Consumer medicine information

PROVEN PLUS

Ibuprofen and Codeine Phosphate Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about PROVEN PLUS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your pharmacist has weighed the risks of you taking PROVEN PLUS against the benefits this medicine is expected to have for you.

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

Keep this leaflet with the medicine. You may need to read it again

What is PROVEN PLUS used for

PROVEN PLUS tablets contain two active ingredients: Ibuprofen and Codeine phosphate.

Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDS). This group of medicines work by relieving pain, inflammation (swelling, redness, soreness) and fever.

Codeine is an opioid analgesic that works in the brain and spinal cord to relieve pain.

PROVEN PLUS tablets relieve inflammation and strong pain associated with migraine headache, tension headache, headache, period pain, dental pain, back pain, neuralgia, rheumatic pain, arthritic pain and muscular pain.

PROVEN PLUS is not recommended for use in children under the age of 12 years.

Before you take PROVEN PLUS

When you must not take it

Do not take PROVEN PLUS if you have an allergy to:

  • Ibuprofen, codeine or other opioid analgesics such as morphine or pethidine, or any of the ingredients of PROVEN PLUS, listed at the end of this leaflet;
  • Aspirin;
  • any other NSAID medicine.

Symptoms of an allergic reaction to these medicines may include:

  • asthma, wheezing or shortness of breath.
  • swelling of the face, lips, or tongue; this may affect swallowing or breathing.
  • hives, itching or skin rash.
  • Fainting.

If you are allergic to Aspirin or NSAID group of medicines and take PROVEN PLUS tablets, these symptoms may be severe.

Do not take PROVEN PLUS if you are also taking any other medicines that contain one or more NSAID medicine, whether prescribed by your doctor or obtained without prescription.

Several medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAIDs. If you are not sure if the medicines you are taking contain these ingredients, ask your pharmacist.

Do not take PROVEN PLUS at all during the last 3 months of pregnancy.

Unless advised by a medical doctor, do not take PROVEN PLUS tablets during the first six months of pregnancy. NSAIDs should not be taken during pregnancy.

Do not take PROVEN PLUS if:

  • you are vomiting blood or material that looks like coffee grounds
  • you are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea
  • you have a stomach ulcer
  • you have chronic constipation or shallow breathing, or severe diarrhoea
  • you consume heavy amounts of alcohol regularly
  • the packaging is torn or shows signs of tampering
  • the expiry date (EXP) printed on the pack has passed; it may not work as well
  • you are not sure whether you should start taking PROVEN PLUS, contact your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if you:

  • are pregnant or intend to become pregnant. PROVEN PLUS is not recommended for use during pregnancy. Your doctor will decide if you should take PROVEN PLUS.
  • are breast-feeding or plan to breast-feed. PROVEN PLUS is not recommended while you are breast-feeding. If there is a need to consider PROVEN PLUS while you are breast-feeding, your pharmacist or doctor will discuss with you the benefits and risks of using it
  • have any medical conditions, especially the following:
  • a history of stomach ulcer.
  • liver disease.
  • kidney disease.
  • heart failure.
  • swelling of ankles or feet.
  • asthma, or have suffered in the past from asthma.
  • thyroid problems or low blood pressure.
  • a head injury or intercranial pressure.
  • prostate problems.
  • stomach problems or recent stomach surgery

Taking other medicines

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

Some medicines may interfere with each other. These include:

  • aspirin, salicylates or other NSAID medicines.
  • warfarin or other medicines used to stop blood clots or thin the blood.
  • medicines that are used to treat high blood pressure eg diuretics (fluid tablets) or heart problems.
  • methotrexate.
  • zidovudine.
  • lithium and other medicines used to treat depression or anxiety eg MAOIs (even if taken within the last 14 days).
  • medicines used to relieve stomach cramps.
  • medicines used to treat diarrhoea (eg. kaolin, pectin, loperamide).
  • metoclopramide.
  • other pain relieving medicines including other opioids.

These medicines may be affected by PROVEN PLUS or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you. Your pharmacist and doctor have more information on medicines to avoid or be careful with while taking PROVEN PLUS.

How to take PROVEN PLUS

How much to take

The usual dose of PROVEN PLUS for adults and children over 12 years of age is 2 tablets followed by, if necessary 1 or 2 tablets every 4 hours. Do not take more than 6 tablets in 24 hours.

PROVEN PLUS is not recommended for children under 12 years of age. If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How to take it

Take PROVEN PLUS by mouth with fluid. It may also be taken before, or after food.

How long to take it

You should not take PROVEN PLUS for more than a few days.

If your symptoms persist, worsen or new symptoms develop, talk to your doctor/pharmacist.

If you take too much (overdose)

If you take too much of this medicine you may experience nausea or upset stomach, vomiting and gastric irritation, drowsiness, dizziness or very slow, laboured breathing. You may also experience blurred vision, ringing in the ears, or rapid uncontrollable movements of the eyes. Excitability, convulsions and unconsciousness may be experienced in rare cases. If you think you have taken too many PROVEN PLUS tablets, talk to your pharmacist or doctor, or contact the Poisons Information Centre in Australia on 13  11  26 for advice.

While you are taking PROVEN PLUS

Things you must do

  • If you become pregnant while taking PROVEN PLUS tablets tell your doctor immediately.
  • If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking PROVEN PLUS tablets.
  • Tell all of the doctors, dentists and pharmacists that are treating you that you are taking PROVEN PLUS tablets.
  • If you are going to have surgery, tell your doctor you are taking PROVEN PLUS tablets.

Things you must not do

  • Do not give PROVEN PLUS to anyone else, even if they have the same condition as you
  • Do not use PROVEN PLUS to treat any other complaints
  • Do not take PROVEN PLUS tablets with any other product containing ibuprofen and or codeine/ other opioid unless your doctor tells you

Things to be careful of

  • Be careful driving or operating machinery until you know how PROVEN PLUS affects you.
  • PROVEN PLUS may cause dizziness, light-headedness or drowsiness in some people. If this occurs, do not drive or operate machinery. If you drink alcohol, dizziness, light-headedness or drowsiness may be worse.
  • Products containing codeine should not be taken for prolonged periods; Codeine may be habit forming.

Side effects

Check with your pharmacist or doctor as soon as possible if you have any problems while taking PROVEN PLUS, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, PROVEN PLUS can cause some side effects in rare cases. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention. Ask your pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following symptoms that worry you:

  • stomach upset including nausea (feeling sick), vomiting.
  • heartburn, indigestion.
  • diarrhoea, pain in the stomach.
  • dizziness, light-headedness, drowsiness.
  • constipation.
  • shallow breathing.
  • cough suppression.
  • headache.
  • hearing disturbance.

These are the more common side effects of PROVEN PLUS and are usually mild and short lived.

If any of the following happen, stop taking PROVEN PLUS and tell your doctor immediately or go to casualty at your nearest hospital:

  • vomiting blood or material that looks like coffee grounds.
  • bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing.
  • asthma, wheezing, shortness of breath, pain or tightness in the chest
  • sudden or severe itching, skin rash, hives, skin peeling
  • easy bruising

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare. Some people may get other side effects while taking PROVEN PLUS. Tell your doctor or pharmacist if you notice anything else that worries you.

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

After taking PROVEN PLUS

Storage

Keep the tablets in the pack until it is time to take the dose. If you take them out they will not keep well.

Keep the tablets in a cool dry place where the temperature stays below 25°C.

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

Do not leave the tablets in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep the tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground are a good place to store medicines.

Disposal

When you stop taking PROVEN PLUS or it has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.

More Information

If you have any further questions or if you are not sure about anything relating to the use of PROVEN PLUS, your doctor or pharmacist can best assist you.

Product description

What it looks like?

PROVEN PLUS is white to off-white capsule-shaped, biconvex, film-coated tablet.

Ingredients

PROVEN PLUS contains 200mg ibuprofen and 12.8mg codeine phosphate as the active ingredients. The other ingredients in PROVEN PLUS are:

  • Lactose
  • Starch-maize
  • Glyceryl behenate
  • Silica-colloidal anhydrous
  • Magnesium stearate
  • Opadry film coating system white

PROVEN PLUS does not contain gluten or preservatives.

Presentation:

PROVEN PLUS is available in Australia in blister packs of 12 and 24 tablets.

Sponsor

PROVEN PLUS is supplied in Australia by:

www.ascentpharma.com.au
Ascent Pharma Pty Ltd
151 – 153 Clarendon Street
South Melbourne VIC 3205

Telephone number: 1800 554 414

AUST R 160536

This leaflet was prepared in April 2010.

Published by MIMS September 2010