Doxycycline capsules BP 50 mg – patient leaflet, side effects, dosage

1. What Doxycycline Capsules are and what they are used for

Doxycycline Capsules 50mg contain the active substance doxycycline. It belongs to a group of medicines known as antibiotics or anti-bacterial agents.

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

! respiratory tract infections such as pneumonia, bronchitis

or sinusitis.

! urinary tract infections

! sexually transmitted diseases such as chlamydia,

gonorrhoea, syphilis or chancroid

! skin infections such as acne

! infections of the eye such as conjunctivitis

! rickettsial infections such as tick fevers, Q fever, rocky

mountain spotted fever, coxiella endocarditis and typhus group

! other infections including psittacosis, leptospirosis,

cholera, meliodosis, other infections due to yersinia species, brucella species (in combination with streptomycin), clostridium species, francisella tularensis and chloroquine-resistant falciparum malaria.

This medicine may also be used to prevent malaria (in those who are travelling or have travelled to malarial infected areas), traveller's diarrhoea, scrub typhus and leptospirosis.

2. What you need to know before you take Doxycycline Capsules

Do not take Doxycycline Capsules if you:

! are allergic or have previously been allergic to

doxycycline, tetracycline antibiotics or any of the other ingredients in this medicine (listed in section 6). ! are pregnant or trying to become pregnant. ! are breast feeding.

You should not take Doxycycline Capsules during periods of tooth development (pregnancy, infancy or in children below 8 years old) as such use may lead to permanent discolouration (yellow-grey-brown) or affect the proper growth of the teeth.

There may be circumstances (e.g. severe or life-threatening conditions), where your doctor may decide that the benefits outweigh this risk in children below 8 years and Doxycycline Capsules should be prescribed.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxycycline Capsules if you:

! have myasthenia gravis (a disease which causes unusual

tiredness and weakness of certain muscles, particularly in the eyelid)

! have kidney or liver problems

! have an immune system disease that causes joint pain,

skin rashes and fever (systemic lupus erythematosus). The condition may be worsened by taking Doxycycline Capsules

! are likely to be exposed to strong sunlight or uv light (e.g.

on a sun bed). You should avoid exposure to strong sunlight while taking this medicine as your skin may be more sensitive to sunburn than normal

! have porphyria (a rare disease of blood pigments) ! are suspected as having syphilis. Your doctor will continue

to monitor you after your treatment has stopped ! have diarrhoea or usually get diarrhoea when you take

antibiotics or have suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Doxycycline Capsules tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics

! are taking oral retinoids as there is a higher risk of

suffering from increased pressure in your skull (severe headache with change in vision) when taken with Doxycycline Capsules.

When used for a long duration, Doxycycline Capsules may cause infections that cannot be treated with this antibiotic. Your doctor can explain the signs and symptoms of such types of infection.

Other medicines and Doxycycline Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (including medicines you have obtained without a prescription). If you are taking any of the medicines listed below tell your doctor before taking Doxycycline Capsules.

Some medicines can reduce the effectiveness of Doxycycline Capsules, these include:

! Antacids (indigestion remedies), iron preparations, oral

zinc or bismuth.

These should not be taken at the same time of day as

Doxycycline Capsules.

! Carbamazepine, phenytoin (medicines used to control

epilepsy) and barbiturates (used to control epilepsy or as a sedative).

Doxycycline Capsules can affect the action of some other

medicines, these include:

! Increased action of warfarin or coumarins (used to

prevent blood clots)

! Reduced effectiveness of oral contraceptives (birth control

pills)

! Reduced effectiveness of penicillin antibiotics (used to

treat infections)

! Increased blood levels of ciclosporin (a medicine used to

affect the body's immune response).

If you are going to have a general anaesthetic for an operation or dental surgery you must tell your anaesthetist or dentist that you are taking doxycycline as you may have more side effects.

Taking Doxycycline Capsules with food, drink and alcohol

Please see section 3 How to take Doxycycline Capsules. Alcohol may reduce the effect of Doxycycline Capsules and should be avoided.

Pregnancy and breast-feeding

Do not take Doxycycline Capsules if you are or might be pregnant as it can harm your developing baby.

Do not take Doxycycline Capsules if you are breast-feeding.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Doxycycline Capsules contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Doxycycline Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole with a glass of water one hour before or two hours after meals. Swallow the capsules when standing or sitting down, do not take them immediately before going to bed.

The recommended doses are given below. These are the different doses that your doctor may prescribe depending on the infection being treated.

Children aged 8 years to less than 12 years:

Doxycycline for the treatment of acute infections in children aged 8 years to less than 12 years should be used in situations where other drugs are not available or are not likely to be effective. In such circumstances, the usual doses are:

For children 45 kg or less:

First day: 4.4 mg for each kg of bodyweight (in single or 2 divided doses) then 2.2 mg for each kg of bodyweight (in single or 2 divided doses) from the second day. The length of treatment is dependent on the infection being treated. In more severe infections, up to 4.4 mg for each kg of bodyweight should be given throughout treatment.

For children, over 45 kg:

Dose administered for adults should be used; 200mg on the first day, then 100 mg daily. The length of treatment is dependent on the infection being treated.

Adults and children aged 12 years to less than 18 years:

200mg on the first day, then 100 mg daily. The length of treatment is dependent on the infection being treated.

Acne Vulgaris:

50mg a day with food or fluid for 6 to 12 weeks.

Sexually transmitted disease:

100mg, twice a day for 7 days may be prescribed. Where co-existent syphilis is suspected, your doctor may carry out examinations and monthly tests for at least 4 months.

Primary and secondary syphilis:

300mg per day, in divided doses, for at least 10 days.

Louse and tick-borne relapsing fevers:

A single dose may be prescribed of 100mg or 200mg according to severity.

Chloroquine-resistant falciparum malaria:

200mg per day, for at least 7 days. You may also be prescribed quinine.

Prevention of malaria:

100mg daily in adults and children over the age of 12 years. Treatment should begin 1-2 days before travelling to a malarial area and continue daily whilst travelling in malarial areas. On leaving a malarial area treatment should continue for a further 4 weeks.

Prevention of travellers' diarrhoea:

200mg on the first day of travel (as a single dose or as 100mg every 12 hours), followed by 100mg per day throughout your stay in the infected area.

Prevention of scrub typhus:

200mg taken as a single dose.

Prevention of leptospirosis:

200mg once a week, throughout the stay in the infected area, and 200mg at the end of the trip.

Elderly patients:

If you are elderly, you may be specifically instructed about administering doxycycline preparations by your doctor. Please see the instructions given at the beginning of this section about taking the capsules with plenty of water, taking them whilst you are in an upright position, etc.

If you take more Doxycycline Capsules than you should

If you (or someone else) take more Doxycycline Capsules than you should, 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 Doxycycline Capsules

If you have forgotten to take your medicine, take it as soon as you remember. If your next dose is due within 6 hours, take a single dose straight away and skip the next. Do not take a double dose to make up for the forgotten dose. If you are concerned, consult your doctor or pharmacist.

If you stop taking Doxycycline Capsules

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

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.

Stop taking this medicine and tell your doctor immediately if you experience any of the following serious side effects after taking this medicine. Although they are very rare, the symptoms can be severe.

! Sudden wheeziness, difficulty in breathing, chest pain,

fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

! Upset stomach, loss of appetite, severe, persistent or

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 serious bowel inflammation.

! Fever, swollen lymph nodes or skin rash. These may be

symptoms of a condition known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and can be severe and life-threatening.

! Very severe headache which may be associated with

visual disturbances such as blurred vision, double vision or loss of vision.

Permanent visual loss has been reported. The possible symptoms in benign intracranial hypertension include headache, vomiting, visual disturbances including blurred vision, a localized defect in the visual field bordered by an area of normal vision (scotoma), double vision (diplopia), and possible vision loss, in some cases, even permanent. ! Serious illness with widespread severe blistering of the

skin, mouth, eyes and genitals.

If any of the side effects listed below occur, contact your doctor as soon as possible.

! The Jarisch-Herxheimer reaction which causes fever,

chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting doxycycline treatment for infections with spirochete such as Lyme disease.

! Skin that is more sensitive to sunlight than normal. You

may get a skin rash, itching, redness or severe sunburn. If this happens stop taking the medicine and tell your doctor.

! Inflammation and/or ulcers of the gullet.

! Blood disorders. These are due to changes in numbers of

different cell types in the blood. Symptoms may include tiredness, easy bruising or infections.

! Low blood pressure.

! Increased heart rate.

! Aches in the joints or muscles.

! Stomach pain and diarrhoea.

The side effects listed below may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects

continue to bother you:

Common: may affect up to 1 in 10 people

! feeling or being sick

! worsening of a disease called systemic lupus erythematous (SLE). This is an allergic condition which causes joint pain, skin rash and fever headache ! pericarditis (inflammation affecting the heart)

Uncommon: may affect up to 1 in 100 people

! heartburn

! vaginal infection

Rare: may affect up to 1 in 1,000 people

! anxiety

! difficulty in swallowing, sore or painful tongue or mouth ! skin reddening (flushing)

! a ringing or buzzing noise in the ear

! soreness and itching of the rectal and/or genital area ! inflammation of the bowel

! bulging fontanelles (soft spot on head) of infants ! increased pressure in the skull (severe headache with change in vision)

! inflammation and damage to the liver

! abnormal liver function tests

! discolouration of the thyroid tissue when given for long periods. The medicine does not impair thyroid function ! round or oval patches of redness and swelling of the skin which reappear at the same site each time the medicine is taken (fixed eruption)

! darker patches on your skin

! loosening of the nail from the nail bed after exposure to the sun

! increased levels of urea in the blood

! yellow skin and eyes (jaundice), inflammation of the pancreas

! upset stomach, loss of appetite, diarrhoea (this may occur up to two or three months after the last dose), stomach pain

Not known: frequency cannot be estimated from the available data

! discolouration and/or lack of growth of teeth

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Doxycycline Capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in a dry place.

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 Capsules contain

The active substance is doxycycline. Each capsule contains doxycycline hyclate BP equivalent to 50mg of the active substance doxycycline.

The other ingredients include: maize starch, magnesium stearate, talc and lactose. The capsule shell consists of a green cap made up of yellow iron oxide (E172), indigotine (E132), titanium dioxide (E171) and gelatin, and a white body made up of titanium dioxide (E171) and gelatin.

What Doxycycline Capsules look like and contents of the pack

Doxycycline Capsules are hard, gelatin capsules with a white, opaque body and green cap.

Doxycycline Capsules are available in packs of 28, 30, 56, 60, 84, 100, 150, 168 and 200 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK

Manufacturer

Clonmel Healthcare Ltd, Clonmel, Ireland.

This leaflet was last revised in: March 2026.

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