FEBRISAN 500 mg/25 mg /5 Mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Febrisan Zatoki, 500 mg + 25 mg + 5 mg, coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Febrisan Zatoki and what is it used for
4. Important information before using Febrisan Zatoki
   1. When not to use Febrisan Zatoki
   2. Warnings and precautions
   3. Children and adolescents
   4. Patients with renal and/or hepatic impairment
   5. Elderly patients
   6. Febrisan Zatoki and other medicines
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
5. How to use Febrisan Zatoki
   1. Using a higher dose of Febrisan Zatoki than recommended
   2. Missing a dose of Febrisan Zatoki
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 (cannot be estimated from the available data):
   4. Reporting side effects
7. How to store Febrisan Zatoki
8. Package contents and other information
   1. What Febrisan Zatoki contains
   2. What Febrisan Zatoki looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Febrisan Zatoki, 500 mg + 25 mg + 5 mg, coated tablets

Paracetamol + Caffeine + Phenylephrine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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 after 3 days in the case of fever or 5 days in the case of pain, no improvement occurs or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Febrisan Zatoki and what is it used for

The medicine contains three active substances: paracetamol, phenylephrine, and caffeine. Paracetamol has antipyretic and analgesic effects. Phenylephrine reduces congestion and swelling of the nasal mucosa, making it easier to breathe through the nose. Caffeine has a stimulating effect on the central nervous system and enhances the analgesic effect of paracetamol.
Febrisan Zatoki is used for the short-term treatment of symptoms of the common cold and flu, such as:
fever, chills, headaches, muscle aches, sore throats, runny nose, and swelling of the nasal mucosa and paranasal sinuses.

2. Important information before using Febrisan Zatoki

When not to use Febrisan Zatoki

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

Warnings and precautions

Before starting to use Febrisan Zatoki, you should discuss it with your doctor or pharmacist.
You should not exceed the recommended dose. Using higher doses than recommended may cause severe liver damage.
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Long-term use of this product without medical supervision may 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, you should not use this medicine simultaneously with other medicines containing paracetamol.
You should be cautious in patients:

• with chronic malnutrition;
• with alcoholism;
• with severe renal impairment;
• with prostate enlargement;
• with vascular obstruction (Raynaud's syndrome);
• with pheochromocytoma;
• with untreated or active hyperthyroidism;
• 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 medicines (e.g., decongestants), appetite suppressants, psychostimulants similar to amphetamines;
• using anticoagulant medicines;
• with diabetes;
• with narrow-angle glaucoma.

Using the medicine in people with liver failure, alcohol abuse, and starvation creates a risk of liver damage.
You should not drink alcohol during treatment with paracetamol.
You should consult a doctor even if the above warnings apply to past situations.

Children and adolescents

You should not use the medicine in children under 12 years of age.

Patients with renal and/or hepatic impairment

You should be particularly cautious in patients with kidney or liver disease.
The medicine is contraindicated in patients with severe liver failure.

Elderly patients

You should be cautious when using Febrisan Zatoki.

Febrisan Zatoki and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The interaction of Febrisan Zatoki with other medicines results from the interaction of the active substances that make up the medicine.
Paracetamol
May enhance the effect of oral anticoagulant medicines from the coumarin group (e.g., warfarin, phenprocoumon) and increase the risk of bleeding. For this reason, monitoring is recommended.
Using paracetamol with medicines that accelerate its metabolism in the liver (e.g., rifampicin - used in the treatment of tuberculosis, leprosy, and staphylococcal infections; some sleeping pills and antiepileptic drugs

• carbamazepine, phenytoin, phenobarbital) increases the risk of liver damage. 2/6

Concomitant use of antiemetic medicines (e.g., metoclopramide) accelerates the absorption of paracetamol from the gastrointestinal tract.
Cholestyramine reduces the absorption of paracetamol, so you should not administer this medicine within an hour after taking paracetamol.
Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing liver cell necrosis, which can subsequently lead to liver failure.
Due to the risk of overdose, you should not use this medicine simultaneously with other medicines containing paracetamol.
Phenylephrine
Concomitant use with MAO inhibitors may enhance the effect of phenylephrine.
Indomethacin (a medicine used in rheumatoid arthritis), beta-adrenergic blockers [medicines used in the treatment of hypertension, arrhythmias (e.g., propranolol)] or methyldopa (a medicine used in the treatment of hypertension) used concomitantly with phenylephrine may cause a hypertensive crisis (a sudden increase in blood pressure, posing a life threat).

Pregnancy, breastfeeding, and fertility

Due to the presence of phenylephrine, you should not use the medicine during pregnancy (see section 2).
Paracetamol passes into breast milk. You should be cautious in breastfeeding women.
You should avoid using phenylephrine in breastfeeding women. Phenylephrine may be excreted in breast milk.

Driving and using machines

Febrisan Zatoki does not affect the ability to drive and use machines.

3. How to use Febrisan Zatoki

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years of age:
1 or 2 coated tablets (500 or 1000 mg of paracetamol, 25 or 50 mg of caffeine, and 5 or 10 mg of phenylephrine hydrochloride), every 4-6 hours. Do not take more than 8 coated tablets per day, which is 4 g of paracetamol, 200 mg of caffeine, and 40 mg of phenylephrine hydrochloride.
Without a doctor's recommendation, do not use for more than 3 days in the case of fever or 5 days in the case of pain.
Method of administration
Oral use.
The coated tablet should be taken after a meal, with a large amount of water.

Using a higher dose of Febrisan Zatoki than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.
The medicine contains three active substances, and symptoms of overdose may result from the action of one or all of these substances.
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Paracetamol
Overdose of paracetamol may lead to liver damage, which can result in liver transplantation or death. There have been reports of acute pancreatitis associated with liver dysfunction (including acute liver failure) and toxic liver damage.
Paracetamol overdose may cause symptoms such as:
nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may resolve the next day despite the development of liver damage, which then manifests as abdominal pain, return of nausea, and jaundice.
Overdose may lead to acute renal failure and/or liver failure.
Liver failure may lead to encephalopathy (disorders of central nervous system function), hemorrhage, hypoglycemia (low blood glucose levels), cerebral edema, coma, and death.
Other symptoms unrelated to the liver reported after paracetamol overdose include cardiac disorders.
Phenylephrine
Symptoms of phenylephrine overdose: tremors, anxiety, insomnia, tachycardia (rapid heart rate), supraventricular extrasystoles, headaches, paresthesia in the limbs, increased blood pressure. The following may occur: shortness of breath, hallucinations, and seizures. In some individuals, phenylephrine may cause reverse reactions: drowsiness, respiratory depression (inhibition of breathing), cardiac arrhythmias, hypotension, circulatory collapse.
In cases of severe poisoning, it is necessary to monitor the patient's vital functions, support breathing, and circulation.
Caffeine
Acute caffeine poisoning is very rare and manifests as abdominal pain, insomnia, increased diuresis, dehydration, and fever. More severe poisoning manifests as tonic-clonic seizures and cardiac arrhythmias.
In every case of taking a single dose of paracetamol of 5 g or more, you should induce vomiting if it has been less than 1 hour since ingestion.
In case of overdose, you should empty the stomach by inducing vomiting or gastric lavage and can administer activated charcoal. In some cases, it may be necessary to use an antidote: N-acetylcysteine and/or methionine. Treatment of poisoning should be carried out in a hospital, in the conditions of an intensive care unit.

Missing a dose of Febrisan Zatoki

The medicine is intended for the temporary treatment of symptoms of the common cold and flu. If a dose is missed and symptoms persist, you should take the next dose.
You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Febrisan Zatoki, 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 (low platelet count) and agranulocytosis (lack of granulocytes in the blood);
• bronchospasm;

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• liver failure;
• anaphylactic reaction.

There have been very rare reports of severe skin reactions (manifesting as acute pustular rash on the whole body or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or exfoliation of large skin plaques).

Frequency not known (cannot be estimated from the available data):

• arrhythmia (too fast or slow or irregular heart rate), bradycardia (too slow heart rate);
• asthma;
• urinary retention, especially in patients with prostate enlargement;
• increased blood pressure.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febrisan Zatoki

Store in a temperature below 25°C, in a dry room.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Febrisan Zatoki contains

• The active substances of the medicine are paracetamol, caffeine, and phenylephrine hydrochloride. One coated tablet contains 500 mg of paracetamol, 25 mg of caffeine, and 5 mg of phenylephrine hydrochloride.
• The other ingredients are: povidone, crospovidone, corn starch, stearic acid, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose (type A), sodium stearyl fumarate; coating: Opadry II Yellow [hypromellose, polydextrose, titanium dioxide (E171), talc, maltodextrin, medium-chain triglycerides, iron oxide yellow (E172), quinoline yellow (E104)]; Opadry Fx Yellow [carmellose sodium, maltodextrin, glucose monohydrate, aluminum potassium silicate (E555), titanium dioxide (E171), iron oxide red (E172), soybean lecithin]. 5/6

What Febrisan Zatoki looks like and contents of the pack

A carton contains 12 or 24 coated tablets in aluminum foil blisters with a white opaque PVC/PVDC film.

Marketing authorization holder

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
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:07/2023
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