Fervex

Patient Information Leaflet: Read this leaflet carefully before using the medicine

Warning! Keep this leaflet. The 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 all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if your condition worsens, or if fever persists beyond 3 days, consult your doctor.

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 pack 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 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 required.
If there is no improvement after 5 days or if symptoms worsen, consult your doctor.

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 urinary retention,
• 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 to use Fervex, consult your 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, mainly psychological, is observed primarily when using doses higher than recommended or during prolonged treatment. The medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines currently used contain paracetamol. In adults weighing more than 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.

Children and adolescents
The medicine may be used in adolescents above 15 years of age.

Fervex and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, 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. Impaired concentration may affect 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 impairment in concentration may affect 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 activity, disopyramide, phenothiazine derivative neuroleptics, clozapine.
Additive anticholinergic 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, barbiturate hypnotics 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 non-steroidal anti-inflammatory drugs may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Paracetamol used with MAO inhibitors may cause excitation and high fever.

Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid by the phosphotungstic acid method, as well as with the determination of glucose concentration by the oxidase-peroxidase method.

Due to the presence of ascorbic acid
Ascorbic acid may reduce the effectiveness of warfarin and decrease plasma levels of fluphenazine. It also reduces urine pH, which may affect the excretion of other concurrently administered drugs.

Taking Fervex with food and drink
No contraindications.

Taking 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 is planning to have a baby, 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 persons 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, he or she should consult a doctor before taking this medicine.
Fervex contains glucose (as a component of maltodextrin); if a patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
Fervex contains 5 mg of fructose in one sachet. The additive effect of simultaneously administered products containing fructose and fructose-containing food should be considered.
Fervex contains 7 mg of alcohol (ethanol) in each sachet. The amount of alcohol in one sachet is equivalent to a very small amount of beer or wine (trace amounts). The small amount of alcohol in this medicine will not cause noticeable effects.
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 renal and/or hepatic impairment
Caution is advised when administering the medicine to patients with impaired renal function.
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.
For treating flu-like conditions, it is preferable to take the medicine dissolved in hot water, in the evening, as soon as possible after the onset of symptoms.
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 effect of the medicine is too strong or too weak, consult your doctor.
Taking more Fervex than recommended
Symptoms of overdose
Related to pheniramine
Pheniramine overdose 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, followed the next day by abdominal distension, recurrence of nausea, and jaundice.
Recommended action
If you have taken more than the recommended dose, seek immediate medical advice from a 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 may cause adverse reactions, although not everyone experiences them.

Related to pheniramine

Adverse reactions 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 disorders, tremors,
• Confusion, hallucinations,
• Less frequently, symptoms of excitation: restlessness, nervousness, insomnia.

Hypersensitivity reactions (rare):

• Erythema, itching, rash, purpura, urticaria,
• Swelling, rarely Quincke's edema (swelling of lips, tongue or larynx),
• Anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).

Blood system disorders:

• Leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
• Thrombocytopenia (reduced platelet count),
• 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 should be discontinued immediately. Very rare cases of thrombocytopenia (reduced platelet count), leukopenia and neutropenia have been observed.

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 be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 492 13 01, fax: +48 22 492 13 09,
website: https://smz.ezdrowie.gov.pl.

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

5. How to store Fervex

Keep this medicine out of sight and reach of children.
Store 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 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 pack and other information

What Fervex contains

• The active substances 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 flavour (Antilles flavour): maltodextrin, arabic gum, dextrose, silicon dioxide (E551), butylated hydroxyanisole (E320), sugar syrup, ethanol, potassium, sodium, Peru balsam; α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, geraniol.

What Fervex looks like and contents of the pack
Pouches made of paper/aluminium/HDPE in a cardboard box. The cardboard box contains 8 or 12 pouches. Not all pack sizes may be marketed.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, 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
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Romania, country of export: 12094/2019/02
Parallel Import Authorisation Number: 450/22