Fervex D

Package Leaflet: Information for the Patient

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

Fervex D Fervex Sugar-Free, 500 mg + 200 mg + 25 mg
Granules for Oral Solution
Paracetamol + Ascorbic Acid + Pheniramine Maleate
Fervex D and Fervex Sugar-Free are different trade names for the same drug.

You Should Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.

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

• You Should Keep this Leaflet, so You Can Read it Again if Necessary.
• If You Need Advice or Additional Information, You Should Consult a Pharmacist.
• If the Patient Experiences Any Adverse Reactions, Including Those Not Listed in this Leaflet, They Should Inform Their 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, They Should Consult a Doctor.

Table of Contents of the Leaflet:

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

1. What Fervex D is and What it is Used for

Fervex D 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.
Indications for Use
Fervex D is Indicated for Use in Adults and Adolescents Over 15 Years of Age for the Symptomatic Treatment of Flu, Common Cold, and Flu-Like Conditions (Headache, Fever, Nasal and Throat Inflammation).
It Can be Used by Diabetic Patients.
In Case of Bacterial Infection, Antibiotic Treatment May be Necessary.
If There is No Improvement After 5 Days or the Patient Feels Worse, They Should Consult a Doctor.

2. Important Information Before Taking Fervex D

When Not to Take Fervex D:

• 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 Urinary Retention,
• In Children and Adolescents Under 15 Years of Age,
• In Patients with Phenylketonuria, Due to the Presence of Aspartame.

Warnings and Precautions

Before Starting Fervex D, the Patient Should Consult 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. Without a Doctor's Recommendation, the Medication Should Not be Used for More than 5 Days.
The Risk of Dependence, Mainly Psychological, is Observed Mainly with the Use of Higher than Recommended Doses and with Long-Term Treatment.
The Medication Contains Paracetamol. To Avoid the Risk of Overdose, the Patient Should 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 a Deficiency of Glucose-6-Phosphate Dehydrogenase (G6PD).

Children and Adolescents

The Medication Can be Used in Adolescents Over 15 Years of Age.

Fervex D and Other Medications

The Patient Should Inform Their Doctor or Pharmacist About All Medications Being Taken, as Well as Those Planned to be Taken.

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 Mechanical Equipment.
The Patient Should Avoid Consuming Alcoholic Beverages or Medications Containing Alcohol.
Combinations to be Used with Caution
Other Medications with a Sedative Effect: Opioids (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 Blocking the H Receptor with a Sedative Effect, Antihypertensive Medications with a Central Effect, Baclofen, and Thalidomide.
Increased Inhibition of the Central Nervous System and Associated Changes in Attention May Impair the Ability to Drive Vehicles and Operate Mechanical Equipment in Motion.
Other Medications with an Atropine-Like Effect: Antidepressants with a Structure Similar to Imipramine, Most Antihistamines Blocking the H Receptor, Anticholinergic Anti-Parkinsonian Medications, Atropine-Like Medications with an Antispasmodic Effect, Dyssopiram, Neuroleptics from the Phenothiazine Group, Clozapine.
Summation of Atropine-Like Adverse 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 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.
Effect on Laboratory Test Results
Paracetamol May Affect the Determination of Uric Acid Levels in the Blood by the Phosphotungstic Method, as Well as the Determination of Glucose Levels by the Oxidase-Peroidase Method.

Due to the Presence of Ascorbic Acid

Ascorbic Acid May Reduce the Effectiveness of Warfarin and the Concentration of Flufenazine in the Blood, as Well as Reduce the pH of Urine, Which May Affect the Excretion of Other Medications Used Concomitantly.

Using Fervex D with Food and Drink

There are No Contraindications.

Using Fervex D with Alcohol

Consuming Alcoholic Beverages or Taking Sedatives (Especially Barbiturates) Enhances the Sedative Effect of Antihistamines, Therefore, They Should be Avoided.
A Special Risk of Liver Damage Exists in Patients Who are Fasting and Regularly Consume Alcohol.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant, or Plans to Have a Child, They Should Consult a Doctor or Pharmacist Before Using this Medication.
Pregnancy
The Medication is Not Recommended During Pregnancy.
Breastfeeding
The Medication is Not Recommended During Breastfeeding.

Driving and Operating Machinery

During Treatment with the Medication, Drowsiness May Occur, Affecting the Physical and Mental Ability of Persons Operating Vehicles and Machinery.
Warnings Regarding Excipients with Known Effects
Fervex D Contains 50 mg of Aspartame (E 951) per Sachet.
Aspartame is a Source of Phenylalanine. It May be Harmful to Patients with Phenylketonuria. This is a Rare Genetic Disorder in Which Phenylalanine Accumulates in the Body Due to its Impaired Elimination.
Fervex D Contains 3.5 g of Mannitol (E 421) per Sachet.
Fervex D Contains 3 mg of Alcohol (Ethanol) per Sachet. The Amount of Alcohol in a Sachet of this Medication is Equivalent to a Small Amount of Beer or Wine (Trace Amounts). A Small Amount of Alcohol in this Medication Will Not Have Noticeable Effects.

3. How to Take Fervex D

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, the Patient Should 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 Use. The Contents of the Sachet Should be Dissolved in a Glass of Hot or Cold Water.
Duration of Treatment
Without Consulting a Doctor, the Medication Should Not be Used for More than 5 Days. 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 is Too Strong or Too Weak, They Should Consult a Doctor or Pharmacist.

Overdose of Fervex D

Symptoms of Overdose

Related to Pheniramine
Overdose of Pheniramine May Cause: Seizures (Especially in Children), Impaired Consciousness, Coma.
Related to Paracetamol
A Special Risk of Paracetamol Poisoning Exists in the Elderly and Small Children (Most Common Causes are Taking Higher than Recommended Doses and Accidental Poisoning); These Poisonings 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 Taking a Higher than Recommended Dose of the Medication, the Patient Should Immediately Consult a Doctor or Pharmacist.

Missing a Dose of Fervex D

The Patient Should Not Take a Double Dose to Make Up for a Missed Dose.

Stopping Fervex D Treatment

In Case of Any Further Doubts Regarding the Use of this Medication, the Patient Should Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Fervex D Can Cause Side Effects, Although Not Everybody Gets 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 Symptoms 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 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 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 Should be Discontinued Immediately and Medications with a Similar Composition Should Not be Used.
Very Rare Cases of Thrombocytopenia (Decreased Platelet Count), Leukopenia, and Neutropenia Have Been Observed.

Reporting Side Effects

If Any Adverse Reactions Occur, Including Those Not Listed in this Leaflet, the Patient Should Inform Their Doctor, Pharmacist, or Nurse. Adverse Reactions Can be Reported Directly to the Department of Monitoring of Adverse Reactions 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.
By Reporting Side Effects, More Information on the Safety of the Medication Can be Collected.

5. How to Store Fervex D

The Medication Should be Stored Out of Sight and Reach of Children.
Do Not Store Above 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. The Patient Should 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 D Contains

• The Active Substances of the Medication are: Paracetamol 500 mg, Ascorbic Acid 200 mg, Pheniramine Maleate 25 mg.
• Other Ingredients are: Mannitol (E 421), Citric Acid, Povidone, Magnesium Citrate, Aspartame (E 951), Lemon Flavor. Lemon Flavor: Flavoring Ingredients (Alpha-Pinene, Beta-Pinene, Sabinene, Myrcene, Limonene,Gamma-Terpinene, Para-Cymene, Linalool, Neral, Geranial, Geranyl Acetate, Geraniol),Triacetin (E 1518), Modified Corn Starch (E 1450), Arabic Gum (E 414), Ethanol.

What Fervex D 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 Sachets.
For More Detailed Information, the Patient Should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization 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.
Strumykowa 28/11 Street
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249 Street
04-458 Warsaw
Marketing Authorization Number in Lithuania, Country of Export:LT/1/97/3290/002

Parallel Import Authorization Number: 210/23

Date of Leaflet Approval: 28.09.2023

[Information about the Trademark]