Fervex

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Fervex

500 mg + 200 mg + 25 mg, Granules for Oral Solution

Paracetamol + Ascorbic Acid + Pheniramine Maleate

Read the 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 Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.

• Keep this Leaflet, so you can Read it Again if Necessary.
• If you Need Advice or Additional Information, Consult a Pharmacist.
• If the Patient Experiences any Undesirable Effects, including those not Listed in this Leaflet, Inform a Doctor, Pharmacist, or Nurse. See Section 4.
• If there is no Improvement after 5 Days or the Patient Feels Worse, or if the Fever does not Subside after 3 Days, Consult a Doctor.

Table of Contents of the Leaflet

• 1. What is Fervex and what is it Used for
• 2. Important Information Before Taking Fervex
• 3. How to Take Fervex
• 4. Possible Undesirable Effects
• 5. How to Store Fervex
• 6. Contents of the Packaging and Other Information

1. What is Fervex and what is it Used for

Fervex is a Combination Medication.
Paracetamol has Analgesic and Antipyretic Effects.
Pheniramine Maleate Reduces Congestion and Swelling of Mucous Membranes, thus Facilitating Nasal Passage, Inhibiting Sneezing and Tear Production.
Ascorbic Acid Supplements Vitamin C Deficiencies in the Body.

Indications for Use

Fervex is Indicated for Use in Adults and Adolescents over 15 Years of Age for the Symptomatic Treatment of Flu, Cold, and Flu-like Conditions (Headache, Fever, Nasal Congestion and Sore Throat).
In Case of Bacterial Infection, Antibiotic Treatment may be Necessary.
If there is no Improvement after 5 Days or the Patient Feels Worse, Consult a Doctor.

2. Important Information Before Taking Fervex

When not to Take Fervex:

• 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 Prostate Enlargement with Difficulty Urinating,
• In Children and Adolescents under 15 Years of Age,
• Do not Use in Patients with Fructose Intolerance, Glucose-galactose Malabsorption Syndrome, or Sucrase-isomaltase Deficiency, due to the Presence of Sucrose in the Medication.

Warnings and Precautions

Before Starting Fervex, Discuss it with a Doctor, Pharmacist, or Nurse.
If Symptoms Persist for more than 5 Days or Fever Lasts for more than 3 Days, the Patient should Consult a Doctor.
Do not Take for more than 5 Days without a Doctor's Recommendation.
The Risk of Dependence, mainly Psychological, is Observed mainly with Higher-than-recommended Doses and Prolonged Treatment.
The Medication Contains Paracetamol. To Avoid the Risk of Overdose, Check if other Medications being Taken Contain Paracetamol. In Adults with a Body Weight over 50 kg, the TOTAL DAILY DOSE OF PARACETAMOL SHOULD NOT EXCEED 4 GRAMS.
Paracetamol should be Used with Caution in Patients with Glucose-6-phosphate Dehydrogenase Deficiency (G6PD).

Children and Adolescents

The Medication can be Used in Adolescents over 15 Years of Age.

Fervex and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking, have Recently Taken, or Plan to Take.

Due to the Presence of Pheniramine

Contraindicated Combinations
Alcohol Enhances the Sedative Effect of most Antihistamines – H 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 Medications with a Sedative Effect: 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 H Receptor with a Sedative Effect, Centrally Acting Antihypertensives, Baclofen, and Thalidomide.
Increased Central Nervous System Depression 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 H Receptor, Anticholinergic Anti-parkinsonian Medications, Atropine-like Medications with an Antispasmodic Effect, Dyssopiram, Neuroleptics from the Phenothiazine Derivative Group, Clozapine.
Summation of Anticholinergic-like Undesirable Effects such as Urinary Retention, Constipation, and Dry Mouth.

Due to the Presence of Paracetamol

Salicylamide Prolongs the Elimination of Paracetamol.
Rifampicin, Antiepileptic Medications, Barbiturate-based 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 Renal Function Disorders.
Paracetamol Enhances the Effect of Oral Anticoagulants from the Coumarin Group.
Paracetamol Used with MAO Inhibitors may Cause Excitement and High Fever.
Influence on Laboratory Test Results
Paracetamol may Affect the Determination of Uric Acid in Blood using the Phosphotungstic Method, as well as the Determination of Glucose using the Oxidase-peroxidase Method.

Due to the Presence of Ascorbic Acid

Ascorbic Acid may Reduce the Efficacy of Warfarin and the Serum Concentration of Flufenazine, as well as Reduce Urine pH, which may Affect the Excretion of other Concomitantly Used Medications.

Using Fervex with Food and Drink

There are no Contraindications.

Using Fervex with Alcohol

Consuming Alcoholic Beverages or Taking Sedatives (especially Barbiturates) Enhances the Sedative Effect of Antihistamines, so their Concomitant Use should be Avoided.
A Special Risk of Liver Damage Exists in Starved Patients and those who Regularly Consume Alcohol.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, suspects she may be Pregnant, or Plans to have a Child, she 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

During Treatment with the Medication, Drowsiness may Occur, Affecting the Physical and Mental Ability of Individuals Operating Vehicles and Machinery.
Warnings regarding Excipients with Known Effects
Fervex Contains 11.6 g of Sucrose. This should be Taken into Account in Patients with Diabetes.
If the Patient has Previously been Diagnosed with Intolerance to some Sugars, the Patient should Consult a Doctor before Taking the Medication.
Fervex Contains Glucose (as a Component of Maltodextrin); if the Patient has Previously been Diagnosed with Intolerance to some Sugars, the Patient should Consult a Doctor before Taking the Medication.
Fervex Contains Fructose. The Additive Effect of Concomitantly Administered Products Containing Fructose and Food Containing Fructose should be Considered.
Fervex Contains less than 1 mmol (23 mg) of Sodium per Sachet, which means the Medication is Considered "Sodium-free".

3. How to Take Fervex

This Medication should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor, Pharmacist, or Nurse. In Case of Doubt, Consult a Doctor, Pharmacist, or Nurse.
Adults and Adolescents over 15 Years of Age: 1 Sachet 2 or 3 Times a Day (corresponding to 1500 mg of Paracetamol, 75 mg of Pheniramine Maleate, and 600 mg of Vitamin C).
Intervals between Consecutive Doses should be at least 4 Hours.
Elderly Patients
There are no Contraindications.
Patients with Renal and/or Hepatic Impairment
Caution should be Exercised when Administering the Medication to Patients with Renal Impairment.
In Case of Renal Impairment (Creatinine Clearance below 10 ml/min), Intervals between Doses should be at least 8 Hours.

Method of Administration

Oral Administration. The Contents of the Sachet should be Dissolved in a Glass of Hot or Cold Water.
In the Treatment of Flu-like Conditions, it is Recommended to Take the Medication Dissolved in Hot Water, in the Evening, as soon as Symptoms Appear.

Duration of Treatment

Do not Take the Medication for more than 5 Days without Consulting a Doctor. If Symptoms Persist for more than 5 Days or Fever Lasts for more than 3 Days, the Patient should Consult a Doctor.
If the Patient Feels that the Medication's Effect is too Strong or too Weak, they should Consult a Doctor.

Overdose of Fervex

Overdose Symptoms

Related to Pheniramine
Overdose of Pheniramine may Cause: Seizures (especially in Children), Altered Consciousness, Coma.
Related to Paracetamol
A Special Risk of Paracetamol Overdose Exists in the Elderly and Small Children (most Common Causes are Taking Higher-than-recommended Doses and Accidental Poisoning); these Overdoses can be Fatal.
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.
Procedure
In Case of Overdose, Immediately Consult a Doctor or Pharmacist.

Missed Dose of Fervex

Do not Take a Double Dose to Make up for a Missed Dose.

Stopping Fervex Treatment

If you have any Further Doubts about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Fervex can Cause Undesirable Effects, although not Everybody will Experience them.

Related to Pheniramine

Undesirable 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 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, Symptoms of Excitement: Restlessness, Nervousness, Insomnia.

Hypersensitivity Reactions (rare):

• Flush, Itching, Rash, Erythema, Urticaria,
• Edema, Rarely Quincke's Edema (edema of the Lips, Tongue, or Larynx),
• Anaphylactic Shock (a Type of Immediate Allergic Reaction with Circulatory and Respiratory Disorders). Effects on the Hematopoietic System:
• Leukopenia (reduced White Blood Cell Count), Neutropenia (reduced Neutrophil Count),
• Thrombocytopenia (reduced Platelet Count),
• Hemolytic Anemia.

Related to Paracetamol

Rare Cases of Hypersensitivity Reactions have been Described, such as: Anaphylactic Shock, Quincke's Edema, Flush, Urticaria, and Skin Rash. If any of these Symptoms Occur, the Medication and Medications with a Similar Composition should be Discontinued Immediately.
Very Rare Cases of Thrombocytopenia (reduced Platelet Count), Leukopenia, and Neutropenia have been Observed.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including those not Listed in this Leaflet, Inform a Doctor, Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of 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.
Reporting Undesirable Effects will Help Gather more Information on the Safety of the Medication.

5. How to Store Fervex

Store the Medication out of Sight and Reach of Children.
Store in a Temperature below 25°C.
Do not Use the Medication after the Expiration Date Stated on the Packaging. 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 Packaging and Other Information

What Fervex Contains

• The Active Substances of the Medication are: Paracetamol 500 mg, Ascorbic Acid 200 mg, Pheniramine Maleate 25 mg.
• Other Ingredients are: Arabic Gum, Citric Acid, Sodium Saccharin, Sucrose, Natural West Indian Cherry Flavor (Maltodextrin, Arabic Gum, α-Pinene, β-Pinene, Limonene, γ-Terpinene, Linalool, Neral, α-Terpineol, Citral (Geraniol)).

What Fervex Looks like and what the Packaging Contains

Paper/Al/PE Sachet Containing Granules for Oral Solution in a Cardboard Box.
A Cardboard Box Containing 5, 8, or 12 Sachets of 13.1 g each.
For more Detailed Information, Contact the Marketing Authorization Holder or Parallel Importer.

Marketing Authorization Holder in Latvia, Country of Export:

UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison, France

Manufacturer:

UPSA SAS
979 Avenue des Pyrenees
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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorization Number in Latvia, Country of Export:98-0132
Parallel Import Authorization Number:129/20

Date of Leaflet Approval: 13.05.2025

[Information about the Registered Trademark]