Doxylar® 100 mg Capsules

50 capsules Doxycycline hydrochloride

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

Prevention of scrub typhus: 200 mg taken as a single dose.

Prevention of leptospirosis: 200 mg 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.

Children:

These capsules are not recommended for children under 12 years of age.

If you take more Doxylar Capsules 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 Doxylar Capsules

If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within 6 hours, take a single dose straight away and skip the next.

If you stop taking Doxylar Capsules

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

4. Possible side effects

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

Stop taking the capsules immediately and seek urgent medical advice if the following occur:

•    Skin irritations, redness, rashes including nettle rash, itching, blistering and peeling.

•    Swelling of the face and around the mouth.

•    Bleeding into the skin.

•    Chest pain.

•    Fever.

•    Difficulty breathing.

•    A red scaly rash on the face, sometimes with accompanying arthritis. Tell your doctor if the following side effects occur:

•    Nausea (feeling sick).

Vomiting (being sick).

Diarrhoea.

Loss of appetite.

Teeth discolouration.

Difficulties with swallowing.

Inflammation of the tongue, lining of the mouth, vagina, or colon and small intestine.

Thrush.

Sensitivity to light.

Liver failure, hepatitis, jaundice (yellowing of skin and whites of eyes) and abnormal liver function tests.

Kidney problems.

Pancreatitis (severe pain in the upper abdomen and back).

Changes in your blood may occur. If you notice an increased tendency to bruise or bleed from the gums or anywhere, or you feel particularly tired and look pale, you should contact your doctor straight away.

Doxycycline may cause ulceration or inflammation of the gullet if they become trapped in it. To avoid this, drink plenty of water when you are taking the capsules, take them while you are in an upright position and not just before going to bed.

Another effect may include raised pressure within the skull in adults, symptoms of which include headache, vomiting, double vision and problems with eyesight. If you suffer with any of these symptoms, please contact your doctor straight away, who may wish to withdraw treatment.

Avoid sunbathing, 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, who may wish to withdraw your treatment.

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.

5.    How to store Doxylar Capsules

Keep out of the reach and sight of children.

Do not take these capsules after the expiry date shown on the label. The expiry date refers to the last day of that month. Any out of date medicines should be returned to your pharmacist for disposal.

These capsules should be stored in a cool dry place and protected from light. Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Doxylar Capsules contains

Each capsule contains doxycycline hydrochloride equivalent to 100 mg of the active substance doxycycline BP.

The other ingredients are: maize starch, magnesium stearate, talc, lactose, gelatin, indigotine (E132), titanium dioxide (E171) and yellow iron oxide (E172).

What Doxylar capsules look like and contents of the pack

Doxylar capsules are hard, gelatin capsules with a white body and yellow cap. The capsules are supplied in packs of 8 or 50.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is: Sandoz Ltd, Woolmer Way, Bordon, Hampshire, GU35 9QE.

The Manufacturer is: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co Tipperary, Ireland.

This leaflet was last approved in: 12/2008 (to be amended on approval)

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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 Capsules are and what they are used for

2.    Before you take Doxylar Capsules

3.    How to take Doxylar Capsules

4.    Possible side effects

5.    How to store Doxylar Capsules

6.    Further information

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

The name of your medicine is Doxylar Capsules 100mg. The active substance doxycycline hydrochloride belongs to a group of medicines known as antibiotics or anti-bacterial agents.

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

•    Respiratory tract infections such as sinusitis, pneumonia or bronchitis.

•    Infections of the urinary tract.

•    Sexually transmitted diseases.

•    Eye infections.

•    Tick fevers, including Rocky Mountain spotted fever.

•    Q fever.

•    Coxiella endocarditis (inflammation of the lining of the heart).

•    Typhus.

•    Psittacosis (parrot fever).

•    Leptospirosis.

•    Cholera.

•    Melioidosis.

•    Chloroquine-resistant falciparum malaria.

This medicine may also be a useful preventative treatment for malaria, leptospirosis, scrub typhus and travellers' diarrhoea.

2. Before you take Doxylar Capsules

Do not take Doxylar Capsules and tell your doctor if you:

•    are allergic or sensitive to tetracyclines.

•    have previously experienced sensitivity to doxycycline, or any of the

other ingredients in this medicine see section 6 Further information.

•    are, or might be, pregnant or you are breast-feeding.

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

Take special care with Doxylar Capsules and tell your doctor if you:

•    are taking ciclosporins, your doctor will need to monitor you whilst you are taking doxycycline.

•    are taking antiepileptic drugs (carbamazepine, phenobarbitone, phenytoin and primidone, see section Taking other medicines).

•    are taking diuretics (water tablets, see section Taking other medicines).

•    have liver problems or you are taking drugs which affect your liver.

•    have systemic lupus erythematosus (SLE).

•    have porphyria (a rare inherited disorder).

•    have myasthenia gravis (symptoms of which are abnormal tiredness and muscle weakness, drooping eyelids, double vision and/or a speech disorder).

•    are exposed to strong sunlight or ultraviolet light as you may

experience a strong sunburn reaction and have to discontinue the treatment.

Taking other medicines

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

It is particularly important that you tell your doctor if you are taking the following:

•    Penicillins (antibiotics).

•    Bismuth compounds.

•    Antacids containing aluminium, calcium, magnesium or zinc (for indigestion and stomach ulcers).

•    Sucralfate (used in the treatment of peptic ulcers).

•    Quinapril (to treat high blood pressure and heart failure).

•    Carbamazepine (for bipolar disorder)

•    Phenobarbital, primidone, phenytoin (for epilepsy and/or seizures).

•    Ciclosporins (given after transplant operations, for severe rheumatoid arthritis or skin conditions).

•    Anticoagulants such as warfarin (to prevent blood clots).

•    Diuretics (water tablets).

•    Ergotamine or ergometrine (used to treat migraines).

•    Retinoids such as acitretin (used to treat skin conditions).

•    Alpha-blockers or angiotensin-II antagonists used to treat high blood pressure (e.g. prazosin or telmisartan).

•    Iron-containing compounds.

If you are going to have an anaesthetic tell the doctor or dentist that you are taking doxycycline.

Women using the contraceptive pill to avoid pregnancy should use an alternative form of contraception while taking antibiotics including doxycycline.

Taking Doxylar Capsules with food and drink

You should not take Doxylar Capsules at the same time as food, milk and milk products as this can affect the absorption of this medicine.

Pregnancy and breast-feeding

You should not take Doxylar Capsules if you are pregnant or breastfeeding. Ask yo ur doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients in Doxylar Capsules

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

3. How to take Doxylar Capsules

Always take Doxylar Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsules one hour before or two hours after meals with plenty of water. Take the capsules whilst standing or sitting in an upright position and do not take them just before going to bed.

Adults and children over 12 years of age:

200 mg on the first day (as a single dose or divided into 2 equal doses, 12 hours apart), followed by a maintenance dose of 100 mg per day. For more severe infections (particularly chronic infections of the urinary tract): 200 mg should be given throughout the treatment.

Sexually transmitted diseases: 100 mg, 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.

Testicular infection: 100 mg, twice a day for 10 days. Primary and secondary syphilis: 300 mg per day, in divided doses, for at least 10 days.

Louse and tick-borne relapsing fevers: A single dose may be prescribed of 100 mg or 200 mg according to severity.

Chloroquine-resistant falciparum malaria: 200 mg per day, for at least 7 days. You may also be prescribed quinine.

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CAPSULES

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