Fervex junior
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet. The outer packaging contains information in a foreign language!
Fervex Junior (Fervex vaikams)
280 mg + 100 mg + 10 mg, effervescent granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Fervex Junior and Fervex vaikams are different brand names for the same medicine.
Please read this 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 your doctor, pharmacist, or nurse.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please contact 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 your 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 mucous membranes, thereby clearing nasal passages, suppressing sneezing reflex, and reducing eye tearing. Ascorbic acid replenishes vitamin C deficiency in the body. The medicine does not contain sugar.
Therapeutic indications
Fervex Junior is indicated for symptomatic relief in children over 6 years of age with flu, colds, and flu-like conditions (headache, fever, inflammation of nasal and throat mucous membranes).
If there is no improvement after 3 days or if symptoms worsen, consult your 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 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 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.
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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Due to the presence of pheniramine
Unrecommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Impaired attention may affect 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 impairment of attention 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 agents, antispasmodics with atropine-like activity, disopyramide, phenothiazine derivative neuroleptics, clozapine.
Additive 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 (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 concomitantly 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.
Particular risk of liver damage exists in patients who are fasting and in regular alcohol consumers.
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 with this medicine, 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, he or she should consult a doctor before taking this medicine.
Fervex Junior contains 0.28 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) in each 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 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.
Maintain intervals of 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 renal function impairment
Exercise caution when administering the medicine to patients with impaired renal function. In cases of severe renal failure (creatinine clearance below 10 ml/min), intervals between doses should be at least 8 hours.
Method of administration
For oral use. Dissolve the contents of the 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 a higher than recommended dose of Fervex Junior
If a higher than recommended dose has been taken, 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, followed the next day by 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 regarding use of the medicine, consult a doctor or pharmacist.
Discontinuation of Fervex Junior
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 everyone will experience them.
Related to pheniramine
Adverse effects of varying intensity, 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,
balance disorders, dizziness, memory or concentration disturbances, more frequently in elderly individuals,
motor coordination disorders, tremors,
confusion, hallucinations,
less frequently, stimulation-type symptoms: physical restlessness, nervousness, insomnia.
Hypersensitivity reactions (rare):
flushing, 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 hematopoietic system:
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 of 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects allows the collection of further information on the safety of using the medicine.
5. How to store Fervex Junior
Keep this medicine out of sight and reach of children.
Do not store above 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 stated 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 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, sodium citrate, potassium acesulfame,
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-hydroxybenzylacetone.
What Fervex Junior looks like and contents of the pack
Paper/Aluminium/Polyethylene sachets 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 further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation 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
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in Lithuania, the country of export: LT/1/97/3290/003
Parallel Import Authorisation number: 317/24