Consumer medicine information

Sulphadiazine Tablets

Sulphadiazine 500mg


Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully before you take Sulphadiazine Tablets.

This leaflet answers some common questions about Sulphadiazine 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 Sulphadiazine Tablets against the benefits they expect it will 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 are Sulphadiazine Tablets used for?

The brand name of your medicine is Sulphadiazine Tablets. The active ingredient in Sulphadiazine Tablets is called sulphadiazine (or sulfadiazine).

Sulphadiazine Tablets belong to a group of medicines called sulphonamides. They are antibacterial tablets used to treat infections.

Your doctor may have prescribed Sulphadiazine Tablets for another use. Ask your doctor if you have any questions about why Sulphadiazine Tablets have been prescribed for you.

Sulphadiazine will not work against viral infections such as cold and flu.

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

Before you take Sulphadiazine Tablets

Do not take if:

You must not take Sulphadiazine Tablets if you have an allergy to:

  • Sulphadiazine tablets
  • Other medications containing sulfur (ask your doctor to check your medication history)
  • Any medicines used to treat high blood pressure or other heart conditions (ask your doctor to check your medication history)
  • Any of the ingredients listed at the end of this leaflet (See “Ingredients”)

You must not take Sulphadiazine Tablets if you have had any of the following medical conditions:

  • severe liver disease
  • severe kidney disease
  • inherited blood diseases known as porphyrias

Do not give Sulphadiazine Tablets to:

  • infants under 2 months of age
  • Pregnant women before labour
  • Breastfeeding mothers with infants less than two months of age or with infants with a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

Do not take Sulphadiazine Tablets after the expiry date (EXP) printed on the bottle/ jar.

Do not take Sulphadiazine Tablets if the bottle/ jar is damaged or shows signs of tampering. Do not take Sulphadiazine Tablets which have not been properly stored. If the bottle/ jar of Sulphadiazine Tablets has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking Sulphadiazine Tablets, talk to your doctor or pharmacist.

Tell your doctor if:

You must tell your doctor if you have had an allergic reaction to any other medicines, foods, dyes or preservatives

In particular, tell your doctor if you have ever had any unusual or allergic reaction to:

  • diuretic (fluid) tablets
  • Other medications containing sulfur
  • Any medicines used to treat high blood pressure or other heart conditions
  • Any medicines used to treat diabetes

If you are not sure, ask your doctor to check your medical history for any previous allergies.

You are pregnant or intend to become pregnant.

Your doctor will discuss with you the possible risks and benefits of using Sulphadiazine Tablets during pregnancy. Sulphadiazine Tablets are not recommended for use at the time of labour or delivery.

You are breast feeding, or wish to breastfeed.

This medicine may pass into the breast milk and there is a possibility that your baby may be affected. Your doctor will discuss with you the possible risks and benefits of using Sulphadiazine Tablets during breastfeeding.

You have any other medical conditions, especially the following:

  • kidney problems
  • liver diseases
  • inherited blood diseases known as porphyrias
  • a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G-6-PD)
  • epilepsy (fits or convulsions)
  • folic acid deficiency
  • asthma
  • rheumatoid arthritis

Taking other medicines:

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

In particular, tell your doctor if you are taking any of the following:

  • Any medicines used to prevent clotting of the blood (e.g. Coumadin®, Marevan®)
  • Medicines used to treat diabetes
  • Phenytoin, a medicine used to treat epilepsy eg Dilantin
  • Indomethacin, used to treat rheumatic disorders e.g. Indocid
  • Methotrexate (e.g. Ledertrexate®)
  • Other medicines used to treat infections (e.g. Hiprex®)
  • Any medicine used to treat gout (e.g. Anturan®)
  • Any medicines used to treat pain, fever or inflammation (e.g. Aspirin)
  • Glaucoma medication you take by mouth (e.g. Diamox®)

Some medicines may affect the way other medicines work. They may also react with Sulphadiazine Tablets resulting in untoward or sometimes dangerous side effects. Your doctor or pharmacist will be able to tell you which medicines are safe to take with Sulphadiazine Tablets.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Sulphadiazine Tablets.

In future, before you start to take any other medicines, tell your doctor or pharmacist that you are taking Sulphadiazine Tablets.

How do I take Sulphadiazine Tablets?

Follow your doctor’s instructions about how to take Sulphadiazine Tablets.

Read the directions label on the bottle/ jar of your Sulphadiazine Tablets carefully. If you have any concerns about how to take Sulphadiazine Tablets, talk to your doctor or pharmacist.

How much to take:

The usual adult dose is 4 to 8 tablets (2 to 4 g) for the first dose, followed by 1 to 2 tablets (500 mg to 1 g) every 6 hours.

You should not take more than 12 tablets (6 g) daily.

Your doctor or pharmacist will tell you how many Sulphadiazine Tablets you will need to take each day.

If you have kidney or liver disease, or are elderly, your doctor may start you on a lower dose to prevent untoward side effects.

Smaller doses are used in children. If Sulphadiazine Tablets have been prescribed for a child, your doctor or pharmacist will tell you what the dose for your child is.

How to take:

Take your tablets with a full glass (250 mL) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help prevent some unwanted effects of sulphonamides.

Take your tablets at the same time each day.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, it is best to take the doses at evenly spaced times day and night. It is also important not to miss any doses.

How long to take it for:

It is important to finish the full course of your Sulphadiazine Tablets.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

If you forget to take:

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 medicine as you would normally.

Do not try and make up for the dose that you missed by taking more than one dose at a time. 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 you medicine, ask your pharmacist for some hints.

What do I do if I take too much? (Overdose)

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

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

Keep telephone numbers for these places handy.

While you are taking Sulphadiazine Tablets

Things you must do:

If you develop a rash while taking Sulphadiazine tablets, stop taking them and see your doctor. A rash may be a sign of a serious side effect. It is important you stop taking the tablets and speak to your doctor if a rash develops.

Tell your doctor immediately if you develop a fever or a sore throat after you start taking Sulphadiazine Tablets.

Take your tablets with a full glass (250 mL) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor.

Drinking extra water will help prevent some unwanted effects of Sulphadiazine Tablets.

Tell your doctor immediately if you become pregnant while taking Sulphadiazine Tablets.

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Sulphadiazine Tablets. If you are about to be started on any new medicines, remind you doctor, dentist or pharmacist that you are taking Sulphadiazine Tablets.

Continue taking Sulphadiazine Tablets even if you feel well. To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return. Do not stop taking Sulphadiazine Tablets without talking to your doctor.

Visit your doctor regularly.

Your doctor will check your progress and may want to take blood and urine tests from time to time. This helps to prevent unwanted side effects.

Things you must not do:

Do not stop taking Sulphadiazine Tablets or lower the dose without first checking with your doctor. To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use Sulphadiazine Tablets to treat any other complaints unless your doctor says to.

Things to be careful of:

If you develop a rash while taking Sulphadiazine Tablets, stop taking taking them and see your doctor. A rash may be a sign of a serious side effect. It is important you stop taking the tablets and speak to your doctor if a rash develops.

If outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sun lamp or tanning bed or booth. Sulphadiazine Tablets may cause your skin to become much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn. If your skin does appear to be burning, tell your doctor immediately. If you have a severe reaction from the sun, check with your doctor.

Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

This medicine may cause some people to become dizzy. If this reaction is especially bothersome, check with your doctor.

What are the side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sulphadiazine Tablets, even if the problem is not listed below. Like other medicines, Sulphadiazine Tablets can sometimes cause unwanted side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you get any unwanted side effects, tell your doctor or pharmacist.

Tell your doctor if you notice any of the following that are troublesome or ongoing, and they worry you:

  • nausea, vomiting
  • diarrhea
  • drowsiness
  • dizziness
  • headache
  • loss of appetite
  • tiredness

Tell your doctor as soon as possible if you notice any of the following:

  • Increased sensitivity of skin to sunlight

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • sudden signs of allergy such as a skin rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; wheezing or troubled breathing
  • redness, blistering, peeling or loosening of the skin
  • sore throat and fever
  • unusual tiredness or weakness
  • confusion
  • yellow eyes or skin
  • unusual bleeding or bruising
  • severe abdominal or stomach cramps
  • watery and severe diarrhea (which may also be bloody)
  • lower back pain
  • passing cloudy urine

These may be serious side effects and you may need urgent medical attention. Serious side effects are rare.

Some of the above side effects (severe abdominal or stomach cramps and pain, and watery and severe diarrhea, which may also be bloody) may also occur up to several weeks after you stop taking Sulphadiazine Tablets.

Your doctor or pharmacist will have more information. Your doctor or pharmacist should discuss the possible side effects of Sulphadiazine Tablets with you.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

How do I store Sulphadiazine Tablets?

Storage:

Sulphadiazine Tablets should be stored in a safe place where children cannot reach it

A locked cupboard at least 1½ meters above the ground is a good place to store medicines.

Keep your Sulphadiazine Tablets in the bottle/ jar until it is time to take them.

Sulphadiazine Tablets should be stored below 25°C and kept away from light.

Do not leave Sulphadiazine Tablets in the car or on windowsills. Do not store medicines in the bathroom or near a sink.

Heat and dampness can destroy some medicines.

Disposal:

If your doctor tells you to stop taking Sulphadiazine Tablets, ask your pharmacist what to do with any tablets that are left over.

Product Description

What it looks like:

Sulphadiazine Tablets 500 mg

White, biconvex tablet, 14 mm diameter, 5 mm deep.

Ingredients:

Active Ingredients: Sulphadiazine

Inactive Ingredients:

  • povidone
  • magnesium stearate
  • water – purified
  • crospovidone
  • lactose

Where to go to for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Sponsor

Sulphadiazine Tablets are supplied in Australia by:
ORION Laboratories Pty Ltd
85 Briggs St
Welshpool WA 6106

Australian Registration Number: AUST R 10813

This leaflet was prepared in October 2003.

Published by MIMS August 2004