Fervex pain and fever instant

Patient Information Leaflet

FERVEX Pain and Fever INSTANT, 500 mg, granules in sachet
Paracetamolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if needed.
• If you need advice or further information, consult 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 3 days (in case of fever) or 5 days (in case of pain), or if you feel worse, consult your doctor.

Table of Contents

1. What Fervex Pain and Fever Instant is and what it is used for
2. Before you take Fervex Pain and Fever Instant
3. How to take Fervex Pain and Fever Instant
4. Possible side effects
5. How to store Fervex Pain and Fever Instant
6. Contents of the pack and other information

1. What Fervex Pain and Fever Instant is and what it is used for

Pharmacotherapeutic group: other analgesics and antipyretics; anilides – ATC code:
N02BE01
The medicine contains paracetamol, a substance with analgesic (pain-relieving) and antipyretic (fever-reducing) properties.
It is indicated for symptomatic treatment of mild to moderate pain and/or fever.
This medicine is intended for adults, adolescents, and children with body weight above 27 kg (approximately 8 years of age or older). Please read carefully the “Dosage” section in this leaflet.
For children with body weight below 27 kg (under 8 years of age), other formulations of paracetamol are available – consult your doctor or pharmacist.

2. Important information before using FERVEX ból i gorączka INSTANT

When not to use FERVEX ból i gorączka INSTANT

• If the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe liver disease.

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting to use FERVEX ból i gorączka INSTANT, discuss it with a doctor or pharmacist.
In case of overdose or accidental ingestion of too high a dose, seek immediate medical advice.
This medicine contains paracetamol. Other medicines may also contain paracetamol.
Check whether the patient is taking other medicines containing paracetamol, including medicines
available without a prescription.
These medicines should not be used at the same time, to avoid exceeding the recommended daily dose of paracetamol (see section 3).
Do not continue treatment without consulting a doctor if:

• pain persists for more than 5 days or fever lasts longer than 3 days, or
• any other symptoms appear, or
• treatment efficacy is insufficient. In case of sudden fever, signs of secondary infection, or persistent symptoms, medical consultation is necessary.

Long-term, inappropriate use and/or high-dose use of this medicine in patients with chronic headaches may lead to worsening of headache or its occurrence. Do not increase the dose of analgesics; instead, consult a doctor.
Before using FERVEX ból i gorączka INSTANT, inform the doctor or pharmacist if:

• the patient is an adult with body weight below 50 kg,
• the patient has mild to moderate liver function impairment,
• the patient has kidney function disorders,
• the patient has Gilbert's syndrome (hereditary non-hemolytic jaundice),
• the patient has chronic alcoholism,
• the patient is taking other medicines affecting liver function concurrently with FERVEX ból i gorączka INSTANT,
• the patient has glucose-6-phosphate dehydrogenase deficiency,
• the patient has hemolytic anemia,
• the patient has nutritional disorders [chronic malnutrition (low hepatic glutathione levels), anorexia or cachexia (significant weight loss), fasting],
• the patient is dehydrated (excessive loss of water from the body),
• the patient has acute viral hepatitis or it has been diagnosed during treatment with FERVEX ból i gorączka INSTANT. Consult a doctor, as treatment with FERVEX ból i gorączka INSTANT may need to be discontinued.

During treatment with FERVEX ból i gorączka INSTANT, immediately inform the doctor if the patient has severe diseases, including severe kidney function 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, severe metabolic acidosis (a blood and body fluid abnormality) has been reported in patients taking paracetamol regularly over a long period or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
If in doubt, consult a doctor or pharmacist.
Children and adolescents
In children and adolescents treated with paracetamol, combining it with another antipyretic is not justified, except in cases of treatment failure. Persistent fever requires medical consultation.
This medicine has a red fruit flavor and may therefore be attractive to children. Keep the medicine out of sight and reach of children.
FERVEX ból i gorączka INSTANT and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription.
Medicines that may affect the action of FERVEX ból i gorączka INSTANT:

• probenecid (a medicine used in the treatment of gout). A dose reduction of FERVEX ból i gorączka INSTANT may be necessary, as probenecid increases paracetamol serum concentration.
• phenobarbital, phenytoin, carbamazepine, primidone (medicines used in epilepsy treatment), and rifampicin (a medicine used in tuberculosis treatment). Concurrent use of these medicines with paracetamol may cause liver damage.
• AZT (zidovudine, a medicine used in HIV infection treatment). Concurrent use of paracetamol with AZT increases the risk of neutropenia (reduced white blood cell count). FERVEX ból i gorączka INSTANT may be used with zidovudine only on a doctor's prescription.
• metoclopramide (a medicine used to treat nausea) and other medicines accelerating gastric emptying. These may increase absorption and accelerate the action of FERVEX ból i gorączka INSTANT.
• medicines delaying gastric emptying. These may delay absorption and action of FERVEX ból i gorączka INSTANT.
• cholestyramine (a medicine used to treat elevated blood lipid levels). It may reduce absorption and weaken the effect of FERVEX ból i gorączka INSTANT. Cholestyramine should not be taken within one hour after paracetamol administration.
• oral anticoagulants, especially warfarin (blood-thinning medicines). Long-term, repeated use of paracetamol for more than one week may increase the tendency to bleed. Long-term paracetamol use should occur only under medical supervision. Occasional paracetamol use has no significant effect on bleeding tendency.
• acetylsalicylic acid and salicylamide (analgesic and antipyretic medicines) and chloramphenicol (an antibiotic). Dose reduction of these medicines may be necessary, as prescribed by a doctor.
• flucloxacillin (an antibiotic). Inform the doctor or pharmacist if the patient is taking flucloxacillin due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Effect of using FERVEX ból i gorączka INSTANT on laboratory test results
If a doctor orders tests for blood uric acid or glucose levels, inform them about using this medicine.
Using FERVEX ból i gorączka INSTANT with food, drink, and alcohol
Alcohol consumption during treatment is not recommended.
No studies have been conducted on interactions with food or milk.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
If necessary, FERVEX ból i gorączka INSTANT may be used during pregnancy and breastfeeding. However, the lowest effective dose that relieves pain and/or fever should be used, and the medicine should be taken for the shortest possible duration. Consult a doctor if pain and/or fever do not subside or if more frequent dosing is needed.
Paracetamol may affect female fertility, but this effect is reversible after discontinuation of treatment.
Driving and operating machinery
Paracetamol has no effect or has a negligible effect on the ability to drive and operate machinery.
FERVEX ból i gorączka INSTANT contains sodium benzoate (E211) and trace amounts of benzyl alcohol and sodium
This medicine contains 14 mg of sodium benzoate (E211) per sachet.
This medicine contains trace amounts of benzyl alcohol per sachet.
Benzyl alcohol may cause allergic reactions. Consult a doctor or pharmacist if the patient is pregnant or breastfeeding, or if the patient has liver or kidney disease. This is important because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects known as "metabolic acidosis."
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free."

3. How to use FERVEX ból i gorączka INSTANT

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

Dosage

Use the lowest effective dose for the shortest possible duration.

Use in children and adolescents

FERVEX ból i gorączka INSTANT is indicated for adults, adolescents and children with body weight above 27 kg (approximately 8 years of age or older).

Dosage in children and adolescents should be adjusted according to the patient's body weight; therefore, an appropriate pharmaceutical form of the medicine should be selected. The age corresponding to body weight is approximate.

The maximum daily dose of paracetamol is 60 mg/kg body weight per day, without exceeding the maximum number of sachets indicated in the table below:

| Body weight
(approximate age) | Single dose | Interval between doses | Maximum daily dose | |----------------------------------------|-----------------|----------------------------|------------------------| | 27 kg to < 41 kg
(8 to < 10 years) | 500 mg paracetamol
(1 sachet) | 6 hours | If body weight 27 kg to < 34 kg:
1500 mg paracetamol per day
(3 sachets)

If body weight 34 kg to < 41 kg:
2000 mg paracetamol per day
(4 sachets) | | 41 kg to < 50 kg
(10 to ≤ 15 years) | 500 mg paracetamol
(1 sachet) | minimum 4 hours | If body weight 41 kg to < 46 kg:
2500 mg paracetamol per day
(5 sachets) |

Increasing the dose above this value will not provide additional pain relief but may have serious consequences for the liver.
Children with body weight below 27 kg (approximately 8 years of age and younger): since the dosage of this medicinal product is not appropriate for this age group, other dosage forms of this medicine should be used.
Warning: to avoid the risk of overdose, check whether other medicinal products being used, including those available without a prescription, contain paracetamol. The maximum recommended doses must be observed.
If the patient considers the effect of Fervex ból i gorączka INSTANT to be too strong or too weak, they should consult a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
Adults with body weight below 50 kg, patients with chronic malnutrition, dehydrated patients, and elderly patients: consult a doctor or pharmacist.
Hepatic impairment (mild to moderate), Gilbert's syndrome (familial non-haemolytic jaundice), and chronic alcoholism: do not exceed a dose of 2000 mg paracetamol (2 g) per day.
Renal impairment: dosage should be adjusted according to the degree of renal impairment.
Method of administration
For oral use only. The granulate should be taken directly into the mouth, placed on the tongue, and swallowed without water. Do not chew the granulate.
Duration of treatment
Unless otherwise prescribed by a physician, treatment duration should be limited to:

• 5 days for pain,
• 3 days for fever.

If pain persists for more than 5 days or fever for more than 3 days, treatment should not be continued without consulting a doctor. Prolonged or frequent use is not recommended. Long-term use, except under medical supervision, may be harmful. In case of doubt, consult a doctor or pharmacist.

Use of a higher than recommended dose of Fervex ból i gorączka INSTANT
Treatment must be immediately discontinued and a doctor consulted or emergency services contacted.
Overdose may lead to death.
The main symptoms of poisoning within the first 24 hours are: nausea, vomiting, loss of appetite, pallor, malaise, excessive sweating, and abdominal pain.
After paracetamol overdose, the following may also occur:

• acute renal failure,
• a condition in which small blood clots form in the bloodstream, blocking small blood vessels,
• rare cases of pancreatitis (causing severe abdominal and back pain).

Missed dose of Fervex ból i gorączka INSTANT
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 or pharmacist.

4. Possible adverse effects

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

Rare adverse effects (may affect up to 1 in 1,000 people)

• skin redness, rash, urticaria. Treatment must be stopped immediately, a doctor must be informed, and no further medicines containing paracetamol should ever be taken.
• bleeding spots on the skin (purpura). Treatment must be stopped immediately and a doctor must be consulted before taking any medicine containing paracetamol.
• diarrhoea, abdominal pain.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• severe skin reactions. Treatment must be stopped immediately, a doctor must be informed, and no further medicines containing paracetamol should ever be taken.
• changes in laboratory tests requiring blood monitoring: liver function disorders, abnormally low count of certain white blood cells or other blood cells (e.g. platelets), which may cause nosebleeds or bleeding gums. In such cases, consult a doctor.

Frequency unknown (cannot be estimated from available data)

• skin redness or allergic reactions with sudden swelling of the face and neck, or sudden malaise with low blood pressure. Treatment must be stopped immediately, a doctor must be informed, and no further medicines containing paracetamol should ever be taken.
• excessive (and prolonged) bronchial muscle contraction causing breathing difficulties.
• increased activity of liver enzymes.
• recurring red-violet spots on the skin, in the same location.
• serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring of 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 effects can also be reported directly to the responsible entity. By reporting adverse effects, additional information on the safety of the medicine’s use can be collected.

5. How to store FERVEX ból i gorączka INSTANT

Keep this medicine out of sight and reach of children.
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 stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What FERVEX ból i gorączka INSTANT contains

• The active substance is: paracetamol. Each sachet contains 500 mg of paracetamol.
• The other ingredients are: basic butyl methacrylate copolymer, polyacrylate dispersion 30%, colloidal anhydrous silica, mannitol (E421), crospovidone, sodium benzoate (E211), sucralose (E955), red fruit flavour (contains trace amounts of benzyl alcohol).

What FERVEX ból i gorączka INSTANT looks like and contents of the pack
Granules in a sachet.
White or almost white to light yellow powder.
FERVEX ból i gorączka INSTANT is available in packs containing 8, 10, 16 or 20 sachets,
in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
UPSA SAS
3 Rue Joseph Monier
92500 Rueil-Malmaison
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 Warszawa
tel.: +48 22 570 27 00

This medicine is authorised in the European Economic Area under the following names:
Belgium: Dafalgan Instant fruits rouges 500 mg / Dafalgan Instant rode vruchten 500 mg / Dafalgan Instant Beerengeschmak 500 mg
Dafalgan Instant agrume 500 mg / Dafalgan Instant agrum 500 mg / Dafalgan Instant Zitrusfrüchte 500 mg
Bulgaria: Fervex DIRECT malina 500 mg
France: EFFERALGANSTIX FRAMBOISE 500 mg
Greece: DEPON InSticks® red berry, 500 mg
Italy: Efferalgo 500 mg
Luxembourg: Dafalgan Instant fruits rouges 500 mg / Dafalgan Instant rode vruchten 500 mg / Dafalgan Instant Beerengeschmak 500 mg
Dafalgan Instant agrume 500 mg / Dafalgan Instant agrum 500 mg / Dafalgan Instant Zitrusfrüchte 500 mg
Romania: Fervex Durere și Febră INSTANT 500 mg

Health education advice

MANAGEMENT IN CASE OF FEVER
Normal body temperature varies between individuals and ranges from 36.5°C to 37.5°C. A temperature rise above 38°C may be considered fever; however, antipyretic medications are not recommended for temperatures below 38.5°C.
This medicine is intended for adults, adolescents and children weighing more than 27 kg (approximately 8 years of age and older).
If symptoms caused by fever are particularly bothersome, this paracetamol-containing medicine may be taken, observing the recommended dosage.
The effectiveness of pharmacological treatment can be improved by:

• uncovering the body,
• drinking fluids regularly to avoid the risk of dehydration,
• avoiding staying in overly warm rooms.

After taking this medicine, fever should decrease rapidly. However:

• if other unusual symptoms occur,
• if fever persists for more than 3 days or worsens,
• if headaches become severe or vomiting occurs, YOU SHOULD CONSULT A DOCTOR IMMEDIATELY.

MANAGEMENT IN CASE OF PAIN
Pain perception and tolerance are individual and vary from person to person.

• If there is no improvement after 5 days of treatment,
• if the pain is severe, unexpected and sudden in onset (particularly severe chest pain) and/or recurs regularly,
• if it is accompanied by other symptoms such as general malaise, fever, unusual swelling in the painful area, or limb weakness,
• if it wakes you at night, YOU SHOULD CONSULT A DOCTOR IMMEDIATELY.