DOMILGAN 1000 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Domilgan, 1000 mg, powder for oral solution, in a sachet
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Domilgan and what is it used for
4. Important information before taking Domilgan
   1. When not to take Domilgan
   2. Warnings and precautions
   3. Children and adolescents
   4. Domilgan and other medicines
   5. Domilgan with food, drinks, or alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Domilgan contains sodium
   9. Domilgan contains glucose
   10. Domilgan contains 3.27 g of mannitol (E421) in one sachet
5. How to take Domilgan
   1. Use in children and adolescents
   2. Overdose of Domilgan
   3. Missed dose of Domilgan
6. Possible side effects
   1. You should stop taking the medicine and seek medical attention immediately in case of severe allergic reactions (anaphylaxis):
   2. You should stop taking the medicine and consult your doctor if you experience any of the following side effects:
   3. Other side effects
   4. Reporting side effects
7. How to store Domilgan
8. Contents of the packaging and other information
   1. What Domilgan contains
   2. What Domilgan looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. Other sources of information

Leaflet attached to the packaging: patient information

Domilgan, 1000 mg, powder for oral solution, in a sachet

Metamizole sodium monohydrate
Domilgan may cause a severely decreased number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).
You should stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth ulcers, or ulcers in the nose, mouth, throat, genital, or anal area.
If the patient has ever had agranulocytosis while taking metamizole or similar medicines, they should never take this medicine again (see section 2).

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Domilgan and what is it used for
• 2. Important information before taking Domilgan
• 3. How to take Domilgan
• 4. Possible side effects
• 5. How to store Domilgan
• 6. Contents of the packaging and other information

1. What is Domilgan and what is it used for

The active substance of Domilgan is metamizole, a pyrazolone derivative with analgesic and antipyretic effects.
Even in high doses, metamizole does not affect intestinal peristalsis and does not cause constipation.
Domilgan is indicated for short-term treatment of severe pain of various origins and fever, when the use of other medicines is contraindicated or ineffective in:

• headaches,
• migraines,
• toothaches,
• muscle and joint pain,
• post-traumatic and post-operative pain,
• renal colic,
• biliary colic,
• pain in cancer patients,
• fever.

2. Important information before taking Domilgan

When not to take Domilgan

• if the patient has a history of significantly decreased white blood cell count with granulocytopenia caused by metamizole or other similar medicines called pyrazolones or pyrazolidines,
• if the patient has bone marrow disorders or diseases that affect the production or function of blood cells,
• if the patient is allergic to metamizole and other pyrazolone and pyrazolidine derivatives, such as propyphenazone, phenazone, or phenylbutazone (medicines with analgesic, antipyretic, and anti-inflammatory effects), especially if agranulocytosis (a severe, life-threatening decrease in granulocytes in the blood) occurred after taking any of these medicines or any of the other ingredients of this medicine (listed in section 6),
• if the patient has analgetic asthma syndrome or intolerance to painkillers, manifested by urticaria, angioedema, or anaphylactoid reaction (similar to an allergic reaction) to salicylates, paracetamol, or other non-opioid analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, indomethacin, or naproxen, or hypersensitivity to NSAIDs,
• severe kidney and liver diseases,
• acute porphyria,
• after cytostatic treatment (medicines used in cancer chemotherapy),
• if blood tests show changes (agranulocytosis, leukopenia),
• if the patient has anemia,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase,
• with other medicines from the pyrazolone group (aminophenazone, phenylbutazone, oxyphenbutazone),
• in children and adolescents under 15 years of age,
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before taking Domilgan, you should discuss it with your doctor, pharmacist, or nurse if you have:

• hypotension (blood pressure below 100 mmHg) or heart disease and circulatory disorders (e.g., heart attack, coronary artery disease, or multiple organ injuries), cerebral vasospasm, decreased blood volume, dehydration, high fever, as the medicine may cause a decrease in blood pressure,
• kidney or liver failure,
• peptic ulcer disease,
• asthma or analgetic asthma or intolerance to painkillers, manifested by urticaria, angioedema of the face, lips, tongue, and/or throat, especially if accompanied by nasal polyposis and sinusitis,
• allergic diseases, including atopic diseases, chronic urticaria,
• intolerance to certain dyes (e.g., tartrazine) or preservatives (e.g., benzoates),
• alcohol intolerance, manifested by sneezing, tearing, and severe flushing of the face in response to even small amounts of alcohol; this may indicate previously undiagnosed analgetic asthma.

You should stop taking the medicine and consult your doctor immediately if you experience:

• agranulocytosis, manifested by fever, chills, sore throat, and painful mouth ulcers, especially in the mouth, nose, throat, genital, or anal area. Patients who have had agranulocytosis in response to metamizole sodium monohydrate are particularly at risk of a similar reaction to other pyrazolones and pyrazolidines;
• thrombocytopenia (decreased platelet count), manifested by petechiae, ecchymoses, or recurrent bleeding from the gums, nose, gastrointestinal tract;
• pancytopenia (significant decrease in all blood cell types: red and white blood cells and platelets), manifested by general malaise, fever, frequent infections, ecchymoses, bleeding, or pallor.

If you experience any of the above symptoms, you should never take metamizole again!
In case of metamizole administration, your doctor will necessarily perform blood tests, as metamizole may cause bone marrow damage.
In cancer patients taking metamizole, blood morphology should be monitored.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with metamizole treatment. If you experience any of these severe skin reactions, you should stop taking metamizole and seek medical attention immediately.
If you have ever had severe skin reactions, you should never take Domilgan again (see section 4).

Children and adolescents

Domilgan is contraindicated in children and adolescents under 15 years of age due to the constant content of metamizole in one sachet of 1000 mg. Other pharmaceutical forms or strengths of metamizole-containing medicines are available for smaller children.

Domilgan and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Domilgan with medicines from the pyrazolone and pyrazolidine group (aminophenazone, phenylbutazone, oxyphenbutazone) is contraindicated. These are medicines with analgesic, antipyretic, and anti-inflammatory effects.
Before taking this medicine, you should consult your doctor if you are taking:

• anticoagulant medicines, coumarin derivatives,
• oral antidiabetic medicines,
• phenytoin (an antiepileptic medicine),
• sulfonamides (antibacterial medicines),
• antidepressant medicines,
• oral contraceptives and allopurinol, as they may slow down the metabolism of metamizole sodium monohydrate and increase its toxicity,
• cyclosporin (an immunosuppressant medicine used, among other things, to prevent transplant rejection). Metamizole sodium monohydrate may decrease cyclosporin blood levels. When concomitantly used, the dose of metamizole sodium monohydrate should be adjusted.
• barbiturates (e.g., phenobarbital - a medicine used, among other things, in epilepsy), barbiturates decrease the effect of metamizole sodium monohydrate.
• monoamine oxidase inhibitors (MAOIs) (e.g., selegiline, moclobemide - medicines used, among other things, in depression). MAOIs enhance the effect of metamizole.
• used, among other things, in depression). MAOIs enhance the effect of metamizole.
• chlorpromazine (a medicine used, among other things, in schizophrenia). Concomitant use of metamizole sodium monohydrate and chlorpromazine may cause severe hypothermia.
• metamizole sodium monohydrate may increase the hematotoxicity of methotrexate, especially in elderly patients. Concomitant use of these two medicines should be avoided.
• in the case of pyrazolone derivatives, to which metamizole sodium monohydrate belongs, interactions with captopril, lithium, and triamterene may occur. These medicines may alter the effectiveness of blood pressure-lowering medicines and diuretics. It is not known whether metamizole sodium monohydrate also causes such interactions;
• bupropion, a medicine used in depression or as an aid to smoking cessation,
• efavirenz, a medicine used in HIV infection (AIDS) treatment,
• methadone, a medicine used in opioid dependence treatment,
• valproate, a medicine used in epilepsy or bipolar disorder treatment,
• tacrolimus, a medicine used to prevent transplant rejection,
• sertraline, a medicine used in depression treatment.

Metamizole may decrease the effect of acetylsalicylic acid on platelets. Caution should be exercised when concomitantly using acetylsalicylic acid for heart disease prevention.

Domilgan with food, drinks, or alcohol

The medicine should be taken during or immediately after meals.
Alcohol may affect the efficacy of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Available data on the use of metamizole in the first three months of pregnancy are limited but do not indicate a harmful effect on the fetus. In selected cases, if there are no other treatment options, after consulting a doctor or pharmacist, the patient may take single doses of metamizole in the first and second trimester, provided that the benefits and risks associated with taking the medicine are carefully weighed. As a rule, metamizole administration in the first and second trimester is not recommended.
You should not take Domilgan in the last three months of pregnancy due to the increased risk of complications in the mother and child (bleeding, premature closure of the ductus arteriosus in the unborn child, which normally closes after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed child cannot be excluded. Therefore, you should avoid repeated use of metamizole during breastfeeding.
In the case of single-dose administration of metamizole, you should recommend that mothers discard and discard breast milk for 48 hours after taking the medicine.

Driving and using machines

Within the recommended dose range, no impairment of concentration and reaction time has been observed. However, as a precaution, you should consider the possibility of impaired concentration and reaction time, especially when taking higher doses, and avoid operating machinery, driving, or performing activities that involve risk.

Domilgan contains sodium

One sachet of the medicine contains 82.7 mg of sodium (the main component of common salt). This corresponds to 4.14% of the maximum recommended daily intake of sodium in the diet for adults.

Domilgan contains glucose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Domilgan contains 3.27 g of mannitol (E421) in one sachet

The medicine may have a mild laxative effect.

3. How to take Domilgan

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The dose depends on the severity of the pain or fever and the individual's response to Domilgan. You should always choose the smallest dose necessary to control the pain and fever. Your doctor will tell you how to take Domilgan.
Adults and adolescents over 15 years old (with a body weight over 53 kg)can take 1 sachet as a single dose, not more than four times a day, at intervals of 6-8 hours. The maximum daily dose for adults and adolescents over 15 years old is 4 sachets of the powder for oral solution (corresponding to 4000 mg of metamizole).
Domilgan should not be taken by adolescents under 15 years old and children, as other pharmaceutical forms containing a smaller amount of the active substance are required (see also "When not to take Domilgan" in section 2).
Method of administration:
The medicine should be taken during or immediately after meals. The contents of the sachet should be dissolved in a glass of water and taken immediately after dissolution, within 5 minutes.
The dissolved medicine that has not been taken within 5 minutes should be discarded.
Elderly patients and patients in poor general health or with kidney failure
In elderly patients, weakened patients, and patients with impaired kidney function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.
Patients with kidney or liver impairment
Due to the decreased elimination rate in patients with kidney or liver impairment, you should avoid repeated administration of high doses. In the case of short-term use, dose reduction is not required. There is a lack of experience with long-term use.

Use in children and adolescents

Domilgan should not be taken by children and adolescents under 15 years old (see also "When not to take Domilgan" in section 2).

Overdose of Domilgan

In case of overdose, you should immediately consult your doctor or pharmacist.
Symptoms of overdose:
Dizziness, tinnitus, hearing disturbances, psychomotor agitation, impaired consciousness, coma, seizures, or decreased blood pressure, arrhythmias (tachycardia). Overdose of metamizole sodium monohydrate may also cause abdominal pain, vomiting, gastric and duodenal ulcers, bleeding, perforation (rupture of the wall of an internal organ), liver cell damage, interstitial nephritis, and renal tubular necrosis, as well as anaphylactic shock. Anaphylactic shock is a life-threatening allergic reaction that can cause confusion, weakness, and loss of consciousness.
There have been reports of rash, urticaria, angioedema, and toxic epidermal necrolysis (Lyell's syndrome). After taking very high doses, the excretion of rubazonic acid may cause red discoloration of the urine.
There is also a possibility of blood and hematopoietic system disorders, such as leukopenia (decreased white blood cell count), thrombocytopenia (decreased platelet count), bone marrow damage, or anemia due to impaired hematopoietic function of the bone marrow.
There is no antidote for metamizole sodium monohydrate.
In case of overdose, you should immediately consult your doctor. Symptomatic and supportive treatment may be necessary.

Missed dose of Domilgan

You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, Domilgan can cause side effects, although not everybody gets them.
You should stop taking Domilgan and seek medical attention immediately if you experience any of the following symptoms:
Malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes, itching, rash, or pain in the upper abdomen. These may be symptoms of liver damage. See also section 2 "Warnings and precautions".

You should stop taking the medicine and seek medical attention immediately in case of severe allergic reactions (anaphylaxis):

Rarely (may occur in less than 1 in 1,000 patients):

• facial, lip, tongue, and/or throat edema, dyspnea, which may cause difficulty swallowing and breathing.
• asthma attack, bronchospasm, dyspnea, Very rarely (may occur in less than 1 in 10,000 patients):
• severe bronchospasm,
• skin and mucous membrane changes, such as itching, burning, redness, urticaria. Frequency not known (frequency cannot be estimated from the available data):
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, loss of consciousness).

You should stop taking the medicine and consult your doctor if you experience any of the following side effects:

Uncommon (may occur in less than 1 in 100 patients) side effects include:

• drug rash
• excessive decrease in blood pressure. Rare (may occur in less than 1 in 1,000 patients) side effects include:
• rash (e.g., maculopapular),
• seizure-like convulsions after high doses of the medicine, Very rare side effects include:
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome),
• thrombocytopenia (petechiae, bleeding),
• pancytopenia,
• agranulocytosis, manifested by high fever, chills, sore throat, and painful mouth ulcers, as well as inflammation of the mucous membranes in the mouth, nose, throat, genital, and anal areas, including cases resulting in death.
• analgetic asthma (see "When not to take Domilgan" in section 2),
• sudden worsening of kidney function with proteinuria, oliguria, or anuria,
• acute kidney failure,
• interstitial nephritis, Frequency not known (frequency cannot be estimated from the available data):
• liver damage, cholestasis (mechanical obstruction of bile flow), hepatitis, jaundice, increased liver enzyme activity in the blood -

hemolytic anemia (anemia caused by faster breakdown of red blood cells), hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency; aplastic anemia, bone marrow damage, sometimes fatal,

• rapid heartbeat, cyanosis,
• severe skin reactions: you should stop taking metamizole and seek medical attention immediately if you experience any of the following severe side effects:
• red, flat patches on the torso in a target-like shape or round, often with blisters in the center, exfoliative dermatitis, ulcers in the mouth, throat, nose, genital, and eye areas. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome).

Other side effects

You should consult your doctor if you experience any of the following side effects:
Rare (may occur in less than 1 in 1,000 patients) side effects include:

• leukopenia (decreased white blood cell count),
• thrombocytopenia. Very rare (may occur in less than 1 in 10,000 patients) side effects include:
• increased bilirubin levels in the blood. Frequency not known (frequency cannot be estimated from the available data):
• nausea, vomiting, abdominal pain, gastric irritation, diarrhea, dry mouth,
• headache, dizziness,
• decreased appetite,
• red discoloration of the urine (after taking very high doses of metamizole).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Domilgan

There are no special recommendations for the storage temperature of the medicinal product.
Store in the original packaging to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine if you notice any changes in the appearance of the powder.
Do not use this medicine after the expiry date stated on the sachet and carton after "EXP". The expiry date refers to the last day of the month.
The "Lot" abbreviation on the packaging indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Domilgan contains

Active substance:metamizole sodium monohydrate.
Each sachet contains 1000 mg of metamizole sodium monohydrate.
Excipients:mannitol (E421), sodium cyclamate, strawberry flavor, colloidal silica anhydrous.
Composition of strawberry flavor: cis-3-hexen-1-ol, 4-hydroxy-2,5-dimethyl-3-furanone, maltol, methyl cinnamate, ethyl 2-methylbutyrate, ethyl caproate, 2-methylvaleric acid, ethyl acetate, hex-2(trans)-en-1-ol, gamma-decalactone, dehydrated corn syrup, gum arabic (E414), silicon dioxide (E551).

What Domilgan looks like and contents of the pack

Domilgan, 1000 mg, is a white or almost white powder with a strawberry flavor, packaged in 4.5 g sachets made of polyethylene/aluminum/paper.
The packaging contains 6 or 20 sachets and a leaflet, in a cardboard box.

Marketing authorization holder

SOLINEA Sp. z o.o.
Elizówka, Szafranowa Street 6
21-003 Ciecierzyn
Poland
Phone: 81463-48-82

Manufacturer

CHEMAX PHARMA LTD
8A Goritsa Street, 1618 Sofia
Bulgaria

Date of last revision of the leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, www.urpl.gov.pl