Fervex Iunior

Leaflet attached to the packaging: patient information

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

FERVEX JUNIOR (FERVEX VAIKAMS)

280 mg + 100 mg + 10 mg

Granules for oral solution
Paracetamol + Ascorbic acid + Pheniramine maleate
FERVEX JUNIOR and FERVEX VAIKAMS are different trade names for the same drug.

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 advised by a doctor, pharmacist, or nurse.
Keep this leaflet, you may need to read it again.
If you need advice or additional information, consult a pharmacist.
If the patient experiences any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
See section 4.
If after 3 days there is no improvement or the patient feels worse, consult a doctor.

Table of contents of the leaflet:

What is FERVEX JUNIOR and what is it used for
Important information before taking FERVEX JUNIOR
How to take FERVEX JUNIOR
Possible side effects
How to store FERVEX JUNIOR
Contents of the pack and other information

1. What is FERVEX JUNIOR and what is it used for

FERVEX JUNIOR is a combination medicine. Paracetamol acts as an analgesic and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby relieving nasal congestion, inhibiting the sneezing reflex, and tearing of the eyes. Ascorbic acid supplements vitamin C deficiency in the body. The medicine does not contain sugar.

Indications for use

FERVEX JUNIOR is indicated for use in children over 6 years of age for the temporary treatment of symptoms of flu, colds, and flu-like conditions (headache, fever, inflammation of the nasal and throat mucosa).
If after 3 days there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking FERVEX JUNIOR

When not to take FERVEX JUNIOR:

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 accompanying urinary retention,
in children under 6 years of age.

Warnings and precautions

Before starting treatment with FERVEX JUNIOR, discuss it with your doctor, pharmacist, or nurse.
The medicine contains paracetamol. To avoid the risk of overdose, check if other medicines being taken contain paracetamol.
The risk of dependence, mainly psychological, is observed especially when taking higher doses than recommended and in the case of long-term treatment.
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 temporarily in children over 6 years of age and adolescents in specific age groups (see section 3).

FERVEX JUNIOR and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you 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. Avoid consuming alcoholic beverages or medicines containing alcohol.
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, 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 a spasmolytic effect, dizopiramid, 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

Salcylamide prolongs the elimination time of paracetamol.
Rifampicin, antiepileptic drugs, sleeping pills from the barbiturate group, and other microsomal enzyme-inducing drugs 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 drugs may increase the risk of kidney 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 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 JUNIOR with alcohol

Drinking alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so they should be avoided during concomitant use. Particular risk of liver damage exists in patients who are fasting and regularly consume alcohol.

Pregnancy, breastfeeding, and fertility

This medicine is intended for children and adolescents (see section 3).
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a 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 using machines

During treatment with the medicine, drowsiness may occur, affecting the psychophysical fitness of persons driving vehicles and operating machinery.
Warnings about excipients with known effects
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
FERVEX JUNIOR contains 0.3 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.
FERVEX JUNIOR contains Orange Yellow FCF (E 110) and Allura Red AC (E 129).
The medicine may cause allergic reactions.
FERVEX JUNIOR contains 0.0036 mg of sodium benzoate (E 211) in each sachet.
FERVEX JUNIOR contains trace amounts (0.0036 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 JUNIOR contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take FERVEX JUNIOR

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist or nurse. In case of doubt, consult a doctor or pharmacist or nurse.
Children and adolescents
Children from 6 to 10 years of age: 1 sachet 2 times a day.
Children from 10 to 12 years of age: 1 sachet 3 times a day.
Adolescents from 12 to 15 years of age: 1 sachet 4 times a day.
Maintain at least 4-hour intervals between doses.
Do not take a higher dose than recommended.
Maximum recommended doses of paracetamol:
Children and adolescents with a body weight of up to 50 kg: the maximum daily dose of paracetamol is 60 mg/kg body weight/day, not exceeding 3 g/day, given in divided doses of 10-15 mg/kg body weight.
Adults and adolescents with a body weight over 50 kg: the maximum daily dose of paracetamol is 4 g/day.
Patients with renal impairment
Caution should be exercised when administering the medicine to patients with renal impairment.
In the case of severe renal failure (creatinine clearance below 10 ml/min), the intervals between doses should be at least 8 hours.
Method of administration
Oral use. The contents of the sachet should be dissolved in a sufficient amount of cold or warm water.
Duration of treatment
Do not use for more than 3 days without consulting a doctor.

Taking a higher dose of FERVEX JUNIOR than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
Symptoms of pheniramine overdose: seizures (especially in children), impaired consciousness, coma.
Symptoms of paracetamol overdose: a particular risk of paracetamol poisoning occurs in the elderly 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 medicine may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, and the next day, abdominal distension, return of nausea, and jaundice.

Missing a dose of FERVEX JUNIOR

Do not take a double dose to make up for a missed dose. In case of doubts about taking the medicine, consult a doctor or pharmacist.

Stopping treatment with FERVEX JUNIOR

In case of further doubts about taking this medicine, consult a 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 actions:
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,
less frequently, symptoms of excitement: restlessness, nervousness, insomnia.
Allergic 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 systemic allergic reaction with immediate circulation and breathing disorders).
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 allergic reactions have been reported, such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, stop taking this medicine and medicines with a similar composition immediately.
Very rare cases of thrombocytopenia (reduced platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store FERVEX JUNIOR

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What FERVEX JUNIOR contains

The active substances of the medicine are: paracetamol 280 mg, ascorbic acid 100 mg, and pheniramine maleate 10 mg.
Other ingredients are: mannitol, citric acid, povidone, magnesium citrate, acesulfame potassium, maline flavor.
Composition of maline flavor: maltodextrin, potassium sorbate (E 202), sodium benzoate (E 211), propylene glycol (E 1520), ethanol, potassium, sodium salt of octenyl succinic acid starch (E 1450), Allura Red AC (E 129), Brilliant Blue (E 133), Orange Yellow FCF (E 110), sodium chloride and (or) sodium sulfate, ethyl acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxybenzyl acetone.

What FERVEX JUNIOR looks like and what the pack contains

Paper/aluminum/polyethylene sachets containing granules for oral solution in a cardboard box.
A cardboard box containing 8 or 12 sachets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, 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
Lithuanian, export country marketing authorization number: LT/1/97/3290/003

Parallel import authorization number: 46/23 Date of leaflet approval: 15.03.2023

[Information about the trademark]