Aliflusin

Aliflusin
500 mg + 200 mg + 4 mg, effervescent granules
Paracetamolum + Acidum ascorbicum + Chlorphenamini maleas
Please read the following 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 doctor 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 in case of fever and 5 days in case of pain (in adolescents over 15 years of age – after 3 days), or if your condition worsens, consult a doctor.

Contents of the leaflet:

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 properties; chlorphenamine maleate, which reduces mucus secretion from the nose, 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 when accompanied by nasal discharge, in adults and adolescents over 15 years of age. Aliflusin should be used only when cold and flu symptoms such as pain and (or) fever and nasal congestion are present.
If there is no improvement after 3 days in case of fever and 5 days in case of pain (in adolescents over 15 years of age – after 3 days), or if your condition worsens, consult a doctor.

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 suffers from narrow-angle glaucoma;
• in patients at risk of urinary retention associated with lower urinary tract obstruction due to prostate gland disorders;
• 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 a doctor or pharmacist.
Warnings
In case of high or persistent fever, signs of bacterial superinfection, 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), consult a doctor.
The risk of overdose with this medicine is increased 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-hemolytic jaundice);
• with low glutathione levels, e.g. severely malnourished, anorexic, with low body mass index (BMI), debilitated patients;
• dehydrated patients;
• regular alcohol consumers;
• patients suffering from sepsis.

Do not use together with other cold and flu medicines.
During treatment with Aliflusin, immediately inform the doctor if the patient has serious conditions, including severe kidney disorders or 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 (an abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly over a prolonged period or who take paracetamol 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 renal dysfunction, 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 currently taking, or who have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) (see section "When not to take Aliflusin").
Due to the presence of chlorpheniramine, alcohol consumption, alcoholic 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, and pyloroduodenal obstruction.
Effect on laboratory test results
Administration of paracetamol may affect blood uric acid and blood glucose test results. Chlorpheniramine may affect skin tests using allergens. It is recommended to discontinue the product at least 3 days before starting skin tests.
Children and adolescents
This medicine must not be used in children and adolescents under 15 years of age.
Aliflusin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.
Do not take Aliflusin with monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of depression) currently or if taken within the last two weeks (see section "When not to take Aliflusin").
Avoid alcoholic medicines during treatment with Aliflusin.
Use with caution when taking:

• opioids (analgesics, antitussives, and substitution drugs);
• neuroleptics (medicines used in the treatment of psychiatric disorders, mainly schizophrenia and other psychoses);
• barbiturates (sleeping medicines and medicines used in epilepsy treatment);
• benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant, and muscle-relaxant effects);
• non-benzodiazepine anxiolytics (e.g. meprobamate);
• sleeping medicines (lorazepam, diazepam);
• sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine);
• H-receptor blocking antihistamines (medicines used in the treatment of allergic diseases);
• antihypertensive medicines acting on the central nervous system;
• baclofen (a muscle relaxant);
• thalidomide (an immunomodulatory medicine used in multiple myeloma treatment);
• anticholinergic antiparkinsonian medicines (e.g. benztropine);
• antispasmodic medicines similar to atropine (containing hyoscine);
• disopyramide (a medicine used in heart diseases);
• phenothiazine derivative neuroleptics (medicines used in psychosis treatment, e.g. chlorpromazine, thioridazine, perphenazine);
• clozapine (a medicine used in schizophrenia and psychiatric disorders in Parkinson's disease);
• salicylamide (an analgesic);
• rifampicin (an antibiotic);
• antiepileptic medicines (e.g. phenytoin, carbamazepine, lamotrigine, and others);
• barbiturate sleeping medicines and other medicines inducing liver enzymes;
• caffeine;
• non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen);
• coumarin anticoagulants (acenocoumarol, warfarin);
• fluphenazine (a medicine used in psychosis treatment);
• 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 disorder (called metabolic acidosis) requiring 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 affect the psychomotor performance of people driving vehicles or operating machinery. This effect may be intensified if alcohol is consumed simultaneously, or if alcoholic medicinal products or sedative medicines are taken. Do not drive or operate machinery while using this medicinal product.
Aliflusin contains sucrose and glucose (a component of maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains 3156 mg of sucrose in one sachet. This should be taken into account in patients with diabetes.
Aliflusin contains sodium
The medicine contains 88.8 mg of sodium (main component of table salt) in each sachet. This corresponds to 4.5% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Aliflusin

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Use in adults and adolescents over 15 years of age:
The recommended single dose is one sachet (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 sachets (1500 mg paracetamol, 600 mg ascorbic acid, and 12 mg chlorphenamine maleate) must not be exceeded within 24 hours.

Patients with impaired kidney function
In cases of impaired kidney function, the interval between doses should be determined by a doctor.

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

Elderly patients
Dosage adjustment is not required in elderly patients with normal kidney 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
Oral administration.
The effervescent granulate should be dissolved in a glass of warm water. It should be taken immediately after preparation.

Duration of treatment
This medicine should not be used without medical consultation 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 and fever occur. If symptoms resolve, treatment should be discontinued.

Overdose of Aliflusin
Treatment should be stopped immediately and medical advice sought from a 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 doses exceeding the recommended amount or accidental poisoning); such poisonings may lead to death. Overdose may result in symptoms appearing within a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the following day, even though liver damage may already be developing, which later manifests as upper abdominal pain, 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.

Missed 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 effects

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

• swelling of the larynx, making breathing impossible (single cases);
• anaphylactic shock, characterized by confusion, pale skin, drop in blood pressure, sweating, reduced 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 characterized by blistering rash over the entire body, erosions in the oral cavity, eyes, genital organs and 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 (pruritus), skin rash, excessive sweating, appearance on the skin of nodular, haemorrhagic or vesicular lesions (purpura), allergic reaction causing swelling of tissues beneath the skin (angioedema), allergic reaction causing formation of blisters on the skin (urticaria); occur rarely;
• acute or chronic pancreatitis, haemorrhage, abdominal pain, diarrhoea, 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 effects include:
Rare (may affect up to 1 in 1000 people):

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

Frequency unknown (cannot be estimated from available data):

• serious condition causing 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 effects are rare and usually related to overdose.
Isolated cases of dizziness have been observed.
Adverse effects associated with chlorphenamine
You must 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, swallowing difficulties, rapid heartbeat, itching, eyelid or periorbital swelling, facial swelling, tongue swelling, shortness of breath, fatigue, etc. may occur);
• central nervous system depression manifesting as drowsiness, nausea and muscle weakness, which in some patients resolves 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, etc.); occur rarely.

Other adverse effects include:
Common (may affect up to 1 in 10 people):

• uncoordinated and involuntary muscle movements in the face (dyskinesias), coordination disorders (rigidity), tremors, numbness, tingling, burning sensation, feeling like being pricked by needles (paresthesias);
• blurred or double vision;
• sensation of dryness in the nose and throat, drying of mucous membranes;
• dry mouth, loss of appetite, altered taste and smell perception, gastrointestinal disturbances (nausea, vomiting, diarrhoea, constipation, upper abdominal pain), which may decrease if the medicine is taken during a meal;
• excessive sweating;
• urinary retention and/or difficulty passing urine.

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

• changes in blood tests (agranulocytosis, decreased white blood cell count, anaemia due to bone marrow atrophy (aplastic anaemia) or decreased platelet count (thrombocytopenia)), which may present with symptoms such as unusual bleeding, sore throat or fatigue;
• photosensitivity, 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 convulsions;
• tinnitus (unpleasant auditory sensations), acute labyrinthitis;
• usually in cases of overdose, cardiac arrhythmias, palpitations, rapid heartbeat (tachycardia) may occur;
• hypotension, increased blood pressure (hypertension), fluid accumulation in tissues (oedema);
• chest tightness, laboured breathing;
• inability to engage in sexual intercourse in men (impotence), intermenstrual bleeding.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects 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 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder. By reporting adverse effects, more information on the safety of the medicine can be collected.

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 tightly closed packaging, protected from light and moisture.
Do not use this medicine after the expiry date stated on the carton and sachet following EXP.
Medicines must not be disposed of via the sewage system 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 are paracetamol, ascorbic acid, and chlorphenamine maleate. Each effervescent granule sachet 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, sucrose, magnesium citrate, sodium cyclamate (E 952), sodium saccharin (E 954), lemon flavour (Tetrarome Lemon P 0551 987323: corn maltodextrin (contains glucose), flavouring components (limonene, beta-pinene, citral, gamma-terpinene, linalool), alpha-tocopherol (E 307)).

What Aliflusin looks like and contents of the pack
The immediate packaging consists of sachets made of Paper/Aluminium/PE foil. The immediate packaging is placed together with the leaflet into an outer cardboard box. The pack contains 10 or 20 sachets.

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 Member States of the European Economic Area under the following names:
Bulgaria Aliflusin
Czech Republic Dehorsan
Lithuania Aliflusin
Slovakia Dehorsan šumivé granule
Romania Aliflusin 500 mg/200 mg/4 mg granule efervescente

For further information on this medicinal product, please contact the representative of the marketing authorisation holder.