Fervex malinovi

Leaflet attached to the packaging: patient information

Fervex raspberry, 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
your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better after 5 days, or if you feel worse after 3 days, you should contact your doctor.

Table of contents of the leaflet

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

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

Fervex raspberry 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, suppressing the cough reflex, and reducing eye tearing.
Ascorbic acid supplements vitamin C deficiencies in the body.
Indications for use
Fervex raspberry is indicated for use in adults and adolescents over 15 years old,
for the temporary relief of symptoms of flu, colds, and flu-like conditions (headache, fever,
inflammation of the nasal and throat mucosa).
In case of bacterial infection, antibiotic treatment may be necessary. The attending physician will decide on this.
If you do not feel better after 5 days or if you feel worse, you should consult your doctor.

2. Important information before taking Fervex raspberry

When not to take Fervex raspberry

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney failure (due to the presence of paracetamol);
• if you have glaucoma (increased eye pressure) with a narrow angle of filtration;
• if you have prostatic hyperplasia with difficult urination;
• if you are under 15 years old;
• if you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Warnings and precautions

Before starting to take Fervex raspberry, you should discuss it with your doctor, pharmacist, or nurse.
If symptoms persist for more than 5 days or fever lasts for more than 3 days, you should consult your doctor.
Do not take the medicine for more than 5 days without consulting a doctor.
The medicine contains paracetamol. To avoid the risk of overdose, you should check if other medicines you are taking contain paracetamol.
In adults with a body weight over 50 kg, the TOTAL DAILY DOSE OF PARACETAMOL MUST NOT EXCEED 4 GRAMS (4000 mg).
You should immediately consult a doctor if you have taken a higher dose of Fervex raspberry than recommended, even if you feel well, as this may lead to dangerous liver damage.
Patient with glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency must consult a doctor before taking Fervex raspberry.
While taking Fervex raspberry, you should immediately inform your doctor if you have 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 you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (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, nausea, and vomiting.

Children and adolescents

The medicine can be used in adolescents over 15 years old.

Fervex raspberry and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During treatment with Fervex raspberry, you should avoid taking medicines containing alcohol.
You should be cautious when taking: morphine derivatives (painkillers, antitussives, and substitute drugs), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g., meprobamate), sleeping pills, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines blocking H1 receptors, antihypertensive drugs with central action, baclofen, and thalidomide, anticholinergic antiparkinsonian drugs, atropine-like drugs with antispasmodic action, dyssopyramide, neuroleptics from the phenothiazine derivative group, clozapine, salicylamide, rifampicin, antiepileptic drugs, sleeping pills from the barbiturate group, and other drugs inducing microsomal enzymes, caffeine, nonsteroidal anti-inflammatory drugs, anticoagulant drugs from the coumarin group, MAO inhibitors, warfarin, and fluphenazine.
You should inform your doctor or pharmacist if you 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).

Using Fervex raspberry with alcohol

The medicine may cause dizziness, which is exacerbated by alcohol.
It is not recommended to drink alcoholic beverages, take medicines containing alcohol, or use sedatives while taking Fervex raspberry.
There is a special risk of liver damage in patients who are fasting and regularly drink alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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 using machines

While taking the medicine, you may experience drowsiness that affects your physical and mental performance, especially when driving vehicles or operating machinery.
Warnings about excipients with known effects
Fervex raspberry contains 7.6 g of sucrose in each sachet. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
Fervex raspberry contains 1.2 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.
Fervex raspberry contains orange yellow (E110) and Allura red (E129). The medicine may cause allergic reactions.
Fervex raspberry contains trace amounts (0.015 mg) of sodium benzoate (E211) in each sachet.
Fervex raspberry contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Fervex raspberry

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
Adults and adolescents over 15 years old: 1 sachet 2 or 3 times a day. The interval between consecutive doses should be at least 4 hours. Do not take more than 3 sachets per day (which corresponds to 1500 mg of paracetamol, 75 mg of pheniramine maleate, and 600 mg of vitamin C).
Elderly patients
There are no contraindications.
Patients with renal and/or hepatic impairment
In case of renal impairment (creatinine clearance below 10 ml/min), you should maintain an interval of at least 8 hours between doses.
Method of 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 symptoms appear.
It is recommended to store the solution for no more than 2 hours after preparation.
Duration of treatment
Do not take the medicine for more than 5 days without consulting a doctor. If symptoms persist for more than 5 days or fever lasts for more than 3 days, you should consult your doctor.

Taking a higher dose of Fervex raspberry than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

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 or accidental poisoning); these poisonings can lead to death.
Accidental or intentional overdose of the medicine may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may resolve the next day, despite the fact that liver damage is developing, which will later manifest as abdominal distension, return of nausea, and jaundice.
Taking more than 10 g of paracetamol in adults or 150 mg/kg body weight in a single dose in children causes complete and irreversible liver cell necrosis.

Missing a dose of Fervex raspberry

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

Stopping Fervex raspberry

If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patient with a predisposition may experience an acute attack of glaucoma (high eye pressure, eye pain, and blurred vision).
Urination disorders (significant reduction in urine output, difficulty urinating).
Dry mouth, vision disorders, palpitations, and constipation.
Balance disorders, memory or concentration disorders, dizziness (more common in the elderly).
Coordination disorders, tremors.
Confusion, hallucinations.
Restlessness, nervousness, insomnia.
Sedation or drowsiness, more pronounced in the initial treatment period.
Decrease in blood pressure when changing position to standing, which may be associated with dizziness.
In some cases, there is a possibility of skin changes, skin redness, or allergic reactions manifesting as sudden swelling of the face or neck, or sudden malaise with a drop in blood pressure. In such a case, you should immediately stop taking the medicine, inform your doctor, and not take medicines containing paracetamol or pheniramine in the future.
In rare cases, a decrease in the number of:

• white blood cells (leukopenia or neutropenia),
• platelets (thrombocytopenia) causing an increased risk of bleeding and bruising,
• red blood cells (hemolytic anemia), manifesting as pale skin, weakness, and shortness of breath. In such a case, you should consult your doctor.

Frequency "not known" (frequency cannot be estimated from the available data): a serious disease 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fervex raspberry

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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fervex raspberry contains

The active substances of the medicine are: 500 mg of paracetamol, 200 mg of ascorbic acid, 25 mg of pheniramine maleate.
Other ingredients are: sucrose, anhydrous citric acid, sodium saccharin, and raspberry flavor.
Composition of the raspberry flavor: maltodextrin, potassium sorbate (E202), sodium benzoate (E211), propylene glycol (E1520), potassium, sodium octenyl succinate starch (E1450), Allura red AC (E129), brilliant blue (E133), orange yellow FCF (E110), sodium chloride, and (or) sodium sulfate; ethyl acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxybenzyl acetone.

What Fervex raspberry looks like and contents of the pack

A sachet made of three-layer paper/Aluminum/PE foil containing granules for oral solution with a light pink to light beige color, in a cardboard box.
The cardboard box contains 6, 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, you 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 revision of the leaflet: