Enstar Sr 75mg Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
.Read all of this leaflet carefully before you start taking this medicine because it contains |important information for you.
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| again.
doctor or pharmacist or nurse.
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Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
|* If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.
hat is in this leaflet:
|1. What Enstar SR 75mg Tablets are and what they are used for
|2. What you need to know 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. Contents of the pack and other 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 ^rugs (NSAIDs). Enstar SR 75mg Tablets are used to relieve symptoms caused by osteoarthritis, Irheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness orjoint pain. It does not cure arthritis and ^ill help you only as long as you continue to take it.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENSTAR SR 75MG TABLETS
Do not take Enstar SR 75mg Tablets if:
• 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
I include swelling of the face and mouth i (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 I 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
L You have established heart disease and/or I 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 |* You have or have had problems with your blood circulation (peripheral arterial disease).
Make sure your doctor knows, before you are given diclofenac
|* Ifyousmoke
• Ifyou have diabetes
|* Ifyou have angina, blood clots, high blood pressure, raised cholesterol or raised I triglycerides.
bde effects may be minimised by using the lowest effective dose for the shortest duration necessary.
fTake special care with Enstar SR 75mg Tablets If 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?
L Do you have kidney or liver problems, or are , you elderly?
I Do you have a condition called porphyria?
|* Do you suffer from any blood or bleeding
disorder? If 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?
L 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 pressure, diabetes or high cholesterol or are a smoker)?_
• Do you have Lupus (SLE) or any similar |
condition?
• Do you have an intolerance to some sugars I
such as lactose? (These tablets contain ,
Other medicines and Enstar SR 75mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially ifyou are taking:
•
• Anticoagulants (blood thinning tablets like 1
• Diuretics (water tablets)
• Lithium (used to treat some mental problems) |
• Methotrexate (for some inflammatory diseases
• Ciclosporin and tacrolimus (used to treat some , inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or I treat urinary tract infections)
• Quinolone antibiotics (for infections) |
• Any other NSAID or COX-2 (cyclo-oxgenase^T inhibitor, for example aspirin or ibuprofen I
• Mifepristone (a medicine used to terminate i pregnancy)
• Cardiac glycosides (for example digoxin), used I to treat heart problems
• Medicines known as SSRIs used to treat I depression
• Oral steroids (an anti-inflammatory drug) I
• Medicines used to treat heart conditions or highi blood pressure, for example beta blockers or ACE inhibitors
• Voriconazole (a medicine used to treat fungal
• Phenytoin (a medicine used to treat seizures) ,
• Colestipol/cholestyramine (used to lower 1
• Zidovudine (a medicine used in the treatment of
Laboratory tests
Regular liver and kidney function tests and ,
monitoring of blood counts are necessary during 1 long-term treatment.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. I
Enstar SR 75mg Tablets may make it more difficult i to become pregnant. You should inform your doctor if you are planning to become pregnant or if I you have problems becoming pregnant.
You should not take Enstar SR 75mg Tablets during the first 6 months of pregnancy unless '
directed by yourdoctor and must not take Enstar i SR 75mg Tablets during the last 3 months of pregnancy as damage to the baby and reduced labour may occur.
You should only use Enstar SR 75mg Tablets whilst breast-feeding if advised by your doctor. .
Other special warnings i
• You should take the lowest dose of Enstar SR 75mg Tablets for the shortest possible time, particularly ifyou are underweight or elderly
• There is a small increased risk of heart attack I or stroke when you are taking any medicine like, Enstar SR 75mg Tablets. The risk is higher if 1 you are taking high doses for a long time. i Always follow the doctor's instructions on how much to take and how long to take it for
• Whilst you are taking these medicines your
doctor may want to give you a check-up from time to time ,
• If you have a history of stomach problems 1 when you are taking NSAIDs, particularly ifyou | are elderly, you must tell your doctor straight away if you notice any unusual symptoms
• Because it is an anti-inflammatory medicine,
Enstar SR 75mg Tablets may reduce the I symptoms of infection, for example, headache i and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Enstar SR 75mg Tablets. |
Driving and using machines I
Some patients may feel dizzy while taking this i medicine. Do not drive or operate machinery if you are affected.
Enstar SR 75mg Tablets contain lactose
If you have been told by your doctor that you have , an intolerance to some sugars, contact your doctor' before taking this medicine. _ _i
3. HOW TO TAKE ENSTAR SR 75MG TABLETS
klways take Enstar SR 75mg Tablets exactly as vour doctor has told you. You should check with your doctor or pharmacist if you are not sure, ^nstar SR 75mg Tablets must not be taken longterm, blood tests should be carried out if taken for Imore than a few days.
The tablets must be swallowed whole with a glass of water, with or after food. Do not crush or chew Jhe tablet.
^he usual dose is:
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I dose should be taken and your doctor will need ' to monitor you regularly. If you are elderly your doctor may prescribe a lower daily dose and reduce the duration of treatment.
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Ifyou take more Enstar SR 75mg Tablets than you should
[f you, or anyone else, accidentally takes too much, Jell your 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, kidney failure, fits, headache, disorientation, excitement, coma, drowsiness, dizziness, ringing in the ears, fainting and liver damage.
Ifyou forget to take Enstar SR 75mg Tablets
Eo not take a double dose to make up for a irgotten dose. Continue the treatment as advised y your doctor.Do not take more than two tablets in 4 hours.
Ifyou stop taking Enstar SR 75mg Tablets
bhanges to dosage or stopping of treatment should only be as directed by your doctor.
4. POSSIBLE SIDE EFFECTS
|_ike all medicines, this medicine may cause you some problems, although not everybody gets them
top taking Enstar SR 75mg Tablets and tell our doctor straight away ifyou notice:
^ Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
^ 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
l Yellowing of your skin or the whites of your I eyes
• Persistent sore throat or high temperature
^ An unexpected change in the amount of urine produced and/or its appearance If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
he side effects listed below have also been Reported.
Common side effects (These may affect between 1 and 10 in every 100 patients):
• Stomach pain, heartburn, nausea, vomiting,
' diarrhoea, indigestion, wind, loss ofappetite ^ Headache, dizziness, vertigo
• Skin rash or spots
f Raised levels of liver enzymes in the blood.
kare side effects (These may affectbetween 1 in every 1000 to 1 in every 10,000 patients):
1 Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)
^ Gastritis (inflammation, irritation or swelling of the stomach lining) l Vomiting blood
• Diarrhoea with blood in it or bleeding from the back passage
^ Black, tarry faeces or stools
• Drowsiness, tiredness
^ Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light I headedness)
• Skin rash and itching
• Fluid retention, symptoms ofwhich include swollen ankles
• Liver function disorders, including hepatitis and I jaundice.
Veryraresideeffects( Thesemay affect less 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, depression, 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 ofthe inside ofthe mouth or lips, taste changes, lower gut disorders (including inflammation of the 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), inflammation ofthe lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, blood disorders (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 ofthe pancreas, impotence. Facial swelling, inflammation ofthe lining ofthe brain (meningitis), stroke, throat disorders.
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.
5. HOW TO STORE ENSTAR SR 75MG TABLETS
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 required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Enstar SR 75mg Tablets contain •
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 embossed on one side. Pack sizes:
a) AI/AI blister: Packsizes: 10, 20, 28, 30, 50, 56, 60, 90, 100 tablets
b) PP-containerwith PE lids: Pack sizes: 28, 56, 100 tablets
c) HDPE-containerwith PE lids: Packsizes: 28, 56, 100 tablets
d) AI/PVDC blister: Pack sizes: 10, 20, 28, 30, 50, 56, 60, 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
This leaflet was last revised: May 2015. 1
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