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
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 doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, 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, consult a doctor.

Table of contents of the leaflet:

1. What Saridon is and what it is 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 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 hypersensitivity (allergy) to propyphenazone, paracetamol, caffeine, or any of the other ingredients,
• if the patient has a known hypersensitivity to pyrazolones or derivatives of these compounds (hypersensitivity to phenazone, aminophenazone, metamizole),
• if the patient has a known hypersensitivity to phenylbutazone or acetylsalicylic acid,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase,
• 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,
• 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 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 doctor may recommend regular liver function tests. Prolonged use of medications containing paracetamol may lead to severe liver failure (e.g. liver cirrhosis). During therapeutic doses of paracetamol, an increase in serum alanine aminotransferase (ALT) levels may occur;
• in patients with kidney diseases, 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 medication containing paracetamol. Prolonged use of paracetamol with other analgesics may lead to permanent kidney damage and risk of renal failure;
• redness, rash, blisters, or peeling skin. The medication should be discontinued immediately and the patient should contact a physician without delay;
• when the patient is taking other medications, abusing alcohol, or 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 analgesics containing paracetamol in addition to Saridon, as this may lead to paracetamol overdose. It is important to check whether other recently taken 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. Prolonged use of analgesics for headache treatment may lead to chronic headache.

During treatment with Saridon, the patient should immediately inform the physician if they have severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (an abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly over a long period or who take paracetamol together 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 treatment with Saridon.

Saridon and other medicines

Inform your doctor about all medications you are currently taking, 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 (anti-anxiety drugs), sympathomimetics – 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), 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, thereby delaying the 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 a disturbance in blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2).

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 her 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 medication may cause kidney and heart-related disorders in the unborn child. Its use may increase the tendency to bleeding in both the mother and the child and may result in prolonged or delayed labor.

Starting from the 20th week of pregnancy, the medication may cause kidney problems in the fetus, leading to reduced amniotic fluid levels surrounding the fetus (oligohydramnios) or causing constriction of the ductus arteriosus in the fetal heart. In such cases, the physician may recommend additional monitoring of the pregnancy. The medication may be used only if the potential benefits to the mother outweigh the risks 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 upon discontinuation of paracetamol.

Driving and operating machinery

The medication 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 - 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
The tablets should be taken with a large amount of water or other liquid.
Overdose of Saridon
Accidental or intentional overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness and general weakness within a few to several hours. These symptoms may subside the next day, although 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 (reduced 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), vomiting should be induced (if less than one hour has passed since ingestion) and immediate medical advice must be sought.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequency of occurrence: "frequency not known" (cannot be estimated from the available data)
A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).
Immediately stop using 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 pustular rash over the entire body; Stevens-Johnson syndrome characterized by blisters and erosions on the skin, in the mouth, eyes and genital organs, accompanied by fever and joint pain; toxic epidermal necrolysis (which may be fatal), characterized by rupture of large blisters under the epidermis, extensive skin erosions, shedding of large epidermal sheets 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, bloating in the upper abdomen, yellowing of the skin and eyes (jaundice), liver tenderness;
• blood disorders (single cases), such as: reduction in granulocytes
  • a certain type of white blood cells (agranulocytosis) leading to increased susceptibility to infections, reduction in all blood cells (pancytopenia), reduction in platelets (thrombocytopenia) leading to reduced blood clotting, petechiae and bruising, reduction in white blood cells (leukopenia) associated with the use of paracetamol and propyphenazone;
• kidney damage, especially in cases of overdose.

The following adverse effects may also occur during the use of Saridon:
gastrointestinal disturbances (heartburn, nausea, vomiting, stomach discomfort, diarrhoea, abdominal pain),
dizziness, drowsiness.
Chronic uncontrolled use may lead to hepatic fibrosis, liver cirrhosis (including cases resulting in death).
Caffeine, when used in high doses, may adversely affect the heart, causing: palpitations, sudden flushing, high blood pressure, tachycardia.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 effects helps to provide more information on the safety of the medicine.

5. How to store Saridon

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the container.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Saridon contains

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

What Saridon looks like and contents of the pack
White, round, biconvex tablets with bevelled edges, embossed with the word
“Saridon” on one side and a break line on the other side.
The break line is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
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 Lithuania, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Lithuania, country of export: LT/1/94/0863/001
Parallel import authorisation number: 149/15