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 children sugar free)
280 mg + 100 mg + 10 mg, effervescent granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
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 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, consult your pharmacist.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 3 days or if the patient feels worse, contact 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 congestion and swelling of mucous membranes, thereby clearing nasal
passages, suppressing the sneezing reflex and eye tearing. Ascorbic acid replenishes vitamin C
deficiencies in the body. The medicine does not contain sugar.
Indications
Fervex Junior is indicated for use in children over 6 years of age for the short-term treatment of
symptoms of influenza, colds, and influenza-like conditions (headache, fever, inflammation of the
nasal and pharyngeal mucosa).
If there is no improvement after 3 days or if the patient feels worse, 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 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 particularly observed 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, immediately inform a doctor if the patient develops 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, patients have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids) when paracetamol was taken in regular doses over a prolonged period or when paracetamol was taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, vomiting.
Children and adolescents
This 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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Due to the presence of pheniramine
Not recommended combinations
Alcohol enhances the sedative effect of most antihistamines – H₁ 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 H₁ receptor-blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide.
Increased central nervous system depression and associated impairment in concentration may affect the ability to drive or operate machinery.
Other medicines with anticholinergic (atropine-like) effects: tricyclic antidepressants similar to imipramine, most H₁ 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 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 agitation and high fever.
Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid levels by the phosphotungstic acid method and with glucose determination 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 may also reduce 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) enhances 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 impair psycho-physical performance in individuals driving vehicles or operating machinery.
Warnings regarding excipients with known effects
If the patient has previously been diagnosed with intolerance to certain sugars, 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 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 taken exactly as described in this patient leaflet, or as directed by your 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 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
Exercise caution when administering this medicine to patients with impaired renal function. In cases of severe renal insufficiency (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.
Overdose of Fervex Junior
In case of overdose, 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 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 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 the use of this medicine, consult your doctor or pharmacist.
Stopping treatment with 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 not everyone will experience them.
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 disturbances, pupil dilation, palpitations, risk of urinary retention,
- Orthostatic hypotension,
- Loss of balance, dizziness, memory or concentration disturbances, more frequent 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 oedema (swelling of lips, tongue or larynx),
- Anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).
Blood system disorders:
- 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 oedema, 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 platelet count), leukopenia and neutropenia have been observed.
Frequency unknown (frequency cannot be estimated based on available data): a serious condition which may lead to blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).
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 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 reactions helps to provide more information on the safety of the medicine.
5. How to store Fervex Junior
Keep this medicine out of 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 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: 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 the 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/Al/PE 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 entity or the parallel importer.
Marketing Authorisation Holder in Bulgaria, 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:
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 Bulgaria, the country of export: 20011146
Parallel Import Authorisation Number: 83/26