteria sensitive to this medicine. Infection treated by ByMycin include, Respiratory tract infections: Pneumonia and other lower respiratory tract infections e.g. bronchitis, sinusitis Urinary Tract Infections: Urethritis (inflammation of the urethra, causes pain, difficult when urinating) and other complicated urinary tract infections Sexually Transmitted Diseases and their infections: Chlamydial infections (Chlamydia trachomatis), gonorrhoea and syphilis infections (Calymmatobacterium granulomatis infections) Dermatological infections: common acne, scaly red skin with black or white heads (acne vulgaris) and uncommon acne, a sever form of the acne vulgaris symptoms (acne conglobata) Ophthalmic infections: Trachoma (an overall eye infection), an inflammation of the membrane that lines the eyelids and covers the white part, or sclera, of the eyeball (inclusion conjunctivitis) By-Mycin is indicated for prophylaxis (prevention) in the following conditions:

2 Scrub typhus travellers' diarrhoea (enterotoxigenic Escherichia coli) Weil's disease (leptospirosis), malaria and cholera By-Mycin is also an alternative drug in the treatment of Weil's disease (leptosporosis), gas gangrene and tetanus and rickettsial infections Rickettsial infections: fevers associated with louse or tick bites eg Rocky Mountain spotted fever, typhus group, Q fever and Coxiella endocarditis and Infections due to susceptible strains of Bacteroides species such as, Listeria and antrax. Other unusual infections treated with ByMycin: Psittocosis (infection caused by bird mainly parrots, parakeets, and budgerigars droppings), Brucellosis (infection caused by contact with already infected animals or animal products, treated by ByMycin in combination with streptomycin), Cholera (infection caused by drinking contaminated water, causes painless diarrhoea leading to dehydration), Bubonic plague (infection caused by rat flea bites), Louse (LRF) and Tick (TRF) -borne relapsing fever, these infections are spread by bites from body-lice, ticks and mosquitoes and including stage 1 Lyme disease, leptospirosis (Weil's disease), tularaemia glanders, chloroquine-resistant falciparum malaria and acute intestinal amoebiasis (treated with ByMycin as an addition to amoebicides). Your doctor will explain the unusual infections listed above, where they occur and symptoms if they are relevant to you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BY-MYCIN CAPSULES Do not take By-Mycin Capsules; - If you are allergic (hypersensitive ) to doxycycline or any of the tetracyclines or any of the ingredients (listed in section 6 )of By-Mycin Capsules. - If you are pregnant, may become pregnant or are breast-feeding - if you suffer from a condition where you have difficulty in swallowing food). - If you are under 12 years of age. Children Use of tetracyclines antibiotics during tooth development (pregnancy, infancy and in children up to 12 years) may cause permanent tooth discolouration. Take special care with By-Mycin Capsules: You should tell your doctor before you take By-Mycin capsules id any of the following apply to you: You are likely to be exposed to strong sunlight or UV light (e.g sun-bed). You should avoid exposure to strong sunlight while taking this medicine as your skin may be more sensitive to sun burn than normal. You have kidney or liver problems, You are suspected of having syphilis; your doctor will continue to monitor you after your treatment has stopped. You have suffered from diarrhoea previously when taking antibiotic drugs You suffer from reflux. By-Mycin may make your condition worse and may not be a suitable medicine for you

3 If you have difficulties when swallowing or feel discomfort in your throat or stomach after taking By-Mycin tell your doctor immediately. Your doctor may advise you to stop taking By-Mycin. Other medicines and By-Mycin capsules: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. - Any other antibiotics such as penicillin, since bacteriostatic drugs (such as By- Mycin) may interfere with the bactericidal action of penicillin, it is advisable to avoid giving doxycycline in conjunction with penicillin. - Any Tetracyclines (like By-Mycin) may prolong the action of coumarin anticoagulants (like Warfarin) and per se delay coagulation (the length of time for your blood will take to congeal) - Antacids and calcium or iron preparation, as they may affect absorption of By-Mycin from your stomach. - Barbiturates and medicines used in epilepsy, Concurrent use of barbiturates, phenytoin or carbamazepine may decrease plasma levels of doxycycline (reducing its antibacterial activity) - Medicines that you have bought for yourself without prescription. Warings and precautions Having a dental operation, if you are undergoing a general anaesthetic for an operation of dental surgery you must tell your anaesthetist or dentist that you are taking By-Mycin as you may have more side-effects. Laboratory Tests By-Mycin may interfere with some tests, tell your doctor if you need to give samples for laboratory assessment. Concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal (kidney) toxicity. Taking By-Mycin with food and drink: Studies indicate that the absorption of By-Mycin is not affected when taken with food or drink. If By-Mycin upsets your stomach than taking it with food or milk is recommended. Pregnancy, breast- feeding and fertility: By-Mycin capsules must not be used if you are pregnant may become pregnant, or you are breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines: Patients on By-Mycin should not drive or operate machinery unless By-Mycin has been shown not to affect their physical ability.

4 By-Mycin capsules contains sucrose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE BY-MYCIN Always take By-Mycin Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual doses for different infections are listed below. Usual dosage for respiratory tract Infections: 200mg on the first day then mg daily usually for 7-10 days; the duration of treatment will be specified by your doctor and on the label of your medicine. Please follow these instructions fully. Acne: 50mg daily for a minimum of 6 weeks. Gonorrhoea (men):100mg twice a day for 7 days, (together with IM ceftriaxone). Gonorrhoea (women):100mg twice a day for 10 days, together with IM ceftriaxone). Uncomplicated Infections caused by Chlamydia trachomatis: 100mg twice a day for 10 days. Syphilis: 200mg twice daily for two weeks. Treatment of Malaria: 200mg daily for at least 7 days (in conjunction with quinine.) Prevention of Malaria: 100mg daily in adults. Take by-mycin Capsules 1-2 days before travelling to the infected area, continuously during travelling and for 4 weeks after leaving the infected area. Treatment and prevention of Cholera: 300mg as a single dose for adults. Prevention of travellers Diarrhoea: For adults, 200mg on the first day of travel followed by 100mg daily throughout the stay in the area. Stage 1 Lyme disease: 100mg twice daily for days, according to the severity of the disease. Treatment of infections caused by Leptospira (infections from contaminated water): 100mg twice daily for 7 days. Prevention of infections caused by Leptospira (infections from contaminated water): 200mg once a week through the stay in the infected area and 20mg at the completion of the trip. Fevers caused by lice or ticks: 100mg or 200mg once only. Use in children (under the age of 12 years) Since By-Mycin may cause staining of developing teeth (in younger children), this product should not be administered to children under the age of 12 years unless your doctor considers it absolutely necessary. Method of administration Your capsules should be taken with a full glass of cold fluid in a sitting or standing position in the morning if possible, but if not, at least before 1 hour before going to bed.

5 It is important not to lie down for fifteen to thirty minutes after taking By-Mycin capsules so that the capsules can move as swiftly as possible to the stomach and prevent irritation of the throat or oesophagus (canal taking food from the mouth to the stomach). If your stomach is upset By-Mycin Capsules can be taken with milk or a meal. If you take more By-Mycin capsules than you should: It is important not to take too many capsules. Contact your nearest hospital causality department or a doctor for advice if you have swallowed too many capsules or if you think a child has swallowed any. Take this leaflet, and any capsules that you still have, to show the doctor. If you forget to take By-Mycin Capsules: If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. If it is almost time to take your next dose, wait until then and then carry on as before. If you stop taking By-Mycin Keep taking your capsules for as long as your doctor tells you. Do not stop just because you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFECTS Like all medicines, this medicine can have side effects, although not everybody gets them. Tell your doctor immediately if you experience the any of the following symptoms of an allergic reaction after taking this medicine. Although they are very rare the symptoms can be severe: Sudden wheeziness, difficulty breathing, tightness in chest, fever, swelling of eyelids, face or lips rash or itching (especially the whole body). Upset stomach, loss of appetite, persistent bloody diarrhoea (this may occur up to two or three months after the last dose and may be associated with stomach pain or fever). This may occur after treatment with antibiotics and can be a sign of bowel inflammation. If any of the side effects listed below occur, contact your doctor as soon as possible. Skin that is more sensitive to sunlight than normal. You may get a skin rash, itching, redness or severe sunburn. Inflammation and/ or ulcers of the gut The side effects listed below may go away during treatment, if they continue to bother you or are sever contact your doctor as soon as possible:

6 Gastrointestinal issues such as burning sensation in the stomach, nausea, vomiting, diarrhoea blood disorders increased heart rate aches in the joints or muscles ringing or bussing in your ear The following side effects have also been reported: bulging fontanelles (soft spot on head) of infants pericarditis ( inflammation) affecting the heart discolouration of teeth when given for a long period of time loosening of the nail from the nail bed after exposure to the sun increased levels of urea in the blood inflammation and damage of the liver, yellow skin and eyeas (jaundice), inflammation of the pancreas and abnormal liver function tests Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. IRELAND: FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland. Tel: , Fax: , Website: [email protected] 5. HOW TO STORE BY-MYCIN CAPSULES Keep out of the sight and reach of children. Do not store above 25 C Do not use after expiry date stated on the carton and on the blister. The expiry refers to the last day of the month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer Use. These measures will help to protect the environment. 6. FURTHER INFORMATION What By-Mycin contains: By-Mycin 50mg capsules: The active substance is doxycycline and each capsule contains 50mg as doxycycline hyclate. The other ingredients are sucrose, maize starch, crospovidone, Eudragit E100, talc. The capsule shells contain gelatine, titanium dioxide (171), indigocarmine (E132),quinoline yellow (E104). By-Mycin 100mg capsules: The active substance is doxycycline and each capsule contains 100mg as doxycycline hyclate. The other ingredients are sucrose, maize starch,

7 crospovidone, Eudragit E100, talc. The capsule shells contain gelatin, titanium dioxide (E171), indigocarmine (E132), erthyrosine (E127). What By-Mycin looks like and the contents of the pack By-Mycin 50mg Capsules have opaque pale green and opaque white bodies. By-Mycin 100mg Capsules have opaque dark blue caps and opaque white bodies. By-Mycin Capsules are available in packs of: 2 or 28 capsules for 50mg strength 2 or 28 capsules for 100mg strength Not all pack sizes are marketed Marketing Authorisation Holder and manufacturer Marketing Authorisation Holder: Manufacturer responsible for batch release: Fannin Ltd. Toll manufacturing Services SL., South County Business Park, C/ Aragoneses 2, Leopardstown, Alcobendas, Dublin 18. Madrid, Spain. Date of preparation: December 2013