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RHEUMATAC RETARD 75

Active substance(s): DICLOFENAC SODIUM

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Patient Information Leaflet

Elderly patients:
The doctor will use as low dose as possible and will keep a check on you
for any side effects.

102969-70/LF/1

Rheumatac™Retard 75

Children:
Not suitable for use in children.

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 a group of medicines called non-steroidal
anti-inflammatory drugs (NSAID), 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

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*

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*

you are going to have surgery or have recently had surgery
(as these tablets can affect the clotting of the blood).
you are at risk of heart attack or stroke (e.g. if you have diabetes,
high 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. They should 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.

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 medical 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
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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