Rheumatac Retard 75
Patient Information Leaflet 102969-70/LF/1
Rheumatac™Retard 75
Diclofenac Sodium Modified Release Tablets
Read all of this leaflet carefully before you start taking this medicine
Please keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Rheumatac Retard Tablets are and what they are used for
2. Before you take Rheumatac Retard Tablets
3. How to take Rheumatac Retard Tablets
4. Possible side effects
5. How to Store Rheumatac Retard Tablets
6. Further information
1. WHAT RHEUMATAC RETARD TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Rheumatac™ Retard 75. It contains 75mg of the active ingredient, diclofenac sodium in each tablet.
Diclofenac sodium belongs to agroup of medicines called non-steroidal anti-inflammatory drugs TNSAID), which are used to reduce inflammation and pain in the joints and muscles and can also reduce a fever.
Rheumatac Retard Tablets are used to treat:
* rheumatoid arthritis
* osteoarthritis
* gout
* low back pain
* relief of pain in fractures
* short-term injuries such as frozen shoulder, sprains and strains and other soft tissue injuries
* ankylosing spondylitis (a condition affecting the spine)
* pain and inflammation in some types of surgery
2. BEFORE YOU TAKE RHEUMATAC RETARD TABLETS Do not take this medicine if:
* you are allergic to Diclofenac or to any of the other ingredients
* you have previously taken another NSAID (e.g. ibuprofen) or aspirin and had an allergic reaction. This reaction may have been signs of asthma (e.g. wheeziness), runny nose, swelling of the skin or itching.
* you have, or have ever had an ulcer of the stomach or duodenum (gut)
* you have ever suffered from bleeding in the stomach or intestines (gastrointestinal bleeding) or bleeding in the brain (cerebrovascular bleeding) or you have a bleeding disorder
* you have severe kidney or liver problems or heart failure
* you are already taking another NSAID medicine e.g. ibuprofen or meloxicam
* you are in the last three moths of pregnancy or if you are breast-feeding.
Tell your doctor or pharmacist if you are not sure if any of the conditions above apply to you.
Rheumatac Retard Tablets are not recommended for children.
Take special care and tell your doctor or pharmacist before taking this medicine if:
* you have a history of stomach or bowel problems e.g. inflammation of the stomach (gastritis) or gullet (oesophagitis), ulcerative colitis, Crohn's disease
* you are elderly
* you have any liver, kidney or heart problems including high blood pressure: your doctor may want to keep a check on these before and during treatment
* you have, or have had, asthma
you are going to have surgery or have recently had surgery as these tablets can affect the clotting of the blood). ou are at risk of heart attack or stroke (e.g. if you have diabetes, igh cholesterol or are a smoker). NSAIDs like Rheumatac Retard Tablets may be associated with an increased risk of heart attack or stroke, so your doctor will want to discuss this with you. Taking Rheumatac Retard Tablets in high doses or for a long time will increase this risk.
* you suffer from rare condition called systemic lupus erythematosus (SLE) or mixed connective tissue disorder.
* you have, or have ever had any blood abnormalities
Tell your doctor or pharmacist if you think any of these apply to you, or you are not sure.
Tell the doctor if you are due to have a liver function test. This is important because taking Rheumatac Retard Tablets can affect the results.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any of the following medicines:
* other non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, ibuprofen or naproxen.
* any medicine used to treat heart problems or high blood pressure e.g. "water tablets" such as bendroflumethiazide, furosemide or digoxin
* medicines which prevent blood clotting such as warfarin
* ciclosporin or tacrolimus used to prevent and treat the rejection of an organ transplant and also used in immune diseases
* steroids (such as cortisol or cortisone) used to treat inflammation
* lithium, used to treat depression
* methotrexate, used to treat some types of cancer, or for psoriasis or rheumatoid arthritis
* quinolone antibiotics to treat infections such as ciprofloxacin
* mifepristone (taken within the last 12 days) which is usually prescribed through hospitals and is used to cause an abortion
* medicines for diabetes (e.g. glibenclamide)
* Selective serotonin reuptake inhibitors used to treat depression
* Zidovudine (a medicine used in the treatment of HIV (Human Immunodeficiency Virus).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including any medicines that you have bought yourself without a prescription.
Pregnancy and breast-feeding
DO NOT take Rheumatac Retard Tablets if you are in the last three months of pregnancy or if you are breast-feeding.
Tell your doctor if you are or think you may be pregnant before taking Rheumatac Retard Tablets. If you are trying to become pregnant Rheumatac Retard Tablets may make it more difficult to become pregnant
Driving and operating machinery
You can drive while taking Rheumatac Retard Tablets but do not drive until you know how the tablets affect you. They may make you feel light headed, dizzy or drowsy, and may cause blurred vision. If they affect you in this way DO NOT drive or operate machinery.
3. HOW TO TAKE RHEUMATAC RETARD TABLETS
Always take Rheumatac Retard Tablets exactly as your doctor has told you. Check with your doctor or the pharmacist if you are not sure.
Rheumatac Retard Tablets have a special coating. Theyshould be taken by mouth and swallowed whole, preferably with food. They should not be broken or chewed.
Your doctor will want to treat you with the lowest dose that is suitable for you, for as short a time as possible. How long you are treated for will depend on what condition you have.
Adults:
The usual dose is one tablet (75 mg) once or twice a day.
DO NOT take more Rheumatac Retard Tablets than you have been told by your doctor.
Elderly patients:
The doctor will use as low dose as possible and will keep a check on you for any side effects.
Children:
Not suitable for use in children.
If you have been taking this or a similar medicine for a long time, your doctor may want to perform regular tests to keep a check on your condition.
If you take more tablets than you should
Contact your nearest hospital casualty department immediately if you have taken more tablets than you should, or if someone else has swallowed any.
Remember to take this leaflet and the pack with you to show the doctor, whether or not there are any tablets left.
If you forget to take your medicine
If you forget to take a dose, just take the next dose at the usual time.
DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
As with all medicines, Rheumatac™ Retard 75 can cause unwanted side effects in some people.
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature.
Nausea (feeling sick), vomiting (being sick), diarrhoea, flatulence (wind), constipation, dyspepsia (indigestion), anorexia, and abdominal pain have all been reported.
Non-steroidal anti-inflammatory medicines have been associated with ulcers of the stomach and intestine which may perforate or bleed.
If you experience any of the following symptoms at any time during your treatment STOP TAKING the medicine and seek immediate medicaT help:
• Passing blood in your faeces (stools/motions).
• Passing black tarry stools.
• Vomiting blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
• Indigestion or heartburn.
• Abdominal pains (pains in your stomach) or other abnormal stomach symptoms.
NSAID use has also been associated with inflammation of the stomach, tongue, mouth and mouth ulcers.
Inflammation of the pancreas has also been reported (pancreatitis).
Using non-steroidal anti-inflammatory medicines has also lead to an exacerbation of inflammatory bowel conditions (ulcerative colitis and Crohn's disease).
Hypersensitivity:
Allergic reactions have been reported following use of NSAIDs.
These may include mild symptoms such as itching and/or rash or more severe symptoms such as swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).
If any of the above occurs tell your doctor immediately.
Cardiovascular:
Oedema (swelling), high blood pressure (hypertension) and heart failure have been reported with NSAID use.
Low blood pressure (hypotension), chest pains and palpitations have also been observed.
Medicines such as Rheumatac™ Retard 75 may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Other side effects include:
• Problems with kidneys including kidney failure and raised levels of protein and blood in the urine;
• Inflammation of the liver (hepatitis) and yellowing of the skin (and whites of eyes) (jaundice);
• Visual disturbances;
• Headaches;
• Pins and needles;
• Depression;
• Confusion;
• hallucinations;
• A ringing noise in the ears (tinnitus);
• Vertigo;
• Dizziness;
• Vague feelings of discomfort;
• Tiredness;
• Drowsiness.
Other 'isolated effects include:
• Difficulty sleeping (insomnia);
• Fits (convulsions);
• Impaired hearing;
• Irritability;
• Anxiety;
• Psychoses;
• Disturbances in memory or changes in sensation (including alterations to taste);
• Nightmares;
• Impotence;
• Sensitivity to light;
• Eczema;
• Hair loss.
NSAID use has been associated with a range of blood disorders, symptoms of which include:
• Sore throat;
• Brusing or bleeding;
• Mouth ulcers;
• Fever;
• Malaise.
If you experience any of these symptoms, stop taking the NSAID and seek medical advice immediately.
There have been isolated cases of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.
If any of the side effects becomes severe, or you experience any other side effect not mentioned above, tell your doctor or pharmacist.
5. HOW TO STORE RHEUMATAC RETARD TABLETS
Do not use your medicine after the expiry date printed on the carton. The expiry date refers to the last day of that month. Do not store above 25°C and protect from light. Keep the tablets in the original packaging. If you notice any tablets that are broken or chipped ask your pharmacist for advice before taking them.
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
6. FURTHER INFORMATION
What Rheumatac Retard Tablets contain
Each Rheumatac Retard Tablet contains 75 mg of the active ingredient diclofenac sodium.
The inactive ingredients are: talc, ethylcellulose, povidone, stearic acid, magnesium stearate.diethyl phthalate, hydroxypropyl methyl cellulose, titanium dioxide (E171), polyethylene glycol.
What Rheumatac Retard Tablets look like and the contents of the pack
Rheumatac Retard Tablets are triangular and white in colour. They are marked with 75 and a crown on one side.
They are available in blister packs containing 28 or 56 tablets.
Marketing Authorisation Holder and Manufacturer
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL, UK
This leaflet was last revised in December 2013
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Rheumatac™ Retard 75
102969-70/LF/1
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06/12/2013 8 pt 1
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