Package leaflet: Information for the user
Arestin 1 mg periodontal powder
Minocycline hydrochloride
Read all of this leaflet carefully before you start using 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 dentist, 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 dentist, doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Arestin is and what it is used for
2.
What you need to know before you use Arestin
3.
How to use Arestin
4.
Possible side effects
5.
How to store Arestin
6.
Contents of the pack and other information
1.
What Arestin is and what it is used for
Arestin is an antibiotic that is used in adults to stop bacterial growth in the mouth in cases of chronic
inflammation of the tooth after a dental treatment.
Only professional healthcare workers with experience in dentistry may apply Arestin.
2.
What you need to know before you use Arestin
Do not use Arestin:
if you are allergic to minocycline, other tetracyclines, or any of the other ingredients of this
medicine (listed in section 6)
in children of 12 years or younger
if you are pregnant or breast-feeding
if your liver function is severely impaired
if you have acute or chronic kidney disease.
Warnings and precautions
Talk to your dentist or doctor before using Arestin:
-
If you have liver or kidney problems
If you use certain medicines, especially anticoagulants (blood thinners) or medicines that affect
your liver function
If you have, or have had, a Candida infection (thrush), tell your dentist because the use of
antibiotics can increase the risk of Candida infections in the mouth.
If, prior to a dental procedure, you have been treated with certain antibiotics (betalactam
antibiotics or aminoglycosides) to prevent inflammation of the lining of your heart
(endocarditis), it is possible that minocycline may influence the efficacy of these antibiotics.
Antibiotics of the tetracycline class are known to cause sensitivity reactions of the skin to the sun. The
possibility of such reactions cannot be ruled out for Arestin since the active ingredient in Arestin is a
tetracycline. The treatment should be discontinued immediately if a skin reaction occurs.
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Fertile women should use effective contraceptives during and up to three weeks following
administration of Arestin.
Children
Arestin must not be used to children of 12 years and younger (see also “Do not use Arestin”).
Arestin is not recommended for use in children under the age of 18 years.
Other medicines and Arestin
Tell your dentist or doctor if you are using, have recently used or might use any other medicines, in
particular anticoagulants (blood thinners) or certain antibiotics, (see also “Warnings and precautions”).
This includes medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your dentist or doctor for advice before using this medicine.
Pregnancy
Arestin must not be used during pregnancy.
Breast-feeding
Arestin must not be used whilst breast-feeding.
Fertility
Fertile women should use effective contraceptives during and up to three weeks following
administration of Arestin.
Driving and using machines
Arestin does not affect your ability to drive or use machines.
3.
How to use Arestin
After the tooth has been treated, your dentist will apply Arestin on your teeth.
After the treatment you may not brush your teeth for 12 hours. You must avoid eating hard, crunchy or
tough food for a period of one week, and you should also avoid touching the treated area during this
time. You may not floss around the treated tooth for 10 days following treatment.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is normal for your teeth to be slightly sensitive during the first week after treatment and the use of
Arestin, but if you suffer pain, swelling or other problems you should consult your dentist. Local
hypersensitivity reactions may occur (frequency not known). In the case of itching, swelling, hives,
reddening of the skin, or other signs and symptoms of possible hypersensitivity, you should contact
your dentist immediately.
You should stop taking Arestin and see your doctor immediately if you experience symptoms of
angioedema, such as
- swollen face, tongue or pharynx
- difficulty to swallow
- hives and difficulties to breathe
(frequency not known)
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Other side effects include:
Common (may affect up to 1 in 10 people):
- headache
- disturbed digestion
- infection, flu-like symptoms
- inflammation of the tissue around the tooth, a transient stabbing pain in the oral cavity, toothache,
inflammation of the gum, inflammation of the mucous membrane of the mouth, mouth ulcers, pain,
inflammation of the throat.
Not known (frequency cannot be estimated from the available data):
- nettle rash (urticaria), rash
- swelling of the gums.
Reporting of side effects
If you get any side effects, talk to your dentist, doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via national reporting system.
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Arestin
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
6.
Contents of the pack and other information
What Arestin contains
-
The active substance is 1 mg minocycline as minocycline hydrochloride.
The other ingredient is poly(D,L-lactide-co-glycolide).
What Arestin looks like and contents of the pack
Arestin is a periodontal yellow powder in single-dose polypropylene container, the pack consists of 1
blister strip of 4 or 12 single-dose containers, or 2 blister strips of 12 single-dose containers each,
packed in a resealable aluminium foil pouch with desiccant.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
[To be completed nationally]
Manufacturer:
T D Packaging Ltd
Groundwell Industrial Estate, Unit 6,
Stephenson Road,
Swindon, Wiltshire, SN25 5AX,
UNITED KINGDOM
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This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
Italy
The Netherlands
Sweden
Arestin
Minotek
Minotek
Arestin
This leaflet was last revised in 2015-11-19
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