Enstar Sr 75mg Tablets
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PACKAGE LEAFLET: INFORMATION FORTHE USER
{Read all ofthis leaflet carefully before you start taking this medicine.
• Keepthisleaflet. Youmayneedtoreaditagain.
L If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
» If you have any of the side effects, or if you notice any I not listed, please tell your doctor or pharmacist.
In this leaflet:
1. What Enstar SR 75mg Tablets are and what they are used for
12. Before you take Enstar SR 75mg Tablets '3. How to take Enstar SR 75mg Tablets .4. Possible side effects |5. How to store Enstar SR 75mg Tablets 6. Further information
1. WHAT ENSTAR SR 75MG TABLETS ARE AND WHAT THEY ARE USED FOR
Enstar SR 75mg Tablets belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). lEnstar SR 75mg Tablets are used to relieve symptoms 'caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis (rheumatism ofthe spine) such as swelling, stiffness orioint pain. It does not cure arthritis and will help you only as long as you continue to take it.
2. BEFORE YOU TAKE ENSTAR SR 75MG TABLETS
|Do not take Enstar SR 75mg Tablets if:
l You think you may be allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Enstar SR 75mg Tablets. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction
• You have now, or 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)
• You have had stomach or bowel problems after you have taken other NSAIDs
• You have severe heart, kidney or liver failure
• You are more than six months pregnant
|> You have established heart disease and/or
cerebrovascular disease e.g. if you have had a heart
I attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
b You have or have had problems with your blood
I circulation (peripheral arterial disease).
IMake sure your doctor knows, before you are given
'diclofenac
Plf you smoke
If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
Side effects may be minimised by using the lowest pffective dose for the shortest duration necessary.
Take special care with Enstar SR 75mg Tablets Ilf you answer YES to any of the questions below,you should talk to your doctor before taking Enstar SR 75mg Tablets:
|> Do you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease?
• Do you nave kidney or liver problems, or are you f elderly?
• Do you have a condition called porphyria? b Do you suffer from any blood or bleeding disorder? If I you do, your doctor may ask you to go for regular check-ups while you are taking these tablets L Have you ever had asthma?
'* Are you breast-feeding?
• Do you have heart problems, or have you had a stroke, or do you think you might be at risk of these conditions (for example, if you have high blood I pressure, diabetes or high cholesterol or are a I smoker)?
• Do you have Lupus (SLE) or any similar condition? b Do you have an intolerance to some sugars such as I lactose? (These tablets contain lactose))
Taking other medicines I
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially if you1 are taking:
• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Lithium (used to treat some mental problems)
• Methotrexate (for some inflammatory diseases and
• Ciclosporin and tacrolimus (used to treat some I
inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or treat
• Quinolone antibiotics (for infections)
• Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate pregnancy),
• Cardiac glycosides (for example digoxin), used to treat | heart problems
• Medicines known as SSRIs used to treat depression i
• Oral steroids (an anti-inflammatory drug) I
• Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors I
• Voriconazole (a medicine used to treat fungal 1
infections)
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cholestyramine (used to lower cholesterol).
Laboratory tests
Regular liver and kidney function tests and monitoring of blood counts are necessary during long-term treatment. i
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any I medicine. 1
Enstar SR 75mg Tablets may make it more difficult to become pregnant. You should inform your doctor if you arel planning to become pregnant or if you have problems becoming pregnant. ,
You should not take Enstar SR 75mg Tablets during the first 6 months of pregnancy unless directed by your doctor i and must not take Enstar SR 75mg Tablets during the last I 3 months of pregnancy as damage to the baby and reduced labour may occur.
You should only use Enstar SR 75mg Tablets whilst breast-1 feeding if advised by your doctor.
Other special warnings
• You should take the lowest dose of Enstar SR 75mg , Tablets for the shortest possible time, particularly if you| are underweight or elderly
• There is a small increased risk of heart attack or strokei when you are taking any medicine like Enstar SR I 75mg Tablets. The risk is higher if you are taking high doses for a Iona time. Always follow the doctor's instructions onhow much to take and how long to take1 it for
• Whilst you are taking these medicines your doctor mayl 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 i
• Because it is an anti-inflammatory medicine, Enstar I SR 75mg Tablets may reduce the symptoms of infection, for example, headache and nigh temperature. If you feel unwell and need to see a 1 doctor, remember to tell him or her that you are taking Enstar SR 75mg Tablets.
Driving and using machines .
Some patients may experience side effects such as dizziness, drowsiness and visual disturbances which may affect their ability to drive or operate machinery. Do not i drive or operate machinery if you are affected. I
Important information about some of the ingredients l ofEnstarSR75mgTablets 1
Enstar SR 75mg Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some I sugars, contact your doctor before taking this medicine.
Always take Enstar SR 75mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Enstar SR 75mg Tablets must not be taken long-term, blood tests should be carried out if taken for more than a few days.
The tablets must be swallowed whole with a glass of pater, with or after food. Do not crush or chew the tablet.
The usual dose is:
» Adults: One tablet once or twice a day.
L Elderly: As adult dose. The lowest effective dose should"be taken and your doctor will need to monitor you regularly. If you are elderly your doctor may 1 prescribe a lower daily dose ana reduce the duration of treatment.
|> Children: not recommended.
more Enstar SR 75mg Tablets than you
lyone else, accidentally takes too much, tell yo'ur doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.
Symptoms of overdose may be gastrointestinal disorders, feeling or being sick, diarrhoea.kidneyfailure, fits, headache, disorientation, excitement, coma, drowsiness, ^lizziness, ringing in the ears, fainting and liver damage.
,lf you forget to take Enstar SR 75mg Tablets
|Do not take a double dose to make up for a forgotten dose. Continue the treatment as advised by your docfor.Do not jtake more than two tablets in 24 hours.
If you stop taking Enstar SR 75mg Tablets
Changes to dosage or stopping of treatment should only be as directed by your doctor.
.Like all medicines, Enstar SR 75mg Tablets, may cause you some problems, although not everybody gets them
Stop taking Enstar SR 75mg Tablets and tell your doctor straight away if you notice:
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) orvomiting (being sick)
l 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
C Yellowing of your skin or the whites ofyour eyes Persistent sore throat or high temperature • An unexpected change in trie amount of urine produced and/or its appearance If you notice that you are bruising more easily than usual or have freguent sore throats or infections, tell your doctor.
^The side effects listed below have also been reported. .Common side effects (These mayaffectbetween 1 and \10 in every 100 patients):
» Stomach pain, heartburn, nausea, vomiting, diarrhoea,
I indigestion, wind, loss ofappetite
L Headache, dizziness, vertigo
• Skin rash or spots
|> Raised levels of liver enzymes in the blood.
Rare side effects (These mayaffectbetween 1 in every 11000 to 1 in every 10,000 patients):
• Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the
• Gastritis (inflammation, irritation or swelling of the I stomach lining)
L Vomiting blood
• Diarrhoea with blood in it or bleeding from the back | passage
l Black, tarry faeces or stools
• Drowsiness, tiredness
L Hypotension (low blood pressure, symptoms of which
may include faintness, giddiness or light headedness)
• Skin rash and itching
|> Fluid retention, symptoms ofwhich include swollen ankles
• Liverfunction disorders, including hepatitis and
I jaundice.
iVery rare side effects (These mayaffectless than 1 in every 10,000 patients):
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, mood changes, pepression, 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.
Effects on the stomach and digestive system:
Constipation, inflammation ofthe tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation ofthe 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), 1 inflammation of the lung (pneumonitis), heart disorders, including congestive heartfailure or heartattack, blooodisorders (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 ofthepancreas, impotence. Facial swelling, inflammation of the lining of the brain (meningitis), stroke, throatdisorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
Keep all medicines out of the sight and reach of children. Do not store above 25°C.
Do not use Enstar SR 75mg Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer reguired. These measures will help to protect the environment.
What Enstar SR 75mg Tablets contain
• The active substance (the ingredient that makes the tablet work) is Diclofenac Sodium 75mg.
• The other ingredients are lactose monohydrate,
magnesium stearate, methylhydroxypropyl-cellulose, | microcrystalline cellulose, povidone, talc, iron oxide red (E172). ,
What Enstar SR 75mg Tablets look like and contents of.
the pack
The sustained release tablets are light pink, round,
biconvex tablets with D3 embossedon one side.
Pack sizes:
a) AI/AI blister: Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90,,
100 tablets I
b) PP-containerwith PE lids: Packsizes: 28, 56, 100 tablets
c) HDPE-containerwith PE lids: Packsizes: 28, 56, 100
d) AI/PVDC blister: Pack sizes: 10, 20, 28, 30, 50, 56, 60,l
90, 100 tablets
(Not all pack sizes may be available)
Marketing Authorisation Holder & Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
The Product Licence number is PL 40147/0032