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Active substance(s): INDOMETHACIN

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In this leaflet:
1. What Indolar Capsules are and what they are used for.
2. Before you take Indolar Capsules.
3. How to take Indolar Capsules.
4. Possible side effects.
5. How to store Indolar Capsules.
6. Further information.

Indolar® SR Capsules 75 mg

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

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If you forget to take Indolar Capsules
If you forget to take your capsules, take the missed dose as soon as you remember, unless it is
nearly time for your next dose. Do not take a double dose to make up for one you have missed.

If you stop taking Indolar Capsules
Do not stop treatment without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Indolar Capsules can cause side effects, although not everybody gets them.
STOP TAKING the medicine and seek immediate medical help if you develop any of the
following at any time during your treatment:
signs of bleeding in the stomach:
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools

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For oral use. Use as directed your
doctor. See the attached leaflet for
further information. Store in a cool,
dry place and protect from light.
Keep out of the reach and
sight of children.
Each capsule contains 75 mg
indometacin in a sustained release
formulation. Also contains sucrose
and lactose.
PL 04416/0066.


100 capsules

• Vomit any blood or dark particles that look like coffee grounds signs of an allergic reaction:
- difficulty breathing or swallowing, asthma, sudden decrease in blood pressure
- swelling of the face, lips, tongue or throat.
STOP TAKING the medicine and tell your doctor if you experience:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms
• effects on the stomach such as feeling or being sick, inflammation of the stomach lining, small
intestine or mouth, constipation, diarrhoea, wind, perforation of previous intestinal damage,
narrowing of or blockage in the intestine.
• abnormal liver function (as seen in blood tests)
• liver disease: yellowing of the skin or whites of the eyes (jaundice), inflammation of the
liver (hepatitis) causing fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever

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• skin reactions such as itching, pale or red irregular raised patches with severe itching (hives),
disorder characterised by blood spots, bruising and discolouring of the skin (purpura), blisters or skin
that is red, flaky or peeling such as severe rash involving reddening, peeling and swelling of the
skin that resembles severe burns (toxic epidermal necrolysis), circular, irregular red patches on the
skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever,
blisters or ulcers (Stevens Johnson syndrome)
• aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) especially in
those who already have an auto-immune disease such as systemic lupus erythematosus or mixed
connective tissue disease.
Medicines such as Indometacin may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke.

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have included coffee-ground vomiting, black stools and stomach pains.
have severe liver, kidney or heart problems.
have had stomach or intestinal bleeding or perforation after taking NSAIDs.
have nasal obstruction (nasal polyps).
are taking any other NSAIDs (e.g. COX-2 inhibitors such as celecoxib, etoricoxib or lumiracoxib) .
have a blood clotting problem.

Indolar Capsules must not be used in children.
Talk to your doctor or pharmacist before taking Indolar Capsules if you are:
• elderly (see Other warnings).
• to have a vaccination with a ‘live’ vaccine.
• a woman trying to become pregnant or undergoing investigation for infertility.

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Tell your doctor if you notice any of the following side effects:
• small purple red spots, nosebleeds, bruising, disorder characterised by blood spots, blood clotting
throughout the body, disturbance of blood count, reduction in blood cell production by the bone
marrow. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness,
breathlessness on exertion, or abnormal paleness of the skin, you should tell your doctor who may
want you to have a blood test.
• high blood sugar
• sugar in the urine
• high blood levels of potassium (muscle cramps or pain, irregular heart beat, unusual tiredness or

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Indometacin 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.
• taking a medicine which is poisonous to the kidneys such as cisplatin or vancomycin.
• about to have, or have recently had surgery.
Or if you have:
• a history of high blood pressure, heart failure (symptoms may include increasing
breathlessness and ankle swelling).
• mental health problems e.g. mood changes.
• epilepsy.
• Parkinson’s Disease (tremor, stiffness and shuffling).
• any infection or sepsis (severe infection).
• any liver, kidney or heart problems.

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• blurred and double vision
• inflammation of the optic nerve (which may cause eye pain and loss of vision)
• eye pain
• changes in your sight.

• depression, nervousness, confusion, hallucinations, anxiety and other mental health problems, a
feeling of unreality to the self (that the mind is separated from the body), difficulty sleeping
• speech disorder, fits or seizures, worsening of epilepsy, disorder of the nerves causing tingling and
numbness, pins and needles, uncontrolled movements, worsening of parkinsonism (tremor, stiffness
and shuffling).

• ringing or buzzing in the ears
• hearing disturbances including deafness.

• fluid retention causing ankle swelling, chest pain, heart failure
• high or low blood pressure
• racing heart beat, irregular heart beat, palpitations

Nervous system:
• headache, dizziness, lightheadedness, spinning sensation (vertigo), tiredness, fainting, coma,
fluid in the brain causing swelling, a feeling of general discomfort and illness, drowsiness

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• increase in the number of white blood cells in the lungs
• narrowing of the airways in those who have a history of asthma or allergic disease.
Stomach and intestines:
• loss of appetite
• development or worsening of ulcerative colitis or Crohns disease
• inflammation of the pancreas causing pain and tenderness in the abdomen and back (pancreatitis).
• blocked bile flow.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines you have obtained without a prescription, particularly:
• other non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, naproxen, or COX-2
inhibitors (e.g. celecoxib) or diflunisal (used for pain and inflammation).
• quinolone antibiotics e.g. ciprofloxacin and norfloxacin (used to treat infections).
• medicines that thin the blood or which prevent blood clotting, such as warfarin, heparin, or
antiplatelet drugs such as clopidogrel.
• selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or venlafaxine (used for depression).
• metformin or sulphonylureas e.g. gliclazide (used for diabetes)
• diazepam (used for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm).
• medicines used to treat high blood pressure such as beta blockers (e.g. atenolol), alpha blockers
(e.g. prazosin), ACE inhibitors (e.g. lisinopril), angiotensin II receptor antagonists

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• inflammation of blood vessels
• sensitivity to sunlight or artificial light (e.g. sun beds)
• tender red lumps usually on the legs (erythema nodosum)
• hair loss, sweating
• worsening of psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts
of the body).
Muscle and bone:
• muscle weakness, increased breakdown of cartilage.
• blood in the urine

Blood vessels:
• flushing.

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Other warnings:
If you are elderly or you have previously had stomach ulcers, you have a higher risk of
getting side effects, especially from the stomach. Your doctor should therefore prescribe the lowest
dose that gives you sufficient relief. If you experience any unusual symptoms from the stomach, you must
tell your doctor about it. Medicines such as indometacin 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 or duration of treatment.
Medicines such as indomethacin 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 or duration of treatment.
If you have heart problems, previous stroke or 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) you should discuss your
treatment with your doctor or pharmacist.

• fluid retention which may be caused by diseases of the heart or kidneys.
• asthma, a history of asthma, a chest infection or lung disease.
• a history of gastrointestinal diseases such as ulcerative colitis, Crohn’s disease, diverticulitis
or cancer.
• systemic lupus erythematosus (SLE) which causes joint pain, skin rash and fever, or other
connective tissue disorders.
• diabetes.
• a decreased amount of fluid around the cells of the body (extracellular volume depletion).
• rheumatoid arthritis (regular eye examinations are recommended).
• peripheral arterial disease (a problem with the circulation in the legs).
• a condition that causes your skin to blister (Stevens-Johnson syndrome or toxic epidermal

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(e.g. valsartan), hydralazine (vasodilator) or nifedipine.
haloperidol (an antipsychotic drug).
zalcitabine, zidovudine or ritonavir (used for viral infections).
cardiac glycosides e.g. digoxin (used for heart failure and irregular heart beat).
ciclosporin, tacrolimus or muromonab-CD3 (used to supress the immune system).
corticosteroids e.g. prednisolone (used in many different diseases).
cyclophosphamide, methotrexate or erlotinib (used to treat some types of cancer or rheumatoid
methotrexate or penicillamine (used to treat rheumatoid arthritis).
desmopressin (used for diabetes insipidus and frequent urination during the night).
diuretics (water tablets) such as triamterene, thiazides (e.g. bendroflumethiazide) or furosemide.
lithium (used for some mental health problems).
mifepristone (used for termination of pregnancy). Indolar Capsules should not be taken within

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8-12 days of taking mifepristone.
baclofen (a muscle relaxant).
pentoxifylline (used for blood vessel disease and leg ulcers).
probenecid (used for gout).
tiludronic acid (used for Paget’s disease of bone).
diazepam (used to treat anxiety).
sibutramine (used to treat obesity).
phenytoin (used to treat epilepsy).

Taking Indolar Capsules with food and drink
• Avoid drinking alcohol whilst you are taking Indolar Capsules as they may increase the risk
of bleeding in your stomach or gut.
• Take Indolar Capsules with food or milk to reduce stomach problems.

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• nephrotic syndrome (increased protein in urine and fluid retention)
• too much protein in the urine
• inflammation of the kidneys, reduced kidney function or kidney failure.

While you are taking this medicine your doctor will carry out blood and urine tests (see section 3)
If any of these side effects gets serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Reproductive system:
• bleeding from the vagina
• breast enlargement or tenderness, enlarged breasts in men.

5. How to store Indolar Capsules

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: By reporting side effects you can help provide more information on the
safety of this medicine.

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Keep out of the reach and sight of children.
Store in a cool dry place and protect from light.
Do not use Indolar Capsules after the expiry date which is stated on the carton/label/bottle.
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.

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Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking Indolar Capsules if you are pregnant or planning
to get pregnant.

Important information about some of the ingredients of Indolar Capsules
This medicine contains sucrose and lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

If you are in the last three months of pregnancy you must not take Indolar Capsules They could harm
your unborn baby or cause a risk of increased bleeding to you and your baby during labour. You
should not take Indolar Capsules in the first six months of pregnancy or if you are breast-feeding Ask
your doctor before taking any medicine.

Your doctor may want to carry out tests to monitor your kidney and liver function, your sight, the levels
of blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have
or have a history of high blood pressure or heart failure (when the heart is unable to pump blood
effectively around the body) your doctor may also want to monitor you.

Driving and using machines
Indolar Capsules may make you feel tired, drowsy, dizzy or affect your vision. Make sure you are not
affected before you drive or operate machinery. Do not drink alcohol as this can make the symptoms

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6. Further information
What Indolar Capsules contain
• The active substance (the ingredient that makes the medicine work) is indometacin. Each
capsule contains 75 mg indometacin.
• The other ingredients are: sucrose, corn starch, lactose, povidone, talc, magnesium stearate
and polymethacrylates.
• The capsule shell contains: gelatin, titanium dioxide (E171), erythrosine (E172), indigotine
(E132) and yellow iron oxide (E172).
What Indolar Capsules look like and contents of the pack
Indolar SR Capsules 75 mg are dark blue/clear hard capsules.

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Adults: One capsule once or twice a day, depending on your response.
For period pain one capsule a day should be taken, starting when cramps or bleeding begin and
continued for as long as symptoms last.
Elderly: If you are elderly, your doctor will give you the lowest effective dose for the shortest
amount of time.

3. How to take Indolar Capsules
Always take Indolar Capsules exactly as your doctor has told you. If you are not sure, check with your
doctor or pharmacist.

Page 14

For oral use. Use as directed by your
doctor. See the attached leaflet for
further information. Store in a cool,
dry place and protect from light.
Keep out of the reach and
sight of children.
Each capsule contains 75 mg
indometacin in a sustained release
formulation. Also contains sucrose
and lactose.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
This leaflet was last revised in 04/2015

Children and adolescents: Indolar Capsules must not be used in children or adolescents.

Page 15

They are available in polypropylene securitainers with polyethylene closures (plastic pot with plastic lid)
containing 28, 30, 56, 60, 84, 90 or 100 capsules.

Larger text version of
the leaflet can be made
available upon request.

PL 04416/0066.

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75 mg
SR Capsules


100 capsules


Page 1 - Top visible panel

#75 mg sr

Artwork Proof Box
Ref: N031 - Brand alignment + RFI

Base label:

35 x 100 mm

Leaflet page 1:

35 x 67 mm

Right hand opening:

Proof no.

Date prepared:

Font size:

Left hand opening:

Pantone 541
Pantone 122


Overall leaflet size:

35 x 870 mm

Pantone 165

Page widths:

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Dimensions: 35 x 870 mm

Base Label

Swallow each capsule whole, with food or milk to reduce side effects on the stomach and
intestines. Take your capsules at the same time each day.

additional leaflet label information:

Indolar® 75 mg
SR Capsules

2. Before you take Indolar Capsules
Do not take Indolar Capsules if you:
• are in the last three months of pregnancy.
• are allergic (hypersensitive) to indomethacin or any of the ingredients of Indolar Capsules
(see section 6).
• are allergic (hypersensitive) to aspirin, ibuprofen or other NSAIDs (e.g. diclofenac or
naproxen). You may have developed signs of asthma (wheezing), runny nose, swelling of the face,
lips, tongue or throat or a skin rash with pale or red irregular raised patches with severe itching,
when taking these medicines.
• suffer with angioneurotic oedema (swelling of the face, lips, tongue or throat).
• have or have had a history of two or more episodes of peptic ulcer (ulcer in your stomach
or duodenum) or bleeding in your stomach or intestines in the past. Symptoms may

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Peel Here But Do Not Remove

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Indolar Capsules contain a medicine called indometacin. This belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). These medicines are pain killers which reduce inflammation.
Indolar Capsules are for:

Page 3

If you take more Indolar Capsules than you should
It is important not to take too many capsules. If you have taken more than you should, contact
your doctor or nearest hospital casualty department immediately. Show them the pack or this
leaflet. Symptoms of overdose are pain in the upper part of the stomach, bleeding in the
stomach or intestines, diarrhoea, disorientation, excitation, coma, dizziness, ringing or buzzing in
the ears, fainting, fits, liver damage, feeling or being sick, stomach pain, loss of appetite,
drowsiness, headache, ringing or buzzing in the ears, restlessness, agitation and kidney failure.


1. What Indolar Capsules are and what they are used for

• inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and
degenerative hip disease.
• disorders occurring around a joint such as inflammation of:
- fluid surrounding a joint (bursitis)
- tendons (tendinitis)
- a joint membrane (synovitis)
- the lining of a tendon (tenosynovitis)
- the capsule surrounding a joint (capsulitis).
• pain and stiffness in the backbone (ankylosing spondylitis).
• sprains and strains (acute muscle and bone diorders).
• lower back pain.
• pain,and swelling following muscle or bone surgery.
• period pain.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.