Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Paracetamol ALTAN 10 mg/mL solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Paracetamol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever). The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml bag is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg. Paracetamol ALTAN is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever. 2.
What you need to know before you take it
e Paracetamol ALTAN
Do not use Paracetamol ALTAN
- if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of Paracetamol ALTAN
- if you are allergic (hypersensitive) to propacetamol (another analgesic for infusion and a precursor of paracetamol).
- if you suffer from a severe liver disease. Warnings and precautions
- use a suitable analgesic oral treatment as soon as this administration route is possible.
- if you suffer from a liver or kidney disease, or from alcohol abuse.
- if you are taking other medicines containing paracetamol.
- in cases of nutrition problems (malnutrition) or dehydration. Inform your doctor before treatment if any of the above mentioned conditions apply to you. During treatment with Paracetamol Altan, tell your doctor straight away if: If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these 1
situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting). Other medicines and Paracetamol ALTAN Do not give with any other paracetamol-containing medicines. This medicine contains paracetamol and this must be taken into account if other medicines containing paracetamol or propacetamol are taken, in order not to exceed the recommended daily dose (see following section). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol. A dose reduction should be considered for concomitant treatment with Probenecid. Please inform your doctor or pharmacist if you are taking oral anticoagulants. Closer check-ups of the effect of the anticoagulant might be necessary. Please inform your doctor or pharmacist if you are taking: -flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Pregnancy and breast-feeding Pregnancy Inform your doctor if you are pregnant. If necessary, Paracetamol ALTAN can be used during pregnancy. However, in this case the doctor must evaluate if the treatment is advisable. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often. Ask your doctor or pharmacist for advice before taking any medicine. Breast-feeding If necessary, Paracetamol ALTAN can be used during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients of Paracetamol ALTAN 10 mg/ml, solution for infusion Paracetamol ALTAN contains 39.7 mg sodium per 50 mL and 79.4 mg sodium per 100 mL, which should be taken into account by patients on a low salt diet. This medicine contains glucose. Patients with diabetes mellitus must take into account that this medicine contains 1.65 g glucose per 50 mL and 3.30 g glucose per 100 mL. 3.
How to take it
Paracetamol ALTAN
You should not be given more medicine than the label says. Do not exceed the stated dose. Intravenous use. Paracetamol ALTAN will be administered to you by a healthcare professional by infusion into one of your veins. The dose will be individually adjusted by your doctor, based on your weight and general condition. Check patient's weight before administration. The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg. 2
The 50 ml bag is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg. Dosage Dosing based on patient weight (please see the dosing table here below) Patient weight
≤10 kg* > 10 kg to ≤33kg
Dose per Volume per Maximum volume of Maximum Daily administration administration Paracetamol ALTAN (10 Dose *** mg/mL) per administration based on upper weight limits of group (mL)** 7.5 mg/kg 0.75 mL/kg 7.5 mL 30 mg/kg 15 mg/kg 1.5 mL/kg 49.5 mL 60 mg/kg not exceeding 2g
> 33 kg to ≤50kg
15 mg/kg
1.5 mL/kg
75 mL
60 mg/kg not exceeding 3g
>50kg with additional risk factors for hepatotoxicity > 50 kg and no additional risk factors for hepatotoxicity
1g
100 mL
100 mL
3g
1g
100 mL
100 mL
4g
- Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn. **Patients weighing less 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 insufficiency must be at least 6 hours. No more than 4 doses to be given in 24 hours. *** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.
The paracetamol solution is administered in intravenous infusion over 15 minutes. If you have the impression that the effect of Paracetamol ALTAN 10 mg/ml, solution for infusion is too strong or too weak, talk to your doctor. If you or your child use more Paracetamol ALTAN 10mg/ml, solution for infusion than if you or your child should use, talk to a doctor at once if you or your child take too much of this medicine even if you or your child seem feel well. This is because too much paracetamol can cause delayed, serious liver damage. In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain and a risk of liver injury. If you have any further questions on the use of this product ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, Paracetamol ALTAN can cause side effects, although not everybody gets them.
- In rare cases (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons), the following may occur: a malaise, a drop in blood pressure or changes in laboratory test results: 3
abnormally high levels of hepatic enzymes found during blood checks. Should this occur, inform your doctor as regular blood checks may be required later.
- In very rare cases (less than 1 out of 10,000 persons, including isolated reports), a serious skin rash or allergic reaction may occur. Stop the treatment immediately and inform your doctor.
- In isolated cases, other changes in laboratory test results have been observed which have necessitated regular blood checks: abnormally low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform your doctor.
- Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported.
- Cases of pain and burning sensation at injection site have been reported.
- Frequency not known (cannot be estimated from the available data): A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2). Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Paracetamol ALTAN
Keep this medicine out of the sight and reach of children. Do not store above 25oC. Keep the bag in the protective overwrap in order to protect from light and excessive water loss. After opening the overwrapping immediate use is recommended. Do not use Paracetamol ALTAN after the expiration date indicated on the package. The expiry date is the last day of that month. Do not use Paracetamol ALTAN if you observe the presence of particles or a change to the colour of the solution. For single use only, discard any unused portion. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product must be used immediately. If not used immediately, 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 throw away medicines and containers you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Paracetamol ALTAN contains The active substance is paracetamol. Each ml of solution for infusion contains 10 mg paracetamol. The other ingredients are glucose monohydrate, acetic acid, sodium acetate trihydrate, sodium citrate dehydrate, sodium hydroxide, hydrochloric acid and water for injections. What Paracetamol ALTAN looks like and contents of the pack Paracetamol ALTAN is colourless or faintly straw-brown coloured solution packaged in PVC 4
bags of 50 or 100 ml with a metal overwrap. It is presented in packs containing 10 bags, 12 bags of 50 or 100 ml or 50 bags of 100 ml. Not all pack sizes or presentation may be marketed. Marketing authorisation holder and manufacturer Marketing Authorisation Holder: Altan Pharmaceuticals S.A. C/ Cólquide No 6, Portal 2, 1a Planta, Oficina F. Edificio Prisma Las Rozas, 28231 Madrid, Spain Manufacturer: Altan Pharmaceuticals, S.A. Pol. Ind. De Bernedo s/n 01118 Bernedo (Álava) – Spain For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. This leaflet was last revised in: 01/2026 INFORMATION FOR HEALTH PROFESSIONALS Below is a summary of the dosage, dilution, administration and storage details for Paracetamol ALTAN 10 mg/ml, solution for infusion. Reference should be made to the Summary of Product Characteristics for full prescribing information. Intravenous use. The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml bag is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg. For the 50 ml and 100 ml bag, close monitoring is needed before the end of infusion. Dosage Dosing based on patient weight (please see the dosing table here below): Patient weight
≤10 kg* > 10 kg to ≤33kg
Dose per Volume per Maximum volume of Maximum Daily administration administration Paracetamol ALTAN (10 Dose *** mg/mL) per administration based on upper weight limits of group (mL)** 7.5 mg/kg 0.75 mL/kg 7.5 mL 30 mg/kg 15 mg/kg 1.5 mL/kg 49.5 mL 60 mg/kg not exceeding 2 g
> 33 kg to ≤50kg
15 mg/kg
1.5 mL/kg
75 mL
60 mg/kg not exceeding 3 g
>50kg with additional risk factors for
1g
100 mL
100 mL
3g
5
hepatotoxicity
> 50 kg and no additional risk factors for hepatotoxicity
1g
100mL
100mL
4g
- Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn. **Patients weighing less 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 insufficiency must be at least 6 hours. No more than 4 doses to be given in 24 hours. *** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.
Method of administration RISK OF MEDICATION ERRORS Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in accidental overdose and death. The paracetamol solution is administered in intravenous infusion over 15 minutes. Patients weighing ≤10 kg:
- The bag of Paracetamol ALTAN should not be hung as an infusion due to the small volume of the medicinal product to be administered in this population.
- The volume to be administered should be withdrawn from the bag and diluted in a 0.9% sodium chloride solution or 5% glucose solution up to one tenth (one volume Paracetamol ALTAN into nine volumes diluent) and administered over 15 minute.
- A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However, this should never exceed 7.5 ml per dose
- The user should be referred to the product information for dosing guidelines. For the 50 ml and 100 ml bags, a 0.8 mm needle (21 gauge needle) has to be used and the stopper vertically perforated at the spot specifically indicated. It can also be diluted in 0.9% sodium chloride or 5% glucose up to one tenth (one volume Paracetamol ALTAN into nine volumes diluent). The diluted solution should be visually inspected and must not be used if opalescence, visible particulate matter or precipitate are found.
6
Frequently asked questions about Paracetamol ALTAN 10 mg/mL solution for infusion
How do I take Paracetamol ALTAN 10 mg/mL solution for infusion?
Paracetamol ALTAN 10 mg/mL solution for infusion comes as infusion containing 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Paracetamol ALTAN 10 mg/mL solution for infusion?
The active substance in Paracetamol ALTAN 10 mg/mL solution for infusion is paracetamol.
Are there equivalent medicines to Paracetamol ALTAN 10 mg/mL solution for infusion?
Medicines with the same active substance, strength and form include: Paracetamol 10 mg/ml solution for infusion. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Paracetamol ALTAN 10 mg/mL solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Paracetamol ALTAN 10 mg/mL solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: paracetamol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Paracetamol ALTAN is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever, when intravenous administration is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.
4.2. Posology and method of administration
Intravenous use.
The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years of age).
The 50 ml bag is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
Posology
Dosing based on patient weight (please see the dosing table here below):
Patient weight
Dose per administration
Volume per administration
Maximum volume of Paracetamol (10 mg/mL) per administration based on upper weight limits of group (mL)**
Maximum Daily Dose ***
≤10 kg *
7.5 mg/kg
0.75 mL/kg
7.5 mL
30 mg/kg
> 10 kg to ≤33kg
15 mg/kg
1.5 mL/kg
49.5 mL
60 mg/kg not exceeding 2g
> 33 kg to ≤50kg
15 mg/kg
1.5 mL/kg
75 mL
60 mg/kg not exceeding 3g
Patient weight
Dose per administration
Volume per administration
Maximum volume per administration **
Maximum Daily Dose ***
>50kg with additional risk factors for hepatotoxicity
1 g
100 mL
100 mL
3 g
> 50 kg and no additional risk factors for hepatotoxicity
1 g
100 mL
100 mL
4 g
* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants (see section 5.2).
** Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be given in 24 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.
*** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.
Severe renal insufficiency:
when paracetamol is administered to patients with severe renal insufficiency (creatinine clearance ≤ 30 mL/min), it is recommended to increase the minimum interval between administrations to 6 hours (see section 5.2).
In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3 g (see section 4.4).
Method of administration
Take care when prescribing and administering PARACETAMOL ALTAN to avoid dosing errors due to confusion between milligram (mg) and milliliter (ml), which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
The paracetamol solution is administered as an intravenous infusion.
The paracetamol solution is administered slowly, with an infusion time that must never be less than 15 minutes.
Patients weighing ≤ 10 kg:
• The plastic bag of Paracetamol ALTAN should not be hung as an infusion due to the small volume of the medicinal product to be administered in this population.
• The volume to be administered should be withdrawn from the bag and could be administered undiluted or diluted (from one to nine volumes diluent) in a 0.9% sodium chloride solution or 5% glucose solution and administered in 15-minute.
Use the diluted solution within the hour following its preparation (infusion time included).
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However, this should never exceed 7.5ml per dose.
• The user should be referred to the product information for dosing guidelines.
Text for the 50ml and 100ml bags:
To remove solution, use a 0.8 mm needle (21 gauge needle) and vertically perforate the stopper at the spot specifically indicated.
As for all solutions for infusion presented in plastic bags, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid air embolism.
Text for the 50ml bag:
Paracetamol ALTAN of 50ml bag can also be diluted in a 0.9% sodium chloride solution or 5% glucose solution (from one to nine volumes diluent). In this case, use the diluted solution within the hour following its preparation (infusion time included).
4.3. Contraindications
Paracetamol ALTAN is contraindicated in:
- patients with hypersensitivity to paracetamol, propacetamol hydrochloride (product of paracetamol) or to any of the excipients.
- cases of severe hepatocellular insufficiency.
4.4. Special warnings and precautions for use
Special warnings
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter (ml), which could result in accidental overdose and death (see section 4.2).
It is recommended to use an oral analgesic treatment as soon as this route of administration is possible.
To avoid the risk of overdose, check that other medicinal products administered do not contain paracetamol.
Doses higher than those recommended carry a risk of very serious liver damage. Clinical signs and symptoms of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are usually seen after two days of drug administration with a peak seen usually after 4 - 6 days. Treatment with antidote should be administered as soon as possible (See section 4.9).
Text for the 50ml and 100ml bags:
As for all solutions for infusion presented in bags, a close monitoring is needed notably at the end of the infusion (see section 4.2).
Precautions for use
Paracetamol must be used with caution in cases of:
- hepatocellular insufficiency
- severe renal insufficiency (creatinine clearance ≤ 30 mL/min) (see sections 4.2 and 5.2).
- chronic alcoholism
- chronic malnutrition (low hepatic glutathione reserves)
- dehydration
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Important information about some ingredients of Paracetamol ALTAN
This medicinal product contains 3.5 mmol (79.4 mg) sodium per 100 mL, which should be taken into account by patients on a low salt diet.
This medicinal product contains 1.65 g glucose per 50 mL and 3.30 g glucose per 100 mL, which should be taken into consideration when treating patients with diabetes mellitus.
4.5. Interaction with other medicinal products and other forms of interaction
- Probenecid causes an almost 2-fold reduction in clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction of the paracetamol dose should be considered for concomitant treatment with probenecid.
- Salicylamide may prolong the elimination t1/2 of paracetamol.
- Caution should be paid to the concomitant intake of enzyme-inducing substances (see section 4.9).
- Concomitant use of paracetamol (3 g per day for at least 4 days) with oral anticoagulants may lead to slight variations of INR values. In this case, increased monitoring of INR values should be conducted during the period of concomitant use as well as for 1 week after paracetamol treatment has been discontinued.
- Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy:
Clinical experience of intravenous administration of paracetamol is limited. However, epidemiological data from the use of oral therapeutic doses of paracetamol indicate no undesirable effects on the pregnancy or on the health of the foetus / newborn infant. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. Prospective data on pregnancies exposed to overdoses did not show an increase in malformation risk.
No reproductive studies with the intravenous form of paracetamol have been performed in animals. However, studies with the oral route did not show any malformation of foetotoxic effects. Nevertheless, Paracetamol ALTAN should only be used during pregnancy after a careful benefit-risk assessment. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Lactation:
After oral administration, paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported.
Consequently, Paracetamol ALTAN may be used in breast-feeding women.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
As with all products containing paracetamol, the adverse reactions are rare (≥1/10000, <1/1000), very rare (<1/10000) or not known (cannot be estimated from the available data) and are listed below.
Organ system
Rare
≥1/10000, <1/1000
Very rare
<1/10000
Not known
(cannot be estimated from the available data)
General
Malaise
Hypersensitivity reaction
Cardiovascular
Hypotension
Liver
Increased hepatic transaminase levels.
Platelet/blood
Thrombocytopaenia, leucopenia, neutropenia
Metabolism and nutrition disorders
Metabolism and nutrition disorders
Metabolism and nutrition disorders
Metabolism and nutrition disorders
Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation).
Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment.
Cases of erythema, flushing, pruritus and tachycardia have been reported.
Description of selected adverse reactions
High anion gap metabolic acidosis
Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is a risk of liver injury (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. Overdosing may be fatal in these cases.
Symptoms generally appear within the first 24 hours and include nausea, vomiting, anorexia, pallor and abdominal pain.
Overdose, 7.5 g or more of paracetamol in a single administration in adults or 140 mg/kg body weight in a single administration in children, causes hepatic cytolysis that will probably induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy, which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels, which may appear 12 to 48 hours after administration.
Clinical symptoms of liver damage are usually evident initially after two days, and reach a maximum after 4 to 6 days.
Emergency measures
- Immediate hospitalisation.
- Before beginning treatment, take a blood sample to analyse plasma paracetamol as soon as possible after the overdose.
- Treatment includes administration of the antidote, N-acetylcysteine (NAC), intravenously or orally, if possible before 10 hours have passed. However, NAC can give some degree of protection even after 10 hours, but in these cases prolonged treatment should be administered.
- Symptomatic treatment.
- Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases, hepatic transaminases return to normal in one to two weeks with full return of normal liver function. In very severe cases, however, liver transplantation may be necessary.
💬 Ask about this leaflet
Ask anything about Paracetamol ALTAN 10 mg/mL solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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