Fervex

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Fervex (Fervex răceală și gripă pentru adulţi)
500 mg + 200 mg + 25 mg, granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Fervex and Fervex răceală și gripă pentru adulţi are the same medicine sold under different brand names.
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, 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, thus helping to clear nasal passages, suppress sneezing reflex, and reduce eye tearing.
Ascorbic acid helps to replenish vitamin C deficiency in the body.
Indications
Fervex is indicated for the 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 your condition worsens, 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 difficulty urinating,
• 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 treatment with Fervex, discuss it with 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 developing dependence, mainly psychological, is observed primarily when higher than recommended doses are used or with prolonged treatment.
This medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines currently taken by the patient also contain paracetamol. In adults with 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 (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 you are currently taking, have recently taken, or plan to take.

Due to the presence of pheniramine

Unrecommended combinations
Alcohol enhances the sedative effect of most antihistamines – H receptor antagonists. Impaired concentration ability may affect the ability to drive or 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, doxepine, 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 or 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 (atropine-like) adverse effects such as urinary retention, constipation, and dry mouth may occur.

Due to the presence of paracetamol
Salicylamide prolongs paracetamol elimination time.
Rifampicin, antiepileptic drugs, barbiturate hypnotics, and other microsomal enzyme-inducing drugs taken concomitantly with paracetamol increase the risk of liver damage.
Caffeine enhances the analgesic and antipyretic effects of paracetamol.
Concurrent use of high-dose paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Paracetamol taken with MAO inhibitors may cause agitation and high fever.

Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid levels by the phosphotungstic acid method, as well as with 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 decrease plasma levels of fluphenazine. It also lowers 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) enhances 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 might be pregnant, or is planning to become pregnant, 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 impair psycho-physical performance in individuals driving vehicles or operating machinery.

Warnings regarding excipients with known effects
Fervex contains 11.6 g of sucrose per sachet. This should be considered in diabetic patients.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Fervex contains glucose (as a component of maltodextrin); if the patient has previously been diagnosed with intolerance to certain sugars, they 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 taken into account.
Fervex contains 7 mg of alcohol (ethanol) in each sachet. The amount of alcohol in one sachet corresponds to a small quantity 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 information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a 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 impaired kidney and/or liver function
Caution is advised when administering this medicine to patients with impaired kidney function.
In cases of impaired kidney function (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 better to take the medicine dissolved in hot water, in the evening, as soon as possible after symptoms appear.

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 the effect of the medicine seems too strong or too weak, consult a doctor.

Use of a higher than recommended dose of Fervex

Symptoms of overdose

Related to pheniramine:
Pheniramine overdose may cause seizures (especially in children), disturbances in 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; the following day, abdominal discomfort, recurrence of nausea, and jaundice may occur.

What to do in case of overdose
If a higher than recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Fervex
Do not take a double dose to make up for a missed dose.

Stopping Fervex treatment
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 can cause adverse reactions, although not everyone will experience them.

Related to pheniramine

Adverse effects 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 balance, 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 of medicines with similar composition should be discontinued immediately.

Exceptionally rare cases of thrombocytopenia (reduced platelet count), leukopenia, and neutropenia have been observed.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Fervex

Keep the 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Fervex contains

• The active substances are: paracetamol 500 mg, ascorbic acid 200 mg, maleinate of pheniramine 25 mg.
• Other components are: sucrose, citric acid, gum arabic, sodium saccharin, lemon-rum flavour (Antilles flavour): maltodextrin, gum arabic, dextrose, colloidal anhydrous silica (E 551), butylated hydroxyanisole (E 320), 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
Paper/Al/HDPE sachets containing granules for oral solution, packed in a cardboard box.
The cardboard box contains 8 sachets.
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, Rueil Malmaison, 92500
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 12094/2019/02
Parallel import authorisation number: 351/16