PARACETAMOL KERN PHARMA 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Paracetamol Kern Pharma 100 mg/ml Oral Solution EFG

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Contents of the Package Leaflet:

1. What is Paracetamol Kern Pharma and what is it used for
2. What you need to know before taking Paracetamol Kern Pharma
3. How to take Paracetamol Kern Pharma
4. Possible side effects
5. Storage of Paracetamol Kern Pharma
6. Contents of the pack and further information

1. What is Paracetamol Kern Pharma and what is it used for

Paracetamol Kern Pharma belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for febrile states and for the relief of mild or moderate pain.

2. What you need to know before taking Paracetamol Kern Pharma

Do not takeParacetamolKern Pharma

• If you are allergic to paracetamol, other medicines of the antipyretic or analgesic group, or any of the other components of Paracetamol Kern Pharma.
• If you have any liver disease.

Warnings and Precautions

• Do not exceed the recommended dose in section 3. How to take Paracetamol Kern Pharma.
• In patients with kidney, heart, or lung disease, and in patients with anemia (decrease in hemoglobin level in the blood, due to or not due to a decrease in red blood cells), consult your doctor before taking the medicine.
• Consumption of alcoholic beverages can cause paracetamol to damage the liver.
• If the pain persists for more than 3 days in children or 5 days in adults (2 days for throat pain) or fever for more than 3 days, or worsens or other symptoms appear, treatment should be discontinued and a doctor consulted.
• Avoid prolonged treatments.

During treatment with Paracetamol Kern Pharma, inform your doctor immediately if:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children

It is recommended to consult a doctor before administering it to children under 3 years of age.

Interference with Laboratory Tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Use of Paracetamol Kern Pharma with Other Medicines

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

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor. To avoid the risk of overdose, you should check that you are not taking other medicines that contain paracetamol. Prolonged and simultaneous use of paracetamol with salicylates is not recommended due to the increased risk of kidney toxicity.

Paracetamol may increase the toxicity of chloramphenicol.

Barbiturates may potentiate the toxicity of paracetamol.

In case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

In particular, if you are using medicines that contain any of the following active ingredients, it may be necessary to modify the dose or interrupt treatment of either of them:

• Antibiotics (chloramphenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and estrogen treatments
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal, used for diarrhea or gas treatment
• Colestyramine (used to decrease blood cholesterol levels)
• Medicines used to treat gout (anti-gout) (probenecid and sulfinpyrazone)
• Some medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics)
• Medicines used for the heart (digitalis glycosides)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS)
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

• Use of Paracetamol Kern Pharma with Food and Drink

Paracetamol Kern Pharma can be diluted with water, milk, or fruit juice. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) can damage the liver.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

In women, although there are no controlled studies, no teratogenic effects have been found. However, as a general rule, its use is not recommended during the first trimester of pregnancy, and in case of use, it should be done by weighing the possible risks and benefits of treatment. If necessary, Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently. Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medicine.

Driving and Using Machines

It may decrease the ability to drive or operate machinery because it contains propylene glycol, which can produce symptoms similar to those of alcohol.

Paracetamol Kern Pharma Contains Propylene Glycol and Glucose

This medicine contains 2.72 mg of propylene glycol in each ml.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to Take Paracetamol Kern Pharma

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The dosage of Paracetamol Kern Pharma is performed in ml (100 mg/ml), using the oral syringe of 2 or 5 ml.

The recommended dose is:

Children from0 to10 years:

These doses can be repeated every 6 hours.

A dosing schedule of 15 mg/kg per dose, every 6 hours, with a total dose of 60 mg/kg/day, can also be established, especially in children under 1 year of age.

If after 3-4 hours of administration the desired effects are not obtained, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

Administration of the preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Method of use and route of administration

Oral route.

Bottle of 30 ml:

Extract the prescribed amount using the 2 ml dosing syringe.

Bottle of 60 ml with 5 ml syringe:

1. Open the bottle by following the instructions on the cap (on the first opening, the seal will break).

2. Insert the oral syringe, pressing into the hole in the cap.

3. Invert the bottle and withdraw the necessary dose.

4. Administer directly or dilute with water, milk, or fruit juice.

5. The oral syringe should be washed with water after each dose.

Close the bottle well after each administration.

If you take more Paracetamol Kern Pharma than you should

If you have taken more paracetamol than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91-562 04 20, indicating the medicine and the amount used. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you have ingested an overdose, go quickly to a Medical Center, even if there are no symptoms, since often, very serious symptoms do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning. The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Paracetamol overdose is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg/kg of body weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medicine.

In the case of a patient being treated with barbiturates or suffering from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

If you forget to take Paracetamol Kern Pharma

Do not take a double dose to make up for forgotten doses.

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

4. Possible Side Effects

Like all medicines, Paracetamol Kern Pharma can cause side effects, although not everyone gets them.

Paracetamol's adverse reactions are, in general, rare (may affect up to1 in 1,000 patients) or very rare (may affect up to1 in 10,000 patients).

Very rarely, it can damage the liver at high doses or prolonged treatments. Also, very rarely, skin rashes and blood alterations such as neutropenia or leukopenia may appear.

Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Paracetamol Kern Pharma

Keep out of sight and reach of children.

Store the bottle in the outer packaging to protect it from light.

Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date is the last day of the month indicated.

Once opened, the contents of the bottle must be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Paracetamol Kern Pharma

• The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are: macrogol 600, glycerol (E-422), sucralose (E-955), flavor masking agent (contains propylene glycol (E-1520)), strawberry flavor (contains propylene glycol (E-1520)), carmine red (E-120) (contains glucose), and water.

Appearance of the Product and Contents of the Pack

Paracetamol Kern Pharma 100 mg/ml is presented as a clear, red oral solution with a characteristic strawberry odor.

Bottle of 30 ml with 2 ml dosing syringe and bottle of 60 ml with 5 ml dosing syringe.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Leaflet: February 2025

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