Package leaflet: Information for the patient

Spasmalgon, (500 mg + 2 mg + 0.02 mg)/ml, solution for injection
(Metamizolum natricum + Pitofenoni hydrochloridum + Fenpiverini bromidum)
Spasmalgon may cause abnormally low white blood cell count (agranulocytosis), which
can lead to severe and life-threatening infections (see section 4).
Treatment must be discontinued and medical advice must be sought immediately if any
of the following symptoms occur: fever, chills, sore throat, painful sores in the nose,
mouth and throat, or in the genital or anal area.
If the patient has ever experienced agranulocytosis while taking metamizole or similar
medicines, this medicine must never be taken again in the future (see section 2).
Please read the entire leaflet before using the medicine, as it contains important
information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are identical.
If any side effects occur in the patient, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet

What Spasmalgon is and what it is used for
What you need to know before using Spasmalgon
How to use Spasmalgon
Possible side effects
How to store Spasmalgon
Contents of the pack and other information

1. What Spasmalgon is and what it is used for

Spasmalgon is a combination medicine with spasmolytic action on smooth muscles of the gastrointestinal tract, biliary and urinary tracts, and genital organs. It has strong analgesic properties.
Spasmalgon is used for short-term treatment of pain caused by spasms of the gastrointestinal and urogenital systems: severe stomach cramps, intestinal colic, painful contractions of the urinary tract and urinary bladder, renal colic, biliary colic due to gallstones, and painful menstruation.

2. Important information before using Spasmalgon

When not to use Spasmalgon
Do not use this medicine if the patient:

is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6)
has hypersensitivity to pyrazolone derivatives (including patients with agranulocytosis – reduced number of granulocytes (a type of white blood cells) in history after previous administration of such substances), to analgesics, particularly salicylates, paracetamol or other non-narcotic analgesics and non-steroidal anti-inflammatory drugs (NSAIDs)
has severe impairment of liver function and/or renal failure
has intestinal obstruction or colonic dilation (dilatation of the large intestine)
has acute intermittent porphyria (a hereditary disorder associated with impaired red blood cell formation)
has glucose-6-phosphate dehydrogenase deficiency (an inherited disorder with deficiency of this enzyme)
has bone marrow dysfunction (e.g. after therapy with cytostatic agents) or blood disorders such as aplastic anaemia (reduced number of blood cells leading to fatigue, bruising or increased risk of infection), agranulocytosis, leukopenia (reduced total number of white blood cells)
has second- or third-degree prostatic adenoma
has reduced contractility of the gallbladder or urinary bladder
has low or unstable blood pressure. Do not use 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 previously experienced a significant decrease in white blood cells called granulocytes caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines
if the patient has bone marrow dysfunction or a disease affecting the production or function of blood cells.

Warnings and precautions
Before starting treatment with Spasmalgon, discuss it with your doctor or nurse.
Abnormally low white blood cell count (agranulocytosis)
Spasmalgon may cause agranulocytosis, i.e. a very low number of a certain type of white blood cells called granulocytes, which play an important role in fighting infections (see section 4). Discontinue metamizole and contact your doctor immediately if any of the following symptoms occur, as they may indicate possible agranulocytosis: chills, fever, sore throat and painful mucosal ulcers, particularly in the oral cavity, nose and throat or in the genital or anal area.
Your doctor will order laboratory tests to check your blood cell counts.
If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if the patient is receiving antibiotics.
Agranulocytosis may develop at any time during treatment with Spasmalgon, and even shortly after discontinuation of metamizole.
Agranulocytosis may occur even if metamizole was previously administered without complications.
Treatment with Spasmalgon carries a risk of anaphylactic reactions. At the first signs of hypersensitivity reaction, discontinue the drug and urgently initiate corrective measures (administration of adrenaline, glucocorticosteroids, antihistamines).
The risk of hypersensitivity reaction to metamizole is significantly higher in patients who have:

asthma or urticaria of the angioedema type after administration of analgesics,
bronchial asthma with coexisting sinusitis and nasal polyps,
chronic urticaria,
hypersensitivity to dyes (e.g. tartrazine), preservatives (e.g. benzoates),
alcohol intolerance. In such patients, a reaction to minimal doses of alcohol may occur, manifesting as sneezing, lacrimation, and severe visual disturbances. Such reactions may be a sign of unrecognized analgesic-dependent asthma. During treatment with medicines containing metamizole, there is a risk of shock (circulatory collapse) and agranulocytosis (severe reduction in white blood cell count, increasing the likelihood of infections). These reactions are independent of the dose and unpredictable. They may occur after the first dose or after repeated administration. Typical symptoms include: fever and chills, sore throat, pain on swallowing, inflammation of the mucous membranes of the mouth, nose, throat, anus, and genital area. In case of sudden deterioration of general condition, if body temperature does not decrease or continues to rise, or if painful changes in the mucous membranes and skin appear, discontinue administration of Spasmalgon and contact a doctor immediately.
Regular blood tests are necessary during treatment with Spasmalgon in patients who currently have or have previously had blood disorders.
Before starting treatment with Spasmalgon, inform your doctor if the patient has kidney or liver disease, conditions associated with gastrointestinal tract narrowing and difficulty in gastrointestinal passage (e.g. achalasia of the oesophagus, duodenal stenosis), gastro-oesophageal reflux, intestinal atony, paralytic intestinal obstruction, glaucoma (increased intraocular pressure), myasthenia gravis (muscle weakness), heart diseases (arrhythmia, ischaemic heart disease, congestive heart failure).
Spasmalgon may cause hypotensive reactions (decrease in arterial blood pressure). The risk of such reactions is also increased in patients who have:
low blood pressure;
reduced water-electrolyte volume or dehydration;
impaired cardiac contractility or circulatory failure (e.g. patients with myocardial infarction or multi-organ trauma);
high fever. Spasmalgon should be administered only under strict monitoring of haemodynamic parameters in patients in whom a drop in blood pressure should be avoided, e.g. those with severe ischaemic heart disease or significant cerebral vessel stenosis.

Liver-related disorders
Cases of hepatitis have been reported in patients taking metamizole, with symptoms appearing from several days to several months after starting treatment.
Discontinue Spasmalgon and contact your doctor if the patient experiences liver-related symptoms such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, jaundice (yellowing of the skin or whites of the eyes), itching, rash, or upper abdominal pain. Your doctor will assess liver function.
The patient should not take Spasmalgon if they previously used any medicinal products containing metamizole and experienced liver-related adverse effects.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with metamizole treatment. If the patient develops any of these symptoms associated with severe skin reactions listed in section 4, discontinue metamizole and seek immediate medical attention.
If the patient has ever experienced severe skin reactions, Spasmalgon should never be used again in the future (see section 4).

Spasmalgon with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.
When Spasmalgon is used together with any of the following medicines, unwanted reactions may occur:

medicines affecting blood coagulation (e.g. acenocoumarol, warfarin),
medicines used to treat psychiatric disorders (chlorpromazine and other phenothiazine derivatives),
medicines that suppress the immune system (cyclosporine),
chloramphenicol and other bone marrow-damaging drugs,
antidepressants,
hypnotics,
oral contraceptives,
medicines used to treat gout (allopurinol),
medicines used to treat malaria (chloroquine),
other analgesics and non-steroidal anti-inflammatory drugs such as piroxicam, aspirin, paracetamol, ibuprofen, indomethacin. Spasmalgon may alter the effects of the following medicines:
captopril (used to treat heart disease and high blood pressure),
lithium compounds (used to treat psychiatric disorders),
methotrexate (used to treat rheumatic and oncological diseases),
triamterene (a diuretic increasing water excretion),
may alter the effects of antihypertensive and diuretic medicines,
bupropion, a medicine used to treat depression or as an aid in smoking cessation,
efavirenz, a medicine used to treat HIV infection (AIDS),
methadone, a medicine used to treat addiction to illegal narcotics (so-called opioids),
valproate, a medicine used to treat epilepsy or bipolar affective disorder,
tacrolimus, a medicine used to prevent organ rejection in transplant patients,
sertraline, a medicine used to treat depression. If any of the above medicines are being used, consult your doctor before starting Spasmalgon.

Metamizole (an analgesic and antipyretic substance) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when these medicines are used simultaneously. Therefore, caution is advised when using metamizole in patients receiving acetylsalicylic acid.

Taking Spasmalgon with food, drink and alcohol
Consuming alcohol during treatment with Spasmalgon is not recommended due to an increased risk of adverse effects.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
As there are no data on the safety of Spasmalgon during pregnancy, this medicine should not be administered to pregnant women.
Available data on the use of metamizole during the first three months of pregnancy are limited but do not indicate harmful effects on the embryo. In selected cases, if no other treatment options are available, after consultation with a doctor or pharmacist, the patient may take a single dose of metamizole during the first or second trimester, provided that the benefits and risks of treatment are carefully considered. In principle, administration of metamizole during the first and second trimesters is not recommended.
Metamizole must not be taken during the last three months of pregnancy due to increased risk of complications for both mother and child (e.g. bleeding, premature closure of the ductus arteriosus Botalli – a vital blood vessel in the unborn child that normally closes only after birth).

Breastfeeding
Metabolites of metamizole pass into breast milk in significant amounts, and risk to the breastfed infant cannot be excluded. Therefore, repeated use of metamizole during breastfeeding should be particularly avoided. After a single dose of metamizole, mothers should be advised to express and discard breast milk for 48 hours after administration of the drug.

Driving and operating machinery
Spasmalgon may cause dizziness, visual disturbances, and may negatively affect concentration and slow reaction times in unexpected situations. Therefore, during treatment, patients should avoid driving and operating machinery.

Spasmalgon contains sodium
This medicine contains 32.7 mg of sodium (main component of table salt) per millilitre. This corresponds to 1.6% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Spasmalgon

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
Spasmalgon is administered intramuscularly.
It should only be used for short-term treatment.
Adults and adolescents over 15 years of age
For adults and adolescents over 15 years of age (with body weight above 53 kg), the recommended dose is 2–5 ml of injection solution administered intramuscularly. The dose may 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 injection solution (equivalent to 5 g of metamizole sodium).
Elderly patients and patients in poor general health or with renal impairment
In elderly patients, debilitated patients, and patients with impaired renal function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.
Patients with impaired renal or hepatic function
Due to reduced elimination rate in patients with impaired renal or hepatic function, repeated administration of high doses should be avoided. In case of short-term use, dose reduction is not required. There is no experience regarding long-term use.
In case of doubt, consult your doctor or pharmacist.
Use of a higher than recommended dose of Spasmalgon.
In case of overdose, the most commonly observed symptoms are toxic effects on the haematopoietic system, gastrointestinal disturbances, and, in severe cases, disturbances of the central nervous system.
Treatment is symptomatic and should be conducted 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. However, if a dose is suspected to have been missed, consult your doctor or nurse.
Discontinuation of Spasmalgon treatment
Your doctor will decide how long Spasmalgon should be used.

4. Possible adverse reactions

Discontinue use of Spasmalgon and seek immediate medical help if any of the following symptoms occur:
Malaise (nausea or vomiting), fever, feeling of 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".

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following frequency scale is used to assess the occurrence of adverse reactions:
Very common: occurs in more than 1 in 10 patients
Common: occurs in 1 to 10 in 100 patients
Uncommon: occurs in 1 to 10 in 1,000 patients
Rare: occurs in 1 to 10 in 10,000 patients
Very rare: occurs in fewer than 1 in 10,000 patients
Frequency not known: frequency cannot be estimated from available data

Uncommon (occurs in 1 to 10 in 1,000 patients)

Persistent drug eruption (circular, flat, purple to dark red blisters).
During or after administration – drop in blood pressure, palpitations, increased heart rate, cardiac arrhythmias, cyanosis (bluish discoloration of the skin and mucous membranes).

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

Leukopenia (reduced total number of white blood cells, which may lead to increased susceptibility to infections)
Papular rash (formation of rough bumps on the skin)
Anaphylactic or anaphylactoid reactions, especially after injection. These usually occur mainly within the first hours after administration. These reactions manifest as typical skin and mucosal changes (e.g. itching, burning sensation, redness, rash, urticaria, swelling – local or general), shortness of breath, and rarely gastrointestinal symptoms. These milder reactions may progress to more severe symptoms including generalized urticaria, angioedema (swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing), severe bronchospasm, cardiac arrhythmias, drop in blood pressure (sometimes preceded by a rise), kidney damage with protein in urine, reduced or increased urine output, kidney inflammation, red discoloration of urine.

Very rare (fewer than 1 in 10,000 patients)

Agranulocytosis (reduction in granulocytes – a type of white blood cells – in the blood, which may increase the likelihood of infection). Agranulocytosis may also occur in patients previously treated with metamizole without experiencing adverse reactions. The risk of developing agranulocytosis increases with prolonged treatment with metamizole (beyond 1 week).
Thrombocytopenia (reduced number of platelets, increasing the risk of bleeding or bruising)
Haemolytic anaemia (reduced number of red blood cells, which may cause paleness or yellowing of the skin, weakness, shortness of breath)
Aplastic anaemia (significant reduction in blood cells, leading to fatigue, skin bruising or increased susceptibility to infections). Asthma attack (in patients with analgesic-induced asthma), Stevens-Johnson syndrome and Lyell's syndrome (acute reaction associated with blistering of the skin, mouth, eyes and genital organs), shock (dangerous drop in blood pressure, which, if untreated, may lead to circulatory collapse, coma and death).

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

Dry mouth, nausea, vomiting, abdominal pain and malaise, diarrhoea, constipation, exacerbation of gastritis and peptic ulcer disease, in rare cases ulcers and bleeding
Dizziness, headache
Visual disturbances, disturbances of visual acuity
Urinary retention
Hepatitis, jaundice (yellowing of skin and whites of the eyes), increased liver enzyme activity in blood
Severe skin reactions.

Discontinue use of metamizole and seek immediate medical help if any of the following serious adverse reactions occur:

Reddish, flat lesions on the trunk in the shape of a target or circular, often with blisters in the center, skin peeling, ulceration in the mouth, throat, nose, genital organs and around the eyes. Such severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

During parenteral administration, pain at the injection site and local reactions may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Spasmalgon

Keep this medicine out of sight and reach of children.
Store in the original packaging, protected from light, at 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Spasmalgon contains

The active substances are metamizole sodium 500 mg, pitofenone hydrochloride 2 mg and fenpiperylium bromide 0.02 mg per 1 ml of injection solution. The other component of the medicine is: water for injections, nitrogen with low oxygen content.

What Spasmalgon looks like and contents of the pack
Clear, light yellow solution.
The pack contains 10 brown glass ampoules, each containing 5 ml of injection solution. The ampoules
are placed in a PVC foil blister pack inside a cardboard box.
Marketing Authorisation 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