EFFERALGAN 500 mg/4 mg Film-Coated Tablets

Зміст інструкції

1. EFFERALGAN INFLUENZA E RAFFREDDORE 500 mg + 4 mg film-coated tablets with
   1. What is EFFERALGAN INFLUENZA E RAFFREDDORE and what is it used for
   2. What you need to know before taking EFFERALGAN INFLUENZA E
   3. Possible side effects
   4. How to store EFFERALGAN INFLUENZA E RAFFREDDORE
   5. Package contents and other information

EFFERALGAN INFLUENZA E RAFFREDDORE 500 mg + 4 mg film-coated tablets with

film
Paracetamol 500 mg/Chlorphenamine 4 mg
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 5 days. Contents of this leaflet
• 1. What is EFFERALGAN INFLUENZA E RAFFREDDORE and what it is used for
• 2. What you need to know before you take EFFERALGAN INFLUENZA E RAFFREDDORE
• 3. How to take EFFERALGAN INFLUENZA E RAFFREDDORE
• 4. Possible side effects
• 5. How to store EFFERALGAN INFLUENZA E RAFFREDDORE
• 6. Contents of the pack and other information

1. What is EFFERALGAN INFLUENZA E RAFFREDDORE and what is it used for

Pharmacotherapeutic category: ANTIPYRETICS ANALGESICS ANTIHISTAMINES INHIBITORS OF THE
H1 RECEPTORS, ATC code: R05X
This medicine contains 2 active ingredients:

• paracetamol, which relieves pain and reduces fever,
• chlorphenamine maleate, which reduces nasal secretion, tearing of the eyes and sneezing. This medicine is indicated, during a cold, rhinitis, nasopharyngitis and flu-like conditions in adults and adolescents over 15 years of age, for the treatment of:
• clear nasal secretion and tearing of the eyes,
• sneezing,
• headaches and/or fever.

For children under 15 years of age, other medicines are available: ask your doctor or
pharmacist for advice.
See a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before taking EFFERALGAN INFLUENZA E

RAFFREDDORE
Do not take EFFERALGAN INFLUENZA E RAFFREDDORE:

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6),
• if you are under 15 years of age,
• if you have severe liver disease,
• if you have a risk of glaucoma (increased pressure inside the eye),
• if you have difficulty urinating due to prostate problems or other causes. Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking EFFERALGAN INFLUENZA E RAFFREDDORE. In case of overdose or if you have accidentally taken an excessive dose, consult your doctor immediately. This medicine contains paracetamol and chlorphenamine maleate. Other medicines may contain them. Checkthat you are not taking other medicines containing paracetamol and/or chlorphenamine maleate, including those obtained without a prescription. Do not combinethese medicines in order not to exceed the recommended daily dose. If you need to take other medicines containing these substances, you must first ask your doctor or pharmacist for advice. (See section 3 " How to take EFFERALGAN INFLUENZA E RAFFREDDORE ".)

If you have purulent nasal discharge or if fever or pain persists for more than 3 days, or if symptoms do not improve after 5 days of treatment, consult your doctor.
The dosage, the duration of treatment of 5 days and the contraindications must be observed
strictly.
Regarding the presence of paracetamol:
Before taking this medicine, you must inform your doctor or pharmacistin case of:

• body weight less than 50 kg,
• mild to moderate hepatocellular insufficiency ( liver disease),
• renal impairment ( kidney disease),
• glucose-6-phosphate dehydrogenase deficiency,
• chronic alcoholism,
• anorexia, bulimia, cachexia ( state of severe weakening of the body) or chronic malnutrition (low hepatic glutathione stores),
• dehydration and hypovolemia ( reduction in total blood volume).

Drinking alcohol during treatment is not recommended.
Paracetamol can cause serious skin reactions. If you develop a rash or other signs of
allergy, stop treatment and contact your doctor immediately.
Regarding the presence of chlorphenamine maleate:

You must stop treatment and contact your doctor or pharmacist immediately
if you experience a combination of one or more of the following side effects:

• diarrhea, vomiting, tachycardia, high body temperature (sweating, tremors, muscle stiffness, confusion, agitation.

These adverse reactions may be observed, especially if you are already taking antidepressants and/ or a product containing dextromethorphan.
Use with caution in subjects (especially the elderly) with prostate problems, with severe
hepatic and/or renal impairment, predisposition to chronic constipation, orthostatic hypotension, dizziness or
drowsiness.

Children and adolescents
Not applicable.

Other medicines and EFFERALGAN INFLUENZA E RAFFREDDORE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Regarding the presence of paracetamol:
Talk to your doctor if you are taking an oral anticoagulant, a medicine that slows down
coagulation (vitamin K antagonist). At high doses, EFFERALGAN INFLUENZA E RAFFREDDORE
can enhance the action of the anticoagulant. If necessary, your doctor will adjust the dosage
of the anticoagulant.
Talk to your doctor if you are taking flucloxacillin (an antibiotic of the penicillin class) due to
the increased risk of metabolic acidosis, especially if you have a risk factor for
glutathione deficiency, such as severe renal failure, sepsis (severe general infection of the body
by pathogenic germs), malnutrition or chronic alcoholism.
If your doctor prescribes you or the child to measure the levels of uric acid or sugar in
the blood, inform him that you or the child is taking this medicine.
Regarding the presence of chlorphenamine maleate:
Avoid taking sodium oxybate, alcoholic beverages, medicines containing alcohol during the
treatment period.
Tell your doctor if you are taking antidepressants and/or a product containing
dextromethorphan.

EFFERALGAN INFLUENZA E RAFFREDDORE with food, drinks and alcohol
This medicine can increase the drowsiness caused by alcohol:

• it is preferable to start treatment in the evening,
• and to refrain from drinking alcoholic beverages or taking medicines containing alcohol during the treatment period.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If necessary, EFFERALGAN INFLUENZA E RAFFREDDORE can be used during pregnancy. It is
advisable to use the lowest possible dose that reduces your symptoms and take it for the shortest possible time.
Contact your doctor if symptoms do not improve.
However, in the late stages of pregnancy, excessive intake of this medicine can cause
neurological effects in newborns. Therefore, always ask your doctor for advice before taking this medicine and never exceed the recommended dose.
Breastfeeding
This medicine is very likely to be excreted in breast milk. Given its sedative properties that
may have an effect on the newborn (lethargy, reduced tone) or, conversely, for its stimulating properties
(insomnia), this medicine is not recommended during breastfeeding.
Fertility
It is possible that paracetamol may alter female fertility, reversible with discontinuation of
treatment.

Driving and operating machinery
Be very careful when driving and operating machinery, as this medicine
may induce a risk of drowsiness, especially at the beginning of treatment. If you have further questions,
ask your doctor or pharmacist.
This phenomenon is enhanced by the consumption of alcoholic beverages, medicines containing alcohol or
sedatives. It is preferable to start treatment in the evening.

EFFERALGAN INFLUENZA E RAFFREDDORE contains carmoisine (azorubine) (E122) and
sodium croscarmellose.
This medicine contains azorubine (coating agent) (E122) and may cause allergic
reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
«sodium-free».

How to take EFFERALGAN INFLUENZA E RAFFREDDORE
Take this medicine exactly as your doctor, pharmacist or
nurse has told you. If you have doubts, consult your doctor, pharmacist or nurse.
This presentation is reserved for adults and adolescents over 15 years of age.

Weight (age)Dose per
administration
Administration interval
Maximum daily
dose
(tablets)
Adults and
adolescents
>50 kg(>15 years)

and
1 tablet4 hours 4 tablets
(500 mg of paracetamol (2,000 mg of
4 mg of chlorphenamine) paracetamol
16 mg of
chlorphenamine)
The maximum daily dose of chlorphenamine maleate should not exceed 16 mg per day, i.e.
4 tablets per day.

Checkthat you are not taking other medicines containing paracetamol and/or chlorphenamine, including
those obtained without a prescription.

Do not combinethese medicines in order not to exceed the recommended daily dose. If you need to take
other medicines containing these substances, you must first ask your doctor or pharmacist for advice.
DO NOT TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (considering all the
other medicines containing paracetamol in their composition).

Method of administration
Oral use.
The tablets should be swallowed whole with a drink (e.g. water, milk, fruit juice).
It is preferable to start treatment in the evening considering the sedative effect of this medicine.

Frequency of administration
1 tablet, to be repeated as needed, after an interval of at least 4 hours, without exceeding
4 tablets per day.

Duration of treatment
If fever or pain persists for more than 3 days or if symptoms do not improve after 5 days of
treatment, the management of the treatment must be reassessed.

Renal impairment
In case of renal impairment ( kidney disease), consult your doctor who will adjust the doses and
intervals of administration. The minimum interval between two administrations must be modified in
based on the value of creatinine clearance ( parameter that defines the severity of renal failure

kidney):

Creatinine clearanceAdministration interval
(cl)
cl ≥50 ml/min 4 hours
cl 10-50 ml/min 6 hours
cl <10 ml/min 8 hours

If you take more EFFERALGAN INFLUENZA E RAFFREDDORE than you should
Stop treatment and consult immediatelyyour doctor or go to the nearest Emergency Room.

An overdose can be fatal.
In the first 24 hours, the main symptoms of intoxication are: nausea, vomiting, anorexia, pallor,
malaise, sweating, abdominal pain.
Paracetamol overdose can cause liver damage, brain damage, coma and even death,
in particularly vulnerable populations such as young children, the elderly and in certain situations
(liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, recent weight loss,
Gilbert's syndrome and in patients treated concurrently with certain drugs). Rare cases of pancreatic damage have also been reported.
Chlorphenamine maleate overdose can cause seizures (especially in children), loss of
consciousness and coma.

If you forget to take EFFERALGAN INFLUENZA E RAFFREDDORE
Do not take a double dose to make up for the missed tablet.

If you stop taking EFFERALGAN INFLUENZA E RAFFREDDORE
Not applicable.
If you have any further questions, ask your 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 affect up to 1 in 1,000 people

• redness or allergic reactions with sudden swelling of the face and neck, or sudden feeling unwell with a drop in blood pressure. Treatment must be stopped immediately, the doctor must be informed and you must never take medicines containing paracetamol again.
• skin redness, skin rashes, urticaria. Treatment must be stopped immediately, the doctor must be informed and you must never take medicines containing paracetamol again.
• blood spots on the skin. Treatment must be stopped immediately, consult your doctor before taking any medicine containing paracetamol.

Very rare side effects: may affect up to 1 in 10,000 people

• biological changes requiring a blood test: impaired liver function, abnormally low levels of some white blood cells or some blood components such as platelets, which can cause nosebleeds or bleeding gums. In this case, consult a doctor.
• serious skin reactions. Treatment must be stopped immediately, the doctor must be informed and you must never take medicines containing paracetamol again.

Frequency Not known: frequency cannot be estimated based on available data

• diarrhoea, abdominal pain.
• increased liver enzymes.

RELATED TO CHLORPHENAMINE MALEATE

• Abnormally low levels of some white blood cells or red blood cells or some blood components such as platelets.
• Swelling, more rarely allergic reactions with sudden swelling of the face and neck or sudden feeling unwell with a drop in blood pressure. Treatment must be stopped immediately, the doctor must be informed and you must never take medicines containing chlorphenamine maleate again.
• Redness of the skin, skin rashes, urticaria. Treatment must be stopped immediately, the doctor must be informed and you must never take medicines containing chlorphenamine maleate again.
• Blood spots on the skin. Treatment must be stopped immediately, consult your doctor before taking any medicine containing chlorphenamine maleate.

Other side effects may occur:

• drowsiness, altered state of alertness, more pronounced at the beginning of treatment,
• reduction of blood pressure when standing up, which may be accompanied by dizziness,
• dry mouth, visual disturbances, urinary retention, constipation, palpitations,
• memory or concentration disorders (more common in elderly patients), confusion, balance disorders, dizziness, hallucinations,
• difficulty coordinating movements, tremors.
• More rarely, excitation effects: agitation, nervousness and insomnia.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store EFFERALGAN INFLUENZA E RAFFREDDORE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EFFERALGAN INFLUENZA E RAFFREDDORE contains

• The active ingredients are: Paracetamol...................................................................................................................500.00 mg Chlorphenamine maleate.........................................................................................................4.00 mg

per una coated tablet

• The other ingredients are: Sodium croscarmellose, hypromellose, microcrystalline cellulose, povidone K90, glycerol behenate, magnesium stearate, coating agent*, polishing agent**

*Coating agent:
Hypromellose (E464), propylene glycol (E1520), titanium dioxide (E171), carmoisine (azorubine)
(E122), carmine indigo (E132)
**Polishing agent:
Purified water, white beeswax (E901), carnauba wax (E903), polysorbate 20 (E432), sorbic acid
(E200)

Description of the appearance of EFFERALGAN INFLUENZA E RAFFREDDORE and package contents
This medicine is presented in the form of film-coated tablets of oblong shape and purple color.
Pack of 4 or 8 or 12 or 16 or 20 or 24 or 28 or 32 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
UPSA SAS, 3, rue Joseph Monier, Rueil Malmaison, France

represented in Italy by
UPSA ITALY S.R.L.Viale Luca Gaurico 9/11 – Rome

Manufacturer
UPSA SAS
304, avenue du docteur Jean Bru - 47000 Agen - France
979, avenue des pyrenees - 47520 Le Passage- France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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
Poland: Fervex ExtraTabs, tabletki powlekane; Paracetamol 500 mg + maleinian chlorfenaminy 4 mg
Romania: Fervex raceala si gripa 500 mg / 4 mg comprimate filmate

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency (AIFA) at http://www.aifa.gov.it/

Health education notes:

WHAT TO DO IN CASE OF NASAL CONGESTION OR RHINORRHOEA:
This medicine is used for the treatment of a stuffy nose, headache and/or fever during a cold in adults and adolescents over 15 years of age.
A cold is a very common, mild, acute infection that affects the nasal mucosa (inner wall of the nose). This mucosa secretes a fluid that serves to continuously humidify the inhaled air and fight off infectious agents. When the mucosa is irritated, it swells and increases the normal secretion of fluid, resulting in a "runny nose".
To limit the onset of symptoms, observe the following hygiene rules as much as possible:

• wash your hands regularly, especially before meals or during their preparation;
• cover your mouth when coughing or sneezing;
• blow your nose regularly with disposable paper products (to avoid re-infecting yourself), throw them in the waste container immediately after use and wash your hands;
• if you use a nasal solution, avoid using the same nozzle by all family members;
• avoid visiting a woman who has recently given birth and her baby, the elderly or a person taking immunosuppressants (corticosteroids, medicines for the treatment of blood diseases, cancer, etc.). In such cases, the use of a mask is recommended. For your well-being:
• drink enough fluids;
• humidify the nasal mucosa with suitable washing solutions(saline solution, thermal or sea water spray). Avoid using the same nozzle by the whole family.
• avoid active and passive smoking;
• sleep with your head elevated to improve airflow through the obstructed nostrils and get enough sleep;
• if necessary, protect the skin of the upper lip and nostrils with cream as blowing your nose repeatedly tends to irritate the skin;
• avoid air conditioners that dehumidify the air and dry out the nasal mucosa, the ideal room temperature is around 18-20°C;
• ensure regular ventilation of the rooms.

WHAT TO DO IN CASE OF FEVER:
Normal body temperature varies from person to person and is between 36.5ºC and 37.5ºC. An increase in temperature above 38ºC can be considered a fever.
If the effects of the fever become too bothersome, you can take this medicine containing paracetamol, respecting the dosage indicated.
Remember to drink often to prevent the risk of dehydration.
With this medicine, the fever should decrease rapidly. However:

• if other unusual signs appear,
• if the fever persists for more than 3 days or worsens,
• if the headache worsens or in case of vomiting,

CONSULT YOUR DOCTOR IMMEDIATELY.

WHAT TO DO IN CASE OF PAIN:
The intensity of pain perception and the ability to tolerate it vary from person to person.

• If there is no improvement after 5 days of treatment,
• if the pain is severe, unexpected and occurs suddenly (particularly significant chest pain) and/or, conversely, occurs regularly,
• if the pain is accompanied by other signs, such as a general feeling of malaise, fever, unusual swelling in the painful area, reduced strength in a limb,
• if the pain wakes you up during the night,

CONSULT YOUR DOCTOR IMMEDIATELY.