Tachipirina FlashTab

PACKAGE LEAFLET: INFORMATION FOR THE USER

TACHIPIRINA FLASHTAB 125 mg dispersible tablets

Paracetamol
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• 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 your symptoms worsen after three days.

Contents of this leaflet:

1. What TACHIPIRINA FLASHTAB 125 mg is and what it is used for
2. What you need to know before taking TACHIPIRINA FLASHTAB 125 mg
3. How to take TACHIPIRINA FLASHTAB 125 mg
4. Possible side effects
5. How to store TACHIPIRINA FLASHTAB 125 mg
6. Contents of the pack and other information

1. WHAT TACHIPIRINA FLASHTAB 125 mg IS AND WHAT IT IS USED FOR

This medicinal product is an analgesic and antipyretic. It contains paracetamol.
It is indicated for the symptomatic treatment of fever and/or mild to moderate pain, such as
headache, influenza-like symptoms, toothache, muscle cramps, or other painful conditions.
This medicinal product is intended for CHILDREN weighing between 7 and 25 kg (approximately from 6
months to 10 years of age). See section 3.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TACHIPIRINA FLASHTAB

125 mg
Do not take TACHIPIRINA FLASHTAB 125 mg:
if you are allergic to paracetamol or to any of the other ingredients of this
medicine (listed in section 6).
if you have severe liver disease
if you have phenylketonuria (an inherited condition detected at birth), as this
medicine contains aspartame.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tachipirina Flashtab 125 mg if:
you weigh less than 50 kg (if you are an adult)
you have liver disease
1/21
you suffer from chronic alcoholism
you suffer from chronic malnutrition
you are dehydrated
you have kidney disease
you are taking other medicines that affect liver function

During treatment with TACHIPIRINA FLASHTAB 125 mg, inform your doctor immediately if:
you have serious illnesses, including severe kidney 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 body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
You may need to reduce the amount of paracetamol taken or avoid taking the product altogether.
In case of acute viral hepatitis, stop treatment and consult your doctor.

This medicine contains paracetamol. To avoid the risk of overdose,
do not take any other medicine containing paracetamol during treatment with this medicine.

Children
The total daily dose of paracetamol must not exceed 80 mg/kg per day in children weighing less than 37 kg and 3 g per day in children weighing more than 38 kg. See section: If you take more TACHIPIRINA FLASHTAB 125 mg than you should.
This medicine contains banana flavouring, which may make it attractive to children. Keep out of sight and reach of children.

Other medicines and TACHIPIRINA FLASHTAB 125 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor or pharmacist if you are taking any of the following medicines before taking TACHIPIRINA FLASHTAB 125 mg:

• probenecid (used in the treatment of gout)
• salicylamide (used as an antipyretic)
• enzyme inducers such as carbamazepine, phenobarbital, phenytoin, primidone (used as antiepileptic), rifampicin (antibacterial), St. John’s wort (herbal medicine used in the treatment of mild to moderate depression), etc.
• metoclopramide and domperidone (used in the treatment and prevention of nausea and vomiting)

2/21

• cholestyramine (used to treat high levels of lipids (fats) in the blood)
• anticoagulants such as warfarin (used to prevent blood clotting)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) that require urgent treatment (see section 2).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, Tachipirina Flashtab 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 improve or if you need to take the medicine more frequently.

Driving and using machines
TACHIPIRINA FLASHTAB 125 mg does not affect the ability to drive or operate machinery.

TACHIPIRINA FLASHTAB 125 mg contains aspartame
This medicine contains 15 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

Laboratory tests
If you need blood tests to check glucose or uric acid levels, make sure to inform your doctor that you are taking TACHIPIRINA FLASHTAB 125 mg.

3. HOW TO TAKE TACHIPIRINA FLASHTAB 125 mg

Take 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.
This formulation is intended for children weighing between 7 and 25 kg (approximately from 6 months to 10 years of age).
For children under 6 years of age, the tablets must be dissolved in a spoonful of water or milk (there is a risk they may taste bitter if taken with fruit juice) before administration.
For children over 6 years of age, the tablets may be sucked – they dissolve very quickly in the mouth upon contact with saliva.

Method of administration
Instructions for opening
3/21
This medicine is supplied in single-dose blisters with a removable child-resistant foil.

Separate a single dose by tearing along the perforated line on the blister and remove the foil to extract the tablet.

Dosage:
In children, it is essential to follow the dosage based on body weight, and therefore select the appropriate formulation. Approximate age ranges corresponding to body weight are provided for informational purposes only.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, given in 4 or 6 divided doses, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• In children weighing 7 to 10 kg (approximately 6 to 18 months): the recommended dose is 1 tablet at a time, repeated if necessary after 6 hours, not exceeding 4 tablets per day.
• In children weighing 11 to 12 kg (approximately 18 to 24 months): the recommended dose is 1 tablet at a time, repeated if necessary after 4 hours, not exceeding 6 tablets per day.
• In children weighing 13 to 20 kg (approximately 2 to 7 years): the recommended dose is 2 tablets at a time, repeated if necessary after 6 hours, not exceeding 8 tablets per day.
• In children weighing 21 to 25 kg (approximately 6 to 10 years): the recommended dose is 2 tablets at a time, repeated if necessary after 4 hours, not exceeding 12 tablets per day.

Special patient groups:
For patients with impaired hepatic or renal function or with Gilbert's Syndrome, the doctor will adjust the dose.
For patients with severe renal insufficiency, the interval between doses should be at least 8 hours.

Consult your doctor or pharmacist before taking Tachipirina Flashtab under the following conditions:

• Body weight below 50 kg in an adult
• Chronic alcoholism
• Dehydration

4/21

• Chronic malnutrition

If you feel that the effect of TACHIPIRINA FLASHTAB 125 mg is too strong or too weak, consult your doctor or pharmacist.
Follow the dosing instructions to prevent pain or recurrence of fever.
In children, administration should be performed at regular intervals, including during the night, preferably every 6 hours, or otherwise at intervals of no less than 4 hours.
You should consult a doctor if symptoms worsen or do not improve within 3 days.

If you take more TACHIPIRINA FLASHTAB 125 mg than you should
Stop treatment immediately and contact your doctor right away.
Symptoms of overdose usually appear within the first 24 hours and may include: nausea, vomiting, loss of appetite, pallor (extreme paleness), and abdominal pain.
Inform your doctor immediately in case of accidental overdose, even if the patient shows no apparent signs, as there is a risk of delayed onset of severe and irreversible liver damage.

If you forget to take TACHIPIRINA FLASHTAB 125 mg
Do not take a double dose to make up for the missed tablet.

If you have any doubts about the use of 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.
Possible side effects are:

Rare (may affect up to 1 in 1,000 people): Increase in liver enzyme levels (transaminases).

Very rare (may affect up to 1 in 10,000 people): Allergic reactions: rash or blistering, itchy skin rash, facial or tongue swelling, shortness of breath or breathing difficulties, which may turn into a severe allergic reaction.
If a severe allergic reaction occurs, stop taking TACHIPIRINA FLASHTAB 125 mg and consult your doctor immediately.

Skin reactions: Very rare cases of serious skin reactions have been reported.

Not known (frequency cannot be estimated from the available data):

• Decrease or increase in liver enzymes (liver damage)

• Blood disorders: reduction in the number of platelets in the blood, leading to nosebleeds or bleeding gums, and reduction in the number of white blood cells in the blood, resulting in increased susceptibility to infections.

• Severe condition that may cause the blood to become more acidic (called metabolic acidosis), in patients with serious underlying diseases who are taking paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, 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 http://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 TACHIPIRINA FLASHTAB 125 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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. PACK CONTENTS AND OTHER INFORMATION

What TACHIPIRINA FLASHTAB 125 mg contains

• The active substance is: paracetamol. Each tablet contains 125 mg of paracetamol (as coated paracetamol crystals).
  The other components are: Basic butyl methacrylate copolymer, 30% polyacrylate dispersion, silica (colloidal hydrophobic), mannitol (granules, powder), crospovidone, aspartame (E951), banana flavour, magnesium stearate.

Description of the appearance of TACHIPIRINA FLASHTAB 125 mg and pack contents
Tachipirina Flashtab are white, round, biconvex, dispersible tablets with a central concavity and a characteristic banana aroma.
Pack: 12 tablets in single-dose blisters with child-resistant peelable film.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia No. 70 - 00181 ROMA
6/21

Manufacturer responsible for batch release:

• Ethypharm - Zone Industrielle de Saint-Arnoult, 28170 Chateauneuf-en-Thymerais - France
• Ethypharm - Chemin de la Poudrière, 76120 Grand Quevilly - France
• Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona - Italy
• Delpharm Novara S.r.l. - Via Crosa, 86, 28065 Cerano (NO) - Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Pamol Flash
Finland: Pamol F
France: Paracetamol Prographarm
Italy: Tachipirina Flashtab
7/21

PATIENT LEAFLET: INFORMATION FOR THE USER

TACHIPIRINA FLASHTAB 250 mg dispersible tablets

Paracetamol
Read this entire leaflet carefully before taking this medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after three days.

Contents of this leaflet:

1. What TACHIPIRINA FLASHTAB 250 mg is and what it is used for
2. What you need to know before taking TACHIPIRINA FLASHTAB 250 mg
3. How to take TACHIPIRINA FLASHTAB 250 mg
4. Possible side effects
5. How to store TACHIPIRINA FLASHTAB 250 mg
6. Contents of the pack and other information

1. WHAT TACHIPIRINA FLASHTAB 250 MG IS AND WHAT IT IS USED FOR

This medicinal product is an analgesic and antipyretic. It contains paracetamol.
It is indicated for the symptomatic treatment of fever and/or mild to moderate pain, such as
headache, flu-like syndromes, toothache, muscle cramps, or other painful conditions.
This medicinal product is intended for CHILDREN weighing between 13 and 50 kg (approximately from 2 to 15 years of age). See section 3.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TACHIPIRINA FLASHTAB

250 MG
Do not take TACHIPIRINA FLASHTAB 250 mg:
if you are allergic to paracetamol or to any of the other ingredients of this
medicinal product (listed in section 6)
if you have severe liver disease
if you have phenylketonuria (a hereditary disease identified at birth), as this medicinal product contains aspartame.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tachipirina Flashtab 250 mg if:
you weigh less than 50 kg (if you are an adult)
you have liver disease
8/21
you suffer from chronic alcoholism
you have chronic malnutrition
you are dehydrated
you have kidney disease
you are taking other medicines that affect liver function

During treatment with TACHIPIRINA FLASHTAB 250 mg, inform your doctor immediately if:
you have serious illnesses, including severe kidney 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 body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
You must reduce the amount of paracetamol taken or avoid taking the product altogether.
In case of acute viral hepatitis, stop treatment and consult your doctor.

This medicinal product contains paracetamol. To avoid the risk of overdose,
do not take any other medicine containing paracetamol during treatment with this medicinal product.

Children
The total daily dose of paracetamol must not exceed 80 mg/kg per day in children weighing less than 37 kg and 3 g per day in adults or children weighing more than 38 kg.
See section: If you take more TACHIPIRINA FLASHTAB 250 mg than you should.
This medicinal product contains banana flavouring, which may make it attractive to children. Keep out of sight and reach of children.

Other medicines and TACHIPIRINA FLASHTAB 250 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor or pharmacist if you are taking any of the following medicines before taking TACHIPIRINA FLASHTAB 250 mg:

• probenecid (used in the treatment of gout)
• salicylamide (used as an antipyretic)
• enzyme inducers such as carbamazepine, phenobarbital, phenytoin, primidone (used as an antiepileptic), rifampicin (antibacterial), St. John’s wort (herbal medicine used in the treatment of mild to moderate depression), etc.
• metoclopramide and domperidone (used to treat and prevent nausea and vomiting)
• colestyramine (used to treat high levels of lipids (fats) in the blood)

9/21

• anticoagulants such as warfarin (used to prevent blood clotting)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalances (called metabolic acidosis) that require urgent treatment (see section 2).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicinal product.
If necessary, Tachipirina Flashtab may be used during pregnancy. It is advisable to use the lowest effective dose that relieves pain and/or fever, for the shortest possible duration. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.

Driving and using machines
TACHIPIRINA FLASHTAB 250 mg does not impair the ability to drive or use machinery.

TACHIPIRINA FLASHTAB 250 mg
contains aspartame
This medicinal product contains 30 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

Laboratory tests
If you are scheduled for blood tests to measure glucose or uric acid levels, make sure to inform your doctor that you are taking TACHIPIRINA FLASHTAB 250 mg.

3. HOW TO TAKE TACHIPIRINA FLASHTAB 250 MG

Take 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.
This formulation is intended for children weighing between 13 and 50 kg (approximately from 2 to 15 years of age).
For children under 6 years of age, the tablets should be dissolved in a spoonful of water or milk (they may taste bitter if taken with fruit juice) before administration.
For children over 6 years of age, the tablets can be sucked; they dissolve very rapidly in the mouth upon contact with saliva.

Method of administration
Instructions for opening
This medicine is supplied in single-dose blisters with a child-resistant perforated foil.

Separate a single dose by tearing along the perforated line on the blister, then remove the foil from the blister to extract the tablet.

Dosage:
In children, it is essential to follow the dosage based on body weight, and therefore select the appropriate formulation. Approximate age ranges corresponding to body weight are provided for informational purposes only.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• In children weighing 13 to 20 kg (approximately 2 to 7 years): the recommended dose is 1 tablet at a time, repeated if necessary after 6 hours, not exceeding 4 tablets per day.
• In children weighing 21 to 25 kg (approximately 6 to 10 years): the recommended dose is 1 tablet at a time, repeated if necessary after 4 hours, not exceeding 6 tablets per day.
• In children weighing 26 to 40 kg (approximately 8 to 13 years): the recommended dose is 2 tablets at a time, repeated if necessary after 6 hours, not exceeding 8 tablets per day.
• In children weighing 41 to 50 kg (approximately 12 to 15 years): the recommended dose is 2 tablets at a time, repeated if necessary after 4 hours, not exceeding 12 tablets per day.

Special patient groups:
For patients with impaired hepatic or renal function or with Gilbert's Syndrome, the doctor will adjust the dose.
For patients with severe renal insufficiency, the interval between doses should be at least 8 hours.

Consult your doctor or pharmacist before taking TACHIPIRINA FLASHTAB in the following conditions:

• Body weight below 50 kg in an adult
• Chronic alcoholism
• Dehydration
• Chronic malnutrition

If you feel that the effect of TACHIPIRINA FLASHTAB 250 mg is too strong or too weak, consult your doctor or pharmacist.
Follow the dosing instructions to prevent pain or recurrence of fever.
In children, administration should be carried out at regular intervals, including during the night, preferably every 6 hours, or otherwise at intervals of no less than 4 hours.
You should consult a doctor if symptoms worsen or do not improve after 3 days.

If you take more TACHIPIRINA FLASHTAB 250 mg than you should
Stop treatment immediately and contact your doctor right away.
Symptoms of overdose usually appear within the first 24 hours and may include: nausea, vomiting, loss of appetite, pale skin (extreme pallor), and abdominal pain.
Inform your doctor immediately in case of accidental overdose, even if the patient shows no alarming signs, as there is a risk of delayed onset of serious and irreversible liver damage.

If you forget to take TACHIPIRINA FLASHTAB 250 mg
Do not take a double dose to make up for the missed tablet.

If you have any doubts about how to use 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.
Possible side effects include:
Rare (may affect up to 1 in 1,000 people): increased levels of liver enzymes (transaminases).
Very rare (may affect up to 1 in 10,000 people): allergic reactions: rash or skin eruption with itchy blisters, facial or tongue swelling, shortness of breath or breathing difficulties, which may turn into a severe allergic reaction.
If a severe allergic reaction occurs, stop taking TACHIPIRINA FLASHTAB 250 mg and consult your doctor immediately.
Skin reactions: very rare cases of serious skin reactions have been reported.
Not known (frequency cannot be estimated from the available data):

• Changes in liver enzymes (liver damage), either decrease or increase
• Blood disorders: reduced platelet count leading to bleeding from nose or gums; reduced white blood cell count leading to increased susceptibility to infections

12/21

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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 TACHIPIRINA FLASHTAB 250 MG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the outer box
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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. PACK CONTENTS AND OTHER INFORMATION

What TACHIPIRINA FLASHTAB 250 mg contains

• The active substance is: paracetamol. Each tablet contains 250 mg of paracetamol (as coated paracetamol crystals). The other components are: basic butyl methacrylate copolymer, 30% polyacrylate dispersion, silica (colloidal anhydrous), mannitol (granules, powder), crospovidone, aspartame (E951), banana flavouring, magnesium stearate.

Description of the appearance of TACHIPIRINA FLASHTAB 250 mg and pack contents
Tachipirina Flashtab are dispersible tablets, white in colour, round, biconvex, with a central concavity and characteristic banana aroma.
Pack size: 12 tablets in perforated unit-dose blisters, with child-resistant removable film.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia n. 70 - 00181 ROMA
13/21

Manufacturer responsible for batch release:

• Ethypharm - Zone Industrielle de Saint-Arnoult, 28170 Chateauneuf-en-Thymerais - France
• Ethypharm - Chemin de la Poudrière, 76120 Grand Quevilly - France
• Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 - 60131 Ancona - Italy
• Delpharm Novara S.r.l - Via Crosa, 86 - 28065 Cerano (NO) - Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Pamol Flash
Finland: Pamol F
France: Efferalgan
Italy: Tachipirina Flashtab
14/21

PATIENT LEAFLET: INFORMATION FOR THE USER

TACHIPIRINA FLASHTAB 500 mg orodispersible tablets

Paracetamol
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• 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 your symptoms worsen after three days.

Contents of this leaflet:

1. What TACHIPIRINA FLASHTAB 500 mg is and what it is used for
2. What you need to know before taking TACHIPIRINA FLASHTAB 500 mg
3. How to take TACHIPIRINA FLASHTAB 500 mg
4. Possible side effects
5. How to store TACHIPIRINA FLASHTAB 500 mg
6. Contents of the pack and other information

1. WHAT TACHIPIRINA FLASHTAB 500 MG IS AND WHAT IT IS USED FOR

This medicinal product is an analgesic and antipyretic. It contains paracetamol.
It is indicated for the symptomatic treatment of fever and/or mild to moderate pain, such as
headache, influenza-like syndromes, toothache, muscle cramps, or other painful conditions.
It is a medicinal product for adults and for children weighing more than 30 kg
(approximately 9 years of age).
For children weighing less than 30 kg, other paracetamol formulations are available:
ask your doctor or pharmacist for advice.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TACHIPIRINA FLASHTAB 500 MG

Do not take TACHIPIRINA FLASHTAB 500 mg:

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease
• if you have phenylketonuria (an inherited condition detected at birth), as this medicine contains aspartame.

Warnings and precautions
Talk to your doctor or pharmacist before taking TACHIPIRINA FLASHTAB 500 mg: 15/21
if you weigh less than 50 kg
if you have liver disease
if you suffer from chronic alcoholism
if you suffer from chronic malnutrition
if you are dehydrated
if you have kidney disease
if you are taking other medicines that affect liver function

During treatment with TACHIPIRINA FLASHTAB 500 mg, inform your doctor immediately if:
you have 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 body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
You must reduce the amount of paracetamol taken or avoid taking the product altogether.
In case of acute viral hepatitis, stop treatment and consult your doctor.

This medicine contains paracetamol. To avoid the risk of overdose,
do not take any other medicine containing paracetamol during treatment with this medicine.

Children
This medicine must not be given to children weighing less than 30 kg.
In children treated with paracetamol, combination with other medicines that reduce fever (antipyretics) is justified only if ineffective. Such combination must be initiated and monitored only by a doctor.
This medicine contains a blackcurrant flavouring which may make the medicine appealing to children. Keep out of sight and reach of children.

Other medicines and TACHIPIRINA FLASHTAB 500 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor or pharmacist if you are taking any of the following medicines before taking TACHIPIRINA FLASHTAB 500 mg:

• probenecid (used in the treatment of gout)
• salicylamide (used as an antipyretic)
• enzyme inducers such as carbamazepine, phenobarbital, phenytoin, primidone (used as an antiepileptic), rifampicin (an antibacterial), St. John’s wort (a herbal medicine used in the treatment of mild to moderate depression), etc.
• metoclopramide and domperidone (used in the treatment and prevention of nausea and vomiting)

16/21

• cholestyramine (used in the treatment of high levels of lipids (fats) in the blood)
• anticoagulants such as warfarin (used to prevent blood clotting)
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) which require urgent treatment (see section 2).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Tachipirina Flashtab 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 improve or if you need to take the medicine more frequently.

Driving and using machines
TACHIPIRINA FLASHTAB 500 mg does not affect the ability to drive or operate machinery.

TACHIPIRINA FLASHTAB 500 mg contains aspartame
This medicine contains 40 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

Laboratory tests
If you are scheduled for blood tests to measure glucose or uric acid levels, make sure to inform your doctor that you are taking TACHIPIRINA FLASHTAB 500 mg.

3. HOW TO TAKE TACHIPIRINA FLASHTAB 500 MG

Take 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.
The tablet should be sucked and not chewed.
It dissolves rapidly in the mouth upon contact with saliva. It may also be dissolved in half a glass of water.
Method of administration
Instructions for opening
This medicine is available in single-dose blisters with a child-resistant perforated foil

Separate a single dose by tearing along the perforated line on the blister and remove the foil to extract the tablet.
Dosage
This medicine is intended for adults and children weighing more than 30 kg (approximately 9 years of age).
Use the lowest effective dose for the shortest possible duration. Use a dose of 1000 mg if pain and/or fever are not relieved by a 500 mg dose of paracetamol.
The dose is based on body weight. Age ranges are provided for guidance only. If you do not know your child's weight, you must weigh them to ensure the correct dose of paracetamol is administered. The recommended daily dose should be divided into several doses, without exceeding the maximum values indicated in the table below:

| Weight | Maximum dose per | Dosing interval | Maximum daily dose | |------------|----------------------|---------------------|------------------------| | Children 30 kg – 40 kg | 500 mg | Every 6 hours | 2000 mg per day | | (approx. 9 - 12 years) | (1 tablet) | | (4 tablets) | | Children 41 kg - 49 kg | 500 mg | Every 4 hours | 3000 mg per day | | (approx. 13 - 15 years) | (1 tablet) | | (6 tablets) | | Adults and children ≥ 50 kg | 500 mg to 1000 mg | Every 4 hours | 3000 mg per day | | (approx. 15 years) | (1 to 2 tablets) | | (6 tablets) |

Warning: To avoid the risk of overdose, consider all medications containing paracetamol (with or without prescription).
Special patient groups:
For patients with impaired hepatic or renal function or with Gilbert's syndrome, the doctor will adjust the dose.
For patients with severe renal impairment, the interval between doses should be at least 8 hours.
Do not take more than 4 tablets per day in the following situations, unless otherwise directed by your doctor:

• Weight below 50 kg
• Chronic alcoholism
• Dehydration
• Chronic malnutrition

If you feel that the effect of TACHIPIRINA FLASHTAB 500 mg is too strong or too weak, consult your doctor or pharmacist.
Follow dosage instructions carefully to avoid pain or recurrence of fever.
You should consult a doctor if symptoms worsen or do not improve within 3 days.
If you take more TACHIPIRINA FLASHTAB 500 mg than you should
Stop treatment immediately and contact your doctor right away.
Symptoms of overdose usually appear within the first 24 hours and may include: nausea, vomiting, loss of appetite, pallor (extreme paleness), and abdominal pain.
Contact your doctor immediately in case of accidental overdose, even if the patient shows no alarming signs, as there is a risk of delayed onset of severe and irreversible liver damage.
If you forget to take TACHIPIRINA FLASHTAB 500 mg
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of 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.
Possible side effects:
Rare (may affect up to 1 in 1,000 people): increased levels of liver enzymes (transaminases).
Very rare (may affect up to 1 in 10,000 people): allergic reactions: rash or skin eruption with itchy blisters, facial or tongue swelling, shortness of breath or breathing difficulties, which may indicate a severe allergic reaction.
If a severe allergic reaction occurs, stop taking TACHIPIRINA FLASHTAB 500 mg and consult your doctor immediately.
Skin reactions: very rare cases of serious skin reactions have been reported.
Not known (frequency cannot be estimated from the available data):

• Decrease or increase in liver enzymes (liver damage)
• Blood disorders: reduced platelet count in the blood leading to nosebleeds or bleeding gums, and reduced white blood cell count resulting in increased susceptibility to infections
• Severe condition causing increased acidity of the blood (called metabolic acidosis), in patients with serious underlying illness using paracetamol (see section 2)

Reporting of side effects
If you experience any side effect, 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 http://www.aifa.gov.it/content/21/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TACHIPIRINA FLASHTAB 500 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after EXP.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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. PACK CONTENT AND OTHER INFORMATION

What TACHIPIRINA FLASHTAB 500 mg contains
The active substance is: paracetamol.
Each tablet contains 500 mg of paracetamol (as coated paracetamol crystals).
The other components are: basic butyl methacrylate copolymer, 30% polyacrylate dispersion, silica (colloidal hydrophobic), mannitol (granules, powder), crospovidone, aspartame (E951), blackcurrant flavour, magnesium stearate.

Description of the appearance of TACHIPIRINA FLASHTAB 500 mg and pack contents
Tachipirina Flashtab are white, round, bi-convex orodispersible tablets with a central concavity and characteristic blackcurrant flavour.
Blister packs containing 2, 4, 6, 8, 12 or 16 tablets in perforated single-dose blisters, with child-resistant removable film.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia No. 70 - 00181 ROMA

Manufacturer responsible for batch release:

• Ethypharm - Zone Industrielle de Saint-Arnoult, 28170 Chateauneuf-en-Thymerais - France
• Ethypharm - Chemin de la Poudrière, 76120 Grand Quevilly - France
• Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 - 60131 Ancona
• Delpharm Novara S.r.l - Via Crosa, 86 - 28065 Cerano (NO) - Italy

20/21
This medicinal product is authorised in the European Economic Area Member States
under the following names:
Denmark: Pamol Flash
Finland: Pamol F
France: Dolflash
Italy: Tachipirina Flashtab
21/21