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Periostat – US: Vibramycin (Doxycycline) 20 mg film-coated tablets

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What Periostat [Vibramycin] is and what it is taken for

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Periostat [Vibramycin] belongs to a group of medicines called tetracyclines. Tetracyclines are a type of antibiotic although the very small dose of doxycycline contained in Periostat [Vibramycin] is not high enough for Periostat [Vibramycin] to act as an antibiotic.

Periostat [Vibramycin] tablets are used in the treatment of periodontitis (a condition of the gums which can cause teeth to become loose or fall out).

The standard treatment for periodontitis is a scaling and root planing carried out by your dentist or dental hygienist. Periostat [Vibramycin] is then prescribed by your dentist as an additional treatment. The oral hygiene routine explained by your dentist or dental hygienist should continue at the same time.

The periodontium, which is made up of collagen fibres, is the part of the gum that gives support to each tooth and it is this part that is affected by periodontitis. Periodontitis is caused by the presence of bacteria at the gum line which can cause inflammation and infection of the gum.

The body’s immune system makes special cells to fight the gum infection. The body releases enzymes into the gums which break down the collagen fibres around the tooth and allows these special cells to get to the site of infection. Unfortunately, although the enzymes are part of the body’s own defence system, they actually damage the gum. This can cause teeth to become loose or even fall out. Diagram 1 explains the causes of periodonitis.

Periostat [Vibramycin] reduces the effect of the collagenase enzymes. This can make your gums healthier and increase the stability of your affected teeth.

Check before you take Periostat [Vibramycin]

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Do not take Periostat [Vibramycin]:

  • if you are allergic (hypersensitive) to doxycycline (or any other tetracycline antibiotic e.g. oxytetracycline, tetracycline, chlortetracycline, demeclocycline or minocycline) or any of the ingredients of Periostat [Vibramycin] (see Section 6 Further information)
  • if you are pregnant or think you might be pregnant
  • if you are planning to become pregnant
  • if you are breast-feeding
  • if you have achlorhydria (lack of acid in the stomach)
  • if you suffer from phototoxicity (skin rashes caused by sunlight). Stop taking Periostat [Vibramycin] if this happens and consult your doctor.

Do not give this medicine to children under the age of 12.

If any of the above applies to you, or if you are not sure, speak to your dentist, doctor or pharmacist before you take Periostat [Vibramycin].

Take special care with Periostat [Vibramycin]

Before you take Periostat [Vibramycin] tell your dentist, doctor or pharmacist if:

  1. you have porphyria (a disease which causes stomach pain, constipation, changes in the colour of urine, skin rashes and disturbed behaviour)
  2. you have severe diarrhoea (see Section 4 Possible side effects)
  3. you have myasthenia gravis (a rare muscle weakness disorder)
  4. you have liver problems or are taking medication which may damage your liver (see Section 4 Possible side effects)
  5. you have thrush (a yeast infection caused by Candida)
  6. you are intolerant to some sugars (see Important information about some of the ingredients of Periostat [Vibramycin])
  7. you have systemic lupus erythematosus (SLE). An allergic condition which causes joint pain, skin rashes and fever (see Section 4 Possible side effects)
  8. you have acne and you are taking any medicine containing isotretinoin (see Taking other medicines)
  9. you have diabetes and are taking sulfonylurea agents (see Taking other medicines)
  10. you are about to have surgery under anaesthetic (see Taking other medicines).

If any of the above applies to you, or if you are not sure, speak to your dentist, doctor or pharmacist before you take Periostat [Vibramycin].

Taking other medicines

Tell your dentist, doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Periostat [Vibramycin]:

aluminium containing products (used to neutralise acid in your stomach)
zinc containing products (used to treat low zinc levels)
calcium containing products (used to treat low calcium levels or as an antacid)
anti-coagulant medication for example warfarin (used to thin the blood)
penicillin or rifampicin (antibiotics to treat infections)
antacids (used to neutralise acid in your stomach)
iron containing products (used to treat low iron levels)
bismuth containing products (used to treat stomach ulcers)
sucralfate-containing products (used to treat stomach ulcers)
activated charcoal (used to treat poisoning)
cholestyramine (used to reduce cholesterol levels and prevent heart disease, to treat itching due to liver problems and diarrhoea)  
didanosine tablets (used to treat HIV)  
quinapril (used to treat high blood pressure or heart failure)  
barbiturates, carbamazepine, phenytoin and primidone (medication to control epilepsy)  
ciclosporins (used to suppress your immune system after an organ transplant)  
methoxyflurane (a type of anaesthetic)  
isotretinoin (used to treat acne)  
sulfonylurea agents (used to treat diabetes, e.g. chlorpropamide, glibenclamide, gliclazide, glimepiride, glipizide or gliquidone)  
oral contraceptives (used to prevent pregnancy).  

Please tell your dentist, doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking with food and drink

Periostat [Vibramycin] should be taken at least one hour before meals.

Food containing large amounts of calcium (e.g. milk, dairy products and calcium-containing fruit juices) should be avoided until at least 2 to 3 hours after taking Periostat [Vibramycin].

Consult with your doctor before taking Periostat [Vibramycin] if you regularly drink large amounts of alcohol.

Pregnancy and breast-feeding

Periostat [Vibramycin] should not be used during pregnancy or if you are breast-feeding. Taking Periostat [Vibramycin] during pregnancy may result in permanent discolouration of your child’s teeth.

Periostat [Vibramycin] passes into the milk of breast-feeding mothers and therefore you should not breast-feed whilst taking this medicine.

Driving and using machines

Taking Periostat [Vibramycin] may make you feel sick or dizzy. If you are affected you should not drive or use machines until the effect has worn off.

Important information about some of the ingredients of Periostat [Vibramycin]

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Periostat [Vibramycin]

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Always take Periostat [Vibramycin] exactly as your dentist has told you to. You should check with your dentist, doctor or pharmacist if you are not sure.

The usual dose is one tablet in the morning and one in the evening.

Periostat [Vibramycin] should be taken at least one hour before going to bed for the night and at least one hour before meals. Try and take the medication at the same times each day.

The tablets should be swallowed with a drink of water in the sitting or standing position followed by plenty of fluid. Do not lie down immediately after taking the tablet.

Periostat [Vibramycin] is usually taken for a minimum of 3 months and can be taken for up to 9 months at a time. It is important that you continue to take Periostat [Vibramycin] until your dentist tells you to stop.

What to do if you take more Periostat [Vibramycin] than you should

If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor.

If you forget to take Periostat [Vibramycin]

Do not worry. If you forget to take a dose, just take the next dose as normal. DO NOT take a double dose. Then go on as before.

If you stop taking Periostat [Vibramycin]

Complete the prescribed course unless otherwise directed by your dentist or doctor.

If you have any further questions on the use of this product, ask your dentist, doctor or pharmacist.

Possible side effects

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Like all medicines, Periostat [Vibramycin] can cause side effects, although not everybody gets them.

Contact your doctor or dentist immediately if:

  • you have a severe allergic reaction which includes sudden wheeziness, chest pain, difficulty in breathing, sudden swelling, fever, skin rash or itching (see Section 2 Check before you take Periostat [Vibramycin])
  • you have severe headaches together with disturbed vision. This may mean you have increased pressure in the brain
  • you have diarrhoea which is watery or contains blood (see Section 2 Check before you take Periostat [Vibramycin])
  • you suspect you have a problem with your liver (this may cause yellowing of the skin or whites of the eyes and/or severe stomach pains) (see Section 2 Check before you take Periostat [Vibramycin]).
  • you have Stevens-Johnson syndrome (a serious illness which causes blistering of the skin, lining of the mouth, throat, eyes and genitals).

Very common side effects (more than 1 in 10 patients) of Periostat [Vibramycin] include:

  • headache
  • common cold
  • flu like symptoms (such as fever).

Common side effects (more than 1 in 100 patients) of Periostat [Vibramycin] include:

  • acid indigestion (heartburn)
  • feeling sick
  • diarrhoea
  • indigestion
  • rash
  • sinusitis (inflammation of the nasal passages), coughing and bronchitis
  • tooth abscess
  • sore throat and sinus headache
  • toothache, pain of any sort, joint and back pain
  • period pains
  • infection (e.g. thrush).

Uncommon side effects (more than 1 in 1000 patients) of Periostat [Vibramycin] include:

  • muscle and gum pain
  • flaking or peeling of the skin.

Rare side effects (more than 1 in 10,000 patients) of Periostat [Vibramycin] include:

  • vaginal and anal thrush (causing soreness and/or itching of the rectal and/or genital area) and oral thrush (causing pale patches at the corner of your mouth)

Very rare side effects of Periostat [Vibramycin] include:

  • dizziness
  • stomach pain, constipation, dry mouth and temporary tooth discolouration
  • colitis (inflammation of the intestines which can cause stomach pain, diarrhoea and other symptoms) and pseudomembranous colitis (infection of the intestines which can cause stomach pain, fever and diarrhoea)
  • your skin becoming sensitive to sunlight
  • weakness
  • itching.

Other side effects that have occurred in people taking other tetracyclines similar to Periostat [Vibramycin] are:

  • Blood disorders. These are due to an imbalance in numbers of different cell types in the blood. Symptoms may include tiredness, easy bruising, nose bleeds or susceptibility to infection.
  • Lack or loss of appetite, inflammation of the tongue and difficulty in swallowing.
  • Inflammation and/or ulcers of the gullet (food pipe). This can be avoided by taking Periostat [Vibramycin] in an upright position with water (see Section 3 How to take Periostat [Vibramycin]).
  • Increase in blood urea (this is detected by a blood test).

If you suffer from a disease called systemic lupus erythematosus (SLE), an allergic condition which causes joint pain, skin rashes and fever you may notice your condition gets worse.

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your dentist, doctor or pharmacist.

How to store Periostat [Vibramycin]

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Keep out of the reach and sight of children.

Do not use Periostat [Vibramycin] after the expiry date {EXP mm yyyy} which is stated on the white container or blister pack. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not remove the tablets from the container or blister pack until you are ready to take the medicine. When tablets are supplied in a white container, always ensure the desiccant is returned to the container, and the container tightly closed after each dose is removed. Do not swallow the desiccant, and should this occur, contact your dentist or doctor immediately.

Do not take Periostat [Vibramycin] if you notice the appearance of the tablets has changed in any way.

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.

Further information

What is in Periostat [Vibramycin]?

The active ingredient in this medicine is doxycycline hyclate.

Each tablet contains 23.08 mg doxycycline hyclate equivalent to 20 mg doxycycline. The other ingredients are:

  • tablet core: microcrystalline cellulose, magnesium stearate
  • film-coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and triacetin.

What Periostat [Vibramycin] looks like and contents of the pack

Periostat [Vibramycin] tablets are white to off-white round tablets imprinted on one side with PS-20.

Periostat [Vibramycin] tablets are supplied in either blister packs contained in a carton (28 or 56 tablets) or in a white container, with a child resistant closure (60 tablets). Not all pack sizes may be marketed.

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