Rulide D

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

Rulide D contains the active ingredient roxithromycin. Rulide D is mainly used to treat respiratory tract infections, and skin and soft tissue infections. For more information, see Section 1. Why am I using Rulide D? in the full CMI.

Do not use if you have ever had an allergic reaction to roxithromycin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Rulide D? in the full CMI.

Some medicines may interfere with Rulide D and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

For children weighing less than 40 kg, the dosage can range from one half a tablet, one tablet or two tablets twice a day.

Your doctor will tell you the correct number of tablets to give your child

More instructions can be found in Section 4. How do I use Rulide D? in the full CMI.

For more information, see Section 5. What should I know while using Rulide D? in the full CMI.

Common side effects include: rash; loss of appetite. Refer to the CMI for all side effects. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredient: Roxithromycin (rocks-e-throw-my-sin)

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I using Rulide D?

2. What should I know before I use Rulide D?

3. What if I am taking other medicines?

4. How do I use Rulide D?

5. What should I know while using Rulide D?

6. Are there any side effects?

7. Product details

Rulide D contains the active ingredient roxithromycin. Rulide 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 the infection.

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

Rulide D is used mainly to treat respiratory tract infections, and skin and soft tissueinfections

1. your child has an allergy 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.

2. your child has severe liver problems

3. your child is taking certain medicines migraine headache called ergot alkaloids e.g. Cafergot, Dihydergot; (not all brands listed)

4. the product has expired or the packaging appears tampered with.

have allergies to any other substances, such as foods, preservatives or dyes

has or has had the following medical conditions:

has any other medical conditions

takes any medicines for any other condition

plans 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?

Tell your doctor or pharmacist if your child is 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 be affected by Rulide D, or may affect how well Rulide D works. These include:

theophylline (Neulin), a medicine used to treat asthma

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

terfenadine, over the counter medicine used to treat allergies

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

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

midazolam (Hypnovel, Midazolam Sandoz), used to induce sleep before operations

ciclosporin (Neoral, Cicoral, Cysporin, Sandimmun), 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 (Orap), an antipsychotic medicine

Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements your child is taking and if these affect Rulide D.

For children weighing less than 40 kg, the dosage can range from one half a tablet, one tablet or two tablets twice a day.

Your doctor will tell you the correct number of tablets to give your child

Rulide D works best on an empty stomach so it should be taken at least 15 minutes before food or at least 3 hours after a meal

Follow the instructions below on how to give your child Rulide D.

The number of tablets your doctor has recommended should be added to water

1. Remove the correct number of tablets from the foil.

If your child is only taking half a tablet at a time, place the remaining half of the tablet back in the foil and cover it up

2. Add half, one or two tablets as directed by your doctor, to water and mix well. At least a spoonful of water should be used

3. Wait about 30 or 40 seconds for the tablet to break down into fine granules. (The tablets will not completely dissolve). Stir if necessary

4. Have a glass of water ready and giver your child a drink immediately after taking the medicine to ensure all the Rulide D is swallowed

Rulide D is usually taken for 5 to 10 days. Children should not take Rulide D for more than 10 days

Ask your doctor if you are not sure how long your child should be taking it

Make sure your child takes Rulide D for the number of days your doctor has prescribed, even if they begin to feel better after a few days. If the full course is not finished, the infection may not clear completely or their symptoms may return

Rulide D 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 nextdose when you are meant to.

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

If you think that your child may have used too much Rulide, your child may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

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.

If symptoms of your child’s infection do not improve with a few days, or if they become worse, tell your doctor

If your child is about to start taking any new medicine, tell your doctor or pharmacist that they are taking Rulide D

Rulide D has been prescribed for your child. Do not give to anyone else, even if they have the same condition as your child.

Do not use Rulide D to treat any other complaints unless your doctor tells you to

Keep the tablets in a cool dry place where the temperature stays below 30°C

Keep your tablets in the foil 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 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.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

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

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.

Inform your doctor as soon as possible if your child has any problems while taking Rulide D, even if you do not think the problems are connected with the medicine or they are not listed in this leaflet

Tell your doctor or pharmacist if you notice anything else that may be making yourchild feel unwell.

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

Other side effects not listed here may occur in some people.

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  or medsafe athttps://nzphvc.otago.ac.nz/reporting/  (New Zealand).

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 stoptaking any of your medicines.

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

Do not take this medicine if your child is allergic to any of these ingredients.

Rulide D tablets are round, off-white, scored tablets. Each blister pack contains 10 tablets (Aust R 54811).

Rulide D tablets are manufactured for:

sanofi aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

This leaflet was prepared in September 2020.

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