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VIBRAMYCIN D DISPERSIBLE TABLETS 100MG

Active substance(s): DOXYCYCLINE

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Package leaflet: Information for the patient • Acne (a skin condition).
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.

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.

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
• 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).
• If your stomach is upset Vibramycin-D can be taken with
food or milk.
• 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.
• Alcohol may reduce the effect of Vibramycin-D and
should be avoided.
The list below shows the different doses that your doctor may
prescribe depending on the infection being treated. Always
take Vibramycin-D exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.



• 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.

• 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.



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.
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 25ºC.
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 Pocé-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.
Ref: VM 13_0

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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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