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Doxylar 100mg Tablets

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Doxylar 100mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Doxylar 100mg Tablets are and what they are used for

2.    Before you take Doxylar 100mg Tablets

3.    How to take Doxylar 100mg Tablets

4.    Possible side effects

5.    How to store Doxylar 100mg Tablets

6.    Further information

1.    WHAT DOXYLAR 100MG TABLETS ARE AND WHAT THEY ARE USED FOR

Doxylar 100mg Tablets contain a medicine called doxycycline. It belongs to a group of medicines called tetracycline antibiotics. It is used to treat a wide variety of bacterial infections.

Doxylar 100mg Tablets are useful for the treatment of infections including:-

•    Respiratory tract infections such as pneumonia and bronchitis

•    Urinary tract infections

•    Skin infections such as acne

•    Infections of the eye

•    Soft tissue infections

•    Infections of the digestive tract

•    Other infections including psittacosis (parrot fever).

These tablets can also be used to prevent malaria in those who are travelling, or have travelled to malarial infected areas.

2.    BEFORE YOU TAKE DOXYLAR 100MG TABLETS Do not take Doxylar 100mg Tablets if you:

•    Are hypersensitive (allergic) to doxycycline or any of the other ingredients in this medicine

•    Are pregnant, think you might be pregnant or are breast-feeding as this may cause permanent discolouration of the unborn child's teeth

•    Are a child under 12 years of age.

Take special care with Doxylar 100mg Tablets:

Consult your doctor before taking Doxylar 100mg Tablets if you:

•    Have liver disease or are taking medicines which affect your liver

•    Have porphyria (a genetic disorder of the blood)

•    Suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech

•    Are sensitive to light

•    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.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.

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

•    Penicilllin- used to treat infections

•    Medicines such as antacids containing aluminium, calcium, magnesium, zinc or other medicines containing iron, bismuth or zinc salts

•    Carbamazepine, phenobarbitone, primidone, phenytoin - used to treat epilepsy/seizures

•    Ciclosporin - used after organ transplants and to treat severe rheumatoid arthritis or skin conditions

•    Warfarin - an anticoagulant used to stop the blood clotting

•    Diuretics (water tablets)

•    Alcohol

•    Methoxyflurane- an anesthetic. If you need an operation, tell your doctor or dentist you are taking this medicine.

•    Oral contraceptives (the pill) - Women using the contraceptive pill to avoid pregnancy may wish to use an alternative method of contraception.

Pregnancy and breastfeeding:

Doxylar 100mg Tablets are not recommended for use during pregnancy or breastfeeding. Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant, or are breastfeeding.

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 Doxylar 100mg Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Swallow the tablets whole with a glass of water.

Adults, Elderly and children over 12 years of age:

Usual dose: 200mg on the first day of treatment.

100mg daily as a maintenance dose.

If the infection is more severe, your doctor may prescribe 200mg daily.

For acute gonococcal infection in males:

A single dose of 300mg or 100mg, twice a day, for 4 days may be prescribed.

For acute gonococcal infection in females:

100mg, twice daily.

For primary and secondary syphilis (if you are allergic to penicillin):

300mg daily, in divided doses for a minimum of 10 days.

For the prevention of 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.

Children:

These tablets are not recommended for use in children under 12 years of age.

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 stop taking Doxylar 100mg Tablets:

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

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. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Doxylar 100mg Tablets can cause side effects, although not everyone gets them.

Avoid sunbathing - you should avoid direct exposure to the sun or ultraviolet (UV) light whilst taking doxycycline, as an exaggerated sunburn reaction may occur. If your skin starts to feel uncomfortable contact your doctor immediately.

Contact your doctor at once if the following occur, as they may mean you are having an allergic reaction:

•    wheeziness, difficulty in breathing, fever, sudden swellings 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)

•    swollen tongue, watery diarrhoea, fever and cramps (pseudomembranous colitis), 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).

Tell your doctor if you notice any of the following side effects:

•    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)

•    discolouration of thyroid tissue (does not affect thyroid function)

•    headache, 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.

•    tinnitus (ringing or buzzing in the ears)

•    stomach pain, loss of appetite, feeling or being sick, heartburn, diarrhoea, difficulty swallowing, sore or painful tongue or mouth, inflammation and/or ulcers of the gullet, discolouration or underdevelopment of teeth

•    changes in liver function tests, inflammation of the liver (hepatitis), jaundice (yellowing of the skin or whites of the eyes), liver failure and inflammation of the pancreas (pancreatitis)

•    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)

•    muscle or joint pain

•    an increase in urea in the blood.

Many of the above mentioned side effects should disappear when treatment is stopped. If any of the above affects 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: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. STORING DOXYLAR 100MG TABLETS

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Do not store above 25°C. Store in the original package.

Do not take the Doxylar 100mg Tablets if you notice any visible signs of deterioration.

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

Keep out of the reach and sight of children.

6. FURTHER INFORMATION What Doxylar 100mg Tablets contain:

Doxylar 100mg Tablets contain the active substance doxycycline, 100mg in each tablet.

The other ingredients are: furcellaran, povidine, magnesium sterate, colloidal silicon dioxide, stearic acid, talc, microcrystalline cellulose, hypromellose, dimethicone, propylene glycol, titianium 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.

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 June 2015.