PARACETAMOL COMBINO PHARM 10 mg/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Paracetamol Combino Pharm 10 mg/ml, Solution for InfusionEFG

For children and adults with a weight over 33kg (approximately 11 years)

Read the entire package leaflet carefully before starting to use the medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Paracetamol Combino Pharm and what is it used for
2. What you need to know before taking Paracetamol Combino Pharm
3. How to take Paracetamol Combino Pharm
4. Possible side effects

5. Storage of Paracetamol Combino Pharm

1. Contents of the pack and further information

1. What is Paracetamol Combino Pharm and what is it used for

This medicine is an analgesic (relieves pain) and an antipyretic (reduces fever).

It is used for the short-term treatment of moderate pain, especially after surgery, and for the short-term treatment of fever.

The 100 ml pack is restricted to adults, adolescents, and children who weigh more than 33kg.

2. What you need to know before taking Paracetamol Combino Pharm

Do not use Paracetamol Combino Pharm:

• if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic (hypersensitive) to propacetamol (another analgesic and precursor of paracetamol)
• if you have severe liver disease

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine.

Be particularly careful with this medicine:

• if you have liver or kidney disease, or a history of alcohol abuse,
• if you are taking other medicines that contain paracetamol,
• in case of nutritional problems (malnutrition) or dehydration.

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

It is recommended to use an appropriate oral analgesic treatment as soon as this route of administration is possible.

Other medicines and Paracetamol Combino Pharm

This medicine contains paracetamol, and this should be taken into account if you are taking other medicines that contain paracetamol or propacetamol to avoid exceeding the recommended daily dose (see the next section). Inform your doctor if you are taking other medicines that contain paracetamol. This medicine should not be administered if you are taking other medicines that contain paracetamol or propacetamol.

If you are being treated with Probenecid, a reduction in dose should be considered.

Inform your doctor or pharmacist if you are taking oral anticoagulants. It may be necessary to perform more frequent checks on the anticoagulant effect.

Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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

Pregnancy and breastfeeding

Inform your doctor if you are pregnant. Paracetamol can be used during pregnancy. However, in this case, the doctor must assess whether the treatment is advisable.

This medicine can be used during breastfeeding.

Driving and using machines

This product does not affect the ability to drive or use machines.

Paracetamol Combino Pharm contains less than 1 mmol of sodium (23mg) per 100 ml, so it is considered essentially "sodium-free".

3. How to use Paracetamol Combino Pharm

Paracetamol Combino Pharm will be administered to you by a healthcare professional.

Dosage

Dose according to patient weight (see posology table below):

*Maximum daily dose:The maximum daily dose described in the table above is for patients who are not taking other medicines with paracetamol and should be adjusted accordingly, taking into account these medicines.

**Patients who weigh 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 failure must be at least 6 hours.

Do not administer more than 4 doses in 24 hours.

Method of administration

Intravenous route

RISK OF MEDICATION ERRORS

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

This medicine will be administered to you through a perfusion in one of your veins. The perfusion will last approximately 15 minutes.

If you think the effect of the medicine is too strong or too weak, inform your doctor.

For 100 ml vials, use a 0.8 mm needle (21 gauge needle) and pierce the stopper vertically at the point expressly indicated.

In case of overdose, symptoms usually appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor, abdominal pain, and risk of liver damage. You should receive immediate medical attention in case of overdose due to the risk of irreversible liver damage. Inform your doctor if you notice any of these symptoms.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everybody gets them:

• In rare cases (may affect up to 1 in 1,000 people), the following may occur: discomfort, reduction in blood pressure, changes in laboratory test results: abnormally high levels of liver enzymes in blood tests. If this occurs, consult your doctor, as regular monitoring of blood parameters may be necessary.
• In very rare cases (may affect up to 1 in 10,000 people), a severe skin rash or allergic reaction (redness of the skin, erythema, itching, and abnormally high heart rate) may occur. Stop treatment immediately and inform your doctor.
• In very rare cases, other changes in laboratory test results have been observed, requiring regular monitoring of blood parameters: abnormally low levels of some blood cells (platelets, white blood cells), which can cause bleeding from the nose and gums. If this occurs, inform your doctor.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Combino Pharm

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Vials: Do not refrigerate or freeze. Store in the original packaging to protect from light.

Bags: Do not store above 25°C. Do not refrigerate or freeze. Store in the original packaging to protect from light.

For single use. The product must be used immediately after opening. Any remaining solution must be discarded.

Before administering the product, it must be visually inspected. Do not use this medicine if you notice any particles or if the solution has changed color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Combino Pharm

• The active ingredient is paracetamol. One ml contains 10 mg of paracetamol; the pack contains 1000 mg of paracetamol in 100 ml.
• The other ingredients are mannitol, sodium dihydrogen phosphate dihydrate, sodium hydroxide (for pH adjustment), povidone K-12, and water for injection. Nitrogen is only used for the product packaged in vials.

Appearance and packaging of the product

Paracetamol Combino Pharm is a clear and colorless to slightly brownish solution for infusion.

Paracetamol Combino Pharm is available in packs of 1, 4, 10, and 12 vials and 10, 12, and 20 plastic bags with an outer plastic bag.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MEDICHEM, S.A.

Fructuós Gelabert 6-8

08970-Sant Joan Despí

Spain

Manufacturer

Industria Farmaceutica Galenica Senese S.r.l.

Via Cassia Nord 351

53014 Monteroni d’Arbia

Italy

or

MEDICHEM S.A.

Narcís Monturiol 41A

08970 Sant Joan Despí

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Paracetamol Combino Pharm 10mg/ml solution for infusion EFG

Portugal: Paracetamol Combino Pharm 10mg/ml solução para perfusão

Date of the last revision of this package leaflet:April 2024