FLOGAR FEVER AND PAIN

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLOGAR FEVER AND PAIN 120 mg/5 ml oral solution

Paracetamol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days of treatment.

Contents of this leaflet:

1. What Flogar Fever and Pain is and what it is used for
2. What you need to know before using Flogar Fever and Pain
3. How to use Flogar Fever and Pain
4. Possible side effects
5. How to store Flogar Fever and Pain
6. Contents of the pack and other information

1. What Flogar Fever and Pain is and what it is used for

Flogar Fever and Pain is an oral solution containing the active substance paracetamol.
Paracetamol works by reducing fever (antipyretic) and relieving pain (analgesic).
Flogar Fever and Pain is used in adults and children weighing 7.2 kg (approximately 5–6 months of age) for:

• the treatment of feverish conditions such as influenza, exanthematic diseases (infectious diseases typical in children and adolescents), and acute respiratory tract illnesses.
• various types of pain of differing origin and nature (headache, neuralgia, muscle pain, and other moderate painful conditions).

Consult a doctor if you or the child do not feel better or feel worse after 3 days of treatment.

2. What you need to know before using Flogar Fever and Pain

Do not use Flogar Fever and Pain

• if the person taking the medicine is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
• if the person taking the medicine suffers from severe haemolytic anaemia (a disease caused by the destruction of certain blood cells, red blood cells)
• if the person taking the medicine suffers from severe liver disease (severe hepatocellular insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before using Flogar Fever and Pain.
Use Flogar Fever and Pain with caution in the following cases:

• if the person taking the medicine is a chronic drinker or consumes excessive amounts of alcohol (3 or more alcoholic drinks per day)
• if the person taking the medicine suffers from anorexia (an eating disorder characterised by lack or reduced appetite)
• if the person taking the medicine suffers from bulimia (an eating disorder in which a person ingests excessive amounts of food and then resorts to various methods to eliminate it)
• if the person taking the medicine suffers from cachexia (a condition characterised by extreme thinness, reduced muscle mass, and thinning skin due to chronic diseases)
• if the person taking the medicine has been following an inadequate diet for a long time (chronic malnutrition)
• if the person taking the medicine suffers from dehydration (severe loss of water/fluids from the body)
• if the person taking the medicine suffers from hypovolemia (reduced blood volume in circulation)
• if the person taking the medicine has liver diseases that reduce liver function (hepatic insufficiency, hepatitis, Gilbert's syndrome)
• if the person taking the medicine is undergoing concomitant treatment with medicines that affect liver function (see "Other medicines and Flogar Fever and Pain")
• if the person taking the medicine suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency may cause a blood disorder)
• if the person taking the medicine suffers from haemolytic anaemia (a disease caused by the destruction of certain blood cells, red blood cells)

During treatment with Flogar Fever and Pain, inform your doctor immediately if:
You suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.
Use of high doses and/or prolonged use
Taking high doses and/or prolonged use of this medicine may cause liver disorders (hepatopathy) and even serious adverse effects on the kidneys and blood. In such cases, your doctor will periodically monitor liver and kidney function and blood composition through appropriate tests. Before taking this medicine, inform your doctor if the person taking it suffers from kidney or liver disease.
Other medicines and Flogar Fever and Pain
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called high anion gap metabolic acidosis) that require urgent treatment (see section 2).
• medicines containing paracetamol. During treatment with paracetamol, check before taking or giving any other medicine to a child whether it contains paracetamol, as serious adverse effects may occur if paracetamol is taken in excessive doses;
• medicines that slow gastric emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of Flogar Fever and Pain;
• medicines that accelerate gastric emptying (e.g. prokinetics), as these medicines accelerate the effect of Flogar Fever and Pain;
• colestyramine (a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
• chloramphenicol (an antibiotic), as it may increase the risk of adverse effects;
• anticoagulants, which are medicines that delay blood clotting. In this case, especially during prolonged treatment and high-dose paracetamol (4 g daily for at least 4 days), take or give Flogar Fever and Pain only under strict medical supervision;
• rifampicin (an antibiotic);
• cimetidine (a medicine used in the treatment of stomach ulcers);
• antiepileptics (medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine;
• chronic alcohol use
• zidovudine (a medicine for the treatment of HIV)

The use of these medicines together with Flogar Fever and Pain requires close medical supervision.
Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that administration of paracetamol may interfere with the measurement of uric acid and blood glucose levels.
Flogar Fever and Pain and alcohol
Take Flogar Fever and Pain with caution if you are a chronic drinker or consume excessive amounts of alcohol (3 or more alcoholic drinks per day), as there is a risk of intoxication (see sections "Warnings and precautions" and "If you take/give the child more Flogar Fever and Pain than you should").
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, Flogar Fever and Pain may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and to take it for the shortest possible time. Contact your doctor if pain and/or fever do not decrease or if you need to take the medicine more frequently.
This medicine may be taken during breastfeeding only if strictly necessary and under medical supervision.
Driving and using machines
Flogar Fever and Pain does not impair the ability to drive or operate machinery.
Flogar Fever and Pain contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains 3.5 g of sucrose (sugar) per 10 ml dose. This should be taken into account in people with diabetes mellitus.
Flogar Fever and Pain contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml dose, i.e. essentially 'sodium-free'.
Flogar Fever and Pain contains parahydroxybenzoates
This medicine may cause allergic reactions (including delayed reactions).
Flogar Fever and Pain contains alcohol (from strawberry/mandarin flavouring)
This medicine contains 3.78 mg of alcohol (ethanol) per 10 ml oral solution.
The amount in 10 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Flogar Fever and Pain

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
20 ml at a time (equivalent to 480 mg), repeated if necessary after 4 hours, without exceeding 6 doses per day.
Children (from 7.2 kg)
In children, it is essential to follow the dosage based on body weight and not on age, which is only approximate and provided for informational purposes. If a child's age does not correspond to the weight shown in the table, always refer to body weight when determining the dose.
The dosing schedule for Flogar Fever and Pain is as follows.
FLOGAR FEVER AND PAIN

For children weighing less than 7.2 kg, specific paracetamol-based formulations are available on the market which can be taken/used starting from 3.2 kg.
In children over 10 years of age, the relationship between weight and age becomes less homogeneous due to pubertal development, which, at the same age, differently affects body weight depending on the child's sex and individual characteristics. Therefore, for children over 10 years of age, the dosage of the syrup is indicated in terms of weight and age ranges, as reported below.
Children weighing between 33 and 40 kg (older than 10 years and younger than 12 years): 20 ml of oral solution at a time (equivalent to 480 mg), repeatable if necessary after 6 hours, without exceeding 4 doses per day.
Adolescents weighing over 40 kg (age equal to or greater than 12 years) and adults: 20 ml of syrup at a time (equivalent to 480 mg), repeatable if necessary after 4 hours, without exceeding 6 doses per day.
If your doctor has diagnosed severe renal impairment, the interval between doses should be at least 8 hours.

Duration of treatment
Do not take/give the child Flogar Febbre e Dolore for more than 3 consecutive days without consulting your doctor. Your doctor must evaluate the need for treatments lasting longer than 3 consecutive days.

Instructions for use
To facilitate dose calculation according to body weight, use the dosing syringe provided inside the package.
The package contains a dosing syringe with markings corresponding to 2.5 ml, 5 ml and 10 ml volumes.

If you use more Flogar Febbre e Dolore than you should
In case of accidental ingestion/overdose of Flogar Febbre e Dolore, contact your doctor immediately or go to the nearest hospital.

Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that you/the child may generally experience within the first 12–48 hours include:

• anorexia (lack or reduction of appetite)
• nausea
• vomiting
• severe deterioration of general condition
• severe liver damage (hepatic cytolysis) which may lead to reduced liver function (hepatocellular insufficiency), excessive production of metabolic acids (metabolic acidosis), and brain damage (encephalopathy)
• changes in blood laboratory values (increased transaminases, lactate dehydrogenase, and bilirubin; decreased prothrombin levels).

Taking an excessive dose of paracetamol increases the risk of poisoning and may be fatal, especially in the following cases:

• if you suffer from liver disease,
• chronic alcoholism,
• long-term inadequate diet (chronic malnutrition),
• if you are taking medicines or substances that increase liver activity.

If you forget to use Flogar Febbre e Dolore
Do not take a double dose to make up for the forgotten dose.

If you stop using Flogar Febbre e Dolore
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience the following side effects, STOP taking this medicine immediately and contact your
doctor immediately:

• Allergic reactions such as:
  • skin redness accompanied by itching (urticaria)
  • swelling of the throat (laryngeal edema)
  • swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
  • severe allergic reaction (anaphylactic shock).

In addition, people taking this medicine may experience the following side effects, with frequency not known
(frequency cannot be estimated from the available data).
Effects related to blood

• decrease in the number of platelets in the blood (thrombocytopenia)
• decrease in the number of white blood cells in the blood (leucopenia/agranulocytosis)
• decrease in hemoglobin in the blood, the substance that carries oxygen in the blood (anemia).

Effects related to the nervous system

• dizziness
• abnormal liver function
• inflammation of the liver (hepatitis).

Effects related to the skin and subcutaneous tissue
red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Very rare cases of serious skin reactions have been reported.
Effects related to the kidneys and urinary tract

• reduced kidney function (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• blood in the urine (haematuria)
• cessation or reduction of urine production (anuria)

Disorders of metabolism and nutrition:

• severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Flogar Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry:". The expiry date refers to the last day of that month.
After first opening the bottle, the medicine should be used within 12 months.
Store this medicine below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flogar Fever and Pain contains

• The active substance is: paracetamol (2.4 g of paracetamol in 100 ml of oral solution).
• The other components are: sucrose (see section “Flogar Fever and Pain contains sucrose”), macrogol 6000, sodium citrate, anhydrous citric acid, sodium saccharin, methyl parahydroxybenzoate (see section “Flogar Fever and Pain contains parahydroxybenzoates”), propyl parahydroxybenzoate (see section “Flogar Fever and Pain contains parahydroxybenzoates”), strawberry/mandarin flavour, purified water.

Description of the appearance of Flogar Fever and Pain and contents of the pack
120 ml bottle of oral solution with dosing syringe.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
ABC Farmaceutici S.p.A. - Canton Moretti 29 - 10015 S. Bernardo d'Ivrea (TO)