Product Information for the Patient

Paracetamol Altan 10 mg/ml, Infusion Solution

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again. If you have any questions, consult your doctor or nurse.
• This medication has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this product information.

Paracetamol belongs to a group of medicines called “analgesics” and “antipyretics”, which acts 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 administration routes are not possible.

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

If you have a severe liver disease.

Warnings and precautions

Be especially careful with this medication:

- If you have any liver disease.

- If you have severe kidney disease.

- If you have chronic alcoholism.

- If you are in a state of chronic malnutrition.

- If you are dehydrated.

Inform your doctor before treatment 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 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use an oral analgesic treatment as soon as possible through this administration route.

Use of Paracetamol Altanwithother medications

Inform your doctor that you are using, have recently usedor may need to use any other medication.

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

This medication contains paracetamol, and this should be taken into account if other medications containing paracetamol are used 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, and the 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 administration and after its interruption.

Salicylamide may prolong the elimination half-life of paracetamol.

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

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that must receive urgent treatment (see section 2).

Pregnancy andlactation

Consult your doctor or pharmacist before taking a medication.

If necessary, you can use Paracetamol Altan during pregnancy. Paracetamol should be used during 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 pain or fever do not decrease or if you need to take the medication more frequently. However, as a general rule, its use is not recommended during the first trimester of pregnancy.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor before using this medication.

Driving and use of machines

No effects on driving and use of machines have been described.

Paracetamol Altan contains sodium and glucose

Paracetamol Altan contains 39.7 mg of sodium per 50 ml and79.4 mg of sodium per 100 ml, which should be taken into account in patients with low-sodium diets.

This medication contains glucose. Patients with diabetes mellitus should be aware that this medication contains1.65 gglucose per 50 ml and3.30 gglucose per 100 ml.

This medication is a solution that is administered intravenously.

The paracetamol solution will be administered slowly, with a perfusion time that in no case should be less than 15 minutes. It is essential to respect this perfusion schedule to avoid the appearance of local reactions, especially pain at the injection site. In the event of such reactions appearing, the perfusion speed should be reduced.

This medication will only be administered to you in the hospital by healthcare professionals.

Careful supervision is necessary before completing the perfusion.

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

Dosage:

Adolescents and adults who weigh more than 50 kg:

1 gof paracetamol per administration, that is, a 100 ml bag up to 4 times a day.

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

The maximum daily dose should not exceed4 gof paracetamol,considering all medications that contain paracetamol.

Children who weigh more than33 kg(approximately 11 years), adolescents, and adults who weigh 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 daily dose should not exceed 60 mg of paracetamol per kg and per day (without exceeding 3 g),considering all medications that contain paracetamol..

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

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

**Patients with lower weights 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 insufficiency should be at least 6 hours.

Do not administer more than 4 doses 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, use a 0.8 mm needle (21 gauge needle) to extract the solution. First, open the twist-off, 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 a 5% glucose solution to one-tenth (a volume of Paracetamol Altan in nine volumes of diluent).

Patients with severe renal insufficiency:

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

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you use more Paracetamol Altan than you should

This medication will only be administered to you in a hospital by healthcare professionals, so it is unlikely that you will receive moreparacetamolthan you should; however, if you have been given more paracetamol than you should, inform your doctor immediately. In the event of an overdose or accidental ingestion, consult the Toxicological Information Service (phone:91 562 04 20) indicating the product and the amount administered.

Doses greater than those recommended may cause very severe liver damage.

If you forget to use Paracetamol Altan

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Paracetamol Altan

If you have any other questions about the use of thismedication, ask your doctoror nurse.

Like all medications, Paracetamol Altan may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported:

The observed adverse effects are classified according to their frequency of presentation and are generally rare, very rare, or of unknown frequency: rare (may affect up to 1 in 1,000 patients; very rare (may affect up to 1 in 10,000 patients); 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, discontinue treatment immediately and notify your doctor.

Hepatobiliary disorders

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

Very rare: Hepatotoxicity (jaundice).

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), renal adverse effects.

Skin and subcutaneous tissue disorders

Very rarely, severe skin reactions have been reported.

Metabolism and nutrition disorders

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

If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this leaflet.

Keepthis medicationout of sight and reach of children.

Do not store at a temperature above 25°C.

Store protected from light.

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

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

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacisthow to disposeofthepackaging and of themedications that you no longerneed.By doing so, you will help protect the environment.

Composition of Paracetamol Altan

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

Appearance of the product and content of the packaging

Paracetamol Altan is a transparent, slightly yellowish solution packaged in PVC bags of 50 or 100 ml with a metallic overwrap. It is presented in containers holding 12 bags of 50 ml and containers holding 12 or 50 bags of 100 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/ Cólquide 6. Portal 2. 1st Floor. Office F. Edificio Prisma. 28230 Las Rozas (Madrid)

Responsible for manufacturing:

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 (San Juan de Luz) - 64500 - France

HOSPITAL USE SPECIALTY

Last review date of this prospectus: February 2025

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS), http://www.aemps.gob.es