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, granules for oral solution

Paracetamol + Ascorbic Acid + Pheniramine Maleate

Read the 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 a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• 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, 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, inhibiting 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 symptomatic treatment of flu, colds, and flu-like conditions (headache, fever, inflammation of the nasal and throat mucosa).
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 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 prostatic hyperplasia 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 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, do not use for more than 5 days.
The risk of dependence, mainly psychological, is observed mainly in cases of taking higher-than-recommended doses and long-term treatment.
The medicine contains paracetamol. To avoid the risk of overdose, 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 a deficiency of glucose-6-phosphate dehydrogenase (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 they are currently taking or have recently taken, as well as any medicines 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 medicines containing alcohol should be avoided.
Combinations to be used with caution
Other sedative medicines: morphine derivatives (painkillers, antitussives), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g., meprobamate), sleeping pills, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapina, trimipramine), antihistamines blocking the H receptor with a sedative effect, antihypertensive drugs 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 atropine-like effect: antidepressants with a structure similar to imipramine, most antihistamines blocking the H receptor, anticholinergic anti-Parkinson's drugs, atropine-like medicines with a spasmolytic effect, dyzopiramid, 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 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 they should be avoided.
Particular risk of liver damage exists in fasting patients and those who 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 taking 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 cause 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 a doctor, pharmacist, or nurse. In case of doubt, consult a 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 of at least 8 hours should be maintained between doses.
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, do not use this medicine 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 medicine is too strong or too weak, they should consult their doctor.

Taking a higher-than-recommended dose of Fervex

Overdose symptoms

Related to pheniramine
Overdose of pheniramine may cause: seizures (especially in children), impaired consciousness, coma.
Related to paracetamol
Particular risk of paracetamol poisoning occurs in the elderly and small children (most common causes are taking higher-than-recommended doses and accidental poisoning); these poisonings can be fatal.
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-than-recommended dose of the medicine, the patient should immediately consult a 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 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 concentration disorders, more frequently in the elderly,
• coordination disorders, tremors,
• confusion, hallucinations,
• less frequently, symptoms of excitement: restlessness, nervousness, insomnia. Hypersensitivity reactions (rare):
• flushing, itching, rash, erythema, urticaria,
• edema, less frequently Quincke's edema (edema of the lips, tongue, or larynx),
• anaphylactic shock (a type of immediate, systemic allergic reaction with circulatory and respiratory disorders). Blood system disorders:
• 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 medicine and medicines with a similar composition should be discontinued immediately.
Very rare cases of thrombocytopenia (decreased platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or parallel importer.
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 this 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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). Composition of lemon-rum flavor (Antilles flavor): maltodextrin, arabic gum, dextrose, silicon dioxide (E 551), butylhydroxyanisole (E 320), 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

A paper/Al/HDPE sachet containing granules for oral solution, in a cardboard box.
The cardboard box contains 5, 8, or 12 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
979 avenue des Pyrénées
47520 Le Passage
France
UPSA SAS
304 avenue du Docteur Jean Bru
47000 Agen
France

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35/37
87-100 Toruń

Marketing authorization number in Romania, the country of export:

12094/2019/01
12094/2019/02

Parallel import authorization number: 45/23 Date of approval of the leaflet: 15.03.2023

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