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INDOMETACIN 100 MG SUPPOSITORIES

Active substance(s): INDOMETHACIN

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Indocid® 100 mg Suppositories

2703
13.07.15[4]

(Indometacin)
PATIENT INFORMATION LEAFLET
Read aII 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.
Your medicine will referred to as Indocid Suppositories throughout the
following leaflet.
In this leaflet:
1. What Indocid Suppositories are and what they are used for
2. Before you use Indocid Suppositories
3. How to use Indocid Suppositories
4. Possible Side Effects
5. How to store Indocid Suppositories
6. Further information
1. WHAT INDOCID SUPPOSITORIES ARE AND WHAT THEY ARE
USED FOR
Indocid Suppositories contain the active ingredient indometacin.
This belongs to a group of medicines known as ‘non-steroidal antiinflammatory agents’ or NSAlDs. These work by reducing the body’s ability
to produce Inflammation, which may cause pain and discomfort.
Your doctor has prescribed Indocid for you because you are suffering from
one of the following:
- Rheumatoid arthritis (disease mainly of the joints)
- Osteoarthritis (disease of the joints)
- Ankylosing spondylitis (a form of arthritis which mainly affects the back)
- Pain, inflammation, and swelling following orthopaedic surgery.
- Musculoskeletal disorders (muscles and bone disorders).
- Period pain.
- Low back pain.
- Disease of the hip joint.
- Acute gouty arthritis (a form of arthritis in which crystals build up in the
joints).
2. BEFORE YOU USE INDOCID SUPPOSITORIES
Do not use Indocid Suppositories
- If you are hypersensitive (allergic) to indometacin or any of the other
ingredients in Indocid Suppositories (for example, if you have
experienced breathing difficulties, skin rashes which look like nettle rash,
or a runny nose) or
- If you are hypersensitive to aspirin or another non-steroidal antiinflammatory medicine. A full list of the ingredients is in section 6 –
Further information.
- If you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have had two episodes of peptic ulcers,
stomach bleeding or perforation.
- If you are suffering from inflammation of the rectum causing soreness,
bleeding and sometimes a discharge of mucus and/or pus from your
anus.
- If you have polyps (soft fleshy swellings that grow inside the nose) in your
nose, associated with itching, nettle rash, wheezing, or swelling of the
face, lips, tongue and/or throat or difficulties in swallowing or breathing.

Risk of heart attack or stroke
Medicines such as Indocid may be associated with a small increased risk of
heart attack (‘Myocardial Infarction’) or stroke. Any risk is likely with high
doses and prolonged treatment. Do not exceed the recommended dose or
duration of treatment. 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 other medicines
Tell your doctor or pharmacist if you are taking any of the following:
- Aspirin or similar medicines.
- Other non-steroidal anti-inflammatory medicines including diflunisal.
- Anticoagulants, which thin the blood.
- A medicine for gout called probenecid.
- Methotrexate, a drug used in the treatment of cancer, severe skin
disease and rheumatoid arthritis.
- Cyclosporin, a drug used to prevent the body from rejecting a recent
organ or bone‐marrow transplant, and to treat severe skin disease and
rheumatoid arthritis.
- Lithium for treatment of mental disorders.
- Diuretics (water tablets).
- Cardiac glycosides, such as digoxin, medicines used in the treatment of
congestive heart failure and certain alterations of heart rhythm.
- Antihypertensive medicines for the treatment of high blood pressure.
- A nasal decongestant called phenylpropanolamine usually found in overthe-counter cold relief preparations.
- Corticosteroid drugs, including anti‐Inflammatory and replacement
therapies.
- Mifepristone, a treatment used in emergency for termination of
pregnancy.
- Antibiotics from the quinolone group of antibiotics.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine. If you
are pregnant or planning to become pregnant or if you are breastfeeding,
Indocid may make it more difficult to become pregnant. You should inform
your doctor if you are planning to become pregnant or if you have problems
becoming pregnant.
Driving and using machines
Indocid can cause headaches, dizziness, drowsiness and visual
disturbances in some people. If this happens to you, avoid activities which
require you to be alert; for example, driving a car and operating machinery.
3. HOW TO USE INDOCID SUPPOSITORIES
Always use Indocid Suppositories exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Suppositories must not be taken by the mouth.
They are to be placed in the rectum (back passage). Empty your bowels (if
necessary) before use. Remove the suppository from the foil and, lying on
your back or your side with your knees bent up, push the suppository
pointed end first - up into your back passage.
Lie still for a minute or so, and then wash your hands. The suppository
should remain in place and dissolve completely.
The amount you use will depend upon your condition.
Dosage:
The usual adult dosage is one suppository to be inserted into the rectum
once or twice a day. One should be used at bedtime and if another is
necessary it should be used in the morning.

Take special care with Indocid Suppositories
-

If you are epileptic
If you have Parkinson’s disease
If you have a psychiatric problem
If you have heart disease, high blood pressure or have a tendency for
fluid retention
If you are being treated for infection or you have a fever
If you know you suffer from asthma, digestive tract, liver or kidney
disease, diabetes or heart failure
If you have a problem with your blood clotting.
If you are having blood tests, make sure that the doctor doing them
knows that you are taking Indocid.
If you have rheumatoid arthritis your doctor may want to examine your
eyes at intervals during your treatment with Indocid. You should see your
doctor if you notice any change in your vision

Not recommended for use in children.
If you use more Indocid Suppositories than you should
If you use too many suppositories by mistake or someone else accidentally
uses your suppositories, contact your doctor immediately or go to the
nearest casualty department.
If you forget to use Indocid Suppositories
If you forget to take the suppository, take it as soon as you remember. If it
is nearly time for your next dose, just carry on with the next dose as normal.
Do not use an extra suppository to make up for forgotten doses.
If you stop using Indocid Suppositories
You should use Indocid Suppositories for as long as your doctor tells you
to. It may be dangerous to stop using them without your doctor’s advice.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Indocid can cause side effects although not everybody
gets them.
If you experience an allergic reaction, STOP TAKING the medicine and
seek immediate medical help:
Symptoms of allergic reactions are:
- Itching;
- Rashes;
- Sensitivity to sunlight;
- Loss of hair; swollen face, lips, tongue and throat;
- Difficulty in breathing and swallowing; inflammation of blood or lymph
glands (lymph glands are all over the body but are noticeable in the neck
and armpit when swollen as bean shaped);
- Severe light headedness or dizziness due to a rapid fall in blood
pressure.
- The allergic reaction may include problems with the liver, kidneys or
blood cells (see below for liver, kidney and blood problems).
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate medical
help:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like coffee grounds
STOP TAKING the medicine and tell your doctor if you experience:
- Indigestion or heartburn
- Abdominal pain (pains in your stomach) or other abnormal stomach
symptoms.
- Medicines such as Indocid may be associated with a small increased risk
of heart attack (‘Myocardial Infarction’) or stroke.

Other side effects:
- Bleeding from the vagina in women;
- Increased levels of sugar in the blood, sugar in the urine, high levels of
potassium in the blood, which are generally diagnosed by laboratory
tests;
- Flushing and sweating;
- Bleeding from the nose;
- Breast changes including enlargement and tenderness in men and
women;
- Ulcers in the lining of the mouth.
Side effects associated with the use of Indocid suppositories
- Bleeding, inflammation, burning pain, discomfort, itching or the feeling of
a full back passage.
Laboratory tests
Misleading results have been seen with patients having a Dexamethasone
suppression test (DST) while using this medicine.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any side effects not listed in this leaflet. You can also report side
effects directly via: Yellow Card Scheme Website:
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 INDOCID SUPPOSITORIES
Keep out of the sight and reach of children.
Do not use Indocid Suppositories after the expiry date which is stated on
the carton.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.

Other side effects include:
Problems with the central nervous system:
- Headache, dizziness, light-headedness, depression, vertigo (sensation
that things around you are moving) and tiredness (including feeling
unwell and listlessness).
- Reactions reported infrequently include anxiety, confusion, fainting,
drowsiness, fits, coma, peripheral neuropathy which may be experienced
as loss of sensation, numbness, tingling, and pricking sensations,
sensitivity to touch, or muscle weakness, involuntary muscle movements,
sleeplessness, hallucinations (seeing or hearing things that are not
there), mental disorders including a loss of personal identity. Rarely, pins
and needles, speech problems, worsening of epilepsy and parkinsonism
symptoms (symptoms that mimic those of Parkinson’s disease such as
tremor or abnormal movements).
If these side effects are severe you may need to stop treatment with this
medicine. You should talk to your doctor.
Problems with the digestive system:
- The most frequent reactions are nausea, loss of appetite, vomiting,
trapped wind, constipation, and diarrhoea.
- Reactions reported infrequently include inflammation of the mouth and
stomach, wind, narrowing and/or obstruction of the intestines which may
be seen as a swollen abdomen, and vomiting.
Liver disorders:
- Rarely, inflammation of the liver and jaundice, symptoms of which may be
yellowing of the eyes and skin.
Heart and kidney disorders:
- High or low blood pressure, abnormal heartbeat, chest pain, palpitations,
heart failure, kidney problems which can lead to water retention,
reduction in the amount of urine passed, protein and blood in the urine,
increased levels of urea in the blood.
- These changes in urine and blood composition would normally be picked
up in urine or blood tests.
Blood disorders:
- Infrequently, blood disorders which are usually detected in blood tests,
but may be seen as pale skin, tiredness, fever, sore throat and mouth,
small red spots on the skin, bruising or prolonged bleeding after Injury.
Blood disorders such as leucopenia and anaemia may be seen with
symptoms of severe chills, mouth ulcers, headache, shortness of breath
and dizziness.
Eye disorders:
- Infrequently, blurred vision, double vision, pain in the eye and other visual
disturbances.
Problems with the ear:
- Ringing in the ears and other hearing disturbances, including deafness
rarely.

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 Indocid Suppositories contain
The active ingredient in Indocid Suppositories is indometacin.
Each suppository contains 100 mg indometacin.
Indocid Suppositories also contain:
Macrogol 3350, macrogol 8000, butylhydroxyanisole (E320),
butylhydroxytoluene (E321), edetic acid, glycerol, purified water.
What Indocid Suppositories looks like and the contents of the pack
Indocid Suppositories are white to slight yellow torpedo shaped
suppositories and are available in packs of 10.
Manufacturer and Product Licence holder
Manufactured by Famar S.A, 49th klm, National Road Athens - Lamia,
19011 Avlona, Greece.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2703

Leaflet revision and issue date (Ref) 13.07.15[4]
Indocid is a trademark of Merck Sharp & Dohme Corp.

Indometacin 100 mg Suppositories

2703
13.07.15[4]

PATIENT INFORMATION LEAFLET
Read aII 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.
Your medicine will referred to as Indometacin Suppositories throughout the
following leaflet.
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 contain the active ingredient indometacin.
This belongs to a group of medicines known as ‘non-steroidal antiinflammatory agents’ or NSAlDs. These work by reducing the body’s ability
to produce Inflammation, which may cause pain and discomfort.
Your doctor has prescribed Indometacin for you because you are suffering
from one of the following:
- Rheumatoid arthritis (disease mainly of the joints)
- Osteoarthritis (disease of the joints)
- Ankylosing spondylitis (a form of arthritis which mainly affects the back)
- Pain, inflammation, and swelling following orthopaedic surgery.
- Musculoskeletal disorders (muscles and bone disorders).
- Period pain.
- Low back pain.
- Disease of the hip joint.
- Acute gouty arthritis (a form of arthritis in which crystals build up in the
joints).
2. BEFORE YOU USE INDOMETACIN SUPPOSITORIES
Do not use Indometacin Suppositories
- If you are hypersensitive (allergic) to indometacin or any of the other
ingredients in Indometacin Suppositories (for example, if you have
experienced breathing difficulties, skin rashes which look like nettle rash,
or a runny nose) or
- If you are hypersensitive to aspirin or another non-steroidal antiinflammatory medicine. A full list of the ingredients is in section 6 –
Further information.
- If you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have had two episodes of peptic ulcers,
stomach bleeding or perforation.
- If you are suffering from inflammation of the rectum causing soreness,
bleeding and sometimes a discharge of mucus and/or pus from your
anus.
- If you have polyps (soft fleshy swellings that grow inside the nose) in your
nose, associated with itching, nettle rash, wheezing, or swelling of the
face, lips, tongue and/or throat or difficulties in swallowing or breathing.

Take special care with Indometacin Suppositories
-

If you are epileptic
If you have Parkinson’s disease
If you have a psychiatric problem
If you have heart disease, high blood pressure or have a tendency for
fluid retention
If you are being treated for infection or you have a fever
If you know you suffer from asthma, digestive tract, liver or kidney
disease, diabetes or heart failure
If you have a problem with your blood clotting.
If you are having blood tests, make sure that the doctor doing them
knows that you are taking Indometacin.
If you have rheumatoid arthritis your doctor may want to examine your
eyes at intervals during your treatment with Indometacin. You should see
your doctor if you notice any change in your vision

Risk of heart attack or stroke
Medicines such as Indometacin may be associated with a small increased
risk of heart attack (‘Myocardial Infarction’) or stroke. Any risk is likely with
high doses and prolonged treatment. Do not exceed the recommended
dose or duration of treatment. 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 other medicines
Tell your doctor or pharmacist if you are taking any of the following:
- Aspirin or similar medicines.
- Other non-steroidal anti-inflammatory medicines including diflunisal.
- Anticoagulants, which thin the blood.
- A medicine for gout called probenecid.
- Methotrexate, a drug used in the treatment of cancer, severe skin
disease and rheumatoid arthritis.
- Cyclosporin, a drug used to prevent the body from rejecting a recent
organ or bone‐marrow transplant, and to treat severe skin disease and
rheumatoid arthritis.
- Lithium for treatment of mental disorders.
- Diuretics (water tablets).
- Cardiac glycosides, such as digoxin, medicines used in the treatment of
congestive heart failure and certain alterations of heart rhythm.
- Antihypertensive medicines for the treatment of high blood pressure.
- A nasal decongestant called phenylpropanolamine usually found in overthe-counter cold relief preparations.
- Corticosteroid drugs, including anti‐Inflammatory and replacement
therapies.
- Mifepristone, a treatment used in emergency for termination of
pregnancy.
- Antibiotics from the quinolone group of antibiotics.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine. If you
are pregnant or planning to become pregnant or if you are breastfeeding,
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.
Driving and using machines
Indometacin can cause headaches, dizziness, drowsiness and visual
disturbances in some people. If this happens to you, avoid activities which
require you to be alert; for example, driving a car and operating machinery.
3. HOW TO USE INDOMETACIN SUPPOSITORIES
Always use Indometacin Suppositories exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Suppositories must not be taken by the mouth.
They are to be placed in the rectum (back passage). Empty your bowels (if
necessary) before use. Remove the suppository from the foil and, lying on
your back or your side with your knees bent up, push the suppository
pointed end first - up into your back passage.
Lie still for a minute or so, and then wash your hands. The suppository
should remain in place and dissolve completely.
The amount you use will depend upon your condition.
Dosage:
The usual adult dosage is one suppository to be inserted into the rectum
once or twice a day. One should be used at bedtime and if another is
necessary it should be used in the morning.
Not recommended for use in children.
If you use more Indometacin Suppositories than you should
If you use too many suppositories by mistake or someone else accidentally
uses your suppositories, contact your doctor immediately or go to the
nearest casualty department.
If you forget to use Indometacin Suppositories
If you forget to take the suppository, take it as soon as you remember. If it
is nearly time for your next dose, just carry on with the next dose as normal.
Do not use an extra suppository to make up for forgotten doses.
If you stop using Indometacin Suppositories
You should use Indometacin Suppositories for as long as your doctor tells
you to. It may be dangerous to stop using them without your doctor’s
advice.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Indometacin can cause side effects although not
everybody gets them.
If you experience an allergic reaction, STOP TAKING the medicine and
seek immediate medical help:
Symptoms of allergic reactions are:
- Itching;
- Rashes;
- Sensitivity to sunlight;
- Loss of hair; swollen face, lips, tongue and throat;
- Difficulty in breathing and swallowing; inflammation of blood or lymph
glands (lymph glands are all over the body but are noticeable in the neck
and armpit when swollen as bean shaped);
- Severe light headedness or dizziness due to a rapid fall in blood
pressure.
- The allergic reaction may include problems with the liver, kidneys or
blood cells (see below for liver, kidney and blood problems).
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate medical
help:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like coffee grounds
STOP TAKING the medicine and tell your doctor if you experience:
- Indigestion or heartburn
- Abdominal pain (pains in your stomach) or other abnormal stomach
symptoms.
- Medicines such as Indometacin may be associated with a small
increased risk of heart attack (‘Myocardial Infarction’) or stroke.

Other side effects:
- Bleeding from the vagina in women;
- Increased levels of sugar in the blood, sugar in the urine, high levels of
potassium in the blood, which are generally diagnosed by laboratory
tests;
- Flushing and sweating;
- Bleeding from the nose;
- Breast changes including enlargement and tenderness in men and
women;
- Ulcers in the lining of the mouth.
Side effects associated with the use of Indometacin suppositories
- Bleeding, inflammation, burning pain, discomfort, itching or the feeling of
a full back passage.
Laboratory tests
Misleading results have been seen with patients having a Dexamethasone
suppression test (DST) while using this medicine.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any side effects not listed in this leaflet. You can also report side
effects directly via: Yellow Card Scheme Website:
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 sight and reach of children.
Do not use Indocid Suppositories after the expiry date which is stated on
the carton.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.

Other side effects include:
Problems with the central nervous system:
- Headache, dizziness, light-headedness, depression, vertigo (sensation
that things around you are moving) and tiredness (including feeling
unwell and listlessness).
- Reactions reported infrequently include anxiety, confusion, fainting,
drowsiness, fits, coma, peripheral neuropathy which may be experienced
as loss of sensation, numbness, tingling, and pricking sensations,
sensitivity to touch, or muscle weakness, involuntary muscle movements,
sleeplessness, hallucinations (seeing or hearing things that are not
there), mental disorders including a loss of personal identity. Rarely, pins
and needles, speech problems, worsening of epilepsy and parkinsonism
symptoms (symptoms that mimic those of Parkinson’s disease such as
tremor or abnormal movements).
If these side effects are severe you may need to stop treatment with this
medicine. You should talk to your doctor.
Problems with the digestive system:
- The most frequent reactions are nausea, loss of appetite, vomiting,
trapped wind, constipation, and diarrhoea.
- Reactions reported infrequently include inflammation of the mouth and
stomach, wind, narrowing and/or obstruction of the intestines which may
be seen as a swollen abdomen, and vomiting.
Liver disorders:
- Rarely, inflammation of the liver and jaundice, symptoms of which may be
yellowing of the eyes and skin.
Heart and kidney disorders:
- High or low blood pressure, abnormal heartbeat, chest pain, palpitations,
heart failure, kidney problems which can lead to water retention,
reduction in the amount of urine passed, protein and blood in the urine,
increased levels of urea in the blood.
- These changes in urine and blood composition would normally be picked
up in urine or blood tests.
Blood disorders:
- Infrequently, blood disorders which are usually detected in blood tests,
but may be seen as pale skin, tiredness, fever, sore throat and mouth,
small red spots on the skin, bruising or prolonged bleeding after Injury.
Blood disorders such as leucopenia and anaemia may be seen with
symptoms of severe chills, mouth ulcers, headache, shortness of breath
and dizziness.
Eye disorders:
- Infrequently, blurred vision, double vision, pain in the eye and other visual
disturbances.
Problems with the ear:
- Ringing in the ears and other hearing disturbances, including deafness
rarely.

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 ingredient in Indometacin Suppositories is indometacin.
Each suppository contains 100 mg indometacin.
Indometacin Suppositories also contain:
Macrogol 3350, macrogol 8000, butylhydroxyanisole (E320),
butylhydroxytoluene (E321), edetic acid, glycerol, purified water.
What Indometacin Suppositories looks like and the contents of the
pack
Indometacin Suppositories are white to slight yellow torpedo shaped
suppositories and are available in packs of 10.
Manufacturer and Product Licence holder
Manufactured by Famar S.A, 49th klm, National Road Athens - Lamia,
19011 Avlona, Greece.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2703

Leaflet revision and issue date (Ref) 13.07.15[4]

Expand view ⇕

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.

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