PACKAGE LEAFLET: INFORMATION FOR THE USER

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Rhumalgan® SR 75 mg Modified Release Capsules Rhumalgan® XL 100 mg Modified Release Capsules

(diclofenac sodium)

What you need to know about Rhumalgan Capsules

Your doctor has decided that you need this medicine to help treat your condition.

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 Rhumalgan Capsules are and what they are used for

2.    Things to consider before you start to take Rhumalgan Capsules

3.    How to take Rhumalgan Capsules

4.    Possible side effects

5.    How to store Rhumalgan Capsules

6.    Further Information

A SANDOZ

What Rhumalgan Capsules are and what they are used for

Diclofenac sodium, the active ingredient in Rhumalgan Capsules, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. Rhumalgan Capsules are specially formulated to release the diclofenac sodium slowly. This helps to reduce the number of capsules you may need to take each day.

•    Rhumalgan Capsules relieve pain, reduce swelling and ease inflammation in a wide range of conditions affecting the joints, muscles and tendons including:

-    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.

Things to consider before you start to take Rhumalgan Capsules

Some people MUST NOT take Rhumalgan Capsules. Talk to your doctor if:

•    you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Rhumalgan Capsules. (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.

•    you have now, or have ever had, a stomach (gastric), duodenal (peptic) or intestinal 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).

•    you 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.

•    you 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.

You should also ask yourself these questions before taking Rhumalgan Capsules:

•    Do you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease?

•    Do you have kidney or liver problems, or are you elderly?

•    Do you have a condition called porphyria?

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

•    Have you ever had asthma?

•    Are you breast-feeding?

•    Do you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides?

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

•    Do you smoke?

•    Do you have diabetes?

•    Do you have Lupus (SLE) or any similar condition? If the answer to any of these questions is YES, tell your doctor or pharmacist because Rhumalgan Capsules might not be the right medicine for you.

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any

of the following:

•    Medicines to treat diabetes

•    Anticoagulants (blood thinning tablets like warfarin)

•    Diuretics (water tablets)

•    Lithium (used to treat some mental problems)

•    Methotrexate (for some inflammatory diseases and some cancers)

•    Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)

•    Trimethoprim (a medicine used to prevent or treat urinary tract infections)

•    Quinolone antibiotics (for infections)

•    Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen

•    Mifepristone (a medicine 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

•    Oral steroids (anti-inflammatory drugs)

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

•    Voriconazole (a medicine used to treat fungal infections)

•    Phenytoin (a medicine used to treat seizures)

•    Colestipol/cholestryramine (used to lower cholesterol)

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

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.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Rhumalgan Capsules during the last 3 months of pregnancy as it may affect the baby’s circulation.

Taking Rhumalgan Capsules 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.

You should not take Rhumalgan Capsules if you are breast-feeding.

Will there be any problems with driving or using machinery?

Very occasionally people have reported that Rhumalgan Capsules 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.

Important information about some of the ingredients of Rhumalgan Capsules

This product contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Other special warnings

•    You should take the lowest dose of Rhumalgan 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 Rhumalgan. The risk is higher 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

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•    Whilst you are taking these medicines your doctor may want to give you a check up from time to time

•    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

•    Because it is an anti-inflammatory medicine, Rhumalgan Capsules 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 Rhumalgan Capsules.

•    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.

3 How to take Rhumalgan Capsules

Your doctor will tell you how many Rhumalgan Capsules 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 capsules for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Take the capsules with or after food.

Swallow the capsules whole with a drink of water.

Do not crush or chew them as this will affect the special ‘slow release’ system.

The usual doses are:

Adults

Rhumalgan SR 75 mg Capsules: One capsule, taken once or twice daily.

Rhumalgan XL 100 mg Capsules: One capsule daily.

Elderly

Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check regularly that the Rhumalgan Capsules are not affecting your stomach.

These capsules are not suitable for children.

The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.

What 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 in 24 hours.

What if you take too many Capsules?

If you, or anyone else, accidentally takes too many capsules, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

Very rare side effects (These may affect less than 1 in every 10,000 patients):

Effects on the nervous system:

Tingling or numbness in the fingers, tremor, visual disturbances such as blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, 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, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation of the colon, or worsening of ulcerative colitis or Crohn’s disease).

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), heart disorders including congestive heart failure or heart attack, blood disorders (including anaemia).

Effects on the liver or kidneys:

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

Effects on skin or hair:

Serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Hair loss.

Other side effects that have also been reported include:

Inflammation of the pancreas, impotence, facial swelling, inflammation of the lining of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves of the eye.

Do not be alarmed by this list - most people take Rhumalgan Capsules without any problems.

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

How to store Rhumalgan Capsules

4 Possible side effects

Rhumalgan Capsules 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 Rhumalgan Capsules and tell your

doctor straight away 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

•    Persistent sore throat or high temperature

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

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

The side effects listed below have also been reported.

Common side effects (These may affect between 1 and 10 in every 100 patients):

•    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.

Rare side effects (These may affect between 1 in every 1000 to 1 in every 10,000 patients):

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

•    Gastritis (inflammation, irritation or swelling of the stomach lining)

•    Vomiting blood

•    Diarrhoea with blood in it or bleeding from the back passage

•    Black tarry faeces or stools

Store in the original package.

Keep out of the reach and sight of children.

Do not take Rhumalgan Capsules after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Rhumalgan Capsules, please take any unused capsules 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 Rhumalgan Capsules contain

Rhumalgan SR 75 mg Capsules are white, opaque hard capsules marked ‘DIC75’, containing 75 mg of the active ingredient, diclofenac sodium.

Rhumalgan XL 100 mg Capsules are pink, opaque hard capsules marked ‘DIC100’, containing 100 mg of the active ingredient, diclofenac sodium.

The capsules also contain the inactive ingredients: sucrose, maize starch, macrogol 6000, ammonia methacrylate copolymer type A, talc, lactose monohydrate, polysorbate 80, gelatin, titanium dioxide (E171), shellac, iron oxide (E172) and propylene glycol. Rhumalgan XL 100 mg Capsules also contain red iron oxide and yellow iron oxide.

Rhumalgan SR 75 mg Capsules come in blister packs of 56.

Rhumalgan XL 100 mg Capsules come in blister packs of 28.

Not all pack sizes may be marketed.

The Marketing Authorisation Holder and manufacturer is

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

This leaflet was revised in 10/2013.

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