Nirolex fever and pain: detailed information

PATIENT INFORMATION LEAFLET

NIROLEX FEVER AND PAIN 500 mg tablets

Paracetamol
Please read all of 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 effect, 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 3 days.

Contents of this leaflet:

What NIROLEX FEVER AND PAIN is and what it is used for
What you need to know before taking NIROLEX FEVER AND PAIN
How to take NIROLEX FEVER AND PAIN
Possible side effects
How to store NIROLEX FEVER AND PAIN
Package contents and other information

1. What NIROLEX FEVER AND PAIN is and what it is used for

NIROLEX FEVER AND PAIN contains the active substance paracetamol, which belongs to a group of medicines known as analgesics and antipyretics, as they work by relieving pain (analgesic action) and reducing body temperature in case of fever (antipyretic action).
NIROLEX FEVER AND PAIN is used to reduce fever and to provide relief from mild to moderate pain.
You should consult your 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 FEVER AND PAIN

Do not take NIROLEX FEVER AND PAIN:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking NIROLEX FEVER AND PAIN.
Never exceed the recommended dose.
Stop treatment and contact your doctor immediately if you experience allergic reactions
(see section “Possible side effects”).
Take this medicine with caution:

if you have kidney problems (renal failure)
if you suffer from liver problems that reduce its function, such as hepatocellular insufficiency including Gilbert's syndrome (an inherited condition characterized by yellowish skin discoloration), hepatic insufficiency, or acute hepatitis
if you are taking other medicines that affect liver function (See also section “Other medicines and NIROLEX FEVER AND PAIN”)
if you have hemolytic anemia, characterized by destruction of red blood cells in the blood
if you have a rare inherited disorder characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase. In such conditions, NIROLEX FEVER AND PAIN should be administered only under medical supervision, possibly with reduced doses or prolonged intervals between doses.

During treatment with NIROLEX FEVER AND PAIN, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and 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.
Avoid prolonged or frequent use of the medicine without first consulting your doctor, and do not take other products containing paracetamol simultaneously, since taking paracetamol in high doses may lead to serious adverse reactions.
Prolonged use of pain-relieving medicines (analgesics), especially at high doses, may cause headaches, which should not be treated by increasing the dose of the medicine.
If used for long periods, your doctor should carry out regular checks to monitor liver and kidney function and blood composition (haematological parameters).
Do not take higher doses than recommended, as excessive doses may cause serious liver or kidney damage. For this reason, contact your doctor as soon as possible if you have taken more NIROLEX FEVER AND PAIN than recommended in this leaflet (see section “If you take more NIROLEX FEVER AND PAIN than you should”).
Sudden discontinuation of pain-relieving medicines after prolonged incorrect use at high doses may cause headache, fatigue, muscle pain, nervousness, and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not restart them without consulting your doctor.
Contact your doctor if symptoms persist for more than 3 days, worsen, new symptoms appear, or if redness or swelling occurs.
Taking this medicine may alter the results of certain laboratory tests, such as measurements of uric acid levels (uricemia) or blood sugar (glycemia). Therefore, inform the laboratory that you are being treated with NIROLEX FEVER AND PAIN before undergoing blood tests.

Other medicines and NIROLEX FEVER AND PAIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

medicines containing paracetamol. During treatment with paracetamol, check that any other medicine you take does not contain paracetamol (see sections “Warnings and precautions” and “If you take more NIROLEX FEVER AND PAIN 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 reduce gastric acid secretion, especially if you are a chronic or excessive alcohol user and/or are exposed to substances potentially toxic to the liver (see also sections “Warnings and precautions” and “If you take more NIROLEX FEVER AND PAIN than you should”)
medicines used to thin the blood (anticoagulants), e.g., warfarin. In this case, your doctor must monitor you closely
chloramphenicol, an antibiotic used to treat certain bacterial infections: paracetamol may prolong the action of chloramphenicol and increase the risk of side effects
zidovudine, a medicine used in the treatment of AIDS, as it may increase the risk of low levels of a type of white blood cells (neutropenia). Use of this medicine with NIROLEX FEVER AND PAIN requires close medical monitoring
probenecid (a medicine used to treat gout). Your doctor will reduce the dose of NIROLEX FEVER AND PAIN during concomitant use
colestyramine, a medicine used to lower cholesterol levels in the blood, as it may reduce the effect of paracetamol
medicines that slow gastric emptying, as they may delay the effect of NIROLEX FEVER AND PAIN, such as:
anticholinergics, e.g., propantheline, used to treat spasms
medicines that accelerate gastric emptying, as they may enhance the effect of NIROLEX FEVER AND PAIN, such as:
prokinetics, used to increase gastric emptying rate and relieve nausea symptoms, e.g., metoclopramide
flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalances (called metabolic acidosis) requiring urgent treatment (see section 2).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, NIROLEX FEVER AND PAIN may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, for the shortest possible duration.
Avoid taking the medicine in combination with other medicines.
Contact your doctor if pain and/or fever do not subside or if you need to take the medicine more frequently.
This medicine may be taken during breastfeeding only if strictly necessary and under medical supervision.

Driving and using machines
There are no data available regarding the effects of NIROLEX FEVER AND PAIN on the ability to drive vehicles or operate machinery.
NIROLEX FEVER AND PAIN contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take NIROLEX FEVER AND PAIN

Take NIROLEX FEVER AND PAIN exactly as stated in this leaflet or as directed 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 doses. If symptoms persist for more than 3 days, consult your doctor.
Take the tablet with a glass of water.
The recommended dose for adults is 1 tablet, which may be repeated if necessary, up to a maximum of 3–4 times a day, allowing at least 6 hours between doses.

Use in children
The recommended dose for children from 6 to 12 years of age is half a tablet, which may be repeated if necessary, up to a maximum of 3–4 times a day, allowing at least 6 hours between doses.

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

If you take more NIROLEX FEVER AND PAIN than you should
Paracetamol in very high doses may cause liver toxicity, kidney and heart function disorders, and serious blood abnormalities. Therefore, in case of suspected accidental overdose, contact your doctor immediately or go to the nearest hospital.
Symptoms that may generally occur within the first 24 hours include:

paleness of the skin (pallor)
loss of appetite or reduced appetite (anorexia)
nausea and vomiting
stomach pain.
These symptoms may not reflect the severity of the overdose or the risk of organ damage. Overdose can have very serious consequences and may even lead to death. Immediate treatment is essential due to the risk of severe liver damage.

In cases of severe poisoning, the following may occur: shock (circulatory collapse), serious kidney damage (acute renal failure), yellowish discoloration of the skin (jaundice), and a severe state of unconsciousness (hepatic coma).
The risk of poisoning from an excessive dose of paracetamol is increased in the following cases:

elderly people
young children
liver disorders
chronic or excessive alcohol use
inadequate diet (chronic malnutrition)
concomitant use of other medicines or substances that affect liver function.

Depending on the nature and severity of the symptoms, the doctor will provide appropriate supportive treatment.
The recommended treatment for overdose upon hospital admission, in addition to standard procedures (e.g. gastric emptying), includes administration of agents capable of counteracting the drug’s toxic effects, such as N-acetylcysteine.
Further measures will depend on the severity, nature, and progression of clinical signs of paracetamol intoxication.

If you forget to take NIROLEX FEVER AND PAIN
Do not take a double dose to make up for the missed dose.
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.
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 may cause breathing and swallowing difficulties (angioedema), reduction in blood pressure, breathing problems (dyspnoea), rash, erythema, increased sweating and urticaria. If you experience any

allergic reactions, stop taking this medicine immediately and contact your doctor;

nausea;
increased liver enzymes (transaminases).

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

reduction in platelets (thrombocytopenia), white blood cells (leucopenia), granulocytes (agranulocytopenia), red blood cells (anaemia), or all blood cells (pancytopenia);
bronchospasm (more likely in patients with a history of bronchial asthma or allergy).

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

severe condition leading to increased acidity of the blood (called metabolic acidosis) in patients with serious underlying illness using paracetamol (see section 2);
drug rash, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
changes in liver function, inflammation of the liver (hepatitis), liver damage, even severe (see also section “If you take more NIROLEX FEVER AND PAIN than you should”);
kidney problems (acute renal failure, interstitial nephritis), presence of blood in urine (haematuria), absence of urine production (anuria);
stomach and intestinal disturbances;
dizziness (vertigo).

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 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 FEVER AND PAIN

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

6. Package contents and other information

What NIROLEX FEVER AND PAIN contains

The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other components are: povidone, sodium carboxymethylstarch, maize starch, colloidal silica, stearic acid.

Description of the appearance of NIROLEX FEVER AND PAIN and contents of the pack
Pack containing 20 tablets in blister packs.
Marketing Authorization Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genoa – Italy.
E-mail: [email protected]
Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli, 103/C – 50066 Reggello (FI) – Italy.

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

NIROLEX FEVER AND PAIN 500 mg suppositories, ADULTS 1000 mg suppositories

Paracetamol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What NIROLEX FEVER AND PAIN is and what it is used for
What you need to know before using NIROLEX FEVER AND PAIN
How to use NIROLEX FEVER AND PAIN
Possible side effects
How to store NIROLEX FEVER AND PAIN
Contents of the pack and other information

1. What NIROLEX FEVER AND PAIN is and what it is used for

2. What you need to know before using NIROLEX FEVER AND PAIN

Do not use NIROLEX FEVER AND PAIN:

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

Warnings and precautions
Talk to your doctor or pharmacist before using NIROLEX FEVER AND PAIN.
Never exceed the recommended dose.
Stop treatment and contact 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 failure)
if you suffer from liver problems that reduce its function, such as hepatocellular insufficiency including Gilbert's syndrome (an inherited disease characterized by yellowish skin discoloration) or acute hepatitis
if you are taking other medicines that affect liver function (See also section “Other medicines and NIROLEX FEVER AND PAIN”)
if you suffer from hemolytic anemia, characterized by destruction of red blood cells in the blood
if you have a rare inherited disorder characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase. In such conditions, NIROLEX FEVER AND PAIN should be administered only under medical supervision, possibly reducing the dose or extending the interval between doses.

During treatment with NIROLEX FEVER AND PAIN, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal 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 rapid, deep breathing, drowsiness, nausea, and vomiting.
Avoid prolonged or frequent use of the medicine without first consulting your doctor, and do not take other products containing paracetamol simultaneously, as taking paracetamol in high doses may cause serious adverse reactions.
Prolonged use of pain-relieving medicines (analgesics), especially at high doses, may lead to headache, which should not be treated by increasing the dose of the medicine.
If used long-term, your doctor should perform regular checks to monitor liver and kidney function and blood composition (haematological parameters).
Do not use higher doses than those recommended, as excessive dosing may cause serious liver or kidney damage. For this reason, contact your doctor as soon as possible if you have taken more NIROLEX FEVER AND PAIN than recommended in this leaflet (see section “If you take more NIROLEX FEVER AND PAIN than you should”).
Sudden discontinuation of pain-relieving medicines after prolonged misuse at high doses may cause headache, fatigue, muscle pain, nervousness, and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not restart them without consulting your doctor.
You should consult your doctor if 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 certain laboratory tests, such as measurements of uric acid levels (uricemia) or blood sugar (glycemia). Therefore, inform the laboratory that you are being treated with NIROLEX FEVER AND PAIN before undergoing blood tests.

Other medicines and NIROLEX FEVER AND PAIN
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Take this medicine with caution and inform your doctor if you are using the following medicines:

medicines containing paracetamol. During treatment with paracetamol, check whether any other medicine you take contains paracetamol before taking it (see sections “Warnings and precautions” and “If you take more NIROLEX FEVER AND PAIN 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 reduce gastric acid secretion, especially if you are a chronic or excessive alcohol user and/or are exposed to substances potentially toxic to the liver (see also sections “Warnings and precautions” and “If you take more NIROLEX FEVER AND PAIN than you should”)
medicines used to thin the blood (anticoagulants), e.g. warfarin. In this case, your doctor must monitor you closely
chloramphenicol, an antibiotic used to treat certain bacterial infections. Paracetamol may prolong the action of chloramphenicol and increase the risk of adverse effects
zidovudine, a medicine used in the treatment of AIDS, as it may increase the risk of low levels of a type of white blood cells (neutropenia). Using this medicine with NIROLEX FEVER AND PAIN requires close medical monitoring
probenecid (a medicine used to treat gout). Your doctor will reduce the dose of NIROLEX FEVER AND PAIN during concomitant use
colestyramine, a medicine used to lower cholesterol levels in the blood, as it may reduce the effect of paracetamol
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that requires urgent treatment (see section 2).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, NIROLEX FEVER AND PAIN may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible duration.
Avoid taking the medicine in combination with other medicines.
Contact your doctor if pain and/or fever do not decrease or if you need to take the medicine more frequently.
This medicine may be taken during breastfeeding only if clearly needed and under medical supervision.

Driving and using machines
There are no data available regarding the effects of NIROLEX FEVER AND PAIN on the ability to drive vehicles or operate machinery.
NIROLEX FEVER AND PAIN contains soy lecithin (E322). If you are allergic to peanuts or soy, do not use this medicine.

3. How to use NIROLEX FEVER AND PAIN

Use NIROLEX FEVER AND PAIN exactly as instructed in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses. Suppositories may be administered at intervals of 6-8 hours as prescribed. If symptoms persist for more than 3 days, consult your doctor.
Before administration, remove the suppository from its packaging (from the blister). To release the suppository, pull apart the aluminum blister edges in opposite directions at the marked notch.

NIROLEX FEVER AND PAIN 500 mg suppositories:
This medicine is intended for use in adults and adolescents over 12 years of age.
The recommended dose for adults and children over 12 years of age is 1 suppository of 500 mg, which may be repeated if necessary, up to a maximum of 2-3 times daily, allowing at least 6-8 hours between doses.

NIROLEX FEVER AND PAIN ADULTS 1000 mg suppositories:
The recommended dose for adults is 1 suppository of 1000 mg, which may be repeated if necessary, up to a maximum of 2-3 times daily, allowing at least 6-8 hours between doses.

Use in patients with liver or kidney problems (hepatic or renal dysfunction)
If you have liver or kidney problems, consult your doctor or pharmacist before using this medicine (see section "Warnings and precautions"). The dose should be reduced and/or the administration interval prolonged. If renal function is severely impaired, at least 8 hours should elapse between doses.

If you use more NIROLEX FEVER AND PAIN than you should
Paracetamol in very high doses can cause liver toxicity, impairment of kidney and heart function, and serious blood disorders. Therefore, in case of suspected accidental ingestion of excessive doses of this medicine, contact your doctor immediately or go to the nearest hospital.
Symptoms that generally appear within the first 24 hours may include:

paleness of the skin
loss of appetite (anorexia)
nausea and vomiting
stomach pain

These symptoms may not reflect the severity of the overdose or the risk of organ damage.
Overdose can have very serious consequences and may even lead to death.
Immediate treatment is essential due to the risk of severe liver damage.
In cases of severe poisoning, shock (circulatory collapse), serious kidney damage (acute renal failure), yellowing of the skin (jaundice), and severe unconsciousness (hepatic coma) may occur.

The risk of poisoning is increased in the following cases after taking an excessive dose of paracetamol:

elderly people
young children
liver disorders
chronic or excessive alcohol consumption
inadequate nutrition (chronic malnutrition)
concomitant use of other medicines or substances affecting liver function

The doctor will provide appropriate supportive therapy based on the nature and severity of symptoms.
The recommended treatment for overdose in a hospital setting, in addition to standard procedures (e.g. stomach emptying), includes administration of substances capable of counteracting the drug's toxic effects, such as N-acetylcysteine.
Additional measures depend on the severity, nature, and progression of clinical signs of paracetamol poisoning.

If you forget to use NIROLEX FEVER AND PAIN
Do not take a double dose to make up for the missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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 may cause breathing and swallowing difficulties (angioedema), reduction in blood pressure, breathing problems (dyspnoea), rash, erythema, increased sweating and urticaria. If you experience any allergic reactions, stop taking this medicine immediately and contact your doctor;
nausea;
increased liver enzymes (transaminases).

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

reduction in platelets (thrombocytopenia), white blood cells (leukopenia), granulocytes (agranulocytopenia), red blood cells (anaemia), or all blood cells (pancytopenia) in the blood;
bronchospasm (more likely in patients with a history of bronchial asthma or allergy).

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

severe condition causing increased acidity of the blood (called metabolic acidosis) in patients with serious illness using paracetamol (see section 2);
drug rash, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
changes in liver function, inflammation of the liver (hepatitis), liver damage, even severe (see also section "If you take more NIROLEX FEVER AND PAIN than you should");
kidney problems (acute renal failure, interstitial nephritis), presence of blood in the urine (haematuria), absence of urine production (anuria);
stomach and intestinal disturbances;
dizziness (vertigo).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NIROLEX FEVER AND PAIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.:".
The expiry date refers to the last day of that month.
Suppositories 500 mg: Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIROLEX FEVER AND PAIN contains
NIROLEX FEVER AND PAIN 500 mg suppositories

The active substance is paracetamol. Each suppository contains 500 mg of paracetamol.
The other components are: glycerol esters of saturated fatty acids, soya lecithin (E322).

NIROLEX FEVER AND PAIN ADULTS 1000 mg suppositories

The active substance is paracetamol. Each suppository contains 1000 mg of paracetamol.
The other components are: glycerol esters of saturated fatty acids, soya lecithin (E322).

Description of the appearance of NIROLEX FEVER AND PAIN and contents of the pack
Pack containing 10 suppositories in blister packs.
Marketing Authorization Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genoa – Italy.
E-mail: [email protected]
Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli, 103/C – 50066 Reggello (FI) – Italy.