Enstar XL 100mg Tablets (Diclofenac Sodium) – patient leaflet, side effects, dosage

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 or joint 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 Enstar XL 100mg 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 this medicine (listed in section 6). Signs of an allergic reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction

! Have or previously have had a peptic ulcer bleeding or

perforation in your stomach or intestines

! Have severe heart, kidney or liver failure or cerebrovascular

bleeding (bleeding in your brain)

! Are in your last three months of pregnancy

! Have had stomach or bowel problems after taking other

NSAIDs

! Have established heart disease and/or 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 ! If you have or have had problems with your blood circulation

(peripheral arterial disease).

Tell your doctor or pharmacist if you are not sure if any of the conditions above apply to you.

Enstar XL 100mg Tablets are not recommended for children.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Enstar XL 100mg Tablets if you:

! Have had an ulcer or some other problem affecting your

stomach or intestines (ulcerative colitis, Crohn's disease) ! Have asthma or wheezing attacks (or if you have had

asthma in the past)

! Have any heart, liver or kidney problems

! Are elderly

! Have low body weight

! Have mixed connective tissue disorders and systemic lupus

erythematosus - SLE (which results in joint pain, skin change and disorders of other organs)

! Have a condition called porphyria

! Have recently undergone major surgery

! Are particularly prone to infections (diclofenac may

suppress the signs and symptoms of an infection) ! Have experienced stomach discomfort, had heartburn or

felt nauseous after taking aspirin or any other nonsteroidal anti-inflammatory drugs

! Have a bleeding/blood disorder

! Smoke

! Have diabetes

! Have angina, blood clots, high blood pressure, raised

cholesterol or raised triglycerides

! Have had a previous episode of vomiting blood or blood in

stools

! Have experienced skin rash, itching, painful red areas,

peeling or blistering of the skin or any other allergic reaction within the first few days of treatment with diclofenac. ! Have ever developed a severe skin rash or skin peeling,

blistering and/or mouth sores after taking Enstar XL 100mg Tablets or other pain medications.

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

If you are having a medical examination, tell the doctor that you are taking Enstar XL 100mg Tablets as they reduce the signs of infection, fever and inflammation which would otherwise be noticed.

Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking Enstar XL 100mg Tablets, as this medicine can sometimes worsen wound healing in your gut after surgery.

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

If you have heart problems or have suffered from a previous stroke or think that you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Long term use with diclofenac is not recommended, however it is advised to undergo routine blood tests if diclofenac is indicated for long term treatment.

Other medicines and Enstar XL 100mg Tablets

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

Enstar XL 100mg Tablets may affect or be affected by the following medicines:

! Anticoagulant tablets (to prevent blood clots, e.g. warfarin) ! Medicines for the treatment of high blood pressure

(diuretics, beta-blockers and ACE inhibitors)

! Diuretics (to make you pass more water e.g.

spironolactone, amiloride and triamterene)

! Lithium (for depression)

! Medicines for the treatment of heart conditions (e.g.

digoxin)

! A corticosteroid (e.g. for asthma and various inflammatory

conditions)

! Antibiotics such as quinolone (for an infection e.g.

quinolones like ciprofloxacin, nalidixic acid, norfloxacin) ! Any other NSAID (for painful or inflammatory conditions e.g.

aspirin, ibuprofen, naproxen etc.)

! Mifepristone (used as emergency contraceptive or to

induce abortion or labour)

! Ciclosporin or tacrolimus (used to suppress the body's

immune system e.g. following transplants or in diseases such as psoriasis and rheumatoid arthritis)

! Zidovudine (an anti-viral drug)

! Medicines of the class SSRIs (Selective Serotonin

Reuptake Inhibitors) used to treat depression such as fluoxetine or sertraline

! Medicines used to treat diabetes

! Phenytoin (medicines to treat epilepsy)

! Colestipol and cholestyramine (medicines to lower

cholesterol level)

! CYP2C9 inhibitors: e.g. Sulfinapyrazone and voriconazole ! Methotrexate (used to treat cancer)

! Anti-platelet drugs which affect the clotting of blood which

may increase the risk of bleeding.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Enstar XL 100mg Tablets if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected. You should not take Enstar XL 100mg Tablets during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Enstar XL 100mg Tablets can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

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

Breast-feeding

Diclofenac is known to pass into milk in small amounts and hence should be avoided by nursing mothers.

Fertility

Enstar XL 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.

Driving and using machines

If you feel dizzy, sleepy or experience visual disturbances when you start to use Enstar XL 100mg Tablets, do not drive or use machines until the effect has worn off.

Enstar XL 100mg 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.

3. HOW TO TAKE ENSTAR XL 100MG TABLETS

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets must be swallowed whole with a glass of water, with or after food. Do not crush or chew the tablet.

The recommended dose is:

! Adults: One tablet once a day.

! 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 prescribe a lower daily dose and reduce the duration of treatment.

Use in children

Enstar XL 100mg Tablets are not recommended for use in children.

If you take more Enstar XL 100mg Tablets than you should

If you (or someone else) take too many of these tablets, contact your doctor or hospital immediately for advice. Bring the pack with any remaining tablets with you. Symptoms of overdose may include but are not limited to headache, nausea and vomiting (being sick), stomach pain, bloody diarrhoea, dizziness, disorientation, excitation, drowsiness, tinnitus (perception of noise or ringing in the ears), fainting, shortness of breath and convulsions (uncontrollable shaky movements).

If you forget to take Enstar XL 100mg Tablets

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

If you stop taking Enstar XL 100mg Tablets

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

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

Some side effects can be serious. Stop taking Enstar XL 100mg Tablets and tell your doctor straight away if you notice any of the following side effects:

! Mild cramping and tenderness of the abdomen, starting

shortly after the start of the treatment with Enstar XL 100mg Tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data)

! 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 or

hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing

! Painful red areas, peeling or blistering

! Yellowing of your skin or the whites of your eyes,

inflammation of liver (hepatitis), liver disorder and liver failure

! An unexpected change in the amount of urine produced

and/or its appearance, kidney failure

! Flu-like symptoms with painful red or purplish rashes and

blisters on skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)

! Meningitis (symptoms include stiff neck, headache, nausea,

vomiting, fever or disorientation, frequency very rare) ! Skin rash, which may form blisters and looks like small

targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme, frequency very rare)

! Convulsions (sudden, violent movements of the body) ! Heart failure, heart attack

! Inflammation of the pancreas (pancreatitis, which

commonly causes abdominal pain)

! Stroke (cerebrovascular accident, frequency very rare) ! Chest pain, which can be a sign of a potentially serious

allergic reaction called Kounis syndrome.

! A serious allergic skin reaction which may include large

widespread red and/or dark patches, swelling of the skin, blisters, and itching (Generalised bullous fixed drug eruption).

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

Other side effects

Common (may affect up to 1 in 10 people):

! Headache, dizziness, spinning of head, feeling sick

(nausea), being sick (vomiting), diarrhoea, indigestion, pain in your stomach, wind, loss of appetite, raised liver enzymes and rash.

Rare (may affect up to 1 in 1000 people):

! Skin rashes (hives), drowsiness, asthma, difficulty in breathing, gastritis (inflammation of the stomach), indigestion and stomach ache (signs of a gastrointestinal ulcer) and general swelling of the body.

Very rare (may affect up to 1 in 10,000 people):

! Deficiency of red cells or of haemoglobin in the blood ! Fluid retention in body and face characterised by swelling of the skin

! Disorientation, depression, sleeplessness, nightmare, irritability, psychotic disorder, nervousness, abnormal sensation typically tingling or pricking, memory impairment, dysfunction of the sense of taste

! Visual disturbance, blurred vision, double vision ! Ringing in the ears, impaired hearing

! Palpitations (awareness of your heartbeat), chest pain, abnormally low blood pressure (hypotension), abnormally high blood pressure (hypertension), inflammation of blood vessels

! Colitis (inflammation of the lining of the colon), constipation, mouth ulcers, inflammation of intestines (Crohn's disease) ! Inflammation of skin with blisters containing fluid, increase in reactivity of the skin to sunlight, itching and bleeding of skin, baldness, inflammation of small blood vessels (Henoch-Schönlein purpura)

! Presence of blood in urine

! Tremor (Uncontrollable shaking)

! Pneumonitis (inflammation of the lung)

! Stomatitis including ulcerative stomatitis (inflammation and ulcers of the bowel), glossitis (inflammation of the tongue), oesophageal (food pipe) disorder, large intestinal strictures (narrowing of the gut)

! Erythema (redness of the skin), purpura (bleeding or bruising under the skin)

! Proteinuria (excess protein in the urine).

Not known (frequency cannot be estimated from the available data):

! Confusional state

! Hallucinations (seeing or hearing things that are not really there)

! Sensory disturbances

! Inflammation of the nerves in the eye

! Erectile dysfunction

! Feeling of discomfort.

! An allergic skin reaction, that may include round or oval patches of redness and swelling of the skin, blistering, and itching (Fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is taken again.

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Enstar XL 100mg Tablets contain

! The active substance is Diclofenac Sodium 100mg. ! The other ingredients are lactose (see section 2, "Enstar XL

100mg Tablets contain 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:

1. a) Blister packs (Aluminium/Polyvinylchloride): 20, 21, 28, 30 tablets
2. b)

   Polypropylene bottles with low-density polyethylene caps:

   56, 100, 250 & 500 tablets

3. 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 IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

The Product Licence number is PL 55612/0120

This leaflet was last revised in April 2026. _ENV01