Saridon

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Saridon

250 mg + 150 mg + 50 mg, tablets

Paracetamol + Propyphenazone + Caffeine

Read the 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 patient leaflet or as advised 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 or pharmacist. See section 4.
• If there is no improvement after 3 days in the case of fever and 5 days in the case of pain, or if 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 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 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-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 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 this may lead to paracetamol overdose. 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 hypersensitive to other anti-inflammatory drugs, 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.

Alcohol should not be consumed during the use of Saridon.

Saridon and other medicines

The doctor should be informed about all recently taken medicines, 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 drugs (e.g., phenobarbital, phenytoin, carbamazepine), chloramphenicol (an antibiotic used in bacterial infections), oral anticoagulants from the coumarin group, warfarin, nonsteroidal anti-inflammatory drugs, zidovudine (an antiviral drug), sedatives (barbiturates and antihistamines), benzodiazepines (anxiolytic drugs), sympathomimetic drugs - drugs acting on the nervous system and, among others, reducing nasal congestion (e.g., pseudoephedrine), thyroxine (a drug used in the treatment of thyroid diseases), theophylline (a drug used in the treatment of asthma and allergic conditions), cimetidine (a drug used in the treatment of gastric and duodenal ulcers), disulfiram (a drug used in the treatment of alcoholism), oral contraceptives. These medicines should be used with caution with Saridon, as they may interact with the substances contained in it.
When using drugs 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.
The 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 (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 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
During pregnancy, Saridon should not be taken, 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 patient's and their child's tendency to bleed 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 taken only if the potential benefits to the mother outweigh the risk 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 and operate machines.

3. How to take Saridon

This medicine should always be taken exactly as described in the patient leaflet or as advised 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 occur, the use of the medicine should be stopped, and a doctor should be consulted. The medicine should not be taken in doses higher than recommended.

Method of administration

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

Taking a higher dose of Saridon than recommended

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 beginning to develop, which later manifests as abdominal distension, return of nausea, and jaundice. In the case of acute and/or chronic overdose, hypokalemia (decreased 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, 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, this medicine can cause side effects, although not everybody gets them.
Immediatelystop taking the medicine and consult a doctor if:

• very rare allergic reactions, such as: skin rash, urticaria; itching, flushing, angioedema (swelling of the lips, tongue, throat, or face), dyspnea, 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 bursting large blisters under the skin, widespread erosions on the skin, exfoliation of large skin patches, and fever.

Stop taking the medicine 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, 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 the use of paracetamol and propyphenazone;
• kidney damage, especially in the case of overdose.

During the use of Saridon, the following side effects may also occur:
gastrointestinal disorders (heartburn, nausea, vomiting, stomach upset, 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects 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 packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of unused medicines. 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, formaldehyde casein (esma-spreng), corn starch, talc, magnesium stearate, colloidal silica.

What Saridon looks like and what the pack contains

The pack contains 10 or 20 tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number, country of export:RVG 03780
Parallel import authorization number:201/22

Date of leaflet approval: 29.08.2023

[Information about the trademark]