Fervex

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

FERVEX (Fervex For Adults)

500 mg + 200 mg + 25 mg, granules for oral solution preparation
Paracetamol + Ascorbic Acid + Pheniramine Maleate
FERVEX and Fervex For Adults are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, 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 doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days or the patient feels worse, or if the fever does not subside after 3 days, the patient should contact their doctor.

Table of contents of the leaflet:

• 1. What is FERVEX and what is it used for
• 2. Important information before taking FERVEX
• 3. How to take FERVEX
• 4. Possible side effects
• 5. How to store FERVEX
• 6. Package contents and other information

1. What is FERVEX and what is it used for

FERVEX is a combination drug.
Paracetamol has analgesic and antipyretic effects.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, inhibiting the sneezing reflex, and reducing eye tearing.
Ascorbic acid supplements vitamin C deficiencies in the body.

Indications for use

FERVEX is indicated for use in adults and adolescents over 15 years of age for the symptomatic treatment of flu, colds, and flu-like conditions (headache, fever, nasal and throat congestion).
In case of bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or the patient feels worse, they should consult a doctor.

2. Important information before taking FERVEX

When not to take FERVEX:

• if the patient is allergic to paracetamol, ascorbic acid, pheniramine maleate, or any of the other ingredients of this drug (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has narrow-angle glaucoma,
• if the patient has prostate enlargement with difficulty urinating,
• in children and adolescents under 15 years of age,
• it 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 drug.

Warnings and precautions

Before starting FERVEX, the patient should discuss it with their doctor, pharmacist, or nurse.
If symptoms persist for more than 5 days or fever lasts for more than 3 days, the patient should consult their doctor.
Without a doctor's recommendation, the drug should not be used for more than 5 days.
The risk of dependence, mainly psychological, is observed mainly in cases of using higher-than-recommended doses and long-term treatment.
The drug contains paracetamol. To avoid the risk of overdose, the patient should check if other medications they are taking contain paracetamol. In adults with a body weight over 50 kg, the TOTAL DAILY DOSE OF PARACETAMOL SHOULD NOT EXCEED 4 GRAMS.
Paracetamol should be used with caution in patients with a deficiency of glucose-6-phosphate dehydrogenase (G6PD).

Children and adolescents

The drug can be used in adolescents over 15 years of age.

FERVEX and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.

Due to the presence of pheniramine

Contraindicated combinations
Alcohol enhances the sedative effect of most antihistamines - H receptor antagonists. Changes in attention may impair the ability to drive vehicles and operate machinery.
Alcoholic beverages or drugs containing alcohol should be avoided.
Combinations that should be used with caution
Other sedative drugs: morphine derivatives (painkillers, antitussives), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g., meprobamate), sleeping pills, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines blocking the H receptor with a sedative effect, central-acting antihypertensive drugs, baclofen, and thalidomide.
Increased central nervous system depression and associated changes in attention may impair the ability to drive vehicles and operate machinery.
Other drugs with an atropine-like effect: antidepressants with a structure similar to imipramine, most antihistamines blocking the H receptor, anticholinergic anti-Parkinson's drugs, atropine-like drugs with an antispasmodic effect, dyssopyramide, neuroleptics from the phenothiazine group, clozapine.
Summation of atropine-like side effects, such as urinary retention, constipation, and dry mouth.

Due to the presence of paracetamol

Salicylamide prolongs the elimination of paracetamol.
Rifampicin, antiepileptic drugs, barbiturate sleeping pills, and other microsomal enzyme inducers used in combination 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 may increase the risk of renal function disorders.
Paracetamol enhances the effect of oral anticoagulants from the coumarin group.
Paracetamol used with MAO inhibitors can cause excitement and high fever.

Effect on laboratory test results

Paracetamol may affect the determination of uric acid levels in the blood by the phosphotungstic method, as well as the determination of glucose levels by the oxidase-peroxidase method.

Due to the presence of ascorbic acid

Ascorbic acid may reduce the effectiveness of warfarin and the concentration of flufenazine in plasma, as well as reduce the pH of urine, which may affect the excretion of other concomitantly used drugs.

Using FERVEX with food and drink

There are no contraindications.

Using FERVEX with alcohol

Drinking alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so they should be avoided.
A special risk of liver damage exists in patients who are fasting and regularly drink alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
Pregnancy
It is not recommended to use the drug during pregnancy.
Breastfeeding
It is not recommended to use the drug during breastfeeding.

Driving and operating machinery

During treatment with the drug, drowsiness may occur, affecting the psychophysical fitness of individuals driving vehicles and 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 the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the drug.
FERVEX contains glucose (as a component of maltodextrin); if the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the drug.
FERVEX contains 5 mg of fructose in one sachet. The additive effect of concomitantly administered products containing fructose and food containing fructose should be taken into account.
FERVEX contains 7 mg of alcohol (ethanol) in each sachet. The amount of alcohol in one sachet of this drug is equivalent to a small amount of beer or wine (trace amounts). A small amount of alcohol in this drug will not have noticeable effects.
FERVEX contains less than 1 mmol (23 mg) of sodium per sachet, which means the drug is considered "sodium-free".

3. How to take FERVEX

This drug should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Adults and adolescents over 15 years of age: 1 sachet 2 or 3 times a day (corresponding to 1500 mg of paracetamol, 75 mg of pheniramine maleate, and 600 mg of vitamin C).
Intervals between consecutive doses should be at least 4 hours.
Elderly patients
There are no contraindications.
Patients with renal and/or hepatic impairment
Caution should be exercised when administering the drug to patients with renal impairment.
In case of renal impairment (creatinine clearance below 10 ml/min), intervals between doses should be at least 8 hours.
Method of administration
Oral administration. The contents of the sachet should be dissolved in a glass of hot or cold water.
In the treatment of flu-like conditions, it is better to take the drug dissolved in hot water, in the evening, as soon as possible after the onset of symptoms.
Duration of treatment
Without consulting a doctor, the drug should not be used for more than 5 days. If symptoms persist for more than 5 days or fever lasts for more than 3 days, the patient should consult their doctor.
If the patient feels that the effect of the drug is too strong or too weak, they should consult their doctor.

Taking a higher dose of FERVEX than recommended

Overdose symptoms

Related to pheniramine
Overdose of pheniramine may cause: seizures (especially in children), impaired consciousness, coma.
Related to paracetamol
A special risk of paracetamol poisoning exists in elderly patients and small children (the most common causes are taking higher-than-recommended doses and accidental poisoning); these poisonings can lead to death.
Overdose of the product may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, and the next day, abdominal distension, return of nausea, and jaundice.
Procedure
In case of taking a higher dose of the drug than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of FERVEX

A double dose should not be taken to make up for a missed dose.

Stopping FERVEX treatment

In case of any further doubts regarding the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everyone will experience them.

Related to pheniramine

Side effects of varying severity, dose-dependent and dose-independent, may occur:
Neurovegetative effects:

• sedation or drowsiness, more pronounced in the initial treatment period,
• anticholinergic effects, such as dryness of mucous membranes, constipation, accommodation disorders, pupil dilation, palpitations, risk of urinary retention,
• orthostatic hypotension,
• balance disorders, dizziness, memory or concentration disorders, more frequently in elderly patients,
• coordination disorders, tremors,
• confusion, hallucinations,
• rarely, symptoms of excitement: restlessness, nervousness, insomnia. Hypersensitivity reactions (rare):
• flushing, itching, rash, urticaria, erythema,
• edema, rarely Quincke's edema (edema of the lips, tongue, or larynx),
• anaphylactic shock (a type of systemic allergic reaction with circulatory and respiratory disorders). Effects on the hematopoietic system:
• leukopenia (decreased white blood cell count), neutropenia (decreased granulocyte count),
• thrombocytopenia (decreased platelet count),
• hemolytic anemia.

Related to paracetamol

Rare cases of hypersensitivity reactions have been reported, such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, the drug and similar drugs should be discontinued immediately.
Very rare cases of thrombocytopenia (decreased platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the drug.

5. How to store FERVEX

Store at a temperature below 25°C, in the original packaging.
The drug should be stored out of sight and reach of children.
The drug should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What FERVEX contains

• The active substances of the drug are: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg.
• Other ingredients are: sucrose, citric acid, gum arabic, sodium saccharin, lemon-rum flavor (Antilles flavor): maltodextrin, gum arabic, dextrose, silicon dioxide (E 551), butylhydroxyanisole (E 320), sugar syrup, ethanol, potassium, sodium, Peruvian balsam; α-pinen, β-pinen, limonene, γ-terpinene, linalool, neral, α-terpineol, geraniol.

What FERVEX looks like and what the packaging contains

Paper/Al/HDPE sachets containing granules for oral solution preparation, in a cardboard box.
The cardboard box contains 5 or 8 sachets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

UPSA SAS, 3 rue Joseph Monier, 92500 Rueil-Malmaison, France

Manufacturer:

UPSA SAS, 304 avenue du Dr. Jean Bru, 47000 Agen, France
UPSA SAS, 979 avenue des Pyrénées, 47520 Le Passage, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 12094/2019/02
12094/2019/01

Parallel import authorization number: 146/13

Date of leaflet approval:06.03.2023
[Information about the trademark]