Roximycin

Roxithromycin film coated tablets

CONSUMER MEDICINE INFORMATION

This leaflet answers some common questions about ROXIMYCIN.

It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks.Your doctor has weighed the risks of you taking ROXIMYCIN against the benefits they expect it will have for you.

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

Keep this leaflet with your medicine.

You may need to read it again.

ROXIMYCIN is used to treat infections in different parts of the body caused by bacteria. For example:

acute pharyngitis (sore throat and discomfort when swallowing)

tonsillitis

sinusitis

acute bronchitis (infection of the bronchi causing coughing)

exacerbation of chronic bronchitis

pneumonia (lung infection characterised by fever, malaise, headache)

skin and soft tissue infections

non gonococcal urethritis

impetigo (bacterial infection causing sores on the skin)

ROXIMYCIN is an antibiotic that belongs to a group of medicines called macrolides. These antibiotics work by killing or stopping the growth of the bacteria that are causing your infection.

ROXIMYCIN, like other antibiotics, does not work against viral infections such as the flu.

Ask your doctor if you have any questions about why ROXIMYCIN has been prescribed for you.

Your doctor may have prescribed ROXIMYCIN for another reason.

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

ROXIMYCIN is not addictive.

Do not take ROXIMYCIN if:

1.you have an allergy to:

roxithromycin or any other macrolide antibiotic eg. azithromycin (eg: Zithromax), clarithromycin (eg. Klacid, Kalixocin) or erythromycin (eg. EES, E-Mycin)

any of the ingredients listed at the end of this leaflet (see Product description)

Some of the symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.

2.you have severe liver problems

3.you are taking certain medicines for migraine headache called ergot alkaloids (eg. Cafergot, Dihydergot)

Ask your doctor if you are not sure if you are taking one of these medicines.

4.the packaging is torn or shows signs of tampering

5.the expiry date (EXP) on the pack has passed

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking ROXIMYCIN, talk to your doctor.

Tell your doctor if:

1.you are pregnant or intend to become pregnant

Your doctor will discuss the risks and benefits of using ROXIMYCIN during pregnancy.

2.you are breast-feeding or plan to breast-feed

ROXIMYCIN passes into the breast milk. Your doctor will discuss the risks and benefits of using ROXIMYCIN while breast-feeding.

3.you have or have ever had any other health problems/medical conditions, including:

kidney problems (impaired function)

liver problems (hepatic cirrhosis with jaundice and /or ascites)

congenital prolongation of the QT interval, with ongoing proarrhythmic heart conditions

4.you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell him/her before you take ROXIMYCIN.

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

There may be interference between ROXIMYCIN and some other medicines, including:

theophylline (Nuelin), a medicine used to treat asthma

some medicines for migraine headache such as ergotamine (Cafergot) or dihydroergotamine (Dihydergot )

disopyramide (Rythmodan), a medicine to treat irregular heart rhythms

terfenadine and astemizole, over the counter medicines used to treat allergies

warfarin (Coumadin, Marevan), a medicine used to prevent blood clots

digoxin (Lanoxin), a medicine used to treat heart failure

midazolam (Hypnovel), used to induce sleep before operations

ciclosporin (Neoral, Sandimmun), a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system

cisapride (Prepulsid), a medicine used to treat stomach reflux

pimozide (Orap), an antipsychotic medicine

antiarrhythmic agents

These medicines may be affected by ROXIMYCIN, 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 not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ROXIMYCIN.

Follow all directions given to you by your doctor or 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.

The recommended adult dose is 300 mg per day which may be taken according to one of the following regimens:

one 300 mg tablet once a day or

one 150 mg tablet twice a day or

two 150 mg tablets once a day

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

The recommended dosage for children more than 40 kg is one 150 mg tablet twice daily. The dose for children will depend on the child’s weight.Your doctor will tell you how much ROXIMYCIN your child should take.

Swallow the tablet whole with a glass of water.

Take ROXIMYCIN at least 15 minutes before food or on an empty stomach (i.e. more than 3 hours after a meal).

ROXIMYCIN works best if you take it on an empty stomach.Food in the stomach can reduce the absorption of ROXIMYCIN

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect.It will also help you remember when to take it.

Keep taking ROXIMYCIN until you finish the pack, or for as long as your doctor recommends.

ROXIMYCIN is usually taken for 5 to 10 days.

Do not stop taking ROXIMYCIN, even if you feel better after a few days, unless advised 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.

If 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 tablets as you would normally.

Do not try to make up for missed doses by taking more than one dose at a time.

If you are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering to take your ROXIMYCIN, ask your pharmacist for some hints.

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much ROXIMYCIN.Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Before starting any new medicine, tell your doctor or pharmacist that you are taking ROXIMYCIN.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking ROXIMYCIN.

If you become pregnant while taking ROXIMYCIN, tell your doctor immediately.

If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking ROXIMYCIN.

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 immediately.Do this even if it occurs several weeks after ROXIMYCIN has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel.You may need urgent medical care.

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

If you get a sore, white mouth or tongue while taking, or soon after stopping ROXIMYCIN, 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 ROXIMYCIN allows fungi/yeast to grow and the above symptoms to occur.ROXIMYCIN does not work against fungi/yeast.

Visit your doctor regularly so they can check on your progress.

Do not stop taking ROXIMYCIN, or lower the dose, without checking with your doctor.

If you do not complete the full course prescribed by your doctor, all 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 may return.

Do not use ROXIMYCIN to treat any other conditions unless your doctor tells you to.

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

Be careful driving or operating machinery until you know how ROXIMYCIN affects you.

This medicine may cause dizziness in some people. If you experience any dizziness, do not drive, operate machinery or do anything else that could be dangerous.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ROXIMYCIN.

ROXIMYCIN is generally well tolerated, however, it may have unwanted side effects in some people.Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

See your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

signs of an allergic reaction, eg. swelling of the face, lips, mouth and tongue; difficulty breathing or asthma; itchy skin, rash.

This type of allergy is very serious and requires urgent medical attention.

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

nausea, vomiting, stomach pain, diarrhoea, flatulence

pancreatitis – an inflammation of the pancreas

loss of appetite

red and/or itchy skin

hallucinations

confusion

headache, dizziness, ringing in the ears, temporary deafness,

vertigo

tiredness

altered taste

rash

blurred vision and/or visual impairment

The above list includes the milder side effects of your medicine.

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

severe stomach cramps

severe, persistent diarrhoea, which may be watery or bloody

fever, in combination with one or both of the above

These are rare but serious side effects. ROXIMYCIN can cause some bacteria, which are normally present in the bowel and normally harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention.

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

If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

frequent infections such as fever, severe chills, sore throat or mouth ulcers

severe persistent diarrhoea

swelling of the face, lips, mouth and tongue

difficulty in swallowing and breathing

an allergic reaction (for example, itchy skin, rash, swelling, asthma)

severe skin rash

These are very serious side effects. If you have them, you may have had a serious allergic reaction to ROXIMYCIN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice anything that is making you feel unwell.

This is not a complete list of all possible side effects.Other side effects not listed above may also occur in some patients.

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Keep ROXIMYCIN 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.

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they will not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

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

Do not leave ROXIMYCIN in the car or on window sills.

Heat and dampness can destroy some medicines.

If your doctor tells you to stop taking Roximycin, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

ROXIMYCIN tablets come in 2 strengths:

ROXIMYCIN 150 mg – white, round, film coated, biconvex tablets, marked “150” “R” on one side and “G” on the other.Each pack contains 10 tablets.

ROXIMYCIN 300 mg – white, round, film coated, biconvex tablets, marked “300” “R” on one side and “G” on the other.Each pack contains 5 tablets.

Each tablet contains either 150 mg or 300 mg of the active ingredient, roxithromycin.

The tablets also contain the following inactive ingredients:

povidone

hydroxypropylcellulose

maize starch

poloxamer 188

colloidal anhydrous silica

purified talc

magnesium stearate

glucose

Opadry white OY-S-58918

The tablets are gluten free.

Roximycin is supplied by:

Alphapharm Pty Ltd

Level 1, 30 The Bond,

30 – 34 Hickson Road,

Millers Point, NSW 2000,

www.mylan.com.au

 

Australian registration numbers:

Roximycin 150 mg

AUST R 99937 (blister pack)

Roximycin 300 mg

AUST R 99939 (blister pack)

 

This leaflet was prepared in December 2020.

 

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