Medication Guide App

VIBRAMYCIN D 100MG DISPERSIBLE TABLETS

Active substance: DOXYCYCLINE MONOHYDRATE

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Transcript
Previously assessed against UK PIL dated May 2010
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vibramycin™-D 100mg Dispersible Tablets
(Doxycyline)

MOCK-UP

By rajeevkumarj at 3:35 pm, Oct 22, 2014

This product is available in the above name but will be referred to as
Vibramycin-D throughout the remainder of this leaflet.
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 Vibramycin-D is and what it is used for
2. Before you take Vibramycin-D
3. How to take Vibramycin-D
4. Possible side effects
5. How to store Vibramycin-D
6. Further information
1. What Vibramycin-D is and what is it used for
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. If you
have any questions talk to your doctor.
2. 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 listed in section 6.
 you are pregnant or trying to become pregnant.
 you are breast feeding.
 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-greybrown) or affect the proper growth of the teeth.
Take special care with Vibramycin-D:
You should tell your doctor before you take 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 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.



To correct the misspelt `Dispersable' in the
product name to 'Dispersible'
you are suspected as having syphilis. Your doctor will continue to
monitor you after your treatment has stopped.

Taking 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.
You should tell your doctor if you are taking or have recently taken
any other medicines including those obtained without a prescription.
Taking Vibramycin-D with food or drink
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.
Alcohol may reduce the effect of Vibramycin-D and should be
avoided.
Pregnancy and breast-feeding
Vibramycin-D must not be taken if you are pregnant or breastfeeding.
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.
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. You should check
with your doctor or pharmacist if you are not sure.
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

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 about the use of this product, ask
your doctor or pharmacist for advice.
4. Possible side effects
Like all medicines Vibramycin-D may cause some side effects but
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).
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
disturbance such as blurred vision or loss of vision.
 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.

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.

The side effects listed below are infrequent.
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:
 upset stomach, loss of appetite, diarrhoea (this, may occur up to
two or three months after the last dose), stomach pain,
heartburn, 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.

The following side effects have also been reported:
 Worsening of a disease called systemic lupus erythematous
(SLE). This is an allergic condition which causes joint pain, skin
rash and fever.
 Inflammation of the bowel.
 Bulging fontanelles (soft spot on head) of infants.
 Inflammation and damage to the liver, yellow skin and eyes
(jaundice), inflammation of the pancreas and abnormal
 liver function tests.
 Increased levels of urea in the blood.
 Pericarditis (infl ammation affecting the heart).
 Discolouration and/or lack of growth of teeth.
 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.
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
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 OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 25°C
Do not use Vibramycin-D after the expiry date which is stated on
the 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.
 If you notice signs of your medicine deteriorating, consult your
pharmacist.
6. Further information
What Vibramycin-D contains
 Each dispersible tablet contains 100mg doxycyline
 The other ingredients are colloidal anhydrous silicon dioxide,
microcrystalline cellulose, magnesium stearate, quinoline yellow
aluminium lake E104 & indigo carmine aluminium lake E132.
What Vibramycin-D looks like and contents of the pack
Vibramycin-D Dispersible Tablets are light green, speckled, round
tablets with 'PFIZER' on one side and blank on the reverse.
They are available in blister packs of 8 tablets.
Manufacturer:
This product is manufactured by: Famar S.A., Anthoussa, Greece.
Procured from within the EU. Product Licence Holder:
G-Pharma Ltd, Salford M50 2PU.

POM

PL No. 16369/1578
Vibramycin-D 100mg Dispersable Tablets

Revision date: 24/09/2014
Vibramycin is a trademark of Pfizer.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Vibramycin™-D 100mg Dispersable Tablets
(Doxycyline)
This product is available in the above name but will be referred to as
Vibramycin-D throughout the remainder of this leaflet.
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 Vibramycin-D is and what it is used for
2. Before you take Vibramycin-D
3. How to take Vibramycin-D
4. Possible side effects
5. How to store Vibramycin-D
6. Further information
1. What Vibramycin-D is and what is it used for
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. If you
have any questions talk to your doctor.
2. 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 listed in section 6.
 you are pregnant or trying to become pregnant.
 you are breast feeding.
 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-greybrown) or affect the proper growth of the teeth.
Take special care with Vibramycin-D:
You should tell your doctor before you take 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 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.



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

Taking 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.
You should tell your doctor if you are taking or have recently taken
any other medicines including those obtained without a prescription.
Taking Vibramycin-D with food or drink
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.
Alcohol may reduce the effect of Vibramycin-D and should be
avoided.
Pregnancy and breast-feeding
Vibramycin-D must not be taken if you are pregnant or breastfeeding.
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.
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. You should check
with your doctor or pharmacist if you are not sure.
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

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 about the use of this product, ask
your doctor or pharmacist for advice.
4. Possible side effects
Like all medicines Vibramycin-D may cause some side effects but
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).
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
disturbance such as blurred vision or loss of vision.
 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.

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.

The side effects listed below are infrequent.
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:
 upset stomach, loss of appetite, diarrhoea (this, may occur up to
two or three months after the last dose), stomach pain,
heartburn, 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.

The following side effects have also been reported:
 Worsening of a disease called systemic lupus erythematous
(SLE). This is an allergic condition which causes joint pain, skin
rash and fever.
 Inflammation of the bowel.
 Bulging fontanelles (soft spot on head) of infants.
 Inflammation and damage to the liver, yellow skin and eyes
(jaundice), inflammation of the pancreas and abnormal
 liver function tests.
 Increased levels of urea in the blood.
 Pericarditis (infl ammation affecting the heart).
 Discolouration and/or lack of growth of teeth.
 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.
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
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 OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 25°C
Do not use Vibramycin-D after the expiry date which is stated on
the 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.
 If you notice signs of your medicine deteriorating, consult your
pharmacist.
6. Further information
What Vibramycin-D contains
 Each dispersible tablet contains 100mg doxycyline
 The other ingredients are colloidal anhydrous silicon dioxide,
microcrystalline cellulose, magnesium stearate, quinoline yellow
aluminium lake E104 & indigo carmine aluminium lake E132.
What Vibramycin-D looks like and contents of the pack
Vibramycin-D Dispersible Tablets are light green, speckled, round
tablets with 'PFIZER' on one side and blank on the reverse.
They are available in blister packs of 8 tablets.
Manufacturer:
This product is manufactured by: Famar S.A., Anthoussa, Greece.
Procured from within the EU. Product Licence Holder:
G-Pharma Ltd, Salford M50 2PU.

POM

PL No. 16369/1578
Vibramycin-D 100mg Dispersible Tablets

Revision date: 24/09/2014
Vibramycin is a trademark of Pfizer.

Expand view ⇕

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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