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Indolar® SR Capsules 75mg

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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Swallow each capsule whole, with food or milk to reduce stomach problems. Take at the same time
each day.
Adults: One capsule once or twice a day.
For period pain: One capsule a day, starting with the onset of cramps or bleeding and continue for
as long as the symptoms usually last.
Elderly: Your doctor should check you regularly to make sure you are not experiencing side effects
from the medicine, such as bleeding in your stomach or gut.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration
necessary to control your symptoms.



Base Label

Children and adolescents: Children and adolescents should not take this medicine.
Blood and urine tests
Indolar may affect your blood count or the working of your liver or kidneys, particularly if you are taking
certain other medicines, have heart, liver or kidney disease or you are elderly. This means your doctor
may wish to do blood or urine tests to monitor this while you are taking these capsules.
If you take more Indolar Capsules than you should
If you have accidentally taken too many capsules or if you think a child has swallowed any of the
capsules, contact your nearest hospital casualty department or your doctor immediately. If an overdose
has been taken there may be signs such as headache, feeling or being sick, stomach pain or bleeding,
drowsiness, dizziness, ringing in the ears or fainting. Show them the pack or this leaflet.

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Oral use. Use as directed your doctor.
Read the attached leaflet.
Store in a cool, dry place and protect
from light.
Keep out of the reach and sight
of children.
Each capsule contains 75 mg of the
active ingredient, indometacin BP in a
sustained release formulation.
PL 04416/0066.

Indolar® 75 mg
SR Capsules

100 capsules

• period pain.

1. What Indolar Capsules are and what they are used for
Indolar Capsules contain a medicine called indometacin. This belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs). They are used to reduce pain and inflammation.
Indolar is used as a pain killer and anti-inflammatory used for conditions like:
• rheumatoid arthritis and osteoarthritis, pain and swelling of the joints, ankylosing spondylitis, a
deformity/stiffening of the spine, hip pain and lower back pain.
• joint and tendon problems, swelling and pain where muscles, tendons, fluids and bone move
together at the joints.
• pain, swelling and/or water retention after joint or bone surgery.

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If you forget to take Indolar Capsules
If you miss a dose of Indolar Capsules, take your usual dose as soon as you remember, then take the
next dose as usual. However, if your next dose is due within 3 hours, take a single dose straight away
and skip the next dose. Do not take a double dose to make up for the forgotten capsule.
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.

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Peel Here But Do Not Remove

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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.

2. Before you take Indolar Capsules
Do not take Indolar Capsules if you are/have:
• allergic to Indolar Capsules or any of the ingredients in this medicine (See Section 6 of this leaflet).
• had an allergic reaction (difficulty breathing, a runny or blocked nose, swelling of the lips, face or
throat, or a rash or itchiness) to any other NSAID e.g. aspirin or ibuprofen.
• serious kidney, liver or heart failure.
• in the last three months of pregnancy.

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The most common side effects are headache, dizziness, drowsiness and indigestion. If you get a
prolonged headache tell your doctor.
If you develop a rash or become jaundiced (yellow skin or eyes) stop taking indometacin and talk to
your doctor immediately.
Aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as
headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light.
If you experience any of these symptoms seek medical attention immediately.
Medicines such as Indolar may be associated with a small increased risk of heart attack (chest pains,
shortness of breath, excessive sweating) or stroke (numbness or loss of the use of the muscles in the

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• a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had
two or more episodes of peptic ulcers, stomach bleeding or perforation.
• taking any other NSAIDs (e.g. COX-2 inhibitors such as celecoxib, etoricoxib or lumiracoxib).
• a blood clotting problem.
• a child or adolescent under 18 years old.
If you can say ‘yes’ to any of the above, do not take this medicine. Contact your
doctor or pharmacist for advice.

Talk to your doctor or pharmacist before taking Indolar Capsules if you are/have:
• elderly (increased risk of side effects especially to the stomach and gut).
• had a stomach or bowel disorder (e.g. ulcerative colitis, Crohn’s disease, diverticulitis or cancer).

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face or arms, problems with speech).
If you experience any of the following serious side effects, stop taking the medicine and
contact your doctor immediately or go to your nearest hospitals accident and emergency department.
• pass blood in your faeces, pass black tarry stools or vomit blood or dark particles that look like
coffee grounds.
• indigestion or heartburn, abdominal pains (pains in your stomach) or other abdominal symptoms.
• allergic reactions - skin rash which may be itchy, itching, redness, loss of consciousness, swelling
especially of the throat, difficulty breathing, sudden wheezing and tightness of the chest, asthma
and fluid in the lungs, swelling of the eyelids, face, tongue or lips, fast heart beat.

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high blood pressure, heart or circulatory problems or had a stroke.
diabetes, high cholesterol or you smoke.
liver or kidney problems.
epilepsy, Parkinson’s disease or a psychiatric disorder.
asthma, a chest infection or a lung disease.
hay fever, nasal polyps (lumps in your nose) or have had an allergic reaction to anything in the past.
systemic lupus erythematosus (SLE) which causes joint pain, skin rash and fever, or other
connective tissue disorders.
• an infection or you are about to have a ‘live’ vaccine or an operation.
• rheumatoid arthritis (regular eye examinations are recommended).

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• severe fatal skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic
epidermal necrolysis.
Other side effects are:
• Effects on the blood - changes in the numbers and types of blood cells, anaemia. If you develop
bruising, sore throats, nose bleeds or infections tell your doctor who may wish to test your blood.
• Effects on the nervous system - fatigue, drowsiness, dizziness, headaches, problems with speech,
fainting, nervousness, coma, lightheadedness, vertigo, tiredness, hallucinations (seeing things that are not
there), difficulty sleeping, depression, confusion, anxiety, mental disturbances, involuntary movements,
loss of co-ordination, numbness and tingling, fits or worsening of fits and Parkinson’s syndrome.

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• already taking another NSAID.
• taking Antiplatelet agents (as indometacin can inhibit platelet aggregation and can exaggerate
effects in patients with haemostatic defects), such as aspirin.
• a condition that causes your skin to blister (Stevens-Johnson syndrome or toxic epidermal necrolysis).
If you can say YES to any of the above, ask your doctor or pharmacist for advice before
taking this medicine.
Other Special warnings:
• Medicines such as Indolar may be associated with a small increased risk of heart attack or
stroke. Any risk is more likely with high doses and long term treatment. Do not take a higher
dose or take for longer than recommended.

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• Effects on the eye - pain in and around the eye, blurred or double vision, inflammation of the optic
nerve, deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina).
• Effects on the ears - ringing or buzzing or other hearing disturbances (rarely deafness).
• Effects on the heart - swelling especially of ankles, water retention, high or low blood pressure,
chest pain, fast or irregular heartbeats and heart failure.
• Effects on the stomach - feeling or being sick, abdominal pain or discomfort, loss of appetite,
constipation or diarrhoea, flatulence, inflammation of the mouth or guts or worsening of these
conditions and ulceration of the intestines which can cause bleeding, obstruction or can perforate
(burst), worsening of Crohn’s disease or ulcerative colitis.
• Effects on the liver - inflammation, jaundice (yellow skin or eyes see above).

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• Indolar may make it more difficult to get pregnant. Tell your doctor if you plan to get pregnant
or if you have problems getting pregnant.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
medicines you have obtained without a prescription. Some medicines can cause problems if you take
them with Indolar Capsules. These include:
• Other anti-inflammatory drugs:
- NSAIDs such as aspirin, diflunisal and ketorolac, COX-2 inhibitors.
- Corticosteroids such as prednisolone.
• Medicines that reduce blood clotting e.g. warfarin, heparin, clopidogrel.

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• Effects on the skin - sensitivity to light, eczema, worsening of psoriasis, hair loss.
• Effects on the kidney - inflammation, disease or failure, blood or protein in the urine and increase
in blood urea, frequent urination.
• Other effects - increase in blood sugar, sugar in the urine, high blood potassium, bleeding from
the vagina, breast changes (enlargement, tenderness, breast development in men), flushing,
sweating, mouth ulcers, muscle weakness and worsening of cartilage damage.
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.

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Desmopressin used to treat haemophilia.
Medicines used to treat depression (SSRIs) e.g. venlafaxine.
Lithium to treat bipolar disorder, haloperidol to treat schizophrenia or diazepam to treat anxiety.
Cyclophosphamide and erlotinib used to treat cancer.
Penicillamine used to treat rheumatoid arthritis.
Methotrexate used to treat cancer and rheumatoid arthritis.
Medicines to treat high blood pressure e.g. ilprost.
Diuretics (‘water tablets’) used to reduce high blood pressure and water retention.
Ritonavir and zalcitabine used to treat HIV/AIDS.
Probenecid to treat gout.

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6. Further information

5. How to store Indolar Capsules
Keep out of the reach and sight of children.
Do not use Indolar Capsules after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Store in a cool dry place and protect from light.
Do not throw away any medicines through wastewater or household waste. Ask your pharmacist how
to get rid of medicines that you no longer need. This will help you to protect the environment.

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• Ciclosporin, tacrolimus or muromonab-CD3 used to treat inflammatory conditions and after transplants.
• Mifepristone to terminate pregnancy (do not take Indolar for 12 days after taking mifepristone).
• Quinolone antibiotics e.g. ciprofloxacin and norfloxacin.
• Treatments for diabetes e.g. metformin.
• Pentoxifylline used to treat poor circulation.
• Sibutramine used to treat obesity.
• Phenytoin used to treat epilepsy.
• Tiludronic acid used to treat osteoporosis.
• Baclofen used to treat multiple sclerosis.
Talk to your doctor before taking Indolar if you are taking any of these medicines.

What Indolar Capsules contain
The active substance 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 slow release dark blue/clear hard capsules.

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#75 mg sr

Taking Indolar with food and drink
• Avoid drinking alcohol whilst you are taking Indolar as it may increase the risk of bleeding in your
stomach or gut.
• Take Indolar Capsules with food or milk to reduce stomach problems.
Pregnancy and breast-feeding
Indolar may make it more difficult to become pregnant, if you are planning to become pregnant or if
you are having problems becoming pregnant.
If you are pregnant or breast-feeding ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Indolar may cause side effects such as dizziness, drowsiness, fatigue, vertigo, sleepiness and visual

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

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They are available in polypropylene securitainers with polyethylene closures (plastic pot with plastic lid)
containing 28, 30, 56, 60, 84, 90 or 100 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder and manufacturer is:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
This leaflet was last approved in 04/2012
(to be amended upon approval).

disturbances (see Section 4). If any of these affect you, do not drive or use machines. Do not drink
alcohol as this can make the symptoms worse.
Important information about some of the ingredients of Indolar
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.

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

Oral use. Use as directed your
doctor. Read the attached leaflet.
Store in a cool, dry place and
protect from light.
Keep out of the reach and
sight of children.
Each capsule contains 75 mg of the
active ingredient, indometacin BP in
a sustained release formulation.
PL 04416/0066.

Page 1 - Top visible panel

Indolar® 75 mg
SR Capsules

100 capsules

+ 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.