Fervex Iunior

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 medicine.

You should carefully read the contents of the leaflet before taking 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 advised by a doctor, pharmacist, or nurse.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their 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 packaging and other information

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

Fervex Junior is a combination medicine. Paracetamol acts as a pain reliever and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, inhibiting the sneezing reflex, and reducing eye tearing. Ascorbic acid supplements vitamin C deficiencies in the body. The medicine does not contain sugar.

Indications for use

Fervex Junior is indicated for use in children over 6 years old for the temporary treatment of flu, cold, and flu-like symptoms (headache, fever, nasal and throat inflammation).
If there is no improvement after 3 days or if the patient feels worse, they should consult a doctor.

2. Important information before taking Fervex Junior

When not to take 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 prostatic hyperplasia with urinary retention,
• in children under 6 years old.

Warnings and precautions

Before starting to take Fervex Junior, you should discuss it with your doctor, pharmacist, or nurse.
The medicine contains paracetamol. To avoid the risk of overdose, you should check if other medicines you are taking contain paracetamol.
The risk of dependence, mainly psychological, is observed especially when taking higher doses than recommended 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 medicine can be used temporarily in children over 6 years old and adolescents in specific age groups (see section 3).

Fervex Junior and other medicines

You should 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

Contraindicated combinations
Alcohol enhances the sedative effect of most antihistamine drugs - H receptor antagonists. Changes in attention may impair the ability to drive vehicles and operate machinery. You should avoid consuming alcoholic beverages or medicines containing alcohol.
Combinations that should be used with caution
Other sedative medicines: 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, mirtazapina, trimipramine), antihistamines blocking the H receptor with a sedative effect, antihypertensive drugs with a central action, 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 medicines with an atropine-like effect: antidepressants with a structure similar to imipramine, most antihistamines blocking the H receptor, anticholinergic anti-Parkinson's drugs, atropine-like medicines with an antispasmodic effect, dizopiramid, neuroleptics from the phenothiazine 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 drugs, 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 drugs may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulant drugs 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 blood uric acid levels 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 concomitantly used medicines.

Using Fervex Junior with alcohol

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

Pregnancy, breastfeeding, and fertility

This medicine 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, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is not recommended to take the medicine during pregnancy.
Breastfeeding
It is not recommended to take the medicine during breastfeeding.

Driving and using machines

While taking the medicine, drowsiness may occur, affecting the physical and mental abilities of people driving vehicles and operating machinery.
Warnings about excipients with known effects
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
Fervex Junior contains 0.3 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 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 a sachet of this medicine is equivalent to a small amount of beer or wine (trace amounts). A small amount of alcohol in this medicine will not have noticeable effects.
Fervex Junior contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Fervex Junior

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist or nurse. If you have any doubts, you should consult your 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.
There should be at least a 4-hour interval between consecutive doses.
Do not take a higher dose than recommended.
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, given 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 medicine to patients with renal impairment.
In cases of severe renal failure (creatinine clearance below 10 ml/min), the interval between consecutive 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
The medicine should not be taken for more than 3 days without consulting a doctor.

Taking a higher dose of Fervex Junior than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.
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 higher doses than recommended and accidental poisoning), which can lead to death.
Overdose of the medicine may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, and the next day, abdominal distension, return of nausea, and jaundice.

Missing a dose of Fervex Junior

You should not take a double dose to make up for a missed dose. If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.

Stopping treatment with Fervex Junior

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Related to pheniramine

Side effects of varying severity may occur, depending on and independent of the dose:
Neurovegetative effects:

• sedation or drowsiness, more pronounced in the initial treatment period,
• anticholinergic symptoms such as: dryness of mucous membranes, constipation, accommodation disorders, pupil dilation, palpitations, risk of urinary retention,
• orthostatic hypotension,
• balance disorders, dizziness, memory or concentration disorders, more frequently in the elderly,
• coordination disorders, tremors,
• confusion, hallucinations,
• rarely, symptoms of excitement: restlessness, nervousness, insomnia.

Allergic reactions (rare):

• flushing, itching, rash, erythema, urticaria,
• edema, rarely Quincke's edema (edema of the lips, tongue, or larynx),
• anaphylactic shock (a type of systemic allergic reaction with circulatory and respiratory disorders).

Blood system disorders:

• leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
• thrombocytopenia (reduced platelet count),
• hemolytic anemia.

Related to paracetamol

There have been rare reports of allergic reactions such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, you should immediately stop taking this medicine and medicines with a similar composition.
Very rare cases of thrombocytopenia (reduced platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Fervex Junior

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Fervex Junior contains

The active substances of the medicine 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, maline flavor.
The composition of the maline flavor: 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), 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 packaging contains

Paper/aluminum/polyethylene sachets containing granules for oral solution, in a cardboard box.
A cardboard box containing 8 or 12 sachets.
For more detailed information, you should 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
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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian marketing authorization number, in the country of export:LT/1/97/3290/003
Parallel import authorization number:91/23
Date of leaflet approval:22.05.2023
[Information about the trademark]