Piralgina Bul i Goromhka

Leaflet attached to the packaging: patient information

Pyralgina Pain and Fever, 500 mg/sachet, granulate for oral solution

Metamizole magnesium
The Pyralgina Pain and Fever medicine may cause an abnormally low 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,
nose, throat, or genital and anal areas.
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.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
your doctor, pharmacist, or nurse.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Pyralgina Pain and Fever and what is it used for

Pyralgina Pain and Fever belongs to non-opioid analgesics from the pyrazolone derivative group with analgesic and antipyretic effects.
It also has a spasmolytic effect on smooth muscles.
The medicine is indicated for the treatment of pain of various origins with high intensity and fever, when
the use of other agents is contraindicated or ineffective.

2. Important information before taking Pyralgina Pain and Fever

When not to take Pyralgina Pain and Fever:

• if the patient has a history of significant reduction 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,
• if the patient is allergic to metamizole, other pyrazolone and pyrazolidine derivatives (e.g. propyphenazone, phenazone or phenylbutazone) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has analgesic asthma syndrome or known intolerance to painkillers manifested by hives, angioedema (swelling of the face, lips and/or tongue), i.e. patients who react with bronchospasm or other anaphylactoid reaction to salicylates, paracetamol or other non-opioid analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs), such as: diclofenac, ibuprofen, indomethacin or naproxen;
• if the patient has acute renal or liver failure, acute porphyria;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if the patient is taking a medicine from the pyrazolone and pyrazolidine derivative group (e.g. phenylbutazone, propyphenazone);
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting to take Pyralgina Pain and Fever, you should discuss it with your doctor or
pharmacist:

• if you have a systolic blood pressure below 100 mm Hg or heart disease and circulatory disorders (e.g. heart attack, coronary artery disease or multiple organ injuries), cerebral vessel constriction, decreased blood volume, as well as in dehydrated patients, as the medicine may cause a decrease in blood pressure;
• if you have a high fever;
• if you have kidney or liver failure;
• if you have stomach or duodenal ulcers;
• if you have bronchial asthma, especially if it is accompanied by nasal and sinus polypous inflammation;
• if you have allergic diseases, including atopic ones, chronic urticaria;
• if you are intolerant to certain dyes (e.g. tartrazine) or preservatives (e.g. benzoates);
• in patients with 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 analgesic asthma.

Due to the life-threatening risk, the medicine should be stopped immediately and medical help should be sought in case of
symptoms of an allergic reaction (anaphylactic), such as:

• swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing;
• severe bronchospasm;
• skin and mucous membrane changes, such as itching, burning, redness, hives;
• shock (decreased blood pressure, weakness, fainting). Patients who have had an allergic reaction or other immunological reaction to metamizole are also at risk of a similar reaction to other pyrazolones and pyrazolidines and other non-opioid analgesics. In patients with allergies, anaphylactic shock may occur. Therefore, when taking the medicine, special caution is recommended in patients with asthma or atopy (e.g. atopic dermatitis or mucous membrane inflammation, hay fever, allergic asthma). Patients with an increased risk of reactions similar to severe allergic reactions should only be given metamizole after careful consideration of the benefit-risk ratio. If necessary, it should be administered under close medical supervision, with the possibility of providing assistance in an emergency.

The medicine should be stopped immediately and a doctor should be consulted if symptoms occur:

• thrombocytopenia, e.g.: bruising on the skin and mucous membranes, hemorrhages, recurrent bleeding from the gums, nose, gastrointestinal tract;
• pancytopenia (significant reduction in the number of all blood cells: red and white blood cells and platelets), e.g.: general malaise, fever, signs of infection, hemorrhages, bleeding, pallor.

Agranulocytosis (a very low number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections)
Pyralgina Pain and Fever 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). You should stop taking metamizole and contact your doctor immediately if you experience
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 and anal areas.
Your doctor will order a laboratory 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 treatment with Pyralgina Pain and Fever, and even for a short time after stopping metamizole.
Agranulocytosis can occur even if metamizole was previously administered without complications.
Severe skin reactions
Severe skin reactions have been reported in association with metamizole, including Stevens-Johnson syndrome: blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever and joint pain, toxic epidermal necrolysis: large blisters, extensive skin ulcers, skin exfoliation, and fever, drug rash with eosinophilia and systemic symptoms (DRESS syndrome). If the patient experiences any of these severe skin reactions mentioned in section 4, they should stop taking metamizole and seek medical attention immediately.
If the patient has ever had severe skin reactions during metamizole treatment, they should never take Pyralgina Pain and Fever or other medicines containing metamizole again (see section 4).
Liver disorders
There have been reports of liver inflammation in patients taking metamizole, with symptoms appearing within a few days to a few months after starting treatment.
You should stop taking Pyralgina Pain and Fever and consult your doctor if you experience
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 Pyralgina Pain and Fever if you have previously taken medicines containing metamizole and had liver disorders.

Pyralgina Pain and Fever and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Taking Pyralgina Pain and Fever is contraindicated:

• with medicines from the pyrazolone and pyrazolidine derivative group (phenylbutazone, propyphenazone).

You should inform your doctor about:

• anticoagulant medicines (e.g. warfarin);
• oral antidiabetic medicines;
• phenytoin (an antiepileptic medicine);
• sulfonamides (antibacterial medicines);
• cyclosporine, tacrolimus (immunosuppressive medicines used, among other things, to prevent transplant rejection);
• barbiturates (e.g. phenobarbital - a medicine used, among other things, in epilepsy);
• monoamine oxidase inhibitors (e.g. selegiline, moclobemide - medicines used, among other things, in depression);
• chlorpromazine (a medicine used, among other things, in the treatment of schizophrenia);
• lithium, sertraline (antidepressant medicines);
• bupropion (a medicine used in the treatment of depression or as an aid to smoking cessation);
• medicines that lower blood pressure (e.g. captopril);
• diuretic medicines (e.g. triamterene);
• methotrexate (a medicine used in the treatment of cancer);
• efavirenz (a medicine used in the treatment of HIV infection (AIDS));
• methadone (a medicine used in the treatment of opioid dependence);
• valproate (a medicine used in the treatment of epilepsy or bipolar disorder).

Metamizole may reduce the effect of acetylsalicylic acid on platelets.
You should be cautious when taking acetylsalicylic acid used to prevent heart disease.

Pyralgina Pain and Fever with food, drink, and alcohol

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 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 associated with taking the medicine are carefully weighed. As a rule, administering metamizole in the first and second trimester is not recommended.
You should not take Pyralgina Pain and Fever 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, which normally closes only after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts and the risk to the breastfed infant cannot be excluded. Therefore, you should avoid repeated use of metamizole during breastfeeding.
In the event of a single dose of metamizole, mothers should be advised to discard and discard breast milk for 48 hours after administration of the medicine.

Driving and using machines

Within the recommended dose range, no impairment of concentration and reaction time has been observed. However, when taking higher doses, you should be cautious and avoid operating machinery, driving, or performing activities that involve risk.

Pyralgina Pain and Fever contains sodium and orange yellow (E110)

The medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. the medicine is considered "sodium-free".
The medicine may cause allergic reactions.
Each sachet contains 0.04 carbohydrate exchange units.

3. How to take Pyralgina Pain and Fever

This medicine should always be taken exactly as described in the patient leaflet or as advised by
your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The dose depends on the severity of the pain or fever and the individual's response to Pyralgina Pain and Fever.
You should always choose the smallest dose necessary to control the pain and/or fever.
Adults and adolescents over 15 years of age (with a body weight over 53 kg) can take a maximum of 1000 mg of metamizole in a single dose (2 sachets) no more than 4 times a day at 6-8 hour intervals. The maximum daily dose is 4000 mg (equivalent to 8 sachets).
A noticeable effect can be expected within 30 to 60 minutes of oral administration.
Pyralgina Pain and Fever should not be used in children under 15 years of age. For younger children, other forms and strengths of this medicine are available; you should ask your doctor or pharmacist about this.
Method of administration:
The contents of the sachet should be dissolved in a glass of water. The medicine should be taken during or immediately after meals.
The medicine should not be taken for more than 3-5 dayswithout consulting a doctor or you should go to the doctor immediately if, despite taking the medicine, the symptoms worsen.
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 reduced elimination rate in patients with renal or hepatic 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.

Overdose of Pyralgina Pain and Fever

In case of overdose, you should immediately consult a doctor or pharmacist.
During overdose, dizziness, tinnitus, hearing disorders, psychomotor agitation, impaired consciousness, coma, tonic-clonic seizures, or decreased blood pressure, cardiac arrhythmias (tachycardia) may occur. Overdose of metamizole can also cause abdominal pain, vomiting, gastric and duodenal ulcers, bleeding, perforation, liver cell damage, interstitial nephritis, and allergic bronchospasm. Cases of rash, urticaria, edema, exfoliative dermatitis, and toxic epidermal necrolysis have been reported.
After taking very high doses, the excretion of rubazonic acid may cause red discoloration of the urine.
There have also been reports of blood morphology disorders, such as bone marrow damage with a decrease in the number of white blood cells (leukopenia or agranulocytosis), platelets (thrombocytopenia), or aplastic anemia.
There is no antidote for metamizole.
In case of overdose, you should immediately consult a doctor. Symptomatic and supportive treatment may be necessary.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to the life-threatening risk, the medicine should be stopped immediately and medical help should be sought if the patient experiences any of the following severe side effects:

• severe allergic reactions (anaphylactic):
• rarely occurring swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing;
• very rarely occurring severe bronchospasm;
• skin and mucous membrane changes, such as itching, burning, redness, hives;
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, fainting) - frequency not known;
• severe skin reactions:
• red, flat patches on the torso in a target shape or round, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, and genitals, and eyes. The occurrence of such serious skin rashes 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 hypersensitivity syndrome).

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

• pancytopenia (significant reduction in the number of all blood cells: red and white blood cells and platelets), manifested by general malaise, fever, signs of infection, hemorrhages, bleeding, pallor;
• agranulocytosis (complete or almost complete disappearance of granulocytes from the blood), including cases of death, manifested by:
• fever, chills;
• sore throat, difficulty swallowing, and inflammation of the mucous membranes of the mouth, nose, throat, genitals, and anus;
• increased ESR;
• not always normal hemoglobin, erythrocyte, and platelet values, although they are usually normal;
• slightly enlarged lymph nodes and spleen, although they are usually unchanged (see also section 2 "Warnings and precautions");
• 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".

Other side effects:

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

• drug rash (transient rash of various types: papular, macular, pustular, erythematous);
• excessive decrease in blood pressure.

Rare (less than 1 in 1,000 patients) side effects include:

• papulomacular skin changes;
• leukopenia (decrease in the number of white blood cells in the blood).

Very rare (less than 1 in 10,000 patients) side effects include:

• analgesic asthma (see "When not to take Pyralgina Pain and Fever" in section 2), asthma attacks;
• agranulocytosis (complete or almost complete disappearance of granulocytes from the blood), including cases of death (see above "You should stop taking the medicine and consult a doctor immediately if you experience any of the following severe side effects");
• thrombocytopenia (bleeding, hemorrhages);
• sudden deterioration of kidney function with proteinuria, oliguria, or anuria;
• acute kidney failure;
• interstitial nephritis.

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

• nausea, vomiting, abdominal pain, gastric irritation, diarrhea, dry mouth;
• liver damage;
• hepatitis, jaundice, elevated liver enzyme activity in the blood;
• headache, dizziness;
• hemolytic anemia, aplastic anemia, bone marrow damage, sometimes fatal. In patients with glucose-6-phosphate dehydrogenase deficiency, the medicine causes hemolysis of red blood cells;
• 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, 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
Al. Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pyralgina Pain and Fever

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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 Pyralgina Pain and Fever contains

• The active substance of the medicine is metamizole magnesium. Each sachet contains 500 mg of metamizole magnesium in the form of metamizole magnesium hexahydrate.
• The other ingredients are: mannitol, povidone K29/32, sodium saccharin, orange flavor, orange yellow (E110).

What Pyralgina Pain and Fever looks like and what the pack contains

Pyralgina Pain and Fever is an orange, uniform, non-granulated granulate with an orange flavor, packaged in sachets made of paper-aluminum foil with a heat-sealed SURLYN layer, placed in a cardboard box.
The packaging contains 6 sachets of 1.168 g of granulate.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Laboratorios Alcala Farma, S.L.
Avenida de Madrid, n° 82
28802 Alcala de Henares (Madrid)
Spain
Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: