Diclofenac Sandoz®

diclofenac sodium enteric-coated tablets

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Diclofenac Sandoz.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.sandoz.com.au .

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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 DICLOFENAC SANDOZ IS USED FOR

This medicine is used to treat:

• inflammatory and degenerative forms of rheumatism, rheumatoid arthritis and osteoarthritis
• relief of acute or chronic pain states in which there is an inflammatory component
• symptoms of menstrual pain (period pain).

It contains the active ingredient diclofenac sodium.

Diclofenac sodium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It works by reducing pain and inflammation (swelling and redness).

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

There is no evidence that this medicine is addictive.

BEFORE YOU TAKE DICLOFENAC SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:

• diclofenac sodium, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
• any other similar medicines, such as aspirin, ibuprofen or other NSAIDs.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

If you are allergic to aspirin or NSAID medicines and take Diclofenac Sandoz, these symptoms may be severe.

Do not take this medicine if you have or have had any of the following medical conditions:

• stomach or intestinal ulcer
• bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools)
• severe kidney or liver problems
• severe heart failure.

Do not take this medicine during the first 6 months of pregnancy, except on doctor's advice. Do not use during the last three months of pregnancy. It may affect your developing baby if you take it during the last three months of pregnancy.

Use of non-aspirin NSAIDs can increase the risk of miscarriage, particularly when taken close to the time of conception.

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.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Your doctor will want to know if you are prone to allergies, especially if you get skin reaction with redness, itching or rash.

Tell your doctor if you have or have had any of the following medical conditions:

• history of ulcers (stomach or intestinal)
• gastrointestinal problems such as stomach ulcer, bleeding or black stools, or have experienced stomach discomfort or heartburn after taking anti-inflammatory medicines in the past
• Crohn's disease or ulcerative colitis, which are diseases of the bowel
• a tendency to bleed or other blood problems such as anaemia
• history of haemorrhoids (piles) or irritation of the rectum (back passage)
• any heart problems, including disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up; high blood pressure or significant risk of high level of fat in your blood, diabetes or if you smoke, as treatment with Diclofenac Sandoz is not recommended, and if your doctor decides to prescribe Diclofenac Sandoz you must not increase the dose above 100 mg per day if you are treated for more than 4 weeks
• problems with your liver or kidney function
• a rare liver condition called porphyria
• asthma or any other chronic lung disease that causes difficulty in breathing
• seasonal allergies (e.g. hay fever)
• repeated chest infections
• polyps in the nose
• diabetes
• recent major surgery

It is generally important to take the lowest dose that relieves your pain and/ or swelling and for the shortest time possible in order to keep your risk for heart problems or high blood pressure as small as possible.

Tell your doctor if you are pregnant or plan to become pregnant. Do not use Diclofenac Sandoz during the first 6 months of pregnancy, except on doctor's advice and it must not be used during the last 3 months. Diclofenac Sandoz may also reduce fertility and affect your chances of becoming pregnant. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breastfeeding. The active ingredient in Diclofenac Sandoz passes into breast milk. Breastfeeding is not recommended while you are using this medicine.

Tell your doctor if you are lactose intolerant. Diclofenac Sandoz 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.

If you have not told your doctor about any of the above, tell him/ her before you start taking Diclofenac Sandoz.

Taking other medicines

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

Some medicines and Diclofenac Sandoz may interfere with each other. These include:

• aspirin, salicylates, ibuprofen, or other NSAID medicines
• anticoagulants such as warfarin, medicines used for thinning the blood or stop blood clots
• digoxin, a medicine used to treat heart problems
• lithium or selective serotonin-reuptake inhibitors (SSRIs), medicines used to treat some types of depression
• diuretics, also called fluid or water tablets, medicines used to increase the amount of urine
• ACE inhibitors or beta-blockers, medicines used to treat high blood pressure, heart conditions, glaucoma and migraine
• corticosteroids, medicines such as prednisone and cortisone, used to reduce the activity of your immune system
• antidiabetic agents, medicines used to treat diabetes
• methotrexate, a medicine used to treat arthritis, as well as some types of cancers
• cyclosporine and tacrolimus, medicines used in patients who have received organ transplants
• glucocorticoids, a group of anti-inflammatory medications, used to treat arthritis
• certain antibiotics called quinolones
• sulfinpyrazone, a medicine used to treat gout
• voriconazole, a medicine used to treat fungal infections
• phenytoin, a medicine used to treat seizures
• trimethoprim used to treat urinary tract infections.

These medicines may be affected by Diclofenac Sandoz, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

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

HOW TO TAKE DICLOFENAC SANDOZ

Follow all directions given to you by your doctor or 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.

How much to take

The usual starting dose is 75mg to 150mg per day. For long-term treatment, 75mg to 100mg daily is usually sufficient.

In period pain, the usual starting dose is 50mg to 100mg per day, beginning as soon as cramps begin and continuing until the pain goes away, but for no longer than 3 days. If necessary, the dose can be increased over several menstrual cycles up to a maximum of 200mg per 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, Diclofenac Sandoz may not work as well and your problem may not improve.

How to take it

Diclofenac Sandoz are usually taken in 2 or 3 doses during the day.

Swallow the tablets whole with a full glass of water or other liquid.

Do not chew them. These tablets have a special coating to stop them dissolving until they have gone through the stomach and into the intestines, where they can start to work. If you chew them, the coating is destroyed.

When to take Diclofenac Sandoz

It is recommended to take the tablets before meals. You may take them with, or immediately after food in order to reduce the chance of stomach upset.

How long to take Diclofenac Sandoz

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition but does not cure it.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. 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 your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Diclofenac Sandoz. 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
• convulsions (fits).

WHILE YOU ARE TAKING DICLOFENAC SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Diclofenac Sandoz.

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. It can slow down blood clotting and affect kidney function.

If you become pregnant while taking this medicine, tell your doctor immediately. Your doctor can discuss with you the risk of using it while you are pregnant.

Tell your doctor if you get an infection while taking this medicine. This medicine may hide some of the signs of an infection (pain, fever, swelling, redness). You may think, mistakenly, that you are better or that the infection is not serious.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor will periodically re-evaluate whether you should continue treatment, if you have established heart disease or significant risks for heart disease, especially in case you are treated for more than 4 weeks.

Your doctor may do some tests (check your kidneys, liver and blood) from time to time to prevent unwanted side effects.

If, at any time while taking CLONAC you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.

Things you must not do

Do not take any of the following medicines while you are taking Diclofenac Sandoz without first telling your doctor:

• aspirin (also called ASA or acetylsalicylic acid)
• other salicylates
• other medicines containing diclofenac
• ibuprofen
• any other NSAID medicine.

If you take these medicines together with Diclofenac Sandoz, they may cause unwanted side effects.

If you need to take something for headache or fever, it is usually okay to take paracetamol. If you are not sure, your doctor or pharmacist can advise you.

Do not stop any other forms of treatment for arthritis that your doctor has told you to follow. This medicine does not replace exercise or rest programs or the use of heat/cold treatments.

Do not take Diclofenac Sandoz to treat any other complaints unless your doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how Diclofenac Sandoz affects you. This medicine may cause dizziness or light-headedness in some people. If you have any of these symptoms, 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 Diclofenac Sandoz than other adults.

SIDE EFFECTS

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

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.

Do not be alarmed by the following list of 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:

• stomach pain including nausea (feeling sick), vomiting, indigestion, loss of appetite, weight loss, wind, abdominal cramps
• heartburn or pain behind or below the breastbone (possible symptoms of an ulcer in the tube that carries food from the throat to the stomach)
• constipation, diarrhoea
• skin rashes, skin inflammation with flaking or peeling
• dizziness, spinning sensation
• drowsiness, disorientation, forgetfulness
• headache
• sore mouth or tongue
• altered taste sensation
• feeling depressed, anxious or irritable
• strange or disturbing thoughts or moods, nightmares, sleeplessness, shakiness
• tingling or numbness of the hands or feet
• feeling fast or irregular heart beat
• unusual weight gain or swelling of ankles or legs due to fluid build up
• symptoms of sunburn that happen more quickly than usual (redness, itching, swelling, blistering of the lips, eyes, mouth and/or skin)
• blurred or double vision*
• difficulty hearing, buzzing or ringing of the ears
• hair loss or thinning
• hypertension (high blood pressure).

*If symptoms of vision disorders occur during treatment with Diclofenac Sandoz, contact your doctor as an eye examination may be considered to exclude other causes.

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

• red or purple skin
• severe pain or tenderness in the stomach, vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
• rash, itching or hives on the skin, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, low blood pressure (hypotension), fainting, shortness of breath (possible allergic reaction)
• wheezing, troubled breathing or feelings of tightness in the chest (signs of asthma)
• persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the upper right abdomen, yellowing of the skin or eyes, dark urine or pale bowel motions
• constant "flu-like" symptoms (chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy), bleeding or bruising more easily than normal
• development of painful red areas, large blisters, peeling of skin, bleeding lips, eyes, mouth, nose or genitals which may be accompanied by fever and chills, aching muscles and generally feeling unwell (possible serious skin reaction)
• sudden and severe headache, stiff neck, severe nausea, dizziness, numbness, difficulty in speaking, paralysis, fainting, convulsions/seizures (fits)
• change in the colour or amount of urine passed, blood in the urine, burning feeling when passing urine and frequent need to urinate
• sudden and oppressive chest pains which may be a sign of a heart attack
• breathlessness, difficulty breathing when lying down, swelling of the feet or legs.

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 else that is making you feel unwell. Other side effects not listed above may also occur in some people.

AFTER TAKING DICLOFENAC SANDOZ

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

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

Do not store Diclofenac Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it 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.

Disposal

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

PRODUCT DESCRIPTION

What it looks like

Diclofenac Sandoz tablets come in two strengths:

Diclofenac Sandoz 25mg - round, brown-yellow enteric-coated tablets.

Diclofenac Sandoz 50mg - round, brown-yellow enteric-coated tablets.

Available in blisters or bottles* of 50 tablets.

Ingredients

Active ingredients:

• Diclofenac Sandoz 25mg - 25mg diclofenac sodium
• Diclofenac Sandoz 50mg - 50mg diclofenac sodium

Inactive ingredients:

• lactose
• calcium hydrogen phosphate dihydrate
• microcrystalline cellulose
• maize starch
• sodium starch glycollate
• magnesium stearate
• colloidal silicon dioxide
• methacrylic acid copolymer
• triethyl citrate
• talc
• titanium dioxide
• yellow ferric oxide.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500

Novartis New Zealand Ltd
PO Box 99102
Newmarket, Auckland 1149
New Zealand
Tel: 0800 354 335

This leaflet was revised in May 2017.

Australian Register Numbers:

Diclofenac Sandoz 25mg - AUST R 63664 (blisters)

Diclofenac Sandoz 25mg - AUST R 61297 (bottles)*

Diclofenac Sandoz 50mg - AUST R 63661 (blisters)

Diclofenac Sandoz 50mg - AUST R 61298 (bottles)*

* Not registered in New Zealand