Aliflusin

Aliflusin
500 mg + 200 mg + 4 mg, effervescent tablets
Paracetamolum + Acidum ascorbicum + Chlorphenamini maleas
Please read the entire 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 directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for fever and 5 days for pain (in adolescents aged over 15 years – 3 days), or if your condition worsens, consult a doctor.

Leaflet contents:

1. What Aliflusin is and what it is 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 Aliflusin is and what it is used for

Aliflusin is a combination medicine containing three active substances: paracetamol, which has analgesic and antipyretic effects; chlorphenamine maleate, which reduces nasal mucus secretion, suppresses sneezing reflex and eye tearing; and ascorbic acid, which replenishes vitamin C deficiency in the body.
This medicine is used for the short-term treatment of symptoms of influenza, colds, and flu-like conditions such as headache, fever, sore throat, especially accompanied by nasal discharge, in adults and adolescents over 15 years of age. Aliflusin should only be used when symptoms of cold or flu are present, such as pain and/or fever and nasal congestion.
If there is no improvement after 3 days of treatment for fever and 5 days for pain (in adolescents aged over 15 years – 3 days), or if the patient feels worse, medical advice should be sought.

2. Important information before taking Aliflusin

When not to take Aliflusin:

• if the patient is allergic to paracetamol, ascorbic acid, chlorpheniramine maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient suffers from severe liver failure;
• if the patient is taking other medicines affecting liver function;
• if the patient has narrow-angle glaucoma;
• in patients at risk of urinary retention associated with urethral obstruction caused by an enlarged prostate gland;
• in patients currently taking, or who have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs, used in the treatment of depression);
• in children and adolescents under 15 years of age.

Warnings and precautions
Before starting treatment with Aliflusin, consult your doctor or pharmacist.
Warnings
If high or persistent fever occurs, or signs of bacterial superinfection develop, or if symptoms persist for more than 3 days in case of fever and 5 days in case of pain (in adolescents aged over 15 years – 3 days), contact a doctor.
The risk of overdose with this medicine increases in patients with liver disease.
Use with caution in patients:

• with mild to moderate liver disease, including liver failure not caused by alcoholic cirrhosis, Gilbert's syndrome (hereditary non-haemolytic jaundice);
• with low glutathione levels, e.g. severely malnourished patients, those with anorexia, low body mass index (BMI), or weakened patients;
• who are dehydrated;
• who regularly consume alcohol;
• who have sepsis.

Paracetamol use may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include deep, rapid, laboured breathing, nausea, vomiting, and loss of appetite. Contact a doctor immediately if these symptoms occur together.
Do not use together with other cold and flu medicines.
During treatment with Aliflusin, inform the doctor immediately if the patient has serious conditions, including severe kidney dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (a blood and fluid imbalance) have been reported in patients taking paracetamol regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Precautions
Paracetamol should be used with caution in patients with impaired kidney function, acute hepatitis, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, or methemoglobin reductase deficiency.
Due to the risk of hypertensive crisis, this medicine is contraindicated in patients currently taking, or who have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) (see section "When not to take Aliflusin").
Because of the presence of chlorpheniramine, alcohol, alcohol-containing medicines, and sedatives (especially barbiturates) should be avoided during treatment with this medicine. These drugs enhance the sedative effect of antihistamines, which may affect the ability to drive or operate machinery.
Use with caution in patients with bronchial asthma or chronic obstructive pulmonary disease, cardiovascular disorders, arterial hypertension, hyperthyroidism, or pyloroduodenal obstruction.

Effect on laboratory test results
Administration of paracetamol may affect laboratory test results for serum uric acid and blood glucose levels. Chlorpheniramine may interfere with skin allergy tests using allergens. It is recommended to discontinue the product at least 3 days before starting skin testing.

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

Aliflusin with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Aliflusin must not be taken with monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) currently or if taken within the last two weeks (see section "When not to take Aliflusin").
During treatment with Aliflusin, avoid alcohol-containing medicines.
Use with caution when taking:

• opioids (analgesics, antitussives, and substitution therapies);
• neuroleptics (medicines used to treat psychiatric disorders, mainly schizophrenia and other psychoses);
• barbiturates (hypnotics and antiepileptic medicines);
• benzodiazepines (anxiolytics, sedatives, hypnotics, anticonvulsants, and muscle relaxants);
• non-benzodiazepine anxiolytics (e.g. meprobamate);
• hypnotics (lorazepam, diazepam);
• sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine);
• H-receptor blocking antihistamines (medicines used to treat allergic conditions);
• antihypertensive medicines acting on the central nervous system;
• baclofen (a muscle relaxant);
• thalidomide (an immunomodulatory agent used in the treatment of multiple myeloma);
• anticholinergic antiparkinsonian agents (e.g. benzatropine);
• antispasmodic drugs with atropine-like action (containing hyoscine);
• disopyramide (a medicine used in heart diseases);
• phenothiazine derivative neuroleptics (medicines used to treat psychoses, such as chlorpromazine, thioridazine, perphenazine);
• clozapine (a medicine used to treat schizophrenia and psychiatric disorders in Parkinson's disease);
• salicylamide (an analgesic);
• rifampicin (an antibiotic);
• antiepileptic medicines (e.g. phenytoin, carbamazepine, lamotrigine, and others);
• barbiturate hypnotics and other medicines inducing liver enzymes;
• caffeine;
• non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen);
• coumarin anticoagulants (acenocoumarol, warfarin);
• fluphenazine (a medicine used to treat psychosis);
• zidovudine;
• lamotrigine;
• domperidone;
• metoclopramide;
• probenecid;
• cholestyramine;
• chloramphenicol;
• any substances harmful to the liver.

Inform your doctor or pharmacist if the patient is taking:

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

Aliflusin with food, drink, and alcohol
During treatment with Aliflusin, avoid alcohol consumption, as it may cause liver damage and excessive sedation.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Aliflusin is not recommended during pregnancy due to the presence of chlorpheniramine.
Breastfeeding
Aliflusin is not recommended during breastfeeding due to the presence of chlorpheniramine.
Fertility
Animal studies have not shown harmful effects of paracetamol, chlorpheniramine maleate, or ascorbic acid on fertility.

Driving and operating machinery
Drowsiness may occur, especially at the beginning of treatment, which may impair psycho-motor performance in individuals driving vehicles or operating machinery. This effect may be intensified by concomitant alcohol consumption, alcohol-containing medicinal products, or sedative medicines. Driving vehicles or operating machinery should be avoided during treatment with this medicinal product.

Aliflusin contains sodium
This medicine contains 254.5 mg of sodium (the main component of table 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 the patient has been advised to follow a low-salt (sodium) diet.

Aliflusin contains isomalt and glucose (component of maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this 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 information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use in adults and adolescents over 15 years of age:
The recommended single dose is one effervescent tablet (500 mg paracetamol, 200 mg ascorbic acid, and 4 mg chlorphenamine maleate) as needed, up to 3 times daily, with at least a 4-hour interval between doses. The maximum daily dose of 3 effervescent tablets (1500 mg paracetamol, 600 mg ascorbic acid, and 12 mg chlorphenamine maleate) must not be exceeded within 24 hours.

Patients with renal impairment
In patients with impaired kidney function, the dosing interval will be determined by the doctor.

Patients with hepatic impairment
In patients with mild to moderate liver dysfunction or Gilbert's syndrome, the dose should be reduced or the interval between doses prolonged. The doctor will determine the appropriate dose and dosing interval.
Aliflusin must not be used in patients with severe liver impairment (see section "When not to take Aliflusin").

Elderly patients
Dose adjustment is not required in elderly patients with normal renal and/or liver function.

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

Method of administration
For oral use.
Dissolve the effervescent tablet in a glass of warm water. Take immediately after preparation.

Duration of treatment
This medicine should not be used without consulting a doctor for longer than 3 days for fever or 5 days for pain (in adolescents over 15 years of age: 3 days). This medicine should be used only when pain or fever occur. If symptoms resolve, treatment should be discontinued.

Taking more Aliflusin than recommended
Stop treatment immediately and contact your doctor or emergency services without delay.

Symptoms related to chlorphenamine maleate
Overdose of chlorphenamine may cause: seizures (especially in children), disturbances of consciousness, coma.

Symptoms related to paracetamol
There is a particular risk of paracetamol poisoning in elderly individuals and young children (most commonly due to taking higher than recommended doses or accidental poisoning); such poisonings may be fatal. Overdose may cause symptoms within several to several dozen hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, even though liver damage may already be developing, which subsequently manifests as upper abdominal discomfort, recurrence of nausea, and jaundice. In case of ingestion of a higher than recommended dose, immediate medical advice must be sought, even if the patient feels well, due to the risk of delayed, serious, and irreversible liver damage.

If you miss a dose of Aliflusin
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions associated with paracetamol:
You should stop taking the medicine and consult a doctor immediately or go to
hospital if the following occur:

• swelling of the larynx, making breathing impossible (single cases);
• anaphylactic shock, manifested by confusion, paleness of the skin, drop in blood pressure, sweating, low urine output, 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 presenting with pustular rash over the entire body, erosions in the oral cavity, eyes, genital organs and on the skin, red spots on the trunk, often with blisters in the center, bursting giant blisters, peeling of large epidermal sheets, weakness, fever and joint pain (very rare cases);
• persistent itching of the skin (pruritus), skin rash, excessive sweating, appearance on the skin of nodular, hemorrhagic or vesicular eruptions (purpura), allergic reaction causing swelling of tissues beneath the skin (angioedema), allergic reaction causing blister formation on the skin (urticaria); occur rarely;
• acute or chronic pancreatitis, hemorrhage, abdominal pain, diarrhea, nausea, vomiting, impaired liver function (liver failure), irreversible liver damage (necrosis), yellowing of the skin, mucous membranes and whites of the eyes (jaundice); occur rarely.

Other adverse reactions include:
Rare (may occur in no more than 1 in 1000 people):

• anemia due to various deficiencies, bone marrow suppression, decreased platelet count;
• fluid accumulation in tissues (edema);
• kidney dysfunction (nephropathy) and impaired reabsorption or secretion in renal tubules (tubulopathies).

Frequency unknown (cannot be estimated from available data):

• serious condition that may cause blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Paracetamol is a commonly used medicine, and the described adverse reactions are rare and usually related to overdose.
Isolated cases of dizziness have been observed.
Adverse reactions associated with chlorpheniramine
You should stop taking the medicine and consult a doctor immediately or go to
hospital if an allergic reaction occurs:

• hypersensitivity reactions (allergic), anaphylactic reactions (severe allergic reactions, during which coughing, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or areas around the eyes, face, tongue, shortness of breath, fatigue, etc. may occur);

• central nervous system depression manifesting as drowsiness, nausea and muscle weakness, which in some patients resolve after 2-3 days of treatment; occurs frequently;

• blockage of bile ducts (cholestasis), hepatitis or other liver function disorders (including upper abdominal or abdominal pain, dark urine color, etc.); occur rarely.
  Other adverse reactions include:
  Frequent (may occur in no more than 1 in 10 people):

• uncoordinated and involuntary muscle movements in the face (dyskinesias), motor coordination disorders (stiffness), tremors, numbness, tingling, burning sensation, feeling like needle pricks (paresthesias);

• blurred or double vision;

• sensation of dryness in the nose and throat, drying of mucous membranes;

• sensation of dryness in the mouth, loss of appetite, changes in taste and smell perception, gastrointestinal disturbances (nausea, vomiting, diarrhea, constipation, upper abdominal pain), which may decrease if the medicine is taken during a meal;

• profuse sweating;

• urinary retention and (or) difficulty urinating.

Rare (may occur in no more than 1 in 1000 people):

• changes in blood tests (agranulocytosis, decreased white blood cell count, anemia due to bone marrow atrophy (aplastic anemia) or decreased platelet count (thrombocytopenia)), which may present with symptoms such as unusual bleeding, sore throat or fatigue;
• light sensitivity, hypersensitivity to similar medicines;
• occasionally excitement, especially when high doses are used in children or elderly people, characterized by restlessness, insomnia, nervousness, delirium, palpitations, and also seizures;
• tinnitus (unpleasant auditory sensations), acute labyrinthitis;
• usually, in case of overdose, heart rhythm disturbances, palpitations, rapid heartbeat (tachycardia) may occur;
• arterial hypotension (hypotension), increased arterial pressure (hypertension), fluid accumulation in tissues (edema);
• chest tightness, labored breathing;
• inability to engage in sexual intercourse in men (impotence), intermenstrual bleeding.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Aliflusin

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original tightly closed packaging, protected from light and moisture.
Do not use this medicine after the expiry date stated on the carton and tube after EXP.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Aliflusin contains

• The active substances in this 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).

• The other ingredients are: citric acid, sodium hydrogen carbonate, isomalt (E 953), macrogol 6000, sodium saccharin (E 954), lemon flavour (Tetrarome Lemon P 0551 987323: corn maltodextrin (contains glucose), flavouring ingredients (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 consists of cylindrical, white containers made of polypropylene, closed with a white cap made of polyethylene containing a desiccant. The immediate container is placed together with the package leaflet into an outer cardboard box. The outer packaging contains 10 (1 container) or 20 (2 containers) effervescent tablets.

Marketing Authorisation Holder
Natur Produkt Zdrovit Sp. z o.o.
ul. Nocznickiego 31
01-918 Warszawa
Tel. +48 22 569 8 200
Fax. +48 22 635 15 51
(logo of the marketing authorisation holder)

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 authorised in the European Economic Area countries under the following names:
Bulgaria Aliflusin
Czech Republic Dehorsan
Lithuania Aliflusin
Slovakia Dehorsan šumivé tablety
Romania Aliflusin 500 mg/200 mg/4 mg comprimate efervescente

For more detailed information about this medicine, please contact the representative of the marketing authorisation holder.