DOXYCYCLINE CAPSULES 100MG
Active substance: DOXYCYCLINE HYCLATE
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Glue Area
Braille Translation: doxycycline capsules #100 mg
doxycycline capsules #100 mg
TOP VARNISH AREA
any side effects not listed in this leaflet, please tell your doctor or pharmacist.
BASE LABEL
PEEL HERE BUT DO NOT REMOVE
100 mg
Doxycycline capsules
8 capsules
PACKAGING LEAFLET: INFORMATION FOR THE USER
Each capsule contains: Doxycycline Hyclate Ph Eur equivalent to 100 mg Doxycycline. Dosage: For oral use as directed by a doctor. Read the enclosed leaflet. Keep out of the reach and sight of children. Keep well closed and store in a dry place below 25C.
PL 4569/0035 POM ITEM CODE LL0448AC Mylan, Potters Bar, Herts, EN6 1TL, U.K.
Leave Blank. Glue Area.
1 7, 8, 10, 14, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100 or 250 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturer Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
DOXYCYCLINE CAPSULES 100 mg
1212121
Read all of this leaflet carefully before you start taking this medicine. Keep this leaet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others.It may harm them, even if their symptoms are the same as yours If any side eect gets serious, or if you notice
LEAVE BLANK
LEAVE BLANK
In this leaflet: 1. What Doxycycline is and what it is used for. 2. Before you take Doxycycline. 3. How to take Doxycycline. 4. Possible side effects. 5. How to store Doxycycline. 6. Further information. 1. WHAT DOXYCYCLINE IS AND WHAT IT IS USED FOR
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Doxycycline belongs to the tetracycline group of antibiotics. Doxycycline can be used to treat 2 avoid strong sunlight or ultra violet light as Doxycycline can make the skin more sensitive. If your skin becomes red and patchy, tell your doctor as he may need to stop treatment if you are having tests, such as liver function tests or a urine test, tell your doctor you are taking Doxycycline. Taking other medicines - Please tell your doctor if you are taking any other medicines including medicines obtained without a prescription, herbal medicines or any of the following: anticoagulants to thin the blood e.g. Warfarin antacids, used for indigestion
a variety of infections including bacterial infections that affect the eyes, nose, throat and respiratory system (chest infections); skin infections (acne), sexually transmitted diseases and infections of the urinary tract; malaria and diseases spread by either lice, fleas, ticks (e.g. scrub typhus) or animals (e.g. leptospirosis); to prevent traveller's diarrhoea, scrub typhus, leptospirosis and malaria. 2. BEFORE YOU TAKE DOXYCYCLINE Do not take Doxycycline: if you are allergic (hypersensitive) to doxycycline, a similar medicine or any of the other ingredients of Doxycycline
6. FURTHER INFORMATION What Doxycycline contains - The active substance is doxycycline hyclate, equivalent to 100 mg of doxycycline. The other ingredients are magnesium stearate, talc, maize starch. The capsule shell is made of gelatin and contains colourings, patent blue (E131), titanium dioxide (E171) and iron oxides (E172). The printing ink contains shellac, titanium dioxide (E171), propylene glycol and either ammonium hydroxide and simeticone, or sodium hydroxide and povidone. Contents of the pack - Doxycycline is available in glass or plastic bottles or blister packs of 5,
if you are pregnant or breast-feeding if you are a child under 12 years old; as tetracyclines can aect growing bones and teeth causing staining and reduce the amount of enamel in the teeth. Take special care with Doxycycline: if you have liver disease or are taking medicine which can aect the liver if you suer from a rare disorder called porphyria if you suer from myasthenia gravis (a disease causing muscle weakness) if you have SLE (systemic lupus erythematosus) 4 5
5. HOW TO STORE DOXYCYCLINE Keep out of the reach and sight of children. Do not take Doxycycline after the expiry date which is stated on the label or carton after 'EXP'. The expiry date refers to the last day of that month. If in a bottle keep well closed. Store in a dry place, at a temperature below 25C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 18
3
This leaet was last approved in: 04/2011
19 20
Your blood tests may show: reduction in red blood cells which can make the skin pale or yellow and cause weakness or breathlessness reduction in white blood cells which can cause more infections e.g. colds than usual reduction in blood platelets which increase risk of bleeding or bruising a rise in blood urea a rise in liver function tests. If any side effect gets serious, or if you notice any side effects not mentioned in the leaflet, please tell your pharmacist or doctor. 17
Sucralfate to treat stomach or gut ulcers zinc sulphate barbiturates antiepileptics e.g. Carbamazepine, Phenytoin medicine containing iron penicillin antibiotic oral contraceptives: Doxycycline may reduce the effectiveness of the combined oral contraceptive pill. Additional contraceptive precautions should be taken as advised by your doctor Ciclosporin if you need an anaesthesic. Taking Doxycycline with food and drink - Do not drink alcohol during treatment.
Pregnancy and breast-feeding - Do not take Doxycycline if you are pregnant or plan to become pregnant, as it can affect the development of your unborn baby. Do not breast-feed if you are taking Doxycycline as it can pass into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines - Do not drive or use machines if you suffer from visual disturbances such as blurred vision while taking Doxycycline.
Doxycycline can also cause pain and diculty swallowing - this is less likely to happen if the capsules are taken with plenty of uid whilst sat upright (see 'section 3') soreness, itchiness and a fungal infection (candida) in the genital or anal area bulging fontanelle (soft spot on head) of babies pericarditis (inammation of the membrane around the heart) ringing in the ears rarely, liver problems which can cause yellowing of skin and whites of eyes, dark urine, pale stools inammation of the pancreas which causes severe pain in the abdomen and back.
Stop taking this medicine and tell your doctor straight away if this happens to you. It is more likely in patients on long-term treatment. If you have SLE (lupus), Doxycycline may make the symptoms worse. Stop taking this medicine and tell your doctor if this happens to you. Other side effects include: muscle and joint pain feeling or being sick, diarrhoea, loss of appetite, swelling of the tongue or mouth, stomach pain, wind, feeling ushed, severe diarrhoea with blood in the stools
3. HOW TO TAKE DOXYCYCLINE Always take Doxycycline exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You must complete the course of treatment as directed by your doctor, even if you feel better. Swallow the capsules with plenty of uid Take these capsules with milk or food to reduce the likelihood of stomach upset. Take whilst sitting or standing upright: this medicine should not be taken immediately before bedtime or if lying down. Patients being treated for certain diseases may need monthly blood tests to check the
6 7
16 15
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infection is clearing up. Adults and the elderly - Take two capsules (200 mg) on the first day (either as a single dose or one capsule followed by a further 100 mg capsule 12 hours later), followed by one 100 mg capsule daily thereafter. To treat more serious infections your doctor may prescribe two capsules (200 mg) to be taken daily. The following doses may be given to treat the specific infection: Sexually transmitted diseases: the recommended dose is 100 mg twice daily. Depending on the type of infection being treated, your treatment may continue for between 7 to 10 days.
allergic reactions such as severe skin rashes, red itchy swollen skin, blistering of the skin, swollen ankles, joint pain, fever, swelling of the face or throat, tightening of the chest and difficulty breathing, chest pain, shock, low blood pressure, a racing heart beat severe headaches with changes in eyesight and blurred or double vision. Stop taking Doxycycline and tell your doctor if your skin becomes sensitive to sunlight or UV light. Doxycycline can cause staining of the teeth during tooth development (e.g. during pregnancy and if given to children under 12 years).
If you stop taking Doxycycline - Do not stop taking Doxycycline without talking to your doctor first. It is important to finish the course of antibiotic as instructed by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Doxycycline can cause side effects, although not everybody gets them. If any of the following happen, stop taking Doxycycline and tell your doctor immediately or go to your nearest hospital emergency department:
Primary and secondary syphilis: the usual dose is 200 mg twice a day for 2 weeks. Louse and tick-borne fevers (e.g. scrub typhus): a single dose of 100 mg or 200 mg Doxycycline. To treat malaria: (when Chloroquine is not eective): The recommended dose is 200 mg a day for at least 7 days. Your doctor will also prescribe another medicine as well, possibly Quinine, to help treat the disease. To prevent malaria: The recommended dose is 100 mg daily starting 1 or 2 days before travelling to the malarial area.
Treatment should continue for 4 weeks after leaving the area. To prevent scrub typhus: take a single dose of 200 mg of Doxycycline. To prevent traveller's diarrhoea: the recommended dose is 200 mg as a single dose on the day of travel (or 100 mg followed by a second dose of 100 mg twelve hours later), then 100 mg daily throughout the stay (up to 3 weeks). To prevent leptospirosis: 200 mg once a week throughout the stay in the area and 200 mg on completion of the trip.
Children - Doxycycline must not be given to children under 12 years of age. If you take more Doxycycline than you should - If you take more Doxycycline than you should contact your doctor or hospital emergency department immediately. The signs and symptoms of Doxycycline overdose include low blood pressure, stomach upset, headache and in some cases, chest pain. If you forget to take Doxycycline - If you forget to take a dose of Doxycycline take it as soon as you remember unless it is nearly time for your next dose. Never take two doses at the same time. 12
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13 14
10
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Braille Translation: doxycycline capsules #100 mg
doxycycline capsules #100 mg
TOP VARNISH AREA
any side effects not listed in this leaflet, please tell your doctor or pharmacist.
BASE LABEL
PEEL HERE BUT DO NOT REMOVE
100 mg
Doxycycline capsules
8 capsules
PACKAGING LEAFLET: INFORMATION FOR THE USER
Each capsule contains: Doxycycline Hyclate Ph Eur equivalent to 100 mg Doxycycline. Dosage: For oral use as directed by a doctor. Read the enclosed leaflet. Keep out of the reach and sight of children. Keep well closed and store in a dry place below 25C.
PL 4569/0035 POM ITEM CODE LL0448AC Mylan, Potters Bar, Herts, EN6 1TL, U.K.
Leave Blank. Glue Area.
1 7, 8, 10, 14, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100 or 250 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturer Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
DOXYCYCLINE CAPSULES 100 mg
1212121
Read all of this leaflet carefully before you start taking this medicine. Keep this leaet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others.It may harm them, even if their symptoms are the same as yours If any side eect gets serious, or if you notice
LEAVE BLANK
LEAVE BLANK
In this leaflet: 1. What Doxycycline is and what it is used for. 2. Before you take Doxycycline. 3. How to take Doxycycline. 4. Possible side effects. 5. How to store Doxycycline. 6. Further information. 1. WHAT DOXYCYCLINE IS AND WHAT IT IS USED FOR
22
21
Doxycycline belongs to the tetracycline group of antibiotics. Doxycycline can be used to treat 2 avoid strong sunlight or ultra violet light as Doxycycline can make the skin more sensitive. If your skin becomes red and patchy, tell your doctor as he may need to stop treatment if you are having tests, such as liver function tests or a urine test, tell your doctor you are taking Doxycycline. Taking other medicines - Please tell your doctor if you are taking any other medicines including medicines obtained without a prescription, herbal medicines or any of the following: anticoagulants to thin the blood e.g. Warfarin antacids, used for indigestion
a variety of infections including bacterial infections that affect the eyes, nose, throat and respiratory system (chest infections); skin infections (acne), sexually transmitted diseases and infections of the urinary tract; malaria and diseases spread by either lice, fleas, ticks (e.g. scrub typhus) or animals (e.g. leptospirosis); to prevent traveller's diarrhoea, scrub typhus, leptospirosis and malaria. 2. BEFORE YOU TAKE DOXYCYCLINE Do not take Doxycycline: if you are allergic (hypersensitive) to doxycycline, a similar medicine or any of the other ingredients of Doxycycline
6. FURTHER INFORMATION What Doxycycline contains - The active substance is doxycycline hyclate, equivalent to 100 mg of doxycycline. The other ingredients are magnesium stearate, talc, maize starch. The capsule shell is made of gelatin and contains colourings, patent blue (E131), titanium dioxide (E171) and iron oxides (E172). The printing ink contains shellac, titanium dioxide (E171), propylene glycol and either ammonium hydroxide and simeticone, or sodium hydroxide and povidone. Contents of the pack - Doxycycline is available in glass or plastic bottles or blister packs of 5,
if you are pregnant or breast-feeding if you are a child under 12 years old; as tetracyclines can aect growing bones and teeth causing staining and reduce the amount of enamel in the teeth. Take special care with Doxycycline: if you have liver disease or are taking medicine which can aect the liver if you suer from a rare disorder called porphyria if you suer from myasthenia gravis (a disease causing muscle weakness) if you have SLE (systemic lupus erythematosus) 4 5
5. HOW TO STORE DOXYCYCLINE Keep out of the reach and sight of children. Do not take Doxycycline after the expiry date which is stated on the label or carton after 'EXP'. The expiry date refers to the last day of that month. If in a bottle keep well closed. Store in a dry place, at a temperature below 25C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 18
3
This leaet was last approved in: 04/2011
19 20
Your blood tests may show: reduction in red blood cells which can make the skin pale or yellow and cause weakness or breathlessness reduction in white blood cells which can cause more infections e.g. colds than usual reduction in blood platelets which increase risk of bleeding or bruising a rise in blood urea a rise in liver function tests. If any side effect gets serious, or if you notice any side effects not mentioned in the leaflet, please tell your pharmacist or doctor. 17
Sucralfate to treat stomach or gut ulcers zinc sulphate barbiturates antiepileptics e.g. Carbamazepine, Phenytoin medicine containing iron penicillin antibiotic oral contraceptives: Doxycycline may reduce the effectiveness of the combined oral contraceptive pill. Additional contraceptive precautions should be taken as advised by your doctor Ciclosporin if you need an anaesthesic. Taking Doxycycline with food and drink - Do not drink alcohol during treatment.
Pregnancy and breast-feeding - Do not take Doxycycline if you are pregnant or plan to become pregnant, as it can affect the development of your unborn baby. Do not breast-feed if you are taking Doxycycline as it can pass into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines - Do not drive or use machines if you suffer from visual disturbances such as blurred vision while taking Doxycycline.
Doxycycline can also cause pain and diculty swallowing - this is less likely to happen if the capsules are taken with plenty of uid whilst sat upright (see 'section 3') soreness, itchiness and a fungal infection (candida) in the genital or anal area bulging fontanelle (soft spot on head) of babies pericarditis (inammation of the membrane around the heart) ringing in the ears rarely, liver problems which can cause yellowing of skin and whites of eyes, dark urine, pale stools inammation of the pancreas which causes severe pain in the abdomen and back.
Stop taking this medicine and tell your doctor straight away if this happens to you. It is more likely in patients on long-term treatment. If you have SLE (lupus), Doxycycline may make the symptoms worse. Stop taking this medicine and tell your doctor if this happens to you. Other side effects include: muscle and joint pain feeling or being sick, diarrhoea, loss of appetite, swelling of the tongue or mouth, stomach pain, wind, feeling ushed, severe diarrhoea with blood in the stools
3. HOW TO TAKE DOXYCYCLINE Always take Doxycycline exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You must complete the course of treatment as directed by your doctor, even if you feel better. Swallow the capsules with plenty of uid Take these capsules with milk or food to reduce the likelihood of stomach upset. Take whilst sitting or standing upright: this medicine should not be taken immediately before bedtime or if lying down. Patients being treated for certain diseases may need monthly blood tests to check the
6 7
16 15
8
infection is clearing up. Adults and the elderly - Take two capsules (200 mg) on the first day (either as a single dose or one capsule followed by a further 100 mg capsule 12 hours later), followed by one 100 mg capsule daily thereafter. To treat more serious infections your doctor may prescribe two capsules (200 mg) to be taken daily. The following doses may be given to treat the specific infection: Sexually transmitted diseases: the recommended dose is 100 mg twice daily. Depending on the type of infection being treated, your treatment may continue for between 7 to 10 days.
allergic reactions such as severe skin rashes, red itchy swollen skin, blistering of the skin, swollen ankles, joint pain, fever, swelling of the face or throat, tightening of the chest and difficulty breathing, chest pain, shock, low blood pressure, a racing heart beat severe headaches with changes in eyesight and blurred or double vision. Stop taking Doxycycline and tell your doctor if your skin becomes sensitive to sunlight or UV light. Doxycycline can cause staining of the teeth during tooth development (e.g. during pregnancy and if given to children under 12 years).
If you stop taking Doxycycline - Do not stop taking Doxycycline without talking to your doctor first. It is important to finish the course of antibiotic as instructed by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Doxycycline can cause side effects, although not everybody gets them. If any of the following happen, stop taking Doxycycline and tell your doctor immediately or go to your nearest hospital emergency department:
Primary and secondary syphilis: the usual dose is 200 mg twice a day for 2 weeks. Louse and tick-borne fevers (e.g. scrub typhus): a single dose of 100 mg or 200 mg Doxycycline. To treat malaria: (when Chloroquine is not eective): The recommended dose is 200 mg a day for at least 7 days. Your doctor will also prescribe another medicine as well, possibly Quinine, to help treat the disease. To prevent malaria: The recommended dose is 100 mg daily starting 1 or 2 days before travelling to the malarial area.
Treatment should continue for 4 weeks after leaving the area. To prevent scrub typhus: take a single dose of 200 mg of Doxycycline. To prevent traveller's diarrhoea: the recommended dose is 200 mg as a single dose on the day of travel (or 100 mg followed by a second dose of 100 mg twelve hours later), then 100 mg daily throughout the stay (up to 3 weeks). To prevent leptospirosis: 200 mg once a week throughout the stay in the area and 200 mg on completion of the trip.
Children - Doxycycline must not be given to children under 12 years of age. If you take more Doxycycline than you should - If you take more Doxycycline than you should contact your doctor or hospital emergency department immediately. The signs and symptoms of Doxycycline overdose include low blood pressure, stomach upset, headache and in some cases, chest pain. If you forget to take Doxycycline - If you forget to take a dose of Doxycycline take it as soon as you remember unless it is nearly time for your next dose. Never take two doses at the same time. 12
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
