Fervex sugar-free

Patient Information Leaflet

Fervex bez cukru, 500 mg + 200 mg + 25 mg,
effervescent granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has instructed.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if your condition worsens, or if fever persists beyond 3 days, consult your doctor.

Table of contents

1. What Fervex bez cukru is and what it is used for
2. What you need to know before taking Fervex bez cukru
3. How to take Fervex bez cukru
4. Possible side effects
5. How to store Fervex bez cukru
6. Contents of the pack and other information

1. What Fervex bez cukru is and what it is used for

Fervex bez cukru is a combination medicine. Paracetamol has analgesic and antipyretic properties.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby improving nasal passage, suppressing sneezing reflex, and reducing eye tearing. Ascorbic acid replenishes vitamin C deficiency in the body.
Indications
Fervex bez cukru is indicated for the short-term relief of symptoms of influenza, colds, and influenza-like conditions (headache, fever, inflammation of nasal and pharyngeal mucosa) in adults and adolescents over 15 years of age.
It may be used by diabetic patients.
If a bacterial infection occurs, antibiotic treatment may be necessary.
If there is no improvement after 5 days or if symptoms worsen, consult your doctor.

2. Important information before using Fervex bez cukru

When not to use Fervex bez cukru

• if the patient is allergic to paracetamol, pheniramine maleate, ascorbic acid, 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 glaucoma (increased pressure in the eye) with a narrow filtration angle,
• if the patient has benign prostatic hyperplasia with difficulty in urination,
• in children and adolescents under 15 years of age.

Warnings and precautions
Before starting to use Fervex bez cukru, discuss this with your doctor, pharmacist, or nurse.
If symptoms persist for more than 5 days or fever lasts longer than 3 days, the patient should consult a doctor.
Do not use the medicine for longer than 5 days without consulting a doctor.
The risk of developing dependence, mainly psychological, is mainly observed when higher than recommended doses are used or during prolonged treatment.
The medicine contains paracetamol and pheniramine maleate.
Check whether other medicines being taken (including those prescribed or available without a prescription) contain paracetamol, pheniramine maleate, or other antihistamines. These medicines should not be used simultaneously to avoid the risk of overdose.
In adults and adolescents with body weight over 50 kg, the TOTAL DAILY DOSE OF PARACETAMOL (including all other medicines containing paracetamol) SHOULD NOT EXCEED 4000 MILLIGRAMS PER DAY.

Related to paracetamol
Before using the medicine, you should inform your doctor or pharmacist if:

• body weight is below 50 kg,
• there is mild or moderate liver failure,
• there are kidney function disorders,
• there is chronic alcohol-related disease,
• there is prolonged malnutrition (low glutathione reserves in the liver),
• there is dehydration.

If acute viral hepatitis is detected, treatment should be discontinued.
Alcohol consumption is not recommended during treatment.
Paracetamol may cause severe skin reactions. You should immediately stop treatment and contact your doctor if a skin rash or other allergy symptoms occur.
During treatment with Fervex bez cukru, immediately inform your doctor if the patient has serious conditions, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids), when paracetamol was taken in regular doses over a long period or when paracetamol was taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Related to pheniramine maleate
During treatment, avoid consuming alcoholic beverages and using sodium hydroxymethylglycinate, as they enhance the sedative effect of antihistamines.

Related to ascorbic acid
Use with caution in patients with iron metabolism disorders and glucose-6-phosphate dehydrogenase deficiency.

Children and adolescents
The medicine may be used in adolescents over 15 years of age (with body weight over 50 kg).

Fervex bez cukru and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Due to the presence of paracetamol
Contact your doctor if the patient is taking oral anticoagulants or drugs that slow blood clotting (vitamin K antagonists). Fervex bez cukru, when taken in high doses, may enhance the effect of anticoagulant medicines. If necessary, the doctor will adjust the dose of the anticoagulant.
Inform your 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 require urgent treatment (see section 2).
Rifampicin, antiepileptic drugs, barbiturate sleep medicines, and other drugs inducing microsomal enzymes, when used together with paracetamol, increase the risk of liver damage.
Concurrent use of high doses of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of kidney function disorders.
Paracetamol used together with MAO inhibitors may cause a state of excitation and high fever.
Inform your doctor about using this medicine if your doctor orders tests for uric acid or blood glucose.

Due to the presence of pheniramine maleate
Avoid consuming alcoholic beverages or using medicines containing alcohol. Alcohol enhances the sedative effect of most antihistamines—H receptor antagonists. Changes in attention and concentration ability may impair the ability to drive vehicles and operate machinery.
Contact your doctor if the patient is taking sodium hydroxymethylglycinate. It enhances the depressive effect on the central nervous system and causes changes in concentration ability, which may impair the ability to drive vehicles and operate machinery.
Use caution when using other medicines with sedative effects: morphine derivatives (analgesics, antitussives), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g. meprobamate), sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative antihistamines blocking H receptors, centrally acting antihypertensives, baclofen, and thalidomide. Increased central nervous system depression and associated changes in concentration ability may impair the ability to drive vehicles and operate machinery.
Use caution with other medicines with anticholinergic effects: antidepressants structurally similar to imipramine, most antihistamines blocking H receptors, anticholinergic antiparkinsonian drugs, antispasmodic drugs with anticholinergic properties, disopyramide, phenothiazine derivative neuroleptics, clozapine. The additive anticholinergic side effects, such as urinary retention, constipation, and dry mouth, may occur.
Contact your doctor if the patient is taking cholinesterase inhibitors, due to the risk of reduced effectiveness caused by the antagonistic action of pheniramine on acetylcholine receptors.
Contact your doctor if the patient is taking morphine-like drugs, due to the significant risk of colonic akinesia with severe constipation.

Due to the presence of ascorbic acid
Ascorbic acid may reduce the effectiveness of warfarin and fluphenazine plasma concentration and decrease urine pH, which may affect the excretion of other concurrently administered medicines.

Using Fervex bez cukru with food and drink
There are no contraindications.

Using Fervex bez cukru with alcohol
Consuming alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines; therefore, simultaneous use should be avoided.
Particular risk of liver damage exists in patients who are fasting and regularly consume alcohol.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Use of this medicine during pregnancy is not recommended.
Paracetamol may be used during pregnancy if necessary. In such cases, the lowest effective recommended dose should be administered for the shortest possible time and as infrequently as possible.

Breastfeeding
Use of this medicine during breastfeeding is not recommended.
Paracetamol may be used during breastfeeding only with a doctor's approval and in individual cases. Caution should be exercised when using paracetamol during lactation.
There are insufficient available data to demonstrate the effect of paracetamol on fertility.

Driving and operating machinery
During use of the medicine, especially at the beginning of treatment, drowsiness may occur, affecting the psycho-physical performance of individuals driving vehicles or operating machinery.
This effect is intensified by consumption of alcoholic beverages, use of medicines containing alcohol, or use of sedative medicines.

Fervex bez cukru contains aspartame, mannitol, and ethanol
The medicine 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 improper excretion.
The medicine contains 3.5 mg of mannitol in each sachet.
The medicine contains 3 mg of alcohol (ethanol) in each sachet. The amount of alcohol in one sachet of this medicine is equivalent to a trace amount of beer or wine and will not cause any noticeable effects.

3. How to use Fervex bez cukru

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

Recommended dose:
Adults and adolescents aged over 15 years (with body weight above 50 kg):
One sachet 2 or 3 times daily (corresponding to 1500 mg paracetamol, 75 mg pheniramine maleate, and 600 mg vitamin C).
Intervals between doses should be at least 4 hours. Do not exceed 3 sachets per day.

Use the lowest effective dose. Do not exceed the recommended dose.
If symptoms persist, the patient should seek medical advice.

Patients with renal function impairment
For patients with impaired renal function, the doctor will determine the dosage regimen, modify the minimum interval between doses, and reduce the maximum daily dose according to the following scheme:

| Creatinine clearance | Interval between doses | Maximum daily dose of paracetamol | |----------------------|------------------------|-----------------------------------| | CrCl > 50 ml/min | 4 hours | 4000 mg (4 g) | | CrCl 10–50 ml/min | 6 hours | 3000 mg (3 g) | | CrCl < 10 ml/min | 8 hours | 2000 mg (2 g) |

The maximum daily dose of paracetamol refers to the total intake from all medications containing paracetamol taken concurrently with Fervex bez cukru.
Depending on creatinine clearance (as indicated above), the total daily paracetamol dose (including other paracetamol-containing medicines) should not exceed 2000–3000 mg/day.

Method of administration
For oral use. Dissolve the contents of one sachet in a glass of warm or cold water.
For the treatment of influenza-like conditions, it is recommended to take the medicine dissolved in warm water, in the evening, as soon as possible after the onset of symptoms.

Duration of treatment
Do not use this medicine for longer than 5 days without consulting a doctor. If symptoms persist for more than 5 days or fever lasts longer than 3 days, the patient should consult a doctor.

Overdose of Fervex bez cukru
In case of accidental ingestion of an excessive dose or overdose, contact a doctor immediately for appropriate advice.

Overdose of pheniramine maleate may cause: seizures (especially in children), disturbances of consciousness, coma.

There is a particular risk of paracetamol poisoning in elderly individuals and young children (most commonly due to ingestion of doses exceeding recommendations or accidental poisoning); such poisonings may lead to death.

Overdose may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness; the following day, upper abdominal discomfort, recurrence of nausea, and jaundice may occur.
Rare cases of acute pancreatitis have been observed.

Overdose of ascorbic acid may cause gastrointestinal disturbances (heartburn, diarrhoea, abdominal pain). Doses of ascorbic acid exceeding 1 g/day may carry a risk of haemolysis in individuals with G6PD deficiency.

Missed dose of Fervex bez cukru
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Related to paracetamol

Adverse reactions occurring rarely (may affect less than 1 in 1,000 but more than 1 in 10,000 treated patients):

• anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema,
• erythema, skin rash, urticaria. If any of these occur, this medicine and medicines with similar composition must be permanently discontinued.

Adverse reactions occurring very rarely (may affect no more than 1 in 10,000 patients):

• thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP). If any of these occur, this medicine and medicines with similar composition must be permanently discontinued.

Frequency not known (cannot be estimated from available data):

• diarrhoea, abdominal pain,
• increased liver enzyme activity,
• purpura,
• serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2). If any of the above symptoms occur, treatment with this medicine must be immediately discontinued. The medicine may only be re-administered after consultation with a physician.

Related to pheniramine maleate

Adverse reactions of varying severity, both dose-dependent and independent, may occur.

Nervous system disorders:

• sedation or drowsiness, more pronounced at the beginning of treatment,
• anticholinergic effects such as dryness of mucous membranes, constipation, accommodation disturbances, pupil dilation, palpitations, risk of urinary retention,
• orthostatic hypotension,
• disturbances in balance, dizziness, memory or concentration impairment, more frequent in elderly patients,
• motor coordination disturbances, tremors,
• confusion, hallucinations,
• less frequently, symptoms of excitation: restlessness, nervousness, insomnia.

Skin and subcutaneous tissue disorders:

• erythema, itching, rash, urticaria. If any of these occur, this medicine and medicines with similar composition must be permanently discontinued.
• purpura. Occurrence of this symptom requires immediate discontinuation of the medicine. The medicine may only be re-administered after consultation with a physician.

Blood and lymphatic system disorders:

• leukopenia,
• neutropenia,
• thrombocytopenia,
• haemolytic anaemia.

Immune system disorders:

• swelling, less frequently angioedema (Quincke's oedema),
• anaphylactic shock. If any of these occur, this medicine and medicines with similar composition must be permanently discontinued.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Fervex bez cukru

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

6. Contents of the pack and other information

What Fervex bez cukru contains
The active substances are: 500 mg paracetamol, 200 mg ascorbic acid, 25 mg
pheniramine maleate in each sachet.
The other ingredients are: mannitol, anhydrous citric acid, povidone, anhydrous magnesium citrate,
aspartame (E951), lemon flavouring.
Composition of lemon flavouring: flavouring components (alpha-pinene, beta-pinene, sabinene, myrcene,
limonene, gamma-terpinene, para-cymene, linalool, neral, geranial, geranyl acetate, geraniol), triacetin
(E1518), modified corn starch (E1450), gum arabic (E414), ethanol.
What Fervex bez cukru looks like and contents of the pack
A three-layer foil sachet (paper/Al/PE) containing white to off-white granules for oral solution,
packaged in a cardboard box.
The cardboard box contains 8 sachets.
Marketing Authorisation 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
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
tel.: + 48 22 570 27 00