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Sandoz Ltd

Diclofenac 25 & 50mg Tablets

PL 04416/0361 & 0362

Package leaflet: Information for the user Diclofenac® Tablets 25 and 50 mg (diclofenac sodium)

Please read this leaflet carefully before you start to take your medicine. It contains important information.

•    Keep the leaflet in a safe place because you may want to read it again.

•    If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Diclofenac Tablets are and what they are used for

2.    Before you take Diclofenac Tablets

3.    How to take Diclofenac Tablets

4.    Possible side effects

5.    How to store Diclofenac Tablets

6.    Further Information

1. What Diclofenac Tablets are and what they are used for

Diclofenac sodium, the active ingredient in Diclofenac Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

•    Diclofenac Tablets relieve pain, reduce swelling and ease inflammation in a wide range of conditions:

-    Rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis.

-    Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures.

-    Tendonitis, tenosynovitis, bursitis.

•    They are also used to treat pain and inflammation associated with orthopaedic (bone and joint surgery), dental and minor surgery

2. Before you take Diclofenac Tablets

DO NOT take Diclofenac Tablets. Talk to your doctor if you:

• are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Tablets. (These are listed at the end of the

leaflet). Signs of an allergic reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction.

•    have ever had a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces).

•    have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages.

•    have or have had problems with your blood circulation (peripheral arterial disease).

•    have had stomach or bowel problems after you have taken other NSAIDs.

•    have severe heart, kidney or liver failure.

•    are more than six months pregnant.

•    are having an acute attack of porphyria.

Talk to your doctor before taking Diclofenac Tablets if any of the following apply to you:

•    any stomach or bowel disorders including ulcerative colitis or Crohn's disease.

•    kidney or liver problems or you are elderly.

•    a condition called porphyria.

•    any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets.

•    asthma, allergic rhinitis (including hay fever), nasal polyps (swelling or lumps in your nose), problems with your lungs including a long-term chest infection or had an allergic reaction to anything.

•    angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

•    heart problems or have had a stroke or you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or you are a smoker).

•    you smoke.

•    you have diabetes.

•    Lupus (SLE) or any similar condition.

•    an inherited intolerance to some sugars such as lactose. (Diclofenac Tablets contain a small amount of lactose).

If you can say ‘yes’ to any of the above, ask your doctor or pharmacist for advice before taking this medicine. It may not be suitable for you or you may need to take special care when taking it.

Taking other medicines

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself, including herbal remedies, as well as medicines on prescription from your doctor.

There may be problems if you take Diclofenac Tablets with certain other medicines.

Tell your doctor or pharmacist if you are taking any of the following:

•    Medicines to treat diabetes.

•    Medicines that affect blood clotting (eg anticoagulants to ‘thin’ your blood such as warfarin or anti-platelet agents such as aspirin).

•    Diuretics (water tablets).

•    Lithium (used to treat some mental problems).

•    Methotrexate (for some inflammatory diseases and some cancers).

•    Ciclosporin and tacrolimus (for some inflammatory diseases and after transplants).

•    Quinolone antibiotics (for infections).

•    Any other NSAID or COX-2 inhibitor, for example aspirin, ibuprofen or celecoxib).

•    Mifepristone (used to terminate pregnancy).

•    Cardiac glycosides (for example digoxin), used to treat heart problems.

•    Medicines known as SSRIs, and an SNRI, venlafaxine, used to treat depression.

•    Corticosteroids (anti-inflammatory drugs).

•    Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors.

•    Ritonavir and zidovudine (used to treat HIV AIDS).

•    Baclofen, a muscle relaxant often used in MS.

•    Drospirenone (used in an oral contraceptive pill).

•    Ketorolac (used to treat post-operative pain).

•    Penicillamine, a treatment for rheumatoid arthritis.

•    Erlotinib (for cancer).

•    Iloprost, a treatment for pulmonary hypertension (high blood pressure in the artery carrying blood from the heart to the lungs).

•    Pentoxifylline (used to treat circulation disorders).

•    Sibutramine (for obesity).

•    Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections).

•    Phenytoin, a treatment for epilepsy.

Pregnancy and lactation

You should not take Diclofenac Tablets during the last 3 months of pregnancy as it may affect the baby’s circulation. If you are in the first 6 months of pregnancy talk to your doctor before taking this medicine as Diclofenac Tablets should only be taken if the benefit is likely to outweigh the risks.

Taking Diclofenac Tablets may make it more difficult for you to get pregnant. You should talk to your doctor if you are planning to become pregnant or if you have problems getting pregnant.

If you are breast-feeding, avoid taking this medicine because very small amounts of diclofenac sodium have been found in breast milk.

Driving or using machinery

Very occasionally people have reported that Diclofenac Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.

Other special warnings

•    You should take the lowest dose of Diclofenac for the shortest possible time, particularly if you are underweight or elderly.

•    There is a small increased risk of heart attack or stroke when you are taking any medicine like Diclofenac. The risk is greater if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for. Do not exceed the recommended dose or duration of treatment.

•    Your doctor may want to give you an occasional check-up whilst you are taking this medicine.

•    If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.

•    Diclofenac may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac.

•    The 50 mg tablets are not suitable for children aged under 12.

•    The 25 mg tablets contain sunset yellow FCF (E110), which may cause allergic reactions in some people.

3. How to take Diclofenac Tablets

Your doctor will tell you how many Diclofenac Tablets to take and when to take them. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told. If you have any problems, talk to your doctor.

Swallow the tablets whole with a drink of water. Do not crush or chew the tablets. If possible, take the tablet at meal times.

Your doctor may prescribe another medicine at the same time to protect your stomach, particularly if you have ever had stomach problems before, you are elderly or you are taking certain other medicines as well.

Adults and children over 12

75 mg to 150 mg daily divided into two or three doses. The number of tablets which you take will depend on the strength the doctor has given you.

Elderly

Your doctor may give you a lower dose than the usual adult dose. He or she may want to check regularly that the Diclofenac Tablets are not affecting your stomach.

Children aged 1-12 years

Doses vary with the age and weight of the child. The usual dose is 1 mg to 3 mg per kilogram of body weight a day. This is usually divided into two or three separate doses. The 50 mg tablets are not recommended for use in children.

If you forget to take a dose

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, just take the next dose and forget about the one you missed. Do not double up on the next dose to make up for the one missed. Do not take more than 150 mg (three 50 mg tablets or six 25 mg tablets) in 24 hours.

If you take too many tablets

If you, or anyone else, accidentally take too many tablets (an overdose) tell your doctor or your nearest hospital casualty department. Take the medicine pack with you.

4. Possible side effects

Diclofenac Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Some side effects can be serious

Stop taking Diclofenac Tablets and tell your doctor immediately if you notice:

•    Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick).

•    Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces.

•    Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering.

•    Wheezing or shortness of breath (bronchospasm).

•    Swollen face, lips, hands or fingers.

•    Yellowing of your skin or the whites of your eyes.

•    A persistent sore throat or high temperature.

•    An unexpected change in the amount of urine produced and/or its appearance.

•    You bruise more easily than usual or have frequent sore throats or infections.

The side effects listed below have also been reported.

Between 1 in 100 and 1 in 10 people have experienced:

•    Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite.

•    Headache, dizziness, vertigo.

•    Skin rash or spots.

•    Raised levels of liver enzymes in the blood.

Between 1 in 10,000 and 1 in 1,000 people have experienced:

•    Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly).

•    Inflammation of the stomach, which may cause pain and an upset stomach.

•    Drowsiness, tiredness.

•    Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness).

•    Skin rash and itching.

•    Fluid retention, symptoms of which include swollen ankles.

•    Liver function disorders, including hepatitis and jaundice.

•    Allergic reactions, including anaphylaxis and shock.

•    Asthma, difficulty breathing and lung disorders (alveolitis and pulmonary eosinophilia).

•    Kidney problems, which may lead to kidney failure.

Very rare side-effects, reported in less than 1 in 10,000 people include:

Effects on the nervous system:

Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, feeling irritable, depression, anxiety, mental disorders, confusion, hallucinations, malaise, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation.

Effects on the stomach and digestive system:

Constipation, a red swollen tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon).

Effects on the heart, chest or blood:

Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia).

Effects on the liver or kidneys:

Kidney or liver disorders, the presence of blood or protein in the urine.

Effects on skin or hair:

Serious skin reactions, including Stevens-Johnson syndrome and Lyell’s syndrome, as well as other skin problems, some of which may be made worse by exposure to sunlight. Hair loss or eczema.

Other effects:

Inflammation of the pancreas or impotence. Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.

If any of the symptoms become troublesome or if you notice anything else not mentioned here, please tell your doctor. He/she may want to give you a different medicine.

5. How to store Diclofenac Tablets

Store below 25°C. Store in the original package to protect from moisture. Keep out of the reach and sight of children.

Do not take Diclofenac Tablets after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking the tablets, please take any unused tablets back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.

6. Further Information

What Diclofenac Tablets contain

The tablets come in two strengths containing either 25 mg or 50 mg of the active ingredient, diclofenac sodium. The tablets are gastro-resistant. This gastro-resistant coating reduces the risk of stomach irritation.

The 25 mg tablets also contain the inactive ingredients sodium starch glycollate, microcrystalline cellulose, lactose, starch maize, magnesium stearate, purified talc, cellulose acetate phthalate, titanium dioxide (E171), quinoline yellow (E104), sunset yellow FCF (E110) and indigo carmine (E132).

The 50mg tablets also contain the inactive ingredients, povidone K25, starch maize, lactose, magnesium stearate, purified talc, cellulose acetate phthalate, titanium dioxide (E171) quinoline yellow (E104), iron oxide (E172) and indigo carmine (E132).

Contents of the pack

The tablets come in blister packs containing 28, 50, 84 and 100 tablets. Not all pack sizes may be marketed.

The Marketing Authorisation Holder and manufacturer is

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.

This leaflet was revised 10/2013

This leaflet applies to PL 04416/0361 and 0362.

PIL.0361-2.004d 23/10/2013 V016: SPC & PIL referral updates RC