Fervex

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Fervex
500 mg + 200 mg + 25 mg, effervescent granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Please read this 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
your doctor, pharmacist, or nurse.

• 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if symptoms worsen, or if fever persists beyond 3 days, consult your doctor.

Table of Contents

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

1. What Fervex is and what it is used for

Fervex is a combination medicine.
Paracetamol has analgesic and antipyretic effects.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, suppressing sneezing reflex, and reducing eye tearing.
Ascorbic acid replenishes vitamin C deficiency in the body.
Indications
Fervex is indicated for short-term relief of symptoms of influenza, colds, and flu-like conditions (headache, fever, inflammation of nasal and throat mucosa) in adults and adolescents over 15 years of age.
In case of bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or if the patient feels worse, consult a doctor.

2. Important information before using Fervex

When not to use Fervex:

• if the patient is allergic to paracetamol, ascorbic acid, pheniramine maleate, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has narrow-angle glaucoma,
• if the patient has benign prostatic hyperplasia with urinary retention,
• in children and adolescents under 15 years of age,
• should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency due to the presence of sucrose in the medicine.

Warnings and precautions
Before starting treatment with Fervex, consult your doctor, pharmacist, or
nurse.
If symptoms persist for more than 5 days or fever lasts longer than 3 days, the patient should consult a doctor.
Do not use for longer than 5 days without medical advice.
The risk of dependence, mainly psychological, is mainly observed when higher than recommended doses are used or during prolonged treatment.
This medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines currently being taken also contain paracetamol. In adults with body weight over 50 kg,
THE TOTAL DAILY DOSE OF PARACETAMOL MUST NOT EXCEED 4
GRAMS.
Paracetamol should be used with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Children and adolescents
The medicine may be used in adolescents above 15 years of age.

Fervex and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.

Due to the presence of pheniramine
Not recommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Changes in concentration ability may impair the ability to drive or operate machinery.
Avoid consuming alcoholic beverages or taking medicines containing alcohol.

Combinations requiring caution
Other medicines with sedative effects: morphine derivatives (analgesics, antitussives), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (e.g. meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H receptor-blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide.
Increased central nervous system depression and associated impairment in concentration may affect the ability to drive or operate machinery.

Other medicines with anticholinergic (atropine-like) effects: tricyclic antidepressants similar to imipramine, most H receptor-blocking antihistamines, anticholinergic antiparkinsonian drugs, antispasmodic drugs with atropine-like activity, disopyramide, phenothiazine derivative neuroleptics, clozapine.
Additive anticholinergic (atropine-like) adverse effects such as urinary retention, constipation, and dry mouth may occur.

Due to the presence of paracetamol
Salicylamide prolongs the elimination time of paracetamol.
Rifampicin, antiepileptic drugs, hypnotics from the barbiturate group, and other drugs inducing microsomal enzymes, when used concomitantly with paracetamol, increase the risk of liver damage.
Caffeine enhances the analgesic and antipyretic effects of paracetamol.
Concurrent use of high doses of paracetamol and nonsteroidal anti-inflammatory drugs may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Paracetamol used together with MAO inhibitors may cause a state of excitation and high fever.

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.

Due to the presence of ascorbic acid
Ascorbic acid may reduce the effectiveness of warfarin and plasma levels of fluphenazine, and may decrease urine pH, which may affect the excretion of other concurrently administered drugs.

Use of Fervex with food and drink
No contraindications.

Use of Fervex with alcohol
Consuming alcoholic beverages or taking sedatives (especially barbiturates) intensifies the sedative effect of antihistamines; therefore, simultaneous use should be avoided.
There is a particular risk of liver damage in fasting patients and those who regularly consume alcohol.

Pregnancy and breastfeeding
If the patient is pregnant or 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
The use of this medicine during pregnancy is not recommended.

Breastfeeding
The use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
Drowsiness may occur during treatment, which may affect the psycho-physical performance of individuals driving vehicles or operating machinery.

Warnings regarding excipients with known effects
Fervex contains 11.6 g of sucrose. This should be taken into account in patients with diabetes.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Fervex contains glucose (as a component of maltodextrin); if a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Fervex contains fructose. The additive effect of simultaneously administered products containing fructose and food containing fructose should be considered.
Fervex contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use Fervex

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

Adults and adolescents over 15 years of age: 1 sachet 2 or 3 times daily (corresponding to 1500 mg paracetamol, 75 mg pheniramine maleate, and 600 mg vitamin C).
Intervals between doses should be at least 4 hours.

Elderly patients
No contraindications.

Patients with renal and/or hepatic impairment
Caution is advised in patients with impaired kidney function.
In cases of renal impairment (creatinine clearance below 10 ml/min), intervals between doses should be at least 8 hours.

Method of administration
For oral use. The contents of the sachet should be dissolved in a glass of hot or cold water.
For treating flu-like symptoms, it is preferable to take the medicine dissolved in hot water, in the evening, as soon as possible after the onset of symptoms.

Duration of treatment
Do not use this medicine for longer than 5 days without consulting a doctor. If symptoms persist beyond 5 days or fever lasts more than 3 days, the patient should consult a doctor.

If the effect of the medicine seems too strong or too weak, consult a doctor.

Use of a higher than recommended dose of Fervex

Symptoms of overdose

Related to pheniramine:
Pheniramine overdose may cause convulsions (especially in children), disturbances of consciousness, coma.

Related to paracetamol:
There is an increased risk of paracetamol poisoning in elderly patients and young children (most commonly due to ingestion of doses exceeding the recommended amount or accidental poisoning); such poisonings may lead to death.

An overdose of this product may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness; on the following day, abdominal fullness, return of nausea, and jaundice may occur.

What to do in case of overdose
In case of ingestion of more than the recommended dose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Fervex
Do not take a double dose to make up for a missed dose.

Discontinuation of Fervex
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 may cause adverse effects, although not everybody will experience them.

Related to pheniramine
Adverse effects of varying severity, both dose-dependent and independent, may occur:
Neurovegetative effects:

• Sedation or drowsiness, more pronounced at the beginning of treatment,
• Anticholinergic symptoms such as dryness of mucous membranes, constipation, accommodation disturbances, pupil dilation, palpitations, risk of urinary retention,
• Orthostatic hypotension,
• Impaired balance, dizziness, memory or concentration disturbances, more frequent in elderly patients,
• Motor coordination disorders, tremors,
• Confusion, hallucinations,
• Less frequently, symptoms of excitation: restlessness, nervousness, insomnia.

Hypersensitivity reactions (rare):

• Erythema, itching, rash, purpura, urticaria,
• Swelling, rarely Quincke's edema (swelling of lips, tongue or larynx),
• Anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).

Effects on the haematopoietic system:

• Leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
• Thrombocytopenia (reduced platelet count),
• Hemolytic anemia.

Related to paracetamol
A few cases of hypersensitivity reactions have been reported, such as: anaphylactic shock, Quincke's edema, erythema, urticaria and skin rash. If any of these symptoms occur, administration of this medicine and other medicines with similar composition should be discontinued immediately.
Exceptionally rare cases of thrombocytopenia (reduced platelet count), leukopenia and neutropenia have been observed.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fervex

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Fervex contains

• The active substances are: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg.
• The other components are: acacia gum, citric acid, sodium saccharin, sucrose, natural West Indian flavor (maltodextrin, acacia gum, α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, citral (geraniol)).

What Fervex looks like and contents of the pack
A paper/Al/PE sachet containing granules for oral solution in an outer cardboard
box.
The cardboard box contains 5, 8 or 12 sachets of 13.1 g each.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Latvia, country of export:
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison, France
Manufacturer:
UPSA SAS
979 Avenue des Pyrenees
47520 Le Passage, France
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorization number in Latvia, country of export: 98-0132
Parallel import authorization number: 129/20