Package leaflet: Information for the patient

UNITED KINGDOM

Vibramycin-D 100 mg

Dispersible Tablets

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 side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Vibramycin-D is and what it is used for

2.    What you need to know before you take Vibramycin-D

3.    How to take Vibramycin-D

4.    Possible side effects

5.    How to store Vibramycin-D

6.    Contents of the pack and other information

1. What Vibramycin-D is and what is it used for

This medicine contains doxycycline, which is an antibiotic belonging to a group of medicines called tetracyclines. It is used to treat many different types of infections including:

•    Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis.

•    Urinary tract infections (the passage through which urine passes) e.g. cystitis, urethritis.

•    Acne (a skin condition).

•    Eye infections.

•    Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia.

•    Fevers associated with louse or tick bites.

•    Malaria, when chloroquine is not effective.

Vibramycin-D is also used to prevent certain infections developing, these are scrub typhus (a disease carried by small insects) travellers’ diarrhoea, malaria and leptospirosis (a bacterial infection).

Your doctor may want you to take Vibramycin-D to treat another infection not listed above. You may also be prescribed an additional medicine to take with Vibramycin-D to treat your infection. Talk to your doctor if you have any questions, if you do not feel better or if you feel worse.

2. What you need to know before you take Vibramycin-D

Do not take Vibramycin-D:

•    If you are allergic (hypersensitive) to doxycyline 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.

•    If the medicine has been prescribed for a child under the age of 12 years.

You should not use Vibramycin-D during periods of tooth

development (pregnancy, infancy or in children below 12

years old) as such use may lead to permanent discolouration

(yellow-grey-brown) or affect the proper growth of the teeth.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vibramycin-D:

•    If you 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.

•    If you have kidney or liver problems.

•    If you have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain muscles, particularly in the eyelid).

•    If you have porphyria (a rare disease of blood pigments).

•    If you have (or have ever had) systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes and fever). This condition may be worsened by taking Vibramycin-D.

•    If you are suspected as having syphilis. Your doctor will continue to monitor you after your treatment has stopped.

•    If you 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 Vibramycin-D tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembraneous colitis) which can occur following treatment with antibiotics.

When used for a long duration, Vibramycin-D 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 Vibramycin-D

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).

Some medicines can reduce the effectiveness of Vibramycin-D, these include:

•    Antacids (indigestion remedies), iron preparations, oral zinc or bismuth. These should not be taken at the same time of day as Vibramycin-D.

•    Carbamazepine, phenytoin (medicines used to control epilepsy) and barbiturates (used to control epilepsy or as a sedative).

Vibramycin-D 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.

Pregnancy and breast-feeding

Do not take Vibramycin-D if you are pregnant, trying to become pregnant or breast-feeding (see section 2).

Driving and using machines

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

3. How to take Vibramycin-D

You will find more about Vibramycin-D on the back of this leaflet

►    Acne

Half a tablet daily for 6-12 weeks, with food or a drink.

►    Sexually Transmitted Diseases

1    tablet twice daily for 7 - 10 days.

►    Primary and Secondary Syphilis

2    tablets twice daily for 2 weeks. Your doctor will continue to monitor you after your treatment has stopped.

►    Fevers associated with louse or tick bites

Single dose of one or two tablets depending on severity.

►    Treatment of malaria, when chloroquine is not effective 2 tablets daily for at least 7 days.

►    Prevention of malaria

1 tablet daily from 1-2 days before travelling to a malarial area until 4 weeks after returning.

►    Prevention of scrub typhus Single dose of 2 tablets.

►    Prevention of travellers’ diarrhoea

1 tablet twice daily on the first day of travel, followed by

1    tablet daily throughout the stay in the area. If you are planning to take these tablets for more than 21 days, please consult your doctor.

►    Prevention of leptospirosis

2    tablets once each week during the stay in the area; 2 tablets on completion of the trip. If you are planning to take these tablets for more than 21 days, please consult your doctor.

You should start to feel better within a few days. If you have been given Vibramycin-D for acne it may be a few weeks before you start to see an improvement. If your infection gets worse or you do not start to feel better within a few days (except for acne), or a new infection develops, go back and see your doctor.

If you take more Vibramycin-D than you should

If you take too much Vibramycin-D contact your doctor or nearest hospital Casualty Department immediately. Always take the labelled medicine package with you, whether there is any Vibramycin-D left or not.

If you forget to take Vibramycin-D

If you forget to take a tablet take it as soon as you can. Take your next tablet at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vibramycin-D

If you stop taking the tablets too soon, the infection may return. Take the tablets for the full time of treatment, even when you begin to feel better.

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 may cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms of an allergic reaction after taking this medicine. Although they are very rare, the symptoms can be severe.

•    Sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings, rash or itching (especially affecting the whole body).

•    Fever, swollen lymph nodes or skin rash. These may be symptoms of a condition known as DRESS (Drug rash with eosinophilia and systemic symptoms) and can be severe and life-threatening.

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

•    Skin rash, or flaking or peeling of the skin.

•    Severe skin reactions which may cause you to feel very unwell.

•    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.

•    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.

•    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.

These 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

•    pericarditis (inflammation affecting the heart)

Uncommon (may affect up to 1 in 100 people):

heartburn

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

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

•    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

•    thrush or fungal infections

•    inflammation of the bowel

•    bulging fontanelles (soft spot on head) of infants

•    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

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

•    increased levels of urea in the blood

•    discolouration and/or lack of growth of teeth

Not known (frequency cannot be estimated from the available data):

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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. How to store Vibramycin-D

Keep this medicine out of the sight and reach of children. Store below 25°C.

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

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 Vibramycin-D contains

The active substance is doxycycline as doxycycline monohydrate. Each tablet contains 100 mg of doxycycline. The other ingredients are: anhydrous colloidal silica, magnesium stearate and microcrystalline cellulose.

What Vibramycin-D looks like and contents of the pack

Vibramycin-D Dispersible tablets are light yellow round tablets scored on one side and marked VN on the other side. Vibramycin-D Dispersible tablets come in blister packs of 8.

Marketing Authorisation Holder

Pfizer Limited

Sandwich

Kent

CT13 9NJ United Kingdom

Manufacturer

Fareva Amboise Zone Industrielle 29 route des industries 37530 Poce-sur-Cisse France

Company Contact Address

For further information on your medicine, contact Medical Information at Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161.

This leaflet was last revised in 03/2016.

Re^f: ^VM 1³_0    MOCK-UP FROM 8807766