Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Saridon
250 mg + 150 mg + 50 mg, tablets
Paracetamolum + Propyphenazonum + Coffeinum
Please read the entire 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
a doctor or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days in case of fever or 5 days in case of pain, or if the patient feels worse, contact a doctor.

Table of contents:

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 colds and influenza.

2. Important information before using Saridon

When not to use Saridon

if the patient has a known allergy (hypersensitivity) to propyphenazone, paracetamol, caffeine, or any of the other ingredients,
if the patient has a known allergy to pyrazolones or their derivatives (hypersensitivity to phenazone, aminophenazone, metamizole),
if the patient has a known allergy to phenylbutazone or acetylsalicylic acid,
if the patient has congenital glucose-6-phosphate dehydrogenase deficiency,
if the patient has alcoholic 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 a deficiency of the enzyme glucuronyltransferase) or hematopoietic disorders (blood cell formation). In these patients, a dose reduction or shorter duration of treatment may be necessary;
hepatic insufficiency (Child-Pugh score < 9), infections affecting liver function (e.g. viral hepatitis), or other liver diseases. For these patients, during high-dose or long-term treatment, the physician may recommend regular liver function tests. Long-term use of medications containing paracetamol may lead to severe liver failure (e.g. cirrhosis). During therapeutic doses of paracetamol, serum alanine aminotransferase (ALT) levels may increase;
in patients with kidney disease, 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 paracetamol-containing medication. Long-term use of paracetamol with other analgesics may lead to permanent kidney damage and risk of renal failure;
redness, rash, blisters, or peeling skin. The use of the medication should be discontinued and immediate medical advice sought;
when the patient is taking other medications, abusing alcohol, or has sepsis or diabetes;
in patients with 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. It is important to check whether other recently used 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. Long-term use of analgesics for headache treatment may lead to chronic headache.

Alcohol should not be consumed while taking Saridon.
Saridon and other medicines
Inform your doctor about all medications you have recently taken, including those available without a prescription.
Your doctor should decide whether you can use Saridon if you are also taking the following medications: 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), sympathomimetic drugs – drugs acting on the nervous system and, among others, reducing mucosal congestion (e.g. pseudoephedrine), thyroxine (a drug used in thyroid disorders), theophylline (a drug used in asthma and allergic conditions), cimetidine (a drug used in peptic ulcer disease), 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 components.
During treatment with drugs that delay gastric emptying, such as propantheline, the absorption rate of paracetamol may be slowed, thereby delaying the onset of analgesic effect. Accelerated gastric emptying, e.g. after 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 a disorder affecting blood and body fluids (metabolic acidosis with a high anion gap), which requires 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 medication.
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. Its use may increase the risk of bleeding in both the mother and the child and may result in prolonged or delayed labor.
Starting from the 20th week of pregnancy, the drug may cause kidney problems in the fetus, which may lead to reduced amniotic fluid levels surrounding the fetus (oligohydramnios) or cause 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 the breast milk of nursing mothers.
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 as directed by 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, the dose is 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 occur, 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.

Overdose 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, even though 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 (decreased 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), induce vomiting (if less than one hour has passed since ingestion) and seek immediate medical advice.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediately discontinue use of the medicine and consult a doctor if any of the following occur:

very rare: allergic reactions such as skin rash, urticaria; 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 reaction (very rare): acute pustular rash over the entire body; Stevens-Johnson syndrome manifested by blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain; toxic epidermal necrolysis (can be fatal) manifested by rupturing of large subepidermal blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever; drug eruption, erythema multiforme.

Discontinue use of the medicine and consult a doctor if any of the following occur:

liver failure, hepatitis, as well as dose-dependent liver failure, liver necrosis (including fatal cases) manifested by nausea, vomiting, bloating in the upper abdomen, yellowing of the skin and eyes, liver tenderness;
blood disorders (single cases), such as: reduction in granulocyte count
of a certain type of white blood cells (agranulocytosis) causing increased susceptibility to infections, reduction in all blood cells (pancytopenia), reduction in platelet count (thrombocytopenia) causing decreased blood coagulation, petechiae and bruising, reduction in white blood cell count (leukopenia) associated with the use of paracetamol and propyphenazone;
kidney damage, especially in cases of overdose.

During the use of Saridon, the following adverse reactions may also occur:
gastrointestinal disturbances (heartburn, nausea, vomiting, stomach discomfort, diarrhoea, abdominal pain),
dizziness, drowsiness.
Chronic uncontrolled use may lead to liver 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 reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. 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
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Saridon

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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 Saridon contains

The active substances are: 250 mg paracetamol, 150 mg propyphenazone, 50 mg caffeine.
The 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.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in the Netherlands, 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing authorisation number in the Netherlands, country of export: RVG 03780
Parallel import authorisation number: 166/23