Septrin Forte Tablets

Septrin Forte Tablets is a brand of medicine containing the active ingredients sulfamethoxazole - trimethoprim.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

SEPTRIN Tablets, SEPTRIN Forte Tablets & SEPTRIN Sugar-Free Paediatric Suspension

Trimethoprim and Sulfamethoxazole


Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions about SEPTRIN. It does not contain all of the available information.

Reading this leaflet does not take the place of talking to your doctor or pharmacist.

Taking any medicine involves some risk. It is possible that all risks associated with this medicine might not have been detected, despite proper testing.

Only your doctor or pharmacist is able to weigh up all of the relevant facts, and you should consult them if you have any queries.

If you have any concerns about taking SEPTRIN, ask your doctor or pharmacist.

Keep this information. You may want to read it again.

This leaflet provides information about SEPTRIN. The statements that are made in this leaflet cannot be applied to any other medicine, even those that are similar or appear to contain the same ingredients.

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What SEPTRIN is used for

SEPTRIN is used for the treatment of a variety of bacterial infections, including bronchitis and infections of the ear, sinus, kidney, bladder, stomach, bowel, skin and wounds.

How does SEPTRIN work?

Trimethoprim and sulfamethoxazole (the active ingredients in SEPTRIN) belong to a group of medicines called "anti-infectives". They work in slightly different ways to stop the growth of bacteria causing the infection.

If you have any questions about why you are taking SEPTRIN, ask your doctor or pharmacist.

Before taking SEPTRIN

Read this section carefully. If you have any concerns about the use of SEPTRIN, please discuss them with your doctor. SEPTRIN is not suitable for everyone.

Before taking SEPTRIN you must tell your doctor if:

  1. You are allergic to:
  • trimethoprim, sulfamethoxazole or any other ingredient listed at the end of this information.
  • any other sulphonamide type antibiotics, any diuretics (medicines that increase the volume of your urine), or medicines for diabetes or an overactive thyroid gland.
  1. You are pregnant or breastfeeding or become pregnant, while taking SEPTRIN.
  2. You have ever had any type of liver, kidney or bladder complaint or disease (eg. hepatitis).
  3. You have ever had any type of blood disorder (including porphyria and glucose-6-phosphate dehydrogenase deficiency).
  4. You have asthma or an allergic disorder.
  5. You have a folic acid vitamin deficiency.
  6. You have phenylketonuria.
  7. You suffer from alcoholism.
  8. You suffer from rheumatoid arthritis.
  9. You are being treated for epilepsy (fits).
  10. You have been diagnosed with AIDS.

People with AIDS may not tolerate or respond to SEPTRIN in the same manner as someone who does not have AIDS. There may be an increase in the number and severity of side effects.

  1. You are taking any medicines, including:
  • Any malaria medicines (eg. pyrimethamine)
  • Any diabetes medicines
  • Any diuretics
  • Any epilepsy (fits) medicines (eg. phenytoin, primidone and some barbiturates)
  • Rifampicin, methotrexate, cyclosporin, warfarin, digoxin, procainamide or amantadine
  1. You are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Your doctor will have a complete list of the medicines that may cause problems when taken with SEPTRIN.

SEPTRIN and very young children

SEPTRIN should not be used in premature babies or in children younger than 2 months old.

SEPTRIN and the elderly

The use of SEPTRIN in elderly patients, particularly those with a liver or kidney disease or those taking certain other medicines, carries an increased risk of severe adverse reactions.

When you must not take SEPTRIN

Do not take SEPTRIN after the expiry date printed on the pack or bottle. SEPTRIN may have no effect if you take it after the expiry date.

Do not take SEPTRIN if the packaging appears to have been tampered with.

Do not take SEPTRIN to treat any other conditions unless advised by your doctor.

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

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Using SEPTRIN

Take SEPTRIN as directed by your doctor or pharmacist. Never change the dose yourself. If you have any questions about the dose that you have been prescribed, ask your doctor or pharmacist.

Your doctor or pharmacist will be able to tell you:

  • how much SEPTRIN to take at each dose.
  • how many doses to take each day.
  • when to take each dose.

The label on the container that your SEPTRIN was supplied in will give the same information.

For adults and children over 12 years old the usual dose is one SEPTRIN Forte Tablet, or two SEPTRIN Tablets, twice a day.

The dose of SEPTRIN Sugar-Free Paediatric Suspension for children under 12 years old depends on your child's weight and age. Your doctor or pharmacist will be able to tell you how much your child should be given.

Depending on the type of infection, and your overall health, your doctor may prescribe a different dose of SEPTRIN.

Always take the full course of SEPTRIN prescribed by your doctor.

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How to take SEPTRIN

SEPTRIN Tablets and SEPTRIN Forte Tablets should be taken with a glass of water. Do not crush or chew the tablets.

SEPTRIN Sugar-Free Paediatric Suspension should be shaken before use. The correct amount of the suspension should be measured before being given by mouth.

If you forget to take your dose

If it is almost time for your next dose, skip the dose that you have missed and take your next dose when you are supposed to. Otherwise take the dose that you have missed as soon as you remember, then go back to your normal schedule.

If you have forgotten to take more than one dose, contact your doctor or pharmacist.

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

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

In case of overdose

Immediately contact your doctor or Poisons Information Centre for advice, or go to Casualty at your nearest hospital, if you think that you or anyone else may have taken too much SEPTRIN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If too much SEPTRIN has been taken signs and symptoms may include nausea, vomiting, dizziness, headache, depression and confusion. It is also possible that you will feel drowsy and you may lose consciousness.

When to stop taking SEPTRIN

Do not stop taking SEPTRIN just because you feel better. It is important that you take the full course of SEPTRIN prescribed by your doctor. This will reduce the risk of your infection recurring.

Your doctor will advise you when to stop taking SEPTRIN.

If you are unsure whether you should stop taking SEPTRIN, talk to your doctor or pharmacist.

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While you are taking SEPTRIN

It is important that you drink plenty of fluids (water) while you are taking SEPTRIN.

Tell your doctor that you are taking SEPTRIN before you have any blood tests. If you are taking SEPTRIN over a long period, or you have kidney problems, your doctor may ask you to undergo regular blood and urine tests.

Your doctor or pharmacist will be able to tell you whether there are any other special instructions while you are taking SEPTRIN.

There is no evidence that SEPTRIN is addictive.

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Side Effects

All medicines have side effects. Sometimes they are serious. Most of the time they are not.

Stop taking SEPTRIN and tell your doctor immediately if you notice, or experience, any of the following (you may need urgent medical attention):

  • Any form of skin rash.

The rash may indicate that you are allergic to SEPTRIN. In very rare circumstances, patients have died from complications that may arise from certain severe allergic reactions. Your doctor will know what action to take if you develop a severe reaction.

  • Severe fever, chills, sore throat, joint pains, cough or bruising.
  • Difficulty breathing or chest pains.
  • Severe, persistent diarrhoea. This is particularly important if there is any blood or mucus present. It is possible for this reaction to only become apparent several weeks after taking SEPTRIN.
  • Jaundice (yellowing of the skin), which is related to the function of your liver.

SEPTRIN may also cause more common side effects such as nausea, vomiting and inflammation of the mouth or tongue.

Other rare side effects include various other allergic side effects, pins and needles in the hands and feet, ringing in the ears, diarrhoea, loss of appetite, kidney damage, fits, headaches, depression, imagined sensations (hallucinations), nervousness, an increase or decrease in urine production, unsteadiness, dizziness, sleeplessness, weakness, tiredness, increased sensitivity to light and stomach pains.

If you experience any of these side effects, please contact your doctor as soon as possible. Various effects on the blood, particularly in the elderly, have been attributed to the use of SEPTRIN. In very rare circumstances, patients have died from some of these effects. Having a blood test may be able to detect these effects.

A small number of patients have had other unwanted effects after taking SEPTRIN.

Tell your doctor or pharmacist as soon as possible if you think you are experiencing any side effects from taking SEPTRIN.

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After using SEPTRIN

If your doctor advises you to stop taking SEPTRIN, ask your pharmacist what to do with any SEPTRIN that you may have left.

Storage

Keep SEPTRIN Tablets and SEPTRIN Forte Tablets in a cool dry place where the temperature stays below 30°C. Protect the tablets from light.

Keep SEPTRIN Sugar-Free Suspension in a cool dry place where the temperature stays below 30°C. Protect the suspension from light.

Keep your SEPTRIN in the container it was supplied with.

Do not store SEPTRIN in the bathroom or near a sink. Heat and dampness may affect SEPTRIN.

Do not leave SEPTRIN in the car on hot days.

Keep SEPTRIN and all other medicines, where children cannot reach them.

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Product description

What SEPTRIN looks like

SEPTRIN Tablets are round, white, scored and marked "SEPTRIN".

They are supplied in bottles of 10 tablets.

SEPTRIN Forte Tablets are elongated, white, scored and marked "SEPTRIN FORTE".

They are supplied in blister packs of 10 tablets.

SEPTRIN Sugar-Free Suspension is a thick, pink cherry flavoured liquid in a 100 mL bottle.

Ingredients

Each SEPTRIN Tablet contains 80 mg of trimethoprim and 400 mg sulfamethoxazole.

Each SEPTRIN Forte Tablet contains 160 mg of trimethoprim and 800 mg sulfamethoxazole.

The tablets also contain:

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

Every 5 mL of Septrin Sugar-Free Paediatric Suspension contains 40 mg trimethoprim and 200 mg sulfamethoxazole.

The suspension also contains:

  • carmellose sodium
  • saccharin sodium
  • cellulose-dispersible
  • glycerol
  • polysorbate 80
  • citric acid - anhydrous
  • sorbitol
  • ethanol
  • water
  • sunset yellow FCF (CI 5985)
  • allura red AC (CI 16035)
  • imitation cherry flavour 50001OU
  • methyl hydroxybenzoate
  • sodium benzoate

The Australian Registration numbers are:

Septrin Tablets:
AUST R 11001

Septrin Forte Tablets:
AUST R 10998

Septrin Sugar-Free Paediatric Suspension: AUST R 11000

Supplier

Sigma Pharmaceuticals Pty Ltd
A.C.N. 004 118 594
1408 Centre Rd
Clayton Victoria, 3168
Australia

Telephone: (03) 9839-2800

Date of preparation:
March 2002

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CMI provided by MIMS Australia, November 2012  

Latest information - Septrin Forte Tablets

Audience:
       

(Medicine)
29 Oct 2012 Information on medicines available in Australia containing sulfamethoxazole - trimethoprim, including our latest evidence-based information and resources for health professionals and consumers. The active ingredient is the chemical in a medicine that makes it work. Medicines that contain the same active ingredient can be available under more than one brand name. Brands include both active ingredients and inactive ingredients. You'll find information about brands of medicines that contain sulfamethoxazole