Nisidinasol

Patient Information Leaflet

NISIDINASOL 500 mg granules for oral solution

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, contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

1. What NISIDINASOL is and what it is used for

NISIDINASOL contains the active substance paracetamol, which works by reducing fever (antipyretic) and
relieving pain (analgesic).
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NISIDINASOL is used in adults, adolescents and children for:

• Symptomatic treatment of feverish conditions such as influenza, exanthematous diseases (infectious diseases typical in children and adolescents), acute respiratory tract illnesses, etc.
• Pain of various origin and nature (headache, neuralgia, muscle pain and other moderate pain manifestations). 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 NISIDINASOL

Do not take NISIDINASOL

• if you are allergic 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 NISIDINASOL.
During treatment with NISIDINASOL, inform your doctor immediately if:

• you chronically consume alcohol or use it excessively (3 or more alcoholic drinks per day)
• you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite)
• you suffer from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
• you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic illness)
• you have long-term inadequate nutrition (chronic malnutrition)
• you suffer from dehydration (severe loss of water/fluids from the body)
• you suffer from hypovolemia (reduced blood volume in circulation)
• you have liver diseases that reduce liver function (hepatic insufficiency, hepatitis, Gilbert's syndrome)
• you are concurrently taking medicines that affect liver function (see "Other medicines and NISIDINASOL")
• you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency may cause a blood disorder)
• you have haemolytic anaemia (destruction of red blood cells)
• 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 at regular doses for prolonged periods or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.

Use of high doses and/or prolonged use
Taking high doses and/or prolonged use of this medicine may cause even severe adverse effects on the kidneys and blood. In such cases, your doctor will periodically monitor, through appropriate tests, liver and kidney function and blood composition. Before taking this medicine, inform your doctor if the person who will take the medicine suffers from kidney or liver disease.

Children and adolescents
NISIDINASOL can be given to children and adolescents (see section 3 “How to use NISIDINASOL”)

Other medicines and NISIDINASOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist before taking NISIDINASOL if you are taking the following medicines:

• medicines containing paracetamol. During paracetamol treatment, before taking or giving the child any other medicine, check that it does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in excessive doses
• medicines that delay gastric emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of NISIDINASOL
• medicines that accelerate gastric emptying (e.g. prokinetics), as these medicines accelerate the effect of NISIDINASOL
• cholestyramine (a medicine used to reduce blood cholesterol levels), as it reduces the effect of paracetamol
• chloramphenicol (an antibiotic), as it may increase the risk of adverse effects
• anticoagulants (medicines used to make blood less likely to clot). In case of high-dose paracetamol treatment (4 g daily for at least 4 days), take or give the child NISIDINASOL only under strict medical supervision
• rifampicin (an antibiotic)
• cimetidine (a medicine used to treat gastric ulcer)
• antiepileptics (medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine
• zidovudine (a medicine used to treat HIV)
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

Taking these medicines with NISIDINASOL requires strict medical supervision.

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, note that administration of paracetamol may interfere with the measurement of uric acid and blood glucose levels.

NISIDINASOL and alcohol
Take NISIDINASOL with caution if you chronically consume alcohol or use it excessively (3 or more alcoholic drinks per day), as there is a risk of poisoning (see sections “Warnings and precautions” and “If you take more NISIDINASOL than you should”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, NISIDINASOL can be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
This medicine may be taken during breastfeeding only if clearly needed and under medical supervision.

Driving and using machines
NISIDINASOL does not affect the ability to drive or operate machinery.

NISIDINASOL contains sucrose, sorbitol and aspartame
NISIDINASOL 500 mg granules for oral solution contain:

• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Sorbitol: this medicine contains 95.184 mg of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, talk to your doctor before you (or the child) take this medicine.
• Aspartame: this medicine contains 45.307 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take NISIDINASOL

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 sachet at a time, which may be repeated if necessary after 4 hours, without exceeding 6 doses per day.
In the case of severe pain or high fever, 2 sachets of 500 mg may be taken, repeated if necessary after at least 4 hours.
In adults, the maximum oral dose is 3000 mg of paracetamol per day (see “If you take more NISIDINASOL than you should”).
Use in children and adolescents
For children, it is essential to follow the dose based on their body weight. Your doctor will advise you on the most suitable formulation according to the child's body weight. Approximate age ranges corresponding to body weight are provided for informational purposes only.
Dissolve the contents of one sachet in a glass of water.

For children weighing less than 26 kg, other specific formulations of NISIDINASOL are available on the market.
Please consult your doctor or pharmacist.
If you/your child suffer from severe renal insufficiency (severe reduction in kidney function)
If your doctor has diagnosed severe renal insufficiency, the interval between doses must be at least 8 hours.
Duration of treatment
Do not use NISIDINASOL for more than 3 consecutive days without consulting your doctor. Your doctor must evaluate the need for treatment lasting longer than 3 consecutive days.
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If you take more NISIDINASOL than you should
In case of accidental ingestion/overdose of NISIDINASOL, inform your doctor immediately or go to the nearest hospital.
Symptoms
In case of accidental ingestion of very high doses of paracetamol, symptoms that you/your child may generally experience within the first 12–48 hours include:

• anorexia (loss or reduced appetite), nausea and vomiting followed by a marked deterioration in general condition
• changes in blood laboratory values (increased blood bilirubin, lactate dehydrogenase, liver transaminase levels, decreased blood prothrombin levels)
• liver damage which may lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can be fatal, especially in the following cases:
• if the person taking the medicine suffers from liver disease
• chronic alcoholism
• if the person taking the medicine has been following a poor diet for a long time (chronic malnutrition)
• if the person taking the medicine is taking other medicines or substances that increase liver metabolism.

Treatment
Depending on the nature and severity of symptoms, the doctor will provide appropriate supportive therapy.
If you forget to take NISIDINASOL
Do not take a double dose to make up for the missed dose.
If you stop treatment with NISIDINASOL
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking this medicine and contact your doctor immediately if you/your child experience any of the following side effects:

• Allergic reactions such as:
  • skin redness accompanied by itching (urticaria)
  • swelling of the throat (laryngeal edema)
  • swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
  • severe allergic reaction (anaphylactic shock).

Additionally, the following side effects may occur in people taking this medicine,
Frequency not known (cannot be estimated from the available data): reduction in the number of
platelets in the blood (thrombocytopenia)

• reduction in the number of white blood cells in the blood (leucopenia/agranulocytosis)
• reduction in haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia)
• dizziness
• stomach and intestinal disturbances
• abnormal liver function
• inflammation of the liver (hepatitis)
• red spots, blistering lesions with areas of skin detachment, blisters, skin rashes

(erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

• reduced kidney function (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• blood in the urine (haematuria)
• cessation or reduction in urine production (anuria)
• severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious underlying diseases using paracetamol (see section 2)

Very rare cases of serious skin reactions have been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, 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 NISIDINASOL

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 NISIDINASOL contains

• The active substance is paracetamol. Each sachet contains 500 mg of paracetamol.
• The other components are sucrose, anhydrous citric acid, tropical fruit flavour, grapefruit flavour, sorbitol (E420), aspartame (E951), sucralose, sodium saccharin, polysorbate 20, beetroot red colour, riboflavin sodium phosphate colouring.

Description of the appearance of NISIDINASOL and package contents
NISIDINASOL 500 mg is presented as granules for oral solution.
Pack contents: 20 sachets.
Marketing Authorization Holder
Euromed Pharma Srl, Viale della Liberazione 111, 80125 Naples
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 - 38123 Trento (TN)