<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV type=0>

<HEAD weight="bold"  justified="center" >
Patient Information Leaflet
</HEAD>


<DIV type=1>

<HEAD weight="bold"  justified="center" >
Diclomax SR Diclofenac sodium
</HEAD>


<BLOCK>
Please read this leaflet carefully before you start to take Diclomax SR. This leaflet contains important information about your medicine. If you have any questions, or are not sure about anything ask your doctor or pharmacist. Keep this leaflet until you have finished all your treatment. You may want to read it again.
</BLOCK>

<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
What is in the pack?
</HEAD>


<BLOCK>
Diclomax SR are yellow capsules with Diclomax SR 75 mg printed on them. Each capsule contains 75 mg of the active ingredient, Diclofenac sodium. Each capsule also contains the following ingredients: sucrose, maize starch, purified stearic acid, polyethylene glycol 6000, ammonia methacrylate copolymer type A, talc, lactose, polysorbate 80, gelatin, E172 and E171.
</BLOCK>


<BLOCK>
Each blister pack contains 56 capsules.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
What does the active ingredient in Diclomax SR do?
</HEAD>


<BLOCK>
Diclomax SR is one of a group of medicines called non-steroidal anti-inflammatory analgesics. These are used for control of pain and inflammation.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
Who supplies Diclomax SR
</HEAD>


<BLOCK>
The product licence holder is Parke, Davis &amp; Company, Usk Road, Pontypool, Gwent, NP4 0YH. The manufacturer of Diclomax SR is Eurand SpA, Via Privata Pasteur 1, 20092 Cinisello, Balsamo, Milan, Italy.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
What is Diclomax SR used for?
</HEAD>


<BLOCK>
Diclomax SR is used to treat a number of painful conditions affecting the joints and muscles. These include rheumatoid arthritis; osteoarthritis; low back pain; acute musculo-skeletal disorders such as periarthritis (especially frozen shoulder), tendinitis (inflammation of a tendon), tenosynovitis (inflammation of the tendon sheath), bursitis (inflammation of the bursa-connective tissue surrounding a joint); sprains; strains and dislocations; relief of pain in fractures; acute gout; ankylosing spondylitis; control of pain and inflammation in orthopaedic, dental and other minor surgery.
</BLOCK>

<CB n=2>

</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
Before taking your Diclomax SR Capsules
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
If you are pregnant, think you might be pregnant, trying to become pregnant or are breastfeeding, you should tell your doctor.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
If the answer to any of the following questions is 
<EMPH weight="bold">
yes
</EMPH>
, tell your doctor or pharmacist at once.
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Are you allergic to diclofenac sodium, aspirin or any other medicines used to treat painful conditions affecting the joints and muscles? Allergies may cause symptoms such as sickness, runny nose, stomach pains, wheezing, heartburn or skin rashes.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you have or have you ever had a gastric or duodenal ulcer or gastrointestinal bleeding, including vomiting fresh blood or with the appearance of coffee grounds - or passing black tarry stools.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you suffer from asthma?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you suffer from heart, liver or kidney disease?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you suffer from porphyria?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you suffer from Crohn’s disease or ulcerative colitis?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you have or have you ever had bloody diarrhoea?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you suffer from any blood disorders including abnormal bleeding or bruising?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you taking any of the following medicines?
</BLOCK>

</ITEM>

</LIST>


<DIV type=3>

<HEAD>
Digoxin, anticoagulants, methotrexate, diuretics, cyclosporin, antidiabetic agents or medicines containing lithium
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Are you taking any other medicines which your doctor does not know about?
</BLOCK>

</ITEM>

</LIST>



</DIV>

</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
How to take Diclomax SR
</HEAD>


<BLOCK>
Adults:The normal dose is one or two 75 mg capsules daily to be taken as directed by your doctor.
</BLOCK>


<BLOCK>
Children:Diclomax SR is not recommended for children.
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Swallow the capsules whole with food or just after food. Do not chew the capsules or remove the contents as this will affect the special &quot;slow release&quot; properties.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If you forget to take a dose, take it as soon as you remember, then go on as before.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If you accidentally take too many capsules contact your doctor at once or go to your nearest hospital casualty department.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If you go into hospital or visit a dentist or another doctor, tell them you are taking this medicine.
</BLOCK>

</ITEM>

</LIST>

<PB n=2>
<CB n=1>


</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
Side Effects
</HEAD>


<BLOCK>
Diclomax SR can sometimes cause side-effects. The side effects seen most often are:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Headache
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Dizziness
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Vertigo
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Skin rashes
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Stomach pain
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Other reactions more rarely seen are:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Peptic ulcers and gastro-intestinal bleeding
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Bloody diarrhoea
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Skin troubles such as eruptions or itching
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Drowsiness or tiredness
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Yellowing of your skin or whites of your eyes due to liver disorders
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Wheezing or shortness of breath
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Body swelling and allergies
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Abnormal blood tests of liver function
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
If any of these side effects or any other side effects occur and continue for longer than a few days, or are troublesome you should tell your doctor.
</BLOCK>


<BLOCK>
Whilst you are taking Diclomax SR your doctor may want to give you a check up from time to time and this may include a check on your blood, liver and kidneys, particularly if you are taking
</BLOCK>


<BLOCK>
Diclomax SR for a long time or with Diuretics.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD slant="italic"  weight="bold"  justified="center" >
How to store Diclomax SR
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Do not use Diclomax SR after the expiry date on the package.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Store Diclomax SR below 25°C and protect from heat and moisture in the original pack
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
As with all medicines keep your Diclomax SR capsules out of reach of children.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If the capsules look as if they are deteriorating in any way, do not take them and return them to the pharmacist.
</BLOCK>

</ITEM>

</LIST>

<CB n=2>


<BLOCK>
REMEMBER:This medicine is yours. Never give it to others. It may not be suitable for them even if their symptoms are the same as yours.
</BLOCK>


<BLOCK>
This leaflet provides a summary of the information available on your medicine. This information applies only to Diclomax SR capsules. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.
</BLOCK>


<BLOCK>
For further information please contact: Parke Davis, Lambert Court, Chestnut Avenue, Eastleigh, Hampshire, SO53 3ZQ Date issued: December 1994 <FIGURE></FIGURE>
</BLOCK>

</DIV>

</DIV>

</DIV>

</DOCUMENT>
