Fervex Adult Raspberry 8 Sachets Cold, rhinitis, rhinophagyngitis, flu

The medicine Fervex Etat flupal for Adult raspberry flavor granules is indicated to relieve colds, rhinitis, nasopharyngitis and flu conditions in adults only.

It is available in a box of 8 sachets. And each tablet contains 500 mg of paracetamol, 200 mg of vitamin C (ascorbic acid) and 25 mg of pheniramine maleate.

The other ingredients are:  Gum arabic, anhydrous citric acid, sodium saccharin, sucrose, raspberry flavor containing sunset yellow S (E110), benzyl alcohol, sodium benzoate (E202), allura red AC (E129), sunset yellow S (E 110) and traces of ethanol, propylene glycol (E1520), sodium in the flavor.

Dosage of Fervex Adulte raspberry flavor

It is recommended that you take one sachet of Fervex to be renewed if necessary after at least 4 hours, without exceeding 3 sachets per day.
Please read the following full disclosure before taking or purchasing this pro
The sachets must be taken in a sufficient quantity of water, cold or hot.

During flu-like conditions , it is preferable to take this medicine in hot water in the evening.

In case of renal insufficiency, the interval between 2 doses will be at least 8 hours.

The maximum duration of treatment is 5 days.

Caution in case of overdose, please consult your doctor quickly.
 

Precautions for use of Fervex Adulte raspberry sachet

Fervex Adulte raspberry flavor granules will be contraindicated in case of a history of allergy to the constituents of the product, in certain forms of glaucoma, in case of difficulty urinating of prostatic or other origin, or in case of serious liver disease due to the presence of paracetamol.

If your doctor has informed you of an intolerance to certain sugars, contact him before taking this medicine.

Fervex Adulte raspberry flavor granules causes drowsiness, so you should avoid drinking alcohol or any other product containing it, as well as sedative medicines, during the treatment. The treatment is rather started in the evening. 
Be very careful if you drive or use machines because this medicine can cause drowsiness.

It is preferable not to use Fervex Adulte in pregnant women and during breastfeeding. 

If you have taken or are taking any medication, you must inform your doctor or pharmacist, to be sure that there are no interactions or overdose. 

Read the instructions before administration or ask your doctor or pharmacist for advice.
Keep out of the sight and reach of children.

Packaging: 8 sachets

Please read the following full disclosure before taking or purchasing this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 26/01/2023

1. NAME OF THE MEDICINE

FERVEX ADULT RASPBERRY, granules for oral solution in sachet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol......................................................................................................................... 500 mg

Ascorbic acid (Vitamin C).................................................................................................. 200 mg

Pheniramine maleate........................................................................................................... 25 mg

Per sachet.

Notable excipients: sucrose (11.6 g per sachet), and in the flavoring: benzyl alcohol (1.2 mg per sachet), sunset yellow FCF (E110) (0.05 mg per sachet), allura red AC (E129) (0.63 mg per sachet), traces of sodium benzoate (E211) (0.02 mg per sachet) and ethanol (0.02 mg per sachet) (see section 4.4).

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Granules for oral solution in sachet.

Light pink to light beige granulated powder.

4. CLINICAL DATA

4.1. Therapeutic indications

FERVEX ADULT RASPBERRY, granules for oral solution in sachet is indicated for adults and children (from 15 years old) for the treatment of colds, rhinitis, rhinopharyngitis, and flu-like conditions:

• Runny nose and watery eyes
• Sneezing
• Headaches and/or fever

4.2. Dosage and administration

Dosage

This presentation is reserved for adults and children (from 15 years old).

Patients with renal insufficiency

In cases of renal insufficiency, unless otherwise advised by a doctor, the dose should be reduced, and the minimum interval between doses should be increased according to the table below:

The total dose of paracetamol (taking into account other medications containing paracetamol) should not exceed 3 g/day.

Special clinical situations

The lowest effective daily dose of paracetamol should be considered, not exceeding 60 mg/kg/day (and not exceeding 3 g/day) in the following situations:

• Adults under 50 kg
• Mild to moderate hepatic insufficiency
• Chronic alcoholism
• Chronic malnutrition (low hepatic glutathione reserves)
• Dehydration

Maximum recommended doses:

• In adults and children over 50 kg, the TOTAL DOSE OF PARACETAMOL (INCLUDING ALL MEDICINES CONTAINING PARACETAMOL) SHOULD NOT EXCEED 4 GRAMS PER DAY (see section 4.9).

Method of administration

Oral route.

The sachets should be dissolved in a sufficient quantity of water, either cold or hot.

In flu-like conditions, it is preferable to take this medicine in hot water in the evening.

Duration of treatment

The maximum treatment duration is 5 days.

4.3. Contraindications

• Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
• Severe hepatic insufficiency.
• Risk of angle-closure glaucoma.
• Risk of urinary retention related to urethroprostatic disorders.
• Children under 15 years old.

4.4. Special warnings and precautions for use

In cases of high or persistent fever, signs of superinfection, or persistent symptoms beyond 5 days, treatment should be re-evaluated.

Special warnings

Dependence, primarily psychological, only occurs with doses higher than recommended and in long-term treatments.

To avoid the risk of overdose:

• Verify the absence of paracetamol, pheniramine, or other antihistamines in other concurrent treatments (including over-the-counter medications).
• Respect the maximum recommended doses (see section 4.2).

Very rare cases of severe skin adverse effects have been reported. Patients should be informed of the early signs of these severe skin reactions, and the appearance of a rash or any other sign of hypersensitivity necessitates stopping the treatment.

Precautions for use

Related to the presence of paracetamol:

Paracetamol should be used with caution in the following cases:

• Patients weighing less than 50 kg
• Mild to moderate hepatic insufficiency
• Renal insufficiency (see table in section 4.2)
• Chronic alcoholism
• Chronic malnutrition (low hepatic glutathione reserves)
• Dehydration (see section 4.2).

In case of acute viral hepatitis, treatment should be discontinued.

Alcohol consumption during treatment is not recommended.

Caution is advised when paracetamol is administered concomitantly with flucloxacillin due to an increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal insufficiency, sepsis, malnutrition, and other sources of glutathione deficiency (e.g., chronic alcoholism), as well as in those using maximum daily doses of paracetamol. Close monitoring, including urinary 5-oxoproline measurement, is recommended.

Precautions for use relating to pheniramine maleate:

The consumption of alcoholic beverages, sodium oxybate, or sedatives (especially barbiturates), which potentiate the sedative effect of antihistamines, should be avoided during treatment (see section 4.5).

Precautions related to the presence of vitamin C:

Vitamin C should be used with caution in patients with iron metabolism disorders and those with glucose-6-phosphate dehydrogenase deficiency.

Precautions for use related to notable excipients:

This medicine contains 11.6 g of sucrose per sachet. This should be taken into account for patients with diabetes. Patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare hereditary disorders) should not take this medication.

This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is essentially "sodium-free."

This medicine contains 1.2 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.

This medicine contains traces of sodium benzoate (E211) per sachet.

This medicine contains azo dye coloring agents, sunset yellow FCF (E110), and allura red AC (E129), which may cause allergic reactions.

This medicine contains 0.02 mg of alcohol (ethanol) per sachet. The amount per sachet is equivalent to less than 1 ml of beer or 1 ml of wine, which is not likely to have a noticeable effect.

4.5. Interactions with other medicines and other forms of interactions

Related to the presence of paracetamol:

Associations requiring precautions for use

• Antivitamin K
  There is a risk of increased effect of antivitamin K and hemorrhagic risk when paracetamol is taken at maximum doses (4 g/day) for at least 4 days.
  More frequent INR monitoring is recommended. Adjustments to the dosage of antivitamin K may be necessary during paracetamol treatment and after its cessation.

• Flucloxacillin
  Caution should be exercised when using paracetamol and flucloxacillin together, as simultaneous use has been associated with high anion gap metabolic acidosis (HAGMA), especially in patients with risk factors (see section 4.4).

Interactions with laboratory tests

Taking paracetamol may interfere with blood glucose measurements using the glucose oxidase-peroxidase method if abnormal concentrations are present.
It may also affect the measurement of blood uric acid levels using the phosphotungstic acid method.

Related to the presence of pheniramine maleate:

Discouraged combinations

• Alcohol (beverage or excipient)
  Alcohol increases the sedative effect of H1 antihistamines. Impaired alertness may make driving and using machines dangerous.
  Avoid alcoholic beverages and medications containing alcohol.

• Sodium oxybate
  Increased central depression. Impaired alertness may make driving and using machines dangerous.

Combinations to consider

• Other anticholinergic medicines: imipramine antidepressants, most anticholinergic H1 antihistamines, anticholinergic antiparkinsonians, antispasmodic anticholinergics, disopyramide, phenothiazine neuroleptics, and clozapine.
  There is an additive effect of anticholinergic adverse reactions, such as urinary retention, constipation, and dry mouth.

• Other sedative medications: morphine derivatives (analgesics, antitussives, and substitution treatments), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (e.g., meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensives, baclofen, and thalidomide.
  Increased central depression. Impaired alertness may make driving and using machines dangerous.

• Anticholinesterases
  There is a risk of decreased efficacy of anticholinesterases due to the antagonism of acetylcholine receptors by pheniramine maleate.

• Morphine derivatives
  There is a significant risk of colonic akinesia, leading to severe constipation.

4.6. Fertility, pregnancy, and breastfeeding

Pregnancy

There are no clinical data available on the use of paracetamol in combination with vitamin C and pheniramine. A large body of data on pregnant women shows no evidence of malformations or fetal/neonatal toxicity associated with paracetamol use. Epidemiological studies on the neurodevelopment of children exposed to paracetamol in utero have produced inconclusive results.
As a precaution, FERVEX ADULT RASPBERRY, granules for oral solution in sachet is not recommended for pregnant women.

Breastfeeding

In the absence of animal studies and human clinical data, the risk to a breastfed infant is unknown. Therefore, FERVEX ADULT RASPBERRY, granules for oral solution in sachet should not be used during breastfeeding.

Fertility

Due to its potential effect on cyclooxygenases and prostaglandin synthesis, paracetamol may impair female fertility by affecting ovulation, which is reversible upon discontinuation of the treatment. Its use is not recommended in women who are trying to conceive.
Effects on male fertility have been observed in animal studies. The relevance of these effects in humans is unknown.

4.7. Effects on the ability to drive and use machines

FERVEX ADULT RASPBERRY, granules for oral solution in sachet has a significant impact on the ability to drive and use machines.

Particular attention should be paid to drivers and machine operators due to the risk of drowsiness associated with the use of this medication, especially at the beginning of treatment.

This effect is increased by the consumption of alcoholic beverages, medications containing alcohol, or sedative medications.

4.8. Undesirable effects

Related to the presence of paracetamol:

Adverse effects are classified by system organ class, and their frequency is defined as follows:

• Very common (≥1/10)
• Common (≥1/100 to <1/10)
• Uncommon (≥1/1,000 to <1/100)
• Rare (≥1/10,000 to <1/1,000)
• Very rare (<1/10,000)
• Unknown frequency (cannot be estimated based on available data)

¹ The occurrence of these effects requires the permanent discontinuation of this medication and similar medicines.
² The occurrence of this effect requires the immediate discontinuation of this medication. The product can only be reintroduced upon medical advice.

Related to the presence of pheniramine maleate:

The pharmacological properties of this molecule cause adverse effects of varying intensity, depending on the dose (see section 5.1):

¹ The occurrence of these effects requires the permanent discontinuation of this medication and similar medicines.
² The occurrence of this effect requires the immediate discontinuation of this medication. The product can only be reintroduced upon medical advice.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after the authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medication. Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement.social-sante.gouv.fr.

4.9. Overdose

Related to the presence of paracetamol:

The risk of severe poisoning (therapeutic overdose or accidental poisoning) may be particularly high in the elderly, young children, patients with liver disease, chronic alcoholism, or those suffering from chronic malnutrition. In these cases, intoxication can be fatal.

Symptoms:

Nausea, vomiting, loss of appetite, pallor, and abdominal pain typically appear within the first 24 hours.

An overdose causes hepatic cytolysis, which can result in complete and irreversible necrosis, leading to hepatocellular insufficiency, metabolic acidosis, encephalopathy, coma, and potentially death.

Simultaneously, there is an increase in liver transaminases, lactate dehydrogenase, bilirubin, and a decrease in prothrombin levels, which can appear 12 to 48 hours after ingestion.

Clinical signs of liver damage are usually observed 1 to 2 days after ingestion, reaching a maximum after 3 to 4 days.

Overdose may also lead to acute pancreatitis, hyperamylasemia, acute renal failure, and pancytopenia.

Emergency management:

• Discontinue the treatment.
• Immediate transfer to a hospital.
• Take a blood sample to measure initial plasma paracetamol levels.
• Quickly evacuate the ingested product by gastric lavage.
• Overdose treatment usually involves administering N-acetylcysteine as early as possible, either intravenously or orally, preferably within 10 hours.
• Symptomatic treatment.
• Liver function tests should be performed at the start of treatment and repeated every 24 hours. In most cases, liver transaminases return to normal within 1 to 2 weeks, with full recovery of liver function. However, in very severe cases, liver transplantation may be necessary.

Related to the presence of pheniramine maleate:

Overdose of pheniramine can cause seizures (especially in children), altered consciousness, and coma.

Related to the presence of vitamin C:

Vitamin C overdose can cause digestive issues (gastric burning, diarrhea, abdominal pain).

At doses exceeding 1 g/day of vitamin C, there is a risk of hemolysis in individuals with G6PD deficiency.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: OTHER COLD MEDICATIONS IN COMBINATION, ATC code: R05X

FERVEX ADULT RASPBERRY, granules for oral solution in sachet, works through three pharmacological actions:

• An antihistaminic action, which reduces rhinorrhea and watery eyes often associated with colds and opposes spasmodic phenomena such as sneezing fits.
• An analgesic and antipyretic action, which relieves fever and pain (headaches, muscle pain).
• Compensation for ascorbic acid deficiency in the body.

5.2. Pharmacokinetic properties

Paracetamol:

• Absorption: Paracetamol is completely and rapidly absorbed through the oral route. Maximum plasma concentrations are reached 30 to 60 minutes after ingestion.
• Distribution: Paracetamol is rapidly distributed in all tissues, with similar concentrations in blood, saliva, and plasma. Protein binding is low.
• Biotransformation: Paracetamol is primarily metabolized in the liver. The two main metabolic pathways are glucuronidation and sulfation. The latter pathway is rapidly saturated at doses higher than therapeutic ones. A minor pathway, catalyzed by cytochrome P450, produces a reactive intermediate (N-acetyl benzoquinone imine), which, under normal conditions, is quickly detoxified by reduced glutathione and eliminated in urine after conjugation with cysteine and mercapturic acid. In the case of massive intoxication, the quantity of this toxic metabolite increases.
• Elimination: Elimination is primarily renal. 90% of the ingested dose is excreted by the kidneys within 24 hours, mainly as glucuronide (60 to 80%) and sulfate conjugates (20 to 30%). Less than 5% is excreted unchanged. The elimination half-life is about 2 hours.

Physiopathological variations:

• Renal insufficiency: In cases of severe renal insufficiency (see section 4.2), the elimination of paracetamol and its metabolites is delayed.
• Elderly patients: The conjugation capacity is not affected.

Pheniramine maleate:

Pheniramine maleate is well absorbed in the digestive tract. Its plasma half-life is approximately 1 to 1.5 hours. It has a high affinity for tissues and is primarily eliminated via the kidneys.

Ascorbic acid:

Absorption is good in the digestive tract. In cases of intake exceeding the body's needs, the excess is eliminated in the urine.

5.3. Preclinical safety data

Paracetamol:

No conventional studies meeting current standards for evaluating reproductive and developmental toxicity are available.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Gum arabic, anhydrous citric acid, sodium saccharin, sucrose, raspberry flavor containing sunset yellow FCF (E110), benzyl alcohol, traces of sodium benzoate (E211), allura red AC (E129), brilliant blue (E133), and traces of ethanol.

6.2. Incompatibilities

None.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store at a temperature not exceeding 25°C.

6.5. Nature and contents of the outer packaging

Granules for oral solution in sachet (paper/aluminum/PE). Box of 6 or 8 sachets.

Not all presentations may be marketed.

6.6. Special precautions for disposal and handling

No special disposal requirements.

7. MARKETING AUTHORIZATION HOLDER

UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
FRANCE

[Phone, fax, e-Mail: to be completed later by the holder]

8. MARKETING AUTHORIZATION NUMBERS

• 498 982-9 or 34009 498 982 9 9: granules for oral solution in sachet (paper/aluminum/PE). Box of 6
• 498 983-5 or 34009 498 983 5 0: granules for oral solution in sachet (paper/aluminum/PE). Box of 8

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

[To be completed later by the holder]

• Date of first authorization: {DD month YYYY}
• Date of last renewal: {DD month YYYY}

10. DATE OF TEXT REVISION

[To be completed later by the holder]

<{DD month YYYY}>

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

This medicine is not subject to medical prescription.