SPASMALGON (500 mg + 2 mg + 0.02 mg)/ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Spasmalgon may cause a low white blood cell count (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).
   2. Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth sores, or genital or anal ulcers.
   3. If the patient has ever had agranulocytosis while taking metamizole or similar medicines, they should never take this medicine again (see section 2).
   4. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   5. Table of contents of the leaflet
2. What is Spasmalgon and what is it used for
3. Important information before taking Spasmalgon
   1. When not to take Spasmalgon
   2. Do not take Spasmalgon:
   3. Warnings and precautions
   4. Agranulocytosis (low white blood cell count)
   5. Spasmalgon may cause agranulocytosis, a very low number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). 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 sores, especially in the mouth, nose, and throat or in the genital or anal area.
   6. Your doctor will order a blood test to check your blood cell count.
   7. 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.
   8. Agranulocytosis may develop at any time during treatment with Spasmalgon, and even for a short time after stopping metamizole.
   9. Agranulocytosis may occur even if metamizole was previously taken without complications.
   10. Spasmalgon and other medicines
   11. Taking Spasmalgon with food, drink, and alcohol
   12. Pregnancy, breastfeeding, and fertility
   13. Driving and using machines
   14. Spasmalgon contains sodium
4. How to take Spasmalgon
   1. Overdose of Spasmalgon
   2. Missed dose of Spasmalgon
   3. Stopping treatment with Spasmalgon
5. Possible side effects
   1. Reporting side effects
6. How to store Spasmalgon
7. Contents of the pack and other information
   1. What Spasmalgon contains
   2. What Spasmalgon looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Spasmalgon, (500 mg + 2 mg + 0.02 mg)/ml, solution for injection
(Metamizole sodium + Pitofenone hydrochloride + Fenpiverine bromide)

Spasmalgon may cause a low white blood cell count (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).

Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth sores, or genital or anal ulcers.

If the patient has ever had agranulocytosis while taking metamizole or similar medicines, they should never take this medicine again (see section 2).

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Spasmalgon and what is it used for

Spasmalgon is a combination medicine that relaxes the smooth muscles of the digestive tract, bile ducts, urinary tract, and genital tract. It has a strong analgesic effect.
Spasmalgon is used for the short-term treatment of pain caused by colic of the digestive and genitourinary systems: strong stomach cramps, intestinal colic, painful contractions of the urinary tract and bladder, kidney colic, biliary colic in cholelithiasis, painful menstruation.

2. Important information before taking Spasmalgon

When not to take Spasmalgon

If the patient has:

• hypersensitivity to the active substances or any of the other ingredients of this medicine (listed in section 6)
• hypersensitivity to pyrazolone derivatives (including patients with agranulocytosis - a decrease in the number of granulocytes, a type of white blood cell, in the blood) after previous administration of such substances, to painkillers, especially salicylates, paracetamol, or other non-narcotic painkillers, and non-steroidal anti-inflammatory drugs (NSAIDs)
• severe liver and/or kidney dysfunction
• obstruction of the digestive tract and colon dilatation (enlargement of the large intestine)
• acute intermittent porphyria (a hereditary disease related to impaired red blood cell production)
• glucose-6-phosphate dehydrogenase deficiency (a hereditary disease with a deficiency of this enzyme)
• bone marrow disorders (e.g., after cytostatic therapy) or blood disorders such as aplastic anemia (a decrease in the number of blood cells, leading to weakness, bruising, or increased risk of infection), agranulocytosis, leukopenia (a decrease in the total number of white blood cells)
• prostate adenoma grade II and III
• decreased contractility of the gallbladder and urinary bladder
• low or unstable blood pressure.

Do not take Spasmalgon:

• if the patient is in the last three months of pregnancy
• in children and adolescents under 15 years of age
• if the patient has had a significant decrease in the number of white blood cells called granulocytes, caused by metamizole or other similar medicines called pyrazolones or pyrazolidines,
• if the patient has bone marrow disorders or a disease that affects the production or function of blood cells.

Warnings and precautions

Before starting treatment with Spasmalgon, discuss it with your doctor or nurse.

Agranulocytosis (low white blood cell count)

Spasmalgon may cause agranulocytosis, a very low number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). 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 sores, especially in the mouth, nose, and throat or in the genital or anal area.

Tell your doctor or nurse if you experience any of these symptoms, as they may indicate possible agranulocytosis:
chills, fever, sore throat, and painful mouth sores, 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 may develop at any time during treatment with Spasmalgon, and even for a short time after stopping metamizole.

Agranulocytosis may occur even if metamizole was previously taken without complications.

During treatment with Spasmalgon, there is a risk of anaphylactic reactions. At the first signs of an allergic reaction, stop taking the medicine and take urgent measures (administer adrenaline, glucocorticoids, antihistamines).
The risk of an allergic reaction to metamizole is significantly higher in patients who have:

• asthma or urticaria after taking painkillers,
• bronchial asthma with concurrent sinusitis and nasal polyps,
• chronic urticaria,
• hypersensitivity to dyes (e.g., tartrazine), preservatives (e.g., benzoates),
• alcohol intolerance. Such patients experience a reaction to minimal amounts of alcohol, manifested by sneezing, tearing, and severe visual disturbances. These reactions may be a sign of unrecognized asthma caused by painkillers. During treatment with metamizole, there is a risk of shock (circulatory collapse) and agranulocytosis (a significant decrease in the number of white blood cells, which increases the risk of infection). These reactions are independent of the dose of the medicine and are unpredictable. They can occur after the first dose or after repeated administration. Typical symptoms are: fever and chills, sore throat, pain when swallowing, inflammation of the mucous membranes of the mouth, nose, throat, anus, and genital area. If the patient's condition suddenly worsens, if the body temperature does not decrease or continues to rise, if

painful changes appear on the mucous membranes and skin, stop taking Spasmalgon and contact your doctor.
During treatment with Spasmalgon, regular blood tests are necessary for patients who currently have or have had blood disorders in the past.
Before starting treatment with Spasmalgon, tell your doctor if you have kidney or liver disease, diseases related to narrowing of the digestive tract and difficulty in the passage of gastrointestinal contents (achalasia of the esophagus, pyloric stenosis), gastroesophageal reflux, intestinal atony, paralytic ileus, glaucoma (increased intraocular pressure), myasthenia gravis(muscle weakness), heart disease (arrhythmia, coronary artery disease, congestive heart failure).
Spasmalgon may cause hypotensive reactions (decrease in blood pressure). The risk of such reactions is also increased in patients who have:

• low blood pressure;
• decreased water and electrolyte balance or dehydration;
• unstable cardiac contractility or circulatory failure (e.g., patients with myocardial infarction or multiple organ injury);
• high fever. Spasmalgon should be administered only under close hemodynamic monitoring in patients who should avoid a decrease in blood pressure, e.g., those with severe coronary artery disease or significant cerebral vessel stenosis.

Liver disorders
In patients taking metamizole, there have been cases of liver inflammation, the symptoms of which appeared within a few days to several months after starting treatment.
Stop taking Spasmalgon and contact your doctor if you experience any liver disorders, such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored 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 Spasmalgon if you have previously taken any medicinal products containing metamizole and had liver disorders.
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). If you experience any of these severe skin reactions, stop taking metamizole and seek medical attention immediately.
If you have ever had severe skin reactions, you should never take Spasmalgon again (see section 4).

Spasmalgon and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
When taking Spasmalgon and other medicines, the following unwanted reactions may occur:

• medicines that affect blood clotting (e.g., acenocoumarol, warfarin),
• medicines used to treat mental disorders (chlorpromazine and other phenothiazine derivatives),
• medicines that reduce immune system activity (cyclosporine),
• chloramphenicol and other medicines that damage bone marrow,
• medicines used to treat depression,
• sleeping pills,
• oral contraceptives,
• medicines used to treat gout (allopurinol),
• medicines used to treat malaria (chloroquine),
• other painkillers and non-steroidal anti-inflammatory drugs, such as piroxicam, aspirin, paracetamol, ibuprofen, indomethacin. Spasmalgon may change the effect of the following medicines:
• captopril (used to treat heart disease and high blood pressure),
• lithium compounds (used to treat mental disorders),
• methotrexate (used to treat rheumatic and oncological diseases),
• triamterene (a diuretic),
• may change the effect of blood pressure-lowering medicines and diuretics,
• bupropion, a medicine used to treat depression or as an aid to smoking cessation,
• efavirenz, a medicine used to treat HIV infection (AIDS),
• methadone, a medicine used to treat opioid dependence,
• valproate, a medicine used to treat epilepsy or bipolar disorder,
• tacrolimus, a medicine used to prevent organ rejection in transplant patients,
• sertraline, a medicine used to treat depression. If you are taking any of these medicines, consult your doctor before taking Spasmalgon.

Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and formation of a clot) if these medicines are taken together. Therefore, caution is advised when taking metamizole in patients receiving acetylsalicylic acid.

Taking Spasmalgon with food, drink, and alcohol

Drinking alcohol during treatment with Spasmalgon is not recommended due to the increased risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Pregnancy
Since there is no data on the safety of Spasmalgon during pregnancy, this medicine should not be given to pregnant women.
The 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 a doctor or pharmacist, the patient may take a single dose of metamizole in the first and second trimester, provided that the benefits and risks of taking the medicine are carefully weighed. As a rule, the administration of metamizole in the first and second trimester is not recommended.
Metamizole should not be taken during 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 infant cannot be excluded. Therefore, it is recommended to avoid repeated use of metamizole during breastfeeding. In the case of a single dose of metamizole, it is recommended that mothers discard breast milk for 48 hours after taking the medicine.

Driving and using machines

Spasmalgon may cause dizziness, visual disturbances, and may have a negative impact on concentration and reactions in unexpected situations, so it is recommended to avoid driving and operating machines during treatment.

Spasmalgon contains sodium

The medicine contains 32.7 mg of sodium (the main component of common salt) per milliliter. This corresponds to 1.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Spasmalgon

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Spasmalgon is administered intramuscularly.
It should only be used for short-term treatment.
Adults and adolescents over 15 years of age
Adults and adolescents over 15 years of age (with a body weight over 53 kg) should be given 2-5 ml of the solution for injection. The dose can be repeated if necessary after 6-8 hours. The defined daily dose of metamizole sodium is 3 g. The maximum daily dose should not exceed 10 ml of the solution for injection (equivalent to 5 g of metamizole sodium).
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 possible prolongation of the elimination time of metamizole metabolites.
Patients with impaired renal or hepatic function
Due to the reduced elimination rate in patients with impaired renal or hepatic function, it is recommended to 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. In case of doubt, consult your doctor or pharmacist.

Overdose of Spasmalgon

In case of overdose, the following symptoms are most commonly observed: toxic effects on the hematopoietic system, gastrointestinal disorders, and in severe cases, central nervous system disorders.
Treatment is symptomatic and should be carried out in a hospital.

Missed dose of Spasmalgon

It is unlikely that a dose of Spasmalgon will be missed, as it is administered by medical personnel. If you think you have missed a dose, consult your doctor or nurse.

Stopping treatment with Spasmalgon

Your doctor will decide how long to take Spasmalgon.

4. Possible side effects

Stop taking Spasmalgon and seek medical attention immediately if you experience any of the following symptoms:
Malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored 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".
Like all medicines, Spasmalgon can cause side effects, although not everybody gets them.
The following convention has been used for the classification of frequencies:
Very common:
occurring in more than 1 in 10 patients
Common:
occurring in 1 to 10 in 100 patients
Uncommon:
occurring in 1 to 10 in 1,000 patients
Rare:
occurring in 1 to 10 in 10,000 patients
Very rare:
occurring in less than 1 in 10,000 patients
Frequency not known:
frequency cannot be estimated from the available data
Uncommon (occurring in 1 to 10 in 1,000 patients)

• persistent drug rash (round, flat, purple to dark red patches).
• during or after administration - a drop in blood pressure and tachycardia, accelerated heart rate, arrhythmia, cyanosis (bluish discoloration of the skin and mucous membranes).

Rare (occurring in 1 to 10 in 10,000 patients)

• leukopenia (a decrease in the total number of white blood cells, which can lead to increased susceptibility to infections)
• papular rash (formation of rough patches on the skin)
• anaphylactic or anaphylactoid reactions, especially after injection. These reactions usually occur within the first few hours after administration. They appear as typical skin and mucous membrane changes (e.g., itching, burning, redness, rash, urticaria, swelling - local or general), shortness of breath, and rarely gastrointestinal disorders. These milder reactions can develop into more severe symptoms with generalized urticaria, angioedema (swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing), severe bronchospasm, arrhythmia, a drop in blood pressure (sometimes with a preceding increase), kidney damage with proteinuria, decreased or increased urine output, kidney inflammation, red urine.

Very rare (occurring in less than 1 in 10,000 patients)

• agranulocytosis (a decrease in the number of granulocytes - a type of white blood cell - in the blood, which can increase the risk of infection). Agranulocytosis may also occur in patients who have previously taken metamizole without complications. The possibility of agranulocytosis is higher in cases of longer treatment with metamizole (more than 1 week)
• thrombocytopenia (a decrease in the number of platelets, which can increase the risk of bleeding or bruising)
• hemolytic anemia (a decrease in the number of red blood cells, which can cause pallor or yellowing of the skin, weakness, shortness of breath)
• aplastic anemia (a significant decrease in the number of blood cells, leading to weakness, bruising, or increased risk of infection). Asthma attack (in patients with asthma caused by painkillers), Stevens-Johnson syndrome, and Lyell's syndrome (an acute reaction characterized by blistering of the skin, mouth, eyes, and genitals), anaphylactic shock (a life-threatening drop in blood pressure, which can lead to collapse, coma, and death if left untreated).

Frequency not known (cannot be estimated from the available data):

• dry mouth, nausea, vomiting, abdominal pain, and malaise, diarrhea, constipation, exacerbation of gastritis and gastric ulcer disease, and in rare cases, ulcers and bleeding
• dizziness, headache
• visual disturbances, blurred vision
• urinary retention
• hepatitis, jaundice, increased liver enzyme activity in the blood
• severe skin reactions.

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 shape or round, often with blisters in the center, peeling of the skin, mouth sores, 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 or drug hypersensitivity syndrome).

When administered parenterally, pain at the injection site and local reactions may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Spasmalgon

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Spasmalgon contains

• The active substances of Spasmalgon are metamizole sodium 500 mg, pitofenone hydrochloride 2 mg, and fenpiverine bromide 0.02 mg per 1 ml of solution for injection. The other ingredients are: water for injection, oxygen-free nitrogen.

What Spasmalgon looks like and contents of the pack

Clear, light yellow solution.
The pack contains 10 ampoules of brown glass with 5 ml of solution for injection each. The ampoules are in a blister pack of PVC foil in a cardboard box.

Marketing authorization holder

Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw
tel.: 22 613 39 30

Manufacturer

SOPHARMA AD
16, Iliensko Shosse str., 1220 Sofia, Bulgaria
Date of last revision of the leaflet:12-2024