Fervex junior

Package leaflet: information for the patient

Warning! Keep the leaflet, information on the immediate packaging 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 the leaflet carefully before using 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, so that you can read it again if necessary.
• 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 a doctor.

Table of contents:

1. What Fervex Junior is and what it is 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 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, suppressing sneezing reflex and eye tearing. Ascorbic acid replenishes vitamin C
deficiency in the body. The medicine does not contain sugar.
Indications
Fervex Junior is indicated for symptomatic relief in children over 6 years of age with influenza,
common cold, and influenza-like conditions (headache, fever, inflammation of nasal and throat
mucosa).
If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought.

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 being 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.
During treatment with Fervex Junior, inform the doctor immediately if the patient suffers from serious conditions, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In such cases, severe metabolic acidosis (a disturbance in blood and body fluid balance) has been reported in patients taking paracetamol regularly over a long period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents
The 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, recently used, or planned for use.

Due to the presence of pheniramine
Unrecommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Changes in attention and concentration ability may impair the ability to drive vehicles and 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, doxepin, mianserin, mirtazapine, trimipramine), sedative H receptor-blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide.
Increased central nervous system depression and associated changes in attention and concentration may impair the ability to drive vehicles and operate machinery.

Other medicines with anticholinergic (atropine-like) effects: antidepressants structurally similar to imipramine, most H receptor-blocking antihistamines, anticholinergic antiparkinsonian drugs, antispasmodic drugs with atropine-like action, 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 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 may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).
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 decrease 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 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 baby, 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 psychomotor performance of individuals driving vehicles or operating machinery.

Warnings regarding excipients with known effects
If the patient has previously been diagnosed with intolerance to certain sugars, they 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).
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 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 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.
At least a 4-hour interval should be maintained 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 function impairment
Caution is advised when administering the medicine to patients with impaired renal 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
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 than the recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist.
Symptoms of pheniramine overdose: convulsions (particularly in children), disturbances of consciousness, coma.
Symptoms of paracetamol overdose: particular risk of paracetamol poisoning occurs in elderly individuals and young children (most commonly due to ingestion of doses exceeding recommendations or accidental poisoning); such poisonings may lead to death.
Overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness; the following day, abdominal distension, 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 regarding use of the medicine, consult a doctor or pharmacist.

Stopping Fervex Junior
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can 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 effects such as: dryness of mucous membranes, constipation, accommodation disturbances, pupil dilation, palpitations, risk of urinary retention,
orthostatic hypotension,
impaired coordination, dizziness, memory or concentration disturbances,
more frequent in elderly patients,
motor coordination disturbances, 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 blood-forming system:
leukopenia (reduced number of white blood cells), neutropenia (reduced number of granulocytes),
thrombocytopenia (reduced number of blood platelets),
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 must be discontinued immediately.
Exceptionally rare cases of thrombocytopenia (reduced number of blood platelets), leukopenia and neutropenia have been observed.
Frequency unknown (frequency cannot be estimated from available data): a serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any 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 at 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

Keep the medicine out of the sight and reach of children.
Store below 25 °C.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fervex Junior contains
The active substances are: 280 mg of paracetamol, 100 mg of ascorbic acid, and 10 mg of pheniramine maleate.
The other ingredients are: mannitol, citric acid, povidone, magnesium citrate, potassium acesulfame, 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 of 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
Pouches made of paper/aluminium/polyethylene, containing granules for oral solution, packed in a cardboard box.
Cardboard box containing 8 sachets of 3 g or 12 sachets of 3 g.
For more detailed information, please contact the Marketing Authorisation Holder 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
304, Avenue du Docteur Jean Bru
47000 Agen
France
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20011146
Parallel Import Licence Number: 406/25