FEBRISAN (750 mg + 60 mg + 10 mg)/5 g Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Febrisan, (750 mg + 60 mg + 10 mg)/5 g, Effervescent Powder
   1. Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Febrisan and what is it used for
4. Important information before using Febrisan
   1. When Not to Use Febrisan
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Patients with Renal and/or Hepatic Impairment
   5. Elderly Patients
   6. Febrisan and Other Medications
   7. Pregnancy, Breastfeeding, and Fertility
   8. Driving and Using Machines
   9. Warnings Regarding Excipients
5. How to Use Febrisan
   1. Using a Higher Than Recommended Dose of Febrisan
   2. Missing a Dose of Febrisan
6. Possible Side Effects
   1. Rare (more than 1 in 10,000 patients):
   2. Very Rare (less than 1 in 10,000 patients):
   3. Frequency Not Known (frequency cannot be estimated from the available data):
   4. Reporting Side Effects
7. How to Store Febrisan
8. Contents of the Pack and Other Information
   1. What Febrisan Contains
   2. What Febrisan Looks Like and What the Pack Contains
   3. Marketing Authorization Holder
   4. Manufacturer
   5. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Febrisan, (750 mg + 60 mg + 10 mg)/5 g, Effervescent Powder

Paracetamol + Ascorbic Acid + Phenylephrine Hydrochloride

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, or if the fever does not subside after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Febrisan and what is it used for
• 2. Important information before using Febrisan
• 3. How to use Febrisan
• 4. Possible side effects
• 5. How to store Febrisan
• 6. Contents of the pack and other information

1. What is Febrisan and what is it used for

The medication contains three active substances: paracetamol, phenylephrine, and ascorbic acid (vitamin C).
Paracetamol acts as an antipyretic and analgesic. Phenylephrine reduces nasal congestion and swelling of the nasal mucosa, facilitating nasal passage clearance. Ascorbic acid meets the increased need for vitamin C during colds and flu.
Febrisan is used for the short-term treatment of cold and flu symptoms, such as: fever, chills, headache, muscle pain, sore throat, runny nose, and sinus pain.

2. Important information before using Febrisan

When Not to Use Febrisan

• If the patient is allergic to the active substances or any of the other ingredients of this medication (listed in section 6).
• If the patient has:
• hypertension;
• heart disease;
• severe liver failure;
• phenylketonuria.
• In the case of treatment with MAO inhibitors and for up to 2 weeks after their discontinuation.
• During pregnancy.
• In children under 12 years of age.

Warnings and Precautions

Before starting to use Febrisan, discuss it with a doctor or pharmacist.
The medication contains paracetamol. To avoid the risk of overdose, check if other medications being taken contain paracetamol. Do not exceed the recommended dose. Using higher doses than recommended can cause severe liver damage.
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During the use of Febrisan, immediately inform a doctor if the patient has severe diseases, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
In these situations, patients have reported the occurrence of a severe disease called metabolic acidosis (a blood and body fluid disorder), when they used paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin.
Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Patient reports have indicated severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, in patients taking paracetamol-containing medications. Patients should be informed of the symptoms of these skin reactions. If symptoms occur, the product should be discontinued immediately, symptomatic treatment should be provided, and the patient should be closely monitored (see section 4).
Long-term use of this product without medical supervision can be harmful (see section 3).
During long-term use or treatment with high doses of painkillers, headaches may occur, which should not be treated with higher doses of paracetamol.
Due to the risk of overdose, the medication should not be used simultaneously with other medications containing paracetamol.
Particular caution should be exercised in patients:

• with chronic malnutrition;
• with alcoholism;
• with severe kidney failure;
• with prostate enlargement;
• with pheochromocytoma;
• with untreated or active hyperthyroidism;
• with Raynaud's syndrome;
• allergic to acetylsalicylic acid and patients with asthma sensitive to acetylsalicylic acid, as there have been reports of mild bronchospasm after the use of paracetamol in patients sensitive to acetylsalicylic acid (cross-reaction);
• treated with sedatives and other sympathomimetic medications (i.e., reducing nasal congestion), appetite suppressants, psychostimulants similar to amphetamine;
• taking anticoagulant medications;
• with diabetes;
• with narrow-angle glaucoma.

Using the medication in patients with liver failure, alcohol abuse, and starvation poses a risk of liver damage.
Alcohol should not be consumed during treatment with paracetamol.
A doctor should be consulted, even if the above warnings refer to past situations.

Children and Adolescents

The medication should not be used in children under 12 years of age.

Patients with Renal and/or Hepatic Impairment

Particular caution should be exercised in patients with kidney and/or liver diseases.
The medication is contraindicated in patients with severe liver failure.
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Elderly Patients

Cautious use of Febrisan is recommended.

Febrisan and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The interaction of Febrisan with other medications results from the interaction of the active substances contained in the medication.
Paracetamol
May enhance the effect of oral anticoagulant medications from the coumarin group (e.g., warfarin, phenprocoumon) and increase the risk of bleeding. For this reason, monitoring is recommended.
Concomitant use with medications that accelerate paracetamol metabolism in the liver (e.g., rifampicin, some sleeping pills and antiepileptic medications - carbamazepine, phenytoin, phenobarbital) increases the risk of liver damage.
Concomitant use with antiemetic medications (e.g., metoclopramide) accelerates paracetamol absorption from the gastrointestinal tract.
Cholestyramine reduces paracetamol absorption, so it should not be administered within an hour of paracetamol administration.
Consuming alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing liver cell necrosis, which can result in liver failure.
Due to the risk of overdose, the medication should not be used simultaneously with other medications containing paracetamol.
The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Phenylephrine
Concomitant use with MAO inhibitors may enhance the effect of phenylephrine.

Pregnancy, Breastfeeding, and Fertility

Due to the presence of phenylephrine, the use of the medication during pregnancy is contraindicated (see section 2).
Paracetamol passes into breast milk. Caution should be exercised in breastfeeding women.
Phenylephrine should be avoided in breastfeeding women. Phenylephrine may be excreted in breast milk.
The decision to breastfeed should be made considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and Using Machines

Febrisan does not affect the ability to drive or operate machinery.

Warnings Regarding Excipients

Febrisan contains sucrose, aspartame (E 951), glucose (a component of the flavor), and sodium.
Sucrose
The medication contains 2.458 g of sucrose in 1 sachet and 9.832 g in the maximum daily dose (4 sachets).
This should be taken into account in patients with diabetes.
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If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
Aspartame (E 951)
The medication contains 110 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (see section 2). This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Glucose (flavor component)
The medication contains 85 mg of glucose in each sachet.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
Sodium
The medication contains 166 mg of sodium (the main component of common salt) in each sachet. This corresponds to 8.2% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to Use Febrisan

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years:
1 sachet every 4-6 hours. Do not take more than 4 sachets per day, which corresponds to 3 g of paracetamol, 240 mg of ascorbic acid, and 40 mg of phenylephrine hydrochloride.
Without a doctor's recommendation, do not use for more than 3 days in case of fever or 5 days in case of pain.
Method of administration
Oral use.
Before use, the powder should be dissolved in a glass of hot water.

Using a Higher Than Recommended Dose of Febrisan

In case of taking a higher dose of the medication than recommended, immediately consult a doctor or pharmacist.
The medication contains three active substances, and symptoms of overdose may result from the action of one or all of these substances.
Paracetamol
Overdose of paracetamol can lead to liver damage, which can result in liver transplantation or death. Cases of acute pancreatitis have been observed, usually associated with liver dysfunction (including acute liver failure) and toxic liver damage.
Paracetamol overdose can cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the next day despite the development of liver damage, which then manifests as abdominal pain, return of nausea, and jaundice.
Overdose can lead to acute kidney failure and/or liver failure.
Liver failure can lead to encephalopathy (central nervous system dysfunction), bleeding, hypoglycemia (low blood glucose), cerebral edema, coma, and death.
Other symptoms unrelated to the liver reported after paracetamol overdose include cardiac dysfunction.
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In every case of taking paracetamol in a single dose of 5 g or more, vomiting should be induced if it has not been more than 1 hour since ingestion.
60-100 g of activated charcoal should be administered orally, preferably mixed with water.
In some cases, it may be necessary to use an antidote: N-acetylcysteine and/or methionine. Treatment of paracetamol poisoning should be carried out in a hospital, in intensive care unit conditions.
Phenylephrine
Symptoms of phenylephrine overdose: tremors, anxiety, insomnia, tachycardia (rapid heart rate), supraventricular extrasystoles, headaches, paresthesia in the limbs, elevated blood pressure. The following may occur: shortness of breath, hallucinations, and seizures. In some individuals, phenylephrine may cause reverse reactions: drowsiness, respiratory depression (breathing inhibition), arrhythmia, hypotension, circulatory collapse. The procedure involves gastric lavage.
In cases of severe poisoning, it is necessary to monitor the patient's vital functions, support breathing and circulation.

Missing a Dose of Febrisan

The medication is intended for the temporary treatment of cold and flu symptoms. If a dose is missed and symptoms persist, the next dose should be taken.
A double dose should not be taken to make up for a missed dose.

4. Possible Side Effects

Like all medications, Febrisan can cause side effects, although not everybody gets them.
During the use of Febrisan, the following side effects may occur:

Rare (more than 1 in 10,000 patients):

• symptoms of liver damage;
• skin hypersensitivity reactions, including urticaria and rash;
• hypersensitivity.

Very Rare (less than 1 in 10,000 patients):

• thrombocytopenia (reduced platelet count) and agranulocytosis (absence of granulocytes in the blood);
• bronchospasm;
• liver failure;
• anaphylactic reaction.

Frequency Not Known (frequency cannot be estimated from the available data):

• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2);
• arrhythmia (too fast or slow or irregular heart rate), bradycardia (too slow heart rate);
• asthma;
• urinary retention, especially in patients with prostate enlargement;
• hypothermia (especially in patients without fever);
• increased blood pressure;
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (severe skin reactions characterized by acute pustular rash all over the body or

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blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or exfoliation of large skin plates).

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Febrisan

Store in a temperature below 25°C, in a dry place.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and sachet. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What Febrisan Contains

• The active substances of the medication are paracetamol, ascorbic acid, and phenylephrine hydrochloride. One sachet (5 g of effervescent powder) contains 750 mg of paracetamol, 60 mg of ascorbic acid (vitamin C), and 10 mg of phenylephrine hydrochloride.
• Other ingredients are: sucrose, citric acid, aspartame (E 951), quinoline yellow 70 (E 104), natural lemon flavor powder 213 841 (contains, among others, maltodextrin, which contains glucose; sucrose; sulfites; d-limonene; citral; geraniol; linalool; citronellol; farnesol), Contramarum flavor (Contramarum Trockenaroma 201 227) (contains, among others, glucose, ethanol, propylene glycol, benzyl alcohol, sulfites), sodium bicarbonate.

What Febrisan Looks Like and What the Pack Contains

Febrisan is a yellowish effervescent powder with a lemon flavor.
The carton contains 8, 12, or 16 sachets made of three-layer foil: paper/Aluminum/PE.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medication, contact the local representative of the marketing authorization holder:
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Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]

Manufacturer

Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland

Date of Last Revision of the Leaflet:

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