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VIBRAMYCIN D DISPERSIBLE TABLETS 100MG

Active substance(s): DOXYCYCLINE

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Package leaflet: Information for the user • Acne (a skin condition)
UNITED KINGDOM

Vibramycin®-D 100 mg
Dispersible Tablets

Doxycycline (as doxycycline monohydrate)

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.
2.
3.
4.
5.
6.

What Vibramycin-D is and what it is used for
What you need to know before you take Vibramycin-D
How to take Vibramycin-D
Possible side effects
How to store Vibramycin-D
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

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).

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 (including medicines you have obtained
without a prescription). 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.



• 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. You must
talk to your doctor 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.

 
Acne

Half a tablet daily for 6-12 weeks, with food or a drink.
You will find more about Vibramycin-D
on the back of this leaflet



 
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
disturbances such as blurred vision, double vision or loss of vision.
Permanent visual loss has been reported.
• 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.
• The Jarisch-Herxheimer reaction which causes fever, chills,
headache, muscle pain, and skin rash that is usually self-limiting. This
occurs shortly after starting doxycycline treatment for infections with
spirochete such as Lyme disease.
• 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
• anxiety
• 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 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 or search for MHRA Yellow card in the Google
Play or Apple App Store. 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
blister and carton 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
dispersible 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 tablets are light yellow round tablets scored on one side
and marked VN on the other side.
Vibramycin-D tablets come in cartons containing a blister strip of 8
tablets.

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
This leaflet was last revised in 01/2018.
Ref: VM 19_0

+ Expand Transcript

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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