Package leaflet: Information for the user

Pyretolek, 500 mg, coated tablets
Metamizolum natricum monohydricum
Pyretolek may cause a significantly low number of white blood cells (agranulocytosis), which
can lead to severe and life-threatening infections (see section 4).
The medicine must be discontinued and medical advice must be sought immediately if any
of the following symptoms occur: fever, chills, sore throat, painful ulcers 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 this leaflet carefully before taking this medicine, as it contains important
information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or worsen after 3–5 days of treatment, consult your doctor.

Contents of the leaflet

What Pyretolek is and what it is used for
What you need to know before taking Pyretolek
How to take Pyretolek
Possible side effects
How to store Pyretolek
Contents of the pack and other information

1. What Pyretolek is and what it is used for

Pyretolek contains the active substance metamizole sodium monohydrate and is an analgesic and antipyretic medicine belonging to a group of medicines called pyrazolones.
Pyretolek is used to treat:

acute, severe pain following injuries or surgery,
colicky abdominal pain (colic),
pain in cancer diseases,
other acute and prolonged severe pain when the use of other medicinal products is contraindicated,
high fever unresponsive to other treatments.

2. Important information before using Pyretolek

When not to use Pyretolek:

if the patient has previously experienced a significant decrease in the number of white blood cells called granulocytes, caused by metamizole or other similar drugs known as pyrazolones or pyrazolidines;
if the patient has bone marrow dysfunction or a disease affecting the production or function of blood cells;
if the patient is allergic to metamizole or other pyrazolones (e.g. propyphenazone, phenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone); this also applies to patients who have experienced severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)) after administration of these substances (see section "Warnings and precautions");
if the patient is allergic to any of the excipients listed in section 6;
if the patient has intolerance to painkillers (analgesic-induced asthma syndrome or analgesic intolerance, manifesting as urticaria, angioedema); this applies to patients who react with sudden bronchoconstriction or other hypersensitivity reactions such as itchy rash with blisters, rhinitis, angioedema (urticaria, rhinitis, angioedema) to painkillers such as salicylates, paracetamol, diclofenac, ibuprofen, indometacin or naproxen;
if the patient has a hereditary condition (congenital defect) with risk of red blood cell breakdown (congenital glucose-6-phosphate dehydrogenase deficiency);
if the patient has a hereditary disorder affecting hemoglobin synthesis (acute intermittent hepatic porphyria);
if the patient is in the last three months of pregnancy (third trimester of pregnancy).

Warnings and precautions
Before starting treatment with Pyretolek, discuss this with your doctor or pharmacist.
Low white blood cell count (agranulocytosis)
Pyretolek may cause agranulocyt游戏副本

3. How to use Pyretolek

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The dose depends on the severity of pain or fever and the individual's response to Pyretolek.
Always use the lowest effective dose required to control pain and fever.
For adults and adolescents aged 15 years and older (with body weight exceeding 53 kg), the maximum single dose is 1000 mg of metamizole (2 tablets), administered no more than 4 times daily at intervals of 6–8 hours. The maximum daily dose is 4000 mg (equivalent to 8 tablets).
A noticeable effect can be expected within 30 to 60 minutes after oral administration.
Pyretolek should not be used in children under 15 years of age. Other formulations and strengths of this medicine are available for younger children; consult the treating doctor or pharmacist.
Elderly patients and patients in poor general health or with renal impairment
In elderly patients, weakened patients, and those with impaired renal function, the dose should be reduced due to the potential for prolonged elimination of metamizole metabolites.
Patients with renal or hepatic impairment
Due to reduced elimination rate in patients with renal or hepatic impairment, repeated administration of high doses should be avoided. For short-term use, dose adjustment is not required. There is no experience with long-term use.
Duration of treatment
The duration of treatment depends on the type and severity of the illness.
Do not use analgesic medicines for longer than 3 to 5 days unless otherwise advised by a doctor or dentist.
Seek medical advice if symptoms do not improve or worsen after 3–5 days of treatment.
Method of administration
Pyretolek is intended for oral administration.
Film-coated tablets should be swallowed whole with an adequate amount of liquid (e.g. a glass of water).
Use of a higher than recommended dose of Pyretolek
Symptoms of overdose include:

nausea, vomiting, abdominal pain;
impaired renal function up to acute renal failure;
dizziness, drowsiness, loss of consciousness;
seizures;
drop in arterial blood pressure up to circulatory shock;
rapid heartbeat.

In case of overdose, contact a doctor immediately for appropriate countermeasures.
Note: After administration of higher doses, excretion of a harmless metabolite of metamizole may cause red discoloration of urine.
Missed dose of Pyretolek
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions that may have serious consequences, requiring immediate
discontinuation of Pyretolek and prompt contact with a doctor.
If any of the following adverse reactions occur suddenly or progress rapidly in a patient, immediate contact with a doctor is required. Some adverse reactions (e.g.
severe hypersensitivity reactions, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, pancytopenia) may be life-threatening. Under no circumstances should Pyretolek be used without medical supervision.
Rapid discontinuation of the medicine may be crucial.
If symptoms of agranulocytosis, pancytopenia or thrombocytopenia occur in a patient (see below and section 2 "Warnings and precautions"), Pyretolek must be discontinued immediately, and the doctor should order blood tests, including a blood smear. The medicine should be discontinued even before laboratory results are available.
Discontinue taking Pyretolek 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 part of the abdomen. These may be symptoms of liver damage. See also section 2 "Warnings and precautions".
Other adverse reactions
Uncommon (may occur in up to 1 in 100 people)

purple to dark red rash, sometimes vesicular (drug eruption);
drop in blood pressure, which is probably due to the direct effect of the medicine and not accompanied by other symptoms of hypersensitivity reactions. Only in rare cases do these reactions cause a significant drop in blood pressure. The risk of hypotension may be higher in patients with high fever. Typical symptoms of excessive drop in blood pressure include rapid heartbeat, pallor, tremors, dizziness, nausea and loss of consciousness.

Rare (may occur in up to 1 in 1000 people)

hypersensitivity reactions (anaphylactic or anaphylactoid reactions); Symptoms of milder reactions include:
- burning eyes,
- cough, runny nose, sneezing,
- feeling of tightness in the chest,
- skin redness, especially in the face and head area,
- urticaria and facial swelling,
- less frequently - nausea and abdominal cramps.

Symptoms that require particular attention are burning, itching and a feeling of warmth on the
tongue and underneath it, as well as on the palms and soles.
These milder reactions may progress to more severe forms such as:

severe urticaria,
severe angioedema (swelling, including within the larynx),
severe bronchospasm,
rapid heartbeat, sometimes bradycardia, cardiac arrhythmia,
drop in blood pressure, sometimes preceded by a rise,
loss of consciousness, circulatory shock. These reactions may occur despite previous use of this medicine without complications and may be severe or life-threatening, and in some cases may even be fatal. In patients with analgesic-induced asthma syndrome, hypersensitivity reactions manifest as typical asthma attacks (see section 2 "When not to use Pyretolek").
- decreased number of white blood cells in the blood (leukopenia);
- skin rash (e.g. maculopapular).

Very rare (may occur in up to 1 in 10,000 people)

agranulocytosis (marked decrease in granulocytes, a type of white blood cell), including fatal cases, decreased number of blood platelets (thrombocytopenia) (see section 2 "Warnings and precautions"). These reactions are probably of immunological origin. The above reactions may occur even if metamizole was previously used without complications or even shortly after discontinuation of metamizole. Typical symptoms of agranulocytosis include fever, chills, sore throat, difficulty swallowing, inflammation in the oral cavity, nose, throat, genital organs and rectum. In patients taking antibiotics (medicines used to treat bacterial infections), these symptoms may be masked. Erythrocyte sedimentation rate is markedly accelerated, while lymph nodes may remain unchanged or only slightly enlarged. Typical symptoms of thrombocytopenia include increased bleeding and minor hemorrhages in the skin and mucous membranes.
asthma attacks;
large areas of skin affected by blisters and skin peeling (Stevens-Johnson syndrome or toxic epidermal necrolysis);
sudden deterioration in kidney function, with some cases developing oliguria or anuria, proteinuria, acute kidney failure, kidney inflammation (acute interstitial nephritis).

Frequency unknown (frequency cannot be estimated from available data)

sudden circulatory shock due to severe allergic reaction (anaphylactic shock);
myocardial infarction during an allergic reaction (Kounis syndrome);
anemia occurring simultaneously with impaired bone marrow function (aplastic anemia), decreased number of white and red blood cells and platelets (pancytopenia), including fatal cases; Symptoms of aplastic anemia and pancytopenia include general malaise, infection, persistent fever, bruising, bleeding, pallor.
gastrointestinal bleeding;
hepatitis, jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme activity in the blood;
severe skin reactions.

Metamizole should be discontinued and immediate medical help sought if any of the following severe adverse reactions occur in a patient:

reddish, flat spots on the trunk in the shape of a target or circular, often with blisters in the center, skin peeling, oral, throat, nasal, genital and ocular mucosal ulcers. Such severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reddish discoloration of urine may occur, caused by excretion of a harmless metabolite of metamizole.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +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 Pyretolek

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated 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 Pyretolek contains
The active substance is metamizole sodium monohydrate.
Each coated tablet contains 500 mg of metamizole sodium monohydrate.
The other ingredients are:
Hypromellose, talc, magnesium stearate, macrogol 4000, macrogol 8000, sodium saccharin, titanium dioxide (E 171).
What Pyretolek looks like and contents of the pack
Pyretolek is a white, oval, biconvex coated tablet.
Pyretolek is available in PVC/PVDC/Aluminium blisters, in packages of 20 or 50 coated tablets in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69
Manufacturer
Trommsdorff GmbH & Co. KG
Trommsdorffstrasse 2-6
52477 Alsdorf
Nordrhein-Westfalen
Germany