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 so that it can be read again if necessary.
• 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 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, postoperative 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.

Warnings and precautions

• prolonged 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 medications can lead to severe liver failure (e.g., liver cirrhosis). During therapeutic doses of paracetamol, there may be an increase in the serum alanine aminotransferase (ALT) level;
• 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-to-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 flaky skin. The use of the medicine should be discontinued, 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 whether other recently taken medicines 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 for a long time. 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 Saridon with caution, as they may interact with the substances contained in it.
During the use of 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, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The decision to take the medicine will be made by the doctor. During pregnancy, Saridon should not be taken, especially in the first trimester and during the last six weeks. The medicine can be used 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 the breast milk of nursing mothers.
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 directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
Recommended dose
Usually, the recommended 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 longer than 3 days, the symptoms worsen, or additional symptoms appear, the use of the medicine should be discontinued, and a doctor should be consulted. The product should not be used in doses higher than recommended.

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, despite the fact that liver damage is developing, 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, 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 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 fatal) characterized by bursting giant blisters under the skin, widespread erosions on the skin, exfoliation of large skin areas, 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, 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
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 given month.
Medicines should not be disposed of in the sewage system 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, anhydrous 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.
Energieweg 1
3641 RT Mijdrecht
Netherlands

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
Netherlands marketing authorization number: RVG 03780

Parallel import authorization number: 10/22 Date of leaflet approval: 10.10.2022

[Information about the trademark]