VIBRAMYCIN-D 100 MG DISPERSIBLE TABLETS - patient leaflet, side effects, dosage

Patient leaflet - VIBRAMYCIN-D 100 MG DISPERSIBLE TABLETS

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.

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

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) Rocky Mountain spotted fever, 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 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

*You should not use Vibramycin-D during periods of tooth development (pregnancy, infancy or in children below 8 years old) as such use may lead to permanent discolouration (yellow-grey-brown).

There may be circumstances (e.g. severe or life threatening conditions), where your physician may decide that the benefits outweigh this risk in children below 8 years and Vibramycin-D should be prescribed.

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 an immune system disease that causes joint pain, skin rashes and fever (systemic lupus erythematosus). The condition may be worsened by taking Vibramycin-D.
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)

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.

k Children aged 8 years to less than 12 years

Doxycycline for the treatment of acute infections in children aged 8 years to less than 12 years should be used in situations where other drugs are not available or are not likely to be effective. In such circumstances, the usual doses are:

- For children 45 kg or less

First day: 4.4 mg for each kg of bodyweight (in single or 2 divided doses) then 2.2 mg for each kg of bodyweight (in single or 2 divided doses) from the second day. The length of treatment is dependent on the infection being treated.

In more severe infections, up to 4.4 mg for each kg of bodyweight should be given throughout treatment.

- For children over 45 kg

Dose administered for adults should be used; 200mg on the first day, then 100 mg daily. The length of treatment is dependent on the infection being treated.

- Adults and children aged 12 years to less than 18 years

200mg on the first day, then 100 mg daily. The length of treatment is dependent on the infection being treated.

k Acne

Half a tablet daily for 6–12 weeks, with food or a drink.

k Sexually Transmitted Diseases

1 tablet twice daily for 7 – 10 days.

k Primary and Secondary Syphilis

2 tablets twice daily for 2 weeks. Your doctor will continue to monitor you after your treatment has stopped.

k Fevers associated with louse or tick bites

Single dose of one or two tablets depending on severity.

k Treatment of malaria, when chloroquine is not effective

2 tablets daily for at least 7 days.

k Prevention of malaria

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

k Prevention of scrub typhus

Single dose of 2 tablets.

k 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.

k 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.

Adults: 100 mg every 12 hours. Children: weighing less than 45 kg: 2.2 mg/kg body weight given twice a day. Children weighing 45 kg or more should receive the adult dose. Patients should be treated for at least 3 days after the fever subsides and until there is evidence of clinical improvement. Minimum course of treatment is 5–7 days.

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. The possible symptoms in benign intracranial hypertension include headache, vomiting, visual disturbances including blurred vision, a localized defect in the visual field bordered by an area of normal vision (scotoma), double vision (diplopia), and possible vision loss, in some cases, even permanent.
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
darker patches on your skin

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: 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.

Manufacturer:

Manufactured by: Famar S.A., Anthoussa, Greece. Procured from within the EU and repackaged by the Product Licence Holder: G-Pharma Ltd, Salford M50 2PU. -------

POM PL No. 16369/1578 -------

Vibramycin-D 100mg Dispersible Tablets Revision date: 07/08/2020

Vibramycin is a trademark of Pfizer.

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5. how to store vibramycin-d

6. contents of the pack and other information- 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.