PARACETAMOL ALTAN 10 mg/mL SOLUTION FOR INFUSION

1. What is Paracetamol Altan and what is it used for

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

Paracetamol Altan 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 routes of administration are not possible.

2. What you need to know before you use Paracetamol Altan

If you are allergic to paracetamol, propacetamol (another analgesic for infusion and precursor of paracetamol), or to any of the other components.

If you have severe liver disease.

Warnings and Precautions

Be especially careful with this medicine:

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

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

During treatment with Paracetamol Altan, inform your doctor immediately:

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 have 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 unwell (nausea) and vomiting.

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

Using Paracetamol Altan with other medicines

Tell your doctor that you are using, have recently used, or might use any other medicine.

Inform your doctor or pharmacist if you are using or have recently used any other medicine, even those bought 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 dose reduction should be considered, and concomitant use of paracetamol (4g 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 and after administration.

Salicylamide may prolong the elimination half-life of paracetamol.

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

Inform your doctor or pharmacist if you are taking:

• 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 taking any medicine.

If necessary, Paracetamol Altan can be used during pregnancy. Paracetamol should be used in pregnancy only after a careful assessment of the benefit-risk ratio. You should use the lowest possible dose that reduces pain or fever and use it 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. However, as a general rule, its use is not recommended during the first trimester of pregnancy.

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

Driving and Using Machines

No effects on driving and using machines have been described.

Paracetamol Altan contains Sodium and Glucose

Paracetamol Altan contains 39.7 mg of sodium per 50 ml and 79.4 mg of sodium per 100 ml, which should be taken into account in patients with low-sodium diets.

This medicine contains glucose. Patients with diabetes mellitus should note that this medicine contains 1.65 g glucose per 50 ml and 3.30 g glucose per 100 ml.

3. How to use Paracetamol Altan

This medicine is a solution that is administered intravenously.

The paracetamol solution will be administered slowly, with an infusion time that should not be less than 15 minutes. It is important to respect this infusion schedule to avoid the appearance of local reactions, especially pain at the injection site. If such reactions appear, the infusion rate should be decreased.

This medicine will only be administered in a hospital by healthcare professionals.

Careful supervision is necessary before finishing the infusion.

Its use is restricted to adults, adolescents, and children who weigh 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 bag 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 that contain 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 exceeding 3 g),taking into account all medicines that contain paracetamol.

Dose based on patient weight (see the dose table below):

*Maximum daily dose: The maximum daily dose indicated in the table above refers to patients who are not receiving other medicines that contain paracetamol. The dose should be adjusted taking into account these other medicines.

**Patients with lower weight will require smaller volumes.

The minimum interval between each administration should be at least 4 hours.

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

No more than 4 doses should be administered in 24 hours.

Method of administration

Be careful to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml), which could lead to accidental overdose and death.

For 50 ml and 100 ml bags, a 0.8 mm needle (21 gauge needle) should be used to extract the solution. Open the twist-off first, insert the needle, extract the desired volume, and immediately insert the infusion equipment for administration.

It can also be diluted in a 0.9% sodium chloride solution or in a 5% glucose solution up to one-tenth (one volume of Paracetamol Altan in nine volumes of diluent).

Patient with severe renal failure:

It is recommended to increase the interval between each administration to 6 hours. The maximum daily dose should not exceed 3 g.

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

If you use more Paracetamol Altan than you should

This medicine will only be administered in a hospital by healthcare professionals, so it is unlikely that you will receive more paracetamol than you should; however, if you have been administered more paracetamol 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.

Doses higher than recommended may produce very severe liver damage.

If you forget to use Paracetamol Altan

Do not take a double dose to make up for forgotten doses.

If you stop using Paracetamol Altan

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

The following side effects have been reported:

Side effects are classified according to their frequency of occurrence and are generally rare, very rare, or of unknown frequency: rare (may affect up to1 in 1,000 patients); very rare (may affect up to1 in 10,000 patients); unknown frequency (cannot be estimated from the available data).

General disorders and administration site conditions.

Rare: Malaise.

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 happens, stop treatment immediately and notify your doctor.

Hepatobiliary disorders

Rare: Increased levels of hepatic transaminases (liver enzymes).

Very rare: Hepatotoxicity (jaundice).

Blood and lymphatic system disorders

Very rare: Decrease in blood cells.

Vascular disorders

Rare: Hypotension (decrease in blood pressure).

Renal and urinary disorders

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

Skin and subcutaneous tissue disorders

Very rare cases of severe skin reactions have been reported.

Metabolism and nutrition disorders

Unknown frequency: A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you experience side effects, consult your doctor or nurse, even if it is a side effect not listed in this leaflet.

5. Storage of Paracetamol Altan

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

Do not store above 25°C.

Keep protected from light.

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

Do not use Paracetamol Altan if you notice the presence of particles or if you notice a change in the color of the solution.

For single use only. Any unused solution for injection should be discarded. From a microbiological point of view, unless the opening method prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Altan

• The active substance is paracetamol. Each ml of the solution for infusion contains 10 mg of paracetamol.
• The other ingredients are glucose monohydrate, glacial acetic acid, sodium acetate trihydrate, sodium citrate dihydrate, and water for injection.

Appearance of the product and pack contents

Paracetamol Altan is a slightly yellowish transparent solution packaged in 50 or 100 ml PVC bags with a metal overwrap. It is presented in packs containing 12 bags of 50 ml and packs containing 12 or 50 bags of 100 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide 6. Portal 2. 1ª Planta. Oficina F. Edificio Prisma. 28230 Las Rozas (Madrid)

Manufacturer:

Altan Pharmaceuticals, S.A.

Poligono Industrial de Bernedo s/n, Bernedo, 01118 (Álava) - Spain

RENAUDIN ZA Errobi (Itxassou) - F-64250 - France S.C.

INFOMED FLUIDS S.R.L. Str. Theodor Pallady NR.50 (Bucharest) - 032266 - Romania

BIOLUZ Zone Industrielle de Jalday, BP 129 (Saint-Jean-de-Luz) - 64500 - France

HOSPITAL USE ONLY

Date of last revision of this leaflet: February 2025

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