Saridon

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language

Saridon

250 mg + 150 mg + 50 mg, tablets

Paracetamol + Propyphenazone + Caffeine

You should carefully read the contents of the leaflet 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 advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your 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 you feel worse, you should contact your 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 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, 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 you have been diagnosed with an allergy (hypersensitivity) to propyphenazone, paracetamol, caffeine, or any of the other ingredients,
• if you have been diagnosed with an allergy to pyrazolones or their derivatives
• (hypersensitivity to phenazone, aminophenazone, metamizole),
• if you have been diagnosed with an allergy to phenylbutazone or acetylsalicylic acid,
• if you have a congenital deficiency of glucose-6-phosphate dehydrogenase,
• if you have alcoholic disease,
• if you have severe liver failure (Child-Pugh > 9),
• if you have severe kidney failure,
• if you have acute hepatic porphyria,
• in children under 12 years of age,
• if you have blood system disorders,
• if you have 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 individuals, 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 may 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 disease, 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 medicine.< li>
• Long-term use of paracetamol with other painkillers may lead to permanent kidney damage and an increased risk of kidney failure;
• redness, rash, blisters, or peeling skin. You should stop taking the medicine and contact your doctor immediately;
• when you are taking other medicines, abusing alcohol, or have sepsis or diabetes;
• when you have a hereditary deficiency of glucose-6-phosphate dehydrogenase, as there is a risk of hemolytic anemia (accelerated breakdown of red blood cells);
• if you are taking other painkillers containing paracetamol in addition to Saridon, as this may lead to paracetamol overdose. You should check if other recently taken medicines do not contain paracetamol;
• if you are taking Saridon and have asthma, chronic rhinitis, or chronic urticaria, especially if you are allergic to other anti-inflammatory medicines, as there are known cases of allergic reactions and anaphylactic shock after using propyphenazone and paracetamol;
• when the medicine is used long-term. Long-term use of painkillers for headache treatment may lead to chronic headache.

You should not drink alcohol while taking Saridon.

Saridon and other medicines

You should tell your doctor about all the medicines you have taken recently, including those available without a prescription.
Your doctor should decide whether you can take Saridon if you are also taking the following medicines: rifampicin, certain sleeping pills, certain antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine), chloramphenicol (an antibiotic used in bacterial infections), oral anticoagulants from the coumarin group, warfarin, non-steroidal anti-inflammatory medicines, zidovudine (an antiviral medicine), sedatives (barbiturates and antihistamines), benzodiazepines (anxiolytic medicines), sympathomimetic medicines - medicines that act on the nervous system and, among others, reduce nasal congestion (e.g., pseudoephedrine), thyroxine (a medicine used to treat thyroid diseases), theophylline (a medicine used to treat asthma and allergic conditions), cimetidine (a medicine used to treat stomach and duodenal ulcers), disulfiram (a medicine used to treat alcoholism), oral contraceptives. These medicines should be used with caution with Saridon, as they may interact with the substances contained in it.
When taking medicines that slow down gastric emptying, such as propanteline, 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.
You should inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

Saridon should not be used during pregnancy, especially in the first and second trimester and also during the last six weeks. The medicine may cause kidney and heart problems in the unborn child. Taking the medicine may increase the risk of bleeding in the mother and her 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 only be used if the potential benefits to the mother outweigh the risk to the fetus.

Breastfeeding

The medicine should not be used during breastfeeding. The ingredients of the medicine pass into breast milk.

Fertility

Paracetamol may affect fertility. This effect disappears after stopping paracetamol.

Driving and using machines

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

3. How to take Saridon

This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should speak to your 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 can be repeated up to three times a day. If the pain persists for more than 5 days, the fever lasts more than 3 days, the symptoms worsen, or additional symptoms occur, you should stop taking the medicine and consult your doctor. Do not take more than the recommended dose.

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, even though liver damage is developing, which will then 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 (decreased blood pH), may occur. In any case of taking more than 20 Saridon tablets (5 g of paracetamol) at once, you should induce vomiting (if it has been less than an hour since ingestion) and contact your doctor immediately.

4. Possible side effects

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

You should stop taking the medicine and contact your doctor immediately if you experience:

• very rare allergic reactions, such as: skin rash, urticaria; itching, redness, angioedema (swelling of the lips, tongue, throat, or face), difficulty breathing, or asthma; anaphylactic reactions (severe allergic reaction) or anaphylactic shock (life-threatening allergic reaction) have been reported in individual cases;
• severe skin reactions (very rare): acute generalized exanthematous pustulosis; Stevens-Johnson syndrome characterized by blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain; toxic epidermal necrolysis (potentially life-threatening) characterized by large blisters under the skin, widespread skin erosions, exfoliation of large skin areas, and fever.

You should stop taking the medicine and contact your doctor if you experience:

• 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, and liver tenderness;
• blood disorders (individual cases), such as: decreased granulocyte count - a type of white blood cell (agranulocytosis) causing a tendency to infections, decreased count of all blood cells (pancytopenia), decreased platelet count (thrombocytopenia) causing reduced blood clotting, bruising, and petechiae,

decreased white blood cell count (leukopenia) associated with paracetamol and propyphenazone use;

• kidney damage, especially in case of overdose.

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, you can help 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 at a temperature below 25°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 containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 contents of the pack

The pack contains 10 or 20 tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Bayer B.V.
Siriusdreef 36
2132 WT Hoofddorp
Netherlands

Manufacturer:

Delpharm Gaillard
33, rue de l’industrie
F-74240 Gaillard
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Netherlands, the country of export: RVG 03780
Parallel import authorization number: 299/24

Date of leaflet approval: 24.07.2024

[Information about the trademark]