VIBRAMYCIN D 100MG DISPERSIBLE TABLETS

Active substance: DOXYCYCLINE MONOHYDRATE

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S1642 LEAFLET Vibramycin 20120221

PACKAGE LEAFLET: INFORMATION FOR THE USER

VIBRAMYCIN-D 100 mg DISPERSIBLE TABLETS
(doxycycline)

Take special care with Vibramycin-D:
You should tell your doctor before you take Vibramycin-D if any of
the following apply to you:


The name of your medicine is Vibramycin-D 100mg Dispersible
Tablets but will be referred to as Vibramycin-D throughout the
following leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

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).



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.





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

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.





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.

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.



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

In this leaflet:
1. What Vibramycin-D is and what it is used for
2. Before you take Vibramycin-D

Taking other medicines
If you are taking any of the medicines listed below tell your doctor
before taking Vibramycin-D.

3. How to take Vibramycin-D

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

4. Possible side effects



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).

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:

Vibramycin-D can affect the action of some other medicines, these
include:


Increased action of warfarin or coumarins (used to prevent
blood clots).



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





Reduced effectiveness of oral contraceptives (birth control
pills).

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





Reduced effectiveness of penicillin antibiotics (used to treat
infections).

Acne (a skin condition).





Eye infections.

Increased blood levels of ciclosporin (a medicine used to affect
the body’s immune response).



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.

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
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



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.

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:


 Prevention of scrub typhus

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.

Single dose of 2 tablets.



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 (inflammation 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.

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

 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 any of these side effects get serious, or you notice side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE VIBRAMYCIN-D


Keep all medicines out of the reach and sight of children.



Do not store above 25°C.



Do not use Vibramycin-D after the expiry date which is stated
on the carton after EXP. 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 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.

6. FURTHER INFORMATION
What Vibramycin-D contains


Each dispersible tablet contains 100mg doxycycline as
doxycycline monohydrate.



The other ingredients are: Colloidal silicone dioxide,
microcrystalline cellulose, magnesium stearate, quinoline yellow
aluminium lake (E104) and Indigotin aluminium lake (E132)
What Vibramycin-D looks like and contents of the pack
Vibramycin-D Dispersible tablets are green round tablets marked
‘Pfizer’ on one side and plain on the other side.
Vibramycin-D Dispersible tablets come in blister packs of 8.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



Skin rash, or flaking or peeling of the skin.



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

This product is manufactured by Famar ABE, B Lab. Anthousa,
Greece.



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.

Leaflet revision date: 21 February 2012



Very severe headache which may be associated with visual
disturbance such as blurred vision or loss of vision.

POM

PL No: 19488/1642

Vibramycin is a registered trademark of Pfizer Ltd.
S1642 LEAFLET Vibramycin 20120221

S1642 LEAFLET Doxycycline 20120221

PACKAGE LEAFLET: INFORMATION FOR THE USER

DOXYCYCLINE 100 mg DISPERSIBLE TABLETS

Take special care with Doxycycline Tablets:
You should tell your doctor before you take Doxycycline Tablets if
any of the following apply to you:


The name of your medicine is Doxycycline 100mg Dispersible
Tablets but will be referred to as Doxycycline Tablets throughout
the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

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).



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.





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

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.





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.

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.



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

In this leaflet:
1. What Doxycycline Tablets are and what they are used for
2. Before you take Doxycycline Tablets

Taking other medicines
If you are taking any of the medicines listed below tell your doctor
before taking Doxycycline Tablets.

3. How to take Doxycycline Tablets

Some medicines can reduce the effectiveness of Doxycycline
Tablets, these include:

4. Possible side effects



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



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

5. How to store Doxycycline Tablets
6. Further information
1. WHAT DOXYCYCLINE TABLETS ARE AND WHAT THEY ARE
USED FOR
Doxycycline Tablets are antibiotics 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.

Doxycycline Tablets are 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 Doxycycline Tablets to treat
another infection not listed above. You may also be prescribed an
additional medicine to take with Doxycycline Tablets to treat your
infection. If you have any questions talk to your doctor.
2. BEFORE YOU TAKE DOXYCYCLINE TABLETS
Do not take Doxycycline Tablets 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.



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



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 Doxycycline Tablets with food or drink
For the treatment of infections, Doxycycline Tablets 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 Doxycycline Tablets upset your stomach then taking it with food
or milk is recommended.
Alcohol may reduce the effect of Doxycycline Tablets and should be
avoided.
Pregnancy and breast-feeding
Doxycycline Tablets must not be taken if you are pregnant or
breast-feeding.
Driving and using machines

you are breast feeding.



Doxycycline Tablets can affect the action of some other medicines,
these include:

You should not use Doxycycline Tablets 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.

This medicine should not affect your ability to drive or use
machines.
3. HOW TO TAKE DOXYCYCLINE TABLETS


Take Doxycycline 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 Doxycycline 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 Doxycycline Tablets 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
Doxycycline Tablets 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
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



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.

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:


 Prevention of scrub typhus

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.

Single dose of 2 tablets.



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 (inflammation 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.

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

 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 Doxycycline Tablets 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 Doxycycline Tablets than you should
If you take too much Doxycycline Tablets contact your doctor or
nearest hospital Casualty Department immediately. Always take the
labelled medicine package with you, whether there is any
Doxycycline Tablets left or not.
If you forget to take Doxycycline Tablets
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 any of these side effects get serious, or you notice side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DOXYCYCLINE TABLETS


Keep all medicines out of the reach and sight of children.



Do not store above 25°C.



Do not use Doxycycline Tablets after the expiry date which is
stated on the carton after EXP. 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 stop taking Doxycycline Tablets
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 Doxycycline Tablets 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.

6. FURTHER INFORMATION
What Doxycycline Tablets contain


Each dispersible tablet contains 100mg doxycycline as
doxycycline monohydrate.



The other ingredients are: Colloidal silicone dioxide,
microcrystalline cellulose, magnesium stearate, quinoline yellow
aluminium lake (E104) and Indigotin aluminium lake (E132)
What Doxycycline Tablets look like and contents of the pack
Doxycycline tablets are green round tablets marked ‘Pfizer’ on one
side and plain on the other side.
Doxycycline Tablets come in blister packs of 8.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



Skin rash, or flaking or peeling of the skin.



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

This product is manufactured by Famar ABE, B Lab. Anthousa,
Greece.



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.

Leaflet revision date: 21 February 2012



Very severe headache which may be associated with visual
disturbance such as blurred vision or loss of vision.

POM

PL No: 19488/1642
S1642 LEAFLET Doxycycline 20120221

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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