Fenirex

Package Leaflet: Information for the User

Fenirex

500 mg + 25 mg + 200 mg, powder for oral solution preparation
Paracetamol + Pheniramine maleate + Ascorbic acid

Read the package 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 information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

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

1. What is Fenirex and what is it used for

The medicine contains three active substances. Paracetamol acts as an analgesic and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby relieving nasal passages, inhibiting the sneezing reflex, and reducing eye tearing. Ascorbic acid supplements vitamin C deficiencies in the body.
Fenirex is indicated for the symptomatic treatment of flu, colds, and flu-like conditions such as fever, headache, muscle aches, and inflammation of the nasal and throat mucosa.
The medicine is indicated for use in adults and adolescents over 15 years of age.

2. Important information before taking Fenirex

When not to take Fenirex:

• severe liver failure,
• glaucoma (increased eye pressure) with a narrow angle of filtration,
• prostate enlargement;

Warnings and precautions

Before taking Fenirex, discuss with your doctor or pharmacist if you have:

• kidney failure,
• eye diseases,
• hypertension,
• diabetes,
• thyroid disorders,
• heart diseases,
• asthma or allergies (especially to sulfites).

Consult a doctor or pharmacist if you have a high fever, signs of secondary infection, or if symptoms persist for more than 5 days.
It is not recommended to drink alcoholic beverages, take medicines containing alcohol, or use sedatives while taking Fenirex.
To avoid the risk of overdose, do not take other medicines containing paracetamol at the same time as Fenirex (see section: How to take Fenirex).
Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Inform your doctor about any skin reactions and stop taking the medicine if you experience a skin rash or any other sign of allergy.
Paracetamol should be used with caution in patients with a deficiency of glucose-6-phosphate dehydrogenase (G6PD).
Effect on laboratory tests
Paracetamol may affect the determination of uric acid in the blood by the phosphotungstic method, as well as the determination of glucose by the oxidase-peroxidase method.

Children and adolescents

Fenirex should not be given to children and adolescents under 15 years of age.

Fenirex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
While taking Fenirex, it is not recommended to use:

• sedatives, especially barbiturates (medicines that cause relaxation and sleepiness),
• antidepressants and sedatives,
• antipsychotics,
• phenobarbital, primidone, phenytoin, carbamazepine (medicines used to treat epilepsy),
• chloramphenicol, rifampicin, isoniazid (antibiotics),
• zidovudine (a medicine used to treat HIV infection),
• anticoagulants (warfarin and acenocoumarol),
• metoclopramide, domperidone (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine that lowers lipid levels in the blood),
• diflunisal (a salicylate, a derivative of acetylsalicylic acid),
• interferon (a medicine used to treat hepatitis C),
• MAO inhibitors, including moclobemide (medicines used to treat depression),
• muscle relaxants (such as atropine, hyoscine),
• disopyramide (a medicine used to treat heart rhythm disorders),
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage),

malnutrition, chronic alcoholism, as well as patients taking maximum daily doses of paracetamol.
Before taking Fenirex with the above-mentioned medicines, consult a doctor.
If you are taking diuretics or have been taking painkillers for a long time, consult a doctor or pharmacist before taking Fenirex.
To avoid overdose, make sure that other medicines taken at the same time do not contain paracetamol or pheniramine.

Fenirex with food, drink, and alcohol

While taking Fenirex, do not drink alcohol or take medicines containing alcohol. Alcohol may enhance the sedative effect of the Fenirex component.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
It is not recommended to take Fenirex during pregnancy or breastfeeding.

Driving and using machines

Do not drive or operate machinery, as the medicine may cause daytime drowsiness, dizziness, or impaired concentration or vision.
The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, i.e., 3 sachets per day, which means that the medicine is considered "sodium-free".
The medicine contains mannitol.The medicine may have a mild laxative effect.

3. How to take Fenirex

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Recommended dose
The recommended dose is 1 sachet 2 or 3 times a day. The interval between doses should be at least 4 hours. Do not exceed the recommended dose.
The contents of the sachet should be dissolved in a glass (about 250 ml) of cold or hot water.
In patients with severe kidney failure (creatinine clearance <10 ml min), the interval between doses should be at least 8 hours.
Do not take for more than 5 days without consulting a doctor.

Overdose of Fenirex

If you have taken more than the recommended dose of Fenirex, inform your doctor or pharmacist immediately.
Overdose of paracetamol may cause severe liver damage. Symptoms of overdose usually appear within the first 24 hours (nausea, vomiting, loss of appetite, malaise, impaired consciousness). In case of severe overdose, seek medical attention immediately.

Missed dose of Fenirex

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

• decrease in red blood cell count, manifested as pale skin, weakness, and shortness of breath (hemolytic anemia),
• changes in blood morphology (decrease in granulocyte count - granulocytopenia),
• malaise, increased liver enzyme activity

Very rare side effects(occur in less than 1 in 10,000 people):

• changes in blood morphology (decrease in platelet count - thrombocytopenia, leukocytes - leukopenia, or neutrophils - neutropenia),
• allergic reactions (anaphylactic shock, Quincke's edema, rash, urticaria, skin rash)
• severe skin reactions.

Other possible side effects(frequency cannot be estimated from available data) that may occur with this type of medicine:
disorientation, hallucinations, agitation, anxiety, dizziness, drowsiness, insomnia, memory disorders, difficulty concentrating, coordination disorders, tremors, accommodation disorders, pupil dilation, balance disorders, dizziness, palpitations, blood pressure drop when changing position to standing, dry mouth, constipation, itching, eczema, rash, swelling, urinary retention.
Anticholinergic side effects, such as dry mouth, accommodation disorders, urinary retention, agitation, and excitement, are more common in the elderly.
Vitamin C in doses exceeding 1 g facilitates the development of kidney stones and may lead to sudden breakdown of red blood cells in patients with glucose-6-phosphate dehydrogenase deficiency-related hemolysis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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
Phone: +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 Fenirex

There are no special precautions for storage.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date (EXP) stated on the carton.
The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Fenirex contains

• The active substances are: paracetamol 500 mg, pheniramine maleate 25 mg, and ascorbic acid (vitamin C) 200 mg.
• Other ingredients are: mannitol (E 421), sodium cyclamate, citric acid, lemon flavor*. *Lemon flavor contains: maltodextrin, flavoring substances (including citral and limonene), arabic gum (E414), silicon dioxide (E551), alpha-tocopherol (E307).

What Fenirex looks like and contents of the pack

A mixture of powder and granules, white in color.
Sachets made of C/PAP/Aluminum/PE foil, placed in a cardboard box.
The pack contains: 8 sachets.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Phone: +48 61 66 51 500

Manufacturer

Fortex Nutraceuticals Ltd.
10, Prohladen kat str.,
Suhodol Dist.,
1362 Sofia, Bulgaria

Date of last revision of the leaflet: