Rhumalgan Cr75
Sandoz Ltd Page 1
Rhumalgan 75 and 100 mg CR PL 04416/0242-3
Tablets
Package leaflet: Information for the user Rhumalgan®75 and 100 CR Tablets (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 Rhumalgan Tablets are and what they are used for
2. Before you take Rhumalgan Tablets
3. How to take Rhumalgan Tablets
4. Possible side effects
5. How to store Rhumalgan Tablets
6. Further information
1. What Rhumalgan Tablets are and what they are used for
Diclofenac sodium, the active ingredient in Rhumalgan Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
• Rhumalgan 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.
Rhumalgan Tablets are controlled release tablets, this means they are designed to release the diclofenac sodium more gradually over the day, compared with a standard release tablet. This helps to reduce the number of tablets you may need to take each day.
2. Before you take Rhumalgan Tablets
DO NOT take Rhumalgan Tablets. Talk to your doctor if you:
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• are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Rhumalgan 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 Rhumalgan 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 suggest 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.
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 Rhumalgan 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 breast-feeding
You should not take Rhumalgan 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 Rhumalgan Tablets should only be taken if the benefit is likely to outweigh the risks.
Taking Rhumalgan 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 Rhumalgan 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 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 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 these medicines.
• 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.
• Rhumalgan 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.
3. How to take Rhumalgan Tablets
Your doctor will tell you how many Rhumalgan 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 had stomach problems before, you are elderly, or you are taking certain other medicines as well.
Adults and children over 12
Rhumalgan CR 75 tablets: One tablet, taken once or twice daily.
Rhumalgan CR 100 tablets: One tablet 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 Tablets are not affecting your stomach.
Children aged 1-12 years
Rhumalgan Tablets 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 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
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Some side effects can be serious
Stop using Rhumalgan Tablets and tell your doctor straight away if you notice:
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick).
• Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Rhumalgan Tablets and followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
• 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, local irritation.
• 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), exacerbation of haemorrhoids.
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 talk to your doctor. He/she may want to give you a different medicine.
5. How to store Rhumalgan Tablets
Store below 25°C. Store in the original package to protect from light. Keep out of the reach and sight of children.
Do not take Rhumalgan 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 Rhumlagan Tablets contain
Rhumalgan CR 75 Tablets contain 75 mg of the active ingredient, diclofenac sodium. Rhumalgan CR 100 Tablets contain 100 mg of the active ingredient, diclofenac sodium.
The other ingredients are: talc, ethylcellulose, magnesium stearate, povidone, stearic acid, hydroxypropyl methylcellulose, diethyl phthalate, titanium dioxide and polyethylene glycol. Rhumalgan CR 100 Tablets also contain iron oxide.
Contents of the pack
Rhumalgan Tablets come in blister packs of 28, 30, 50, 56, 60, 84,
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100, 250, 500 and 1,000. 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 09/2016.
PIL.0242-3.004.0d 05/09/16 V013 : PSUSA update JV