PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language
Saridon
250 mg + 150 mg + 50 mg, tablets
Paracetamolum + Propyphenazonum + Coffeinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days in case of fever or 5 days in case of pain, or if your condition worsens, consult a doctor.

Table of contents of the leaflet:

What Saridon is and what it is used for
Important information before taking Saridon
How to take Saridon
Possible side effects
How to store Saridon
Contents of the pack and other information

1. What Saridon is and what it is used for

Saridon is a combination medicine with synergistic action of its components. Saridon contains paracetamol and propyphenazone, which have analgesic and antipyretic effects, and a small dose of caffeine, which enhances the analgesic effect of paracetamol.
Indications:

headache, toothache, menstrual pain, postoperative pain, rheumatic pain;
pain and fever associated with cold and flu.

2. Important information before using Saridon

When not to use Saridon

if the patient has hypersensitivity (allergy) to propyphenazone, paracetamol, caffeine, or any of the other ingredients,
if the patient has hypersensitivity to pyrazolones or derivatives of these compounds,
(hypersensitivity to phenazone, aminophenazone, metamizole),
if the patient has hypersensitivity to phenylbutazone or acetylsalicylic acid,
if the patient has congenital glucose-6-phosphate dehydrogenase deficiency,
if the patient has alcoholic liver disease,
if the patient has severe hepatic insufficiency (Child-Pugh score > 9),
if the patient has severe renal insufficiency,
if the patient has acute hepatic porphyria,
in children under 12 years of age,
if the patient suffers from blood-forming system disorders,
if the patient has Gilbert's syndrome,
during the third trimester of pregnancy.

Warnings and precautions

prolonged use in patients with Gilbert's syndrome (a mild jaundice caused by deficiency of the enzyme glucuronyltransferase), or hematopoietic disorders (blood cell formation). In these patients, it may be necessary to reduce the dose or duration of treatment;
hepatic insufficiency (Child-Pugh score < 9), infections affecting liver function (e.g. viral hepatitis), or other liver diseases. For these patients, during treatment with high doses or prolonged therapy, the physician may recommend regular liver function tests.
prolonged use of medications containing paracetamol may lead to severe liver damage (e.g. liver cirrhosis). During treatment with therapeutic doses of paracetamol, serum alanine aminotransferase (ALT) levels may increase;
in patients with kidney diseases, dosage adjustment by a physician may be necessary. In patients with severe renal insufficiency (creatinine clearance <10 ml/min), the physician should assess the benefit-risk ratio of using a medication containing paracetamol.
prolonged use of paracetamol with other analgesics may lead to permanent kidney damage and risk of renal failure;
redness, rash, blisters, or peeling skin. Discontinue use of the medication and contact a physician immediately;
when the patient is taking other medications, abusing alcohol, has sepsis, or diabetes;
when the patient has hereditary glucose-6-phosphate dehydrogenase deficiency, as there may be a risk of hemolytic anemia (accelerated breakdown of red blood cells);
if the patient is taking other analgesics containing paracetamol besides Saridon, as paracetamol overdose may occur. Check whether other recently taken medications contain paracetamol;
if the medication is taken by patients with asthma, chronic rhinitis, or chronic urticaria, especially if they have hypersensitivity to other anti-inflammatory drugs, as isolated cases of allergic reactions and anaphylactic shock after administration of propyphenazone and paracetamol have been reported;
when the medication is used long-term. Prolonged use of analgesics for headache treatment may lead to chronic headache.

Do not drink alcohol while taking Saridon.
Saridon and other medicines
Inform your doctor about all medications you are currently taking, including those available without a prescription.
Your doctor should decide whether you may use Saridon if you are also taking the following medicines: rifampicin, certain sedatives, certain anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine), chloramphenicol (an antibiotic used in bacterial infections), oral anticoagulants of the coumarin group, warfarin, non-steroidal anti-inflammatory drugs, zidovudine (an antiviral drug), sedatives (barbiturates and antihistamines), benzodiazepines (anxiolytic drugs), sympathomimetics – drugs acting on the nervous system and, among others, reducing mucosal congestion (e.g. pseudoephedrine), thyroxine (a drug used in thyroid disease treatment), theophylline (a drug used in asthma and allergic conditions), cimetidine (a drug used in peptic ulcer disease treatment), disulfiram (a drug used in alcoholism treatment), oral contraceptives. These medications should be used with caution together with Saridon, as they may interact with its active ingredients.
During treatment with drugs delaying gastric emptying, such as propantheline, the absorption rate of paracetamol may be slowed, resulting in delayed analgesic effect. Accelerated gastric emptying, e.g. after taking metoclopramide, leads to faster absorption of paracetamol.
Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of fluid and electrolyte disturbances (metabolic acidosis with high anion gap), which require urgent treatment and may occur particularly in patients with severe renal dysfunction, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.
Pregnancy, breastfeeding and effects on 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 or pharmacist before using this medicine.
Pregnancy
Saridon should not be used during pregnancy, especially during the first and second trimesters and during the last six weeks. The drug may cause kidney and heart problems in the unborn child. Use of the drug may increase the risk of bleeding in both the mother and the child and may result in prolonged or delayed labor. From the 20th week of pregnancy, the drug may cause kidney problems in the fetus, leading to reduced amniotic fluid levels surrounding the fetus (oligohydramnios) or causing constriction of the ductus arteriosus in the fetal heart. In such cases, the doctor may recommend additional monitoring of the pregnancy. The drug may be used only if the potential benefits to the mother outweigh the risks to the fetus.
Breastfeeding
Saridon should not be used during breastfeeding. The drug's components pass into breast milk.
Fertility
Paracetamol may impair fertility. This effect reverses after discontinuation of paracetamol.
Driving and operating machinery
Saridon does not impair the ability to drive or operate machinery.

3. How to use Saridon

This medicine should always be taken exactly as described in the patient leaflet or according to the instructions of a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
The usual dose of Saridon for adults is 1-2 tablets; for adolescents aged 12-16 years - 1 tablet. If necessary, the dose may be repeated up to three times daily. If pain persists for more than 5 days, fever lasts longer than 3 days, symptoms worsen or new symptoms appear, discontinue use and consult a doctor. Do not use the product in doses higher than recommended.
Method of administration
Tablets should be taken with a large amount of water or another liquid.
Use of a higher than recommended dose of Saridon
Accidental or intentional overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the next day, although liver damage may begin to develop, later manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice. In cases of acute and/or chronic overdose, hypokalemia (reduced potassium concentration in blood) and metabolic acidosis, including lactic acidosis (decreased blood pH), may occur. In any case of ingestion of more than 20 Saridon tablets at once (5 g of paracetamol), vomiting should be induced (if less than one hour has passed since ingestion) and immediate contact with a doctor should be made.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody will experience them.
You must stop taking the medicine immediately and consult a doctor if any of the following occur:

very rare: allergic reactions such as skin rash, urticaria (hives), itching, erythema, angioedema (swelling of lips, tongue, throat or face), shortness of breath or asthma; in isolated reports, anaphylactic reactions (severe allergic reaction) or anaphylactic shock (acute, life-threatening allergic reaction) have been reported;
severe skin reactions (very rare): acute pustular rash over the entire body; Stevens-Johnson syndrome characterized by blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain; toxic epidermal necrolysis (which may be fatal), characterized by rupturing of large subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever; drug eruption, erythema multiforme.

You should stop taking the medicine and consult a doctor if any of the following occur:

liver failure, hepatitis, as well as dose-dependent liver dysfunction, liver necrosis (including fatal cases), manifested by nausea, vomiting, upper abdominal fullness, jaundice (yellowing of the skin and eyes), and liver tenderness;
blood disorders (single cases), such as reduction in granulocytes – a type of white blood cells (agranulocytosis), leading to increased susceptibility to infections; reduction in all blood cells (pancytopenia); reduction in platelet count (thrombocytopenia), leading to reduced blood clotting, petechiae and bruising;

reduction in white blood cells (leukopenia) associated with the use of paracetamol and
propyphenazone;

kidney damage, especially in cases of overdose.

During the use of Saridon medicine, the following adverse reactions may also occur:
gastrointestinal disturbances (heartburn, nausea, vomiting, gastric discomfort, diarrhoea, abdominal pain),
dizziness, drowsiness.
Chronic uncontrolled use may lead to hepatic fibrosis, liver cirrhosis (including fatal cases).
Caffeine, when used in high doses, may adversely affect the heart, causing: palpitations, sudden flushing,
high blood pressure, tachycardia.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Saridon

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack. 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 required. Such measures help protect the environment.

6. Contents of the pack and other information

What Saridon contains

The active substances are: paracetamol, propyphenazone, caffeine.
Other ingredients are: hypromellose, microcrystalline cellulose, esma-spreng, maize starch, talc, magnesium stearate, colloidal anhydrous silica.

What Saridon looks like and contents of the pack
The pack contains 10 or 20 tablets in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in the Netherlands, the country of export:
Bayer B.V.
Siriusdreef 36
2132 WT Hoofddorp
The Netherlands
Manufacturer:
Delpharm Gaillard
33, rue de l’industrie
F-74240 Gaillard
France
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Dutch marketing authorisation number in the country of export: RVG 03780
Parallel import authorisation number: 299/24