Fervex pain and fever instant forte

Package leaflet: Information for the patient

FERVEX pain and fever INSTANT FORTE, 1000 mg, granules in sachet
Paracetamolum
Please read this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, 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.

Leaflet contents

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

1. What Fervex pain and fever Instant Forte is and what it is used for

Pharmacotherapeutic group: Other analgesics and antipyretics; anilides – ATC code: N02BE01
This medicine contains paracetamol, a substance with analgesic (pain-relieving) and antipyretic (fever-reducing) properties.
It is indicated for the symptomatic treatment of mild to moderate pain and/or fever.
This medicine is intended for adults and adolescents with body weight of 50 kg or more (aged above 15 years). Please read carefully the “Dosage” section in this leaflet.
For children with body weight below 50 kg (approximately 15 years of age or younger), other formulations of paracetamol are available – consult your doctor or pharmacist.

2. Important information before using FERVEX ból i gorączka INSTANT FORTE

When not to use FERVEX ból i gorączka INSTANT FORTE

• 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 treatment with FERVEX ból i gorączka INSTANT FORTE, 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 simultaneously, 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 treatment and/or use of high doses 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 FORTE, inform your 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 (familial non-hemolytic jaundice),
• the patient has chronic alcoholism,
• the patient is taking other medicines affecting liver function concurrently with FERVEX ból i gorączka INSTANT FORTE,
• the patient has glucose-6-phosphate dehydrogenase deficiency,
• the patient has haemolytic anaemia,
• the patient has nutritional disorders [chronic undernutrition (low glutathione levels in the liver), anorexia or cachexia (significant weight loss), fasting],
• the patient is dehydrated (excessive loss of water from the body),
• the patient has been diagnosed with acute viral hepatitis or it is diagnosed during treatment with FERVEX ból i gorączka INSTANT FORTE. Consult a doctor, as treatment with FERVEX ból i gorączka INSTANT FORTE may need to be discontinued.

During treatment with FERVEX ból i gorączka INSTANT FORTE, 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), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin have experienced a serious condition called metabolic acidosis (abnormality in blood and body fluids). 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 inefficacy. Persistent fever requires medical consultation.
FERVEX ból i gorączka INSTANT FORTE 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. This includes medicines available without a prescription.
Medicines that may affect the action of FERVEX ból i gorączka INSTANT FORTE:

• probenecid (a medicine used in the treatment of gout). It may be necessary to reduce the dose of FERVEX ból i gorączka INSTANT FORTE, 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 the treatment of HIV infections). Concurrent use of paracetamol with AZT increases the risk of neutropenia (reduced number of white blood cells). FERVEX ból i gorączka INSTANT FORTE may be used together 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 effect of FERVEX ból i gorączka INSTANT FORTE.
• medicines delaying gastric emptying. These may delay absorption and action of FERVEX ból i gorączka INSTANT FORTE.
• cholestyramine (a medicine used in the treatment of elevated blood lipid levels). It may reduce absorption and weaken the effect of FERVEX ból i gorączka INSTANT FORTE. Cholestyramine should not be taken within one hour after paracetamol intake.
• oral anticoagulants, particularly 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 only occur under medical supervision. Occasional paracetamol use does not significantly affect bleeding tendency.
• acetylsalicylic acid and salicylamide (analgesic and antipyretic medicines) and chloramphenicol (an antibiotic). Dose reduction of these medicines may be necessary, which should be done only on a doctor's prescription.
• flucloxacillin (an antibiotic). Inform your 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 FORTE on laboratory test results
If your doctor orders tests for blood uric acid or glucose levels, inform them about using this medicine.
Using FERVEX ból i gorączka INSTANT FORTE 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 is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
If necessary, FERVEX ból i gorączka INSTANT FORTE 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 time. 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 negligible effect on the ability to drive vehicles and operate machinery.
FERVEX ból i gorączka INSTANT FORTE contains sodium benzoate (E211) and trace amounts of benzyl alcohol and sodium
This medicine contains 27 mg of sodium benzoate (E211) in each sachet.
This medicine contains trace amounts of benzyl alcohol in each 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 FORTE

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

Dosage

Use the lowest effective dose for the shortest possible time.

FERVEX ból i gorączka INSTANT FORTE is indicated for adults and adolescents with a body weight of 50 kg or more (aged over 15 years).

Warning: This medicinal product contains 1000 mg of paracetamol (1 g) per sachet – do not take two sachets at the same time.

| Body weight | Single dose | Interval between | Maximum daily dose | |-----------------|-----------------|----------------------|------------------------| | (approximate age) | | doses | | | ≥ 50 kg | 1000 mg paracetamol | At least 4 hours | 3000 mg paracetamol per day | | (>15 years) | (1 sachet) | | (3 sachets) |

Increasing the dose beyond this level will not provide additional pain relief and may have serious consequences for the liver.

Adolescents and children with body weight below 50 kg (approximately 15 years of age and younger): Since the dosage is not appropriate for this age group, other formulations of this medicine should be used.

Warning: To avoid the risk of overdose, check whether other medicines being used, including those available without a prescription, contain paracetamol. The maximum recommended doses must be observed.

If the patient feels that the effect of FERVEX ból i gorączka INSTANT FORTE is 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 daily dose of 2000 mg paracetamol (2 g).

Renal impairment: Dosage should be adjusted according to the degree of renal impairment.

Method of administration

For oral use only. The granules should be taken directly into the mouth, placed on the tongue, and swallowed without drinking water. Do not chew the granules.

Duration of treatment

Unless otherwise directed by a doctor, 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, do not continue treatment 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.

Taking more FERVEX ból i gorączka INSTANT FORTE than recommended

Immediately stop treatment and consult a doctor or contact an emergency department.

Overdose can lead to death.

The main symptoms of poisoning within the first 24 hours include: 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 FORTE

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 a doctor or pharmacist.

4. Possible adverse reactions

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

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

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

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

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department for 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 reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store FERVEX ból i gorączka INSTANT FORTE

Keep the medicine out of the 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 instructions apply.
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. Package contents and other information

What FERVEX ból i gorączka INSTANT FORTE contains

• The active substance is: paracetamol. Each sachet contains 1000 mg of paracetamol.
• Other ingredients are: basic butyl methacrylate copolymer 30% polyacrylate dispersion, colloidal anhydrous silica, mannitol (E421), crospovidone, sodium benzoate (E211), sucralose (E955), red fruit flavour (containing trace amounts of benzyl alcohol).

What FERVEX ból i gorączka INSTANT FORTE looks like and contents of the pack
Granules in a sachet.
White or almost white to light yellow powder.
FERVEX ból i gorączka INSTANT FORTE 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 about 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
This medicinal product is authorised for sale in the European Economic Area under the following names:
Belgium: Dafalgan Instant Forte fruits rouges 1 g / Dafalgan Instant Forte rode vruchten 1 g / Dafalgan Instant Forte Beerengeschmak 1 g
Bulgaria: Фервекс ДИРЕКТ малина 1000 mg
France: EFFERALGANSTIX FRAMBOISE 1000 mg
Greece: DEPON InSticks® Maximum red berry 1000 mg
Italy: Efferalgo 1000 mg
Luxembourg: Dafalgan Instant Forte fruits rouges 1 g / Dafalgan Instant Forte rode vruchten 1 g / Dafalgan Instant Forte Beerengeschmak 1 g
Romania: Fervex Durere și Febră INSTANT Forte 1000 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 medicines are not recommended when body temperature is below 38.5°C.
This medicine is intended for adults and adolescents with body weight of 50 kg or more (aged over 15 years).
If fever-related discomfort is significant, this paracetamol-containing medicine may be taken, following the recommended dosage.
The effectiveness of pharmacological treatment can be improved by:

• removing excess clothing,
• drinking fluids regularly to prevent 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 headache becomes severe or vomiting occurs, CONSULT A DOCTOR IMMEDIATELY.

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

• If there is no improvement after 5 days of treatment,
• if 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, limb weakness,
• if it wakes you up at night, CONSULT A DOCTOR IMMEDIATELY.