SARIDON 250 mg/150 mg /50 Mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents:
2. What is Saridon and what is it used for
   1. Indications:
3. Important information before taking Saridon
   1. When not to take Saridon
   2. Warnings and precautions
   3. Saridon and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
4. How to take Saridon
   1. How to take the medicine
   2. Overdose of Saridon
5. Possible side effects
   1. Frequency of occurrence: "frequency not known" (cannot be estimated from available data)
   2. Reporting side effects
6. How to store Saridon
7. Package contents and other information
   1. What Saridon contains
   2. What Saridon looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer:

Package Leaflet: Information for the Patient

SARIDON, 250 mg + 150 mg + 50 mg, tablets
Paracetamol + Propyphenazone + Caffeine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days in the case of fever and 5 days in the case of pain, no improvement occurs or the patient feels worse, they should contact their doctor.

Package Leaflet Contents:

• 1. What is Saridon and what is it used for
• 2. Important information before taking Saridon
• 3. How to take Saridon
• 4. Possible side effects
• 5. How to store Saridon
• 6. Package contents and other information

1. What is Saridon and what is it used for

Saridon is a combination medicine with a synergistic effect 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 flu.

2. Important information before taking Saridon

When not to take Saridon

• -if the patient has been diagnosed with hypersensitivity (allergy) to propyphenazone, paracetamol, caffeine, or any of the other ingredients,
• -if the patient has been diagnosed with hypersensitivity to pyrazolones or their derivatives (hypersensitivity to phenazone, aminophenazone, metamizole),
• if the patient has been diagnosed with hypersensitivity to phenylbutazone or acetylsalicylic acid,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase,
• if the patient has alcoholic disease,
• if the patient has severe liver failure (Child-Pugh > 9),
• if the patient has severe kidney failure,
• if the patient has acute hepatic porphyria,
• in children under 12 years of age,
• if the patient has blood system disorders,
• if the patient has Gilbert's syndrome,
• during the third trimester of pregnancy.

Warnings and precautions

• long-term use in people with Gilbert's syndrome (mild jaundice caused by enzyme deficiency - glucuronyltransferase), hematopoietic disorders (blood cell formation process). In these patients, it may be necessary to reduce the dose or duration of the medicine;
• liver failure (Child-Pugh <9), infections affecting liver function (e.g., viral hepatitis) or other liver diseases. For these patients, during high-dose or long-term treatment, the doctor will recommend regular liver function tests. Long-term use of paracetamol-containing medicines can lead to severe liver failure (e.g., liver cirrhosis). During therapeutic doses of paracetamol, an increase in alanine aminotransferase (ALT) levels in serum may occur;
• in patients with kidney diseases, dose adjustment by a doctor may be necessary. In patients with severe kidney failure (creatinine clearance <10 ml min), the doctor should assess benefit-to-risk ratio of using a paracetamol-containing medicine. long-term use paracetamol with other painkillers can lead to permanent kidney damage and an increased risk failure;< li>
• redness, rash, blisters, or flaking skin. The use of the medicine should be stopped, and a doctor should be consulted immediately;
• when the patient is taking other medicines, abusing alcohol, has sepsis, or has diabetes;
• when the patient has a hereditary deficiency of glucose-6-phosphate dehydrogenase, as there is a risk of hemolytic anemia (accelerated breakdown of red blood cells);
• if the patient is taking other painkillers containing paracetamol in addition to Saridon, as paracetamol overdose may occur. It should be checked if other recently taken medicines do not contain paracetamol;
• if the medicine is taken by patients with asthma, chronic rhinitis, or chronic urticaria, especially if they are allergic to other anti-inflammatory medicines, as there are known cases of allergic reactions and anaphylactic shock after the use of propyphenazone and paracetamol;
• when the medicine is used long-term. Long-term use of painkillers for headache treatment can lead to chronic headache. During the use of Saridon, a doctor should be informed immediately if the patient has severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (blood and fluid disorder) in patients taking paracetamol regularly for a longer period or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting. Alcohol should not be consumed during the use of Saridon.

Saridon and other medicines

The doctor should be informed about all medicines taken recently, including those available without a prescription.
The doctor should decide whether the patient can take Saridon if they are also taking the following medicines: rifampicin, certain sedatives, certain antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine), chloramphenicol (an antibiotic used in bacterial infections), oral anticoagulants from the coumarin group, warfarin, nonsteroidal anti-inflammatory medicines, zidovudine (an antiviral medicine), sedatives (barbiturates and antihistamines), benzodiazepines (anxiolytic medicines), sympathomimetic medicines - medicines acting on the nervous system, and others, including those reducing nasal congestion (e.g., pseudoephedrine), thyroxine (a medicine used in the treatment of thyroid diseases), theophylline (a medicine used in the treatment of asthma and allergic conditions), cimetidine (a medicine used in the treatment of stomach and duodenal ulcers), disulfiram (a medicine used in the treatment of alcoholism), oral contraceptives. These medicines should be used with caution with Saridon, as they may interact with the ingredients it contains.
During the use of medicines that slow down gastric emptying, such as propantheline, the absorption of paracetamol may be slowed down, which may delay the analgesic effect. Accelerated gastric emptying, e.g., after taking metoclopramide, leads to faster absorption of paracetamol.
A doctor or pharmacist should be informed if the patient is taking flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires immediate treatment (see section 2).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Saridon should not be taken during pregnancy, especially in the first and second trimesters, as well as during the last six weeks. The medicine may cause kidney and heart problems in the unborn child. The use of the medicine may increase the risk of bleeding in the patient and their child and may cause longer or delayed labor.
From the 20th week of pregnancy, the medicine may cause kidney problems in the fetus, leading to a decrease in the level of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the arterial duct in the fetus's heart. In such a situation, the doctor may recommend additional monitoring of the pregnancy. The medicine can be used only if the potential benefits to the mother outweigh the risks to the fetus.
Breastfeeding
The medicine should not be taken during breastfeeding. The ingredients of the medicine pass into breast milk.
Fertility
Paracetamol may affect fertility. This effect disappears after stopping the use of paracetamol.

Driving and using machines

The medicine does not affect the ability to drive vehicles or operate machines.

3. How to take Saridon

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
Recommended dose
Usually, the recommended dose of Saridon for adults is 1-2 tablets, for adolescents aged 12-16 - 1 tablet. If necessary, the dose can be repeated up to three times a day. If the pain persists for more than 5 days, the fever lasts for more than 3 days, the symptoms worsen, or additional symptoms occur, the use of the medicine should be stopped, and a doctor should be consulted. The product should not be used in doses higher than recommended.

How to take the medicine

The tablets should be taken with a large amount of water or other liquid.

Overdose of Saridon

Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may disappear the next day, despite the fact that liver damage is developing, which later manifests as abdominal distension, return of nausea, and jaundice. In case of acute and/or chronic overdose, hypokalemia (low potassium levels in the blood) and metabolic acidosis, including lactic acidosis (low blood pH), may occur. In any case of taking more than 20 Saridon tablets (5 g of paracetamol) at once, vomiting should be induced (if it has been less than an hour since ingestion) and a doctor should be consulted immediately.

4. Possible side effects

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

Frequency of occurrence: "frequency not known" (cannot be estimated from available data)

A serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
Immediatelystop taking the medicine and consult a doctor if the following occur:

• very rare: allergic reactions, such as skin rash, urticaria; itching, redness, angioedema (swelling of the lips, tongue, throat, or face), dyspnea, or asthma; anaphylactic reactions or anaphylactic shock (severe, life-threatening allergic reaction) have been reported in individual cases;
• severe skin reactions (very rare): acute pustular rash on the entire body; Stevens-Johnson syndrome characterized by blisters and ulcers on the skin, mouth, eyes, and genitals, fever, and joint pain; toxic epidermal necrolysis (potentially fatal) characterized by bursting large blisters under the skin, extensive skin ulcers, skin peeling, and fever; drug rash, erythema multiforme. The use of the medicine should be stopped, and a doctor should be consulted if the following occur:
• liver failure, hepatitis, as well as dose-dependent liver failure, liver necrosis (including fatal cases) characterized by nausea, vomiting, abdominal distension, yellowing of the skin and eyes, liver tenderness;
• blood disorders (individual cases), such as: decreased granulocyte count (agranulocytosis) leading to increased susceptibility to infections, decreased count of all blood cells (pancytopenia), decreased platelet count (thrombocytopenia) leading to decreased blood clotting, bruising, and petechiae, decreased white blood cell count (leukopenia) associated with the use of paracetamol and propyphenazone;
• kidney damage, especially in case of overdose. During the use of Saridon, the following side effects may also occur: gastrointestinal disorders (heartburn, nausea, vomiting, abdominal discomfort, diarrhea, abdominal pain), dizziness, drowsiness. Chronic uncontrolled use may lead to liver fibrosis, liver cirrhosis (including fatal cases).

Caffeine in high doses may have a negative effect on the heart, causing: palpitations, sudden flushing, high blood pressure, tachycardia.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Saridon

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Saridon contains

• The active substances of the medicine are: paracetamol, propyphenazone, caffeine.
• The other ingredients are: hypromellose, microcrystalline cellulose, esma-spreng, corn starch, talc, magnesium stearate, anhydrous colloidal silica.

What Saridon looks like and what the package contains

The package contains 10 or 20 tablets.

Marketing authorization holder

Bayer Sp. z o.o.
Jerozolimskie Avenue 158
02-326 Warsaw
Phone number: +48 22 572 35 00

Manufacturer:

Delpharm Gaillard
33 rue de l'Industrie
74240 Gaillard
France
Date of last update of the package leaflet:01.2025