NIROLEX 500 mg Tablet

Зміст інструкції

1. NIROLEX FEBBRE E DOLORE 500 mg tablets
   1. What is NIROLEX FEBBRE E DOLORE and what is it used for
   2. What you need to know before taking NIROLEX FEBBRE E DOLORE
   3. How to take NIROLEX FEBBRE E DOLORE
   4. Possible side effects
   5. How to store NIROLEX FEBBRE E DOLORE
   6. Contents of the pack and other information
2. NIROLEX FEBBRE E DOLORE 500 mg suppositories, ADULTI 1000 mg suppositories
   1. What is NIROLEX FEBBRE E DOLORE and what is it used for
   2. What you need to know before using NIROLEX FEBBRE E DOLORE
   3. How to use NIROLEX FEBBRE E DOLORE
   4. Possible side effects
   5. How to store NIROLEX FEBBRE E DOLORE
   6. Contents of the pack and other information

NIROLEX FEBBRE E DOLORE 500 mg 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 to.

• 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What NIROLEX FEBBRE E DOLORE is and what it is used for
• 2. What you need to know before you take NIROLEX FEBBRE E DOLORE
• 3. How to take NIROLEX FEBBRE E DOLORE
• 4. Possible side effects
• 5. How to store NIROLEX FEBBRE E DOLORE
• 6. Contents of the pack and other information

1. What is NIROLEX FEBBRE E DOLORE and what is it used for

NIROLEX FEBBRE E DOLORE contains the active ingredient paracetamol, which belongs to a group
of medicines known as analgesics and antipyretics, as they work by relieving pain (analgesic action) and
lowering body temperature in case of fever (antipyretic action).
NIROLEX FEBBRE E DOLORE is used to lower fever and provide relief from mild to
moderate pain.
You should see a doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking NIROLEX FEBBRE E DOLORE

Do not take NIROLEX FEBBRE E DOLORE:

• If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIROLEX FEBBRE E DOLORE.
Never exceed the recommended dose.
Stop treatment and consult your doctor immediately if you experience allergic reactions

(see section “Possible side effects”).
Take this medicine with caution:

• if you have kidney problems (renal insufficiency)
• if you suffer from liver problems that reduce its function such as hepatocellular insufficiency including Gilbert's syndrome (a hereditary disease that presents with a yellowish discoloration of the skin), hepatic insufficiency or acute hepatitis
• if you are taking other medicines that alter liver function (See also section “Other medicines and NIROLEX FEBBRE E DOLORE”)
• if you suffer from hemolytic anemia, characterized by a destruction of red blood cells in the blood
• if you have a rare hereditary disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase. In such conditions NIROLEX FEBBRE E DOLORE must be administered only under control

medical supervision, if necessary, reducing the dose or prolonging the interval between individual administrations.
During treatment with NIROLEX FEBBRE E DOLORE, 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 the
paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in
association with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.
Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take
at the same time other products containing paracetamolbecause if paracetamol is taken in
high doses, serious adverse reactions can occur.
Prolonged use of medicines that relieve pain (analgesics), especially at high doses, can
induce headache, which should not be treated with increasing doses of the drug.
In case of prolonged use, your doctor will need to subject you to checks to monitor the functionality of
the liver and kidneys and the ratio between the various blood elements (blood picture).
Do not take higher doses than those recommended because a higher dose can cause serious damage to
the liver or kidneys. For this reason, contact your doctor as soon as possible if you have taken more NIROLEX
FEBBRE E DOLORE than recommended in this leaflet (see section “If you take more
NIROLEX FEBBRE E DOLORE than you should”).
The sudden interruption of taking pain-relieving medicines after a
prolonged period of incorrect use at high doses can cause headache, fatigue, muscle pain, nervousness and withdrawal symptoms that resolve within a few days. Until then,
avoid taking other painkillers and do not start taking them again without consulting your
doctor.
You should consult your doctor if the symptoms persist for more than 3 days, worsen, or new symptoms appear, or if you experience redness or swelling.
Taking this medicine can alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood. Therefore, inform
the analysis center that you are being treated with NIROLEX FEBBRE E DOLORE before undergoing
blood tests.

Other medicines and NIROLEX FEBBRE E DOLORE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Take this medicine with cautionand inform your doctor if you are taking the following medicines:

• medicines that contain paracetamol. During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol (see sections “Warnings and precautions” and “If you take more NIROLEX FEBBRE E DOLORE than you should”)
• medicines that interfere with liver metabolic functions (induction of hepatic monooxygenases):
• rifampicin, an antibiotic used to treat tuberculosis
• medicines used to treat epilepsy (carbamazepine, glutethimide, phenobarbital)
• cimetidine, a medicine used to decrease acid secretion in the stomach, if you use alcohol chronically or excessively and/or are exposed to substances potentially toxic to the liver (see also sections “Warnings and precautions” and “If you take more NIROLEX FEBBRE E DOLORE than you should”)
• medicines used to thin the blood (anticoagulants) e.g. warfarin. In this case your doctor will need to keep you under strict control
• chloramphenicol, an antibiotic used to treat some infections caused by bacteria: paracetamol can prolong the duration of action of chloramphenicol and increase the risk of side effects
• zidovudine, a medicine used to treat AIDS as it increases the risk of lowering a type of white blood cells (neutropenia). The use of this medicine with NIROLEX FEBBRE E DOLORE requires strict medical supervision
• probenecid (a medicine used to treat gout). The doctor will reduce the dose of NIROLEX FEBBRE E DOLORE during concomitant use
• cholestyramine, a medicine used to lower cholesterol levels in the blood as it reduces the effect of paracetamol
• medicines that slow down stomach emptying as they delay the effect of NIROLEX FEBBRE E DOLORE such as:
• anticholinergics, e.g. propantheline used to treat spasms
• medicines that speed up stomach emptying as they increase the effect of NIROLEX FEBBRE E DOLORE such as:
• prokinetics, used to increase the speed of stomach emptying and to relieve symptoms of nausea e.g. metoclopramide
• flucloxacillin (antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis) that must be treated urgently (see paragraph 2).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, NIROLEX FEBBRE E DOLORE can be used in pregnancy. It is advisable to use the
lowest possible dose that relieves pain and/or fever and take it for the shortest possible time.
Avoid taking the medicine in combination with other medicines.
Contact your doctor if the pain and/or fever does not decrease or if you have to take the medicine more
often.
This medicine can be taken during breastfeeding only if necessary and under the
control of your doctor.

Driving and operating machinery
There is no data available regarding the effects of NIROLEX FEBBRE E DOLORE on the ability to
drive vehicles or operate machinery.
Nirolex Febbre e Dolore contains less than 1 mmol (23 mg) of sodiumper tablet, i.e.
essentially ‘sodium-free’.

3. How to take NIROLEX FEBBRE E DOLORE

Take NIROLEX FEBBRE E DOLORE following the instructions contained in this leaflet exactly, or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Do not exceed the recommended doses. Allow at least 6 hours between each dose. If symptoms persist for more than 3 days, consult your doctor.
Take the tablet with a glass of water.
The recommended dose in adultsis 1 tablet, to be repeated if necessary, up to a maximum of 3-4 times a day, allowing at least 6 hours between each dose.

Use in children
The recommended dose in children aged 6 to 12 yearsis half a tablet, to be repeated if necessary, up to a maximum of 3-4 times a day, allowing at least 6 hours between each dose.

Use in patients with liver or kidney problems (hepatic or renal insufficiency)
If you have liver or kidney problems, ask your doctor or pharmacist for advice before taking this medicine (see section “Warnings and precautions”). The dose must be reduced and/or the interval between administrations must be prolonged. If renal function is severely impaired, at least 8 hours must pass between each dose.

If you take more NIROLEX FEBBRE E DOLORE than you should
Paracetamol at very high doses can cause liver toxicity, alterations in kidney, heart and blood function, even serious ones, so in cases of suspected accidental intake of high doses of the medicine immediately notify your doctor or go to the nearest hospital.
The symptoms that generally may appear within the first 24 hours include:

• loss of skin color (pallor)
• lack or reduction of appetite (anorexia)
• nausea and vomiting
• abdominal pain. Symptoms may not reflect the severity of the overdose or the risk of organ damage. Overdose has very serious consequences and can also lead to death. Immediate treatment is essential due to the risk of serious liver damage.

In case of severe poisoning, shock (circulatory collapse), serious kidney damage (acute renal failure), yellowish discoloration (jaundice) and severe unconsciousness (hepatic coma) may occur.
Taking an excessive dose of paracetamol increases the risk of poisoning in the following cases:

• elderly people
• young children
• liver disorders
• chronic or excessive alcohol use
• poor nutrition (chronic malnutrition)
• taking other medicines or substances that alter liver function.

The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
The recommended treatment for overdose in hospital, in addition to common practices (gastric emptying), consists of the administration of substances capable of counteracting the toxic effect of the drug, such as N-acetylcysteine.
Further measures depend on the severity, nature and course of the clinical signs of paracetamol poisoning.

If you forget to take NIROLEX FEBBRE E DOLORE
Do not take a double dose to make up for a missed dose.
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.
The following side effects may occur:

Rare(may affect up to 1 in 1,000 people):

• allergic reactions (hypersensitivity) with swelling of the tongue, larynx and throat which can cause problems with breathing and swallowing (angioedema), reduced blood pressure, breathing problems (dyspnea), rash, erythema, increased sweating and urticaria. If you experience

allergic reactions stop treatment with this medicine and contact your doctor immediately;

• nausea;
• increased liver enzymes (transaminases).

Very rare(may affect up to 1 in 10,000 people):

• reduction of platelets (thrombocytopenia), white blood cells (leukopenia), granulocytes (agranulocytosis), red blood cells (anemia) and all cells (pancytopenia) in the blood;
• bronchospasm (more likely in subjects with a history of bronchial asthma or allergy).

Not known(frequency cannot be estimated based on available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2);
• drug eruption, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis);
• alterations of liver function, liver inflammation (hepatitis), liver damage even severe (see also the paragraph “If you use more NIROLEX FEBBRE E DOLORE than you should”);
• kidney problems (acute renal failure, interstitial nephritis), presence of blood in the urine (hematuria), absence of urine output (anuria);
• stomach and intestinal disorders;
• dizziness (vertigo).

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 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 NIROLEX FEBBRE E DOLORE

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

6. Contents of the pack and other information

What NIROLEX FEBBRE E DOLORE contains

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: povidone, sodium carboxymethylamide, corn starch, colloidal silicon dioxide, stearic acid.

Description of the appearance of NIROLEX FEBBRE E DOLORE and contents of the pack
Pack containing 20 tablets in blisters.

Marketing Authorisation Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genova – Italy.
E-mail: [email protected]

Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli, 103/C – 50066 Reggello (FI) – Italy.

NIROLEX FEBBRE E DOLORE 500 mg suppositories, ADULTI 1000 mg suppositories

Paracetamol
Read this leaflet carefully before using this medicine as 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.

• 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 effects 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 3 days.

Contents of this leaflet:

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

1. What is NIROLEX FEBBRE E DOLORE and what is it used for

NIROLEX FEBBRE E DOLORE contains the active ingredient paracetamol, which belongs to a group
of medicines known as analgesics and antipyretics, as they work by relieving pain (analgesic action) and
lowering body temperature in case of fever (antipyretic action).
NIROLEX FEBBRE E DOLORE is used to reduce fever and relieve mild to
moderate pain.
You should consult a doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before using NIROLEX FEBBRE E DOLORE

Do not use NIROLEX FEBBRE E DOLORE:

• if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using NIROLEX FEBBRE E DOLORE.
Never exceed the recommended dose.

Stop treatment and consult your doctor immediately if you experience allergic reactions
(see section “Possible side effects”).
Use this medicine with caution:

• if you have severe kidney problems (renal insufficiency)
• if you suffer from liver problems that reduce its function, such as hepatocellular insufficiency including Gilbert's syndrome (an inherited condition that presents with a yellowish discoloration of the skin) or acute hepatitis
• if you are taking other medicines that alter liver function (See also section “Other medicines and NIROLEX FEBBRE E DOLORE”)
• if you suffer from hemolytic anemia, characterized by the destruction of red blood cells in the blood
• if you have a rare inherited condition characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase. In such conditions, NIROLEX FEBBRE E DOLORE should only be administered under medical supervision, if necessary, reducing the dose or prolonging the interval between individual administrations.

During treatment with NIROLEX FEBBRE E DOLORE, 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
association with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take
at the same time other products containing paracetamolas if paracetamol is taken in
high doses, serious adverse reactions can occur.
Prolonged use of medicines that relieve pain (analgesics), especially at high doses, can
induce headache, which should not be treated with increasing doses of the drug.
In case of prolonged use, your doctor will need to subject you to checks to monitor the functionality of
the liver and kidneys and the ratio of the various blood elements (blood count).
Do not use doses higher than those recommended because a higher dose can cause serious damage to
the liver or kidneys. For this reason, contact your doctor as soon as possible if you have taken more NIROLEX
FEBBRE E DOLORE than recommended in this leaflet (see section “If you take more
NIROLEX FEBBRE E DOLORE than you should”).
The sudden interruption of taking pain-relieving medicines after a
prolonged period of incorrect use at high doses can cause headache, fatigue, muscle pain,
nervousness and withdrawal symptoms that resolve within a few days. Until then, avoid taking other pain relievers and do not start taking them again without consulting your
doctor.
You should consult your doctor if the symptoms persist for more than 3 days, worsen or if new symptoms appear, or if redness or swelling occurs.
Taking this medicine may alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood. Therefore, inform
the analysis center that you are being treated with NIROLEX FEBBRE E DOLORE before undergoing
blood tests.

Other medicines and NIROLEX FEBBRE E DOLORE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Take this medicine with cautionand inform your doctor if you are taking the following medicines:

• medicines that contain paracetamol. During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol (see sections “Warnings and precautions” and “If you take more NIROLEX FEBBRE E DOLORE than you should”)
• medicines that interfere with liver metabolic functions (induction of hepatic monooxygenases):
• rifampicin, an antibiotic used to treat tuberculosis
• medicines used to treat epilepsy (carbamazepine, glutethimide, phenobarbital)
• cimetidine, a medicine used to decrease acid secretion in the stomach, if you use alcohol chronically or excessively and/or are exposed to substances potentially toxic to

the liver (see also sections “Warnings and precautions” and “If you take more NIROLEX FEBBRE
E DOLORE than you should”)

• medicines used to thin blood (anticoagulants) e.g. warfarin. In this case, your doctor will need to keep you under strict control
• chloramphenicol, an antibiotic used to treat some bacterial infections. Paracetamol may prolong the duration of action of chloramphenicol and increase the risk of side effects
• zidovudine, a medicine used to treat AIDS as it increases the risk of lowering a type of white blood cells (neutropenia). The use of this medicine with NIROLEX FEBBRE E DOLORE requires strict medical supervision
• probenecid (a medicine used to treat gout). The doctor will reduce the dose of NIROLEX FEBBRE E DOLORE during concomitant use
• cholestyramine, a medicine used to lower cholesterol levels in the blood as it reduces the effect of paracetamol
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid alterations (called metabolic acidosis) which must be treated urgently (see paragraph 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, NIROLEX FEBBRE E DOLORE can be used during pregnancy. It is advisable to use the
lowest possible dose that reduces pain and/or fever and take it for the shortest possible time.
Avoid taking the medicine in combination with other medicines.
Contact your doctor if the pain and/or fever does not decrease or if you have to take the medicine more
often.
This medicine can be taken during breastfeeding only if absolutely necessary and under the
control of the doctor.

Driving and using machines
There is no data available regarding the effects of NIROLEX FEBBRE E DOLORE on the ability to
drive vehicles or use machines.
Nirolex Febbre e Dolore contains soy lecithin(E322). If you are allergic to peanuts or soy, do not
use this medicine.

3. How to use NIROLEX FEBBRE E DOLORE

Use NIROLEX FEBBRE E DOLORE following exactly the instructions contained in this leaflet or the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Do not exceed the recommended doses. The suppositories can be administered at intervals of 6-8 hoursas prescribed. If symptoms persist for more than 3 days, consult your doctor.
Before administration, remove the suppository from the blister pack (from the cavity) and administer rectally. To remove the suppository, pull the flaps of the aluminum blister in opposite directions at the marked point.

NIROLEX FEBBRE E DOLORE 500 mg suppositories:
The use of this medicine is reserved for adults and children over 12 years of age.
The recommended dose in adults and children over 12 years of ageis 1 suppository of 500 mg, to be repeated if necessary, up to a maximum of 2-3 times a day, allowing at least 6-8 hours between doses.

NIROLEX FEBBRE E DOLORE ADULTI 1000 mg suppositories:
The recommended dose in adultsis 1 suppository of 1000 mg, to be repeated if necessary, up to a maximum of 2-3 times a day, allowing at least 6-8 hours between doses.

Use in people with liver or kidney problems (hepatic or renal dysfunction)
If you have liver or kidney problems, ask your doctor or pharmacist for advice before using this medicine (see section “Warnings and precautions”). The dose must be reduced and/or the interval between administrations must be prolonged. If renal function is severely impaired, at least 8 hours must elapse between doses.

If you use more NIROLEX FEBBRE E DOLORE than you should
Paracetamol at very high doses can cause liver toxicity, alterations in kidney, heart function, and blood alterations, even serious ones, therefore in cases of suspected accidental intake of high doses of the medicine immediately notify your doctor or go to the nearest hospital.
The symptoms that generally can manifest within the first 24 hours include:

• loss of skin color (pallor)
• lack or reduction of appetite (anorexia)
• nausea and vomiting
• abdominal pain.

The symptoms may not reflect the severity of the overdose or the risk of organ damage.
Overdose has very serious consequences and can also lead to death.
Immediate treatment is essential, due to the risk of severe liver damage.
In the case of severe poisoning, shock (circulatory collapse), severe kidney damage (acute renal failure), yellowish discoloration (jaundice) and severe unconsciousness (hepatic coma) may occur.
Taking an excessive dose of paracetamol increases the risk of poisoning in the following cases:

• elderly people
• small children
• liver disorders
• chronic or excessive alcohol use
• poor nutrition (chronic malnutrition)
• taking other medicines or substances that alter liver function.

The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
The recommended treatment for overdose in hospital, in addition to common practices (gastric emptying), consists of the administration of substances capable of counteracting the toxic effect of the drug, such as N-acetylcysteine.
Further measures depend on the severity, nature and course of the clinical signs of paracetamol poisoning.

If you forget to use NIROLEX FEBBRE E DOLORE
Do not use a double dose to make up for a missed dose.
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.
The following side effects may occur:

Rare(may affect up to 1 in 1,000 people):

• allergic reactions (hypersensitivity) with swelling of the tongue, larynx and throat which can cause problems with breathing and swallowing (angioedema), reduced blood pressure, breathing problems (dyspnea), rash, erythema, increased sweating and urticaria. If you experience allergic reactions, stop treatment with this medicine and contact your doctor immediately;
• nausea;
• increased liver enzymes (transaminases).

Very rare(may affect up to 1 in 10,000 people):

• reduction of platelets (thrombocytopenia), white blood cells (leukopenia), granulocytes (agranulocytosis), red blood cells (anemia) and all cells (pancytopenia) in the blood;
• bronchospasm (more likely in subjects with a history of bronchial asthma or allergy).

Not known(frequency cannot be estimated based on available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2);
• drug rash, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis);
• alterations in liver function, inflammation of the liver (hepatitis), liver damage even severe (see also the paragraph “If you use more NIROLEX FEBBRE E DOLORE than you should”);
• kidney problems (acute renal failure, interstitial nephritis), presence of blood in the urine (hematuria), absence of urine output (anuria);
• stomach and intestinal disorders;
• dizziness (vertigo).

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 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 NIROLEX FEBBRE E DOLORE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.:”. The
expiry date refers to the last day of that month.
500 mg suppositories: Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NIROLEX FEBBRE E DOLORE contains
NIROLEX FEBBRE E DOLORE 500 mg suppositories

• The active ingredient is paracetamol. Each suppository contains 500 mg of paracetamol.
• The other ingredients are: saturated fatty acid glycerides, soybean lecithin (E322).

NIROLEX FEBBRE E DOLORE ADULTI 1000 mg suppositories

• The active ingredient is paracetamol. Each suppository contains 1000 mg of paracetamol.
• The other ingredients are: saturated fatty acid glycerides, soybean lecithin (E322).

Description of the appearance of NIROLEX FEBBRE E DOLORE and contents of the pack
Pack containing 10 suppositories in blisters.

Marketing Authorisation Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genova – Italy.
E-mail: [email protected]

Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli, 103/C – 50066 Reggello (FI) – Italy.