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DOXSIG® Tablets

doxycycline hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about DOXSIG Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking DOXSIG Tablets against the benefits the medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What DOXSIG Tablets are used for

The name of your medicine is DOXSIG. It contains the active ingredient doxycycline (as hydrochloride).

DOXSIG Tablets are an antibiotic used to:

  • treat bacterial infections
  • control acne
  • prevent malaria

DOXSIG Tablets belong to a class of medicines called tetracyclines.

These medicines work by killing or stopping the growth of bacteria which cause infections or make acne worse. They also work against parasites which cause malaria.

Tetracyclines will not work against viral infections such as colds or the flu.

Your doctor may have prescribed this medicine for another purpose.

Ask your doctor if you have any questions about why DOXSIG tablets have been prescribed for you.

This medicine is only available with a doctor’s prescription.

There is no evidence that DOXSIG Tablets are addictive.

Before you take it

When you must not take it

Do not take DOXSIG Tablets if:

  1. You have ever had an allergic reaction to:
  • medicines containing doxycycline, or doxycycline hydrochloride.
  • medicines containing other tetracyclines
  • any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction to tetracyclines may include: rash, itching, or hives on the skin, swelling of the face, lips and tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
  1. 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.
  1. If you are pregnant or breastfeeding.
As with many medicines, tetracyclines can harm the developing or breastfeeding baby. This may include enamel loss and staining of the child’s teeth.
High doses of tetracyclines may also cause liver problems in pregnant women.

If you are not sure whether you should be taking DOXSIG Tablets, talk to your doctor.

Do not take DOXSIG Tablets if

  • The expiry date on the pack has passed
    If you take this medicine after the date has passed it may have no effect at all, or worse, an entirely unexpected effect.
  • The packaging is torn or shows signs of tampering.

Do not give DOXSIG Tablets to children of eight years and under unless directed by the child’s doctor. DOXSIG Tablets like all other tetracyclines may cause enamel loss and staining in developing teeth.

Before you start to take DOXSIG Tablets

You must tell your doctor if:

  1. You are allergic to any other medicines or other substances such as foods, dyes or preservatives.
  2. You have or have ever had any other health problems, especially the following:
  • liver disease
  • systematic lupus erythematosus (a disease affecting the skin, joints and kidneys).
  1. You work outdoors or you are exposed to direct sunlight or ultra-violet light
Doxycycline may cause your skin to become more sensitive to UV or sunlight, resulting in severe sunburn.
  1. You are currently pregnant or plan to become pregnant, or you are breastfeeding.
This medicine should not be taken during the last half of pregnancy. Doxycycline, like other tetracyclines, may cause enamel loss and staining in developing teeth or increase the pressure on your child's brain.
High doses of tetracyclines may cause liver problems in pregnant women.
  1. You are scheduled to have surgery under general anaesthetic.
  2. You are currently receiving or are planning to receive dental treatment.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking DOXSIG Tablets.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

There may be an interference between DOXSIG Tablets and some other medicines, including:

  • oral retinoid medicines such as preparations containing Vitamin A, isotretinoin or etretinate

You must not take doxycycline with these medicines.

  • warfarin and other medicines used to stop blood clotting
  • another group of antibiotics called penicillins
  • barbiturates such as phenobarbitone
  • anticonvulsant medicines that are used to treat seizures, such as phenytoin and carbamazepine
  • methoxyflurane, an anaesthetic
  • acetazolamide and ethoxzolamide, medicines used to help the body get rid of salt and water
  • disodium hydrogen edetate
  • sodium bicarbonate, found in indigestion remedies and also given by injection
  • sodium lactate
  • the contraceptive pill (birth control pill). DOXSIG Tablets may decrease the effectiveness of some birth control pills.

Your doctor may advise you to use an alternative method of contraception while taking DOXSIG Tablets

If you are taking any of these, you may need a different dose or you may need to take different medicines.

Some medicines interfere with the absorption of DOXSIG Tablets. These include:

  • calcium, magnesium or aluminium salts found in antacids, medicines for indigestion
  • bismuth salts, found in some medicines used to treat stomach ulcers or indigestion
  • iron preparations, including vitamin preparations which contain iron.
  • other preparations containing calcium, magnesium or aluminium.

In addition, alcohol can reduce the blood levels of doxycycline and should be avoided.

Other medicines not listed above may also interact with doxycycline.

How to take it

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 box/bottle, ask your doctor or pharmacist for help.

How much to take

For treating infections, the usual dose of DOXSIG Tablets is:

  • 2 tablets (200mg) on the first day of treatment (usually given as one tablet every 12 hours), the dose is then decreased to 100mg (one tablet) daily. For more severe infections the (such as long term urinary tract infections) the dose may be 100mg (one tablet) every 12 hours.

For controlling acne, the usual dose is:

  • 50mg (half a tablet) taken once a day, for several weeks.

For the prevention of malaria, the usual dose is:

  • one 100mg tablet each day, commencing two days prior to entering an malarious area, during the visit, and for two weeks after leaving the area. DOXSIG Tablets are normally used in combination with another anti-malarial medicine.

However, depending on your condition and how you react to the medicine, your doctor may ask you to take a different dose.

How to take it

Swallow DOXSIG Tablets whole with a full glass of water or milk while standing upright. Do not lie down immediately after swallowing DOXSIG Tablets. It is important to stay upright, for example sitting, standing or walking for at least half an hour after swallowing your tablet. This is to help avoid irritation to your food pipe, also called oesophagus.

When to take it

Take DOXSIG Tablets during or immediately after a meal, at about the same time each day (usually in the morning). If taken on an empty stomach, DOXSIG Tablets may cause a stomach upset.

How long to take it

For treating infections DOXSIG Tablets are usually taken for one to two weeks.

Do not stop taking DOXSIG Tablets because you are feeling better. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

For controlling acne, DOXSIG tablets are normally taken for a few months.

For preventing malaria, DOXSIG Tablets are normally recommended to be taken for up to a maximum of eight weeks.

However, your doctor may prescribe DOXSIG Tablets for longer periods. Check with your doctor if you are not sure how long you should be taking it for.

Continue taking DOXSIG Tablets until you finish the bottle or until your doctor recommends.

If you forget to take it

If it is almost time to take your next dose, skip the dose that you have missed and take your next dose when you are meant to. Otherwise take it as soon as you remember, then go back to taking your tablets as usual.

Do not double a dose to make up for a dose that you have missed.

If you take too much (overdose):

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to the Accident and Emergency department at your nearest hospital, if you think that you or anyone else may have taken too many DOXSIG Tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places/services handy.

If you take too many DOXSIG Tablets, you may suffer nausea, vomiting and diarrhoea.

While you are using it

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if this occurs several weeks after you have stopped taking DOXSIG Tablets. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping DOXSIG Tablets, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of DOXSIG Tablets allows fungi to grow and the above symptoms to occur. DOXSIG Tablets do not work against fungi.

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you plan to have any vaccinations or immunisations
  • you are pregnant or plan to become pregnant
  • you are breastfeeding or are planning to breastfeed
  • you are about to have any blood tests
  • you are going to have surgery.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not stop taking your tablets because you are feeling better, unless advised to do so by your doctor. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

Do not give your medicine to anyone else even if they have the same condition as you.

Do not use DOXSIG Tablets 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. Do not use a sunlamp while taking DOXSIG. DOXSIG may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause skin rash, itching, redness, or a severe sunburn.

If outdoors, wear protective clothing and use a 30+ sunscreen.

If your skin does appear to be burning, tell your doctor as soon as possible.

Be careful of driving or operating machinery until you know how DOXSIG Tablets affect you. This medicine does not normally cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines DOXSIG Tablets may cause tiredness in some people.

Side effects

Check with your doctor or pharmacist as soon as possible if you have any problems while you are taking DOXSIG Tablets, even if you do not think that the problems are connected with the medicine or are not listed in this leaflet.

Like all medicines, DOXSIG Tablets can cause side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

While you are taking DOXSIG Tablets

Tell your doctor if you notice any of the following and they worry you:

  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • mail changes (i.e. change in colour or loosening from the nail bed)
  • stomach upsets, such as pain, indigestion, or feeling sick
  • loss of appetite or taste sensation
  • sore mouth or tongue
  • mild irritation of the oesophagus (food pipe)
  • difficulty or pain when swallowing
  • tooth discolouration, changes in tooth enamel

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

  • increased pressure in the brain (headache, blurred vision, vomiting)
  • severe diarrhoea, stomach cramps
  • severe sunburn
  • flaking of the skin
  • more frequent bruising than normal
  • passing of less urine than normal
  • yellowing of the skin of eyes, and/or pale stools, dark urine (jaundice)
  • a rare, potentially life-threatening, drug-induced sensitivity reaction that includes skin rashes, blood changes, fever and dysfunction of internal organs (e.g. liver, kidney, lung)

After finishing DOXSIG® Tablets

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with DOXSIG Tablets.

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever in combination with one or both of the above

These are rare but serious side effects.

You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention. However, this side effect is very rare.

Do not take any diarrhoea medicine without checking with your doctor first.

Some people may experience other side effects while taking DOXSIG Tablets.

Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side affects you may not experience any of them.

After using it

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep as well.

Keep DOXSIG Tablets in a cool dry place where the temperature stays below 30°C.

Do not store DOXSIG Tablets or any other medicine in the bathroom or near a sink.

Do not leave DOXSIG Tablets in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep your medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Tell your doctor if you stop taking the tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets which are left over.

Product Description

What DOXSIG Tablets look like

DOXSIG Tablets are white, film-coated, biconvex tablets with a breakline on one face, the other face is plain. DOXSIG Tablets are available as bottles of 7 tablets.

Ingredients

Active ingredient:

DOXSIG Tablets contain, 100mg doxycycline as doxycycline hydrochloride.

Other ingredients (excipients):

  • microcrystalline cellulose
  • maize starch
  • colloidal anhydrous silica
  • magnesium stearate
  • Opadry white Y-1-7000B.

DOXSIG Tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo food dyes.

Supplier

DOXSIG Tablets are supplied by:

Arrow Pharma Pty Ltd
15 - 17 Chapel Street
Cremorne VIC 3121

TGA registration No. AUST R 62056

This leaflet was revised in December 2018.

Published by MIMS January 2019

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