Fervex junior

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
FERVEX JUNIOR (FERVEX VAIKAMS)
280 mg + 100 mg + 10 mg
effervescent granules for oral solution
Paracetamol + Acidum ascorbicum + Pheniramine maleate
FERVEX JUNIOR and FERVEX VAIKAMS are different trade names for the same medicinal product.
Please read this 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 for future reference.
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 3 days or if symptoms worsen, consult a doctor.

Table of contents of the leaflet:
What FERVEX JUNIOR is and what it is 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 FERVEX JUNIOR is and what it is used for

FERVEX JUNIOR is a combination medicine. Paracetamol has analgesic and antipyretic effects.
Pheniramine maleate reduces congestion and swelling of the mucous membranes, thereby improving nasal passage, and suppresses sneezing and tearing. Ascorbic acid replenishes vitamin C deficiency in the body. The medicine does not contain sugar.
Therapeutic indications
FERVEX JUNIOR is indicated for short-term relief of symptoms of influenza, colds, and flu-like conditions (headache, fever, inflammation of the nasal and throat mucosa) in children over 6 years of age.
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

2. Important information before using FERVEX JUNIOR

When not to use 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 benign prostatic hyperplasia with associated urinary retention,
in children under 6 years of age.

Warnings and precautions
Before starting to use FERVEX JUNIOR, consult a doctor, pharmacist or nurse.
This medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines currently taken also contain paracetamol.
The risk of dependence, mainly psychological, is observed especially when doses higher than recommended are used or during long-term treatment.
Paracetamol should be used with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Children and adolescents
This medicine may be used occasionally in children over 6 years of age and adolescents within specific age groups (see section 3).

Fervex Junior and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines planned for future use.

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. Consumption of alcoholic beverages or taking medicines containing alcohol should be avoided.

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 of 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 action, 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 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 used together with MAO inhibitors may cause a state of excitation and high fever.

Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid concentration 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 lower plasma levels of fluphenazine. It also decreases urine pH, which may affect the excretion of other concurrently administered drugs.

Use of FERVEX JUNIOR with alcohol
Consumption of alcoholic beverages or taking sedatives (especially barbiturates) intensifies the sedative effect of antihistamines; therefore, simultaneous use should be avoided. There is a particular risk of liver damage in patients who are fasting and those who regularly consume alcohol.

Pregnancy, breastfeeding and fertility
This medicine is intended for children and adolescents (see section 3).
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a child, 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 psycho-physical performance in individuals driving vehicles or operating machinery.

Warnings regarding excipients with known effects
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Fervex Junior contains 0.3 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.
Fervex Junior contains Sunset Yellow FCF (E 110) and Allura Red AC (E 129).
This medicine may cause allergic reactions.
Fervex Junior contains 0.0036 mg of sodium benzoate (E 211) per sachet.
Fervex Junior contains trace amounts (0.0036 mg) of alcohol (ethanol) in each sachet. The amount of alcohol in one sachet is equivalent to a small quantity of beer or wine (trace amounts). This small amount of alcohol will not cause noticeable effects.
Fervex Junior contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use FERVEX JUNIOR

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.

Children and adolescents
Children aged 6 to 10 years: 1 sachet twice daily.
Children aged 10 to 12 years: 1 sachet three times daily.
Adolescents aged 12 to 15 years: 1 sachet four times daily.

Leave at least 4 hours between doses.
Do not exceed the recommended dose.

Maximum recommended doses of paracetamol:
Children and adolescents with body weight up to 50 kg: maximum daily dose of paracetamol is 60 mg/kg body weight/day, not exceeding 3 g/day in total, administered in divided doses of 10–15 mg/kg body weight.
Adults and adolescents with body weight above 50 kg: maximum daily dose of paracetamol is 4 g/day.

Patients with impaired renal function
Caution is advised when administering this medicine to patients with impaired kidney function.
In cases of severe renal impairment (creatinine clearance below 10 ml/min), intervals between doses should be at least 8 hours.

Method of administration
For 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 longer than 3 days without consulting a doctor.

Overdose of FERVEX JUNIOR
If more medicine has been taken than recommended, seek immediate medical advice from a doctor or pharmacist.

Symptoms of pheniramine overdose: convulsions (especially in children), disturbances of consciousness, coma.

Symptoms of paracetamol overdose: 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 may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness; on the following day, upper abdominal discomfort, recurrence of nausea, and jaundice may occur.

Missed dose of FERVEX JUNIOR
Do not take a double dose to make up for a missed dose. If in doubt about the use of the medicine, consult a doctor or pharmacist.

Stopping FERVEX JUNIOR
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.

Related to pheniramine

Adverse effects of varying severity, both dose-dependent and independent, may occur:

Neurovegetative effects:
drowsiness or sedation, 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,
balance disorders, dizziness, memory or concentration disturbances, more frequently in elderly patients,
motor coordination disturbances, tremors,
confusion, hallucinations,
less frequently, stimulant-type symptoms: restlessness, nervousness, insomnia.

Hypersensitivity reactions (rare):
flushing, 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).

Haematological system effects:
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 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 effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store FERVEX JUNIOR

Store below 25°C.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What FERVEX JUNIOR contains
The active substances are: paracetamol 280 mg, ascorbic acid 100 mg and pheniramine maleate 10 mg.
The other ingredients are: mannitol, citric acid, povidone, magnesium citrate, potassium acesulfame,
raspberry flavour.
Raspberry flavour composition: maltodextrin, potassium sorbate (E 202), sodium benzoate (E 211),
propylene glycol (E 1520), ethanol, potassium, sodium octenyl succinate starch (E 1450), Allura Red AC
(E 129), brilliant blue (E 133), sunset yellow FCF (E 110), sodium chloride and (or) sodium sulphate, ethyl
acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxybenzylacetone.

What FERVEX JUNIOR looks like and contents of the pack
Paper/aluminium/polyethylene sachets containing granules for oral solution in a cardboard box.
Cardboard box containing 8 or 12 sachets.
For more detailed information, please contact the responsible party or parallel importer.

Responsible party in Lithuania, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorisation number in Lithuania, country of export: LT/1/97/3290/003
Parallel import authorisation number: 46/23