Saridon

Package leaflet: Information for the patient

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 using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, please consult a pharmacist.
• If any adverse reactions occur, 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 of the leaflet:

1. What Saridon is and what it is used for
2. What you need to know before taking Saridon
3. How to take Saridon
4. Possible side effects
5. How to store Saridon
6. 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 influenza.

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.

Warnings and precautions

• prolonged use in patients with Gilbert's syndrome (mild jaundice caused by deficiency of the enzyme glucuronyltransferase), or hematopoietic disorders (blood cell formation). In these patients, a reduced dose 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 monitoring of liver function tests. Long-term use of medications containing paracetamol may lead to severe liver damage (e.g. liver 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 evaluate the benefit-risk ratio of using a medication containing paracetamol. 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 immediately and medical advice sought without delay;
• when the patient is taking other medications simultaneously, abusing alcohol, has sepsis, or diabetes;
• when the patient has hereditary glucose-6-phosphate dehydrogenase deficiency, as there is a risk of hemolytic anemia (accelerated breakdown of red blood cells);
• if the patient is taking other analgesics containing paracetamol in addition to Saridon, as this may lead to paracetamol overdose. It is important to check whether other recently used medications contain paracetamol;
• if the patient has asthma, chronic rhinitis, or chronic urticaria, especially if hypersensitive 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.

Alcohol should not be consumed during treatment with Saridon.
Saridon and other medicines
Inform your doctor about all medications recently taken, including those available without a prescription.
Your doctor should decide whether you may 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 medication), 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 medication used in thyroid disorders), theophylline (a medication used in asthma and allergic conditions), cimetidine (a medication used in peptic ulcer disease), disulfiram (a medication used in alcoholism treatment), or oral contraceptives. These medications should be used with caution together with Saridon, as they may interact with its active ingredients.
During treatment with drugs that delay gastric emptying, such as propanteline, 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 blood and body fluid disorder (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal dysfunction, sepsis (a condition where 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 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
The decision to administer the medication will be made by a physician. Saridon should not be used during pregnancy, particularly during the first trimester and the last six weeks. The medication may be used only if the potential benefit to the mother outweighs the risk to the fetus.
Breastfeeding
The medication should not be used during breastfeeding. The active ingredients 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 take Saridon

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
The usual dose of Saridon in adults is 1-2 tablets; in 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.

Taking more Saridon than recommended
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 have started developing, which subsequently manifests as 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 (reduced 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 attention.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody gets 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 reactions (very rare): acute generalized pustular rash; 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 large bullae under the epidermis, 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, including dose-dependent liver failure, 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 granulocyte count
  • 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 reduced blood coagulability, petechiae and bruising, reduction in white blood cell count (leukopenia) associated with paracetamol and propyphenazone use;
• kidney damage, especially in cases of overdose.

During use of Saridon, 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 liver fibrosis, liver cirrhosis (including fatal cases).
Caffeine, when used in high doses, may adversely affect the heart causing: palpitations, sudden flushing, high arterial blood pressure, tachycardia.
Reporting of adverse reactions
If any adverse symptoms occur, including any 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
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 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Saridon contains

• The active substances in the medicine are: paracetamol, propyphenazone, caffeine.
• Other components: hypromellose, microcrystalline cellulose, casein formaldehyde (esma-spreng), maize starch, talc, magnesium stearate, anhydrous colloidal silicon dioxide.

What Saridon looks like and contents of the pack
The pack contains 10 or 20 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Netherlands, country of export:
Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
The Netherlands
Manufacturer:
Delpharm Gaillard
33 rue de l’Industrie
F-74240 Gaillard
France
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Number of marketing authorisation in the Netherlands, country of export: RVG 03780
Parallel Import Authorisation Number: 10/22