Fervex junior
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Fervex Junior (Fervex vaikams)
280 mg + 100 mg + 10 mg
effervescent granules for oral solution
Paracetamol + Acidum ascorbicum + Phenirami maleas
Fervex Junior and Fervex vaikams are different trade names for the same medicinal product.
Please read carefully all the information in this leaflet before taking this 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, 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 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 mucosal congestion and swelling, thereby clearing nasal passages,
inhibiting the 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 the symptomatic treatment of flu, colds, and flu-like conditions (headache, fever, inflammation of the nasal and pharyngeal 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 accompanying urinary retention,
- in children under 6 years of age.
Warnings and precautions
Before taking Fervex Junior, consult your 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, may occur especially when higher than recommended doses 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
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 – H receptor antagonists. Changes in attention may impair the ability to drive or 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 in attention may affect the ability to drive or operate machinery.
Other medicines with anticholinergic (atropine-like) effects: tricyclic 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 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 microsomal enzyme-inducing drugs taken 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 non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Paracetamol taken with MAO inhibitors may cause excitation and high fever.
Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid levels by the phosphotungstic acid method, as well as with 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 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
Consuming 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 or 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 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 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, 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) per sachet. The amount of alcohol in one sachet is equivalent to a small amount of beer or wine (trace amounts). This small amount of alcohol in the 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 your 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 weighing 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 weighing over 50 kg: maximum daily dose of paracetamol is 4 g/day.
Patients with impaired renal function
Exercise caution when administering this medicine to patients with impaired kidney function. In cases of severe renal impairment (creatinine clearance below 10 ml/min), the interval between doses should be at least 8 hours.
Method of administration
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.
Overdose of Fervex Junior
If you take more than the recommended dose, seek immediate medical advice from a doctor or pharmacist.
Symptoms of pheniramine overdose: seizures (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 taking higher-than-recommended doses or accidental ingestion); such poisonings may lead to death.
Overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. The following day, upper abdominal discomfort, return 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 how to use the medicine, consult your 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 reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Related to pheniramine
Adverse effects of varying severity, both dose-dependent and independent, may occur:
Neurovegetative effects:
- Sedation or drowsiness, 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 disturbances, dizziness, memory or concentration disorders, more frequent in elderly patients,
- Motor coordination disturbances, tremors,
- Confusion, hallucinations,
- Less frequently, symptoms of excitation: motor 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 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 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 reactions helps to collect more 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 should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer 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 (E 421), citric acid, povidone, magnesium citrate, acesulfame potassium, 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
Paper/aluminium/polyethylene sachets containing granules for 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 parallel importer.
Marketing Authorisation Holder in Lithuania, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/97/3290/003
Parallel Import Authorisation Number: 91/23