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PERIOSTAT 20MG FILM COATED TABLETS

Active substance(s): DOXYCYCLINE HYCLATE

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PATIENT INFORMATION LEAFLET

PERIOSTAT® 20 mg film-coated tablets
doxycycline
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 dentist, 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 dentist, doctor or
pharmacist.
The information in this leaflet has been divided into the
following sections:
1. What Periostat is and what it is taken for
2. Check before you take Periostat
3. How to take Periostat
4. Possible side effects
5. How to store Periostat
6. Further information
1. What Periostat is and what it is taken for
Periostat belongs to a group of medicines called tetracyclines.
Tetracyclines are a type of antibiotic although the very small dose
of doxycycline contained in Periostat is not high enough for
Periostat to act as an antibiotic.
Periostat 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 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.
Diagram 1: The causes of periodontitis
plaque

Plaque and bacteria
accumulate on the
tooth near the gum

Destructive enzymes
(collagenase)

The body releases
enzymes into the gum

Tissue damage results from
too much collagenase

The enzymes destroy
the tissues supporting
the tooth

Periostat reduces the effect of the collagenase enzymes. This can
make your gums healthier and increase the stability of your
affected teeth.
Diagram 2 explains how scaling and root planing with the addition
of Periostat treats periodontitis.
Diagram 2: How scaling and root planing with Periostat treats periodontitis
Remove bacteria
with scaling and
root planing

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:
• aluminium containing (used to neutralise acid in your stomach)
products
• zinc containing
(used to treat low zinc levels)
products
• calcium containing
(used to treat low calcium levels or as an
products
antacid)
• anti-coagulant
for example warfarin (used to thin the
medication
blood)
• penicillin or rifampicin (antibiotics to treat infections)
• antacids
(used to neutralise acid in your stomach)
• iron containing
(used to treat low iron levels)
products
• bismuth containing (used to treat stomach ulcers)
products
• sucralfate-containing (used to treat stomach ulcers)
products
• activated charcoal
(used to treat poisoning)
• colestyramine
(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,
(medication to control epilepsy)
carbamazepine,
phenytoin and
primidone
• 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.

The activity of the
destructive enzymes
is then reduced by
Periostat

Scaling & root planing with
Periostat

Take special care with Periostat
Before you take Periostat tell your dentist, doctor or pharmacist if:
• you have porphyria (a disease which causes stomach pain,
constipation, changes in the colour of urine, skin rashes and
disturbed behaviour)
• you have severe diarrhoea (see Section 4 Possible side effects)
• you have myasthenia gravis (a rare muscle weakness disorder)
• you have liver problems or are taking medication which may
damage your liver (see Section 4 Possible side effects)
• you have thrush (a yeast infection caused by Candida)
• you are intolerant to some sugars (see Important information
about some of the ingredients of Periostat)
• you have systemic lupus erythematosus (SLE). An allergic
condition which causes joint pain, skin rashes and fever (see
Section 4 Possible side effects)
• you have acne and you are taking any medicine containing
isotretinoin (see Taking other medicines)
• you have diabetes and are taking sulfonylurea agents (see
Taking other medicines)
• 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.

The body works to restore
the damaged tissue making
teeth more stable

2. Check before you take Periostat
Do not take Periostat:
• 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 (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 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.

Taking with food and drink
Periostat 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.
Consult with your doctor before taking Periostat if you regularly
drink large amounts of alcohol.
Pregnancy and breast-feeding
Periostat should not be used during pregnancy or if you are breastfeeding. Taking Periostat during pregnancy may result in
permanent discolouration of your child’s teeth.
Periostat 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 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
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.

3. How to take Periostat
Always take Periostat 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 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 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 until your dentist tells you to stop.
What to do if you take more Periostat 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.

• 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 in an upright position with water
(see Section 3 How to take Periostat).
• 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.
• Separation or loosening of a fingernail or toenail from its nail
bed following exposure to sunlight or ultraviolet rays
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.
You can also report side effects directly via the internet at
www.mhra.gov.uk/yellowcard or call Freephone 0808 100 3352.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Periostat

If you forget to take Periostat
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
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.
4. Possible side effects
Like all medicines, Periostat 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)
• 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)
• 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)
• 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
include:
• headache
• common cold
• flu like symptoms (such as fever).
Common side effects (more than 1 in 100 patients) of Periostat
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).

Keep out of the reach and sight of children.
Do not use Periostat 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 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.
6. Further information
What is in Periostat?
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 looks like and contents of the pack
Periostat tablets are white to off-white round tablets imprinted on
one side with PS-20.
Periostat 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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is: Alliance Pharmaceuticals
Limited, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.
Periostat is manufactured by: Chanelle Medical, Loughrea, Co.
Galway, Ireland and TD Packaging Ltd, Unit 6, Stephenson Road,
Groundwell Industrial Estate, Swindon, Wiltshire, SN25 5AX, UK.
The information in this leaflet applies only to Periostat. If you have
any questions or you are not sure about anything, ask your dentist,
doctor or a pharmacist.
This leaflet was last revised: November 2013.
Periostat is a registered trademark of Alliance Pharmaceuticals
Limited.
Alliance and associated devices are registered trademarks of
Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2013.

Uncommon side effects (more than 1 in 1000 patients) of Periostat
include:
• muscle and gum pain
• flaking or peeling of the skin.
Rare side effects (more than 1 in 10,000 patients) of Periostat
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 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 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.
LA5130

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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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