Fervex junior

Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
FERVEX JUNIOR (FERVEX children sugar free)
280 mg + 100 mg + 10 mg
effervescent granules for oral solution
Paracetamol + Acidum ascorbicum + Pheniramine maleate
FERVEX JUNIOR and FERVEX children sugar free are different trade names for the same
medicinal product.
Please read this leaflet carefully before taking this medicine, as 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, as you may need to read it again.
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 your condition worsens, consult your doctor.

Table of contents of the leaflet:
What FERVEX JUNIOR is and what it is used for
What you need to know 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 mucous membranes, thus improving nasal
airway patency, and suppresses sneezing reflex and eye tearing. Ascorbic acid replenishes vitamin C
deficiency in the body. This medicine does not contain sugar.
Therapeutic indications
FERVEX JUNIOR is indicated in children over 6 years of age for the short-term symptomatic treatment
of influenza, colds, and flu-like conditions (headache, fever, inflammation of nasal and pharyngeal
mucosa).
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.

2. 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 impairment,
if the patient has narrow-angle glaucoma,
if the patient has benign prostatic hyperplasia with urinary retention,
in children under 6 years of age.

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

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

FERVEX JUNIOR and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Due to the presence of pheniramine
Not recommended combinations
Alcohol intensifies the sedative effect of most antihistamines. Changes in attention and concentration may impair the ability to drive or operate machinery. Avoid consuming alcoholic beverages or 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 H₁-receptor blocking antihistamines, centrally acting antihypertensives, baclofen, and thalidomide.
Increased central nervous system depression and associated impairment of attention may affect the ability to drive or operate machinery.

Other medicines with anticholinergic (atropine-like) effects: tricyclic antidepressants structurally similar to imipramine,
most H₁-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
Acetanilide 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.
Concurrent 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 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 decrease plasma levels of fluphenazine. It also reduces urine pH, which may affect the excretion of other concurrently administered drugs.

Use of FERVEX JUNIOR with alcohol
Consumption of alcoholic beverages or use of 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 or 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, suspects she may 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 the psycho-physical performance of persons 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 per 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) per sachet. The amount of alcohol in one sachet of this medicine is equivalent to a small amount of beer or wine (trace amounts). The small amount of alcohol in this medicine 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 used 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 a 4-hour interval 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 a total of 3 g/day, 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 renal impairment
Caution is advised when administering this medicine to patients with impaired kidney function. In cases of severe renal failure (creatinine clearance below 10 ml/min), the interval between doses should be at least 8 hours.

Method of administration
For oral use. Dissolve the contents of one sachet in a sufficient amount of cold or warm water.

Duration of treatment
Do not use for longer than 3 days without consulting a doctor.

Use of more than the recommended dose of FERVEX JUNIOR
If an overdose is taken, seek immediate advice from a doctor or pharmacist.
Symptoms of pheniramine overdose: convulsions (especially in children), disturbances of consciousness, coma.
Symptoms of paracetamol overdose: paracetamol poisoning is particularly risky in elderly individuals and young children (most commonly due to ingestion of higher-than-recommended doses or accidental poisoning); such poisonings may lead to death. Overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness, followed the next day by upper abdominal discomfort, recurrence of nausea, and jaundice.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody 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
disorders, pupil dilation, palpitations, risk of urinary retention,
orthostatic hypotension,
balance disorders, dizziness, memory or concentration disturbances, more frequently in elderly
patients,
motor coordination disorders, tremors,
confusion, hallucinations,
less frequently, stimulant-type symptoms: restlessness, nervousness, insomnia.

Hypersensitivity reactions (rare):
erythema, itching, rash, purpura, urticaria,
swelling, less frequently Quincke's edema (swelling of lips, tongue or larynx),
anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).

Effects on the haematopoietic system:
leukopenia (reduced number of white blood cells), neutropenia (reduced number of granulocytes),
thrombocytopenia (reduced number of platelets),
hemolytic anaemia.

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 number of platelets), leukopenia and neutropenia have been observed.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store FERVEX JUNIOR

Store below 25°C.
Keep the medicine in a place 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 household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 components are: mannitol, citric acid, povidone, magnesium citrate, acesulfame potassium,
and raspberry flavour.
Composition of raspberry flavour: 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-hydroxybenzyl acetone.

What FERVEX JUNIOR looks like and contents of the pack
Paper/Al/PE sachets containing granules for preparing an oral solution, packed in a cardboard box.
The cardboard box contains 8 or 12 sachets.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Bulgaria, 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, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Bulgaria, country of export: 20011146
Parallel Import Licence Number: 221/24