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VIBRAMYCIN D 100MG DISPERSIBLE TABLETS

Active substance(s): DOXYCYCLINE / DOXYCYCLINE MONOHYDRATE / DOXYCYCLINE / DOXYCYCLINE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

VIBRAMYCIN®-D 100mg DISPERSIBLE TABLETS /
DOXYCYCLINE 100mg DISPERSIBLE TABLETS
(doxycycline)
This medicine is available as either of the above names but will be referred to as Vibramycin-D throughout
the following leaflet
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
Vibramycin-D contains the active substance doxycycline as doxycycline monohydrate. Vibramycin-D 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. You must talk to your
doctor 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 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
• 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 any of the following apply to you:
• 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.
• you have kidney or liver problems.
• you have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain
muscles, particularly in the eyelid).
• you have porphyria (a rare disease of blood pigments).
• 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.
• you are suspected as having syphilis. Your doctor will continue to monitor you after your treatment has
stopped.
• 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 (pseudomembranous colitis) which can occur following
treatment with antibiotics.
• you are taking oral retinoids as there is a higher risk of suffering from increased pressure in your skull
(severe headache with change in vision) when taken with Vibramycin-D.
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. If
you are taking any of the medicines listed below tell your doctor before taking Vibramycin-D.
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.
Taking Vibramycin-D with food, drink and alcohol
Please see section 3 how to take Vibramycin-D.
Alcohol may reduce the effect of Vibramycin-D and should be avoided.
Pregnancy and 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.
Vibramycin-D must not be taken if you are pregnant or breast-feeding.
Driving and using machines
This medicine should not affect your ability to drive or use machines.
3. HOW TO TAKE VIBRAMYCIN-D
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your
doctor or pharmacist if you are not sure.
• Take Vibramycin-D tablets by letting the tablet break up in a small amount of water. Do not swallow the
tablet without letting it break up in water first.
• It is best to take your tablets at the same time(s) each day, when sitting or while standing.
• It is important not to lie down for at least thirty minutes after taking Vibramycin-D tablets, so that the tablet
can move as swiftly as possible into the stomach and prevent irritation of the throat or oesophagus (canal
taking food from the mouth to the stomach).
• For the treatment of infections, Vibramycin-D can be taken with or without food.
• For the treatment of acne, it is recommended to take Vibramycin D with food or a drink.
• If Vibramycin-D upsets your stomach then taking it with food or milk is recommended.
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)
2 tablets on the first day, then 1 tablet daily. The length of treatment is dependent on the infection being
treated.
• 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 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 can cause side effects although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you experience any of the following
serious side effects after taking this medicine. Although they are very rare, the symptoms can be severe.
• Sudden wheeziness, difficulty in breathing, chest pain, fever, swelling of eyelids, face or lips, rash or
itching (especially affecting the whole body).
• Upset stomach, loss of appetite, severe, persistent or bloody diarrhoea (this may occur up to two or three
months after the last dose and may be associated with stomach pain or fever). This may occur after
treatment with antibiotics and can be a sign of serious bowel inflammation.
• Fever, swollen lymph nodes or skin rash. These may be symptoms of a condition known as DRESS
(Drug Reaction with Eosinophilia and Systemic Symptoms) and can be severe and life-threatening.
• Very severe headache which may be associated with visual disturbance such as blurred vision or loss of
vision.
• Serious illness with widespread severe blistering of the skin, mouth, eyes and genitals.
If any of the side effects listed below occur, contact your doctor as soon as possible.
• 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.
• 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.
• Stomach pain and diarrhoea.
The side effects listed below 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 feverheadache
• pericarditis (inflammation affecting the heart)
Uncommon: may affect up to 1 in 100 people
• heartburn
• vaginal infection
Rare: may affect up to 1 in 1,000 people
• 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
• inflammation of the bowel
• bulging fontanelles (soft spot on head) of infants
• increased pressure in the skull (severe headache with change in vision)
• 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
• yellow skin and eyes (jaundice), inflammation of the pancreas
• upset stomach, loss of appetite, diarrhoea (this may occur up to two or three months after the last dose),
stomach pain
Not known: frequency cannot be estimated from the available data
• discolouration and/or lack of growth of teeth
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 VIBRAMYCIN-D
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use after the expiry date which is stated on the carton after EXP. The expiry date refers to the last
day of that month.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your
pharmacist who will tell you what to do.
• 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 Vibramycin-D contains
Each dispersible tablet contains 100mg doxycycline.
The other ingredients are: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, quinoline
yellow aluminium lake (E104) and aluminium lake indigo (E132).
What Vibramycin-D looks like and contents of the pack
Vibramycin-D is light green speckled round tablets marked "PFIZER" on one side and plain on the other side.
Vibramycin-D is available in blister packs of 8 tablets.
PL: 15814/1122
POM
Manufactured by Famar ABE, Anthousa, Greece. Procured from within the EU and repackaged by the
Product Licence Holder: OPD Laboratories Ltd., Colonial Way, Watford, Herts WD24 4PR.
Vibramycin is a registered trademark of Pfizer Limited.
Leaflet revision and issue date (ref): 25.01.2017.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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