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
your doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for fever or 5 days for pain, or if your condition worsens, consult your doctor.

Table of contents:

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 cold and flu.

2. Important information before using Saridon

When not to use Saridon

• if the patient has hypersensitivity to propyphenazone, paracetamol, caffeine, or any of the other excipients,
• 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 impairment (Child-Pugh score > 9),
• if the patient has severe renal impairment,
• if the patient has acute hepatic porphyria,
• in children under 12 years of age,
• if the patient suffers from disorders of the haematopoietic system,
• 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 haematopoietic disorders. In these patients, a reduced dose or duration of treatment may be necessary;
• hepatic impairment (Child-Pugh score < 9), infections affecting liver function (e.g. viral hepatitis), or other liver diseases. For these patients, the doctor may recommend regular monitoring of liver function tests during high-dose or long-term treatment. Long-term use of medications containing paracetamol may lead to severe liver failure (e.g. cirrhosis). During treatment with therapeutic doses of paracetamol, an increase in serum alanine aminotransferase (ALT) levels may occur;
• in patients with kidney disease, dosage adjustment by the physician may be necessary. In patients with severe renal impairment (creatinine clearance <10 ml/min), the physician should assess the benefit-risk ratio of using a paracetamol-containing medicine. 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 medicine should be discontinued and medical advice sought immediately;
• when the patient is taking other medicines, abusing alcohol, or has sepsis or diabetes;
• when the patient has hereditary glucose-6-phosphate dehydrogenase deficiency, as there may be a risk of haemolytic anaemia (accelerated breakdown of red blood cells);
• if, in addition to Saridon, the patient is taking other analgesics containing paracetamol, as this may lead to paracetamol overdose. It is necessary to check whether other recently taken medicines contain paracetamol;
• if the medicine 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 medicine is used long-term. Long-term use of analgesics for headache treatment may lead to chronic headache.

Do not drink alcohol while taking Saridon.
Saridon and other medicines
Inform your doctor about all medicines 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 medicines: 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 medicine), sedatives (barbiturates and antihistamines), benzodiazepines (anxiolytic medicines), sympathomimetic agents – medicines acting on the nervous system and, among others, reducing mucosal congestion (e.g. pseudoephedrine), thyroxine (a medicine used in thyroid disease treatment), theophylline (a medicine used in asthma and allergic conditions), cimetidine (a medicine used in peptic ulcer disease), disulfiram (a medicine used in alcoholism treatment), oral contraceptives. The above-mentioned medicines should be used with caution together with Saridon, as they may interact with its active substances.
During treatment with medicines that delay gastric emptying, such as propantheline, the absorption rate of paracetamol may be slowed, leading to 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 a disorder affecting blood and body fluids (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal impairment, 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Saridon should not be used during pregnancy, especially during the first and second trimesters and during the last six weeks. The medicine may cause kidney and heart problems in the unborn child. Its use may increase the tendency to bleeding in the mother and her child and may result in prolonged or delayed labour.
From the 20th week of pregnancy, the medicine may cause kidney problems in the foetus, which may lead to reduced amniotic fluid levels surrounding the foetus (oligohydramnios) or cause constriction of the ductus arteriosus in the foetal heart. In such cases, the doctor may recommend additional monitoring of the pregnancy. The medicine may be used only if the potential benefits to the mother outweigh the risks to the foetus.
Breastfeeding
Saridon should not be used during breastfeeding. The active substances of the medicine 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 according to the instructions of a doctor or pharmacist. If in doubt, consult a 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 take more than the recommended dose.
How to take the medicine
Tablets should be taken with a large amount of water or another liquid.
Taking a higher than recommended dose of Saridon
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, 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 (decreased 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 (5 g of paracetamol) at one time, vomiting should be induced (if less than one hour has passed since ingestion) and immediate medical advice must be sought.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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), dyspnoea 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, accompanied by fever and joint pain; toxic epidermal necrolysis (which may be fatal), characterized by rupturing giant blisters 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, as well as dose-dependent liver failure, liver necrosis (including fatal cases), manifested by nausea, vomiting, upper abdominal fullness, jaundice (yellowing of the skin and eyes), liver tenderness;
• blood disorders (single cases), such as: reduction in the number of granulocytes – a type of white blood cells (agranulocytosis) leading to increased susceptibility to infections, reduction in all blood cells (pancytopenia), reduction in the number of platelets (thrombocytopenia) causing reduced blood coagulation, petechiae and bruising, reduction in the number of white blood cells (leukopenia) associated with the use of paracetamol and propyphenazone;
• kidney damage, especially in cases of overdose.

During the use of Saridon, the following adverse reactions may also occur:
gastrointestinal disturbances (heartburn, nausea, vomiting, stomach upset, diarrhoea, abdominal pain),
dizziness, drowsiness.
Chronic uncontrolled use may lead to hepatic fibrosis, liver cirrhosis (including fatal outcomes).
Caffeine, when used in high doses, may adversely affect the heart causing: palpitations, sudden flushing, high blood pressure, tachycardia.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Saridon contains

• The active substances in this medicine are: paracetamol, propyphenazone, caffeine.
• The other ingredients are: hypromellose, microcrystalline cellulose, casein formaldehyde (esma-spreng), maize starch, talc, magnesium stearate, 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.
Siriusdreef 36
2132 WT Hoofddorp
The Netherlands
Manufacturer:
Delpharm Gaillard
33, rue de l’industrie
F-74240 Gaillard
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in the Netherlands, country of export: RVG 03780
Parallel import authorisation number: 201/22