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INDOMETACIN SUPPOSITORIES BP 100MG

Active substance(s): INDOMETACIN

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Indometacin 100mg suppositories
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.
• 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.
In this leaflet:
1.
What Indometacin suppositories are and what they are used for
2.
Before you use Indometacin suppositories
3.
How to use Indometacin suppositories
4.
Possible side effects
5.
How to store Indometacin suppositories
6.
Further information

1.

What Indometacin suppositories are and what they are used for

Indometacin suppositories belong to a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). These medicines are pain killers which reduce swelling.
Indometacin suppositories are for:
• inflammatory diseases of the joints such as rheumatoid arthritis, osteoarthritis and degenerative
hip disease
• pain and stiffness in the backbone (ankylosing spondylitis)
• sprains and strains (acute muscle and bone disorders)
• lower back pain
• pain and swelling following muscle or bone surgery
• period pain
• gout.

2.

Before you use Indometacin suppositories

Do not use Indometacin suppositories if you:
• are in the last three months of pregnancy
• are allergic (hypersensitive) to indometacin or any of the ingredients of Indometacin
suppositories (see section 6)
• are allergic (hypersensitive) to aspirin, ibuprofen or other NSAIDs or you 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
• are taking other NSAIDs (e.g. Naproxen) or COX II inhibitors (e.g. Celecoxib)
• 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 include
vomiting particles that look like coffee-grounds, black tarry stools and blood in your faeces
(stools/motions)
• have severe liver, kidney or heart problems
• have had bleeding in your stomach or intestines or perforation after taking NSAIDs
• have nasal obstruction (nasal polyps)
• have piles (haemorrhoids) or inflammation or bleeding of the back passage.
Indometacin suppositories must not be used in children.

Check with your doctor before using Indometacin suppositories 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. 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.

or if you have:















a history of high blood pressure or congestive heart failure
a bleeding or blood clotting disorder
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
fluid retention which may be caused by diseases of the heart or kidneys
asthma or a history of asthma
have or have a history of gastrointestinal diseases such as ulcerative colitis or Crohns disease
systemic lupus erythematosus (SLE) or other connective tissue disorders
diabetes
a decreased amount of fluid around the cells of the body (extracellular volume depletion)
peripheral arterial disease (a problem with the circulation in the legs).

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.
If you have heart problems, previous stroke or think that 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.
Taking painkillers for headaches too often or for too long can make them worse.

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription, particularly:
• other non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, naproxen or COX II
inhibitors (e.g. celecoxib) or diflunisal (for pain and inflammation)
• quinolone antibiotics e.g. ciprofloxacin (to treat infections)
• medicines which thin the blood or which prevent blood clotting, such as warfarin or antiplatelet
drugs such as clopidogrel
• selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine (for depression)
• metformin or sulphonylureas e.g. gliclazide (for diabetes)
• phenytoin (for epilepsy)
• diazepam (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 (e.g.
valsartan), hydralazine (vasodilator) or nifedipine
• haloperidol (an antipsychotic drug)
• zalcitabine, zidovudine or ritonavir (for HIV infection)
• cardiac glycosides e.g. digoxin (for heart failure and irregular heart beat)
• ciclosporin, tacrolimus or muromonab-CD3 (to suppress the immune system)
• corticosteriods e.g. prednisolone (used in many different diseases)











cyclophosphamide or methotrexate (to treat some types of cancer, psoriasis or rheumatoid
arthritis)
desmopressin (for diabetes insipidus and frequent urination during the night)
diuretics (water tablets) such as triamterene, thiazides (e.g. bendroflumethiazide) or
furosemide
lithium (for some mental health problems)
mifepristone (used for termination of pregnancy). Indometacin suppositories should not be used
within 8-12 days of taking mifepristone
baclofen (a muscle relaxant)
pentoxifylline (for blood vessel disease and leg ulcers)
probenecid (for gout)
tiludronic acid (for Paget’s disease of bone).

Pregnancy and breast-feeding
If you are in the last three months of pregnancy, you must not use Indometacin suppositories. You
should only use Indometacin suppositories in the first six months of pregnancy or if you are breastfeeding under medical supervision. Always ask your doctor before taking any medicine.

Driving and using machines
Indometacin suppositories may make you feel drowsy, dizzy or affect your vision. Make sure you are
not affected before you drive or operate machinery.

Tests
Your doctor may want to carry out tests to monitor your kidney and liver function, the levels of
blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have
or have had a history of high blood pressure or heart failure, your doctor may also want to monitor
you. If you have rheumatoid arthritis you may be advised to have regular eye tests to check your
sight.

Surgery
If you are about to have, or have recently had surgery, please contact your doctor before using this
medicine.

3.

How to use Indometacin suppositories

Always use Indometacin suppositories exactly as your doctor has told you. If you are not sure, check
with your doctor or pharmacist.
For rectal use only.
Dose
• Adults (including the elderly):
Insert one suppository into your back passage at night and repeat in the morning if necessary. Your
doctor will give you the lowest effective dose for the shortest amount of time.
• Children:
Indometacin suppositories must not be used in children.

If you use more Indometacin suppositories than you should
It is important not to use too many suppositories. Contact your doctor or nearest hospital casualty
department immediately, if you have used more suppositories than you should or a child
accidentally swallows a suppository. Symptoms of overdose are pain in the upper part of the
stomach, bleeding in the stomach or intestines, diarrhoea, disorientation, excitation, coma,
dizziness, 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.

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

4.

Possible side effects

Like all medicines, Indometacin suppositories can cause side effects, although not everybody gets
them.
STOP USING 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
- 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 USING 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
• 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 (see Section 2 ‘Other warnings’).
Tell your doctor or pharmacist if you notice any of the following side effects:
• Blood:
- 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.


Metabolism:
- high blood sugar
- sugar in the urine
- high blood levels of potassium (muscle cramps or pain, irregular heart beat, unusual
tiredness or weakness).



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



Eyes:
- blurred and double vision
- inflammation of the optic nerve (which may cause eye pain and loss of vision)

-

eye pain
changes to your sight.



Ear:
- ringing or buzzing in the ears
- hearing disturbances including deafness.



Breathing:
- 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.



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
- depression, nervousness, confusion, hallucinations, anxiety and other mental health
problems, a feeling of unreality (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).



Blood vessels:
- flushing.



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)
- effects on the back passage include painful inability to empty the bowel or bladder,
inflammation, irritation, bleeding, burning pain, discomfort and itching of the back passage.



Liver:
- blocked bile flow.



Skin:
- 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.



Kidneys (Not known: Cannot be estimated from the available data):
- blood in the urine
- 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.



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

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 Indometacin suppositories

Keep out of the reach and sight of children.
Store in a cool place.
Do not use Indometacin suppositories after the expiry date which is stated on the carton.
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.

Further information

What Indometacin suppositories contain



The active substance (the ingredient that makes the medicine work) is indometacin. Each
suppository contains 100mg indometacin.
The other ingredients are vegetable fat.

What Indometacin suppositories look like and contents of the pack
Indometacin suppositories are yellow suppositories.
Pack size is 10.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in November 2017.

If you would like a leaflet with larger text, please contact
01271 311257.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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