may be used to treat a wide range of infections caused by bacteria, these include:

· Chest, lung or nasal infections

· Infections of the kidneys and bladder

· Infections of the skin such as acne

· Eye infections

· Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia

· Malaria

What this product is and what it is used for

DuraDox belongs to a group of medicines called tetracycline antibiotics. It may be used to treat a wide range of infections caused by bacteria, these include:

· Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis

· Infections of the kidneys and bladder e.g. cystitis, urethritis

· Infections of the skin such as acne

· Eye infections

· Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia

· Rickettsial infections such as Q fever or fevers associated with louse or tick bites

· Malaria, when chloroquine is not effective

· Other infections such as cholera, brucellosis, leptospirosis and psittacosis

DuraDox capsules are also used to prevent certain infections developing such as scrub typhus, traveller‟s diarrhoea, malaria and leptospirosis (a bacterial infection caused by exposure to bacteria in fresh water contaminated by animal urine).

2. What you need to know before you use this product

Do not take your medicine and tell your doctor, if you:

· have taken DuraDox or any other antibiotic before and suffered an allergic reaction (e.g. rash, itching, swelling of the face, fainting and breathing problems)

· are allergic to any of the other ingredients in Doxycycline (see section 6 More information)

· are pregnant or trying to become pregnant

· are breast-feeding

· are giving it to a child under 12 years of age.

Take special care with your medicine

You should let your doctor know and ask their advice, if you:

· are likely to be exposed to strong sunlight or ultraviolet light (e.g. on a sunbed)

· have liver problems or are taking medicines which affect your liver

· have severe kidney problems

· have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain muscles, particularly in the eyelid, difficulty chewing and swallowing and slurred speech)

· have porphyria (a rare genetic disease of blood pigments)

· have systemic lupus erythematosus (SLE) a condition characterised by a rash (especially on the face), hair loss, fever, malaise and joint pain. This condition may be worsened by taking DuraDox.

Taking other medication

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

· Penicillin antibiotics (used to treat infections)

· Rifampicin (used to treat tuberculosis)

· Anticoagulants (used to thin the blood, e.g. warfarin)

· Quinapril (used to lower high blood pressure)

· Kaolin (used to treat diarrhoea)

· Sucralfate (used to treat and prevent stomach ulcers)

· Oral contraceptives (“The Pill‟). This medicine may make the oral contraceptive pill less effective. You should use additional contraceptive precautions whilst taking this medicine and for 7 days after stopping.

· Barbiturates (strong sleeping tablets, e.g. phenobarbital)

· Ergotamine or methysergide (used to treat migraines or headaches)

· Typhoid vaccine (used to prevent typhoid fever if travelling to infected areas of the world)

· Carbamazepine, phenytoin, primidone or other drugs used to control epilepsy

· Ciclosporin (used to affect the body‟s immune response following organ transplants)

· Methoxyflurane (an anaesthetic). If you need an operation, tell your doctor or dentist that you are taking DuraDox.

· Methotrexate (used to treat cancer, psoriasis or rheumatoid arthritis)

· Medicines such as antacids (indigestion tablets or liquids) containing aluminium, calcium, magnesium or other medicines containing iron, bismuth or zinc salts, should not be taken at the same time as your medicine, as absorption of your medicine may be reduced

· Retinoids (used to treat various skin conditions)

Alcohol

Alcohol may reduce the effect of your medicine. It is therefore advisable to avoid drinking any alcohol.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking any medicine as DuraDox could harm the baby.

Driving and using machines

Do not drive or use machines if you suffer from visual disturbances such as blurring of vision while taking DuraDox.

3. How to use this product.

Always take your medicine exactly as your doctor has instructed you. You should check with your doctor or pharmacist, if you are unsure. Do not take more than your doctor has recommended.

Your medicine should be taken by mouth as follows:

· You must take your capsules as your doctor has told you to.

· It is important to swallow each DuraDox whole with a glass of water.

· It is best to take your capsules at the same time(s) each day, when standing or while sitting.

· It is important not to lie down for at least thirty minutes after taking DuraDox, so that the capsule can move as swiftly as possible into the stomach and prevent irritation of the throat or oesophagus (canal taking food from the mouth to the stomach).

· If your stomach is upset, DuraDox can be taken with milk or a meal.

DOSAGE

Adults and the elderly

Respiratory, urinary tract, ophthalmic and other infections

The usual dose is 200mg on the first day as a single dose or two 100mg doses, followed by 100mg daily. For severe infections your doctor may increase the dose to 200mg a day. The duration of treatment is dependent on the infection being treated.

Acne

50mg daily for 6-12 weeks, with food or fluid.

Sexually transmitted diseases

100mg twice daily for 7-10 days.

Primary and secondary syphilis

300mg daily in divided doses for at least 10 days.

Fevers associated with louse or tick bites:

Single dose of 100mg or 200mg depending on severity.

Treatment of malaria, when chloroquine is not effective

200mg daily for at least 7 days.

Prevention of malaria

100mg daily for 1-2 days before travelling until 4 weeks after returning.

Prevention of scrub typhus

Single dose of 200mg.

Prevention of travellers’ diarrhoea

100mg twice daily on the first day of travel, followed by 100mg daily throughout the stay in the area. If you are planning to take these capsules for more than 21 days, please consult your doctor.

Prevention of leptospirosis

200mg once each week during the stay in the area; 200mg on completion of the trip. If you are planning to take these capsules for more than 21 days, please consult your doctor.

Doctors may prescribe different doses to these depending on the infection being treated. Check with your doctor if you are not sure why you have been prescribed the medicine.

Children over 12 years of age

The recommended dosage schedule for children over 12 years of age, weighing 50 kg or less is 4 mg/kg of body weight on the first day of treatment (given as a single dose or divided into two equal doses with a 12 hour interval), followed by 2 mg/kg of body weight on subsequent days. For more severe infections up to 4 mg/kg of body weight may be used daily.

For children over 50 kg the usual adult dose should be used.

Children under 12 years of age

DuraDox are not recommended for use in children under 12 years of age as it can cause permanent discolouration of tooth enamel and affect bone development.

Overdose: If you take more of your medicine than you should

If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take your medicine

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking your medicine

Do not stop treatment early as your infection may return if you do not finish the course of capsules

If you have any questions on the use of this product, ask your pharmacist or doctor

4. Possible side effects

Like all medicines, DuraDox can cause side effects, although not everybody gets them.

Stop taking your medicine and tell your doctor immediately, or go to accident and emergency if you notice any of the following symptoms. Although the symptoms are very rare, they may be severe.

·    Symptoms of an allergic reaction - sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings of the face, lips, tongue, throat, hands or feet, rash or itching (especially affecting the whole body), pericarditis (inflammation of the membrane surrounding the heart), worsening of systemic lupus erythematosus (autoimmune disease)

If you experience any of the side effects listed below, tell your doctor as soon as possible:

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

·    Sensitivity to sunlight - you may get a skin rash, itching, redness or severe sunburn when out in sunlight or after using a sun bed

·    Increased pressure in the skull (severe headaches, blurred and/or double vision, blind spots, permanent loss of vision)

·    Bulging fontanelles (soft spot on head) of infants

·    Swollen tongue, severe watery or bloody diarrhoea, fever and cramps (pseudomembranous colitis)

·    Low blood pressure

·    Aches in the joints or muscles

·    Unusual rapid heart beats (palpitations), fainting

·    Blood disorders (symptoms may include tiredness, weakness, easy bruising or susceptibility to infection)

·    Porphyria (sensitivity of the skin to sunlight, inflammation of nerves and stomach pains)

·    Discolouration of thyroid tissue (does not affect thyroid function)

·    Changes in liver function tests

·    Hepatitis (inflammation of the liver)

·    Liver failure

·    An increase in urea in the blood

·    Jaundice (yellowing of the skin or white of the eyes) has rarely been reported

·    Pancreatitis (manifested by severe upper abdominal pain) has rarely been reported

·    Discolouration or underdevelopment of teeth

·    Loosening of the nail from the nail bed after exposure to the sun

Most of these side effects are infrequent but if they persist or are troublesome you should see your doctor.

·    Inflammation and/or ulcers of the gastrointestinal tract (symptoms may include sore mouth, indigestion and difficulty swallowing)

·    Feeling or being sick, diarrhoea

·    Loss of appetite

·    A ringing or buzzing noise in the ear

·    Soreness and itching of the rectal and/or genital area

·    Yeast infection around the anus or genitals

The list of side effects mentioned above is not complete. If you should suffer from any of these side effects or any other undesired effect please tell your doctor or pharmacist. Do not be alarmed by this list of possible side effects. You may not experience any of them.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222

Exts: 2317-2356-2353-2354-2334-2340

Toll free phone: 8002490000

E-mail: [email protected]

Website: www.sfda.gov.sa/npc

5. How to store this product

- Keep out of the reach and sight of children.

- Do not take your capsules after the expiry date shown on the carton and blister. The expiry date refers to the last day of that month.

- Store below 30°C, in a dry place and protected from light.

- Keep this medicine in the original container (blister). Do not use if you notice any visible signs of deterioration.

- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.