Fluxin

Leaflet attached to the packaging: patient information

Fluxin

Paracetamol + Ascorbic Acid + Pheniramine Maleate
500 mg + 200 mg + 25 mg
granules for oral solution in a sachet

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 the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• 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 the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Fluxin and what is it used for

Fluxin is indicated for the relief of symptoms of colds, flu, and upper respiratory tract infections such as runny nose, tearing, sneezing, headache, and/or fever.
The medicine should only be used to relieve the following combined symptoms: pain and/or fever and at the same time runny nose, tearing, or sneezing. The medicine should not be used if the patient has only one of these symptoms.
Fluxin is indicated for adults and adolescents over 15 years of age (with a body weight of 50 kg and above).
If symptoms persist or worsen after 5 days, the patient should contact their doctor.

2. Important information before taking Fluxin

When not to take Fluxin

• if the patient is allergic to paracetamol, ascorbic acid, pheniramine maleate, or any of the other ingredients of the medicine (listed in section 6);
• if the patient has severe liver disease;
• if the patient has a risk of narrow-angle glaucoma;
• if the patient has prostatic hyperplasia;
• Fluxin should not be given to children and adolescents under 15 years of age.

Warnings and precautions

Patient should talk to their doctor or pharmacist before taking Fluxin

• if the patient has a body weight below 50 kg
• if the patient has mild to moderate liver or kidney function disorders
• if the patient is an alcoholic
• if the patient has nutritional problems (has low glutathione reserves in the liver)
• if the patient is dehydrated
• if the patient has hemolytic anemia (abnormal breakdown of red blood cells)
• if the patient has acute viral hepatitis or if acute viral hepatitis is diagnosed during treatment with Fluxin, treatment with this medicine should be discontinued
• if the patient has asthma, chronic obstructive pulmonary disease, cardiovascular diseases, hypertension, hyperthyroidism, and pyloric stenosis.

While taking Fluxin, the patient should immediately inform their doctor:
If the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
There have been reports of a serious disease called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a longer period or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.
This medicine contains paracetamol.The patient should not take any other products containing paracetamol while taking this medicine, as this may exceed the recommended daily dose.
(See section: How to take Fluxin). Higher doses than recommended may cause serious liver damage.
In very rare cases, paracetamol may cause serious skin reactions. If a rash or other signs of an allergic reaction occur, the patient should stop taking the medicine and contact their doctor immediately.
Vitamin C should be used with caution in patients with iron metabolism disorders and in individuals with a deficiency of glucose-6-phosphate dehydrogenase.
The patient should consult their doctor or pharmacist in case of high fever, signs of secondary infection, or if symptoms persist for more than 5 days.

Fluxin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

Do not take Fluxin with other medicines containing paracetamol or antihistamines

The patient should inform their doctor before taking Fluxin if they are taking any of the following medicines:

• metoclopramide or domperidone (medicines used to treat nausea and vomiting);
• cholestyramine (a medicine used to lower cholesterol levels);
• anticholinergic medicines (e.g., glycopyrrolate (a medicine used to treat chronic obstructive pulmonary disease), propantheline (a medicine used to treat ulcers), medicines used to treat Parkinson's disease);
• opioids (morphine derivatives - medicines used to treat severe pain and cough);
• sedating antihistamine H medicines (medicines used to treat allergy symptoms);
• warfarin and other coumarin derivatives (medicines used to thin the blood);
• probenecid (a medicine used to treat gout);
• isoniazid and rifampicin (medicines used to treat tuberculosis);
• phenytoin (a medicine used to treat epilepsy);
• sedatives, especially barbiturates (medicines that cause relaxation and sleepiness);
• antidepressant medicines (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine) (medicines used to treat depression);
• antipsychotic medicines, e.g., clozapine (medicines used to treat psychoses, such as schizophrenia);
• benzodiazepines and other anxiolytic medicines (e.g., meprobamate) (medicines used to treat anxiety disorders);
• sleeping medicines (medicines used to treat insomnia);
• antidepressant medicines called monoamine oxidase inhibitors (medicines used to treat depression);
• centrally acting antihypertensive medicines (medicines used to treat high blood pressure);
• baclofen and other antispastic medicines (medicines used to treat muscle spasms of various origins);
• thalidomide (a medicine used to treat several types of cancer);
• disopyramide (a medicine used to treat heart rhythm disorders);
• zidovudine (a medicine used to treat HIV/AIDS infections);
• hydroxymethylsuccinate sodium (a medicine used to treat narcolepsy);
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment.

The patient should inform their doctor about taking this medicine if the doctor advises a test for uric acid or blood sugar levels. This medicine may affect the results of these tests.

Fluxin and alcohol

It is not recommended to drink alcohol or take medicines containing alcohol while taking Fluxin. The medicine may cause drowsiness, which can be increased by alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking Fluxin.
Fluxin is not recommended during pregnancy and breastfeeding.

Driving and using machines

Fluxin may cause drowsiness and/or dizziness. This effect can be increased by consuming alcoholic beverages, taking medicines containing alcohol, or sedatives. If the patient feels drowsy and/or dizzy, they should not drive or operate machines.

Fluxin contains sucrose

This medicine contains 11.555 g of sucrose in a single dose. This should be taken into account in the diet of patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Fluxin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".

Fluxin contains alcohol (ethanol)

This medicinal product contains less than 15.2 mg of alcohol (ethanol) in each sachet.
The amount in one dose of this medicinal product is equivalent to less than 1 ml of beer or wine.
The small amount of alcohol in this medicine will not cause any noticeable effects.

3. How to take Fluxin

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Fluxin is indicated for adults and adolescents over 15 years of age (with a body weight of 50 kg and above).
The recommended dose is 1 sachet 2 or 3 times a day. The intervals between doses should be at least 4 hours.
If the patient has kidney problems, the interval between doses should be determined by the doctor.
The patient should not take more than 3 sachets per day.
The maximum duration of treatment without consulting a doctor is 5 days.
Method of administration:
The contents of the sachet should be dissolved in a glass of warm or cold water.

Overdose of Fluxin

In case of overdose of Fluxin or if it has been accidentally taken by a child, the patient should immediately consult their doctor due to the risk of delayed, severe liver damage. Symptoms of paracetamol overdose are nausea, vomiting, and decreased appetite.

Missed dose of Fluxin

The patient should not take a double dose to make up for a missed dose.
If the patient has further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluxin can cause side effects, although not everybody gets them.
Rare(may affect up to 1 in 1,000 people):

• skin rash, redness, or allergic reaction with sudden swelling of the face or neck or a feeling of general discomfort with a significant drop in blood pressure. In such cases, the patient should stop taking the medicine, inform their doctor, and not take medicines containing paracetamol in the future.

Very rare(may affect up to 1 in 10,000 people):

• severe skin reactions. In such cases, the patient should stop taking the medicine, inform their doctor, and not take medicines containing paracetamol in the future.
• blood disorders (decreased platelet count, low levels of certain white blood cells, decreased red blood cell count), which may cause nosebleeds or bleeding gums. In such cases, the patient should consult their doctor.

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

• drowsiness, decreased alertness, more pronounced in the initial treatment period
• dry mouth, constipation, vision disturbances
• urination disorders (significant decrease in urine output, difficulty urinating)
• dizziness when changing position (to standing or lying down), which may be associated with a drop in blood pressure
• dizziness, memory or concentration difficulties (more common in elderly patients)
• coordination disorders, tremors
• disorientation, hallucinations
• excitement, nervousness, insomnia
• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects
If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Fluxin

Keep out of sight and reach of children.
Do not use Fluxin after the expiry date stated on the sachet and packaging after EXP. The expiry date refers to the last day of the month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fluxin contains

• The active substances of Fluxin are: paracetamol, ascorbic acid, pheniramine maleate. Each sachet contains 500 mg of paracetamol, 200 mg of ascorbic acid, and 25 mg of pheniramine maleate.
• The other ingredients are: sucrose, citrus and rum flavor, citric acid, gum arabic, dried dispersion, and sodium saccharin (E 954).

What Fluxin looks like and contents of the pack

Fluxin is packaged in sachets (containing 13.1 g of granules for oral solution) consisting of layers: paper/Aluminum/PE (layer in direct contact with the product). Each sachet contains a white to light yellow powder with a characteristic citrus and rum odor.
The pack contains: 2, 4, 5, 6, 8, 10, 12, 14, 15, 16, 18, 20 sachets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Farmea
10, Rue Bouché Thomas - ZAC d’Orgemont, Angers
49000
France

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

Date of revision of the leaflet:July 2025