Paracetamol Altan 10 mg/ml solution for infusion
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Paracetamol Altan 10 mg/ml, solution for infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again. If you have any questions, consult your doctor or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet.
Contents of the leaflet
- What Paracetamol Altan is and what it is used for
- What you need to know before using Paracetamol Altan
- How to use Paracetamol Altan
- Possible side effects
- How to store Paracetamol Altan
- Contents of the pack and other information
1. What Paracetamol Altan is and what it is used for
Paracetamol belongs to a group of medicines called "analgesics" and "antipyretics", which work by relieving pain and reducing fever.
Paracetamol Altan is indicated for the short-term treatment of moderate pain, particularly 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 using Paracetamol Altan
If you are allergic to paracetamol, to propacetamol (another intravenous analgesic and precursor of paracetamol), or to any of the other ingredients.
If you have severe liver disease.
Warnings and precautions
Take special care with this medicine:
- If you have any liver disease.
- If you suffer from severe kidney disease.
- If you suffer from chronic alcoholism.
- If you are in a state of 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 serious conditions 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 if you 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 at regular doses over a prolonged period or when paracetamol is taken together 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 treatment as soon as possible via this route of administration.
Using Paracetamol Altan with other medicines
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
This medicine contains paracetamol, which should be taken into account if other medicines containing paracetamol are used, so as not to exceed the recommended daily dose. (See the following section.)
When used concomitantly with probenecid (a medicine used to treat gout), a dose reduction should be considered. Concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may cause slight changes in INR values (prothrombin time). In such cases, INR values should be monitored both during and after discontinuation of treatment.
Salicylamide may prolong the elimination half-life of paracetamol.
Caution should be exercised regarding the simultaneous intake of enzyme-inducing substances.
Inform your doctor or pharmacist if you are taking:
- flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
Paracetamol Altan may be used during pregnancy if necessary. Paracetamol should be used during pregnancy only after careful assessment of the benefit-risk balance. Use the lowest possible dose that relieves 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 medicine more frequently. However, as a general rule, its use is not recommended during the first trimester of pregnancy.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.
Driving and using machines
No effects on driving and using machines have been reported.
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 on low-sodium diets.
This medicine contains glucose. Patients with diabetes mellitus should take into account that this medicine contains 1.65 g of glucose per 50 ml and 3.30 g of glucose per 100 ml.
3. How to use Paracetamol Altan
This medicine is a solution for intravenous administration.
The paracetamol solution should be administered slowly, with an infusion time of no less than 15 minutes. It is important to follow this infusion regimen to avoid the occurrence of local reactions, especially pain at the injection site. If such reactions occur, the infusion rate should be reduced.
This medicine will only be administered to you in a hospital setting by healthcare professionals.
Careful monitoring is required before completing the infusion.
Its use is restricted to adults, adolescents, and children weighing more than 33 kg (approximately 11 years of age).
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 daily.
Allow an interval of at least 4 hours between each administration.
The maximum dose must not exceed 4 g of paracetamol per day, taking into account all medications containing paracetamol.
Children weighing more than 33 kg (approximately 11 years of age), adolescents, and adults weighing less than 50 kg:
15 mg/kg of paracetamol per administration, i.e., 1.5 ml of solution per kg.
Allow an interval of at least 4 hours between each administration.
The maximum dose must not exceed 60 mg of paracetamol per kg per day (without exceeding 3 g), taking into account all medications containing paracetamol.
Dose based on patient weight (see the dosage table below):
Weight of patient | Dose per administration | Volume per administration | Maximum volume of Paracetamol (10 mg/ml) per administration, based on upper weight limits of the group (ml)** | Maximum daily dose* |
> 33 kg up to ≤ 50 kg | 15 mg/kg | 1.5 ml/kg | 75 ml | 60 mg/kg Not exceeding 3 g |
> 50 kg with additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 3 g |
> 50 kg and without additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 4 g |
*Maximum daily dose: The maximum daily dose indicated in the table above refers to patients who are not receiving other medications containing paracetamol. The dose should be adjusted taking into account these other medications.
**Patients with lower body weight will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
No more than 4 doses should be administered within 24 hours.
Method of administration
Take care 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) must be used; first open the twist-off cap, insert the needle, withdraw the desired volume, and immediately insert the infusion set for administration.
It may also be diluted in 0.9% sodium chloride solution or 5% glucose solution up to one-tenth (one volume of Paracetamol Altan in nine volumes of diluent).
Patients with severe renal impairment:
It is recommended to increase the dosing interval to 6 hours. The maximum daily dose must not exceed 3 g.
If you think that the effect 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 to you in a hospital setting by healthcare professionals, so it is unlikely that you will receive more paracetamol than you should; however, if you have been given more paracetamol than recommended, inform your doctor immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91 562 04 20), indicating the product and amount administered.
Doses higher than recommended may cause severe liver damage.
If you forget to use Paracetamol Altan
Do not take a double dose to make up for missed doses.
If you stop using Paracetamol Altan
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, Paracetamol Altan can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported:
The observed adverse effects are classified according to their frequency of occurrence 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); frequency not known (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 occurs, stop treatment immediately and inform your doctor.
Hepatobiliary disorders
Rare: Increased levels of liver 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), adverse effects on the kidney.
Skin and subcutaneous tissue disorders
Very rare cases of serious skin reactions have been reported.
Metabolism and nutrition disorders
Frequency not known: A serious illness that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects 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.
Store protected from light.
Do not use Paracetamol Altan after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Do not use Paracetamol Altan if you observe the presence of particles or if you notice any change in the solution's colour.
For single use only. Any unused solution for injection 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 during use 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 and packaging that you no longer need. 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 infusion solution contains 10 mg of paracetamol.
- The other components are monohydrate glucose, glacial acetic acid, sodium acetate trihydrate, sodium dihydrate citrate, and water for injection.
Appearance of the product and contents of the pack
Paracetamol Altan is a slightly yellowish, transparent solution, supplied in 50 ml or 100 ml PVC bags with a metallic overwrap. It is available 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. 1st Floor. Office F. Prisma Building. 28230 Las Rozas (Madrid)
Manufacturer:
Altan Pharmaceuticals, S.A.
Polígono 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 MEDICINAL PRODUCT
Date of the most recent review of this summary: February 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS): http://www.aemps.gob.es