Dialginum

Leaflet attached to the packaging: patient information

Dialginum, 500 mg, powder for oral solution, in a sachet

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

1. What is Dialginum and what is it used for

Dialginum is a pyrazolone derivative with analgesic and antipyretic effects, as well as weak spasmolytic effects.
Even in high doses, it does not affect intestinal peristalsis and does not cause constipation.
The Dialginum medicine 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 Dialginum

When not to take Dialginum

• if the patient has a history of significantly decreased white blood cell count (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), or to any of the excipients listed in section 6,
• if the patient has analgesic asthma or intolerance to painkillers, manifested by urticaria, angioedema, or anaphylactoid reactions (similar to allergic reactions) 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 therapy (cancer chemotherapy),
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase, or has taken other pyrazolone derivatives (aminophenazone, phenylbutazone, oxyphenbutazone),
• if the patient is in the last three months of pregnancy,
• children and adolescents under 15 years of age.

Warnings and precautions

Agranulocytosis (severely decreased number of white blood cells)
Dialginum may cause agranulocytosis, a severely decreased number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4).
You should stop taking metamizole and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful mouth ulcers, especially in the mouth, nose, and throat, or in the genital or anal area. Your doctor will order a blood test to check your blood cell count.
If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if the patient is taking antibiotics.
Agranulocytosis can develop at any time during Dialginum treatment, even after a short period of treatment.
Agranulocytosis can occur even if metamizole was previously taken without complications.
Patients who have developed agranulocytosis in response to metamizole treatment are particularly at risk of developing a similar reaction to other pyrazolones and pyrazolidines.
You should stop taking the medicine and contact your doctor immediately if you experience any of the following disorders:

• pancytopenia (significant decrease in the number of all blood cells: red and white blood cells and platelets), such as general malaise, fever, frequent infections, bruising, bleeding, or pallor.

In case of the above-mentioned symptoms, you should never take metamizole again!
Patients with cancer who are taking metamizole should have their blood morphology checked regularly.
Taking Dialginum should be discussed with your doctor if you have:

• diastolic blood pressure below 100 mmHg or heart disease and circulatory disorders (e.g., heart attack, coronary artery disease, or multiple organ injuries), cerebral vessel constriction, decreased circulating blood volume, dehydration, high fever, as the medicine may cause a decrease in blood pressure,
• kidney or liver failure,
• stomach or duodenal ulcers,
• bronchial asthma or analgesic asthma or intolerance to painkillers, manifested by urticaria, angioedema of the tongue, face, lips, 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 facial flushing in response to even small amounts of alcohol; this may indicate previously undiagnosed analgesic asthma.

Liver disorders
Patients taking metamizole have experienced cases of liver inflammation, with symptoms appearing within a few days to several months after starting treatment.
You should stop taking Dialginum and contact your doctor if you experience any liver disorders, such as malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. Your doctor will check your liver function.
You should not take Dialginum if you have previously taken any medicinal products containing metamizole and experienced liver disorders.
You should stop taking the medicine and seek medical help immediately if you experience any symptoms of anaphylactic (allergic) reactions, such as:

• facial, lip, tongue, and/or throat swelling, which can cause difficulty swallowing or breathing,
• severe bronchospasm,
• skin and mucous membrane changes, such as itching, burning, redness, urticaria,
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, fainting). Patients with a history of asthma or atopy (e.g., atopic dermatitis or mucosal allergies, hay fever, analgesic asthma) are at increased risk of developing anaphylactoid reactions to metamizole. If you experience any allergic reactions or other immune reactions to metamizole, you are also at risk of developing a similar reaction to other pyrazolones and pyrazolidines, as well as other non-opioid analgesics.

Severe skin reactions
Metamizole treatment has been associated with severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome). If you experience any of these severe skin reactions, you should stop taking metamizole and seek medical help immediately.
If you have ever experienced severe skin reactions, you should never take Dialginum again (see section 4).

Children and adolescents

Dialginum is contraindicated in children and adolescents under 15 years of age, as they require pharmaceutical forms containing a smaller amount of the active substance (see also "When not to take Dialginum" in section 2).

Dialginum 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.
It is contraindicated to take Dialginum with medicines from the pyrazolone and pyrazolidine group (aminophenazone, phenylbutazone, oxyphenbutazone). These are medicines with analgesic, antipyretic, and anti-inflammatory effects.
Before taking the medicine, you should inform your doctor about the use of:

• anticoagulant medicines, coumarin derivatives,
• oral antidiabetic medicines,
• phenytoin (an antiepileptic medicine),
• sulfonamides (antibacterial medicines),
• antidepressants,
• bupropion, a medicine used to treat depression or to help quit smoking,
• efavirenz, a medicine used to treat HIV infection (AIDS),
• methadone, a medicine used to treat opioid addiction,
• valproate, a medicine used to treat epilepsy or bipolar disorder,
• tacrolimus, a medicine used to prevent organ rejection in patients who have undergone a transplant,
• sertraline, a medicine used to treat depression,
• oral contraceptives and allopurinol, as they may slow down the metabolism of metamizole and increase its toxicity,
• cyclosporin (an immunosuppressant medicine, used, among other things, to prevent transplant rejection). Metamizole may decrease cyclosporin levels in the blood. When both medicines are taken together, the dose of metamizole may need to be adjusted.
• barbiturates (e.g., phenobarbital - a medicine used, among other things, to treat epilepsy), barbiturates decrease the effect of metamizole.
• monoamine oxidase inhibitors (MAOIs) (e.g., selegiline, moclobemide - medicines used, among other things, to treat depression). MAOIs enhance the effect of metamizole.
• used, among other things, to treat depression). MAOIs enhance the effect of metamizole.
• chlorpromazine (a medicine used, among other things, to treat schizophrenia). Concurrent use of metamizole and chlorpromazine may cause severe hypothermia.
• metamizole may increase the hematotoxicity of methotrexate, especially in elderly patients. It is recommended to avoid concurrent use of these two medicines.
• in the case of pyrazolone derivatives, to which metamizole belongs, interactions with captopril, lithium, and triamterene may occur. These medicines may change the effectiveness of blood pressure-lowering medicines and diuretics. There is no information on whether metamizole also causes such interactions.
• metamizole may decrease the effect of acetylsalicylic acid on platelets. Caution is advised when taking acetylsalicylic acid used to prevent heart disease.

Dialginum with food and drink or with 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 during the first 3 months of pregnancy are limited, but they do not indicate a harmful effect on the fetus. In selected cases, if there are no other treatment options, after consulting your doctor or pharmacist, you 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, taking metamizole in the first and second trimester is not recommended.
You should not take Dialginum 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, a vital blood vessel in the fetus that normally closes after birth).

Breastfeeding

Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed infant cannot be excluded. Therefore, it is recommended to avoid repeated use of metamizole during breastfeeding.
In the case of single administration of metamizole, it is recommended 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, especially when taking higher doses, you should consider the possibility of impaired concentration and reaction time and refrain from operating machinery, driving vehicles, or performing activities that involve risk.

Special warnings about excipients

Dialginum contains sodium

One sachet of the medicine contains 49.8 mg of sodium (the main component of common salt). This corresponds to 2.2% of the maximum recommended daily intake of sodium in the diet for adults.

Dialginum contains 3.775 g of mannitol (E421) in one sachet

The medicine may have a mild laxative effect.

Dialginum contains glucose (a component of the flavor)

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

3. How to take Dialginum

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 Dialginum. You should always choose the smallest dose necessary to control the pain and fever. Your doctor will tell you how to take Dialginum.
Adults and adolescents over 15 years of age or older (with a body weight over 53 kg)can take 1-2 sachets in a single dose, no more than four times a day. The maximum daily dose for adults and adolescents over 15 years of age is 8 sachets of powder for oral solution (corresponding to 4000 mg of metamizole).
Dialginum is contraindicated in adolescents under 15 years of age and in children, as they require pharmaceutical forms containing a smaller amount of the active substance (see also "When not to take Dialginum" 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 is not taken within 5 minutes should be discarded.
Elderly patients and patients in poor general health or with renal impairment
In elderly patients, weakened patients, and patients with impaired renal function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.

Patients with renal or hepatic impairment

Due to the decreased elimination rate in patients with renal or hepatic impairment, it is recommended to avoid repeated administration of high doses. In the case of short-term use, dose reduction is not required. There is no experience with long-term use.

Use in children and adolescents

Dialginum should not be used in children and adolescents under 15 years of age (see also "When not to take Dialginum" in section 2).

Overdose of Dialginum

In case of overdose, you should immediately consult your doctor or pharmacist.
Symptoms of overdose:
Dizziness, tinnitus, hearing disorders, psychomotor agitation, impaired consciousness, coma, seizures, or decreased blood pressure, cardiac arrhythmias (tachycardia). Overdose of metamizole 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, necrosis of the renal tubules, and bronchospasm.
There have been reports of rash, urticaria, angioedema, and toxic epidermal necrolysis. 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 (decrease in white blood cell count), thrombocytopenia (decrease in platelet count), bone marrow damage, or anemia due to impaired bone marrow function.
There is no antidote for metamizole.
In case of overdose, you should immediately consult your doctor. Symptomatic and supportive treatment may be necessary.

Missed dose of Dialginum

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, this medicine can cause side effects, although not everybody gets them.
You should stop taking Dialginum and seek medical help 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 whites of the 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 help immediately if you experience any of the following severe allergic reactions (anaphylaxis):

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

• facial, lip, tongue, and/or throat swelling, which can cause difficulty swallowing or breathing,
• severe bronchospasm,
• skin and mucous membrane changes, such as itching, burning, redness, urticaria. Very rarely (may occur in less than 1 in 10,000 patients):
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, fainting).

You should stop taking the medicine and seek medical help immediately if you experience any of the following very rare but serious side effects:

• Stevens-Johnson syndrome (blisters from mucosal ulcers, on the mucous membranes of the mouth, eyes, genitals),
• toxic epidermal necrolysis, skin and mucous membrane changes, such as rash, blisters, leading to shedding of large areas of the skin, exposure of large areas of skin,
• agranulocytosis, manifested by fever, chills, sore throat, difficulty swallowing, and inflammatory conditions of the mucous membranes of the mouth, nose, throat, genitals, and anus, including cases resulting in death.

Other side effects:

You should consult your doctor if you experience any of the following side effects:
Uncommon (occurring in less than 1 in 100 patients):

• drug rash
• excessive decrease in blood pressure. Rare (occurring in less than 1 in 1,000 patients):
• rash (e.g., maculopapular),
• seizure-like convulsions after high doses of the medicine
• asthma attack, bronchospasm, shortness of breath,
• leukopenia (decrease in white blood cell count),
• thrombocytopenia (decrease in platelet count). Very rarely (occurring in less than 1 in 10,000 patients):
• analgesic asthma (see "When not to take Dialginum" in section 2),
• thrombocytopenia (decrease in platelet count), bleeding,
• sudden deterioration of kidney function with proteinuria, oliguria, or anuria,
• acute kidney failure,
• interstitial nephritis,
• pancytopenia,
• 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,
• liver damage, cholestasis (mechanical obstruction of bile flow), jaundice,
• hepatitis, yellowing of the skin and whites of the eyes, increased liver enzyme activity in the blood
• headache, dizziness,
• loss of appetite,
• hemolytic anemia (anemia caused by faster breakdown of red blood cells),
• aplastic anemia, bone marrow damage, sometimes resulting in death,
• in patients with glucose-6-phosphate dehydrogenase deficiency, the medicine may cause
• red discoloration of the urine (after taking very high doses of metamizole),
• tachycardia, cyanosis.
• severe skin reactions: you should stop taking metamizole and seek medical help immediately if you experience any of the following severe side effects:
• red, flat patches on the torso, target-like or round, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. 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 this medicine.

5. How to store Dialginum

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from moisture.
Store at a temperature below 25°C.
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.
Do not use this medicine if you notice any changes in the appearance of the powder.
The "Lot" abbreviation on the packaging means 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 Dialginum contains

Active substance:Metamizole sodium in the form of metamizole sodium monohydrate.
One sachet contains 500 mg of metamizole sodium.
Excipients:mannitol, sodium cyclamate, strawberry flavor 877874, anhydrous colloidal silica,
Composition of strawberry flavor 877874: glucose syrup, corn syrup, ethyl 2-methylacetoacetate, 4-hydroxy-2,5-dimethyl-3-furanone, methyl cinnamate, cis-3-hexen-1-ol, maltol, hexanoic acid, silicon dioxide, gum arabic.

What Dialginum looks like and what the pack contains

Dialginum 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 sachets and a leaflet, in a cardboard box.

Marketing authorization holder and manufacturer

CHEMAX PHARMA Ltd.
8A Goritsa Str.
1618 Sofia
Bulgaria
Phone: +359 2 955 6298
e-mail: [email protected]

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