Fervex pain and fever duo

Package leaflet: Information for the patient

FERVEX Pain and Fever DUO
500 mg + 65 mg
tablets
Paracetamolum + Coffeinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet for future reference.
• 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 doctor or pharmacist. 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 a doctor.

Table of contents

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

1. What FERVEX Pain and Fever DUO is and what it is used for

FERVEX Pain and Fever DUO contains paracetamol, which has analgesic and antipyretic effects (reduces body temperature in fever), and caffeine, which enhances the analgesic effect of paracetamol.
FERVEX Pain and Fever DUO is indicated in adults and adolescents aged 12 years and older for the relief of fever and the treatment of mild to moderate pain, including:

• symptoms associated with influenza-like syndromes and colds,
• headache, including migraine,
• toothache and pain following dental procedures,
• sore throat,
• menstrual pain,
• muscle pain,
• post-traumatic pain.

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 a doctor.

2. Important information before using FERVEX ból i gorączka DUO

When not to use FERVEX ból i gorączka DUO

• If the patient is allergic to paracetamol or caffeine or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe liver disease.
• If the patient has acute hepatitis.
• If the patient is under 12 years of age.

Warnings and precautions
When taking FERVEX ból i gorączka DUO, do not take other medicines containing paracetamol, such as over-the-counter medicines used to relieve pain, flu symptoms, fever, etc. If symptoms persist or worsen, consult a doctor.
Before starting treatment with FERVEX ból i gorączka DUO, discuss with your doctor or pharmacist if you have:

• severe skin reactions,
• diagnosed Gilbert's syndrome,
• diagnosed glucose-6-phosphate dehydrogenase deficiency,
• haemolytic anaemia,
• asthma and hypersensitivity to acetylsalicylic acid (cross-reaction),
• kidney problems,
• liver problems,
• alcoholism and (or) chronic malnutrition,
• high fever (above 39°C),
• fever lasting longer than 3 days,
• fever that subsides and then returns (recurrent fever),
• pain lasting longer than 5 days.

Prolonged, inappropriate use of large amounts of painkillers (analgesics) may cause headaches. Do not treat these headaches by increasing the dose of FERVEX ból i gorączka DUO.
This medicine should not be used for self-treatment of pain for longer than 5 days unless prescribed by a doctor, as intense and prolonged pain may require medical evaluation and treatment.
Do not exceed the recommended daily dose.
Children
This medicine must not be given to children under 12 years of age.
Athletes should be warned that FERVEX ból i gorączka DUO contains an active substance (caffeine) that may cause positive results in anti-doping controls.
During treatment with FERVEX ból i gorączka DUO, inform your doctor immediately if the patient has serious conditions, including severe kidney dysfunction 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, patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin have been reported to develop a serious condition called metabolic acidosis (a disturbance in blood and body fluid balance).
Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid and deep breathing, drowsiness, nausea and vomiting.
Fervex ból i gorączka DUO and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:

• warfarin or other anticoagulant coumarins (medicines that prevent blood clotting),
• carbamazepine, phenobarbital and phenytoin (antiepileptic medicines),
• rifampicin, chloramphenicol (used to treat bacterial infections),
• zidovudine (used in the treatment of HIV and AIDS),
• metoclopramide, domperidone, propantheline (used to treat nausea, vomiting, stomach ulcers),
• cholestyramine (lowers blood cholesterol levels),
• probenecid (reduces uric acid levels in the body),
• flucloxacillin (antibiotic): due to the serious risk of blood and body fluid disorders (called metabolic acidosis) that require urgent treatment (see section 2).

Do not take other medicines containing paracetamol while taking FERVEX ból i gorączka DUO.
Taking FERVEX ból i gorączka DUO with food, drink and alcohol
When taking FERVEX ból i gorączka DUO, avoid drinks containing caffeine (coffee, tea, soft drinks). Large amounts of caffeine may cause difficulty sleeping, restlessness and chest discomfort due to rapid heartbeat.
Do not consume alcohol while taking FERVEX ból i gorączka DUO, as this may increase the risk of liver damage.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Avoid using FERVEX ból i gorączka DUO during pregnancy and breastfeeding due to its caffeine content, unless otherwise advised by a doctor. Consult your doctor if symptoms do not improve or if more frequent dosing is required.
Driving and using machines
Fervex ból i gorączka DUO does not affect the ability to drive or operate machinery.
Fervex ból i gorączka DUO contains sodium
Fervex ból i gorączka DUO contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use FERVEX ból i gorączka DUO

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.
Recommended dose:
Adults (including elderly) and adolescents aged 15 years and older with body weight above 50 kg:
1 to 2 tablets, 3 to 4 times daily (every 6–8 hours), depending on need.
Adolescents aged 12 to 15 years with body weight below 50 kg:
1 tablet, 3 to 4 times daily (every 6–8 hours), depending on need.
Maximum daily dose:
Do not exceed a daily dose of 3 g of paracetamol, i.e. 6 tablets per day. Always leave at least a 4-hour interval between doses.
The tablets should be swallowed with a suitable amount of water.
Duration of treatment
Do not take paracetamol-containing medicines in high doses unless prescribed by a doctor.
If there is no improvement after 3 days (in case of fever) or 5 days (in case of pain), or if the patient feels worse, consult a doctor.
Use in children
Do not give FERVEX ból i gorączka DUO to children under 12 years of age.
Patients with renal or hepatic impairment
Patients with impaired liver or kidney function should consult a doctor before taking this medicine, as they may require an adjusted dose and/or longer intervals between doses.
Taking more than the recommended dose of FERVEX ból i gorączka DUO
In case of overdose or accidental ingestion by a child, seek immediate medical attention at a doctor's office or nearest hospital and provide the exact amount of FERVEX ból i gorączka DUO taken. Show the used packaging and the package leaflet to the doctor.
Symptoms of paracetamol overdose include nausea, vomiting, loss of appetite, pallor, and abdominal pain, usually appearing within the first 24 hours. Seek immediate medical help even if no symptoms are present, as serious liver damage or liver failure may occur.
Paracetamol overdose can cause severe liver and kidney damage, and even death.
High doses of caffeine may cause headache, tremor, nervousness, and irritability.
The doctor will initiate appropriate treatment and recommend supportive measures.
Missed dose of FERVEX ból i gorączka DUO
Do not take a double dose to make up for a missed dose.
If necessary, take the missed dose as soon as remembered. The medicine may be taken again no sooner than 4 hours after the previous dose. Then continue with the recommended dosing schedule.
Stopping FERVEX ból i gorączka DUO
Suddenly stopping analgesic (pain-relieving) medicines after inappropriate long-term use of high doses may cause symptoms such as headache, fatigue, muscle pain, and irritability. These symptoms usually resolve within a few days. Until these symptoms subside, do not take other analgesics or resume taking FERVEX ból i gorączka DUO, unless otherwise directed by a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When used at recommended doses, FERVEX ból i gorączka DUO is generally well tolerated.
Stop taking the medicine immediately and contact your doctor if facial swelling occurs,
particularly around the mouth (lips, tongue, oral cavity and (or) throat), difficulty breathing,
sweating, nausea or sudden drop in blood pressure. These symptoms may indicate a severe
allergic reaction which could be life-threatening. However, such a reaction is very rare.

Possible adverse reactions of paracetamol
Common adverse reactions (may affect up to 1 in 10 people)

• Nausea
• Vomiting

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Dizziness
• Nervousness
• Diarrhea
• Abdominal pain (including cramps and burning sensation)
• Constipation
• Headache
• Sweating/Increased sweating
• Excessive lowering of body temperature

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

• Slight increase in activity of certain liver enzymes (serum aminotransferases)
• Skin redness

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

• Irritability
• Insomnia
• Blood disorders (reduced platelet count; reduced white blood cell count, sometimes severely; general reduction in the number of all blood cells)
• Breathing difficulties (analgesic-induced asthma) in individuals who previously experienced breathing problems after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
• Hypersensitivity reactions
• Severe skin reactions

Frequency not known (cannot be estimated from available data): a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).
Long-term use of FERVEX ból i gorączka DUO may cause kidney damage.

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

• Irritability
• Nausea
• Insomnia

If the medicine is taken together with food/beverages containing caffeine, the frequency of caffeine-related adverse reactions such as insomnia, restlessness, anxiety, irritability, headache, gastrointestinal irritation (nausea) and palpitations may increase.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, consult your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 provide more information on the safety of the medicine.

5. How to store FERVEX ból i gorączka DUO

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

6. Contents of the pack and other information

What FERVEX Pain and Fever DUO contains

• The active substances in this medicine are paracetamol and caffeine. Each tablet contains 500 mg of paracetamol and 65 mg of caffeine.
• Other ingredients are: maize starch, microcrystalline cellulose, povidone K 29/32, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.

What FERVEX Pain and Fever DUO looks like and contents of the pack
FERVEX Pain and Fever DUO are white, elongated tablets, 17.0 mm x 8.5 mm, in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Pack sizes: 2, 4, 6, 8, 10, 12, 16, 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison, France

Manufacturer
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5
Condeixa-a-Nova
3150-194 Sebal, Portugal

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw, Poland
Tel.: +48 22 570 27 00

This medicine is authorised in the Member States of the European Economic Area under the following names:
Portugal: Paramolan Caf
Bulgaria: FERVEX Plus 500 mg + 65 mg, tablets
Greece: DEPON Plus
Romania: Fervex durere și febră Extra 500 mg/65 mg comprimate