Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking DORYX?
DORYX contains the active ingredient doxycycline hyclate (hydrochloride). DORYX is
an antibiotic used to treat certain types of infections, control acne and prevent
some forms of malaria, sometimes in combination with another antimalarial medicine.
For more information, see Section
1. Why am I taking DORYX? in the full CMI.
2. What should I know before I take DORYX?
Do not use if you have ever had an allergic reaction to doxycycline hyclate (hydrochloride),
other tetracyclines, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have allergies to any medicines, have any other medical
conditions, take any other medicines, work outdoors or are likely to be exposed to
strong sunlight or ultra-violet light, are scheduled to have surgery under general
anaesthetic, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take DORYX? in the full CMI.
3. What if I am taking other medicines?
4. How do I take DORYX?
Your doctor or pharmacist will tell you how many capsules you will need to take each
day.
Swallow the capsules whole with a full glass of water or milk while sitting or standing
upright.
5. What should I know while taking DORYX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking DORYX.
Tell your doctor if your symptoms do not improve or worsen, you get severe diarrhoea,
you become pregnant while taking this medicine, or you are about to have any blood
tests.
If you are taking iron preparations you must take them at least two hours before or
two hours after DORYX.
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Things you should not do
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Do not stop taking your medicine because you are feeling better unless advised by
your doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not use DORYX to treat any other complaints unless your doctor tells you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how DORYX
affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your capsules in their pack until it is time to take them.
Store below 25°C. Protect from light.
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6. Are there any side effects?
Less serious side effects include: oral/vaginal thrush, rash/itching, nail changes,
stomach upset/vomiting, mild irritation of the oesophagus, taste loss, ringing in
ears. Serious side effects include: depression, feeling anxious/nervous, muscle tenderness/
weakness, painful swollen joints, increased pressure in brain, severe blisters and
bleeding in lips, eyes, mouth, nose and genitals, severe skin reactions, difficulty
in/pain with swallowing, dizziness, fast heart rate, frequent bruising, passing less
urine, yellowing of eyes/skin, severe upper stomach pain often with nausea and vomiting.
Active ingredient(s):
doxycycline hyclate (hydrochloride) (dox-I-SYE-kleen)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking DORYX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking DORYX.
Where to find information in this leaflet:
1. Why am I taking DORYX?
DORYX contains the active ingredient doxycycline hyclate (hydrochloride). This medicine belongs to a group of medicines called tetracyclines.
DORYX is an antibiotic used to:
treat certain types of infections
control acne
prevent some forms of malaria, sometimes in combination with another antimalarial
medicine.
It works by killing or stopping the growth of bacteria which cause infections or make
acne worse. It also works against parasites that cause malaria.
Tetracyclines will not work against viral infections such as colds or flu.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
It is available only with a doctor's prescription.
2. What should I know before I take DORYX?
Warnings
Do not take DORYX if:
you are allergic to doxycycline hyclate (hydrochloride), other tetracyclines, or any
of the ingredients listed at the end of this leaflet.
Always
check the ingredients to make sure you can take this medicine
.
you are taking preparations containing vitamin A, isotretinoin or etretinate. Ask
your doctor or pharmacist if you are not sure if you are taking one of these medicines.
if you are more than 18 weeks pregnant or are breast-feeding.
Do not give this medicine to children aged eight years or under (or to children under
50 kg) unless directed by the child's doctor. DORYX like other tetracyclines, may cause enamel loss and staining in developing teeth.
It may also cause increased pressure on the brain if used in infants.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should be taking DORYX, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes,
have any other medical conditions,
take any medicines for any other condition,
work outdoors or if you are likely to be exposed to strong sunlight or ultra-violet
light. Doxycycline may cause your skin to become more sensitive to UV or sunlight,
resulting in severe sunburn.
are scheduled to have surgery under general anaesthetic.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
As with many medicines, tetracyclines may harm your developing or breast-feeding baby.
Tetracyclines may cause enamel loss and staining of your child's teeth or increase
the pressure on your child's brain. High doses of tetracyclines may also cause liver
problems in pregnant women.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and DORYX may interfere with each other and affect how they work.
These Include:
preparations containing Vitamin A
some medicines used for skin problems, such as isotretinoin or etretinate
warfarin, a medicine used to prevent blood clotting
another group of antibiotics called penicillins
some medicines used in the treatment of epilepsy such as phenytoin, carbamazepine
or phenobarbitone
methoxyflurane, an anaesthetic
acetazolamide, a medicine used to help the body get rid of salt and water
the contraceptive pill (birth control pill). DORYX may decrease the effectiveness
of some birth control pills. Your doctor may advise you to use an additional method
of contraception while taking DORYX and for 7 days after taking DORYX. Refer to your
doctor or pharmacist for advice.
These medicines may be affected by DORYX or may affect how well it works. You may
need different amounts of your medicine or you may need to take different medicines.
If you are taking the following medicines, take them at least two hours before or
two hours after taking DORYX:
antacids (containing aluminium, calcium or magnesium) used for indigestion
bismuth salts, found in some medicines used to treat stomach ulcers
preparations that contain iron including vitamin preparations.
These medicines may interfere with the absorption of DORYX.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DORYX.
4. How do I take DORYX?
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
How much to take
Your doctor or pharmacist will tell you how many capsules you will need to take each
day.
For treating infections, the usual dose of doxycycline is two 100 mg capsules on the
first day, followed by one 100 mg capsule each day from then on.
For controlling acne, the usual dose is one 50 mg capsule each day.
For the prevention of malaria, the usual dose is one 100 mg capsule each day, commencing
two days before entering the malarious area, during the visit, and for four weeks
after leaving the area.
Your doctor may ask you to take a different dose, depending on your condition and
how you react to the medicine.
Follow the instructions provided when DORYX was prescribed, including the number of
days it should be taken.
Keep taking this medicine for the full time of treatment even if you begin to feel
better after a few days.
If you do not complete the full course prescribed by your doctor, the infection may
not clear completely or your symptoms may return.
For treating infections, DORYX is usually taken for one to two weeks.
For controlling acne, DORYX is normally taken over a period of 12 weeks.
For preventing malaria, DORYX is recommended to be taken for up to a maximum of 8
weeks. However, your doctor may prescribe DORYX for longer periods.
If you are not sure how long you should be taking this medicine, talk to your doctor.
How to take DORYX
Swallow the capsules whole with a full glass of water or milk while sitting or standing
upright.
Do not lie down immediately after swallowing DORYX. It is important to stay upright, for example sitting, standing or walking around for
at least half an hour after swallowing your capsule. This is to help avoid irritation
to your food pipe, also called the oesophagus.
Do not chew the capsules.
When to take DORYX
Take your medicine at about the same time each day (usually in the morning). Taking it at the same time each day will have the best effect. It will also help
you to remember when to take it.
Take your medicine during or immediately after a meal. If taken on an empty stomach, it may cause stomach upset.
If you forget to take DORYX
DORYX should be taken regularly at the same time each day.
If you miss a dose and it is almost time for your next dose, skip the dose you missed
and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much DORYX
If you think that you have taken too much DORYX, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include an upset stomach or vomiting.
5. What should I know while taking DORYX?
Things you should do:
Call your doctor straight away if:
you are taking DORYX for an infection and your symptoms do not improve within a few
days or they become worse
you get severe diarrhoea. Do this even if it occurs several weeks after DORYX has
been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care. Do not take diarrhoea medicine without first checking with your doctor.
Remind any doctor, dentist or pharmacist you visit that you are taking DORYX.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine. It may interfere with the results of some tests.
If you are taking iron preparations, including vitamin preparations containing iron,
bismuth salts or antacids (containing aluminium, calcium or magnesium), you must take
them at least two hours before or two hours after DORYX to make sure there is no problem
with absorption.
Things you should not do:
Do not stop taking your medicine because you are feeling better unless advised by
your doctor. If you do not complete the full course, all of the bacteria causing your infection
may not be killed. These bacteria may continue to grow and multiply so that your infection
may not clear completely or it may return.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not use DORYX to treat any other complaints unless your doctor tells you to.
Things to be careful of:
Protect your skin when you are in the sun, especially between 10am and 3pm. If outdoors,
wear protective clothing and use a 30+ sunscreen. DORYX may cause your skin to be much more sensitive to sunlight than it is normally.
Exposure to sunlight may cause a skin rash, itching, redness, or a severe sunburn. If your skin does appear to be burning, see your doctor as soon as possible. You
may need alternative treatment.
If you get thrush (a fungal infection which can affect the mouth and/or vagina) or
any other infection while taking, or soon after stopping DORYX, tell your doctor.
Sometimes the use of this medicine allows fungi to grow as they are not killed by
DORYX.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DORYX
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your capsules in their pack until it is time to take them. Avoid exposure to
light. If you take the capsules out of the pack they may not keep as well.
Store below 25°C.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina with or without discharge
rash or itching
nail changes
stomach upset or vomiting
mild irritation of the oesophagus (food-pipe)
taste loss
ringing or other persistent noise in the ears
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
After finishing it
Tell your doctor immediately if you notice any of the following side effects, particularly
if they occur several weeks after stopping treatment with DORYX.
These are rare but serious side effects. You may have a serious condition affecting
your bowel. DORYX may cause the bacteria which are normally harmless and present in
the bowel to multiply, resulting in the above symptoms. Therefore you may need urgent
medical attention.
Do not take any medicine for this diarrhoea without first checking with your doctor.
Ask your doctor or pharmacist to answer any questions you may have about the side
effects.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DORYX contains
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Active ingredient
(main ingredient)
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doxycycline hyclate (hydrochloride)
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
povidone
hypromellose phthalate
hypromellose
diethyl phthalate
wheat starch (contains gluten)
magnesium stearate
hyprolose
gelatin
Opacode Black A-10259
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Potential allergens
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This medicine does not contain sucrose, tartrazine or any other azo dyes
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Do not take this medicine if you are allergic to any of these ingredients.
What DORYX looks like
DORYX capsules come in two strengths:
DORYX 100 mg - clear capsules filled with yellow pellets, marked DORYX 100 in black.
It is available in HDPE bottles of 7 or 21* capsules (AUST R 30100).
DORYX 50 mg - clear capsules filled with yellow pellets, marked DORYX 50 in black.
It is available in HDPE bottles of 25 capsules (AUST R 29728).
*Not all pack sizes may be marketed.
Who distributes DORYX?
Mayne Pharma International Pty Ltd
1538 Main North Road
Salisbury South, SA 5106
Doryx® is a registered trademark of Mayne Pharma International Pty Ltd.
This leaflet was prepared in January 2023.