TACHIPIRINA 50 mg Tabletki Orodispersyjne

Treść ulotki

1. TACHIPIRINA FLASHTAB 125 mg dispersible tablets
   1. WHAT IS TACHIPIRINA FLASHTAB 125 mg AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING TACHIPIRINA FLASHTAB
   3. HOW TO TAKE TACHIPIRINA FLASHTAB 125 mg
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TACHIPIRINA FLASHTAB 125 mg
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. TACHIPIRINA FLASHTAB 250 mg dispersible tablets
   1. WHAT IS TACHIPIRINA FLASHTAB 250 MG AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING TACHIPIRINA FLASHTAB
   3. HOW TO TAKE TACHIPIRINA FLASHTAB 250 MG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TACHIPIRINA FLASHTAB 250 MG
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. TACHIPIRINA FLASHTAB 500 mg orodispersible tablets
   1. WHAT IS TACHIPIRINA FLASHTAB 500 MG AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TACHIPIRINA FLASHTAB 500
   3. HOW TO TAKE TACHIPIRINA FLASHTAB 500 MG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TACHIPIRINA FLASHTAB 500 mg
   6. PACKAGE CONTENTS AND OTHER INFORMATION

TACHIPIRINA FLASHTAB 125 mg dispersible tablets

Paracetamol
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 or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you take 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 IS TACHIPIRINA FLASHTAB 125 mg AND WHAT IS IT USED FOR

This medicine is an analgesic and an 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 contractions or other painful manifestations.
This medicine is reserved for CHILDREN weighing between 7 and 25 kg (approximately from 6
months to 10 years). See section 3.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TACHIPIRINA FLASHTAB

125 mg
Do not take TACHIPIRINA FLASHTAB 125 mg:
if you are allergic to paracetamol or any of the other ingredients of this
medicine (listed in section 6).
if you suffer from severe liver disease
if you suffer from phenylketonuria (a hereditary 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)
if you suffer from a liver disease
1/21
if you suffer from chronic alcoholism
if you suffer from chronic malnutrition
if you suffer from dehydration
if you suffer from a kidney disease
if you are taking other medicines that have an effect on liver function
During treatment with TACHIPIRINA FLASHTAB 125 mg, immediately inform your
doctor 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
in these situations, a serious condition called metabolic acidosis
(an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a
prolonged period or when paracetamol is taken in combination with flucloxacillin. The
symptoms of metabolic acidosis may include: severe breathing difficulties with
deep rapid breathing, drowsiness, nausea and vomiting.
You need to reduce the amount of paracetamol you take 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
during treatment with this medicine, do not take any other medicine that
contains paracetamol.

Children
The total dose of paracetamol should not exceed 80 mg/kg per day for children
weighing less than 37 kg and 3 g per day in children weighing more than 38 kg. See
section: If you take moreTACHIPIRINA FLASHTAB 125 mg than you should.
This medicine contains banana flavour which may make the medicine appealing to
children. Keep out of the sight and reach of children.

Other medicines and TACHIPIRINA FLASHTAB 125 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 125 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 (antibiotic), St. John's Wort or Hypericum perforatum (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 in the treatment of 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 alterations in blood and fluids (called metabolic acidosis) that need to be treated urgently (see section 2).

Pregnancy, breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
If necessary, Tachipirina Flashtab can be used during pregnancy. It is advisable to use the
lowest possible dose that relieves pain and/or fever and take it for the shortest possible time.
Contact your doctor if the pain and/or fever does not decrease or if you need to take the
medicine more often.

Driving and operating machinery
TACHIPIRINA FLASHTAB 125 mg does not impair the ability to drive or operate machinery.

TACHIPIRINA FLASHTAB 125 mg containsaspartame
This medicine contains 15 mg of aspartame in each tablet. Aspartame is a
source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic
condition that causes a build-up of phenylalanine because the body cannot break it down
correctly.

Laboratory tests
If you are going to have blood tests to check your 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 following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This formulation is reserved for children weighing between 7 and 25 kg (approximately from 6
months to 10 years).
For children under 6 years of age, the tablets should be dissolved in a spoonful of water
or milk (there is a risk they may experience a bitter taste if taken with fruit juices) before
being administered to them.
For children over 6 years of age, the tablets can be sucked – they dissolve
very quickly in the mouth upon contact with saliva.

Method of administration
Instructions for opening
3/21
This medicine is available in perforated single-dose blisters, with child-resistant removable film
Separate a single dose by tearing along the perforated line on the blister and remove the film
from the blister to extract the tablet.

Dosage:
In children, it is essential to respect the dosage defined on the basis of body weightand
therefore choose the appropriate formulation. The approximate ages based on body weight
are provided for informational purposes.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, in
4 or 6 daily administrations, i.e. about 15mg/kg every 6 hours or 10mg/kg every 4 hours.

• In children weighing between 7 and 10kg: (approximately between 6 and 18 months), the recommended dose is 1 tablet at a time, to be repeated if necessary after 6 hours, withoutexceeding 4 tablets per day.
• In children weighing between 11 and 12kg: (approximately between 18 and 24 months), the recommended dose is 1 tablet at a time, to be repeated if necessary after 4 hours, withoutexceeding 6 tablets per day.
• In children weighing between 13 and 20kg: (approximately between 2 and 7 years), the recommended dose is 2 tablets at a time, to be repeated if necessary after 6 hours, withoutexceeding 8 tablets per day.
• In children weighing between 21 and 25kg: (approximately between 6 and 10 years), the recommended dose is 2 tablets at a time, to be repeated if necessary after 4 hours, withoutexceeding 12 tablets per day.

Special patient groups:
For patients with impaired liver or kidney function or with Gilbert's Syndrome, the doctor will adjust the dose,
For patients with severe renal failure, the interval between the two doses should be at least
8 hours.
Consult your doctor or pharmacist before taking Tachipirina Flashtab in the following
conditions:

• Weight less than 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 dosage instructions to avoid pain or recurrence of fever.
In children, administration should be carried out at regular intervals, including at
night, preferably at intervals of 6 hours, 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 125 mg than you should
Stop treatment immediately and seek medical attention immediately.
Symptoms of overdose usually appear within the first 24 hours and include:
nausea, vomiting, loss of appetite, pale skin (extreme pallor) and abdominal pain.

Immediately inform your doctor in case of accidental intake of an
excessive dose of the medicine even if the patient does not show any concerning signs, as
there is a risk of delayed presentation of serious 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 gets them.
Possible side effects are:
Rare (may affect up to 1 in 1,000 ): Increased level of liver enzymes
(transaminases).
Very rare (may affect up to 1 in 10,000): Allergic reactions: rash or
skin eruption with itchy blisters, swelling of the face or tongue, shortness of breath or
difficulty breathing which may be a serious allergic reaction.

If a serious 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 available data:

• Decrease or increase of liver enzymes (damage caused to the liver)
• Blood disorders: decrease in the number of platelets in the blood resulting in bleeding from the nose or gums and decrease in the number of white blood cells in the blood resulting in increased susceptibility to infections.

5/21

• Severe condition that can 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister and on the package
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in 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 TACHIPIRINA FLASHTAB 125 mg contains

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

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

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
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 - ACRAF S.p.A. Via Vecchia del Pinocchio, 22 - 60131 Ancona
• Delpharm Novara S.r.l - Via Crosa, 86 28065 Cerano (NO) - Italy

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations :
Denmark:Pamol Flash

Finland:Pamol F

France:Paracetamol Prographarm

Italy:Tachipirina Flashtab
7/21

TACHIPIRINA FLASHTAB 250 mg dispersible tablets

Paracetamol
Read this leaflet carefully before taking this medicinebecause it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you take TACHIPIRINA FLASHTAB 250 mg
• 3. How to take TACHIPIRINA FLASHTAB 250 mg
• 4. Possible side effects
• 6. How to store TACHIPIRINA FLASHTAB 250 mg
• 6. Contents of the pack and other information

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

This medicine is an analgesic and an 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 contractions or other painful manifestations.
This medicine is reserved for CHILDREN weighing between 13 and 50 kg (approximately 2
to 15 years). See section 3.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TACHIPIRINA FLASHTAB

250 MG
Do not take TACHIPIRINA FLASHTAB 250 mg:
if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
if you have severe liver disease
if you suffer from phenylketonuria (a hereditary condition detected at birth), as this medicine 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)
if you have a liver disease
8/21
if you suffer from chronic alcoholism
if you suffer from chronic malnutrition
if you suffer from dehydration
if you have a kidney disease
if you are taking other medicines that affect liver function
During treatment with TACHIPIRINA FLASHTAB 250 mg, immediately inform your doctor 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 in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. The symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
You need to reduce the amount of paracetamol you take 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
during treatment with this medicine, do not take any other medicine that
contains paracetamol.

Children
The total dose of paracetamol should not exceed 80 mg/kg per day for 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 medicine contains banana flavour which may make the medicine appealing to children. Keep out of the sight and reach of children.

Other medicines and TACHIPIRINA FLASHTAB 250 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Always tell 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 (antibiotic), St. John's Wort or Hypericum perforatum (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)
• cholestyramine (used in the treatment of 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 alterations in blood and fluids (called metabolic acidosis) that need to be treated urgently (see section 2).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Tachipirina Flashtab can be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or fever does not decrease or if you need to take the medicine more often.

Driving and operating machinery
TACHIPIRINA FLASHTAB 250 mg does not impair the ability to drive or operate machinery.

TACHIPIRINA FLASHTAB 250 mg
contains aspartame
This medicine contains 30 mg of aspartame in each tablet. Aspartame is a
source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic
condition that causes phenylalanine to build up because the body cannot process it
correctly.

Laboratory tests
If you are going to have blood tests to check your glucose or uric acid levels, make sure to
tell your doctor that you are taking TACHIPIRINA FLASHTAB 250 mg.

3. HOW TO TAKE TACHIPIRINA FLASHTAB 250 MG

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This formulation is reserved for children weighing between 13 and 50 kg (approximately 2
to 15 years).
For children under 6 years of age, the tablets must be dissolved in a spoonful of water
or milk (there is a risk that they may taste bitter if taken with fruit juices) before
being administered to them.
For children over 6 years of age, the tablets can be sucked, they dissolve
very quickly in the mouth, on contact with saliva.

Method of administration
Instructions for opening
This medicine is available in perforated single-dose blisters, with a child-resistant removable film.
10/21
Separate a single dose by tearing along the perforated line on the blister and remove the film
from the blister to extract the tablet.

Dosage:
In children, it is essential to respect the dosage defined on the basis of body weightand
therefore choose the appropriate formulation. The approximate ages based on body weight
are provided for informational purposes.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, in
4 or 6 daily administrations, i.e. approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• In children weighing between 13 and 20 kg(approximately between 2 and 7 years): the recommended dose is 1 tablet at a time, to be repeated if necessary after 6 hours, withoutexceeding 4 tablets per day.
• In children weighing between 21 and 25 kg(approximately between 6 and 10 years): the recommended dose is 1 tablet at a time, to be repeated if necessary after 4 hours, withoutexceeding 6 tablets per day.
• In children weighing between 26 and 40 kg(approximately between 8 and 13 years): the recommended dose is 2 tablets at a time, to be repeated if necessary after 6 hours, withoutexceeding 8 tablets per day.
• In children weighing between 41 and 50 kg(approximately between 12 and 15 years): the recommended dose is 2 tablets at a time, to be repeated if necessary after 4 hours, withoutexceeding 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 failure, the interval between the two doses should be at least
8 hours.
Consult your doctor or pharmacist before taking TACHIPIRINA FLASHTAB in the
following conditions:

• Weight less than 50 Kg in an adult
• Chronic alcoholism
• Dehydration
• Chronic malnutrition

11/21
If you feel that the effect of TACHIPIRINA FLASHTAB 250 mg is too strong or
too weak, consult your doctor or pharmacist.
Follow the dosage instructions to avoid pain or the return of fever.
In children, administration should be carried out at regular intervals, including at
night, preferably at intervals of 6 hours, 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
Immediately stop treatment and seek medical attention immediately.
Symptoms of overdose usually appear within the first 24 hours and include:
nausea, vomiting, loss of appetite, pale skin (extreme pallor) and abdominal pain.

Immediately inform your doctor in case of accidental ingestion of an
excessive dose of the medicine even if the patient does not show any worrying signs, as
there is a risk of delayed presentation 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 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 everyone will experience them.
Possible side effects are:
Rare (may affect up to 1 in 1,000 ): increased level of liver enzymes
(transaminases).
Very rare (may affect up to 1 in 10,000): allergic reactions: rash or
skin eruption with itchy blisters, swelling of the face or tongue, shortness of breath or
difficulty breathing which may reveal a serious allergic reaction.

If a serious allergic reaction occurs, stop taking TACHIPIRINA
FLASHTAB 250 mg and consult a doctor immediately.
Skin reactions: very rare cases of serious skin reactions have been reported.
Not known (frequency cannot be estimated based on available data):

• Decrease or increase of liver enzymes (damage caused to the liver)
• Blood disorders: decrease in the number of platelets in the blood resulting in bleeding from the nose or gums and decrease in the number of white blood cells in the blood resulting in increased susceptibility to infections.

12/21

• Serious condition that can make the blood more acidic (called metabolic acidosis), in patients suffering from 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, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 which is reported on the blister and on the package
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in 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 TACHIPIRINA FLASHTAB 250 mg contains

• The active ingredient is: paracetamol. Each tablet contains 250 mg of paracetamol (as paracetamol crystals coated). The other ingredients are: basic butylated methacrylate copolymer, 30% polyacrylate dispersion, silica (hydrophobic colloidal), mannitol (granules, powder), crospovidone, aspartame (E951), banana flavour, magnesium stearate.

Description of the appearance of TACHIPIRINA FLASHTAB 250 mg and package contents
Tachipirina Flashtab are dispersible tablets, white in colour, round, biconvex, with a
central concavity and a characteristic banana flavour.
Pack of 12 tablets in perforated single-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 ROME
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
• Delpharm Novara S.r.l - Via Crosa, 86 - 28065 Cerano (NO) - Italy

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Denmark:Pamol Flash

Finland:Pamol F

France:Efferalgan

Italy:Tachipirina Flashtab
14/21

TACHIPIRINA FLASHTAB 500 mg orodispersible tablets

Paracetamol
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 or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you take 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 IS TACHIPIRINA FLASHTAB 500 MG AND WHAT IS IT USED FOR

This medicine is an analgesic and an 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 contractions or other painful manifestations.
It is a medicinal product for adults and for children weighing more than 27 Kg
(approximately 8 years old).
For children weighing less than 27 kg, other formulations of paracetamol are available:
ask your doctor or pharmacist for advice.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TACHIPIRINA FLASHTAB 500

MG
Do not take TACHIPIRINA FLASHTAB 500 mg:

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe liver disease
• if you suffer from phenylketonuria (a hereditary 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 suffer from a liver disease
if you suffer from chronic alcoholism
if you suffer from chronic malnutrition
if you suffer from dehydration
if you suffer from a kidney disease
if you are taking other medicines that have an effect on liver function
During treatment with TACHIPIRINA FLASHTAB 500 mg, immediately inform your
doctor 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
in these situations, a serious condition called metabolic acidosis
(an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a
prolonged period or when paracetamol is taken in combination with flucloxacillin. The
symptoms of metabolic acidosis may include: severe difficulty breathing with
rapid deep breathing, drowsiness, nausea and vomiting.
You need to reduce the amount of paracetamol you take 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
during treatment with this medicine, do not take any other medicine that
contains paracetamol.

Children
This medicine should not be given to children weighing less than 27 Kg.
In children treated with paracetamol, the association with other medicines that reduce
fever (antipyretics) is justified only in case of ineffectiveness. The association must be
started and monitored only by a doctor.
This medicine contains ribes flavour which may make the medicine palatable to
children. Keep out of the 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 tell 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 (antibiotic), St. John's Wort or Hypericum perforatum (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)

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• colestyramine (used in the treatment of 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 changes in blood and fluids (called metabolic acidosis) that need to be treated urgently (see section 2).

Pregnancy and breastfeeding
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.
If necessary, Tachipirina Flashtab can be used during pregnancy. It is advisable to use the
lowest possible dose that relieves pain and/or fever and take it for the shortest possible time.
Contact your doctor if the pain and/or fever does not decrease or if you need to take the
medicine more often.

Driving and operating machinery
TACHIPIRINA FLASHTAB 500 mg does not impair the ability to drive or operate machinery.

TACHIPIRINA FLASHTAB 500 mg contains aspartame
This medicine contains 40 mg of aspartame in each tablet. Aspartame is a
source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic
condition that causes phenylalanine to build up because the body cannot process it
correctly.

Laboratory tests
If you need to have blood tests to check your glucose or uric acid levels, make sure to
tell your doctor that you are taking TACHIPIRINA FLASHTAB 500 mg.

3. HOW TO TAKE TACHIPIRINA FLASHTAB 500 MG

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have 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 can also be dissolved in
half a glass of water.

Method of administration
Instructions for opening
This medicine is available in perforated single-dose blisters, with a child-resistant removable film

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

Dosage
This medicine is for adults and children weighing more than 27 kg (approximately 8
years),

Use the minimum effective dose for the shortest period of time.Use the 1000 mg dose in
case of pain and/or fever not relieved by a 500 mg dose of paracetamol.
The dose depends on the weight. Ages are provided for information only. If you do not know your
child's weight, you must weigh them in order to administer the appropriate dose of paracetamol. The
recommended daily dose should be divided into several doses, without exceeding the maximum
value indicated in the table below:

Weight
(Approximate age)
Maximum dose perInterval of
administration
Maximum
administrationdaily dose
2000 mg per day

Children 27 kg – 40 kg500 mg
(1 tablet)
Every 6 hours i.e. 2 g
(4 tablets)
(approx. 8 - 12 years)
3000 mg per day

Children 41 kg - 49 kg500 mg
(1 tablet)
Every 4 hours i.e. 3 g
(6 tablets)
(approx. 13 - 15 years)
from 500 mg to 1000 mg
3000 mg per day

Adults and children from 50 kg onwardsi.e. 500 mg up to 1
Every 4 hours i.e. 3 g
(6 tablets)
(approx. 15 years) g
(1 to 2 tablets)
Warning: to avoid the risk of overdose, consider all medicines containing
paracetamol (with or without a prescription).
Special patient groups:
For patients with impaired liver or kidney function or with Gilbert's Syndrome, the doctor will adjust the dose.
For patients with severe renal failure, the interval between the two doses must be at least 8
hours.
Do not take more than 4 tablets per day in the following situations, unless indicated by your doctor:

• Weight less than 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.
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Follow the dosage instructions to avoid pain or the recurrence of fever.
You should consult a doctor if symptoms worsen or do not improve after 3 days.

If you take more TACHIPIRINA FLASHTAB 500 mg than you should
Stop treatment immediately and seek medical attention immediately.
Symptoms of overdose usually appear within the first 24 hours and include: nausea,
vomiting, loss of appetite, pale skin (extreme pallor) and abdominal pain.

Immediately warn your doctor in case of accidental ingestion of an
excessive dose of the product even if the patient does not show worrying signs, as
there is a risk of delayed presentation of serious 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 gets them.
Possible side effects:
Rare (may affect up to 1 in 1,000 people): increased level of liver enzymes
(transaminases).
Very rare (may affect up to 1 in 10,000 people): allergic reactions: rash or
blistering skin rash with itching, swelling of the face or tongue, shortness of breath or
difficulty breathing which may be a serious allergic reaction.

If a serious allergic reaction occurs, stop taking TACHIPIRINA
FLASHTAB 500 mg and consult a doctor immediately.
Skin reactions: very rare cases of serious skin reactions have been reported.
Not known (frequency cannot be estimated based on available data):

• Decrease or increase of liver enzymes (damage caused to the liver)
• Blood disorders: decrease in the number of platelets in the blood with consequent bleeding from the nose or gums and decrease in the number of white blood cells in the blood with consequent increased susceptibility to infections
• Serious condition that can make the blood more acidic (called metabolic acidosis), in patients suffering from a serious illness who use paracetamol (see section 2)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at http://www.aifa.gov.it/content/
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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 which is stated on the blister and the packaging
after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in 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 TACHIPIRINA FLASHTAB 500 mg contains
The active ingredient is: paracetamol.
Each tablet contains 500 mg of paracetamol (as paracetamol crystals with a coating).
The other ingredients are: basic butyl methacrylate copolymer, polyacrylate dispersion
at 30%, silica (hydrophobic colloidal), mannitol (granules, powder), crospovidone, aspartame
(E951), blackcurrant flavour, magnesium stearate.

Description of the appearance of TACHIPIRINA FLASHTAB 500 mg and package contents
Tachipirina Flashtab are orodispersible tablets, white in colour, round, biconvex,
with a central concavity and a characteristic blackcurrant flavour.
Packs of 2, 4, 6, 8, 12 or 16 tablets in perforated single-dose blisters, with child-resistant
removable foil.
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 n. 70 - 00181 ROME

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

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This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Denmark:Pamol Flash

Finland:Pamol F

France:Dolflash

Italy:Tachipirina Flashtab
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