Fervex Extratabs

Leaflet attached to the packaging: patient information

Fervex ExtraTabs, 500 mg + 4 mg, coated tablets

Paracetamol + Chlorphenamine 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 a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• In case of purulent nasal discharge, if fever or pain persists for more than 3 days or symptoms do not improve after 5 days, consult a doctor.

Table of contents of the leaflet

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

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

Pharmacotherapeutic group: antipyretic, analgesic, antihistamine H receptor inhibitor, ATC code: R05X.
The medicine contains two active substances:

• paracetamol - relieves pain and reduces fever,
• chlorphenamine maleate - reduces the amount of nasal discharge, eye watering, and sneezing.

Fervex ExtraTabs is indicated for the treatment of symptoms of the common cold, rhinitis, pharyngitis, and flu-like conditions, such as:

• runny nose and eye watering
• sneezing
• headache
• fever. The medicine is intended for use in adults and adolescents over 15 years of age.

For children under 15 years of age, other medicines are intended, consult a doctor or pharmacist.
If there is no improvement after 5 days or the patient feels worse, consult a doctor.

2. Important information before taking Fervex ExtraTabs

When not to take Fervex ExtraTabs:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• in children under 15 years of age,
• in case of severe liver disease,
• in case of risk of glaucoma (increased eye pressure),
• in case of difficulty urinating due to prostate problems (prostate gland) or other causes.

Warnings and precautions

Before starting treatment with Fervex ExtraTabs, discuss it with a doctor, pharmacist, or nurse.
In case of overdose or accidental administration of a higher dose than recommended, contact a doctor immediately.
In case of purulent nasal discharge, if fever or pain persists for more than 3 days or symptoms do not improve after 5 days, consult a doctor.
Strictly follow the dosage, duration of treatment (5 days), and contraindications.
Related to paracetamol
Before taking the medicine, inform your doctor or pharmacist:

• if the patient is an adult and weighs less than 50 kg,
• if kidney or liver disease has been diagnosed,
• if the patient is elderly,
• if the patient regularly consumes alcohol or has recently stopped drinking alcohol,
• in case of chronic malnutrition, fasting, recent weight loss, anorexia, or cachexia (low reserves or deficiency of glutathione in the liver),
• in case of dehydration,
• in case of glucose-6-phosphate dehydrogenase deficiency (G6PD) (which can lead to hemolytic anemia),
• in case of Gilbert's syndrome (familial non-hemolytic jaundice).

In case of acute viral hepatitis, treatment should be discontinued and a doctor consulted.
Long-term improper use and (or) high doses of this medicine in patients with chronic headaches may cause or worsen headaches. Do not increase the dose of painkillers, but consult a doctor.
Related to chlorphenamine maleate
Discontinue treatment and immediately contact a doctor or pharmacist, if one (or more) of the following side effects occurs:

• diarrhea, vomiting, tachycardia, high body temperature (>38°C), sweating, trembling, muscle stiffness, confusion, anxiety.

Such side effects can be observed, especially if the patient is already taking antidepressant medications and (or) a medicine containing dextromethorphan.
Caution should be exercised in patients (especially the elderly) with prostate problems, severe liver and (or) kidney failure, tendency to chronic constipation, orthostatic hypotension, dizziness, or drowsiness.

Children

Not applicable.

Fervex ExtraTabs and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

The medicine contains paracetamol and chlorphenamine maleate. Other medicines may also contain these substances.

Checkif other medicines you are taking contain paracetamol and (or) chlorphenamine maleate, including over-the-counter medicines.
Do not take these medicines at the same time,to avoid exceeding the recommended daily dose.
If it is necessary to take other medicines containing these substances, consult a doctor or pharmacist. (See section 3. How to take Fervex ExtraTabs)

Due to the content of paracetamol

Consult a doctor or pharmacist:

• if you are taking medicines that are potentially toxic to the liver. Paracetamol toxicity may increase.
• if you or your child have been prescribed a test for uric acid or blood sugar levels, as this medicine may affect the results of these tests.
• if you are taking medicines that slow down blood clotting (oral anticoagulants). In high doses, Fervex ExtraTabs may enhance the effect of anticoagulant medicines. If necessary, the doctor will adjust the dose of the anticoagulant medicine.
• if you are taking flucloxacillin (an antibiotic), due to the serious risk of blood and plasma disorders (metabolic acidosis with high anion gap), which require emergency treatment and may occur especially in case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and use of maximum daily doses of paracetamol.

Due to the content of chlorphenamine maleate

During treatment, avoid using sodium hydroxymethanethiol, consuming alcoholic beverages, or taking medicines containing alcohol.
Consult a doctor if you are taking other serotonergic medicines, medicines containing atropine (antispasmodic), other sedative medicines, acetylcholinesterase inhibitors (used in Alzheimer's disease or myopathy), or opioids (painkillers, antitussives, and used in replacement therapies).
Consult a doctor if you are taking antidepressant medications and (or) a product containing dextromethorphan.

Fervex ExtraTabs with food, drink, and alcohol

The medicine may cause drowsiness, which can be increased by alcohol:

• treatment is best started in the evening,
• during treatment, avoid consuming alcoholic beverages or taking medicines containing alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Pregnancy
In case of need, Fervex ExtraTabs can be used during pregnancy. Take the lowest effective dose that reduces symptoms for the shortest possible time. Consult a doctor if symptoms do not improve
However, in case of excessive administration of the medicine at the end of pregnancy, the medicine may cause neurological symptoms in newborns. Before taking this medicine, always consult a doctor and never exceed the recommended dose.
Breastfeeding
The medicine is likely to pass into breast milk. It is not recommended to take this medicine during breastfeeding due to its sedative effect on the child (may cause lethargy, decreased tone) or, on the contrary, stimulation (insomnia).
Fertility
Paracetamol may affect fertility in women, but this effect is reversible after stopping treatment.

Driving and using machines

Be particularly careful when driving or operating machinery, as the medicine may cause drowsiness, especially at the beginning of treatment. In case of any doubts, consult a doctor or pharmacist.
This effect can be increased by consuming alcoholic beverages, taking medicines containing alcohol, or sedative medicines. Treatment is best started in the evening.

Fervex ExtraTabs contains sodium and carmoisine (azorubine) (E122)

The medicine contains carmoisine (azorubine as a coating agent) (E122), which may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Fervex ExtraTabs

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubts, consult a doctor, pharmacist, or nurse.
This form of the medicine is intended only for adults and adolescents over 15 years of age.

Use the lowest effective dose for the shortest possible time.

The maximum daily dose of chlorphenamine maleate should not exceed 16 mg per day (4 tablets per day).
The maximum daily dose of paracetamol (including all other medicines containing paracetamol in their composition) should not exceed 4000 mg (4 g) per day.
Warning:To avoid the risk of overdose, check if other medicines you are taking, including over-the-counter medicines, contain paracetamol and (or) chlorphenamine maleate. Follow the maximum recommended doses or the dose prescribed byyour doctor: a higher dose will not relieve pain, but may seriously harm the liver.

Adults weighing less than 50 kg, persons with chronic malnutrition, dehydration, or

belonging to the population of elderly persons:consult a doctor or pharmacist.

Dose (tablets)

Adults and adolescents

1 tablet (500 mg paracetamol and 4 mg chlorphenamine maleate)
Minimum 4 hours

4 tablets for adults

weighing more than 50 kg(age over 15 years)
(2000 mg paracetamol and 16 mg chlorphenamine maleate)
In case of liver failure, chronic alcoholism, and Gilbert's syndrome:never exceed a dose of 2000 mg (2 g) of paracetamol per day.

Kidney function disorders

Dosage should be adjusted according to the degree of kidney failure. Before taking this medicine, consult a doctor. If the effect of the medicine is too strong or too weak, do not exceed the recommended doses and consult a doctor or pharmacist.

Method of administration

Oral administration.
Tablets should be swallowed whole with a liquid (e.g., water, milk, fruit juice).
Due to the sedative effect of the medicine, treatment is best started in the evening.

Duration of treatment

Long-term or frequent use without medical supervision is not recommended.
If fever or pain persists for more than 3 days or symptoms do not improve after 5 days, reconsider the treatment used.

Using a higher dose of Fervex ExtraTabs than recommended

Discontinue treatment and immediatelycontact a doctor or the emergency department at a hospital.

Overdose can be fatal.

Paracetamol overdose can cause liver damage, brain damage, coma, and even death, especially in people who are particularly sensitive, such as small children and the elderly, as well as in certain situations (liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, recent weight loss, anorexia, or cachexia, and patients taking certain medications). There have been rare reports of pancreas damage (causing severe abdominal and back pain), increased blood amylase levels, kidney failure, and simultaneous decrease in red blood cell, white blood cell, and platelet counts in the blood.
Within the first 24 hours, the main symptoms of poisoning are: nausea, vomiting, loss of appetite, pallor, malaise, sweating, loss of appetite, abdominal pain.
Chlorphenamine maleate overdose can cause seizures (especially in children), loss of consciousness, and coma.

Missing a dose of Fervex ExtraTabs

Do not take a double dose to make up for a missed dose.

Stopping treatment with Fervex ExtraTabs

Not applicable.
In case of any further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

RELATED TO PARACETAMOL

Rare side effects:may occur in less than 1 in 1000 people

• Redness of the skin, rash, urticaria. Treatment should be stopped immediately, and a doctor informed before taking any medicines containing paracetamol again.
• Blood spots on the skin (petechiae). Treatment should be stopped immediately, and a doctor informed before taking any medicines containing paracetamol.
• Diarrhea, abdominal pain.

Very rare side effects:may occur in less than 1 in 10,000 people

• Severe skin reactions. Treatment should be stopped immediately, and a doctor informed. Never take any medicines containing paracetamol again.
• Changes in blood tests: liver function disorders, abnormally low levels of certain types of white blood cells or other types of blood cells, such as platelets, which can lead to nosebleeds or gum bleeding. Consult a doctor.

Frequency not known:cannot be estimated from the available data.

• Rash or skin redness or allergic reaction, which can include sudden swelling of the face and neck, leading to breathing difficulties (angioedema) or sudden malaise with low blood pressure (anaphylactic shock). Treatment should be stopped immediately, and a doctor informed before taking any medicines containing paracetamol again.
• Abnormal liver function test results, excess acid in the blood due to excess pyroglutamic acid caused by low glutathione levels.
• Skin rash with red, itchy spots and a burning sensation, leaving discolored areas, which can appear in the same places after re-taking the medicine (fixed drug eruption), breathing difficulties (bronchospasm), especially if there have been previous hypersensitivity reactions to aspirin or other non-steroidal anti-inflammatory drugs. Consult a doctor.

RELATED TO CHLORPHENAMINE MALEATE

Frequency not known:cannot be estimated from the available data.

• Abnormally low levels of certain types of white blood cells or red blood cells or other types of blood cells, such as platelets.
• Swelling, allergic reactions with sudden swelling of the face and neck or sudden malaise with low blood pressure. Treatment should be stopped immediately, and a doctor informed. Never take any medicines containing chlorphenamine maleate again.
• Redness of the skin, rash, urticaria. Treatment should be stopped immediately, and a doctor informed. Never take any medicines containing chlorphenamine maleate again.
• Blood spots on the skin. Treatment should be stopped immediately. Before taking any medicines containing chlorphenamine maleate, consult a doctor.

Other side effects may occur:

• drowsiness, impaired alertness, especially at the beginning of treatment,
• low blood pressure when standing up, which may be accompanied by dizziness,
• dry mouth, vision disturbances, urinary retention, constipation, palpitations,
• memory or attention disorders (especially in the elderly), confusion, balance disorders, dizziness, hallucinations,
• coordination disorders, tremors.
• stimulation: anxiety, nervousness, and insomnia.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 ExtraTabs

Keep the medicine out of the sight and reach of children.
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 specified month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. 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 ExtraTabs contains

• The active substances of the medicine are paracetamol and chlorphenamine maleate. Each coated tablet contains 500 mg of paracetamol and 4 mg of chlorphenamine maleate.
• Other ingredients are: sodium croscarmellose, hypromellose, microcrystalline cellulose, povidone K 90, glycerol dibehenate, magnesium stearate, coating agent**.

** hypromellose (E464), carmoisine (azorubine) (E122) , indigo carmine (E132), polydextrose (E1200), calcium carbonate, talc, triglycerides of medium-chain fatty acids* See section 2

What Fervex ExtraTabs looks like and contents of the pack

The medicine is in the form of purple, elongated, coated tablets.
The pack contains 4, 8, 12, 16, 20, 24, 28, or 32 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer

UPSA SAS
304, Avenue du Docteur Jean Bru
47000 Agen
France
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage
France
To obtain more detailed information about this medicine, 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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Фервекс настинка и грип 500 mg/ 4 mg филмирани таблетки
Greece: Depon Cold & Flu, επικαλυμμένο με λεπτό υμένιο δισκίο, (500 + 4) mg/TAB
France: FERVEXRHUME, comprimé pelliculé
Italy: EFFERALGAN INFLUENZA E RAFFREDDORE 500 mg + 4 mg compresse rivestite con film
Romania: Fervex raceala si gripa 500 mg /4 mg comprimate filmate
Date of last revision of the leaflet:January 2025

Advice and health education

WHAT TO DO IN CASE OF A STUFFY NOSE OR RUNNY NOSE:

This medicine is used to treat the common cold, in adults and adolescents over 15 years of age, in case of a stuffy nose, headache, and (or) fever.
The common cold is a very common, mild, acute infection of the nasal mucosa (the inner surface of the nose). The mucosa produces fluid, which helps to humidify the inhaled air and fight infectious agents. Irritation of the mucosa causes its swelling and increased fluid production, resulting in a runny nose.
To limit the risk of symptoms, follow these hygiene rules:

• wash your hands regularly, especially before meals and during their preparation,
• cover your mouth when coughing or sneezing,
• regularly blow your nose using disposable tissues (to avoid re-infection) and throw them away in the trash immediately after use, then wash your hands,
• when using nasal sprays, avoid using the same nozzle for all family members,
• avoid visiting women after childbirth and newborns, elderly people, or those taking immunosuppressive medicines (e.g., corticosteroids, blood diseases, anticancer medicines). In such cases, it is recommended to wear masks.

For your own comfort, you should:

• drink plenty of fluids,
• humidify the nasal mucosa with appropriate solutions(physiological saline, thermal or sea water). Avoid using the same nasal spray nozzle for all family members,
• avoid smoking or inhaling smoke,
• sleep with your head elevated to improve air flow through blocked nostrils and get enough sleep,
• protect your upper lip and skin on your nostrils with cream, as frequent nose-blowing can irritate the skin,
• avoid air conditioners, which dry out the air and dry out the nasal mucosa, the ideal temperature in the room should be around 18-20°C,
• regularly ventilate the rooms.

WHAT TO DO IN CASE OF FEVER:

Normal body temperature varies from person to person and ranges from 36.5°C to 37.5°C. A temperature rise above 38°C can be considered a fever.
If fever causes too much discomfort, you can take a medicine containing paracetamol, following the recommended dosage.
To avoid the risk of dehydration, remember to drink plenty of fluids.
This medicine should quickly lower the fever. However, in case of:

• other unusual symptoms,
• if fever persists for more than 3 days or worsens,
• if headache becomes severe or vomiting occurs,

CONSULT A DOCTOR IMMEDIATELY.

WHAT TO DO IN CASE OF PAIN:

The intensity of pain and the ability to tolerate it vary from person to person.

• If there is no improvement after 5 days of treatment,
• if pain is severe, unexpected, and sudden (especially severe chest pain) or if pain regularly recurs,
• if it is accompanied by other symptoms, such as general malaise, fever, unusual swelling of the painful area, weakness of the limbs, if pain wakes you up at night,

CONSULT A DOCTOR IMMEDIATELY.