PARACETAMOL SERRACLINICS 10 mg/ml SOLUTION FOR INFUSION

2. Before using Paracetamol Serraclinics

Do not useParacetamol Serraclinics

• If you are allergic (hypersensitive) to paracetamol, propacetamol (another analgesic for infusion and precursor of paracetamol), or any of the other components of Paracetamol Serraclinics.
• If you have severe liver disease.

Take special care with Paracetamol Serraclinics

• If you have any liver disease.
• If you have severe kidney disease.
• If you suffer from chronic alcoholism.
• If you have chronic malnutrition.
• If you are dehydrated.

Before treatment with Paracetamol Serraclinics, inform your doctor if any of the above conditions apply to you.

During treatment with Paracetamol Serraclinics, inform your doctor immediately if:

• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Use an appropriate oral analgesic treatment as soon as possible when this route of administration is possible.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

This medicine contains paracetamol, and this should be taken into account if other medicines containing paracetamol are used to avoid exceeding the recommended daily dose. (See the next section).

In concomitant treatment with Probenecid (a medicine used to treat gout), a reduction in dose should be considered.

The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may produce slight variations in INR (prothrombin time) values. In this case, INR values should be monitored both during administration and after its interruption.

Salicylamide may prolong the elimination half-life of paracetamol.

Attention should be paid to the simultaneous intake of enzyme-inducing substances.

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Paracetamol Serraclinics can be used during pregnancy if necessary. The lowest possible dose that reduces pain or fever should be used and for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medicine.

Driving and using machines

No effects on driving or using machines have been described.

Important information about some of the components of Paracetamol Serraclinics

This medicine contains 79.4 mg of sodium per 100 ml, which should be taken into account in patients with low-sodium diets.

3. How to use Paracetamol Serraclinics

Paracetamol Serraclinics is a solution administered intravenously, as an intravenous infusion over 15 minutes. This medicine will only be administered in a hospital by healthcare professionals.

Careful monitoring is necessary before finishing the infusion.

Its use is restricted to adults, adolescents, and children weighing more than 33 kg (approximately 11 years).

Dosage

Adolescents and adults weighing more than 50 kg:

1 g of paracetamol per administration, i.e., one 100 ml vial up to 4 times a day.

Leave an interval of at least 4 hours between each administration.

The maximum dose should not exceed4 gof paracetamol per day,taking into account all medicines containing paracetamol.

Children weighing more than33 kg(approximately 11 years), adolescents, and adults weighing less than 50 kg:

15 mg/kg of paracetamol per administration, i.e., 1.5 ml of solution per kg.

Leave an interval of at least 4 hours between each administration.

The maximum dose should not exceed 60 mg of paracetamol per kg and per day (not exceeding4 g),taking into account all medicines containing paracetamol.

Patient with severe renal impairment:

It is recommended to increase the interval between each administration to 6 hours.

If you think the action of Paracetamol Serraclinics is too strong or too weak, tell your doctor or pharmacist.

If you use more Paracetamol Serraclinicsthan you should

This medicine will only be administered in a hospital by healthcare professionals, so it is unlikely that you will receive more Paracetamol Serraclinics than you should; however, if you have been given more Paracetamol Serraclinics than you should, inform your doctor immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone: 91 562 04 20) indicating the product and the amount administered.

The most frequent symptoms in case of overdose are: nausea, vomiting, anorexia, pallor, and abdominal pain. Doses higher than recommended may produce very severe liver damage.

4. Possible side effects

Like all medicines, Paracetamol Serraclinics can cause side effects, although not everybody gets them.

The following side effects have been reported:

Side effects observed are classified according to their frequency of presentation and are generally rare or very rare: rare (less than 1 in 1,000 patients but at least 1 in 10,000); very rare (less than 1 in 10,000 patients) and frequency not known (cannot be estimated from the available data).

General disorders and administration site conditions.

Rare: Discomfort.

Very rare: Allergic reactions ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction). If this occurs, treatment should be interrupted immediately and the doctor notified.

Gastrointestinal disorders

Rare: Increased liver transaminase levels.

Very rare: Hepatotoxicity (jaundice).

Metabolism and nutrition disorders

Very rare: Decreased blood glucose.

Frequency not known: A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Blood and lymphatic system disorders

Very rare: Decreased blood cells.

Vascular disorders

Rare: Hypotension (decreased blood pressure).

Renal and urinary disorders

Very rare: Sterile pyuria (cloudy urine), kidney adverse effects.

Very rare cases of severe skin reactions have been reported.

If you consider that some of the side effects you are suffering from are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Serraclinics

Keep out of the reach and sight of children.

Do not store above 25°C.

Keep the bag in the metal outer packaging to protect it from light.

Do not use Paracetamol Serraclinics after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use Paracetamol Serraclinics if you observe the presence of particles or if the solution has discolored.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Further information

Composition of Paracetamol Serraclinics

The active substance is paracetamol. Each ml of solution contains 10 mg of paracetamol in solution for infusion.

The other components (excipients) are: glucose monohydrate, glacial acetic acid, sodium acetate trihydrate, sodium citrate dihydrate, and water for injection.

Appearance of the product and packaging contents

Paracetamol Serraclinics is a clear, slightly yellowish solution. It is presented in 12 bags of 50 or 100 ml with a metal outer packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

Altan Pharmaceuticals S.A.

Pol. Ind. De Bernedo s/n

01118 Bernedo (Álava)

HOSPITAL USE MEDICINE

Date of last revision of this leaflet: February 2025

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

The following information is intended only for healthcare professionals

Intravenous route.

The use of this medicine is restricted to adults, adolescents, and children weighing more than 33 kg.

Dosage:

Dose according to patient weight (see the posology table below)

** Patients weighing less will require smaller volumes.

The minimum interval between each administration should be at least 4 hours. Do not administer more than 4 doses in 24 hours.

The minimum interval between each administration in patients with severe renal impairment should be at least 6 hours.

***Maximum daily dose:The maximum daily dose described in the table above is for patients who are not taking other medicines containing paracetamol and should be adjusted accordingly, taking into account these medicines.

Severe renal impairment:

In case paracetamol needs to be administered to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), it is recommended to reduce the dose and increase the minimum interval between each administration to 6 hours.

Adults with severe hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), or dehydration:

The maximum daily dose should not exceed 3 g.

Method of administration:

The paracetamol solution is administered as an infusion over 15 minutes.

The diluted solution should be visually examined and should not be used if it presents opalescence (a certain turbidity), visible particles, or precipitate.