Paracetamol ALTAN 10 mg/mL solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Paracetamol ALTAN is and what it is used for
2. What you need to know before you use Paracetamol ALTAN
3. How to use Paracetamol ALTAN
4. Possible side effects
5 How to store Paracetamol ALTAN
6. Contents of the pack and other information

• 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.

• 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 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).

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

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.

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.

Dosing based on patient weight (please see the dosing table here below)

Patient weight ≤10 kg*, Dose per administration 7.5mg/kg, Volume per administration 0.75 mL/kg, Maximum volume of Paracetamol ALTAN (10 mg/mL) per administration based on upper weight limits of group (mL)** 7.5 ML, Maximum daily dose *** 30mg/kg.

Patient weight > 10 kg to ≤33kg, Dose per administration 15 mg/kg, Volume per administration 1.5 mL/kg, Maximum volume of Paracetamol ALTAN (10 mg/mL) per administration based on upper weight limits of group (mL)** 49.5 mL, Maximum daily dose *** 60 mg/kg not exceeding 2g.

Patient weight > 33 kg to ≤50kg, Dose per administration 15 mg/kg, Volume per administration 1.5 mL/kg, Maximum volume of Paracetamol ALTAN (10 mg/mL) per administration based on upper weight limits of group (mL)** 75 mL, Maximum daily dose *** 60 mg/kg not exceeding 3g.

Patient weight >50kg with additional risk factors for hepatotoxicity, Dose per administration 1g, Volume per administration 100 mL, Maximum volume of Paracetamol ALTAN (10 mg/mL) per administration based on upper weight limits of group (mL)** 100 mL, Maximum daily dose *** 3 g

Patient weight > 50 kg and no additional risk factors for hepatotoxicity, Dose per administration 1 g, Volume per administration 100 mL, Maximum volume of Paracetamol ALTAN (10 mg/mL) per administration based on upper weight limits of group (mL)** 100 mL, Maximum daily dose *** 4 g.

* 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.

• 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.

Paracetamol ALTAN is colourless or faintly straw-brown coloured solution packaged in PVC 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:

Manufacturer:

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.