Fervex Iunior

Package Leaflet: Information for the Patient

Fervex Junior, 280 mg + 100 mg + 10 mg,

Granules for Oral Solution
Paracetamol + Ascorbic Acid + Pheniramine Maleate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in this Patient Information Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.

• Keep this Leaflet to be Able to Read it Again if Necessary.
• If Advice or Additional Information is Needed, Consult a Pharmacist.
• If the Patient Experiences any Adverse Reactions, Including those not Listed in this Leaflet, Inform a Doctor, Pharmacist, or Nurse. See Section 4.
• If there is no Improvement or the Patient Feels Worse after 3 Days, Consult a Doctor.

Table of Contents of the Leaflet:

• 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 Adverse Reactions
• 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 Medication. Paracetamol Acts as an Analgesic and Antipyretic.
Pheniramine Maleate Reduces Congestion and Swelling of Mucous Membranes, thus Facilitating Nasal Breathing, Inhibiting Sneezing and Tear Production. Ascorbic Acid Supplements Vitamin C Deficiency in the Body. The Medication does not Contain Sugar.
Indications for Use
Fervex Junior is Indicated for Use in Children Over 6 Years of Age for the Symptomatic Treatment of Flu, Cold, and Flu-like Conditions (Headache, Fever, Inflammation of the Nasal and Pharyngeal Mucosa).
If there is no Improvement or the Patient Feels Worse after 3 Days, 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 Other Component of this Medication (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 Hypertrophy with Urinary Retention,
In Children Under 6 Years of Age.

Warnings and Precautions

Before Starting Fervex Junior, Discuss it with a Doctor, Pharmacist, or Nurse.
The Medication Contains Paracetamol. To Avoid the Risk of Overdose, Check if Other Medications being Taken Contain Paracetamol.
The Risk of Dependence, Mainly Psychological, is Observed Especially with Higher-than-recommended Doses and with Long-term Treatment.
Paracetamol Should be Used with Caution in Patients with Glucose-6-phosphate Dehydrogenase Deficiency (G6PD).
During Fervex Junior Treatment, Immediately Inform a Doctor if the Patient has Severe Diseases, Including Severe Kidney Dysfunction or Sepsis (When Bacteria and their Toxins are Present in the Blood, Leading to Organ Damage) or Malnutrition, Chronic Alcoholism, or if the Patient is also Taking Flucloxacillin (an Antibiotic). In these Situations, Patients have Developed a Severe Condition Called Metabolic Acidosis (a Blood and Body Fluid Disorder), which Requires Immediate Treatment, when they Took Paracetamol in Regular Doses for a Longer Period or when they Took Paracetamol with Flucloxacillin. Symptoms of Metabolic Acidosis may Include: Severe Breathing Difficulties, Including Rapid Deep Breathing, Drowsiness, Nausea, and Vomiting.

Children and Adolescents

The Medication can be Used in Children Over 6 Years of Age and Adolescents in Specific Age Groups (See Section 3).

Fervex Junior and Other Medications

Inform a Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take.

Due to the Presence of Pheniramine

Contraindicated Combinations
Alcohol Enhances the Sedative Effect of Most Antihistamines - H1 Receptor Antagonists. Changes in Attention may Impair the Ability to Drive Vehicles and Operate Machinery. Avoid Consuming Alcoholic Beverages or Medications Containing Alcohol.
Combinations to be Used with Caution
Other Sedative Medications: Opioid Derivatives (Pain Relievers, Antitussives), Neuroleptics, Barbiturates, Benzodiazepines, Anxiolytics other than Benzodiazepines (e.g., Meprobamate), Sleep Aids, Antidepressants with a Sedative Effect (Amitriptyline, Doxepin, Mianserin, Mirtazapine, Trimipramine), Antihistamines that Block the H1 Receptor with a Sedative Effect, Central-acting Antihypertensives, 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 Medications with an Anticholinergic Effect: Antidepressants with a Structure Similar to Imipramine, Most Antihistamines that Block the H1 Receptor, Anticholinergic Anti-parkinsonian Medications, Anticholinergic-like Medications with an Antispasmodic Effect, Disopyramide, Neuroleptics from the Phenothiazine Group, Clozapine. Summation of Anticholinergic-like Adverse Effects such as: Urinary Retention, Constipation, and Dryness of the Mouth.

Due to the Presence of Paracetamol

Salicylamide Prolongs the Elimination of Paracetamol.
Rifampicin, Antiepileptic Medications, Barbiturate Sleep Aids, 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 Non-steroidal Anti-inflammatory Medications may Increase the Risk of Kidney Function Disorders.
Paracetamol Enhances the Effect of Oral Anticoagulants from the Coumarin Group.
Inform a Doctor or Pharmacist if the Patient is Taking Flucloxacillin (an Antibiotic) due to the Risk of Blood and Body Fluid Disorders (Called Metabolic Acidosis), which Require Immediate Treatment (See Section 2).
Paracetamol Used with MAO Inhibitors may Cause Excitement and High Fever.
Effect on Laboratory Test Results
Paracetamol may Affect the Determination of Uric Acid Levels in the Blood using the Phosphotungstic Method, as well as the Determination of Glucose Levels using the Oxidase-peroxidase Method.

Due to the Presence of Ascorbic Acid

Ascorbic Acid may Reduce the Effectiveness of Warfarin and the Plasma Concentration of Flufenazine, as well as Reduce the pH of Urine, which may Affect the Excretion of other Concurrently Used Medications.

Using Fervex Junior with Alcohol

Consuming Alcoholic Beverages or Taking Sedatives (Especially Barbiturates) Enhances the Sedative Effect of Antihistamines, so it is Recommended to Avoid their Concurrent Use.
A Special Risk of Liver Damage Exists in Patients who are Fasting and Regularly Consume Alcohol.

Pregnancy, Breastfeeding, and Fertility

This Medication is Intended for Children and Adolescents (See Section 3).
If the Patient is Pregnant or Breastfeeding, or Thinks they may be Pregnant or Plans to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
Pregnancy
It is not Recommended to Use the Medication During Pregnancy.
Breastfeeding
It is not Recommended to Use the Medication During Breastfeeding.

Driving and Operating Machinery

Drowsiness may Occur During Treatment, Affecting the Patient's Physical and Mental Ability to Drive Vehicles and Operate 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 the Medication.
Fervex Junior Contains 0.3 mg of Benzyl Alcohol in each Sachet. Benzyl Alcohol may Cause Allergic Reactions.
Fervex Junior Contains Orange Yellow FCF (E110) and Allura Red AC (E129).
The Medication may Cause Allergic Reactions.
Fervex Junior Contains 0.0036 mg of Sodium Benzoate (E211) in each Sachet.
Fervex Junior Contains Trace Amounts (0.0036 mg) of Ethanol in each Sachet. The Amount of Ethanol in this Medication is Equivalent to a Small Amount of Beer or Wine (Trace Amounts). A Small Amount of Ethanol in this Medication will not have Noticeable Effects.
Fervex Junior Contains Less than 1 mmol (23 mg) of Sodium per Sachet, which Means the Medication is Considered "Sodium-free".

3. How to Take Fervex Junior

This Medication Should Always be Taken Exactly as Described in this Patient Information Leaflet or as Advised by a Doctor or Pharmacist or Nurse. In Case of Doubt, Consult a Doctor or Pharmacist or Nurse.
Children and Adolescents
Children from 6 to 10 Years of Age: 1 Sachet 2 Times a Day.
Children from 10 to 12 Years of Age: 1 Sachet 3 Times a Day.
Adolescents from 12 to 15 Years of Age: 1 Sachet 4 Times a Day.
Maintain at Least 4-hour Intervals Between Doses.
Do not Exceed the Recommended Dose.
Maximum Recommended Paracetamol Doses:
Children and Adolescents with a Body Weight of up to 50 kg: the Maximum Daily Dose of Paracetamol is 60 mg/kg Body Weight/Day, not Exceeding 3 g/Day, Administered 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 Kidney Function Disorders
Caution is Advised when Administering the Medication to Patients with Kidney Function Disorders.
In Case of Severe Kidney Failure (Creatinine Clearance Below 10 ml/min), the Interval Between 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
Do not Use for More than 3 Days Without Consulting a Doctor.

Overdose of Fervex Junior

In Case of Overdose, Immediately Consult a Doctor or Pharmacist.
Symptoms of Pheniramine Overdose: Seizures (Especially in Children), Impaired Consciousness, Coma.
Symptoms of Paracetamol Overdose: a Particular Risk of Paracetamol Poisoning Occurs in the Elderly and in Small Children (the Most Common Causes are Taking Higher-than-recommended Doses and Accidental Poisoning), which can Lead to Death.
Overdose of the Medication may Cause Symptoms such as: Nausea, Vomiting, Excessive Sweating, Drowsiness, and General Weakness, Followed by Abdominal Distension, Return of Nausea, and Jaundice the Next Day.

Missing a Dose of Fervex Junior

Do not Take a Double Dose to Make up for a Missed Dose. In Case of Doubt About Taking the Medication, Consult a Doctor or Pharmacist.

Stopping Fervex Junior Treatment

In Case of Further Doubts About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, this Medication can Cause Adverse Reactions, although not Everybody will Experience them.

Related to Pheniramine

Adverse Reactions 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 Effects such as: Dryness of Mucous Membranes, Constipation, Accommodation Disorders, Pupil Dilation, Palpitations, Risk of Urinary Retention,
Orthostatic Hypotension,
Balance Disorders, Dizziness, Memory or Attention Disorders, More Frequently in the Elderly,
Coordination Disorders, Tremors,
Confusion, Hallucinations,
Rarely, Excitement-type Symptoms: 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).
Effects on the Hematopoietic System:
Leukopenia (Decreased White Blood Cell Count), Neutropenia (Decreased Neutrophil Count),
Thrombocytopenia (Decreased Platelet Count),
Hemolytic Anemia.

Related to Paracetamol

Rare Cases of Allergic Reactions have been Described, such as: Anaphylactic Shock, Quincke's Edema, Flushing, Urticaria, and Skin Rash. If any of these Symptoms Occur, the Medication Should be Discontinued Immediately and Medications with a Similar Composition Should not be Used.
Very Rare Cases of Thrombocytopenia, Leukopenia, and Neutropenia have been Observed.
Frequency "Unknown" (Frequency cannot be Estimated from Available Data): a Serious Condition that can Cause Acidification of the Blood (So-called Metabolic Acidosis), in Patients with Severe Disease Taking Paracetamol (See Section 2).

Reporting Adverse Reactions

If Adverse Reactions Occur, Including those not Listed in this Leaflet, Inform a Doctor, Pharmacist, or Nurse. Adverse Reactions can be Reported Directly to the Department of Pharmacovigilance 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.
Adverse Reactions can also be Reported to the Marketing Authorization Holder.
Reporting Adverse Reactions will Help Gather more Information on the Safety of the Medication.

5. How to Store Fervex Junior

Store the Medication in a Place Invisible and Inaccessible to Children.
Store at a Temperature Below 25°C.
Do not Use this Medication After the Expiration Date Stated on the Carton, after EXP.
The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Fervex Junior Contains

The Active Substances of the Medication are: 280 mg of Paracetamol, 100 mg of Ascorbic Acid, and 10 mg of Pheniramine Maleate.
Other Ingredients are: Mannitol, Anhydrous Citric Acid, Povidone, Anhydrous Magnesium Citrate, Acesulfame Potassium, Raspberry Flavor.
Composition of Raspberry Flavor: Maltodextrin, Potassium Sorbate (E202), Sodium Benzoate (E211), Propylene Glycol (E1520), Ethanol, Potassium, Sodium Salt of Octenyl Succinic Acid Starch (E1450), Allura Red AC (E129), Brilliant Blue (E133), Orange Yellow FCF (E110), 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 Pack Contains

A Sachet Made of Three-layer Foil (Paper/Al/PE) Containing Granules for Oral Solution in a Cardboard Box.
A Cardboard Box Containing 8 or 12 Sachets.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder

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
To Obtain more Detailed Information about this Medication, Contact the Local Representative of the Marketing Authorization Holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
Tel. +48 22 570 27 00
Date of Last Update of the Leaflet:….