Fenirex

Package leaflet: Information for the user

Fenirex
500 mg + 25 mg + 200 mg, powder for oral solution
Paracetamolum + Pheniramini maleas + Acidum ascorbicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.
• If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.

Table of contents

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

The medicine contains three active substances. Paracetamol has analgesic and antipyretic effects.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thus clearing nasal
passages, suppressing sneezing reflex and eye tearing. Ascorbic acid replenishes vitamin C deficiency
in the body.
Fenirex is indicated for the short-term symptomatic relief of flu, colds, and flu-like conditions, such
as fever, headache, muscle pain, and inflammation of the nasal and throat mucosa.
The medicine is intended for use in adults and adolescents over 15 years of age.

2. Important information before taking Fenirex
When not to use Fenirex:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
  • severe liver impairment,
  • glaucoma (increased intraocular pressure) with narrow filtration angle,
  • prostate enlargement;
• if the patient is under 15 years of age.

Warnings and precautions
Before starting treatment with Fenirex, consult a doctor or pharmacist if the patient has:

• renal impairment,
• eye disorders,
• hypertension,
• diabetes,
• thyroid disorders,
• heart disease,
• asthma or allergies (especially to sulfites).

Consult a doctor or pharmacist in case of high fever, signs of secondary infection, or if symptoms persist for more than 5 days.
Alcoholic beverages, medications containing alcohol, or sedatives should not be used during treatment with Fenirex.
To avoid the risk of overdose, do not take other medicines containing paracetamol simultaneously with 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 may be fatal. Inform the doctor immediately if skin reactions occur and discontinue the medicine in case of skin rash or any other sign of hypersensitivity.
Paracetamol should be used with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid concentration by the phosphotungstic acid method, as well as with the determination of glucose concentration by the oxidase-peroxidase method.
Children and adolescents
Fenirex should not be administered to children and adolescents under 15 years of age.
Fenirex with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
During treatment with Fenirex, concomitant use is not recommended with:

• sedative medicines, especially barbiturates (medicines causing relaxation and drowsiness),
• antidepressants and tranquilizers,
• antipsychotics,
• phenobarbital, primidone, phenytoin, carbamazepine (medicines used in epilepsy treatment),
• chloramphenicol, rifampicin, isoniazid (antibiotics),
• zidovudine (a medicine used in HIV infection treatment),
• anticoagulants (warfarin and acenocoumarol),
• metoclopramide, domperidone (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine lowering blood lipid levels),
• diflunisal (a salicylate, derivative of acetylsalicylic acid),
• interferon (a medicine used in hepatitis C treatment),
• MAO inhibitors, including moclobemide (medicines used, among others, in depression treatment),
• smooth muscle relaxants (such as atropine, hyoscine),
• disopyramide (a medicine used in cardiac arrhythmia treatment),
• flucloxacillin (an antibiotic), due to a serious risk of a disorder affecting blood and body fluids (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal dysfunction, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage),

malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.
Before taking Fenirex together with any of the above-mentioned medicines, consult a doctor.
If the patient is taking diuretics or has been using painkillers long-term, consult a doctor or pharmacist before using Fenirex.
To avoid overdose, ensure that other concurrently used medicines do not contain paracetamol or pheniramine.
Fenirex with food, drink and alcohol
Do not consume alcohol or use medicines containing alcohol during treatment with Fenirex. Alcohol may intensify drowsiness caused by the components of Fenirex.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Use of Fenirex is not recommended during pregnancy or breastfeeding.
Driving and operating machinery
Do not drive or operate machinery, as the medicine may cause daytime drowsiness, dizziness, or disturbances in concentration or vision.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dosage unit (i.e. 3 sachets per day), meaning 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 used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
The recommended dose is 1 sachet two or three times daily. The interval between doses should be at least 4 hours. Do not exceed the recommended dose.
The contents of a sachet should be dissolved in a glass (approximately 250 ml) of cold or hot water.
In patients with severe renal impairment (creatinine clearance < 10 ml/min), the interval between doses should be at least 8 hours.
Do not use for longer than 5 days without consulting a doctor.
Taking more than the recommended dose of Fenirex
If more than the recommended dose of Fenirex has been taken, contact a doctor or pharmacist immediately.
Paracetamol overdose may cause severe liver damage. Symptoms of overdose usually appear within the first 24 hours (nausea, vomiting, loss of appetite, malaise, disturbances of consciousness). In case of severe overdose, seek immediate medical attention.
If a dose of Fenirex is missed
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.

Uncommon adverse effects (occur in up to 1 in 1,000 people):

• Decrease in red blood cells causing pale skin, weakness and breathlessness (haemolytic anaemia),
• Changes in blood morphology (reduction in granulocytes - granulocytopenia),
• Malaise, increased liver enzyme activity

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

• Changes in blood morphology (reduction in platelets - thrombocytopenia, white blood cells - leukopenia, or neutrophils - neutropenia),
• Hypersensitivity reactions (anaphylactic shock, Quincke's oedema, erythema, urticaria, skin rash),
• Severe skin reactions.

Other possible adverse effects (frequency cannot be determined from available data), which may occur with this type of medicine:
disorientation, hallucinations, agitation, anxiety, dizziness, drowsiness, insomnia, memory disturbances, difficulty concentrating, coordination disturbances, tremor, accommodation disturbances, pupil dilation, balance disturbances, dizziness, palpitations, drop in blood pressure upon changing to upright position, dry mouth, constipation, itching, eczema, purpura, oedema, urinary retention.
Anticholinergic adverse effects such as dry mouth, accommodation disturbances, urinary retention, agitation and excitement are more common in elderly patients.
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 haemolysis associated with glucose-6-phosphate dehydrogenase deficiency.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Fenirex
No special storage instructions are required.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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 components: mannitol (E 421), sodium cyclamate, citric acid, lemon flavour*. *Lemon flavour contains: maltodextrin, flavouring 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 white powder and granules.
Pouches made of C/PAP/Aluminium/PE foil, placed in a cardboard box.
Pack contents: 8 sachets.
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500
Manufacturer
Fortex Nutraceuticals Ltd.
10, Prohladen kat str.,
Suhodol Dist.,
1362 Sofia, Bulgaria