Package leaflet: Information for the patient

DOXYCYCLINE 100 mg CAPSULES, HARD

(doxycydine)

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 any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. 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 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 Doxycydine is and what it is used for

2.    What you need to know before you take Doxycydine

3.    How to take Doxycydine

4.    Possible side effects

5.    How to store Doxycydine

6.    Contents of the pack and other information.

1.    What Doxycycline is and what it is used for Doxycycline belongs to the tetracycline group of antibiotics. Doxycycline can be used to treat a variety of infections, including bacterial infections that affect the eyes, nose, throat and respiratory system (chest infections), sexually transmitted diseases and infections of the urinary tract; malaria, fevers associated with lice, fleas and tick bites

or diseases spread by animals (e.g. leptospirosis); and in the prevention of traveller's diarrhoea, scrub typhus, leptospirosis and malaria.

2.    What you need to know before you take Doxycycline Do not take Doxycycline

•    if you are allergic to doxycydine, a similar medicine or any of the other ingredients of this medicine (listed in section 6).

•    if you are pregnant or breast-feeding

•    if you are a child under 12 years old, as tetracyclines can affect growing bones and teeth and can also cause staining and a reduction in the amount of enamel in the teeth.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxycycline

•    if you have liver disease or are taking medicine which can affect the liver

•    if you suffer from a rare disorder called porphyria

•    if you suffer from myasthenia gravis (a disease causing muscle weakness)

•    if you have SLE (systemic lupus erythematosus)

Avoid strong sunlight or ultra violet light as Doxycydine 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.

Other medicines and Doxycycline 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

•    sucralfate used to treat stomach or gut ulcers

•    zinc sulphate

•    preparations containing iron

•    barbiturates e.g. phenobarbital

•    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 are going to have an operation and need an anaesthetic, tell the anaesthetist or dentist you are taking Doxycycline.

Doxycycline with alcohol

Do not drink alcohol during treatment.

Pregnancy and breast-feeding Do not take Doxycycline if you are pregnant, think you may be 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 doxycycline can pass into breast milk.

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

Do not drive or use machines if you suffer from visual

disturbances such as blurred vision while taking Doxycycline.

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 fluid

•    Take the 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 infection is clearing up.

Adults and older people

The recommended dose is 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 specific infections: 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.

Primary and secondary syphilis: the recommended dose is 200 mg twice a day for 2 weeks.

Louse and tick-borne fevers: the recommended dose is a single dose of 100 mg or 200 mg To treat malaria: (when chloroquine is not effective): the recommended dose is 200 mg daily 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 during your visit and for 4 weeks after leaving the area.

Date: 19 JUN 2014

Time: 14:07

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To prevent scrub typhus: the recommended dose is a single dose of 200 mg

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 12 hours later), then 100 mg daily throughout the stay (up to 3 weeks).

To prevent leptospirosis: the recommended dose is 200 mg once a week throughout the stay in the area and 200 mg on completion of the trip.

Use in 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.

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.

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, this medicine 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:

•    allergic reactions such as severe skin rashes, red itchy swollen skin, blistering of the skin swollen ankles, joint pain, fever, swelling of the lips, tongue, face throat, tightening of the chest and difficulty breathing, chest pain, shock, low blood pressure, a racing heart beat,

•    Severe skin reactions such as erythema multiforme (circular, irregular red patches), Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers) or Toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns),

•    severe headaches with changes in eyesight and blurred or double vision, or loss of vision,

•    rarely, liver problems which can cause yellowing of skin and whites of eyes, dark urine, pale stools,

•    inflammation of the pancreas which causes severe pain in the abdomen and back,

•    severe diarrhoea with blood in the stools,

•    pericarditis (inflammation of the membrane around the heart),

•    haemolytic anaemia (low number of red blood cells). Signs include tiredness, headaches, being short of breath when exercising, dizziness with yellowing of the skin and/ or eyes.

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).

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 or soreness of the tongue or mouth, ulcers, stomach pain, wind, feeling flushed,

•    Doxycycline can also cause pain and difficulty swallowing - this is less likely to happen if the capsules are taken with plenty of fluid 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,

•    Headache,

•    ringing in the ears,

•    discolouration of the thyroid tissue when given for long periods of time (this medicine does not affect thyroid function),

•    loosening of the nail from the nail bed after exposure to the sun.

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

•    an increase in the number of white blood cells

•    reduction in blood platelets which increase risk of bleeding or bruising

•    a rise in blood urea

•    a rise in liver function tests

•    an increase in the number of white blood cells

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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Doxycycline

Keep out of the sight and reach of children.

Do not take Doxycycline after the expiry date which is stated on the label or carton after 'EXP. The expiiy date refers to the last day of that month.

Store in the original package in order to protect from light and moisture. Store below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other 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 the 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.

What Doxycycline looks like and the contents of the pack.

Your medicine comes as green capsules, containing yellow powder marked with 'DE 100' with 'G'

Doxycycline is available in glass or plastic bottles or blister packs of 5, 7, 8, 10, 14, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100 and 250 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13, Ireland.

This leaflet was last revised in June 2014    LT1408AE

Date: 19 JUN 2014

Time: 14:07

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