Fervex

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
FERVEX
500 mg + 200 mg + 25 mg, effervescent granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Please read the entire leaflet carefully before using 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 a
physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a physician, 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 a physician.

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 package 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 symptomatic relief in adults and adolescents over 15 years of age with symptoms of influenza, colds, and flu-like conditions (headache, fever, inflammation of nasal and throat mucosa).
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 physician.

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 syndrome, or sucrase-isomaltase deficiency due to the presence of sucrose in the medicine.

Warnings and precautions
Before starting treatment with Fervex, consult 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, primarily 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 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.
During treatment with Fervex lemon, immediately inform the doctor if the patient develops serious conditions, including severe kidney disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In such cases, patients have been reported to develop a serious condition called metabolic acidosis (abnormality in blood and body fluids), when paracetamol was used regularly over a long period or when paracetamol was taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

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 used, as well as any medicines you plan to take.

Due to the presence of pheniramine
Unrecommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Changes in attention capacity may impair the ability to drive vehicles and 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 changes in attention capacity, may impair 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 action, 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 nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants from the coumarin group.
Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).
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 uric acid concentration in blood by the phosphotungstic method, as well as with glucose concentration measurement by the oxidase-peroxidase method.

Due to the presence of ascorbic acid
Ascorbic acid may reduce the effectiveness of warfarin and lower 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
There are 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.
Particular risk of liver damage exists in patients who are fasting and regularly consume alcohol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may 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 psycho-physical performance of individuals driving vehicles or operating machinery.

Warnings regarding excipients with known effects
Fervex contains 11.6 g of sucrose per sachet. 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 (as a component of maltodextrin). 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 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).
Intervals between doses should be at least 4 hours.

Elderly patients
No contraindications.

Patients with impaired kidney and/or liver function
Caution is required when administering this medicine to patients with impaired kidney function.
In cases of impaired kidney function (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 symptoms appear.
It is recommended that the prepared solution be stored for no longer than three hours.

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 medicine's effect is too strong or too weak, consult your doctor.

Taking more Fervex than recommended
Symptoms of overdose
Related to pheniramine:
Overdose of pheniramine may cause: seizures (especially in children), disturbances of consciousness, 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
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.

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

Stopping 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 disturbances, tremors,
• Confusion, hallucinations,
• Less frequently, stimulant-type symptoms: restlessness, nervousness, insomnia.

Hypersensitivity reactions (rare):

• Erythema, itching, rash, purpura, urticaria,
• Swelling, less frequently 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 hematopoietic system:

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

Related to paracetamol

Rare 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 must be stopped immediately.

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

Frequency unknown (frequency cannot be estimated based on available data): serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of using the medicine.

5. How to store Fervex

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use the 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 packaging and other information

What the medicine Fervex contains

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

What Fervex looks like and contents of the pack
Packs made of paper/Al/PE in a cardboard box.
The cardboard box contains 5 or 8 sachets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
UPSA SAS, 3, rue Joseph Monier, 92500 Rueil-Malmaison, France
Manufacturer:
UPSA SAS, 979 Avenue des Pyrénées, 47520 Le Passage, France
UPSA SAS, 304, Avenue du Docteur Jean Bru, 47000 Agen, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Latvia, country of export: 98-0132
Parallel import authorisation number: 391/17