Doxycycline 50mg Capsules

Document: leaflet MAH GENERIC_PL 13931-0027 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Doxycycline 50 mg Capsules Doxycycline 100 mg Capsules

Doxycycline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible effects not listed in this leaflet. see section 4.

What is in this leaflet:

1. What Doxycycline is and what it is used for

2. What you need to know before you take Doxycycline

3. How to take Doxycycline

4. Possible side effects

5. How to store Doxycycline

6. Contents of the pack and other information

1. WHAT DOXYCYCLINE IS AND WHAT IT IS USED FOR

Doxycycline belongs to a group of medicines called tetracycline antibiotics. It is also known as a broad-spectrum antibiotic and may be used to treat a wide range of infections caused by bacteria, these include:

• Respiratory track infections.

• Urinary tract infections

• Sexually transmitted diseases

• Skin infections such as Acne

• Infections of the eye

• Rickettsial infections such as Q fever or tick fever

• Other infections such malaria, cholera, brucellosis, leptospirosis,

• psittacosis and fevers caused by lice or ticks. or prevent:

• travellers diarrhoea, scrub typhus and leptospirosis.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXYCYCLINE

Do not take Doxycycline if you:

• are allergic to doxycycline, other similar antibiotic ( such as minocycline or tetracycline) or any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Doxycyline 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 sunlight

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

Children and adolescents

Doxycycline capsules 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

Other medicines and Doxycycline

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Warfarin or other anticoagulants (to stop blood clotting).

• Penicillin or rifampicin ( to treat infections).

• Medicines such as Antacids containing aluminium, calcium or magnesium, or other medicines containing iron, bismuth, zinc salts. Do not take at the same time as Doxycycline, as absorption of doxycycline may be reduced.

• Carbamazepine, phenytoin or primidone (to treat epilepsy)

• Methoxyflurane (an anaesthetic), if you need an operation, tell your doctor or dentist you are taking Doxycycline capsules

• Cyclosporin (used following organ transplants).

Pregnancy and breast-feeding

If you are pregnant, breastfeeding, think or may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine as doxycycline could harm the baby.

Important information about some of the ingredients of Doxycycline

Doxycycline 50 mg Capsules contain the colouring agent sunset yellow (E110) which may cause allergic reactions.

3. HOW TO TAKE DOXYCYCLINE

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

You should not drink alcohol whilst taking Doxycycline capsules, speak to your doctor if you have any questions.

Swallow the capsules whole with a full glass of water, if the capsules irritate your stomach take them with food or milk. You should take the capsules either sitting down or standing up and well before you go to bed for the night to stop irritation and ulceration of your gullet. It is important not to lie down for at least thirty minutes after taking Doxycycline capsules.

The recommended dose is for at least 10 days unless otherwise directed by your doctor:

Adults, Elderly and Children 12 years or over:

General infections:

200mg on the first day as a single or two 100mg doses, followed by 100mg a day. For severe infections your doctor may increase the dose to 200mg a day.

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.

• Fevers 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 infection with scrub typhus - 200mg as a single dose.

• Prevent traveller’s 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.

If you take more Doxycycline 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 Doxycycline

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 Doxycycline

Do not stop taking Doxycycline because toy feel better, it is very important to take all the capsules your doctor has prescribed for you, if you do not your condition may recur or get worse.

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 capsules 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 sun bed).

Contact your doctor at once if the following reaction happens:

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).

• swollen tongue, watery diarrhoea, fever and cramps (pseudomembranous colitis), soreness and itching around the back passage and/or of the rectal and/or genital area, inflammation around the vagina, or thrust 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), Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers), toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

• Glands and hormones: discolouration of thyroid tissue (does not affect thyroid function).

• Central nervous system: 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.

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

• Liver: changes in liver function tests

• Skin: detachment of the nail from the nail bed.

• Muscles and bones: muscle or joint pain.

• Kidneys: an increase in urea in the blood.

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, Website: www.mhra.gov.uk/yellowcard

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

5. HOW TO STORE DOXYCYCLINE

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Doxycycline after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Doxycycline contains

• The active substance (the ingredient that makes the capsule work) is doxycycline hyclate.

Each Doxycycline 50 mg Capsule contains 50 mg of the active substance doxycycline.

• The other ingredients are microcrystalline cellulose, talc, magnesium stearate, colloidal anhydrous silica and sodium lauryl sulphate. The capsule shell is made of gelatin. The colouring agents used in the capsule shell are titanium dioxide (E171), quinoline yellow (E104) and sunset yellow (E110).

• The active substance (the ingredient that makes the capsule work) is doxycycline hyclate.

Each Doxycycline 100 mg Capsule contains 100 mg of the active substance doxycycline.

What Doxycycline looks like and the contents of the pack

Doxycycline 50 mg Capsules are white and yellow.

They are available in the following pack sizes: 8, 16 and 28 capsules.

Not all pack sizes may be marketed.

Doxycycline 100 mg Capsules are white and blue.

They are available in the following pack sizes: 8, 16, 28 and 50 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.

The distributor is Chanelle Medical U.K. Ltd.

This leaflet was last revised in 07/2016

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