Fervex D

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

FERVEX D (FERVEX without sugar)

500 mg + 200 mg + 25 mg

Granules for oral solution preparation
Paracetamol + Ascorbic Acid + Pheniramine Maleate
FERVEX D and FERVEX without sugar are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects 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, a doctor should be consulted.

Table of contents of the leaflet:

• 1. What is FERVEX D and what is it 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. Package contents and other information

1. What is FERVEX D and what is it used for

FERVEX D is a combination drug.
Paracetamol acts as an analgesic and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, inhibiting the sneezing reflex, and tearing of the eyes.
Ascorbic acid supplements vitamin C deficiencies 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, colds, and flu-like conditions (headache, fever, nasal and throat inflammation).
It can be used by diabetic patients.
In the event of a bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or the patient feels worse, a doctor should be consulted.

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 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 accompanying 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 treatment with FERVEX D, a doctor, pharmacist, or nurse should be consulted.
In the event of symptoms persisting for more than 5 days or fever lasting more than 3 days, the patient should consult a doctor. Without a doctor's recommendation, the medicine should not be used for more than 5 days.
The risk of dependence, mainly psychological, is observed mainly in cases of using higher than recommended doses and in cases of prolonged treatment.
The medicine contains paracetamol. To avoid the risk of overdose, it should be checked whether other medicines being taken contain paracetamol. In adults with a body weight over 50 kg, the TOTAL DAILY DOSE OF PARACETAMOL MUST 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 medicine can be used in adolescents over 15 years of age.

FERVEX D and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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.
Alcoholic beverages or medicines containing alcohol should be avoided.
Combinations that should be used with caution
Other sedative medicines: morphine derivatives (painkillers, antitussives), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g., meprobamate), sleeping pills, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines blocking the H receptor with a sedative effect, centrally acting antihypertensive drugs, 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 in motion.
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, dyzopiramid, neuroleptics from the phenothiazine derivative 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-inducing drugs 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 renal 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 uric acid levels in blood 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 serum, as well as reduce the pH of urine, which may affect the excretion of other concomitantly used medicines.

Using FERVEX D with food and drink

There are no contraindications.

Using FERVEX D with alcohol

Drinking alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so they should be avoided.
A special risk of liver damage exists in patients who are fasting and regularly drink alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
The use of the medicine is not recommended during pregnancy.
Breastfeeding
The use of the medicine is not recommended during breastfeeding.

Driving and operating machinery

During treatment with the medicine, drowsiness may occur, affecting the psychophysical fitness of people driving vehicles and operating machinery.
Warnings regarding excipients with known effects
FERVEX D contains 50 mg of aspartame (E 951) in each 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 improper excretion.
FERVEX D contains 3.5 g of mannitol (E 421) in each sachet.
FERVEX D contains 3 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 cause noticeable effects.

3. How to take FERVEX D

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubts, a doctor, pharmacist, or nurse should be consulted.
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 medicine to patients with renal impairment.
In the event of renal impairment (creatinine clearance below 10 ml/min), intervals of at least 8 hours should be maintained between doses.
Method of administration
Oral administration. The contents of the sachet should be dissolved in a glass of hot or cold water.
Duration of treatment
Without consulting a doctor, the medicine should not be used for more than 5 days. In the event of symptoms persisting for more than 5 days or fever lasting more than 3 days, the patient should consult a doctor. If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor or pharmacist.

Using a higher than recommended dose of FERVEX D

Overdose symptoms

Related to pheniramine
Overdose of pheniramine may cause: seizures (especially in children), impaired consciousness, coma.
Related to paracetamol
A special risk of paracetamol poisoning occurs in the elderly and small children (the most common causes are taking higher than recommended doses and accidental poisoning); these poisonings can lead to death.
Overdose of the product may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, and the next day, abdominal distension, return of nausea, and jaundice.
Procedure
In the event of taking a higher than recommended dose of the medicine, a doctor or pharmacist should be consulted immediately.

Missing a dose of FERVEX D

A double dose should not be taken to make up for a missed dose.

Stopping treatment with FERVEX D

In case of any further doubts regarding the use of this medicine, a doctor or pharmacist should be consulted.

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 attention disorders, more frequent in the elderly,
• coordination disorders, tremors,
• confusion, hallucinations,
• rarely, symptoms of excitement: restlessness, nervousness, insomnia. Hypersensitivity reactions (rare):
• flushing, itching, rash, urticaria, erythema,
• edema, rarely Quincke's edema (edema of the lips, tongue, or larynx),
• anaphylactic shock (a type of systemic allergic reaction with immediate effects on circulation and respiration). Effects on the hematopoietic system:
• leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
• thrombocytopenia (reduced platelet count),
• hemolytic anemia.

Related to paracetamol

Rare cases of hypersensitivity reactions have been reported, such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, the medicine and medicines with a similar composition should be discontinued immediately.
Very rare cases of thrombocytopenia (reduced platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store FERVEX D

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What FERVEX D contains

• The active substances of the medicine 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 package contains

Paper/aluminum/polyethylene sachets containing granules for oral solution preparation, in a cardboard box.
A cardboard box containing 8 sachets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Lithuania, the country of export:

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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Lithuanian, export country marketing authorization number: LT/1/97/3290/002

Parallel import authorization number: 48/23

Date of leaflet approval:17.03.2023
[Information about the trademark]