Fervex

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Fervex

500 mg + 200 mg + 25 mg, granulate for oral solution

Paracetamol + Ascorbic Acid + Pheniramine Maleate

You should carefully read the contents of the leaflet before using 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.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, or if the fever does not subside after 3 days, they 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. Contents of the packaging and other information

1. What is Fervex and what is it used for

Fervex is a combination medicine.
Paracetamol acts as a pain reliever and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby relieving nasal congestion, reducing sneezing and tearing of the eyes.
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 temporary relief of symptoms of influenza, colds, and flu-like conditions (headache, fever, nasal congestion and sore throat).
In case of bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or if the patient feels worse, they should consult their 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 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 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 medicine.

Warnings and precautions

Before starting treatment with Fervex, the patient should discuss it with their doctor, pharmacist, or nurse.
In case of symptoms persisting for more than 5 days or fever lasting more than 3 days, the patient should consult their doctor. Without the doctor's recommendation, the medicine should not be used for more than 5 days.
The risk of dependence, mainly psychological, is observed mainly in cases of using higher doses than recommended and in cases of long-term treatment. The medicine contains paracetamol. To avoid the risk of overdose, the patient should check if other medicines being taken contain paracetamol. In adults with a 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 deficiency (G6PD).

Children and adolescents

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

Fervex and other medicines

The patient should tell their doctor or pharmacist about all medicines being taken currently or recently, as well as any medicines planned to be taken.

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.
The patient should avoid consuming alcoholic beverages or medicines containing alcohol.
Combinations that should be used with caution
Other sedative medicines: morphine derivatives (pain relievers, 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, antihypertensive medicines with a central effect, baclofen, and thalidomide.
Increased central nervous system depression and associated changes in attention may impair the ability to drive vehicles and operate machinery.
Other medicines with an anticholinergic effect: antidepressants with a structure similar to imipramine, most antihistamines blocking the H receptor, anticholinergic antiparkinsonian medicines, atropine-like medicines with an antispasmodic effect, dyphylline, neuroleptics from the phenothiazine group, clozapine.
Summation of anticholinergic side effects such as urinary retention, constipation, and dry mouth.

Due to the presence of paracetamol

Salicylamide prolongs the elimination time of paracetamol.
Rifampicin, antiepileptic medicines, 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 effect of paracetamol.
Concomitant use of high doses of paracetamol and nonsteroidal anti-inflammatory medicines may increase the risk of renal function disorders.
Paracetamol enhances the effect of oral anticoagulant medicines from the coumarin group.
Paracetamol used with MAO inhibitors may cause excitement and high fever.
Effect on laboratory test results
Paracetamol may affect the determination of blood uric acid levels 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 plasma concentration of flufenazine, as well as reduce the pH of urine, which may affect the excretion of other concomitantly used medicines.

Using Fervex with food and drink

There are no contraindications.

Using Fervex with alcohol

Consuming alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so the patient should avoid taking them concomitantly.
A special risk of liver damage exists in patients who are fasting and regularly consume alcohol.

Pregnancy and breastfeeding

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

Driving and operating machinery

During treatment with the medicine, 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 some sugars, they should consult their doctor before taking the medicine.
Fervex contains glucose (as a component of maltodextrin); if the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
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 a sachet of this medicine is equivalent to a small amount of beer or wine (trace amounts). A small amount of alcohol in this medicine will not have noticeable effects.
Fervex contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Fervex

This medicine should always be taken exactly as described in this patient leaflet or as directed by the 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 medicine 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 use. 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 medicine dissolved in hot water, in the evening, as soon as possible after the onset of symptoms.
Duration of treatment
Without consulting a doctor, the medicine should not be used for more than 5 days. In case of symptoms persisting for more than 5 days or fever lasting more than 3 days, the patient should consult their doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using 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 doses than recommended 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 pain, return of nausea, and jaundice.
Procedure
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Fervex

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Fervex

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Related to pheniramine

Side effects of varying severity may occur, depending on and independent of the dose:
Neurovegetative effects:

• sedation or drowsiness, more pronounced in the initial treatment period,
• anticholinergic symptoms such as dryness of mucous membranes, constipation, accommodation disorders, pupil dilation, palpitations, risk of urinary retention,
• orthostatic hypotension,
• balance disorders, dizziness, memory or attention disorders, more frequently in elderly patients,
• coordination disorders, tremors,
• confusion, hallucinations,
• less frequently, symptoms of excitement: restlessness, nervousness, insomnia. Hypersensitivity reactions (rare):
• flushing, itching, rash, urticaria, erythema,
• edema, less frequently 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.
In case of any of these symptoms, the patient should immediately stop taking this medicine and medicines with a similar composition. Extremely 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 tell 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: Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +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 medicine.

5. How to store Fervex

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers.
The patient should ask their pharmacist how to dispose of medicines that are no longer used.
This will help protect the environment.

6. Contents of the packaging and other information

What Fervex contains

• The active substances of the medicine are: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg.
• The other ingredients are: sucrose, citric acid, arabic gum, sodium saccharin, lemon-rum flavor (Antilles flavor): maltodextrin, arabic gum, dextrose, silicon dioxide (E551), butylhydroxyanisole (E320), sugar syrup, ethanol, potassium, sodium, Peruvian balsam; α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, geraniol.

What Fervex looks like and what the packaging contains

Paper/Aluminum/HDPE sachets in a cardboard box. The cardboard box contains 8 or 12 sachets. Not all pack sizes may be marketed.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 12094/2019/02

Parallel import authorization number: 450/22 Date of leaflet approval: 30.12.2022

[Information about the trademark]