Fervex Iunior

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Fervex Junior(Fervex for Children)

280 mg + 100 mg + 10 mg, Granules for Oral Solution

Paracetamol + Ascorbic Acid + Pheniramine Maleate
Fervex Junior and Fervex for Children are different trade names for the same drug.

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This medication 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 you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or you feel worse after 3 days, consult a doctor.

Table of Contents of the Leaflet:

• 1. What is Fervex Junior and what is it used for
• 2. Important information before taking Fervex Junior
• 3. How to take Fervex Junior
• 4. Possible side effects
• 5. How to store Fervex Junior
• 6. Contents of the pack and other information

1. What is Fervex Junior and what is it used for

Fervex Junior is a combination medication. Paracetamol acts as an analgesic and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby relieving nasal congestion, inhibiting sneezing and tearing of the eyes. Ascorbic acid supplements vitamin C deficiency in the body. The medication does not contain sugar.
Indications for use
Fervex Junior is indicated for use in children over 6 years old for the temporary relief of symptoms of flu, colds, and flu-like conditions (headache, fever, inflammation of the nasal and throat mucosa).
If there is no improvement or you feel worse after 3 days, consult a doctor.

2. Important information before taking Fervex Junior

When not to take Fervex Junior

if you are allergic to paracetamol, ascorbic acid, pheniramine maleate, or any of the other ingredients of this medication (listed in section 6),
if you have severe liver or kidney failure,
if you have narrow-angle glaucoma,
if you have prostate enlargement with urinary retention,
in children under 6 years old.

Warnings and precautions

Before starting Fervex Junior, discuss it with your doctor, pharmacist, or nurse.
The medication contains paracetamol. To avoid the risk of overdose, check if other medications you are taking contain paracetamol.
The risk of dependence, mainly psychological, is observed especially when using higher than recommended doses and during prolonged treatment.
Paracetamol should be used with caution in patients with a deficiency of glucose-6-phosphate dehydrogenase (G6PD).

Children and adolescents

The medication can be used temporarily in children over 6 years old and adolescents in specific age groups (see section 3).

Fervex Junior and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications 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 medications containing alcohol.
Combinations to be used with caution
Other sedative medications: morphine derivatives (pain relievers, 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, central-acting antihypertensive medications, 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 medications with an atropine-like effect: antidepressants with a structure similar to imipramine, most antihistamines blocking the H receptor, anticholinergic anti-Parkinson's medications, atropine-like medications with an antispasmodic effect, dizopiramide, neuroleptics from the phenothiazine derivative group, clozapine. Summation of atropine-like side effects such as: urinary retention, constipation, and dry mouth.

Due to the presence of paracetamol

Salicylamide prolongs the elimination time of paracetamol.
Rifampicin, antiepileptic medications, barbiturate sleeping pills, and other microsomal enzyme inducers used in combination 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 medications may increase the risk of renal function disorders.
Paracetamol enhances the effect of oral anticoagulant medications 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 levels in blood by the phosphotungstic method, as well as 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 the concentration of flufenazine in plasma, as well as reduce the pH of urine, which may affect the excretion of other medications used concomitantly.

Using Fervex Junior with alcohol

Consuming alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so it is recommended to avoid taking them concomitantly.
There is a special risk of liver damage in patients who are fasting and regularly consume alcohol.

Pregnancy, breastfeeding, and fertility

This medication is intended for children and adolescents (see section 3).
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Pregnancy
It is not recommended to use the medication during pregnancy.
Breastfeeding
It is not recommended to use the medication during breastfeeding.

Driving and operating machinery

Drowsiness may occur during medication use, affecting the psychophysical fitness of individuals driving vehicles and operating machinery.
Warnings regarding excipients with known effects
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medication.
Fervex Junior contains 0.28 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 medication 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 medication is equivalent to a small amount of beer or wine (trace amounts). A small amount of alcohol in this medication will not have noticeable effects.
Fervex Junior contains less than 1 mmol (23 mg) of sodium per sachet, which means the medication is considered "sodium-free".

3. How to take Fervex Junior

This medication 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 old: 1 sachet 2 times a day.
Children from 10 to 12 years old: 1 sachet 3 times a day.
Adolescents from 12 to 15 years old: 1 sachet 4 times a day.
Maintain at least 4-hour intervals between doses. Do not exceed the recommended dose.
Maximum recommended doses of paracetamol:
Children and adolescents with a body weight up to 50 kg: the maximum daily dose of paracetamol is 60 mg/kg body weight/day, not exceeding 3 g/day, administered 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 medication to patients with renal impairment.
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
Oral administration. 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.

Overdose of Fervex Junior

In case of overdose, consult a doctor or pharmacist immediately.
Symptoms of pheniramine overdose: seizures (especially in children), impaired consciousness, coma.
Symptoms of paracetamol overdose: there is a particular risk of paracetamol poisoning in the elderly and small children (the most common causes are taking doses higher than recommended and accidental poisoning), which can lead to death.
Overdose of the medication may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, and the next day, abdominal pain, 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 doubt regarding the use of the medication, consult a doctor or pharmacist.

Stopping Fervex Junior

In case of further doubts regarding the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Fervex Junior can cause side effects, although not everybody gets them.

Related to pheniramine

Side effects of varying severity may occur, both dose-dependent and dose-independent:
Neurovegetative effects:
sedation or drowsiness, more pronounced in the initial treatment period,
anticholinergic effects 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, urticaria, angioedema,
less frequently, Quincke's edema (swelling of the lips, tongue, or larynx),
anaphylactic shock (a type of systemic allergic reaction with immediate onset, with circulatory and respiratory disorders).
Effects on the hematopoietic system:
leukopenia (decreased white blood cell count), neutropenia (decreased granulocyte count),
thrombocytopenia (decreased platelet count),
hemolytic anemia.

Related to paracetamol

There have been reports of rare cases of allergic reactions such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, discontinue the medication and medications with a similar composition immediately.
Very rare cases of thrombocytopenia (decreased platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Fervex Junior

Store the medication out of sight and reach of children.
Do not store above 25°C.
Do not use the medication after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fervex Junior contains

The active substances of the medication 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 the 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 sachets of 3 g or 12 sachets of 3 g.
For more detailed information, contact 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Lithuanian marketing authorization number, in the country of export: LT/1/97/3290/003
Parallel import authorization number: 317/24

Date of leaflet approval: 02.08.2024

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