INDOXEN 25 mg Hard Capsules

Зміст інструкції

1. Indoxen 25 mg capsule, 50 mg capsule
   1. What is Indoxen and what is it used for
   2. What you need to know before taking Indoxen
   3. How to take Indoxen
   4. Possible side effects
   5. How to store Indoxen
   6. Contents of the pack and other information
2. Indoxen 50 mg suppositories, 100 mg suppositories
   1. What is Indoxen and what is it used for
   2. What you need to know before using Indoxen
   3. How to use Indoxen
   4. Possible side effects
   5. How to store Indoxen
   6. Contents of the pack and other information

Indoxen 25 mg capsule, 50 mg capsule

indometacin

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Indoxen is and what it is used for
• 2. What you need to know before you take Indoxen
• 3. How to take Indoxen
• 4. Possible side effects
• 5. How to store Indoxen
• 6. Contents of the pack and other information

1. What is Indoxen and what is it used for

Indoxen contains the active ingredient indometacin, which belongs to the class of non-steroidal
anti-inflammatory drugs (NSAIDs).
Indoxen is indicated in the treatment of numerous inflammatory and non-inflammatory conditions affecting
the musculoskeletal system, including:

• rheumatoid arthritis (a rheumatic disease)
• osteoarthritis (a chronic degenerative joint disease that mainly manifests in old age)
• gout (inflammation of the joints).

2. What you need to know before taking Indoxen

Do not take Indoxen

• if you are allergic to indometacin, acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6)
• if you are under 14 years of age
• if you have had episodes of bleeding from the stomach or intestines (gastrointestinal hemorrhage) or perforation after previous pharmacological treatments
• if you have had bleeding or lesions (ulcer) in the stomach in the past (two or more distinct episodes of demonstrated ulceration or bleeding)
• if you have a severe illness in which the heart is unable to pump enough blood to meet the needs of the body (severe heart failure)
• if you have particular, excessive and/or violent reactions of a non-allergic nature to various substances, for example medicines, foods, etc. (idiosyncratic manifestations)
• if you have psychiatric disorders
• if you have epilepsy
• if you have Parkinson's disease
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Indoxen.

Tell your doctor immediately if during treatment with Indoxen:

• you develop widespread and severe skin reactions, especially in the first weeks of treatment, because very rare, serious skin reactions have been reported that can also be fatal (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Indoxen must be discontinued at the first appearance of skin rash, mucous membrane lesions or any other sign of hypersensitivity.

Stop treatment and see your doctor if you experience these reactions:

• you experience any unusual symptoms in the stomach and intestines, especially at the beginning of treatment with this medicine;
• you experience eye problems as Indoxen can cause eye problems. If you have prolonged treatment, your doctor will have your eyes checked at regular intervals;
• you develop fluid retention and swelling from fluid accumulation (edema);
• you have a headache accompanied sometimes by dizziness or lightheadedness, especially if this occurs in the early stages of treatment with Indoxen. The intensity of these effects induces discontinuation of treatment, but if the headache persists despite reducing the dose, therapy with Indoxen should be discontinued.

You must consult your doctor before taking Indoxen:

• if you are elderly, because you may have undesirable effects, especially bleeding and perforations in the stomach and intestines which can be fatal (see section “Elderly patients”);
• if you have or have had problems with the upper part of the stomach and intestines, because Indoxen may not be suitable for you (see section “Do not take Indoxen”);
• if you are using medicines that can increase the risk of bleeding or ulcerations such as: medicines that reduce platelet aggregation, for example aspirin, non-steroidal anti-inflammatory drugs (corticosteroids administered orally), medicines that delay blood clotting (anticoagulants) e.g. warfarin, antidepressants (selective serotonin reuptake inhibitors) (see section “Other medicines and Indoxen”);
• if you have had inflammatory bowel diseases such as ulcerative colitis or Crohn's disease because these conditions may worsen;
• if you have an ongoing infection;
• if you are not adequately hydrated;
• if you have kidney problems;
• if you have liver problems;
• if you have or have had high blood pressure (hypertension);
• if you have had problems with blood circulation in the brain (e.g. stroke);
• if you have heart problems (congestive heart failure);
• if you are at risk of having heart, brain or blood vessel problems (e.g. if you have high blood pressure, diabetes, high cholesterol, smoke, etc.);
• if you are a woman and are planning a pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you are a woman and have fertility problems or are undergoing fertility investigations, because you should stop treatment with Indoxen (see section “Pregnancy, breastfeeding and fertility”).

Take special care:

• avoid using Indoxen together with other NSAIDs, including cyclooxygenase-2 (COX2) selective inhibitors, because it increases the possibility that you will have undesirable effects;
• undesirable effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Indoxen”);
• Indoxen can mask the signs of an infection;
• at any time during treatment with NSAIDs, including Indoxen, gastrointestinal bleeding (stomach and intestines), ulcers (lesions) or perforations can occur, which can also cause death.

Children and adolescents
Indoxen should not be used in patients under 14 years of age.

Elderly
Elderly patients are more likely to experience undesirable effects, especially
bleeding and perforation of the stomach or intestines which are generally more severe and can be
fatal.
If you are elderly, your doctor will prescribe a low dose of Indoxen.
As a precaution, your doctor may have your kidney and liver function checked and prescribe
medicines that act by protecting the gastrointestinal mucosa such as misoprostol or
proton pump inhibitors.
Tell your doctor about any unusual symptoms in the stomach and intestines, especially at the beginning of
treatment with this medicine.

Other medicines and Indoxen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking or have to take:

• probenecid (medicine for gout)
• furosemide (medicine that increases urine production)
• non-steroidal anti-inflammatory drugs (corticosteroids)
• medicines that delay blood clotting (anticoagulants) e.g. warfarin
• medicines that reduce platelet aggregation, for example aspirin
• antidepressants (selective serotonin reuptake inhibitors)
• medicines to lower blood pressure, especially when used in combination: diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Conception, first and second trimester of pregnancy
Do not take Indoxen if you are planning a pregnancy or are in the first or second trimester of pregnancy
without consulting your doctor. The doctor will assess whether the benefits for you clearly outweigh the risks
to the embryo or fetus.
Third trimester of pregnancy
Do not take Indoxen during the third trimester of pregnancy, as it may harm the fetus or cause
problems during childbirth. It can cause problems with the kidneys and heart of the fetus. It may affect the tendency
Yours and the baby's to bleed and delay or prolong labor more than expected. You should not
take Indoxen in the first 6 months of pregnancy unless
absolutely necessary and under medical advice. If you need treatment during this period
or during attempts to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, Indoxen can cause kidney problems in the fetus if taken for more than a few
days, thus reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing
narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need
treatment for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not use Indoxen during breastfeeding.

Driving and using machines
Indoxen can cause dizziness which may affect your ability to drive and use machines.
If you experience these symptoms, do not drive a vehicle or use machines.

Indoxen contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Indoxen

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will establish the most suitable dose for you based on the response to treatment and tolerance to the medicine,
starting with a low dose of Indoxen equal to 75 mg per day. If necessary, the doctor will gradually increase
the dose.
The recommended dose is 100-150 mg per day. The maximum dose is 200 mg per day:

• 1-2 25 mg capsules2-4 times a day, or
• 1 50 mg capsule2-4 times a day

Take the capsules whole, preferably with a full stomach.

Use in children and adolescents
Indoxen must not be used in patients under 14 years of age.

Use in elderly patients
If you are elderly, your doctor will tell you exactly what dose of Indoxen is suitable for you and will assess any
reduction of the above doses.

Use in patients with liver and kidney diseases
Indoxen must be used with particular caution in these patients.

If you take more Indoxen than you should
Follow exactly the doctor's instructions.
In case of accidental ingestion of an excessive dose of Indoxen, immediately inform your doctor or go to
the nearest hospital.

If you forget to take Indoxen
Do not take a double dose to make up for a missed dose.

If you stop taking Indoxen
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are:
headache
dizziness
lightheadedness
mental confusion
syncope (fainting)
drowsiness
convulsions
coma
depression
feeling of unreality (psychiatric disorder)
formation of blood clots causing heart attack or stroke
edema (fluid retention)
high blood pressure (hypertension)
heart problems (heart failure)
peptic ulcer (stomach lesion)
gastrointestinal perforation (of the stomach or intestine)
gastrointestinal bleeding (bleeding of the stomach or intestine)
nausea
vomiting
diarrhea
flatulence (gas production in the abdomen)
constipation
dyspepsia (indigestion)
abdominal pain
melena (blood in the stool)
hematemesis (vomiting blood)
ulcerative stomatitis (mouth sores)
exacerbation of colitis and Crohn's disease (worsening of inflammatory bowel diseases)
gastritis (inflammation of the stomach)
jaundice (yellowing of the skin and eyes)
hepatitis (inflammation of the liver)
itching
urticaria (skin rash)
skin disease characterized by the formation of nodules (erythema nodosum)
inflammation of blood vessels (angitis)
skin swelling (angioedema)
skin redness (erythema)
severe skin reactions (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis)
hair loss
dyspnea (difficulty breathing)
asthma
leukopenia (reduction in the number of white blood cells)
purpura (red spots on the skin)
aplastic anemia (insufficient production of blood cells by the bone marrow)
hemolytic anemia (destruction of red blood cells)
thrombocytopenia (reduction in the number of platelets)
agranulocytosis (reduction in the number of a type of white blood cells)
depression of bone marrow activity
secondary anemia and bleeding from the stomach or intestine, manifest or occult
blurred vision
orbital and periorbital pain (eye pain)
visual problems (corneal deposits, retinal and macular alterations)
tinnitus
hearing loss
vaginal bleeding
hyperglycemia (increased blood sugar levels)
glycosuria (presence of glucose in the urine)
ulcerative stomatitis (mouth sores)
epistaxis (nosebleed)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Indoxen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.” (Expiry). The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Indoxen contains

• The active ingredient is indometacin. Each capsule contains 25 mg or 50 mg of indometacin.
• The other ingredients are lactose, lecithin, silica, magnesium stearate.
• The capsule components are gelatin, titanium dioxide, black iron oxide (only for the 25 mg capsules), indigotine, yellow iron oxide (only for the 50 mg capsules).

Description of the appearance of Indoxen and contents of the pack
Each pack contains 25 capsules of 25 mg or 25 capsules of 50 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)

Indoxen 50 mg suppositories, 100 mg suppositories

indometacin

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Indoxen is and what it is used for
• 2. What you need to know before using Indoxen
• 3. How to use Indoxen
• 4. Possible side effects
• 5. How to store Indoxen
• 6. Contents of the pack and other information

1. What is Indoxen and what is it used for

Indoxen contains the active ingredient indometacin, which belongs to the class of non-steroidal
anti-inflammatory drugs (NSAIDs).
Indoxen is indicated in the treatment of numerous inflammatory and non-inflammatory conditions affecting
the musculoskeletal system, including:

• rheumatoid arthritis (a rheumatic disease)
• osteoarthritis (a chronic degenerative joint disease that mainly manifests in old age)
• gout (inflammation of the joints).

2. What you need to know before using Indoxen

Do not use Indoxen

• if you are allergic to indometacin, acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6)
• if you are under 14 years of age
• if you have had episodes of bleeding from the stomach or intestines (gastrointestinal bleeding) or perforation after previous pharmacological treatments
• if you have had bleeding or lesions (ulcer) in the stomach in the past (two or more distinct episodes of demonstrated ulceration or bleeding)
• if you have a severe condition in which the heart is unable to pump enough blood to meet the needs of the body (severe heart failure)
• if you have particular, excessive and/or violent reactions of a non-allergic nature to various substances such as medicines, foods, etc. (idiosyncratic manifestations)
• if you have psychiatric disorders
• if you have epilepsy
• if you have Parkinson's disease
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding
• inflammatory disease of the anus and rectum (proctitis).

Warnings and precautions
Talk to your doctor or pharmacist before using Indoxen.

Immediately inform your doctor if during treatment with Indoxen:

• you develop widespread and severe skin reactions, especially in the first weeks of treatment, because very rarely serious skin reactions have been reported that can also be fatal (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Indoxen should be discontinued at the first appearance of skin rash, mucous membrane lesions or any other sign of hypersensitivity.

Stop treatment and see your doctor if you experience these reactions:

• you experience any unusual symptoms in the stomach and intestines, especially at the beginning of treatment with this medicine;
• you experience eye problems as Indoxen can cause problems with the eyes. In case of prolonged treatment, your doctor will have your eyes examined at regular intervals;
• you develop fluid retention and swelling from fluid accumulation (edema);
• you have a headache accompanied sometimes by dizziness or lightheadedness, especially if this occurs in the early stages of treatment with Indoxen. The intensity of these effects induces discontinuation of treatment, but if the headache persists despite reducing the dose, therapy with Indoxen should be discontinued. Consult your doctor before using Indoxen:
• if you are elderly, because you may have undesirable effects, especially bleeding and perforations in the stomach and intestines which can be fatal (see section “Elderly patients”);
• if you have or have had problems with the upper part of the stomach and intestines, because Indoxen may not be suitable for you (see section “Do not use Indoxen”);
• if you are using medicines that can increase the risk of bleeding or ulcerations such as: o medicines that reduce platelet aggregation such as aspirin, o non-steroidal anti-inflammatory drugs (corticosteroids administered orally), o medicines that delay blood clotting (anticoagulants) e.g. warfarin, o antidepressants (selective serotonin reuptake inhibitors) (see section “Other medicines and Indoxen”);
• if you have had inflammatory bowel diseases such as ulcerative colitis or Crohn's disease because these conditions may worsen;
• if you have an ongoing infection;
• if you are not adequately hydrated;
• if you have kidney problems;
• if you have liver problems;
• if you have or have had high blood pressure (hypertension);
• if you have had problems with blood circulation in the brain (e.g. stroke);
• if you have heart problems (congestive heart failure);
• if you are at risk of having problems with your heart, brain or blood vessels (e.g. if you have high blood pressure, diabetes, high cholesterol, smoke, etc.);
• if you are a woman and are planning a pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you are a woman and have fertility problems or are undergoing fertility investigations, because you should stop treatment with Indoxen (see section “Pregnancy, breastfeeding and fertility”).

Pay particular attention:

• avoid using Indoxen together with other NSAIDs, including selective cyclooxygenase-2 (COX2) inhibitors, because it increases the possibility that you will have undesirable effects;
• undesirable effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to use Indoxen”);
• Indoxen can mask the signs of an infection;
• at any time during treatment with NSAIDs, including Indoxen, gastrointestinal bleeding (stomach and intestines), ulcerations (lesions) or perforations can occur, which can also cause death.

Children and adolescents
Indoxen should not be used in patients under the age of 14.

Elderly
Elderly patients are more likely to experience undesirable effects, especially
bleeding and perforation of the stomach or intestines which are usually more severe and can be
fatal.
If you are elderly, your doctor will prescribe a low dose of Indoxen.
As a precaution, your doctor may check your kidney function, liver function and prescribe
medicines that act by protecting the gastrointestinal mucosa such as misoprostol or
proton pump inhibitors.
Inform your doctor of any unusual symptoms in the stomach and intestines, especially at the beginning of
treatment with this medicine.

Other medicines and Indoxen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking or have to take:

• probenecid (medicine for gout)
• furosemide (medicine that increases urine production)
• non-steroidal anti-inflammatory drugs (corticosteroids)
• medicines that delay blood clotting (anticoagulants) e.g. warfarin
• medicines that reduce platelet aggregation such as aspirin
• antidepressants (selective serotonin reuptake inhibitors)
• medicines to reduce blood pressure, especially when used in combination: diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Conception, first and second trimester of pregnancy
Do not use Indoxen if you are planning a pregnancy or are in the first or second trimester of pregnancy without
consulting your doctor. The doctor will assess whether the benefits for you clearly outweigh the risks to
the embryo or fetus.
Third trimester of pregnancy
Do not use Indoxen during the third trimester of pregnancy, as it may harm the fetus or cause
problems during childbirth. It can cause problems with the kidneys and heart of the fetus. It may affect the tendency
Yours and the baby's to bleed and delay or prolong labor more than expected. You should not
take Indoxen in the first 6 months of pregnancy, unless absolutely necessary and under the advice of
the doctor. Where treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Indoxen can
cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid
surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus
arteriosus) in the baby's heart. Where treatment is needed for more than a few days, your doctor
may advise additional monitoring.
Breastfeeding
Do not use Indoxen during breastfeeding.

Driving and using machines
Indoxen can cause dizziness which may affect your ability to drive and use machines.
If you experience these symptoms, do not drive a vehicle or use machines.

Indoxen contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before using this
medicine.

3. How to use Indoxen

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the most suitable dose for you based on the response to treatment and tolerance to the medicine,
starting with a low dose of Indoxen equal to 75 mg per day. If necessary, your doctor will gradually increase
the dose.
The recommended dose is 100-150 mg per day. The maximum dose is 200 mg:

• 1 suppository of 50 mg2-4 times a day, or
• 1 suppository of 100 mg1-2 times a day

Use in children and adolescents
Indoxen must not be used in patients under 14 years of age.

Use in elderly patients
If you are elderly, your doctor will tell you exactly what the appropriate dose of Indoxen is for you and will assess any
reduction of the above doses.

Use in patients with liver and kidney diseases
Indoxen must be used with particular caution in these patients.

If you use more Indoxen than you should
Follow exactly the doctor's instructions.
In case of accidental ingestion of an excessive dose of Indoxen, immediately inform your doctor or go to the
nearest hospital.

If you forget to use Indoxen
Do not use a double dose to make up for a missed dose.

If you stop treatment with Indoxen
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are:
headache
dizziness
lightheadedness
mental confusion
syncope (fainting)
drowsiness
convulsions
coma
depression
feeling of unreality (psychiatric disorder)
formation of blood clots causing heart attack or stroke
edema (fluid retention)
high blood pressure (hypertension)
heart problems (heart failure)
peptic ulcer (stomach lesion)
gastrointestinal perforation (of the stomach or intestine)
gastrointestinal bleeding (bleeding of the stomach or intestine)
nausea
vomiting
diarrhea
flatulence (gas production in the abdomen)
constipation
dyspepsia (difficult digestion)
abdominal pain
melena (blood in the stool)
hematemesis (vomiting blood)
ulcerative stomatitis (mouth sores)
exacerbation of colitis and Crohn's disease (worsening of inflammatory bowel diseases)
gastritis (inflammation of the stomach)
jaundice (yellowing of the skin and eyes)
hepatitis (inflammation of the liver)
itching
urticaria (skin rash)
skin disease characterized by the formation of nodules (erythema nodosum)
inflammation of blood vessels (angitis)
skin swelling (angioedema)
skin redness (erythema)
severe skin reactions (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis)
hair loss
dyspnea (difficulty breathing)
asthma
leukopenia (reduction in the number of white blood cells)
purpura (red spots on the skin)
aplastic anemia (insufficient production of blood cells by the bone marrow)
hemolytic anemia (destruction of red blood cells)
thrombocytopenia (reduction in the number of platelets)
agranulocytosis (reduction in the number of a type of white blood cells)
depression of bone marrow activity
secondary anemia and bleeding of the stomach or intestine, manifest or occult
blurred vision
orbital and periorbital pain (eye pain)
visual problems (corneal deposits, retinal and macular alterations)
tinnitus
hearing loss
vaginal bleeding
hyperglycemia (increased amount of sugar in the blood)
glycosuria (presence of glucose in the urine)
ulcerative stomatitis (mouth sores)
epistaxis (nosebleed)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Indoxen

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Indoxen contains

• The active ingredient is indometacin. Each suppository contains 50 mg or 100 mg of indometacin.
• The other ingredients are edetic acid,  -tocopherol, solid semi-synthetic glycerides.

Description of the appearance of Indoxen and contents of the pack
Each pack contains 10 suppositories of 50 mg or 10 suppositories of 100 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)