Roxithromycin Sandoz®

Roxithromycin Sandoz®

Active ingredient(s): roxithromycin (rocks-e-throw-my-sin)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Roxithromycin Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Roxithromycin Sandoz.

Where to find information in this leaflet:

1. Why am I using Roxithromycin Sandoz?
2. What should I know before I use Roxithromycin Sandoz?
3. What if I am taking other medicines?
4. How do I use Roxithromycin Sandoz?
5. What should I know while using Roxithromycin Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Roxithromycin Sandoz?

Roxithromycin Sandoz contains the active ingredient roxithromycin. Roxithromycin Sandoz 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.

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

Roxithromycin Sandoz 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)

2. What should I know before I use Roxithromycin Sandoz?

Warnings

Do not use Roxithromycin Sandoz if:

• you are allergic to roxithromycin, or any other macrolide antibiotic e.g. azithromycin, clarithromycin or erythromycin, any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include skin rash, itching, shortness of breath, or swelling of the face, lips or tongue which cause difficulty in swallowing or breathing.
  Always check the ingredients to make sure you can use this medicine.
• you have severe liver problems
• if you are taking certain migraine headache medicines called ergot alkaloids
• the product has expired or the packaging appears tampered with.

Check with your doctor if you:

• have allergies to any other substances, such as foods, preservatives or dyes
• are pregnant or intend to become pregnant
• are breastfeeding or plan to breastfeed
• have or have had the following medical conditions:
  – kidney problems (impaired function)
  – liver problems (hepatic cirrhosis with jaundice and/ or ascites)
• have any other medical conditions
• take any medicines for any other condition
• plan to have surgery.

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

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Like most medicines of this kind, Roxithromycin Sandoz is not recommended for use during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are pregnant

Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed. Roxithromycin Sandoz passes into breast milk. Your doctor or pharmacist will discuss the risks and benefits of taking it if you are breastfeeding or planning to breastfeed.

Use in the Elderly

Roxithromycin Sandoz can be used in the elderly with no dosage adjustment required.

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 may interfere with Roxithromycin Sandoz and affect how it works. These include:

• theophylline, a medicine used to treat asthma
• some medicines for migraine headache such as ergotamine or dihydroergotamine
• terfenadine and astemizole, over the counter medicines used to treat allergies
• warfarin, a medicine used to prevent blood clots
• digoxin, a medicine used to treat heart failure
• midazolam, used to induce sleep before operations
• ciclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
• cisapride, a medicine used to treat gastrointestinal problems
• pimozide, an antipsychotic medicine
• hydroxychloroquine or chloroquine, used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria. Taking these medicines at the same time as Roxithromycin Sandoz may increase the chance of you getting side effects that affect your heart.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Roxithromycin Sandoz.

4. How do I use Roxithromycin Sandoz?

How much to take

• The recommended adult dosage is 300 mg per day which may be taken according to one of the following alternative dosage 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 dosage of Roxithromycin Sandoz given to children is dependent on the child’s weight.
• Your doctor will tell you exactly how much to take.
• Follow the instructions provided and use Roxithromycin Sandoz until your doctor tells you to stop

When to take Roxithromycin Sandoz

• Roxithromycin Sandoz should be taken at least 15 minutes before food or on an empty stomach (i.e. more than 3 hours after a meal).
• Roxithromycin Sandoz works best if you take it on an empty stomach.

How to take Roxithromycin Sandoz

• Swallow the tablets whole with a glass of water.

How to long to take Roxithromycin Sandoz

• For treating infections, Roxithromycin Sandoz is usually taken for 5 to 10 days. However, your doctor may prescribe Roxithromycin Sandoz for longer periods
• Continue taking the tablets until you finish the pack or until your doctor or pharmacist tells you to stop

If you forget to use Roxithromycin Sandoz

Roxithromycin Sandoz should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Roxithromycin Sandoz

If you think that you have used too much Roxithromycin Sandoz, 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.

5. What should I know while using Roxithromycin Sandoz?

Things you should 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 it occurs several weeks after Roxithromycin Sandoz 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 diarrhoea medicine without first checking with your doctor.
• If you get a sore, white mouth or tongue while taking, or soon after stopping Roxithromycin Sandoz, tell your doctor or pharmacist. Also tell your doctor or pharmacist if you get vaginal itching or discharge. This may mean you have a fungal/yeast infection called thrush. Sometimes the use of Roxithromycin Sandoz allows fungi/yeast to grow and the above symptoms to occur. Roxithromycin Sandoz does not work against fungi/yeast.
• Tell all the doctors, dentists and pharmacists who are treating you that you are taking Roxithromycin Sandoz.
• If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Roxithromycin Sandoz
• If you plan to have surgery that needs a general anaesthetic tell your doctor or dentist that you are taking this medicine.

Call your doctor straight away if you:

• become pregnant while you are taking Roxithromycin Sandoz, tell your doctor or pharmacist immediately.

Things you should not do

• Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not use this medicine to treat any other complaints unless your doctor tells you to.
• Do not stop taking your tablets because you are feeling better, unless advised by your doctor or pharmacist.

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

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Roxithromycin Sandoz affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

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

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 25°C 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 window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

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

Less serious side effects

What to do

Fungal related oral thrush – white, furry, sore tongue and mouth vaginal thrush – sore and itchy vagina and/or discharge Gut or Gastrointestinal related nausea, vomiting, stomach pain, indigestion, diarrhoea, flatulence loss of appetite Skin related red and/or itchy skin rash Eyes or ears related headache, dizziness, ringing in the ears blurred vision and/or visual impairment Others hallucinations confusion tiredness altered taste

Speak to your doctor if you have any of these less serious side effects and they worry you. They are generally mild and short-lived.

Serious side effects

Serious side effects	What to do
Gut or Gastrointestinal related severe abdominal cramps or stomach cramps watery and severe diarrhoea, which may sometimes be bloody Infection related fever, in combination with one or both of the above	Tell your doctor or pharmacist immediately if you notice any of the following, particularly if they occur several weeks after stopping treatment with Roxithromycin Sandoz. These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention Do not take any diarrhoea medicine without first checking with your doctor.
Infection related frequent infections such as fever, severe chills, sore throat or mouth ulcers Gut or Gastrointestinal related severe persistent diarrhoea Allergy related swelling of the face, lips, mouth and tongue difficulty in swallowing or breathing an allergic reaction (for example, itchy skin, rash, swelling, asthma) Skin related severe blisters and bleeding in the lips, eyes, mouth, nose and genitals severe skin rash	Stop taking this medicine and call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. These are very serious side effects. If you have them, you may have had a serious allergic reaction to Roxithromycin Sandoz. You may need urgent medical attention or hospitalisation.

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.

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 Roxithromycin Sandoz contains

Active ingredient (main ingredient)	roxithromycin
Other ingredients (inactive ingredients)	microcrystalline cellulose povidone K30 croscarmellose sodium precipitated silica lactose hypromellose titanium dioxide magnesium stearate macrogol 4000 poloxamer 188
Potential allergens	lactose This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What Roxithromycin Sandoz looks like

Roxithromycin Sandoz 150 mg – white, round, convex film-coated tablets, scored on one side, embossment R150 on the other side. Pack size of 10 tablets (Aust R100989).

Roxithromycin Sandoz 300 mg – white, round, convex film-coated tablets, scored on one side, embossment R300 on the other side. Pack size of 5 tablets (AUST R 101028).

Who distributes Roxithromycin Sandoz

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was prepared in January 2023.