PATIENT INFORMATION LEAFLET

Paracetamol SERRACLINICS 10 mg/ml infusion solution

Read this leaflet carefully before you start taking the medicine

-Keep this leaflet as you may need to read it again.

-Ask your doctor or pharmacist if you have any questions.

-This medicine has been prescribed for you. Do not give it to others even if they have similar symptoms, as it may harm them.

-If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Paracetamol belongs to a group of medicines called “analgesics” and “antipyretics”, which acts by relieving pain and reducing fever.

Paracetamol Serraclinics is indicated for the short-term treatment of moderate pain, especially after surgery, and for the short-term treatment of fever, when intravenous administration is justified by an urgent need to treat pain or fever and/or when other administration routes are not possible.

This medication is restricted to adults, adolescents, and children who weigh more than 33 kg.

No useParacetamol Serraclinics

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

Be especially careful with Paracetamol Serraclinics

• if you have any liver disease.
• if you suffer from severe kidney disease.
• if you have chronic alcoholism.
• if you are chronically malnourished.
• if you are dehydrated.

Inform your doctor before starting treatment with Paracetamol Serraclinics if any of the above conditions apply to you.

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

• you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use an appropriate oral analgesic as soon as possible.

Use of other medications

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

This medication contains paracetamol, and this should be taken into account if using other medications that contain paracetamol to avoid exceeding the recommended daily dose. (See the next section).

In concomitant treatment with Probenecid (a medication used to treat gout) a dose reduction 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.

Care should be taken with simultaneous ingestion 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 medication.

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 pain or fever do not decrease or you need to take the medication more frequently.

Breastfeeding

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

Driving and operating machinery

No effects on driving and operating machinery have been described.

Important information about one of the components of Paracetamol Serraclinics

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

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

Careful supervision is necessary before completing the infusion.

Its use is restricted to adults, adolescents, and children weighing more than33 kg(approximately 11 years).

Dosage

Adolescents and adults weighing more than 50 kg:

1 gof paracetamol per administration, that is, a 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,considering all medications 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, that is, 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 (without exceeding4 g),considering all medications containing paracetamol.

Patients with severe renal insufficiency:

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

If you estimate that the action of Paracetamol Serraclinicsis too strong or too weak, inform your doctor or pharmacist.

If you use more Paracetamol Serraclinicsthan you should

This medication will only be administered in a hospital by healthcare professionals, so it is unlikely that you will receive more Paracetamol Serraclinicsthan you should; however, if you have been administered more Paracetamol Serraclinicsthan you should, inform your doctor immediately. In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 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 greater than recommended may cause very severe liver damage.

Like all medicines, Paracetamol Serraclinics can cause side effects, although not everyone will experience them.

The following side effects have been reported:

The observed side effects 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 unknown frequency (cannot be estimated from 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 severe type of allergic reaction). If this occurs, stop treatment immediately and notify your doctor.

Gastrointestinal disorders

Rare: Elevated levels of liver transaminases (liver enzymes).

Very rare: Hepatotoxicity (jaundice).

Metabolism and nutrition disorders

Very rare:Decreased blood glucose.

Unknown frequency: A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use 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:Purulent urine, renal adverse effects.

Very rarely, severe skin reactions have been reported.

If you consider that some of the side effects you are experiencing are severe 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 type of side effect, consult your doctor, pharmacist or nurse, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not store at a temperature above25°C.

Storethe bag in the metal overpack to protect it from light.

Do not use Paracetamol Serraclinicsafter the expiration date that appears on the packaging after CAD.The expiration 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 medication and all materials that have come into contact with it, will be carried out in accordance with local regulations.

Paracetamol CompositionSerraclinics

The active ingredient is paracetamol. Each ml of solution contains 10 mg of paracetamol in perfusion solution.

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

Product Appearance and Packaging Content

ParacetamolSerraclinicsis a transparent and slightly yellowish solution. It is presented in 12 bags of 50 or 100 ml with a metallic overpackaging.

Marketing Authorization Holderand Responsible for Manufacturing

Marketing Authorization Holder

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for Manufacturing

Altan Pharmaceuticals S.A.

Pol. Ind.De Bernedo s/n

01118 Bernedo (Álava)

HOSPITAL USE MEDICINE

Last review date of this leaflet: February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 following posology table)

** 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 insufficiency should be at least 6 hours.

***Maximum Daily Dose:The maximum daily dose described in the table above is for patients not taking other paracetamol-containing medications and should be adjusted accordingly taking these medications into account.

Severe Renal Insufficiency:

In the case of administering paracetamol to patients with severe renal insufficiency (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 liver cell insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves) or dehydration:

The maximum daily dose should not exceed 3 g.

Administration Form:

Paracetamol solution is administered as a perfusion for 15 minutes.

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