contains the active ingredient diclofenac sodium
Consumer Medicine Information
This leaflet answers some common questions about Fenac.
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 Fenac 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.
Fenac is used to treat the symptoms of:
Fenac belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation (swelling and redness).
Although Fenac can relieve the symptoms of pain and inflammation, it will not cure your condition.
Your doctor may have prescribed Fenac for another reason. Ask your doctor if you have any questions about why Fenac has been prescribed for you.
Fenac is not recommended for use in children as its safety and effectiveness in children has not been established.
There is no evidence that Fenac is addictive.
Fenac is available only with a doctor's prescription.
Do not take Fenac if you are allergic to:
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist.
Symptoms of an allergic reaction to these medicines may include:
If you are allergic to aspirin or NSAID medicines and take Fenac, these symptoms may be severe.
Do not take Fenac if you have any of the following medical conditions:
Do not take this medicine during the last three months of pregnancy. It may affect your baby and may delay labour and birth.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have, or have had, any of the following medical conditions:
Your doctor may want to take special precautions if you have any of the above conditions.
It is generally important to take the lowest dose of Fenac that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk for cardiovascular side effects as small as possible.
Tell your doctor if you are pregnant or plan to become pregnant. There is not enough information to recommend the use of Fenac during the first 6 months of pregnancy and it must not be used during the last 3 months. Fenac may also reduce fertility and affect your chances of becoming pregnant. Your doctor can discuss the risks and benefits involved.
Tell your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended while taking Fenac. The active ingredient, diclofenac, passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking Fenac when breastfeeding.
Tell your doctor if you are lactose intolerant. Fenac tablets contain lactose.
Tell your doctor if you are planning to give this medicine to a child.
Safety and effectiveness in children have not been established.
Tell your doctor if you currently have an infection. If you take Fenac while you have an infection, it may hide some of the signs of the infection (such as pain, fever, swelling or redness). This may make you mistakenly think that you are recovering or that your infection is not serious.
Your doctor will want to know if you are prone to allergies, especially if you get skin reactions with redness, itching or rash.
If you have not told your doctor about any of the above, tell them before you start taking Fenac.
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 and Fenac may interfere with each other. These include:
These medicines may be affected by Fenac or may affect how well it works. You may need different amounts of your medicines, or you may need to take different 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 Fenac.
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
The dose varies from patient to patient.
The usual dose starting dose to treat arthritis or other painful conditions where swelling is present is 75 to 150 mg a day. For long term treatment, your doctor may lower the dose depending on how you respond.
Elderly patients may need smaller doses.
For period pain, the dose starts at 50 to 100 mg a day and may be increased if necessary to a maximum of 200 mg a day.
Do not exceed the recommended dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Fenac may not work as well and your problem may not improve.
Swallow the tablets whole with a glass of water.
Do not crush or chew the tablets. Fenac tablets have a special coating which helps to prevent stomach irritation. If you crush or chew the tablets, you will destroy the coating and increase the likelihood of a stomach upset.
Take Fenac with or after food. This may help reduce the possibility of stomach upset.
Fenac tablets are usually taken in 2 or 3 doses during the day.
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 tablets 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.
Take Fenac only for as long as your doctor recommends.
For arthritis, Fenac usually begins to work within a few hours, but it may take several weeks before you feel the full effects of the medicine. Fenac will not cure your condition but it should help control the pain, swelling and stiffness.
For period pain, Fenac is usually taken during each period as soon as the pain begins and continued for a few days until the pain goes away.
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Fenac. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include vomiting, bleeding from the stomach or bowel, diarrhoea, dizziness, ringing in the ears or convulsions (fits).
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Fenac.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
NSAIDs can cause prolonged bleeding and affect kidney function.
If you become pregnant while taking this medicine, tell your doctor immediately. Your doctor can discuss with you the risks of taking Fenac while you are pregnant.
If you get an infection while taking Fenac, tell your doctor. Fenac may hide some of the signs of an infection (such as pain, fever, redness, swelling). You may mistakenly think that you are better or that your infection is not serious.
Visit your doctor regularly so that they can check on your progress. Your doctor may want to take some tests (check your kidneys, liver and blood) from time to time. This helps to prevent unwanted side effects.
If, for any reason, you have not taken Fenac exactly as prescribed, tell your doctor. Your condition may not improve or you may have unwanted side effects if you do not take the tablets as prescribed. Also, your doctor may think that Fenac is not working for you and change your treatment unnecessarily.
Do not use Fenac to treat any other conditions unless your doctor tells you to.
Do not give Fenac to anyone else, even if they have the same condition as you.
Do not take any other medicines to treat inflammation while you are taking Fenac without first checking with your doctor or pharmacist. These include:
If you take these medicines together with Fenac, they may cause unwanted side effects.
If you need to take something for headache or fever, it is recommended that you take paracetamol. If you are not sure, check with your doctor or pharmacist.
Do not stop any other forms of treatment for arthritis that your doctor has advised.
This medicine does not replace exercise or rest programs or the use of heat/cold treatments.
Be careful driving or operating machinery until you know how Fenac affects you. Fenac may cause dizziness, drowsiness or blurred vision in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.
Elderly patients should take the minimum number of tablets that provides relief of symptoms. Elderly patients may be more sensitive to the effects of Fenac than other adults.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Fenac. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
If you are over 65 years of age, you may have an increased chance of getting side effects. Report any side effects to your doctor.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
If any of the following happen, stop taking Fenac and tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some patients.
Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Fenac or any other medicine in the bathroom or near a sink. Do not leave Fenac in the car or on window sills. Heat and dampness can destroy some medicines.
Keep Fenac 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.
If your doctor tells you to stop taking Fenac, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Fenac is available in two different strengths.
The active ingredient in Fenac is diclofenac sodium. Each Fenac tablet contains either 25 mg or 50 mg of diclofenac sodium.
The tablets also contain:
The tablets are gluten free.
Fenac is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Australian Registration Numbers:
Fenac 25 mg blister pack - AUST R 165707
Fenac 50 mg blister pack - AUST R 165706
This leaflet was prepared on 15 August 2014.
Published by MIMS December 2014