SUPOFEN 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Supofen 10 mg/ml solution for infusion EFG

paracetamol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Supofen and what is it used for

This medicine contains the active substance paracetamol and is an analgesic (pain reliever) and an antipyretic (fever reducer).

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.

2. What you need to know before you use Supofen

Do not use Supofen

• If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to propacetamol (another analgesic that is converted to paracetamol in your body)
• If you have severe liver disease.

Warnings and precautions

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

• if you could take analgesics by mouth (orally) instead, as this is the recommended route of administration;
• if you have reduced liver or kidney function, or if you drink too much alcohol;
• if you are taking other medicines that contain paracetamol;
• in cases of malnutrition or dehydration;
• in case of glucose-6-phosphate dehydrogenase deficiency (may cause hemolytic anemia), a blood disorder.

As soon as oral administration is possible, adequate analgesic treatment via this route is recommended.

Other medicines and Supofen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Supofen may affect or be affected by other medicines:

• other medicines that contain paracetamol or propacetamol, so that 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 drug;
• oral anticoagulants. It may be necessary to monitor the effect of the anticoagulant;
• medicines that activate liver enzymes: in these cases, it is necessary to strictly control the dose of paracetamol to avoid liver damage;
• flucloxacillin (antibiotic): due to a serious risk of alteration of blood and fluids (metabolic acidosis with elevated anion gap) that must be treated urgently and that can occur particularly in case of severe renal impairment, 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.

Using Supofen with alcohol

Limit your alcohol consumption during treatment with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Breastfeeding

Supofen can be used during breastfeeding.

Driving and using machines

Supofen has no or negligible influence on the ability to drive and use machines.

Supofen contains sodium

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

3. How to use Supofen

Supofen will be administered to you by a healthcare professional by infusion into one of your veins, over approximately 15 minutes.

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

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

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

If you receive more Supofen than you should

It is unlikely that an overdose will occur, as it will be a healthcare professional who administers the medicine. Your doctor will make sure that you do not receive a higher dose than recommended.

However, 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. If you receive more Supofen than you should, tell 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 medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

May include:

• pain and burning sensation at the injection site.

Uncommon (may affect up to 1 in 100 people)

May include:

• discomfort
• decrease in blood pressure
• changes in laboratory test results: abnormally high levels of liver enzymes when blood tests are performed. If this occurs, consult your doctor, as regular monitoring of blood parameters may be necessary.

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

May include:

• severe skin rash or allergic reaction (in the form of anaphylactic shock, urticaria, erythema). Stop treatment immediately and inform your doctor.
• Other changes in laboratory test results have been observed that require regular blood tests: abnormally low levels of some types of blood cells (platelets, white blood cells), possibly resulting in nosebleeds or gum bleeding. If this occurs, inform your doctor.
• Very rare cases of alteration of blood and fluids (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 the available data)

• Reports of skin redness, flushing, itching, and abnormally fast heartbeats have been made.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible that they are not listed in this leaflet. You can also report side effects directly via 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 Supofen

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

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

Do not store above 30°C.

Store in the original packaging to protect from light.

For single use only. After opening, 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 you notice any particles or discoloration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Supofen

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

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

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

Appearance and packaging of the product

Vials containing 100 ml of solution for infusion.

Supofen is a clear, particle-free solution, packaged in a polypropylene vial with polypropylene twin head or pull-off caps with a polyisoprene rubber closure.

Supofen is available in packs containing 1 or 50 vials (clinical pack).

Not all pack sizes may be marketed.

Marketing authorisation holder

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920 250 | Fax: + 351 231 921 055

E-mail: [email protected]

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

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

3450-232 Mortágua

Portugal

Local representative

Laphysan, S.A.U

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D

28108 Alcobendas (Madrid)

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

Portugal Supofen

Spain Supofen 10 mg/ml solution for infusion EFG

Latvia Paracetamol Basi 10 mg/ml šķīdums infūzijai

Lithuania Paracetamol Basi 10 mg/ml infuzinis tirpalas

Estonia Paracetamol Basi

Date of last revision of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Intravenous route.

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

Close monitoring is necessary before the end of the infusion.

Dosage

Information before dose preparation:

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

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

• Patients with lower weight will require smaller volumes.

**Maximum daily dose: The maximum daily dose indicated in the table above refers to patients who are not taking other medicines that contain paracetamol and must be adjusted taking into account these other medicines.

Method of administration

The paracetamol solution should be administered as a 15-minute intravenous infusion.

The medicine must be used immediately after opening the vial.

Before administration, the medicine must be visually inspected for particles and discoloration. For single use only.

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