Saridon

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Saridon, 250 mg + 150 mg + 50 mg, tablets

Paracetamol + Propyphenazone + Caffeine

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

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

• The 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 leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 3 days in the case of fever and 5 days in the case of pain, there is no improvement or the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet:

• 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. Contents of the pack and other information

1. What is Saridon and what is it used for

Saridon is a combination medicine with a combined 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, post-operative 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 an allergy (hypersensitivity) to propyphenazone, paracetamol, caffeine, or any of the other ingredients,
• -if the patient has been diagnosed with an allergy to pyrazolones or their derivatives (hypersensitivity to phenazone, aminophenazone, metamizole),
• if the patient has been diagnosed with an allergy 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 treatment;
• 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 medications 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-risk ratio of using a paracetamol-containing medication. 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 medication should be stopped, and a doctor should be consulted immediately;
• when the patient is taking other medications, abusing alcohol, has sepsis, or 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 medications do not contain paracetamol;
• if the medication is taken by patients with asthma, chronic rhinitis, or chronic urticaria, especially if they are allergic to other anti-inflammatory medications, as isolated cases of allergic reactions and anaphylactic shock have been reported after the use of propyphenazone and paracetamol,
• when the medication 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 or sepsis disorders (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 who use paracetamol in regular doses for a longer period or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. Alcohol should not be consumed during the use of Saridon.

Saridon and other medications

A doctor should be informed about all medications taken recently, including those available without a prescription. The doctor should decide whether the patient can take Saridon if they are also taking: rifampicin, certain sedatives, certain antiepileptic medications (e.g., phenobarbital, phenytoin, carbamazepine), chloramphenicol (an antibiotic used in bacterial infections), oral anticoagulants from the coumarin group, warfarin, non-steroidal anti-inflammatory medications, zidovudine (an antiviral medication), sedatives (barbiturates and antihistamines), benzodiazepines (anxiolytic medications), sympathomimetic medications - medications that affect the nervous system and, among others, reduce nasal congestion (e.g., pseudoephedrine), thyroxine (a medication used to treat thyroid diseases), theophylline (a medication used to treat asthma and allergic conditions), cimetidine (a medication used to treat stomach and duodenal ulcers), disulfiram (a medication used to treat alcoholism), oral contraceptives. These medications should be used with Saridon with caution, as they may interact with the substances contained in it. During the use of medications that slow down stomach emptying, such as propanteline, the absorption of paracetamol may be slowed down, which may delay the analgesic effect. Accelerated stomach 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 disorder affecting blood and body fluids (called metabolic acidosis), which should be treated urgently (see section 2).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication. PregnancySaridon should not be taken during pregnancy, especially in the first and second trimesters and during the last six weeks. The medication may cause kidney and heart disorders in the unborn child. The use of the medication may increase the patient's and their child's tendency to bleed and may cause longer or delayed labor. From the 20th week of pregnancy, the medication 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 medication can be used only if the potential benefits to the mother outweigh the risks to the fetus. BreastfeedingThe medication should not be taken during breastfeeding. The ingredients of the medication pass into the breast milk of breastfeeding women. FertilityParacetamol may affect fertility. This effect disappears after stopping the use of paracetamol.

Driving and using machines

The medication does not affect the ability to drive vehicles and use machines.

3. How to take Saridon

This medication should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.

Recommended dose

The usual 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 appear, the use of the medication should be stopped, and a doctor should be consulted. The product should not be used in doses higher than recommended.

How to take the medication

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

Overdose of Saridon

Accidental or intentional overdose of the medication 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 will later manifest 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 (decrease in 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 medications, Saridon can cause side effects, although they may not occur in every patient.

Frequency of occurrence: "unknown frequency" (cannot be determined based on 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 medication and consult a doctor if:

• very rare allergic reactions, such as: skin rash, urticaria; itching, redness, angioedema (swelling of the lips, tongue, throat, or face), shortness of breath, or asthma; anaphylactic reactions (severe allergic reaction) or anaphylactic shock (life-threatening allergic reaction) have been reported in isolated 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 large blisters under the skin, extensive skin ulcers, skin exfoliation, and fever; drug rash, erythema multiforme.

Stop taking the medication and consult a doctor if:

• 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 (isolated cases), such as: decreased granulocyte count (agranulocytosis) leading to a tendency 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, restlessness in the stomach, diarrhea, abdominal pain), dizziness, drowsiness. Chronic uncontrolled use can lead to liver fibrosis, liver cirrhosis (including fatal cases). Caffeine used in high doses can 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 leaflet, a doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 By reporting side effects, more information on the safety of the medication can be collected.

5. How to store Saridon

The medication should be stored in a place invisible and inaccessible to children. Do not store above 30°C. Store in the original packaging to protect from moisture. Do not use this medication after the expiry date stated on the packaging. The expiry date means the last day of the specified month. Medications should not be disposed of in the sewage system or household waste containers. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Saridon contains

• The active substances of the medication are: paracetamol, propyphenazone, caffeine.
• Other ingredients are: hypromellose, microcrystalline cellulose, formaldehyde casein (esma-spreng), cornstarch, talc, magnesium stearate, anhydrous colloidal silica.

What Saridon looks like and what the pack contains

White, round, biconvex tablets with beveled edges, with the inscription "Saridon" on one side and a dividing line on the other. The dividing line is intended to facilitate breaking the tablet, not to divide it into equal doses. The packaging contains 10 or 20 tablets. For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Lithuania, the country of export:

UAB Bayer Sporto 18 LT-09238 Vilnius Lithuania

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 by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Authorization number in Lithuania, the country of export: LT/1/94/0863/001

Parallel import authorization number: 149/15

Date of leaflet approval: 19.03.2025

[Information about the trademark]