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Resprim

contains the active ingredients trimethoprim and sulfamethoxazole

CONSUMER MEDICINE INFORMATION

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What is in this leaflet

This leaflet answers some common questions about Resprim.

It does not contain all of 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 Resprim 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.

What Resprim is used for

Resprim is used to treat infections in different parts of the body caused by bacteria.

Resprim contains two antibiotics called trimethoprim and sulfamethoxazole. These medicines work by stopping the growth of the bacteria that is causing your infection.

Your doctor may have prescribed Resprim for another reason. Ask your doctor if you have any questions about why Resprim has been prescribed for you.

Resprim will not work against infections caused by viruses, such as colds or flu.

Resprim is available only with a doctor`s prescription.

Before you take Resprim

When you must not take it

Do not take Resprim if you are allergic to:

• trimethoprim
• sulfamethoxazole or any other sulfonamide (sulfur) antibiotic
• any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include skin rash, itching or hives, peeling of the skin, swelling of the face, lips or tongue, difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take Resprim if you have severe liver or kidney disease.

Do not take Resprim if you have any of the following blood disorders:

• low red blood cell count (anaemia)
• low white blood cell count
• low blood platelet count.

Do not take Resprim if you are pregnant.

Resprim should not be taken in late pregnancy as it may harm the baby. Your doctor will discuss the risks and benefits of taking Resprim earlier in pregnancy.

Do not take Resprim if the expiry date (Exp.) printed on the pack has passed.

Do not take Resprim if the packaging shows signs of tampering or the tablets or mixture do not look quite right.

Do not give Resprim to premature babies or children under 3 months.

Before you start to take it

Tell your doctor if you are allergic to:

• diuretics (fluid tablets)
• medicines used to treat diabetes
• medicines for an overactive thyroid.

You may have an increased chance of being allergic to Resprim if you are allergic to these medicines.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you plan to become pregnant.

Tell your doctor if you are breastfeeding or wish to breastfeed.

Resprim passes into breast milk. Your doctor will discuss the risks and benefits of taking Resprim when breastfeeding.

Tell your doctor if you have any medical conditions, especially the following:

• any type of blood disorder (including porphyria and glucose-6-phosphate dehydrogenase deficiency)
• liver or kidney problems
• phenylketonuria
• epilepsy (fits)
• asthma
• allergic conditions
• rheumatoid arthritis
• malabsorption syndrome
• malnutrition
• folate deficiency
• thyroid problems.

If you are not sure whether any of these apply to you, check with your doctor.

If you have not told your doctor about any of the above, tell them before you start taking Resprim.

Taking other medicines

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

Some medicines may be affected by Resprim or may affect how well it works. These include:

• sulfonylureas, medicines used to treat diabetes
• diuretics (fluid tablets)
• phenytoin, a medicine used to treat epilepsy
• rifampicin, an antibiotic
• warfarin, a medicine used to prevent blood clots
• pyrimethamine, a medicine used to prevent malaria
• cyclosporin, a medicine used to prevent organ transplant rejections or to treat certain problems with the immune system
• methotrexate, a medicine used to treat arthritis, psoriasis and some cancers
• procainamide, a medicine used to treat irregular heart beats
• digoxin, a medicine used to treat some heart problems
• amantadine, a medicine commonly used to treat Parkinson`s disease
• medicines used to make your urine acidic
• sulfinpyrazone, a medicine used to treat gout
• certain non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and salicylates, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis.

Talk to your doctor about the need for additional contraception while taking Resprim.

Some antibiotics may decrease the effectiveness of some birth control pills.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Resprim.

How to take Resprim

How much to take

The dose varies from patient to patient. Your doctor will decide the right dose for you.

The usual dose for adults and children over 12 years is one Resprim Forte tablet (or two Resprim tablets) twice a day.

For children under 12 years, the dose of Resprim Suspension will depend on the child`s age and weight.

Some people may need to take a folate supplement while taking Resprim. These may include the elderly, people with a folate deficiency, people taking Resprim for a long time or at high doses and people taking certain other medicines. Your doctor will tell you if this is necessary.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take Resprim

Take Resprim after food.

This will lessen the chance of a stomach upset.

Tablets: Swallow with a glass of water.

Suspension: Shake the bottle well before using a metric measure to measure out the correct amount to take.

If you forget to take Resprim

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 the missed dose as soon as you remember, and then go back to taking your medicine as you would normally.

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

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

How long to take Resprim for

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

Do not stop taking Resprim, even if you feel better after a few days, unless advised by your doctor.

Your infection may not clear completely if you stop taking your medicine too soon.

If you take too much Resprim (overdose)

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 Resprim. Do this even if there are no signs of discomfort or poisoning.

If you take too much Resprim, you may feel sick or dizzy, vomit or have a headache.

While you are taking Resprim

Things you must do

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

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

If you become pregnant while taking Resprim, tell your doctor.

Drink plenty of fluids while you are taking Resprim.
If your symptoms do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking Resprim.

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 checking with your doctor.

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

If you have to have any blood tests, tell your doctor that you are taking Resprim.

Resprim may affect the results of some tests.

If you are taking Resprim for a long time, visit your doctor regularly so that they can check on your progress.

You may need to have tests to check your blood, liver and kidneys.

Things you must not do

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

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

Things to be careful of

Be careful drinking alcohol while taking Resprim.

Combining Resprim and alcohol can make you feel sick, vomit, or have stomach cramps, headaches and flushing. Your doctor may suggest you avoid alcohol while being treated with Resprim.

Your skin may burn more easily while you are taking Resprim. If outdoors, wear protective clothing or use a
SPF 30+ sunscreen.

Use in people with HIV infection:

People with HIV infection may not respond to Resprim in the same way as people without HIV, and have been reported to get more side effects.

Side effects

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

Resprim treats infections in most people, but it may have unwanted side effects in some people.

All medicines can have 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.

Very rarely, people have died from complications due to certain severe skin, liver and blood reactions.

If you are over 65 years, you are more at risk of developing severe side effects when taking Resprim. The risk is greater if you have liver or kidney disease or are taking certain other medicines.

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

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

You may not experience any of them.

While you are taking Resprim

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

• feeling sick, vomiting, stomach upset
• loss of appetite
• oral thrush (white, furry sore tongue and mouth)
• vaginal thrush (sore and itchy vagina, vaginal discharge).

Tell your doctor immediately if you notice any of the following:

• watery and severe diarrhoea, which may also be bloody
• severe stomach cramps
• unusual tiredness or weakness and looking pale
• bruising or bleeding more easily than normal
• signs of frequent infections such as fever, chills, sore throat or mouth ulcers
• yellowing of the eyes or skin (jaundice)
• passing very little or no urine
• painful, swollen joints
• fits
• symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
• severe and persistent headache
• pins and needles in the hands & feet.

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

• any type of skin rash, itching or hives, peeling of the skin
• swelling of the face, lips, mouth, throat or other parts of the body
• shortness of breath, wheezing or troubled breathing.

After you have finished taking Resprim

Tell your doctor immediately if you notice any of the following, even if they occur several weeks after stopping treatment with Resprim:

• severe stomach cramps
• watery and severe diarrhoea, which may also be bloody.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

After using Resprim

Storage

Keep Resprim 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 Resprim in a cool dry place where the temperature stays below 30 degrees C.

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

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

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Resprim, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Resprim comes as tablets or a suspension (mixture).

Resprim tablets come in two strengths:

• Resprim – round, white tablet marked 80|400 on one side and R on the other side
• Resprim Forte – oblong, white tablet marked 160|800 on one side and RF on the other side.

Each pack contains 10 tablets.

Resprim Suspension is pink, cherry flavoured and sugar free. Each bottle contains 100 mL of mixture.

Ingredients

The active ingredients in Resprim tablets and suspension are trimethoprim and sulfamethoxazole:

• each Resprim tablet contains 80 mg of trimethoprim and 400 mg of sulfamethoxazole
• each Resprim Forte tablet contains 160 mg of trimethoprim and 800 mg of sulfamethoxazole
• each 5 mL of Resprim Suspension contains 40 mg of trimethoprim and 200 mg of sulfamethoxazole.

Resprim and Resprim Forte tablets contain the following inactive ingredients:

• povidone
• docusate sodium
• sodium starch glycollate
• magnesium stearate.

The tablets are gluten free.

Resprim Suspension contains the following inactive ingredients:

• sorbitol
• carmellose sodium
• dispersible cellulose
• glycerol
• polysorbate 80
• cherry flavour
• ethanol
• saccharin sodium
• anhydrous citric acid
• water
• allura red AC CI16035 (129)
• sunset yellow FCF CI15985 (110)
• methylhydroxybenzoate (218)
• sodium benzoate (211).

Resprim Suspension is gluten free and sugar free.

Supplier

Resprim is supplied by:

• Alphapharm Pty Limited
• (ABN 93 002 359 739)
• Chase Building 2
• Wentworth Park Road
• Glebe NSW 2037
• Phone: (02) 9298 3999
• Medical Information
• Phone: 1800 028 365
• Australian registration numbers:
• Resprim – Aust R 17681
• Resprim Forte – Aust R 17682
• Resprim Suspension – Aust R 17699
• This leaflet was prepared on
• 8 January 2001.

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