Fervex bez cukru

Leaflet attached to the packaging: patient information

Fervex sugar-free, 500 mg + 200 mg + 25 mg, granules for oral solution preparation

Paracetamol + Ascorbic Acid + Pheniramine Maleate

Read the leaflet carefully before taking 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• 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, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Fervex sugar-free and what is it used for
• 2. Important information before taking Fervex sugar-free
• 3. How to take Fervex sugar-free
• 4. Possible side effects
• 5. How to store Fervex sugar-free
• 6. Contents of the pack and other information

1. What is Fervex sugar-free and what is it used for

Fervex sugar-free is a combination medicine.
Paracetamol acts as a pain reliever and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, inhibiting sneezing and tearing of the eyes.
Ascorbic acid supplements vitamin C deficiencies in the body.
Indications for use
Fervex sugar-free is indicated for use in adults and adolescents over 15 years of age, for the temporary relief of symptoms of flu, colds, and flu-like conditions (headache, fever, inflammation of the nasal and throat mucosa).
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 sugar-free

When not to take Fervex sugar-free

• 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 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 taking Fervex sugar-free, consult a doctor, pharmacist, or nurse.
In case 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, do not take for more than 5 days.
The risk of dependence, mainly psychological, is observed mainly in cases of taking higher doses than recommended and in cases of long-term treatment.
The medicine contains paracetamol. To avoid the risk of overdose, check if 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).
During treatment with Fervex sugar-free, immediately inform the doctor if the patient has severe diseases, including severe kidney or liver disorders, or sepsis (when bacteria and their toxins circulate 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 been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), 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, feeling of nausea (nausea) and vomiting.

Children and adolescents

The medicine can be used in adolescents over 15 years of age.

Fervex sugar-free and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans 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 to be used with caution
Other sedative medicines: morphine derivatives (pain relievers, antitussives), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g., meprobamate), sleeping pills, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapina, 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 with anticholinergic effects, antiparkinsonian medicines, atropine-like medicines with an antispasmodic effect, dyzopiramid, neuroleptics from the phenothiazine group, clozapine.
Summing up of atropine-like side 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 drugs, barbiturate sleeping pills, and other microsomal enzyme inducers used in combination with paracetamol increase the risk of liver damage.
Caffeine enhances the analgesic and antipyretic effect of paracetamol.
Concomitant use of high doses of paracetamol and non-steroidal anti-inflammatory drugs may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulant drugs from the coumarin group.
Inform the doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (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 in the blood by the phosphotungstic method, as well as the determination of glucose 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 medicines taken at the same time.

Taking Fervex sugar-free with food and drink

There are no contraindications.

Taking Fervex sugar-free with alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
It is not recommended to take the medicine during pregnancy.
Breastfeeding
It is not recommended to take the medicine 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 about excipients with known effects
Fervex sugar-free contains 50 mg of aspartame (E951) 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 sugar-free contains 3.5 mg of mannitol in each sachet.
Fervex sugar-free 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 sugar-free

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, 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 kidney and/or liver disorders
Caution should be exercised when administering the medicine to patients with kidney disorders.
In case of kidney disorder (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, do not take this medicine for more than 5 days. In case of symptoms persisting for more than 5 days or fever lasting more than 3 days, the patient should consult a doctor.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor or pharmacist.

Taking a higher dose of Fervex sugar-free than recommended

Overdose symptoms

Related to pheniramine
Overdose of pheniramine may cause: seizures (especially in children), disorders of consciousness, coma.
Related to paracetamol
There is a special risk of paracetamol poisoning in the elderly and small children (the most common causes are taking higher doses than recommended 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 pain, return of nausea, and jaundice.
Procedure
In case of taking a higher dose of the medicine than recommended, immediately consult a doctor or pharmacist.

Missing a dose of Fervex sugar-free

Do not take a double dose to make up for a missed dose.

Stopping treatment with Fervex sugar-free

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

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 actions:

• 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 concentration disorders, more common 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 (swelling of the lips, tongue, or larynx),
• anaphylactic shock (a type of systemic allergic reaction with circulatory and respiratory disorders). Blood system disorders:
• 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.
Frequency not known (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 illness taking paracetamol (see section 2).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for the 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fervex sugar-free

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiry date stated on the carton, after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fervex sugar-free contains

• The active substances of the medicine are: 500 mg of paracetamol, 200 mg of ascorbic acid, 25 mg of pheniramine maleate.
• The other ingredients are: mannitol, anhydrous citric acid, povidone, anhydrous magnesium citrate, aspartame (E951), lemon flavor. Lemon flavor: flavoring ingredients (alpha-pinene, beta-pinene, sabinene, myrcene, limonene,gamma-terpinene, para-cymene, linalool, neral, geranial, geranyl acetate, geraniol),triacetin (E1518), modified corn starch (E1450), arabic gum (E414), ethanol.

What Fervex sugar-free looks like and contents of the pack

A sachet made of triple-layer foil (paper/A1/PE) containing granules for oral solution preparation in a cardboard box.
A cardboard box containing 8 sachets.

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 medicine, contact the local representative of the marketing authorization holder:
MagnaPharm Poland sp. z o.o.
Inflancka 4 Street,
00-189 Warsaw
tel. +48 22 570 27 00

Date of last revision of the leaflet: