Saridon 250 mg/150 mg/50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Saridon 250 mg/150 mg/50 mg tablets

Paracetamol/Propyphenazone/Caffeine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if your pain does not improve after 5 days or your fever after 3 days.

Contents of the leaflet

1. What Saridon is and what it is used for
2. What you need to know 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 of paracetamol and propyphenazone, which act on pain and fever, and caffeine, which has a central nervous system stimulating effect.

This medicine is indicated for the symptomatic relief of mild to moderate pain, such as headache, dental pain, or menstrual pain, and for feverish conditions in adults.

2. What you need to know before taking Saridon

Do not take Saridon:

• If you are allergic (hypersensitive) to paracetamol, caffeine, propyphenazone, metamizole, phenylbutazone or other pyrazolones, or to any of the other ingredients of this medicine (listed in section 6),
• If you have severe kidney, liver, or heart disease (renal, hepatic, or cardiac insufficiency),
• If you have severe uncontrolled hypertension,
• If you have a metabolic disorder such as porphyria (a rare, usually hereditary condition characterized by excessive excretion of porphyrins in feces and urine) or congenital glucose-6-phosphate dehydrogenase deficiency,
• If you have blood disorders (granulocytopenia, agranulocytosis),
• If you have active gastroduodenal ulcer,
• If you have previously experienced asthma-like allergic reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• During the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Saridon:

• If you have anemia, arterial hypertension, hyperactive thyroid function (hyperthyroidism), gastritis (inflammation of the stomach), or diseases of the kidney or liver, or if you are over 65 years old,
• If you have or have had heart disorders (cardiac arrhythmia, myocardial ischemia...) especially during physical exercise or when in high-altitude environments,
• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as this may cause thickening of secretions and impair expectoration,
• If you notice skin redness, rash, blisters, or peeling, stop treatment immediately and consult your doctor,
• If you are dehydrated, suffer from chronic malnutrition, or have Gilbert's syndrome (characterized by elevated blood bilirubin levels),
• If you have mental disorders causing nervous excitement or seizures with or without loss of consciousness (epilepsy).

During treatment with Saridon, inform your doctor immediately if you develop serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Do not take more medicine than recommended in section 3. How to take Saridon.

Do not take this medicine continuously or together with other painkillers.

Concurrent use of this medicine with other medicines containing paracetamol should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

It is recommended to limit the use of products containing caffeine while being treated with this medicine.

In individuals with sleep difficulties, it is recommended not to take this medicine in the hours before bedtime to avoid possible insomnia.

Children and adolescents

Use of this medicine is not recommended.

Interaction of Saridon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

In particular, if you are taking any of the following medicines, a dose adjustment or discontinuation of treatment may be necessary:

• ethyl alcohol,
• other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), or lithium,
• oral anticoagulants (medicines used to "thin" the blood and prevent clot formation) such as warfarin,
• anticholinergics (medicines used to relieve spasms or contractions of the stomach, intestines, and bladder) such as propantheline,
• oral contraceptives,
• antiepileptics (medicines used to treat epilepsy) such as lamotrigine, phenytoin,
• antigout agents (medicines used to treat gout) such as probenecid,
• antihistamines (used to reduce symptoms of allergic reactions),
• anti-infective quinolones or erythromycin (antibiotics used to treat infections),
• antituberculosis medicines (medicines used to treat tuberculosis) such as isoniazid,
• barbiturates (medicines used to treat seizures),
• beta-blockers (medicines used to control hypertension),
• bronchodilators (medicines used to treat bronchial asthma),
• calcium,
• cimetidine (used for stomach acidity and stomach ulcers),
• cytochrome P450,
• chloramphenicol (an antibiotic used for severe infections such as typhoid fever),
• cholestyramine (a medicine used to lower blood cholesterol levels),
• corticosteroids, as they may increase the risk of gastrointestinal bleeding,
• disulfiram (used in the treatment of alcohol recovery),
• diuretics and ACE inhibitors (used to treat high blood pressure),
• iron (used to treat anemia); it is recommended to separate administration by at least 2 hours,
• medicines containing caffeine or those that stimulate the central nervous system,
• medicines that may affect blood composition (antimalarials, antithyroid agents, sulfonamides...),
• metoclopramide, domperidone, tropisetron, and granisetron (used to prevent nausea and vomiting),
• mexiletine (used to correct heart rhythm disorders such as cardiac arrhythmias),
• propranolol (used in the treatment of high blood pressure and heart disorders),
• sympathomimetics (used to increase blood pressure),
• substances with broad-spectrum activity such as benzodiazepines or clozapine,
• tobacco,
• theophylline (used to treat bronchial asthma),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV),
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) requiring urgent treatment (see section 2).

Taking Saridon with food, drinks, and alcohol

If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits, etc.—per day), taking Saridon may cause stomach bleeding or liver damage.

Limit consumption of beverages containing caffeine (coffee, tea, chocolate, cola drinks) while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Saridon during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery.

This medicine may cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby, possibly delaying labor or prolonging it beyond the expected duration.

You should not take Saridon during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or while trying to conceive, the dose should be limited to the lowest possible for the shortest possible time.

If you take Saridon for several days starting from week 20 of pregnancy, it may cause kidney problems in the fetus, which could lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment is needed, your doctor may recommend additional monitoring.

Driving and use of machines

Do not drive or operate heavy machinery, as this medicine may cause drowsiness or reduced reaction ability even at recommended doses.

3. How to take Saridon

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your physician or pharmacist. In case of doubt, ask your physician or pharmacist.

The recommended dose is:

Adults: Take 1 to 2 tablets every 4 or 6 hours (6 or 4 times daily), as needed. Do not take more than 6 tablets (equivalent to 1500 mg of paracetamol/900 mg of propyphenazone) in any 24-hour period.

Do not exceed 3 g of paracetamol in any 24-hour period (see section Warnings and precautions).

Always use the lowest effective dose.

Patients with kidney or liver disease, or aged 65 years or older: Consult your doctor before taking this medicine.

Use in children and adolescents

Use is not recommended in individuals under 18 years of age.

Method of administration:

This medicine is administered orally.

The tablets should be swallowed whole, split, or crushed with food or water.

Take preferably with food if gastrointestinal discomfort occurs.

Do not take the last dose within the 6 hours before going to bed to avoid possible insomnia, especially in patients with difficulty sleeping.

Administration of this medicine should only occur when pain or fever symptoms are present. As symptoms resolve, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if symptoms worsen or new symptoms appear, discontinue treatment and consult your doctor.

If you take more Saridon than you should

Symptoms of overdose may include: nausea, dizziness, vomiting, loss of appetite, jaundice (yellowing of the skin and eyes), abdominal pain, kidney or liver failure, sweating, and general malaise.

If you have ingested an overdose, you must immediately go to a medical center even if you do not feel symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Common adverse effects (may affect up to 1 in 100 people):

• Gastrointestinal disorders such as nausea and vomiting.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Hypotension (low blood pressure),
• Increased levels of liver transaminases (markers of liver function),
• Malaise.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Skin-type reactions such as redness or itching, skin disorders with blister formation, urticaria, anaphylactic shock (a severe allergic reaction that may be fatal), serious skin reactions,
• Dyspnea,
• Blood cell count abnormalities such as thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia,
• Hypoglycemia (decreased blood glucose levels),
• Hepatotoxicity (jaundice: yellowing of the skin and eyes),
• Sterile pyuria (cloudy urine), adverse effects on kidney and liver.

Adverse effects for which frequency cannot be precisely estimated:

• Gastrointestinal discomfort such as stomach discomfort, diarrhea, and abdominal pain,
• Dizziness, vertigo, somnolence, restlessness, nervousness, headache, or insomnia due to caffeine,
• Respiratory problems such as bronchospasm and asthma, including analgesic-induced asthma syndrome,
• Blood disorders such as thrombocytopenic purpura and pancytopenia,
• Hyperglycemia (increased blood glucose levels),
• Skin disorders such as edema (swelling), allergic angioedema, rashes, generalized severe pustular eruptions (with pus), outbreaks, erythema multiforme, toxic epidermal necrolysis (a serious skin disease characterized by blistering),
• Liver disorders such as liver failure, hepatitis, dose-dependent hepatic failure, hepatic necrosis (including fatal outcomes),
• Kidney disorders such as kidney damage, especially in cases of overdose.
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Treatment must be immediately discontinued if the patient experiences any episode of dizziness or palpitations.

High doses of caffeine may cause palpitations, tachycardia, and increased blood pressure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Saridon

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use Saridon after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point located at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Saridon

• The active substances are: paracetamol, 250 mg; propyphenazone, 150 mg; and caffeine, 50 mg.
• The other components (excipients) are: microcrystalline cellulose, hydroxypropyl methylcellulose, formaldehyde-casein, corn starch, talc, magnesium stearate, anhydrous colloidal silica.

Appearance of the medicine and contents of the pack

Saridon is white, round tablets. It is presented in a cardboard box containing two PVC/aluminum blisters, each holding 10 tablets.

Marketing Authorization Holder:
Manufacturer:

BAYER HISPANIA, S.L. Delpharm Gaillard
Av. Baix Llobregat, 3 – 5 33, Rue de l’Industrie
08970 Sant Joan Despí (Barcelona) 74240 Gaillard
Spain France

Date of the most recent review of this leaflet: January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/