Tachipirina Kid

Package leaflet: Information for the user

TACHIPIRINAKID 120 mg/5 ml oral suspension

Paracetamol
Please read all of this leaflet carefully before you use 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 any side effects occur, 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 notice a worsening of symptoms after 3 days of treatment.

Contents of this leaflet:

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

1. What TACHIPIRINAKID is and what it is used for

TACHIPIRINAKID is an oral suspension containing the active substance paracetamol.
Paracetamol works by reducing fever (antipyretic effect) and relieving pain (analgesic effect).
TACHIPIRINAKID oral suspension is used in adolescents and children weighing 7.2 kg (approximately 5-6 months of age) for:

• symptomatic treatment of feverish conditions such as influenza, exanthematous diseases (infectious diseases typical of children and adolescents), acute respiratory tract illnesses, etc.
• pain of various origin and nature (headache, neuralgia, muscle pain, and other moderate-intensity painful conditions).
  Consult a doctor if you/your child do not feel better or feel worse after 3 days of treatment.

2. What you need to know before using TACHIPIRINAKID

Do not use TACHIPIRINAKID

• 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 TACHIPIRINAKID.
Use TACHIPIRINAKID with caution in the following cases:

• if the person taking the medicine chronically abuses alcohol 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 reduction of appetite)
• if the person taking the medicine suffers from bulimia (an eating disorder in which a person consumes 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 of the 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 hypovolaemia (reduced blood volume in circulation)
• if the person taking the medicine has liver diseases that impair liver function (hepatic insufficiency, hepatitis, Gilbert's syndrome)
• if the person taking the medicine is receiving concomitant treatment with medicines that affect liver function (see "Other medicines and TACHIPIRINAKID")
• if the person taking the medicine has 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 TACHIPIRINAKID, inform your doctor immediately if:

• You suffer from serious diseases, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), 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 for prolonged periods
The use of high and/or prolonged doses of this medicine may cause even serious adverse effects on the kidneys and blood. In such cases, your doctor will periodically monitor, through appropriate tests, liver and kidney function and blood composition. Before taking this medicine, inform your doctor if the person taking it suffers from kidney or liver disease.

Other medicines and TACHIPIRINAKID
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, inform your doctor if the person taking the medicine is using:

• medicines containing paracetamol. During treatment with paracetamol, before taking or giving the child any other medicine, check that it does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses;
• medicines that slow gastric emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of TACHIPIRINAKID;
• medicines that accelerate gastric emptying (e.g. prokinetics), as these medicines accelerate the effect of TACHIPIRINAKID;
• cholestyramine (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 (medicines used to make the blood more fluid). In case of high-dose paracetamol treatment (4 g per day for at least 4 days), take or give the child TACHIPIRINAKID only under strict medical supervision;
• rifampicin (an antibiotic);
• cimetidine (a medicine used in the treatment of stomach ulcers);
• antiepileptics (medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
• chronic alcohol use;
• zidovudine (a medicine for the treatment of HIV);
• -flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that must be urgently treated. The use of these medicines with TACHIPIRINAKID requires close medical monitoring.

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 levels (uricemia) and blood glucose levels (glycemia).

TACHIPIRINAKID and alcohol
Take TACHIPIRINAKID with caution if you chronically consume alcohol or consume excessive amounts (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 TACHIPIRINAKID than you should").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If necessary, TACHIPIRINAKID 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 subside or if you need to take the medicine more frequently.

Driving and using machines
TACHIPIRINAKID does not affect the ability to drive or use machinery.

TACHIPIRINAKID contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
TACHIPIRINAKID contains 10 g of sucrose per 20 ml of suspension. This should be taken into account in people with diabetes mellitus.

TACHIPIRINAKID contains methyl 4-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

TACHIPIRINAKID contains sodium
This medicine contains less than 1 mmol per 20 ml, i.e. is essentially "sodium-free".

TACHIPIRINAKID contains sorbitol
This medicine contains 1806 mg of sorbitol per 20 ml dose. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which patients are unable to metabolise fructose, speak with your doctor before you (or the child) take this medicine.
It may cause gastrointestinal discomfort and have a mild laxative effect.

3. How to use TACHIPIRINAKID

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.

Children (from 7.2 kg)
In children, it is essential to follow the dosage based on body weight rather than age, which is only approximate and provided for informational purposes. If the child's age does not correspond to the weight indicated in the table, always refer to body weight when determining the correct dose.

The dosing schedule for TACHIPIRINAKID suspension is as follows:

TACHIPIRINAKID SUSPENSION

| Age | Weight | Single Dose | Daily Dose | |--------|------------|-----------------|----------------| | 5-6 months | from 7.2 kg | 4.5 ml | Up to 4 times (every 6 hours) | | 7-10 months | from 8 kg | 5 ml | Up to 4 times (every 6 hours) | | 11-14 months | from 9 kg | 5.5 ml | Up to 4 times (every 6 hours) | | 15-19 months | from 10 kg | 6 ml | Up to 4 times (every 6 hours) | | 20-23 months | from 11 kg | 6.5 ml | Up to 4 times (every 6 hours) | | 2 years | from 12 kg | 7.5 ml | Up to 4 times (every 6 hours) | | 3 years | from 14 kg | 8.5 ml | Up to 4 times (every 6 hours) | | 4 years | from 16 kg | 10 ml | Up to 4 times (every 6 hours) | | 5 years | from 18 kg | 11 ml | Up to 4 times (every 6 hours) | | 6 years | from 20 kg | 12.5 ml | Up to 4 times (every 6 hours) | | 7 years | from 22 kg | 13.5 ml | Up to 4 times (every 6 hours) | | 8 years | from 25 kg | 15.5 ml | Up to 4 times (every 6 hours) | | 9 years | from 28 kg | 17.5 ml | Up to 4 times (every 6 hours) | | up to 10 years | from 31 kg to 32 kg | 19 ml | Up to 4 times (every 6 hours) |

For children weighing less than 7.2 kg, specific Tachipirina formulations are available on the market, such as Tachipirina 100 mg/ml drops, solution, and Tachipirina Neonates 62.5 mg suppositories, which can be used starting from 3.2 kg.

In children over 10 years of age, the relationship between weight and age becomes less consistent due to pubertal development, which differently affects body weight depending on sex and individual characteristics, even at the same age. Therefore, for children over 10 years of age, the dosage of the suspension is indicated in terms of weight and age intervals, as follows:

• Children weighing between 33 and 40 kg (over 10 years and under 12 years): 20 ml of suspension per dose (equivalent to 480 mg), repeatable if necessary after 6 hours, without exceeding 4 doses per day.
• Adolescents weighing more than 40 kg (12 years of age or older): 20 ml of suspension per dose (equivalent to 480 mg), repeatable if necessary after 4 hours, without exceeding 6 doses per day.

If the doctor has diagnosed severe renal insufficiency, the interval between doses must be at least 8 hours.

Duration of treatment
Do not take/give TACHIPIRINAKID to the child for more than 3 consecutive days without consulting a doctor. The doctor must assess the need for treatment beyond 3 consecutive days.

Instructions for use
To measure the dose to be given to the child, the package contains a dosing syringe with markings corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml, and 5 ml, and a dosing cup with markings corresponding to 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 13.5 ml, 15.5 ml, 17.5 ml, and 19 ml.

Child-resistant cap
The TACHIPIRINAKID suspension bottle is equipped with a child-resistant cap.
Instructions for opening and closing are provided below:
To open: To close:
Press down and turn simultaneously
Press and screw tightly

➢ After unscrewing the cap by pressing down and turning left simultaneously, insert the tip of the syringe fully into the opening of the inner cap:

➢ Invert the bottle:

➢ Holding the syringe firmly, gently pull the plunger downward to fill the syringe up to the mark corresponding to the desired dose:

Return the bottle to an upright position:

➢ Remove the syringe by gently rotating it:

➢ Insert the tip of the syringe into the child's mouth and gently press the plunger to dispense the suspension. The product must be used immediately after withdrawal from the bottle. Any residual product in the syringe must be discarded.

For doses exceeding 5 ml, withdraw the required amount using the syringe and pour the contents into the dosing cup. Repeat this step until the total volume reaches the mark corresponding to the prescribed dose, then administer to the child, encouraging them to drink it.

For doses in children over 10 years of age (20 ml), use the dosing cup, filling it twice up to the 10 ml mark.

➢ The product must be used immediately after withdrawal from the bottle. Any residual product in the syringe or dosing cup must be discarded.

After use, close the bottle by screwing the cap tightly. Wash the syringe and dosing cup with warm water, let them dry, and store them out of the reach and sight of children.

If you give the child more TACHIPIRINAKID than you should
In case of accidental ingestion/overdose of TACHIPIRINAKID, contact your doctor immediately or go to the nearest hospital.

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

• Anorexia (lack of or reduced appetite), nausea, and vomiting, followed by a marked deterioration in general condition and changes in blood laboratory values (elevated transaminases, lactic dehydrogenase, and bilirubin; reduced prothrombin levels);
• Liver damage that may lead to coma and death. Overdose of paracetamol increases the risk of poisoning and can be fatal, especially in the following cases:
• If the person taking the medicine has liver disease,
• Chronic alcoholism,
• Long-term inadequate nutrition (chronic malnutrition),
• If the person is taking medicines or substances that increase liver enzyme activity.

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.

If you forget to use TACHIPIRINAKID
Do not take a double dose to make up for a missed dose.

If you stop using TACHIPIRINAKID
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 everybody will experience them.
STOP treatment with this medicine and contact your doctor immediately if the child experiences any of the following side effects:

• allergic reactions such as:
  • skin redness accompanied by itching (urticaria)
  • swelling of the throat (laryngeal oedema)
  • 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, for which insufficient data are available to determine their frequency.

• decreased number of platelets in the blood (thrombocytopenia)
• decreased number of white blood cells in the blood (leucopenia/agranulocytosis)
• reduced haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia)
• dizziness
• stomach and intestinal disturbances
• abnormal liver function
• inflammation of the liver (hepatitis)
• red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• reduced kidney function (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• blood in the urine (haematuria)
• cessation or reduction in urine production (anuria)
• severe condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2). Very rare cases of serious skin reactions have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 TACHIPIRINAKID

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Shelf life after first opening: 1 year.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp." The expiry date refers to the last day of that month.
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. Package contents and other information

What TACHIPIRINAKID contains

• The active substance is paracetamol (each ml of suspension contains 24 mg of paracetamol).
• The other components are: sorbitol, sucrose, xanthan gum, disodium edetate (dihydrate), methyl 4-hydroxybenzoate, microcrystalline cellulose and sodium carmellose (Avicel RC591), sodium citrate, sodium chloride, potassium sorbate, anhydrous colloidal silica, citric acid monohydrate, vanillin-caramel flavour, purified water.

Description of the appearance of TACHIPIRINAKID and package contents
TACHIPIRINAKID is a homogeneous suspension, white milky to slightly brownish in colour, contained in a 120 ml amber-coloured bottle closed with a safety cap.
The package also includes an oral syringe and a dosing cup to facilitate dose calculation according to the child's body weight.

Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy.

Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy.