Fervex

Leaflet attached to the packaging: patient information

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

FERVEX

500 mg + 200 mg + 25 mg, granules for oral solution preparation
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 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, a doctor should be consulted.

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 medicine.
Paracetamol acts as a pain reliever and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, 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 temporary treatment of flu, cold, and flu-like symptoms (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, a doctor should be consulted.

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 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 a doctor.
Without a 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 than recommended doses and 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 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 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 antihistamine drugs - 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 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, centrally acting antihypertensive drugs, baclofen, and thalidomide.
Increased inhibition of the central nervous system 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 an antispasmodic effect, dyssopiramide, 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 anticoagulant drugs 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 uric acid in blood by the phosphotungstic method, as well as the determination of glucose 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 serum, 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.
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 a 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 people 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 a 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 a 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 doubts, a doctor, pharmacist, or nurse should be consulted.
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 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 medicine dissolved in hot water, in the evening, as soon as symptoms appear.
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 a doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a 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
A special risk of paracetamol poisoning occurs in the elderly 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 pain, return of nausea, and jaundice.
Procedure
In case of taking a higher than recommended dose of the medicine, a doctor or pharmacist should be consulted immediately.

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, a doctor or pharmacist should be consulted.

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 the elderly,
• coordination disorders, tremors,
• confusion, hallucinations,
• rarely, symptoms of excitement: restlessness, nervousness, insomnia. Hypersensitivity reactions (rare):
• flushing, itching, rash, erythema, urticaria,
• edema, rarely Quincke's edema (edema of the lips, tongue, or larynx),
• anaphylactic shock (a type of systemic allergic reaction with immediate effects on circulation and respiration). Effects on the hematopoietic system:
• leukopenia (decreased white blood cell count), neutropenia (decreased granulocyte count),
• thrombocytopenia (decreased platelet count),
• hemolytic anemia.

Related to paracetamol

There have been reports of rare cases of hypersensitivity reactions, such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, the medicine and similar medicines 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.
Aleje Jerozolimskie 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 medicine.

5. How to store FERVEX

Store at a temperature below 25°C.
The medicine should be stored in a place invisible and inaccessible to children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What FERVEX contains

• The active substances of the medicine are: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg.
• Other ingredients are: sucrose (11.6 g), citric acid anhydrous, gum arabic, sodium saccharin, flavor (lemon oil, cinnamon oil, clove oil, natural extracts of rum and vanilla, Peruvian balsam, caramel).

What Fervex looks like and what the package contains

Paper/Al/PE sachets in a cardboard box.
The cardboard box contains 5 or 8 sachets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Latvia, 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:

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
Marketing authorization number in Latvia, the country of export: 98-0132

Parallel import authorization number: 391/17

Date of leaflet approval:28.10.2022
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