Fervex raspberry

Package leaflet: Information for the patient

Fervex malinowy, 500 mg + 200 mg + 25 mg,
effervescent granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Please read the entire leaflet carefully before using 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 directed by
the physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if you feel worse, or if fever persists beyond 3 days, consult your physician.

Table of contents

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

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

Fervex malinowy is a combination medicine. Paracetamol has analgesic and antipyretic effects.
Pheniramine maleate reduces congestion and swelling of the mucous membranes, thereby clearing nasal passages, suppressing sneezing reflex and eye tearing. Ascorbic acid replenishes vitamin C deficiency in the body.
Indications
Fervex malinowy is indicated for adults and adolescents over 15 years of age for the short-term relief of symptoms of influenza, colds, and flu-like conditions (headache, fever, inflammation of nasal and throat mucosa).
In case of bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or if symptoms worsen, consult your physician.

2. Important information before using Fervex malinowy

When not to use Fervex malinowy

• 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 narrow-angle drainage,
• if the patient has benign prostatic hyperplasia with difficulty urinating,
• in children and adolescents under 15 years of age.

Warnings and precautions
Before starting treatment with Fervex malinowy, discuss it 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 dependence, mainly psychological, is mainly observed when higher than recommended
doses are used or during long-term treatment.
The medicine contains paracetamol and pheniramine maleate.
Check whether other medicines being taken (including those available by prescription or over-the-counter)
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 above 50 kg, THE TOTAL DAILY DOSE OF PARACETAMOL
(taking into account 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 impairment,
• kidney function disorders,
• chronic alcoholism,
• prolonged malnutrition (low glutathione reserves in the liver),
• 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 stop treatment immediately and contact your doctor
if a skin rash or other allergic symptoms occur.
During treatment with Fervex malinowy, inform your doctor immediately 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 cases, patients have been reported to develop a serious condition called metabolic
acidosis (an abnormality in blood and body fluids) when taking paracetamol regularly over a long period or
when taking paracetamol 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 aged over 15 years (with body weight above 50 kg).

Fervex malinowy and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines
the patient plans to take.

Due to paracetamol content
Contact your doctor if the patient is taking oral anticoagulants or blood-thinning medicines (vitamin K
antagonists). Fervex malinowy, 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 sedatives, 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 agitation and high fever.
Inform your doctor if you are using this medicine when your doctor orders tests for uric acid or blood glucose.

Due to pheniramine maleate content
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 may impair
the ability to drive vehicles or operate machinery.
Contact your doctor if the patient is taking sodium hydroxymethylglycinate. It enhances central nervous
system depression and causes changes in attention and concentration, which may impair the ability to drive
vehicles or operate machinery.
Use other sedative medicines with caution: morphine derivatives (analgesics, antitussives, and substitution
medicines), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (e.g. meprobamate),
sleeping pills, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), H receptor-blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide. Increased central nervous system depression and associated changes in attention and concentration may impair the ability to drive vehicles or operate machinery.
Use other medicines with anticholinergic (atropine-like) effects with caution: tricyclic antidepressants similar to imipramine, most H receptor-blocking antihistamines, anticholinergic antiparkinsonian drugs, antispasmodic drugs with atropine-like action, disopyramide, phenothiazine derivative neuroleptics, clozapine. Cumulative 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 medicines due to the significant risk of colonic akinesia with severe constipation.

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

Taking Fervex malinowy with food and drink
There are no contraindications.

Taking Fervex malinowy 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 effects on 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 used 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 treatment, especially at the beginning, drowsiness may occur, affecting the psycho-physical performance of individuals driving mechanical vehicles or operating machinery.
This effect is intensified by consumption of alcoholic beverages, use of medicines containing alcohol, or use of sedative medicines.

Fervex malinowy contains sucrose, benzyl alcohol, colourings, and sodium benzoate
The medicine 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, the patient should contact a doctor before taking the medicine.
The medicine contains 1.2 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.
The medicine contains Sunset Yellow (E110) and Allura Red (E129). The medicine may cause allergic reactions.
The medicine contains trace amounts (0.015 mg) of sodium benzoate (E211) in each sachet.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use Fervex malinowy

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Recommended dose:
Adults and adolescents over 15 years of age (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 take more than 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 impaired renal function
For patients with impaired renal function, the doctor will determine the dosage and 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 dose from all medicines containing paracetamol taken simultaneously with Fervex malinowy.
Depending on creatinine clearance (as indicated above), the total daily dose of paracetamol (including other paracetamol-containing medicines) should not exceed 2000–3000 mg/day.

Method of administration
Oral use. The contents of the sachet should be dissolved in a glass of hot or cold water.
For the treatment of influenza-like conditions, it is recommended to take the medicine dissolved in hot water in the evening, as soon as possible after the onset of symptoms.
It is recommended to store the prepared solution for no longer than two hours.

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 malinowy
If an excessive dose is taken or if Fervex malinowy is taken by mistake, 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 the recommended amount or accidental poisoning); such poisonings may lead to death.
Overdose of the medicine may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness; the following day, abdominal distension, recurrence of nausea, and jaundice may occur.
Rare cases of acute pancreatitis have been observed.
Overdose of ascorbic acid may cause gastrointestinal disturbances (heartburn, diarrhea, abdominal pain). With ascorbic acid doses exceeding 1 g/day, there is a risk of hemolysis in individuals with G6PD deficiency.

Missed dose of Fervex malinowy
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 they do not occur in everyone.
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. If any of these occur, this medicine and other medicines with similar composition must be permanently discontinued.

Frequency unknown (cannot be estimated from available data):

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

Related to pheniramine maleate
Adverse reactions of varying severity, dose-dependent and independent, may occur.
Nervous system disorders:

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

Skin and subcutaneous tissue disorders:

• erythema, pruritus, 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 this medicine. The medicine may be administered again only after consultation with a doctor.

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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Fervex malinowy

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this 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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Fervex malinowy contains
The active substances are: 500 mg paracetamol, 200 mg ascorbic acid, 25 mg
pheniramine maleate in each sachet.
Other ingredients: sucrose, anhydrous citric acid, sodium saccharin, raspberry flavouring.
Composition of raspberry flavouring: maltodextrin, potassium sorbate (E202), sodium benzoate (E211), propylene glycol (E1520), potassium, sodium octenyl succinate starch (E1450), Allura red AC (E129), brilliant blue (E133), sunset yellow FCF (E110), sodium chloride and (or) sodium sulphate, ethyl acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxybenzylacetone.
What Fervex malinowy looks like and contents of the pack
A sachet made of three-layer foil (paper/aluminium/PE) containing a light pink to light beige granulate for oral solution, packed in a cardboard box.
The cardboard box contains 6, 8 or 12 sachets.
Not all pack sizes may be marketed.
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 regarding 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