Fervex

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Fervex
500 mg + 200 mg + 25 mg, effervescent granules for oral solution
Paracetamol + Ascorbic acid + Pheniramine maleate
Please read this leaflet carefully before taking this 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, please 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 after 5 days there is no improvement in symptoms 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 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.
If a bacterial infection occurs, antibiotic treatment may be necessary.
If symptoms do not improve after 5 days or worsen, 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 difficulty in urination,
• in children and adolescents under 15 years of age,
• should not be used in patients with fructose intolerance, glucose-galactose malabsorption, or saccharase-isomaltase deficiency due to the presence of sucrose in the medicine.

Warnings and precautions
Before starting to use Fervex, consult with a 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.
Risk of dependence, mainly psychological, is mainly observed when doses higher than recommended are used or during prolonged treatment.
The medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines currently taken by the patient 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 planned for future use.

Due to the presence of pheniramine
Unrecommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Changes in attention may impair the ability to drive vehicles and operate machinery.
Avoid consumption of alcoholic beverages or 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, doxepine, mianserin, mirtazapine, trimipramine), sedative H-receptor blocking antihistamines, centrally acting antihypertensives, baclofen, and thalidomide.
Increased central nervous system depression and associated impairment of attention may affect the ability to drive vehicles and 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.
Concomitant use of high doses of paracetamol and non-steroidal anti-inflammatory drugs may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants from 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 decrease plasma levels of fluphenazine. It may also 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
Drinking alcoholic beverages or taking sedatives (especially barbiturates) intensifies the sedative effect of antihistamines; therefore, simultaneous use should be avoided.
Particular risk of liver damage exists in patients who are fasting and in regular alcohol drinkers.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of this medicine during pregnancy is not recommended.

Breastfeeding
Use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
Drowsiness may occur during treatment, which may affect the psychomotor 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 5 mg of fructose per sachet. The additive effect of simultaneously administered products containing fructose and fructose-containing food should be considered.
Fervex contains 7 mg of alcohol (ethanol) per sachet. The amount of alcohol in one sachet is equivalent to a small amount of beer or wine (trace amounts). The small amount of alcohol in this medicine will not cause noticeable effects.
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 your doctor, pharmacist, or nurse. If in doubt, consult your 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).
There should be at least a 4-hour interval between doses.

Elderly patients
No contraindications.

Patients with renal and/or hepatic impairment
Caution is advised when administering this medicine to patients with impaired kidney function.
In cases of renal impairment (creatinine clearance below 10 ml/min), at least an 8-hour interval between doses should be maintained.

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 symptoms appear.

Duration of treatment
Do not use this medicine for longer than 5 days without consulting a doctor. If symptoms persist for more than 5 days or fever lasts longer than 3 days, the patient should consult a doctor.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Overdose of Fervex

Symptoms of overdose

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

Related to paracetamol:
There is a particular risk of paracetamol poisoning in elderly individuals and young children (most commonly due to ingestion of doses exceeding the recommended amount or accidental poisoning); such poisonings may lead to death.
Overdose of this product may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness; the following day, abdominal distension, recurrence 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone 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,
• Loss of coordination, 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, less frequently Quincke's oedema (swelling of lips, tongue or larynx),
• Anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).

Blood system disorders:

• Leukopenia (reduced number of white blood cells), neutropenia (reduced number of granulocytes),
• Thrombocytopenia (reduced number of platelets),
• Hemolytic anemia.

Related to paracetamol

Rare cases of hypersensitivity reactions have been reported, such as: anaphylactic shock, Quincke's oedema, erythema, urticaria and skin rash. If any of these symptoms occur, administration of this medicine and medicines with similar composition must be discontinued immediately.

Exceptionally rare cases of thrombocytopenia (reduced number of platelets), leukopenia and neutropenia have been observed.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 reactions allows the collection of additional information on the safety of using the medicine.

5. How to store Fervex

Keep the medicine out of the 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Fervex contains

• The active substances are: paracetamol 500 mg, ascorbic acid 200 mg, maleinate of pheniramine 25 mg.
• The other components are: sucrose, citric acid, acacia gum, sodium saccharin, lemon-rum flavour. Composition of the lemon-rum flavour: maltodextrin, acacia gum, dextrose, silicon dioxide (E 551), butylhydroxyanisole (E 320), sugar syrup, ethanol, potassium, sodium, Peru balsam, α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, geraniol.

What Fervex looks like and contents of the pack
Paper/Aluminium/PE sachets containing granules for oral solution, packed in a cardboard box.
The cardboard box contains 5, 8 or 12 sachets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, country of export:
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France
Manufacturer:
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen, France
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Lithuania, country of export: LT/1/97/3290/001
Parallel import authorisation number: 452/22