DOXYLAR 100 MG TABLETS, DOXYCYCLINE 100 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take doxylar 100mg tablets

Do not take Doxylar 100mg Tablets:

! If you are allergic to doxycycline or any other tetracycline antibiotic or any of the other ingredients of this medicine (listed in section 6).

! If you are pregnant or trying to become pregnant.

! If you are breast-feeding.

You should not use Doxylar 100mg Tablets 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 Doxylar 100mg Tablets should be prescribed.

Warning and precautions

Talk to your doctor or pharmacist before taking Doxylar 100mg Tablets:

! If you have liver disease or are taking medicines which affect your liver.

! If you have porphyria (a genetic disorder of the blood).

! If you suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech.

! If you are sensitive to sunlight.

! If you have systemic lupus erythematosus (SLE), a condition characterised by a rash (especially on the face), hair loss, fever, malaise and joint pain.

The use of antibiotics may sometimes result in microbial overgrowth.

Other medicines and Doxylar 100mg Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor if you are taking any of the following:

! warfarin or other anticoagulants (to stop the blood clotting)

! penicillin or rifampicin (to treat infections)

! medicines such as antacids containing aluminium, calcium or magnesium or other medicines containing iron, bismuth or zinc salts. Do not take at the same time as Doxylar 100mg Tablets as absorption of doxycycline may be reduced

! carbamazepine, phenytoin or primidone (to treat epilepsy)

! barbiturates (strong sleeping tablets, e.g. phenobarbital)

! sucralfate (used to treat and prevent stomach ulcers)

! methoxyflurane (an anaesthetic), if you need an operation, tell your doctor or dentist you are taking Doxylar 100mg Tablets

! ciclosporin (used following organ transplants)

! ergotamine or methysergide (used to treat migraines or headaches)

! methotrexate (used to treat cancer, psoriasis or rheumatoid arthritis)

! kaolin (used to treat diarrhoea)

! quinapril (used to lower high blood pressure)

! 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

! retinoids (used to treat various skin conditions)

! typhoid vaccine (used to prevent typhoid fever if travelling to infected areas of the world).

Pregnancy and breast-feeding

Doxylar 100mg Tablets are not recommended for use during pregnancy or 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

Taking these tablets should not affect your ability to drive or operate machinery, however, if you think that you are affected you should not drive or operate machines until you feel better.

3. how to take doxylar 100mg tablets

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

You should not drink alcohol whilst taking Doxylar 100mg Tablets, speak to your doctor if you have any questions.

Swallow the tablets whole with a glass of water. If the tablets irritate your stomach take them with food or milk. You should take the tablets either sitting down or standing up and well before you go to bed for the night to stop irritation and ulceration of your gullet (food pipe). It is important not to lie down for at least thirty minutes after taking Doxylar 100mg Tablets.

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

Usual Dose (Chest, lung or nasal, urinary tract, eye and other infections)

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; 200 mg 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 (taken as a single dose or divided into two equal doses with a twelve hour interval), then 100 mg daily. The length of treatment is dependent on the infection being treated.

Specific infections:

! Acne vulgaris – 50mg a day with food or fluid for 6–12 weeks.

! Sexually transmitted disease – 100mg twice a day for 7–10 days.

! Syphilis – 300mg a day in divided doses for 10 days.

! Fever caused by lice or ticks – a single dose of 100–200mg depending upon severity of infection.

! Malaria – 200mg a day for at least 7 days, should be given with other drugs such as quinine.

! Prevent infections with scrub typhus – 200mg as a single dose.

! Prevent travellers' diarrhoea – 200mg on the first day of travel followed by 100mg a day throughout the duration of the stay. Do not use for more than 3 weeks unless advised by your doctor.

! Prevent leptospirosis infections – 200mg once a week throughout the stay in the infected area and 200mg at the end of the trip. Do not use for more than 3 weeks unless advised by your doctor.

! Prevent malaria – 100mg daily. Treatment should begin 1–2 days before travelling and continue daily whilst travelling. On leaving the malaria infected area, treatment should be continued for a further 4 weeks.

ALWAYS follow the dosage given to you by your doctor.

If you have any concerns about the dose to take you should contact your doctor or pharmacist.

If you take more Doxylar 100mg Tablets than you should

This medicine is to be taken at regular intervals, as determined by the doctor. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

If you forget to take Doxylar 100mg Tablets

If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

If you stop taking Doxylar 100mg Tablets

Do not stop taking Doxylar 100mg Tablets without consulting your doctor as your condition may deteriorate.

If you have any further questions on the use of this medicine, 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 the tablets immediately and seek urgent medical advice if:

! you notice that your skin is very sensitive to light (you may get a skin rash, itching, redness or severe sunburn when out in sunlight or after using a sunbed)

! you experience wheeziness, difficulty in breathing, fever, sudden swelling of the face, lips, throat, tongue, hands or feet, fast heart rate, low blood pressure, rash or itching (especially affecting the whole body), pericarditis (inflammation of the membrane surrounding the heart)

! you experience watery diarrhoea, fever and cramps (pseudomembranous colitis)

! you experience Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers) or toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns)

! you experience increased pressure in the skull (severe headaches, blurred and/or double vision, blind spots), bulging fontanelles (soft spot on head) of infants

! you experience a drug-induced hypersensitivity (allergic) reaction that includes fever, rash and blood abnormalities (drug rash with eosinophilia and systemic symptoms – DRESS).

Contact your doctor at once if the following reactions happen:

! swollen tongue, soreness and itching around the back passage and/or genital areas, inflammation around the vagina, or thrush of the vagina or mouth

! worsening of systemic lupus erythematosus (SLE)

! altered numbers of certain types of blood cells, you may notice that you bruise easily, have nose bleeds, or suffer from infections and sore throats, porphyria (sensitivity of the skin to sunlight, inflammation of nerves and stomach pains)

! tinnitus (ringing or buzzing in the ears)

! inflammation of the liver (hepatitis), jaundice (yellowing of the skin or white of the eyes), liver failure and inflammation of the pancreas (pancreatitis)

! severe skin reactions such as erythema multiforme (circular, irregular red patches)

! 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

! permanent loss of vision

! anxiety (frequency rare: may affect up to 1 in 1,000 people).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed: ! discolouration of thyroid tissue (does not affect thyroid function)

! headache

! stomach pain, loss of appetite, feeling or being sick, heartburn, diarrhoea, difficulty swallowing, sore or painful tongue or mouth, black hairy tongue, inflammation and/or ulcers of the gullet (food pipe)

! changes in liver function tests

! detachment of the nail from finger bed

! muscle or joint pain

! an increase in urea in the blood

! discolouration and/or lack of growth of teeth (frequency cannot be estimated from the available data).

Many of the above mentioned side effects should disappear when treatment is stopped. If any of the above effects gets serious, or if you notice any effects not listed in this leaflet please tell your doctor or pharmacist.

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 Yellow Card Scheme at: 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 doxylar 100mg tablets

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 and carton. The expiry date refers to the last day of that month.

Store in a cool dry place and protect from light.

Do not use this medicine if you notice any visible signs of deterioration.

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 protect the environment.

6. contents of the pack and other information

What Doxylar 100mg Tablets contain

The active substance is doxycycline. Each tablet contains 100mg of doxycycline.

The other ingredients are furcellaran, povidone, magnesium stearate, colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose, hypromellose,di­methicone, propylene glycol, titanium dioxide, industrial methylated spirit and hydroxypropyl­methylcellulo­se (E464).

What Doxylar 100mg Tablets look like and contents of the pack

Doxylar 100mg Tablets are pink, round, film-coated tablets with P1 marked on one side and breakline on the other side.

Doxylar 100mg Tablets are available in securitainers containing 10 or 50 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way, Dartford, DA1 5BS, United Kingdom

Manufacturer

Lagap Pharmaceuticals

Woolmer Way, Bordon, Hampshire, GU35 9QE

This leaflet was last revised in May 2020. ENV02