Fervex citrinovi

Leaflet attached to the packaging: patient information

Fervex lemon, 500 mg + 200 mg + 25 mg, granules for oral solution

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 this 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 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 contact their doctor.

Table of contents of the leaflet

• 1. What is Fervex lemon and what is it used for
• 2. Important information before taking Fervex lemon
• 3. How to take Fervex lemon
• 4. Possible side effects
• 5. How to store Fervex lemon
• 6. Package contents and other information

1. What is Fervex lemon and what is it used for

Fervex lemon is a combination medicine.
Paracetamol acts as a pain reliever and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby relieving nasal congestion, inhibiting the sneezing reflex, and reducing eye tearing.
Ascorbic acid supplements vitamin C deficiencies in the body.
Indications for use
Fervex lemon 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 congestion).
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 their doctor.

2. Important information before taking Fervex lemon

When not to take Fervex lemon

• if the patient is allergic to paracetamol, ascorbic acid, pheniramine maleate, or any other component 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 prostate enlargement with difficulty urinating,
• in children and adolescents under 15 years of age,
• it should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency, due to the presence of sucrose in the medicine.

Warnings and precautions

Before taking Fervex lemon, the patient should discuss it with their 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 their doctor.
Without a doctor's recommendation, the medicine should not be taken 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, the patient should check if other medicines they are taking 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 glucose-6-phosphate dehydrogenase deficiency (G6PD).
During treatment with Fervex lemon, the patient should immediately inform their doctor if they have severe diseases, including severe kidney or liver disorders, or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if they are 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 lemon 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.
The patient should avoid consuming alcoholic beverages or medicines containing alcohol.
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 that block the H receptor with a sedative effect, centrally acting antihypertensive medicines, 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 anticholinergic effect: antidepressants with a structure similar to imipramine, most antihistamines that block the H receptor with an anticholinergic effect, antiparkinsonian medicines, antispasmodic medicines with an anticholinergic effect, dyzopiramid, neuroleptics from the phenothiazine group, clozapine.
Summation of anticholinergic side effects such as urinary retention, constipation, and dry mouth.

Due to the presence of paracetamol

Salicylamide prolongs the elimination of paracetamol.
Rifampicin, antiepileptic medicines, sleeping pills from the barbiturate group, and other medicines that induce microsomal enzymes, when 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 nonsteroidal anti-inflammatory medicines may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulant medicines from the coumarin group.
The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
Paracetamol used with MAO inhibitors may cause a state of 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-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 concomitantly.

Using Fervex lemon with food and drink

There are no contraindications.

Using Fervex lemon with alcohol

Consuming alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so the patient should avoid taking them concomitantly.
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 their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine is not recommended during pregnancy.
Breastfeeding
The medicine is not recommended during breastfeeding.

Driving and operating machinery

During treatment with the medicine, drowsiness may occur, affecting the patient's psychophysical fitness to drive vehicles and operate machinery.
Warnings about excipients with known effects
Fervex lemon contains 7.6 g of sucrose in each sachet. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
Fervex lemon contains 195 mg of glucose (as a component of maltodextrin) in each sachet.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
Fervex lemon contains 5 mg of fructose in one sachet. The additive effect of concomitantly administered products containing fructose and food containing fructose should be taken into account.
Fervex lemon contains 7 mg of alcohol (ethanol) in each sachet. The amount of alcohol in one 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.
Fervex lemon contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Fervex lemon

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, the patient should consult their 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 dysfunction (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 better to take the medicine dissolved in hot water, in the evening, as soon as possible after the onset of symptoms.
The solution should not be stored for more than three hours after preparation.
Duration of treatment
Without consulting a doctor, the medicine should not be taken 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 their doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Fervex lemon than recommended

Overdose symptoms

Related to pheniramine
Overdose of pheniramine may cause: seizures (especially in children), disorders of consciousness, coma.
Related to paracetamol
A special risk of paracetamol poisoning exists in elderly patients 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, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Fervex lemon

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Fervex lemon

In case of any further doubts about taking this medicine, the patient should consult their 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 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 elderly patients,
• 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 (decreased white blood cell count), neutropenia (decreased granulocyte count),
• thrombocytopenia (decreased 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 patient should immediately stop taking this medicine and medicines with a similar composition.
Very rare cases of thrombocytopenia (decreased platelet count), leukopenia, and neutropenia have been observed.
Frequency "unknown" (frequency cannot be determined based on available data): a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Fervex lemon

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fervex lemon 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: sucrose, anhydrous citric acid, sodium saccharin, lemon-rum flavor. The composition of the lemon-rum flavor: maltodextrin, arabic gum, dextrose, silicon dioxide (E551), butylhydroxyanisole (E320), sugar syrup, ethanol, potassium, sodium, Peruvian balsam; α-pinen, β-pinen, limonene, γ-terpinene, linalool, neral, α-terpineol, geraniol.

What Fervex lemon looks like and what the package contains

A sachet made of triple-layer foil (paper/Al/PE) containing granules for oral solution in a cardboard box.
A cardboard box containing 5, 8, or 12 sachets.
Not all pack sizes may be marketed.

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, the patient should contact the local representative of the marketing authorization holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
tel.: +48 22 570 27 00
Date of last update of the leaflet:…