nogen Pharma

PACKAGE LEAFLET: INFORMATION FORTHE USER

Enstar XL 100mg Tablets

(Diclofenac Sodium)

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or pharmacist or nurse.

•    This medicine has been prescribed for you only. 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 possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Enstar XL 100mg Tablets are and what they are used for

2.    What you need to know before you take Enstar XL 100mg Tablets

3.    HowtotakeEnstarXL 100mgTablets

4.    Possible side effects

5.    How to store Enstar XL 100mg Tablets

6.    Contents of the pack and other information

1. WHAT ENSTAR XL 100MG TABLETS ARE AND WHAT THEY ARE USED FOR

Enstar XL 100mg Tablets belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Enstar XL 100mg Tablets are used to relieve symptoms caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness orjoint pain. It does not cure arthritis and will help you only as long as you continue to take it.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENSTAR XL 100MG TABLETS

Do not take EnstarXL 100mg Tablets if you:

•    Are allergic (hypersensitive) to diclofenac sodium or any of the other ingredients in Enstar XL 100mg Tablets (see Section 6)

•    Suffer from asthma, hives or a runny nose caused by an allergy to salicylates (e.g. aspirin) or other NSAIDs such as ibuprofen

•    Have severe liver, kidney or heart failure

•    Are in the last three months of pregnancy

•    Have or have ever had, a stomach (gastric) or intestinal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying the bowels, fresh blood in the faeces or black tarry stools)

•    Have had stomach or bowel problems after you have taken other NSAIDs

•    Are currently taking other NSAIDs or COX (cyclooxygenase) 2- inhibitors

•    If you have established heart disease and/or cerebrovasculardisease e.g. ifyou 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

•    If you have or have had problems with your blood circulation (peripheral arterial disease).

If any of these apply to you, you should not be given

Enstar XL 100mg Tablets. Tell yourdoctor immediately.

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before taking

Enstar XL 100mg Tablets if you:

•    Have reduced kidney or liver function

•    Have recently had or you need to have surgery

•    Are elderly, as your doctor may wish to minimise treatment duration and to see you more often while you are taking EnstarXL 100mg Tablets

•    Are taking other medicines like corticosteroids or certain drugs fordepression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clotting, your doctor may prescribe you in addition to the EnstarXL 100mg Tablets a medicine for protecting your stomach and intestines

•    Have ever had asthma

•    Have or had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflammed or infected pouches/pockets of the colon)

•    Sufferfrom any blood or bleeding disorders. Your doctor may ask you to go for regular check-ups while you are taking these tablets

•    Suffer from liver porphyria (disorder of the red blood pigment)

•    Suffer from SLE (systemic lupus erythema) or other connective tissue disorders

•    Have heart problems, have previously had a stroke or think that you might be at risk of these conditions (forexample ifyou have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist

•    Are trying to get pregnant (see section Pregnancy, breastfeeding and fertility).

Make sure your doctor knows, before you are given diclofenac

• If you smoke

• If you have diabetes

•    Ifyou have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

Medicines such as EnstarXL 100mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose orduration of treatment.

Because it is an anti-inflammatory medicine, EnstarXL 100mg Tablets may reduce the symptoms of infection, for example, headache and a high temperature. If you feel unwell and need to see a doctor, remember to tell him/her that you are taking Enstar XL 100mg Tablets.

If you have a history of stomach problems while you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Other medicines and EnstarXL 100mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially if you are taking:

•    Any other NSAIDs or COX-2 (cyclo-oxygenase-2) inhibitor, e.g. aspirin or ibuprofen

•    Corticosteroids (e g hydrocortisone) given to treat a variety of conditions such as allergies and hormone imbalances

•    Anticoagulants such as warfarin to prevent blood clots

•    Lithium and serotonin re-uptake inhibitors

(SSRIs) e.g fluoxetine used to treat depression

•    Diuretics (water tablets) - the effect may be decreased. Potassium-sparing diuretics may increase the blood levels of potassium

•    ACE-inhibitors e.g captopril (medicines used to treat high blood pressure) - the blood pressure lowering effect may be reduced

•    Ciclosporin or tacrolimus (medicines used to prevent rejection after an organ transplant) - may harm kidney function

•    Quinolones e.g ciprofloxacin (antibiotics used to treat infections) - as they may cause fits

•    Medicines to treat diabetes e.g metformin - a dose adjustment of these medicines may be necessary as your blood sugar may drop too low

•    Cytotoxic medicines e.g. methotrexate (to treat cancers) - should not be taken less than 24 hours before or after Enstar XL 100mg Tablets as an increase in the blood levels of this medicine may occur

•    Mifepristone (used to induce abortion) effect of mifepristone may be reduced by NSAIDs

•    Cardiac glycosides such as digoxin (used for some heart conditions) as this may worsen heart failure

•    Trimethoprim used to treat infections

•    Phenytoin used to treat seizures

•    Colestipol and cholestyramine used to treat high cholesterol

•    Voriconazole used to treat fungal infections. Laboratory tests

Regular liver and kidney function tests and monitoring of blood counts are necessary during long-term treatment.

Pregnancy, breastfeeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

EnstarXL 100mg Tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Pregnancy and breastfeeding

You should not take EnstarXL 100mg Tablets during the first 6 months of pregnancy unless directed byyour doctorand must not take EnstarXL 100mg Tablets during the last 3 months of pregnancy as damage to the baby and reduced labour may occur.

You should only use EnstarXL 100mg Tablets whilst breastfeeding ifadvised by yourdoctor.

Driving and using machines

Some patients may experience side effects such as dizziness, drowsiness, feeling tired or sleepy and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving oroperating machinery.

EnstarXL 100mg Tablets contain lactose and sodium

EnstarXL 100mg Tablets contain lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Each tablet contains 8mg of sodium, this should be taken into account if you are on a salt restricted diet.

3. HOW TO TAKE ENSTAR XL 100MG TABLETS

Always take EnstarXL 100mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

EnstarXL 100mg 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 water, with or after food. Do not crush or chew the tablet.

The usual dose is:

•    Adults: One tablet once a day.

•    Elderly: As adult dose. The lowest effective dose should be taken and yourdoctorwill need to monitor you regularly. If you are elderly your doctor may prescribe a lower daily dose and reduce the duration of treatment.

•    Children:Notrecommended.

Ifyou take more EnstarXL 100mg Tablets than you should

Contact your doctor, local hospital casualty department or pharmacist if you have taken more Enstar XL lOOmg Tablets than stated in this leaflet or more than what your doctor has prescribed (and you feel unwell).

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 liverdamage.

If you forget to take Enstar XL 100mg Tablets

Do not take a double dose to make upfor a forgotten dose. Continue the treatment as advised by your doctor.

Ifyou stop taking Enstar XL 100mg Tablets

Changes to dosage or stopping of treatment should only be as directed by your doctor.

STOP TAKING the medicine and tell your doctor if you experience:

•    Indigestion or heartburn

•    Abdominal pain (pains in your stomach) or other abdominal stomach symptoms.

Medicines such as EnstarXL 100mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

The most common side effects are :-

•    Indigestion, heartburn,stomachpainorcramps, feeling or being sick, diarrhoea, flatulence, loss of appetite, constipation, mouth ulcers, worsening of ulcerative colitis or Crohn's disease, inflammation of the pancreas or tongue

•    Skin rash, itching, skin eruptions, eczema.

Other less common side effects are:-

•    Hair loss, sensitivity to light

•    Changes in kidney function, blood or protein in the urine

•    Changes in liverfunction causing yellowing ofyour skin or the whites of the eyes or increased liver enzyme levels in the body, blood disorders including anaemia

•    Palpitation, chest pain, high blood pressure, heart failure

•    Headache, dizziness, 'spinning' sensation, drowsiness or tiredness, disturbances of sensation, 'pins and needles', memory disturbance, disorientation, disturbance ofvision, sleeplessness, impaired hearing, ringing in the ears, irritability, convulsions, depression, anxiety, nightmares, confusion, hallucinations, tremor, psychotic reactions or taste alteration disorders, impotence, low blood pressure (symptoms may include feeling faint and lightheadedness), inflammation ofthe blood vessels (vasculitis), inflammation of the lungs (pneumonitis), stomach ulcers or bleeding.

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: 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 XL 100MG TABLETS

Keep all medicines out of the sight and reach of children.

Do not store above 25°C.

Do not use Enstar XL 100mg 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 of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTSOFTHEPACKANDOTHER INFORMATION

4. POSSIBLESIDEEFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects with EnstarXL 100mg Tablets at any time during your treatment, STOP TAKING your tablets and seek immediate medical help:

•    Passing blood in yourfaeces (stools / motions)

•    Passing black tarry stools

•    Vomiting any blood or dark particles that look like coffee grounds

•    An allergic reaction such as itching, swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing

•    A formof meningitis (aseptic)causing a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling or being sick and disorientation

•    A severe, painful skin disorderwith blisters and peeling skin. You may also have flu-like symptoms such as fever and sore throat - Stevens-Johnson Syndrome

•    A severe rash with reddening, peeling and swelling skin that looks like burns- Lyell's syndrome

•    Round red patches on the skin - Erythema multiforme.

What EnstarXL 100mg Tablets contain

•    The active substance (the ingredient that makes the tabletwork) is Diclofenac Sodium 100mg.

•    The other ingredients are lactose, magnesium stearate, hydrogenated vegetable oil Type 1 (Sterotex), povidone K30 and talc.

What Enstar XL 100mg Tablets look like and contents of the pack

The modified release tablets are white to off white, circular, biconvex tablets with D4 embossed on one side.

Pack sizes:

a)    Blister packs (Aluminium/Polyvinylchloride): 20, 21, 28, 30 tablets

b)    Polypropylene bottles with low-density polyethylene caps: 56, 100, 250 & 500 tablets

c)    High-density polyethylene bottles with low-density polyethylene screw caps: 56, 100, 250 & 500 tablets.

(Not all pack sizes may be available)

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited UnitG4, Riverside Industrial Estate,

RiversideWay, Dartford, DA1 5BS, UK.

The Product Licence number is PL 40147/0033

This leaflet was last revised in April 2014.

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