Leaflet: information for the user

Supofen 10 mg/ml infusion solution EFG

paracetamol

Read this leaflet carefully before you start taking 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Supofen is and what it is used for

2.What you need to know before you start taking Supofen

3.How to use Supofen

4.Possible side effects

5.Storage of Supofen

6.Contents of the pack and additional information

This medication contains the active ingredient paracetamol and is an analgesic (relieves pain) and antipyretic (reduces fever).

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

Supofen is restricted to adults, adolescents, and children who weigh more than 33 kg.

No use Supofen

-If you are allergic to paracetamol or any of the other components of this medication (listed in section 6)

-If you are allergic to propacetamol (another analgesic that converts to paracetamol in your body)

-If you have a severe liver disease.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Supofen, if any of the following situations apply to you:

- if you could take analgesics by mouth (oral route), as this is the recommended administration route;

- if you have reduced liver or kidney function, or if you drink too much alcohol;

- if you are taking other medications that contain paracetamol;

- in cases of malnutrition or dehydration;

- in the case of glucose-6-phosphate dehydrogenase deficiency (may cause hemolytic anemia), a blood disorder.

As soon as the oral administration route is possible, it is recommended to use an appropriate analgesic treatment by this route.

Other Medications and Supofen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Supofen may affect or be affected by other medications:

• other medications that contain paracetamol or propacetamol, so you do not take more than the recommended daily dose (see section 3 “How to use Supofen”).
• probenecid: a lower dose of paracetamol may be necessary;
• salicylamide, an anti-inflammatory medication;
• oral anticoagulants. You may need to control the effect of the anticoagulant;
• medications that activate liver enzymes: in these cases, it is essential to strictly control the dose of paracetamol to avoid liver damage;
• flucloxacillin (antibiotic): due to a serious risk of blood and fluid disorder (metabolic acidosis with elevated anion gap) that must be treated urgently and which may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Use of Supofen with Alcohol

Limit your alcohol consumption during treatment with this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Supofen can be used during pregnancy. However, in this case, the doctor must evaluate whether the treatment is advisable.

Breastfeeding

Supofen can be used during breastfeeding.

Driving and Operating Machines

The influence of Supofen on the ability to drive and operate machines is negligible or insignificant.

Supofen contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per 100 ml vial; this is essentially “sodium-free”.

Supofen will be administered by a healthcare professional through a vein over approximately 15 minutes.

Your doctor will adjust the dose individually based on your weight and overall condition.

Supofen is restricted to adults, adolescents, and children weighing more than 33 kg.

If you feel that the effect of Supofen is too strong or too weak, inform your doctor.

If you receive more Supofen than you should

It is unlikely that an overdose will occur, as a healthcare professional will administer the medication. Your doctor will ensure that you do not receive a dose higher than the recommended one.

However, in cases of overdose, symptoms usually appear within the first 24 hours and may include: nausea, vomiting, loss of appetite, pallor, abdominal pain, and risk of liver damage. If you receive more Supofen than you should, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent (may affect up to 1 in 10 people)

It may cause:

• Pain and burning sensation at the injection site.

Rare (may affect up to 1 in 1,000 people)

It may cause:

• Discomfort
• Decreased blood pressure
• Changes in laboratory test results: abnormally high levels of liver enzymes during blood tests. If this occurs, consult your doctor, as regular monitoring of blood parameters may be necessary.

Very rare (may affect up to 1 in 10,000 people)

It may cause:

• Severe skin rash or allergic reaction (in the form of anaphylactic shock, urticaria, erythema).Stop treatment immediatelyand inform your doctor.
• Other changes in laboratory test results have been observed that have required regular blood controls: abnormally low levels of certain types of blood cells (platelets, white blood cells), which may result in nosebleeds or gum bleeding. If this occurs, inform your doctor.
• Very rare cases of blood and fluid alteration (metabolic acidosis with elevated anion gap) that occur when there is an increase in plasma acidity, when paracetamol is used concomitantly with flucloxacillin, generally in the presence of risk factors (see section 2).

Frequency not known (cannot be estimated from available data)

• Cases of skin redness, flushing, itching, and abnormally rapid heartbeats have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle after EXP. The expiration date is the last day of the month indicated.

Do not store above 86°F.

Store in the original packaging to protect it from light.

For single use only. After opened, the product must be used immediately. Any unused solution must be discarded.

Before administration, the product must be visually inspected. Do not use Supofen, if any particle or discoloration is observed.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Supofen

• The active ingredient is paracetamol. 1 ml contains 10 mg of paracetamol.

Each bottle (100 ml) contains 1,000 mg of paracetamol.

• The other components are edetate disodium, sodium dihydrogen phosphate dihydrate, concentrated hydrochloric acid, mannitol, sodium hydroxide, and water for injectable preparations.

Aspect of the product and content of the packaging

Bottles containing 100 ml of infusion solution.

Supofen is a transparent solution, free of visible particles, packaged in a polypropylene bottle with polypropylene capstwin headorpull-offwith a rubber stopper made of polyisoprene.

Supofen is available in packaging that contains 1 or 50 bottles (clinical packaging).

Only some packaging sizes may be commercially available.

Holder of the marketing authorization

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lot 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920250 | Fax: + 351 231 921 055

E-mail:[email protected]

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lots 8, 15, 16

3450-232 Mortágua

Portugal

Local representative

Laphysan, S.A.U

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Floor 4, door D

28108 Alcobendas (Madrid)

This medicine is authorized in the member states of the European Economic Area with the following names:

PortugalSupofen

SpainSupofen 10 mg/ml infusion solution EFG

LatviaParacetamol Basi 10 mg/ml infusion solution

LithuaniaParacetamol Basi 10 mg/ml infusion solution

EstoniaParacetamol Basi

Last review date of this leaflet: March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Intravenous route.

Supofen is restricted to adults, adolescents, and children weighing more than 33 kg.

Tight monitoring is required before the end of the infusion.

Dosage

Information before preparing the dose:

• 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 in 24 hours.

Risk of medication errors

Be cautious to avoid administration errors due to the possible confusion between milligrams (mg) and milliliters (ml), which could lead to accidental overdose and death.

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

* Patients with lower weights will require smaller volumes.

**Maximum daily dose: The maximum daily dose indicated in the table above refers to patients not receiving other medications containing paracetamol and should be adjusted taking into account these other medications.

Administration form

The paracetamol solution must be administered as an intravenous infusion of 15 minutes.

The medication must be used immediately after opening the bottle.

Before administration, the medication must be visually inspected to detect the presence of particles and discoloration. For single use.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.