INDOMETACIN 25 mg & 50 mg CAPSULES

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 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 signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

1. What Indometacin is and what it is used for

2. What you need to know before you take Indometacin

3. How to take Indometacin

4. Possible side effects

5. How to store Indometacin

6. Contents of the pack and other information

1. WHAT INDOMETACIN IS AND WHAT IT IS USED FOR

Indometacin capsules belongs to a group of medicines called non-steroidal anti-Inflammatory drugs (NSAIDs). These medicines are pain killers which reduce swelling.

Indometacin capsules are for:

• inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease
• pain and stiffness in the backbone (ankylosing spondylitis)
• sprain and strains (acute muscle and bone disorders)
• low back pain
• pain and swelling following muscle or bone surgery
• period pain
• gout

If you are not sure why you have been prescribed this medicine then please ask your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN

Do not take Indometacin capsules if you:

• are in the last three months of pregnancy or while breast-feeding (see ‘Pregnancy and breast-feeding’)
• are allergic (hypersensitive) to indometacin or any of the ingredients of Indometacin capsules (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) including 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 ulcers (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 nasal obstruction (nasal polyps).

Warning and precautions

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 usual symptoms from the stomach, you must tell your doctor about it.

Medicines such as Indometacin may be linked to a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Taking pain killers for headaches too often or for too long can make them worse.

Tell your doctor before you take this medicine if you:

• have heart problems, previous stroke or think you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker)
• are elderly, have ulcerative colitis or Crohn’s disease, as there is a higher risk of stomach problems (e.g. ulcers or bleeding)
• have or have had any problems with your liver, heart or kidneys that may cause fluid retention
• have asthma, mental health problems, epilepsy or Parkinson’s disease (tremor, stiffness and shuffling)
• have blood clotting problems or are taking medicines to stop your blood clotting
• have an infection or are being treated for an infection, or are receiving treatment with live vaccines
• have a connective tissue disorder including Systemic Lupus Erythematosus, which may cause joint pain, skin rashes and fever
• are 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
• are taking medicines poisonous to the kidneys such as cisplatin or vancomycin
• have an infection or sepsis (severe infection)
• have a decreased amount of fluid around the cells of the body (extracellular volume depletion)
• have peripheral arterial disease (a problem with the circulation in the legs).

Tests and Surgery

Indometacin may alter the results of some blood, liver or kidney. If you go into hospital, or are about to have, or have recently had surgery, or have treatment for other conditions, tell the doctor that you are taking Indometacin.

Regular blood and eye tests are recommended when taking this medicine for prolonged treatment.

Use in children and adolescents

Indometacin capsules must not to be used in children.

Other medicines and Indometacin

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Indometacin works: other medicines for pain and swelling including NSAIDs, aspirin, Naproxen or COX II inhibitors (e.g. Celecoxib) or diflunisal (for pain and inflammation)
• medicines for high blood pressure or heart conditions, such as captopril and lisinopril (ACE inhibitors), doxazosin and prazosin (alpha-blockers), atenolol and propranolol (beta-blockers), candersatan and losartan, hydralazine, nifedipine, pentoxifylline or digoxin
• medicines to increase urine production (diuretics), such as furosemide and triamterene
• medicines used to thin the blood and stop blood clots from forming such as anti-platelet medicines or coumarins, heparins, phenindione and warfarin
• medicines to treat cancer such as methotrexate or cyclophosphamide
• quinolone antibiotics (e.g. Ciprofloxacin) to treat bacterial infections
• selective Serotonin Reuptake Inhibitors (SSRIs) for depression
• phenytoin (for epilepsy)
• diazepam (for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm)
• steroids to treat swelling and allergies
• metformin or sulphonylureas e.g. gliclazide for diabetes
• ciclosporin or tacrolimus or Muromonab-CD3 to suppress the immune system and stop the rejection of organs after transplants
• haloperidol (an antipsychotic drug) or lithium for mental health problems
• zalcitabine, ritonavir or zidovudine to treat viral infections
• cardiac glycosides e.g. digoxin (for heart failure and irregular heartbeat)
• pentoxifylline (for blood vessel disease and leg ulcers)
• antacids (used to relieve heartburn, upset stomach or acid indigestion)
• baclofen, a muscle-relaxant
• desmopressin used to control night-time bed wetting
• mifepristone for abortion. Indometacin capsules should not be taken within 8–12 days of taking mifepristone
• probenecid to treat gout
• tiludronic acid to treat bone disease.

Pregnancy and breast-feeding

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

Do not take Indometacin if you are in the last three months of your pregnancy. You should only take Indometacin capsules in first six months of pregnancy or if you are breast-feeding under medical supervision. Always ask your doctor before taking any medicine.

Driving and using machines

Indometacin may cause dizziness, drowsiness, light-headedness, vertigo, tiredness or problems with your vision. If affected do not drive or operate machinery.

Indometacin contains Lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take indometacin

Always take Indometacin capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. These capsules should be swallowed whole with or after food, milk or an antacid (a treatment for indigestion or heartburn).

Dosage

Your doctor will decide your dose, as it depends on your condition.

You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. This may reduce the chance of side effects from occurring.

Adults:

Acute Rheumatoid Arthritis: typical dose is 25 mg two to three times a day.

Long term joint disorder: typical dose is 25 mg two to three times a day followed by a gradual increase of 25 mg a day if necessary. The usual maximum daily dose is 150 mg. Your doctor will decide the best dose for you.

Sudden flare up of long term condition: up to 150–200 mg a day. Your doctor will decide the best dose for you.

Acute Muscle and bone disorders: typical dose is 50 mg two or three times a day, according to severity for 10–14 days.

Normally 150 mg daily, rarely 200 mg daily.

Lower back pain: 50 mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.

Acute attack of gout: 50 mg three or four times daily until symptoms subside.

After muscle or bone surgery: 100–150 mg daily in divided doses, to be taken until symptoms decrease

Painful periods: Up to a maximum of 75 mg a day can be taken at the start of period pain for a few days until the pain lasts.

Elderly: Your doctor will prescribe the lowest dose needed to treat your symptoms. He or she may wish to monitor your progress to make sure there is no bleeding in your stomach or intestines.

Use in Children: Not recommended for children

If you take more Indometacin than you should

Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the medicine pack with you so they know what has been taken.

Symptoms of overdose include; feeling or being sick, headache, abdominal pain and bleeding in the stomach, diarrhoea, dizziness, drowsiness, fainting, disorientation, excitement, coma, numbness, fits, ringing or buzzing in the ear, kidney failure, liver damage.

If you forget to take Indometacin

Don’t worry; just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. possible side effects

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

If you get any of the following serious side effects, STOP TAKING this medicine and seek immediate medical help:

• pass blood in your stools, pass black tarry stools, vomit blood or dark particles that look like coffee grounds. These symptoms may indicate bleeding in the stomach or intestines.
• an allergic reaction

Allergic reactions may cause:

• wheezing, asthma, difficulty breathing or shortness of breath, swelling and irritation inside the nose
• swelling of eyelids, lips, tongue, throat, hands, feet or ankles
• indigestion, heartburn, aches and pains in the stomach area. These symptoms may indicate an ulcer in the stomach or intestines
• aseptic meningitis which may cause stiff neck, headache, vomiting, nausea, 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
• inflammation, damage or failure of the kidneys
• sugar, protein or blood in your urine
• altered liver function
• inflammation of the liver (hepatitis) which may cause loss of appetite, abdominal discomfort, dark urine and yellowing of the skin and whites of the eyes (jaundice)
• change in level of other types of blood cells that may cause bleeding, bruising, fever, frequent infections or sore throats.

Tell your doctor as they may wish to test your blood

• nosebleeds, blood clotting throughout the body, disturbance of blood count, reduction in blood cell production by the bone marrow
• ringing in the ears, hearing disturbances including rarely deafness
• inflammation of the optic nerve that may cause sudden loss in vision or pain on movement of the eye
• inflammation of the pancreas, which can cause severe pain in the abdomen and back
• bleeding from the vagina
• blister on the skin that are red, flaky or peeling, such as severe rash involving reddening, peeling, swelling of the skin, that resembles sever skin burns (toxic epidermal necrolysis), circular irregular red patches on the skin of the hands and arms (erythema multiforme) sever skin rash with flushing fever blisters or ulcers (Stevens Johnson syndrome).

Other side effects:

Effects on the heart and circulatory system:

• flushing, fluid retention, low or high blood pressure (hypotension or hypertension)
• chest pain, or a fast or irregular heartbeat, palpitations
• heart failure, or a small increased risk of heart attack or stroke

Effects on blood:

• reduction in red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness
• high levels of potassium (hyperkalaemia) or sugar (hyperglycaemia) in the blood

Effects on the brain and central nervous system:

• depression, anxiety, disorientation, hallucinations, confusion, nervousness, lack of self-awareness,
• a feeling of dizziness or spinning (vertigo)
• speech problems
• numbness or tingling, involuntary movements, fits, worsening of epilepsy or Parkinson’s disease
• feeling unwell, tiredness, weakness, difficulty sleeping, headache, dizziness, drowsiness, light-headedness, loss of conscious, build up of fluid in the brain, coma

Effects on the eye:

• blurred vision, double-vision
• pain in and around the eye
• deposits on the front surface of the eye (cornea), disorders of the back surface of the eye (retina)

Effects on the ear:

• tinnitus or hearing disturbances

Effects on the stomach and intestines:

• painful inflamed mouth ulcers
• loss of appetite, feeling or being sick, diarrhoea, gas, constipation, anorexia
• developing or worsening of ulcerative colitis or Crohn’s disease
• inflammation of the lining of the stomach or a portion of the small intestine, an obstruction in the intestines

Effects on the skin:

• worsening of psoriasis
• hair loss, sweating
• itching, rash
• tender red lumps under the skin
• sensitivity to sunlight or artificial light (e.g. sun beds)

Effects on the muscles and bones:

• muscle weakness, accelerated deterioration of cartilage

Effects on the breasts and reproductive system:

• enlargement or tenderness of the breasts, breast development in men.
• vaginal bleeding

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 Yellow Card Scheme or search for MHRA Yellow Card in the Google App or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store indometacin

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the package or container. 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 to protect the environment.

6. contents of the pack and other information

What Indometacin capsules contain

The active ingredient in Indometacin capsules is indometacin. The other ingredients are: lactose, sodium laurilsulfate, magnesium stearate, anhydrous colloidal silica, gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), shellac.

What Indometacin capsules look like and contents of the pack

INDOMETACIN 25 mg & 50 mg CAPSULES

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 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 signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

• 1. What Indometacin is and what it is used for

• 2. What you need to know before you take Indometacin

• 3. How to take Indometacin

• 4. Possible side effects

• 5. How to store Indometacin

• 6. Contents of the pack and other information

1. WHAT INDOMETACIN IS AND WHAT IT IS USED FOR

Indometacin capsules belongs to a group of medicines called non-steroidal anti-Inflammatory drugs (NSAIDs). These medicines are pain killers which reduce swelling.

Indometacin capsules are for:

• inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease
• pain and stiffness in the backbone (ankylosing spondylitis)
• sprain and strains (acute muscle and bone disorders)
• low back pain
• pain and swelling following muscle or bone surgery
• period pain
• gout

If you are not sure why you have been prescribed this medicine then please ask your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN

Do not take Indometacin capsules if you:

• are in the last three months of pregnancy or while breast-feeding (see ‘Pregnancy and breast-feeding’)
• are allergic (hypersensitive) to indometacin or any of the ingredients of Indometacin capsules (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) including 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 ulcers (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 nasal obstruction (nasal polyps).

Warning and precautions

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 usual symptoms from the stomach, you must tell your doctor about it.

Medicines such as Indometacin may be linked to a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Taking pain killers for headaches too often or for too long can make them worse.

Tell your doctor before you take this medicine if you:

• have heart problems, previous stroke or think you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker)
• are elderly, have ulcerative colitis or Crohn’s disease, as there is a higher risk of stomach problems (e.g. ulcers or bleeding)
• have or have had any problems with your liver, heart or kidneys that may cause fluid retention
• have asthma, mental health problems, epilepsy or Parkinson’s disease (tremor, stiffness and shuffling)
• have blood clotting problems or are taking medicines to stop your blood clotting
• have an infection or are being treated for an infection, or are receiving treatment with live vaccines
• have a connective tissue disorder including Systemic Lupus Erythematosus, which may cause joint pain, skin rashes and fever
• are 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
• are taking medicines poisonous to the kidneys such as cisplatin or vancomycin
• have an infection or sepsis (severe infection)
• have a decreased amount of fluid around the cells of the body (extracellular volume depletion)
• have peripheral arterial disease (a problem with the circulation in the legs).

Tests and Surgery

Indometacin may alter the results of some blood, liver or kidney. If you go into hospital, or are about to have, or have recently had surgery, or have treatment for other conditions, tell the doctor that you are taking Indometacin.

Regular blood and eye tests are recommended when taking this medicine for prolonged treatment.

Use in children and adolescents

Indometacin capsules must not to be used in children.

Other medicines and Indometacin

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Indometacin works: other medicines for pain and swelling including NSAIDs, aspirin, Naproxen or COX II inhibitors (e.g. Celecoxib) or diflunisal (for pain and inflammation)
• medicines for high blood pressure or heart conditions, such as captopril and lisinopril (ACE inhibitors), doxazosin and prazosin (alpha-blockers), atenolol and propranolol (beta-blockers), candersatan and losartan, hydralazine, nifedipine, pentoxifylline or digoxin
• medicines to increase urine production (diuretics), such as furosemide and triamterene
• medicines used to thin the blood and stop blood clots from forming such as anti-platelet medicines or coumarins, heparins, phenindione and warfarin
• medicines to treat cancer such as methotrexate or cyclophosphamide
• quinolone antibiotics (e.g. Ciprofloxacin) to treat bacterial infections
• selective Serotonin Reuptake Inhibitors (SSRIs) for depression
• phenytoin (for epilepsy)
• diazepam (for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm)
• steroids to treat swelling and allergies
• metformin or sulphonylureas e.g. gliclazide for diabetes
• ciclosporin or tacrolimus or Muromonab-CD3 to suppress the immune system and stop the rejection of organs after transplants
• haloperidol (an antipsychotic drug) or lithium for mental health problems
• zalcitabine, ritonavir or zidovudine to treat viral infections
• cardiac glycosides e.g. digoxin (for heart failure and irregular heartbeat)
• pentoxifylline (for blood vessel disease and leg ulcers)
• antacids (used to relieve heartburn, upset stomach or acid indigestion)
• baclofen, a muscle-relaxant
• desmopressin used to control night-time bed wetting
• mifepristone for abortion. Indometacin capsules should not be taken within 8–12 days of taking mifepristone
• probenecid to treat gout
• tiludronic acid to treat bone disease.

Pregnancy and breast-feeding

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

Do not take Indometacin if you are in the last three months of your pregnancy. You should only take Indometacin capsules in first six months of pregnancy or if you are breast-feeding under medical supervision. Always ask your doctor before taking any medicine.

Driving and using machines

Indometacin may cause dizziness, drowsiness, light-headedness, vertigo, tiredness or problems with your vision. If affected do not drive or operate machinery.

Indometacin contains Lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take indometacin

Always take Indometacin capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. These capsules should be swallowed whole with or after food, milk or an antacid (a treatment for indigestion or heartburn).

Dosage

Your doctor will decide your dose, as it depends on your condition.

You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. This may reduce the chance of side effects from occurring.

Adults:

Acute Rheumatoid Arthritis: typical dose is 25 mg two to three times a day.

Long term joint disorder: typical dose is 25 mg two to three times a day followed by a gradual increase of 25 mg a day if necessary. The usual maximum daily dose is 150 mg. Your doctor will decide the best dose for you.

Sudden flare up of long term condition: up to 150–200 mg a day. Your doctor will decide the best dose for you.

Acute Muscle and bone disorders: typical dose is 50 mg two or three times a day, according to severity for 10–14 days.

Normally 150 mg daily, rarely 200 mg daily.

Lower back pain: 50 mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.

Acute attack of gout: 50 mg three or four times daily until symptoms subside.

After muscle or bone surgery: 100–150 mg daily in divided doses, to be taken until symptoms decrease

Painful periods: Up to a maximum of 75 mg a day can be taken at the start of period pain for a few days until the pain lasts.

Elderly: Your doctor will prescribe the lowest dose needed to treat your symptoms. He or she may wish to monitor your progress to make sure there is no bleeding in your stomach or intestines.

Use in Children: Not recommended for children

If you take more Indometacin than you should

Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the medicine pack with you so they know what has been taken.

Symptoms of overdose include; feeling or being sick, headache, abdominal pain and bleeding in the stomach, diarrhoea, dizziness, drowsiness, fainting, disorientation, excitement, coma, numbness, fits, ringing or buzzing in the ear, kidney failure, liver damage.

If you forget to take Indometacin

Don’t worry; just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. possible side effects

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

If you get any of the following serious side effects, STOP TAKING this medicine and seek immediate medical help:

• pass blood in your stools, pass black tarry stools, vomit blood or dark particles that look like coffee grounds. These symptoms may indicate bleeding in the stomach or intestines.
• an allergic reaction

Allergic reactions may cause:

• wheezing, asthma, difficulty breathing or shortness of breath, swelling and irritation inside the nose
• swelling of eyelids, lips, tongue, throat, hands, feet or ankles
• indigestion, heartburn, aches and pains in the stomach area. These symptoms may indicate an ulcer in the stomach or intestines
• aseptic meningitis which may cause stiff neck, headache, vomiting, nausea, 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
• inflammation, damage or failure of the kidneys
• sugar, protein or blood in your urine
• altered liver function
• inflammation of the liver (hepatitis) which may cause loss of appetite, abdominal discomfort, dark urine and yellowing of the skin and whites of the eyes (jaundice)
• change in level of other types of blood cells that may cause bleeding, bruising, fever, frequent infections or sore throats.

Tell your doctor as they may wish to test your blood

• nosebleeds, blood clotting throughout the body, disturbance of blood count, reduction in blood cell production by the bone marrow
• ringing in the ears, hearing disturbances including rarely deafness
• inflammation of the optic nerve that may cause sudden loss in vision or pain on movement of the eye
• inflammation of the pancreas, which can cause severe pain in the abdomen and back
• bleeding from the vagina
• blister on the skin that are red, flaky or peeling, such as severe rash involving reddening, peeling, swelling of the skin, that resembles sever skin burns (toxic epidermal necrolysis), circular irregular red patches on the skin of the hands and arms (erythema multiforme) sever skin rash with flushing fever blisters or ulcers (Stevens Johnson syndrome).

Other side effects:

Effects on the heart and circulatory system:

• flushing, fluid retention, low or high blood pressure (hypotension or hypertension)
• chest pain, or a fast or irregular heartbeat, palpitations
• heart failure, or a small increased risk of heart attack or stroke

Effects on blood:

• reduction in red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness
• high levels of potassium (hyperkalaemia) or sugar (hyperglycaemia) in the blood

Effects on the brain and central nervous system:

• depression, anxiety, disorientation, hallucinations, confusion, nervousness, lack of self-awareness,
• a feeling of dizziness or spinning (vertigo)
• speech problems
• numbness or tingling, involuntary movements, fits, worsening of epilepsy or Parkinson’s disease
• feeling unwell, tiredness, weakness, difficulty sleeping, headache, dizziness, drowsiness, light-headedness, loss of conscious, build up of fluid in the brain, coma

Effects on the eye:

• blurred vision, double-vision
• pain in and around the eye
• deposits on the front surface of the eye (cornea), disorders of the back surface of the eye (retina)

Effects on the ear:

• tinnitus or hearing disturbances

Effects on the stomach and intestines:

• painful inflamed mouth ulcers
• loss of appetite, feeling or being sick, diarrhoea, gas, constipation, anorexia
• developing or worsening of ulcerative colitis or Crohn’s disease
• inflammation of the lining of the stomach or a portion of the small intestine, an obstruction in the intestines

Effects on the skin:

• worsening of psoriasis
• hair loss, sweating
• itching, rash
• tender red lumps under the skin
• sensitivity to sunlight or artificial light (e.g. sun beds)

Effects on the muscles and bones:

• muscle weakness, accelerated deterioration of cartilage

Effects on the breasts and reproductive system:

• enlargement or tenderness of the breasts, breast development in men.
• vaginal bleeding

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 Yellow Card Scheme or search for MHRA Yellow Card in the Google App or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store indometacin

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the package or container. 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 to protect the environment.

6. contents of the pack and other information

What Indometacin capsules contain

The active ingredient in Indometacin capsules is indometacin. The other ingredients are: lactose, sodium laurilsulfate, magnesium stearate, anhydrous colloidal silica, gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), shellac.

What Indometacin capsules look like and contents of the pack

Indometacin 25 mg capsules are ivory capsules with the marking MP71 printed in black ink.

Indometacin 50 mg capsules are ivory capsules with the marking MP72 printed in black ink.

The capsules come in blisters packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited, 41–43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

• 84 Pembroke Road, London, W8 6NX, UK

For more information about this product, please contact the Marketing Authorisation Holder.

PACKAGE LEAFLET: INFORMATION FOR THE USER

INDOMETACIN 25 mg & 50 mg CAPSULES

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 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 signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

1. What Indometacin is and what it is used for

2. What you need to know before you take Indometacin

3. How to take Indometacin

4. Possible side effects

5. How to store Indometacin

6. Contents of the pack and other information

1. WHAT INDOMETACIN IS AND WHAT IT IS USED FOR

Indometacin capsules belongs to a group of medicines called non-steroidal anti-Inflammatory drugs (NSAIDs). These medicines are pain killers which reduce swelling.

Indometacin capsules are for:

• inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease
• pain and stiffness in the backbone (ankylosing spondylitis)
• sprain and strains (acute muscle and bone disorders)
• low back pain
• pain and swelling following muscle or bone surgery
• period pain
• gout

If you are not sure why you have been prescribed this medicine then please ask your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN

Do not take Indometacin capsules if you:

• are in the last three months of pregnancy or while breast-feeding (see ‘Pregnancy and breast-feeding’)
• are allergic (hypersensitive) to indometacin or any of the ingredients of Indometacin capsules (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) including 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 ulcers (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 nasal obstruction (nasal polyps).

Warning and precautions

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 usual symptoms from the stomach, you must tell your doctor about it.

Medicines such as Indometacin may be linked to a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Taking pain killers for headaches too often or for too long can make them worse.

Tell your doctor before you take this medicine if you:

• have heart problems, previous stroke or think you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker)
• are elderly, have ulcerative colitis or Crohn’s disease, as there is a higher risk of stomach problems (e.g. ulcers or bleeding)
• have or have had any problems with your liver, heart or kidneys that may cause fluid retention
• have asthma, mental health problems, epilepsy or Parkinson’s disease (tremor, stiffness and shuffling)
• have blood clotting problems or are taking medicines to stop your blood clotting
• have an infection or are being treated for an infection, or are receiving treatment with live vaccines
• have a connective tissue disorder including Systemic Lupus Erythematosus, which may cause joint pain, skin rashes and fever
• are 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
• are taking medicines poisonous to the kidneys such as cisplatin or vancomycin
• have an infection or sepsis (severe infection)
• have a decreased amount of fluid around the cells of the body (extracellular volume depletion)
• have peripheral arterial disease (a problem with the circulation in the legs).

Tests and Surgery

Indometacin may alter the results of some blood, liver or kidney. If you go into hospital, or are about to have, or have recently had surgery, or have treatment for other conditions, tell the doctor that you are taking Indometacin.

Regular blood and eye tests are recommended when taking this medicine for prolonged treatment.

Use in children and adolescents

Indometacin capsules must not to be used in children.

Other medicines and Indometacin

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Indometacin works: other medicines for pain and swelling including NSAIDs, aspirin, Naproxen or COX II inhibitors (e.g. Celecoxib) or diflunisal (for pain and inflammation)
• medicines for high blood pressure or heart conditions, such as captopril and lisinopril (ACE inhibitors), doxazosin and prazosin (alpha-blockers), atenolol and propranolol (beta-blockers), candersatan and losartan, hydralazine, nifedipine, pentoxifylline or digoxin
• medicines to increase urine production (diuretics), such as furosemide and triamterene
• medicines used to thin the blood and stop blood clots from forming such as anti-platelet medicines or coumarins, heparins, phenindione and warfarin
• medicines to treat cancer such as methotrexate or cyclophosphamide
• quinolone antibiotics (e.g. Ciprofloxacin) to treat bacterial infections
• selective Serotonin Reuptake Inhibitors (SSRIs) for depression
• phenytoin (for epilepsy)
• diazepam (for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm)
• steroids to treat swelling and allergies
• metformin or sulphonylureas e.g. gliclazide for diabetes
• ciclosporin or tacrolimus or Muromonab-CD3 to suppress the immune system and stop the rejection of organs after transplants
• haloperidol (an antipsychotic drug) or lithium for mental health problems
• zalcitabine, ritonavir or zidovudine to treat viral infections
• cardiac glycosides e.g. digoxin (for heart failure and irregular heartbeat)
• pentoxifylline (for blood vessel disease and leg ulcers)
• antacids (used to relieve heartburn, upset stomach or acid indigestion)
• baclofen, a muscle-relaxant
• desmopressin used to control night-time bed wetting
• mifepristone for abortion. Indometacin capsules should not be taken within 8–12 days of taking mifepristone
• probenecid to treat gout
• tiludronic acid to treat bone disease.

Pregnancy and breast-feeding

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

Do not take Indometacin if you are in the last three months of your pregnancy. You should only take Indometacin capsules in first six months of pregnancy or if you are breast-feeding under medical supervision. Always ask your doctor before taking any medicine.

Driving and using machines

Indometacin may cause dizziness, drowsiness, light-headedness, vertigo, tiredness or problems with your vision. If affected do not drive or operate machinery.

Indometacin contains Lactose

These capsules contain a sugar called lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take indometacin

Always take Indometacin capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. These capsules should be swallowed whole with or after food, milk or an antacid (a treatment for indigestion or heartburn).

Dosage

Your doctor will decide your dose, as it depends on your condition. You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. This may reduce the chance of side effects from occurring.

Adults:

Acute Rheumatoid Arthritis: typical dose is 25 mg two to three times a day.

Long term joint disorder: typical dose is 25 mg two to three times a day followed by a gradual increase of 25 mg a day if necessary. The usual maximum daily dose is 150 mg. Your doctor will decide the best dose for you.

Sudden flare up of long term condition: up to 150–200 mg a day. Your doctor will decide the best dose for you.

Acute Muscle and bone disorders: typical dose is 50 mg two or three times a day, according to severity for 10–14 days.

Normally 150 mg daily, rarely 200 mg daily.

Lower back pain: 50 mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.

Acute attack of gout: 50 mg three or four times daily until symptoms subside.

After muscle or bone surgery: 100–150 mg daily in divided doses, to be taken until symptoms decrease

Painful periods: Up to a maximum of 75 mg a day can be taken at the start of period pain for a few days until the pain lasts.

Elderly: Your doctor will prescribe the lowest dose needed to treat your symptoms. He or she may wish to monitor your progress to make sure there is no bleeding in your stomach or intestines.

Use in Children: Not recommended for children

If you take more Indometacin than you should

Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the medicine pack with you so they know what has been taken.

Symptoms of overdose include; feeling or being sick, headache, abdominal pain and bleeding in the stomach, diarrhoea, dizziness, drowsiness, fainting, disorientation, excitement, coma, numbness, fits, ringing or buzzing in the ear, kidney failure, liver damage.

If you forget to take Indometacin

Don’t worry; just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. possible side effects

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

If you get any of the following serious side effects, STOP TAKING this medicine and seek immediate medical help:

• pass blood in your stools, pass black tarry stools, vomit blood or dark particles that look like coffee grounds. These symptoms may indicate bleeding in the stomach or intestines.
• an allergic reaction

Allergic reactions may cause:

• wheezing, asthma, difficulty breathing or shortness of breath, swelling and irritation inside the nose
• swelling of eyelids, lips, tongue, throat, hands, feet or ankles
• indigestion, heartburn, aches and pains in the stomach area. These symptoms may indicate an ulcer in the stomach or intestines
• aseptic meningitis which may cause stiff neck, headache, vomiting, nausea, 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
• inflammation, damage or failure of the kidneys
• sugar, protein or blood in your urine
• altered liver function
• inflammation of the liver (hepatitis) which may cause loss of appetite, abdominal discomfort, dark urine and yellowing of the skin and whites of the eyes (jaundice)
• change in level of other types of blood cells that may cause bleeding, bruising, fever, frequent infections or sore throats.

Tell your doctor as they may wish to test your blood

• nosebleeds, blood clotting throughout the body, disturbance of blood count, reduction in blood cell production by the bone marrow
• ringing in the ears, hearing disturbances including rarely deafness
• inflammation of the optic nerve that may cause sudden loss in vision or pain on movement of the eye
• inflammation of the pancreas, which can cause severe pain in the abdomen and back
• bleeding from the vagina
• blister on the skin that are red, flaky or peeling, such as severe rash involving reddening, peeling, swelling of the skin, that resembles sever skin burns (toxic epidermal necrolysis), circular irregular red patches on the skin of the hands and arms (erythema multiforme) sever skin rash with flushing fever blisters or ulcers (Stevens Johnson syndrome).
• flushing, fluid retention, low or high blood pressure (hypotension or hypertension)
• chest pain, or a fast or irregular heartbeat, palpitations
• heart failure, or a small increased risk of heart attack or stroke
• reduction in red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness
• high levels of potassium (hyperkalaemia) or sugar (hyperglycaemia) in the blood

Effects on the brain and central nervous system:

• depression, anxiety, disorientation, hallucinations, confusion, nervousness, lack of self-awareness
• a feeling of dizziness or spinning (vertigo)
• speech problems
• numbness or tingling, involuntary movements, fits, worsening of epilepsy or Parkinson’s disease
• feeling unwell, tiredness, weakness, difficulty sleeping, headache, dizziness, drowsiness, light-headedness, loss of conscious, build up of fluid in the brain, coma

Effects on the eye:

• blurred vision, double-vision
• pain in and around the eye
• deposits on the front surface of the eye (cornea), disorders of the back surface of the eye (retina)
• tinnitus or hearing disturbances
• painful inflamed mouth ulcers
• loss of appetite, feeling or being sick, diarrhoea, gas, constipation, anorexia
• developing or worsening of ulcerative colitis or Crohn’s disease
• inflammation of the lining of the stomach or a portion of the small intestine, an obstruction in the intestines
• worsening of psoriasis
• hair loss, sweating
• itching, rash
• tender red lumps under the skin
• sensitivity to sunlight or artificial light (e.g. sun beds)
• muscle weakness, accelerated deterioration of cartilage

Effects on the breasts and reproductive system:

• enlargement or tenderness of the breasts, breast development in men.
• vaginal bleeding

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 Yellow Card Scheme or search for MHRA Yellow Card in the Google App or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store indometacin

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the package or container. 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 to protect the environment.

6. contents of the pack and other information

What Indometacin capsules contain

The active ingredient in Indometacin capsules is indometacin. The other ingredients are: Indometacin 25 mg Capsules: lactose, sodium laurilsulfate, magnesium stearate, anhydrous colloidal silica, gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), shellac.

Indometacin 50 mg Capsules: lactose, sodium laurilsulfate, magnesium stearate, anhydrous colloidal silica, gelatin, quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171), black iron oxide (E172), shellac.

What Indometacin capsules look like and contents of the pack

Indometacin 25 mg capsules are ivory capsules with the marking MP71 printed in black ink.

Indometacin 50 mg capsules are ivory capsules with the marking MP72 printed in black ink.

The capsules come in blisters packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited, 41–43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

• 84 Pembroke Road, London, W8 6NX, UK

For more information about this product, please contact the Marketing Authorisation Holder.

PACKAGE LEAFLET: INFORMATION FOR THE USER

INDOMETACIN 25 mg & 50 mg CAPSULES

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 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 signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

• 1. What Indometacin is and what it is used for

• 2. What you need to know before you take Indometacin

• 3. How to take Indometacin

• 4. Possible side effects

• 5. How to store Indometacin

• 6. Contents of the pack and other information

1. WHAT INDOMETACIN IS AND WHAT IT IS USED FOR

Indometacin capsules belongs to a group of medicines called non-steroidal anti-Inflammatory drugs (NSAIDs). These medicines are pain killers which reduce swelling.

Indometacin capsules are for:

• inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease
• pain and stiffness in the backbone (ankylosing spondylitis)
• sprain and strains (acute muscle and bone disorders)
• low back pain
• pain and swelling following muscle or bone surgery
• period pain
• gout

If you are not sure why you have been prescribed this medicine then please ask your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN

Do not take Indometacin capsules if you:

• are in the last three months of pregnancy or while breast-feeding (see ‘Pregnancy and breast-feeding’)
• are allergic (hypersensitive) to indometacin or any of the ingredients of Indometacin capsules (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) including 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 ulcers (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 nasal obstruction (nasal polyps).

Warning and precautions

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 usual symptoms from the stomach, you must tell your doctor about it.

Medicines such as Indometacin may be linked to a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Taking pain killers for headaches too often or for too long can make them worse.

Tell your doctor before you take this medicine if you:

• have heart problems, previous stroke or think you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker)
• are elderly, have ulcerative colitis or Crohn’s disease, as there is a higher risk of stomach problems (e.g. ulcers or bleeding)
• have or have had any problems with your liver, heart or kidneys that may cause fluid retention
• have asthma, mental health problems, epilepsy or Parkinson’s disease (tremor, stiffness and shuffling)
• have blood clotting problems or are taking medicines to stop your blood clotting
• have an infection or are being treated for an infection, or are receiving treatment with live vaccines
• have a connective tissue disorder including Systemic Lupus Erythematosus, which may cause joint pain, skin rashes and fever
• are 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
• are taking medicines poisonous to the kidneys such as cisplatin or vancomycin
• have an infection or sepsis (severe infection)
• have a decreased amount of fluid around the cells of the body (extracellular volume depletion)
• have peripheral arterial disease (a problem with the circulation in the legs).

Tests and Surgery

Indometacin may alter the results of some blood, liver or kidney. If you go into hospital, or are about to have, or have recently had surgery, or have treatment for other conditions, tell the doctor that you are taking Indometacin.

Regular blood and eye tests are recommended when taking this medicine for prolonged treatment.

Use in children and adolescents

Indometacin capsules must not to be used in children.

Other medicines and Indometacin

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Indometacin works: other medicines for pain and swelling including NSAIDs, aspirin, Naproxen or COX II inhibitors (e.g. Celecoxib) or diflunisal (for pain and inflammation)
• medicines for high blood pressure or heart conditions, such as captopril and lisinopril (ACE inhibitors), doxazosin and prazosin (alpha-blockers), atenolol and propranolol (beta-blockers), candersatan and losartan, hydralazine, nifedipine, pentoxifylline or digoxin
• medicines to increase urine production (diuretics), such as furosemide and triamterene
• medicines used to thin the blood and stop blood clots from forming such as anti-platelet medicines or coumarins, heparins, phenindione and warfarin
• medicines to treat cancer such as methotrexate or cyclophosphamide
• quinolone antibiotics (e.g. Ciprofloxacin) to treat bacterial infections
• selective Serotonin Reuptake Inhibitors (SSRIs) for depression
• phenytoin (for epilepsy)
• diazepam (for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm)
• steroids to treat swelling and allergies
• metformin or sulphonylureas e.g. gliclazide for diabetes
• ciclosporin or tacrolimus or Muromonab-CD3 to suppress the immune system and stop the rejection of organs after transplants
• haloperidol (an antipsychotic drug) or lithium for mental health problems
• zalcitabine, ritonavir or zidovudine to treat viral infections
• cardiac glycosides e.g. digoxin (for heart failure and irregular heartbeat)
• pentoxifylline (for blood vessel disease and leg ulcers)
• antacids (used to relieve heartburn, upset stomach or acid indigestion)
• baclofen, a muscle-relaxant
• desmopressin used to control night-time bed wetting
• mifepristone for abortion. Indometacin capsules should not be taken within 8–12 days of taking mifepristone
• probenecid to treat gout
• tiludronic acid to treat bone disease.

Pregnancy and breast-feeding

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

Do not take Indometacin if you are in the last three months of your pregnancy. You should only take Indometacin capsules in first six months of pregnancy or if you are breast-feeding under medical supervision. Always ask your doctor before taking any medicine.

Driving and using machines

Indometacin may cause dizziness, drowsiness, light-headedness, vertigo, tiredness or problems with your vision. If affected do not drive or operate machinery.

Indometacin contains Lactose

These capsules contain a sugar called lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take indometacin

Always take Indometacin capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. These capsules should be swallowed whole with or after food, milk or an antacid (a treatment for indigestion or heartburn).

Dosage

Your doctor will decide your dose, as it depends on your condition. You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. This may reduce the chance of side effects from occurring.

Adults:

Acute Rheumatoid Arthritis: typical dose is 25 mg two to three times a day.

Long term joint disorder: typical dose is 25 mg two to three times a day followed by a gradual increase of 25 mg a day if necessary. The usual maximum daily dose is 150 mg. Your doctor will decide the best dose for you.

Sudden flare up of long term condition: up to 150–200 mg a day. Your doctor will decide the best dose for you.

Acute Muscle and bone disorders: typical dose is 50 mg two or three times a day, according to severity for 10–14 days.

Normally 150 mg daily, rarely 200 mg daily.

Lower back pain: 50 mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.

Acute attack of gout: 50 mg three or four times daily until symptoms subside.

After muscle or bone surgery: 100–150 mg daily in divided doses, to be taken until symptoms decrease

Painful periods: Up to a maximum of 75 mg a day can be taken at the start of period pain for a few days until the pain lasts.

Elderly: Your doctor will prescribe the lowest dose needed to treat your symptoms. He or she may wish to monitor your progress to make sure there is no bleeding in your stomach or intestines.

Use in Children: Not recommended for children

If you take more Indometacin than you should

Contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and the medicine pack with you so they know what has been taken.

Symptoms of overdose include; feeling or being sick, headache, abdominal pain and bleeding in the stomach, diarrhoea, dizziness, drowsiness, fainting, disorientation, excitement, coma, numbness, fits, ringing or buzzing in the ear, kidney failure, liver damage.

If you forget to take Indometacin

Don’t worry; just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. possible side effects

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

If you get any of the following serious side effects, STOP TAKING this medicine and seek immediate medical help:

• pass blood in your stools, pass black tarry stools, vomit blood or dark particles that look like coffee grounds. These symptoms may indicate bleeding in the stomach or intestines.
• an allergic reaction

Allergic reactions may cause:

• wheezing, asthma, difficulty breathing or shortness of breath, swelling and irritation inside the nose
• swelling of eyelids, lips, tongue, throat, hands, feet or ankles
• indigestion, heartburn, aches and pains in the stomach area. These symptoms may indicate an ulcer in the stomach or intestines
• aseptic meningitis which may cause stiff neck, headache, vomiting, nausea, 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
• inflammation, damage or failure of the kidneys
• sugar, protein or blood in your urine
• altered liver function
• inflammation of the liver (hepatitis) which may cause loss of appetite, abdominal discomfort, dark urine and yellowing of the skin and whites of the eyes (jaundice)
• change in level of other types of blood cells that may cause bleeding, bruising, fever, frequent infections or sore throats.

Tell your doctor as they may wish to test your blood

• nosebleeds, blood clotting throughout the body, disturbance of blood count, reduction in blood cell production by the bone marrow
• ringing in the ears, hearing disturbances including rarely deafness
• inflammation of the optic nerve that may cause sudden loss in vision or pain on movement of the eye
• inflammation of the pancreas, which can cause severe pain in the abdomen and back
• bleeding from the vagina
• blister on the skin that are red, flaky or peeling, such as severe rash involving reddening, peeling, swelling of the skin, that resembles sever skin burns (toxic epidermal necrolysis), circular irregular red patches on the skin of the hands and arms (erythema multiforme) sever skin rash with flushing fever blisters or ulcers (Stevens Johnson syndrome).
• flushing, fluid retention, low or high blood pressure (hypotension or hypertension)
• chest pain, or a fast or irregular heartbeat, palpitations
• heart failure, or a small increased risk of heart attack or stroke
• reduction in red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness
• high levels of potassium (hyperkalaemia) or sugar (hyperglycaemia) in the blood

Effects on the brain and central nervous system:

• depression, anxiety, disorientation, hallucinations, confusion, nervousness, lack of self-awareness
• a feeling of dizziness or spinning (vertigo)
• speech problems
• numbness or tingling, involuntary movements, fits, worsening of epilepsy or Parkinson’s disease
• feeling unwell, tiredness, weakness, difficulty sleeping, headache, dizziness, drowsiness, light-headedness, loss of conscious, build up of fluid in the brain, coma

Effects on the eye:

• blurred vision, double-vision
• pain in and around the eye
• deposits on the front surface of the eye (cornea), disorders of the back surface of the eye (retina)
• tinnitus or hearing disturbances
• painful inflamed mouth ulcers
• loss of appetite, feeling or being sick, diarrhoea, gas, constipation, anorexia
• developing or worsening of ulcerative colitis or Crohn’s disease
• inflammation of the lining of the stomach or a portion of the small intestine, an obstruction in the intestines
• worsening of psoriasis
• hair loss, sweating
• itching, rash
• tender red lumps under the skin
• sensitivity to sunlight or artificial light (e.g. sun beds)
• muscle weakness, accelerated deterioration of cartilage

Effects on the breasts and reproductive system:

• enlargement or tenderness of the breasts, breast development in men.
• vaginal bleeding

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 Yellow Card Scheme or search for MHRA Yellow Card in the Google App or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store indometacin

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the package or container. 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 to protect the environment.

6. contents of the pack and other information

What Indometacin capsules contain

The active ingredient in Indometacin capsules is indometacin. The other ingredients are: Indometacin 25 mg Capsules: lactose, sodium laurilsulfate, magnesium stearate, anhydrous colloidal silica, gelatin, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), shellac.

Indometacin 50 mg Capsules: lactose, sodium laurilsulfate, magnesium stearate, anhydrous colloidal silica, gelatin, quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171), black iron oxide (E172), shellac.

What Indometacin capsules look like and contents of the pack

Indometacin 50 mg capsules are ivory capsules with the marking MP72 printed in black ink.

The capsules come in blisters packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited, 41–43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

• 84 Pembroke Road, London, W8 6NX, UK