Rhumalgan Xl 100 Mg Modified-Release Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
SZ17117LT03B
(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.
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What Rhumalgan Capsules are and what they are used for
Before you take Rhumalgan Capsules How to take Rhumalgan Capsules Possible side effects How to store Rhumalgan Capsules Further Information
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 relieve pain, reduce swelling and ease inflammation in a wide range of conditions 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.
Rhumalgan Capsules are controlled release capsules, this means they are designed to release the diclofenac sodium more gradually over the day, compared with a standard release capsule. This helps to reduce the number of capsules you may need to take each day.
Before you take Rhumalgan Capsules
DO NOT take Rhumalgan Capsules and 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 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
• have 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)
• have had bleeding in the digestive tract after you have taken other NSAIDs
• have severe heart, kidney or liver failure
• are more than six months pregnant.
Talk to your doctor before taking Rhumalgan Capsules if you:
• suffer from any stomach or bowel disorders including ulcerative colitis or Crohn’s disease
• have kidney or liver problems, or are elderly
• have a condition called porphyria
• suffer from any blood or bleeding disorder - your doctor may ask you to go for regular check-ups while you are taking these capsules
• have ever had asthma
• are breast-feeding
• 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)
• have Lupus (SLE) or any similar condition.
If any of the above applies to you, 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 Rhumalgan Capsules 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 (e.g. 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 or ibuprofen
• 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)
• Phenytoin, a treatment for epilepsy.
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.
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
• 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.
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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. If you have any problems talk to your doctor.
Swallow the capsules whole with a drink of water. Do not crush or chew the capsules. If possible, take the capsules at meal times.
Your doctor may prescribe another medicine at the same time to protect your stomach, particularly if you have had stomach problems before, you are elderly, or you are taking certain other medicines as well.
Adults and children over 12
Rhumalgan SR 75 Capsules: One capsule, taken once or twice daily.
Rhumalgan XL 100 Capsules: One capsule daily. Elderly
Your doctor may give you a lower dose than the usual adult dose. He or she may also want to check regularly that the Rhumalgan Capsules are not affecting your stomach.
Children aged 1-12 years
Rhumalgan Capsules are not recommended for 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 in 24 hours.
If you take too many Capsules
If you, or anyone else, accidentally take too many capsules (an overdose) tell your doctor or your nearest hospital casualty department. Take the medicine pack with you.
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
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.
Rhumalgan Capsules are suitable for most people, but, like all medicines, they can sometimes cause side effects.
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
• 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.
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.
6 Further information
What Rhumlagan Capsules contain
Rhumalgan SR 75 Capsules contain 75 mg of the active ingredient, diclofenac sodium.
Rhumalgan XL 100 Capsules contain 100 mg of the active ingredient, diclofenac sodium.
The other ingredients are: 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.
The 75 mg capsules are white, opaque hard capsules marked ‘DIC75’.
The 100 mg capsules are pink, opaque hard capsules marked ‘DIC100’.
Contents of the pack
Rhumalgan Capsules come in blister packs of 56 (Rhumalgan® Sr 75 mg) and 28 (Rhumalgan® XL 100 mg).
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 05/2012.
SZ17117LT03B