ALIFLUSIN 500 mg/200 mg /4 Mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. Aliflusin
3. 500 mg + 200 mg + 4 mg, effervescent tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
4. What is Aliflusin and what is it used for
5. Important information before taking Aliflusin
   1. When not to take Aliflusin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Aliflusin and other medicines
   5. Aliflusin with food, drinks, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Aliflusin contains sodium
   9. Aliflusin contains isomalt and glucose (maltodextrin component)
6. How to take Aliflusin
   1. Taking a higher dose of Aliflusin than recommended
   2. Missing a dose of Aliflusin
7. Possible side effects
   1. Stop taking the medicine and consult your doctor or go to the hospital immediately if you experience:
   2. Other side effects include:
   3. Rare (may occur in up to 1 in 1000 people):
   4. Frequency not known (cannot be estimated from available data):
   5. Stop taking the medicine and consult your doctor or go to the hospital immediately if you experience an allergic reaction:
   6. Common (may occur in up to 1 in 10 people):
   7. Rare (may occur in up to 1 in 1000 people):
8. How to store Aliflusin
9. Contents of the pack and other information
   1. What Aliflusin contains
   2. What Aliflusin looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PATIENT INFORMATION LEAFLET: USER INFORMATION

Aliflusin

500 mg + 200 mg + 4 mg, effervescent tablets

Paracetamol + Ascorbic acid + Chlorphenamine maleate

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days for fever and 5 days for pain (in adolescents over 15 years - 3 days) there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Aliflusin and what is it used for

Aliflusin is a combination medicine containing three active substances: paracetamol, which acts as a pain reliever and antipyretic, chlorphenamine maleate, which reduces nasal secretion, inhibits sneezing and tearing, and ascorbic acid, which supplements vitamin C deficiency in the body.
This medicine is used for the short-term treatment of symptoms of flu, colds and flu-like conditions, such as headache, fever, sore throat, especially with accompanying cough, in adults and adolescents over 15 years of age. Aliflusin should only be used in case of symptoms of colds and flu, such as pain and/or fever and cough.
If after 3 days for fever and 5 days for pain (in adolescents over 15 years - 3 days) there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Aliflusin

When not to take Aliflusin:

• if you are allergic to paracetamol, ascorbic acid or chlorphenamine maleate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver failure;
• if you are taking other medicines that affect liver function;
• if you have narrow-angle glaucoma;
• in patients with a risk of urinary retention associated with disorders of the urethra passing through the prostate gland;
• in patients taking monoamine oxidase inhibitors (MAOIs, used to treat depression), currently or in the last two weeks;
• in children and adolescents under 15 years of age.

Warnings and precautions

Before starting to take Aliflusin, you should discuss it with your doctor or pharmacist.
Warnings
In case of high or persistent fever, starting bacterial superinfection, persistence of symptoms for more than 3 days for fever and 5 days for pain (in adolescents over 15 years - 3 days), you should contact your doctor.
The risk of overdose of this medicine is increased in patients with liver disease.
Caution should be exercised when using in patients:

• with mild to moderate liver disease, including non-alcoholic liver cirrhosis, Gilbert's syndrome (familial non-hemolytic jaundice),
• with low glutathione levels, e.g. seriously malnourished, with anorexia, with low body mass index (BMI), weakened,
• dehydrated,
• regularly consuming alcohol,
• with sepsis.

Taking paracetamol may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deepened, accelerated, labored breathing, nausea, vomiting, loss of appetite. You should immediately contact your doctor if you experience any of these symptoms together.
Do not take with other cold and flu medicines.
While taking Aliflusin, you should immediately inform your doctor if you have severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, alcoholism in the chronic phase or if you are also taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (blood and fluid disorder) in patients who take paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Precautions
Paracetamol should be used with caution in people with kidney disorders, acute hepatitis, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, and methemoglobin reductase deficiency.
Due to the risk of hypertensive crisis, this medicine is contraindicated in patients taking monoamine oxidase inhibitors currently or in the last two weeks (see "When not to take Aliflusin").
Due to the content of chlorphenamine, you should avoid consuming alcohol, alcohol-containing medicines, and sedatives (especially barbiturates) while taking this medicine. These substances enhance the sedative effect of antihistamines, which may affect the ability to drive vehicles and operate machinery.
Caution should be exercised in patients with asthma, chronic obstructive pulmonary disease, cardiovascular disease, hypertension, hyperthyroidism, and pyloric stenosis.
Effect on laboratory tests
Paracetamol may affect the results of blood uric acid tests, as well as glucose tests. Chlorphenamine may affect the results of skin tests using allergens. It is recommended to discontinue the product at least 3 days before starting skin tests.

Children and adolescents

This medicine should not be used in children and adolescents under 15 years of age.

Aliflusin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take Aliflusin with monoamine oxidase inhibitors (MAOIs, used to treat depression) currently or if you have taken them in the last two weeks (see "When not to take Aliflusin").
While taking Aliflusin, you should avoid alcohol-containing medicines.
Caution should be exercised when using:

• opioids (pain relievers, anti-cough medicines, and replacement therapies),
• neuroleptics (medicines used to treat mental disorders, mainly schizophrenia and other psychoses),
• barbiturates (sleeping pills and used to treat epilepsy),
• benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects),
• anxiolytic medicines other than benzodiazepines (e.g. meprobamate),
• sleeping pills (lorazepam, diazepam),
• antidepressants with sedative effects (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine),
• antihistamines blocking H receptors (medicines used to treat allergic diseases),
• antihypertensive medicines acting on the central nervous system,
• baclofen (a muscle relaxant),
• thalidomide (a medicine affecting the immune system, used to treat multiple myeloma),
• anticholinergic antiparkinsonian medicines (such as benzatropine),
• medicines similar to atropine with antispasmodic effects (containing hyoscine),
• dyphylline (used to treat heart diseases),
• neuroleptics from the phenothiazine derivative group (medicines used to treat psychoses, such as chlorpromazine, thioridazine, perphenazine),
• clozapine (a medicine used to treat schizophrenia and mental disorders in Parkinson's disease),
• salicylamide (a pain reliever),
• rifampicin (an antibiotic),
• antiepileptic medicines (e.g. phenytoin, carbamazepine, lamotrigine, and others),
• sleeping pills from the barbiturate group and other medicines inducing liver enzymes,
• caffeine,
• non-steroidal anti-inflammatory medicines (aspirin, ibuprofen, diclofenac, naproxen),
• anticoagulant medicines from the coumarin group (acenocoumarol, warfarin),
• fluphenazine (a medicine used to treat psychosis),
• zidovudine,
• lamotrigine,
• domperidone,
• metoclopramide,
• probenecid,
• cholestyramine,
• chloramphenicol,
• any substances with hepatotoxic effects.

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to the risk of serious blood and fluid disorder (metabolic acidosis), which requires emergency treatment (see section 2).

Aliflusin with food, drinks, and alcohol

While taking Aliflusin, you should avoid consuming alcohol, as it may cause liver damage and excessive sedation.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.
Pregnancy
Aliflusin is not recommended during pregnancy due to the presence of chlorphenamine.
Breastfeeding
Aliflusin is not recommended during breastfeeding due to the presence of chlorphenamine.
Fertility
Animal studies have not shown any adverse effects of paracetamol, chlorphenamine maleate, or ascorbic acid on fertility.

Driving and using machines

Drowsiness may occur, especially at the beginning of treatment, which affects the psychophysical fitness of drivers and machine operators. This effect may be enhanced by concurrent consumption of alcohol, taking medicinal products containing alcohol, or sedatives. While taking this medicinal product, you should not drive vehicles or operate machinery.

Aliflusin contains sodium

This medicine contains 254.5 mg of sodium (the main component of common salt) in each effervescent tablet.
This corresponds to 12.6% of the recommended maximum daily intake of sodium for an adult.
This should be taken into account if you have been advised to follow a low-sodium diet.

Aliflusin contains isomalt and glucose (maltodextrin component)

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains 799.00 mg of isomalt in one effervescent tablet.

3. How to take Aliflusin

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Adults and adolescents over 15 years:
The recommended single dose is one effervescent tablet (500 mg paracetamol, 200 mg ascorbic acid, and 4 mg chlorphenamine maleate) if necessary, up to 3 times a day, with an interval of at least 4 hours between doses. The maximum daily dose of 3 effervescent tablets (1500 mg paracetamol, 600 mg ascorbic acid, and 12 mg chlorphenamine maleate) should not be exceeded within 24 hours.
Patients with kidney disorders
In case of kidney disorders, the time interval between consecutive doses will be determined by your doctor.
Patients with liver disorders
In patients with mild to moderate liver disorders or Gilbert's syndrome, the dose of the medicine should be reduced or the intervals between consecutive doses prolonged. The dose and interval between two doses will be determined by your doctor.
In case of severe liver disorder, the medicine should not be taken (see "When not to take Aliflusin").
Elderly
No dose adjustment is required in elderly patients with normal kidney and/or liver function.
Children and adolescents under 15 years
This medicine should not be used in children and adolescents under 15 years of age.
Method of administration
Oral use.
The effervescent tablet should be dissolved in a glass of warm water. Drink immediately after preparation.
Duration of treatment
This medicine should not be used without consulting a doctor for more than 3 days for fever and 5 days for pain (in adolescents over 15 years - 3 days). This medicine should be used when pain and fever occur. If they disappear, you should stop taking the medicine.

Taking a higher dose of Aliflusin than recommended

Stop treatment and contact your doctor or emergency services immediately.
Symptoms related to chlorphenamine maleate
Overdose of chlorphenamine may cause: seizures (especially in children), disorders of consciousness, coma.
Symptoms related to paracetamol
There is a particular risk of paracetamol poisoning in the elderly and in small children (the most common causes are taking higher doses than recommended and accidental poisoning); these poisonings can lead to death. Overdose of the medicine may cause symptoms within a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may disappear the next day, despite the fact that liver damage is beginning to develop, which will then manifest as abdominal distension, return of nausea, and jaundice. In case of taking a higher dose of the medicine than recommended, you should immediately contact your doctor, even if you feel well, due to the risk of delayed, serious, and irreversible liver damage.

Missing a dose of Aliflusin

Do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to paracetamol:

Stop taking the medicine and consult your doctor or go to the hospital immediately if you experience:

• swelling of the larynx, which makes breathing difficult (single cases);
• anaphylactic shock, manifested by confusion, paleness, low blood pressure, sweating, oliguria, rapid breathing, weakness, and fainting (single cases);
• erythema multiforme (single cases);
• severe skin reaction: toxic epidermal necrolysis (Lyell's syndrome), bullous erythema multiforme (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis with pustules all over the body, erosions in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters bursting, exfoliation of large skin flakes, weakness, fever, and joint pain (very rare cases);
• persistent itching of the skin (pruritus), skin rash, excessive sweating, appearance of papular, hemorrhagic, or vesicular eruptions (papular rash), allergic reaction causing swelling of tissues under the skin (angioedema), allergic reaction causing blistering of the skin (urticaria); these occur rarely;
• acute or chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver dysfunction (liver failure), irreversible liver damage (liver necrosis), jaundice; these occur rarely.

Other side effects include:

Rare (may occur in up to 1 in 1000 people):

• anemia due to various deficiencies, bone marrow depression, decreased platelet count;
• fluid accumulation in tissues (edema);
• kidney dysfunction (nephropathy) and impaired absorption or excretion of renal tubules (tubulopathy).

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

• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Paracetamol is a widely used medicine, and the described side effects are rare and usually related to overdose.
Single cases of dizziness have been observed.
Side effects related to chlorphenamine

Stop taking the medicine and consult your doctor or go to the hospital immediately if you experience an allergic reaction:

• hypersensitivity reactions (allergic), anaphylactic reactions (severe allergic reactions, which may include coughing, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or eyes, face, tongue, shortness of breath, fatigue, etc.);
• central nervous system depression in the form of drowsiness, nausea, and muscle weakness, which in some patients disappear after 2-3 days of treatment; this occurs frequently;
• bile duct obstruction (cholestasis), hepatitis, or other liver function disorders (including abdominal pain or stomach pain, dark urine, etc.); these occur rarely.

Other side effects include:

Common (may occur in up to 1 in 10 people):

• involuntary and uncontrolled facial muscle movements (dyskinesia), coordination disorders (stiffness), tremors, numbness, tingling, burning sensation, feeling of pinpricks (paresthesia);
• blurred or double vision;
• feeling of dryness in the nose and throat, drying of mucous membranes;
• feeling of dryness in the mouth, loss of appetite, changes in taste and smell, gastrointestinal disorders (nausea, vomiting, diarrhea, constipation, abdominal pain), which may decrease if the medicine is taken during meals;
• increased sweating;
• urinary retention and/or difficulty urinating.

Rare (may occur in up to 1 in 1000 people):

• changes in blood tests (lack of granulocytes, decreased white blood cell count, anemia due to bone marrow atrophy (aplastic anemia) or decreased platelet count (thrombocytopenia)), which may be accompanied by symptoms such as unusual bleeding, sore throat, or fatigue;
• photosensitivity, hypersensitivity to similar medicines;
• sometimes excitement, especially when taking high doses in children or the elderly, characterized by restlessness, insomnia, nervousness, hallucinations, palpitations, and seizures;
• tinnitus (unpleasant auditory sensations), acute labyrinthitis;
• usually, in case of overdose, cardiac arrhythmias, palpitations, rapid heartbeat (tachycardia) may occur;
• hypotension, increased blood pressure, fluid accumulation in tissues (edema);
• chest tightness, shortness of breath;
• erectile dysfunction in men (impotence), intermenstrual bleeding.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 4921 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 Aliflusin

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package, in order to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and tube after EXP.
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

What Aliflusin contains

• The active substances of the medicine are paracetamol, ascorbic acid, and chlorphenamine maleate. Each effervescent tablet contains: 500 mg paracetamol (Paracetamolum), 200 mg ascorbic acid (Acidum ascorbicum), 4 mg chlorphenamine maleate (Chlorphenamini maleas).
• Other ingredients are: citric acid, sodium bicarbonate, isomalt (E 953), macrogol 6000, sodium saccharin (E 954), lemon flavor (Tetrarome Lemon P 0551 987323: corn maltodextrin (contains glucose), flavoring agents (limonene, beta-pinene, citral, gamma-terpinene, linalool), alpha-tocopherol (E 307)), magnesium stearate.

What Aliflusin looks like and contents of the pack

The immediate packaging is a cylindrical, white polypropylene container with a white polyethylene cap containing a desiccant. The immediate packaging is placed together with the leaflet in an outer cardboard box. The outer packaging contains 10 (1 container) or 20 (2 containers) effervescent tablets.

Marketing authorization holder

Natur Produkt Zdrovit Sp. z o.o.
ul. Nocznickiego 31
01-918 Warsaw
Tel. +48 22 569 8 200
Fax. +48 22 635 15 51
(marketing authorization holder's logo)

Manufacturer

Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel. +48 29 644 29 00
Fax. +48 29 745 39 95

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Aliflusin
Czech Republic
Dehorsan
Lithuania
Aliflusin
Slovakia
Dehorsan effervescent tablets
Romania
Aliflusin 500 mg/200 mg/4 mg effervescent tablets
In order to obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder.
Date of last revision of the leaflet:28.05.2025