Paracetamol nutra essential

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Nutra Essential, 325 mg, granules in sachet
Paracetamolum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, contact your doctor.

Contents of the leaflet:

1. What Paracetamol Nutra Essential is and what it is used for
2. Important information before taking Paracetamol Nutra Essential
3. How to take Paracetamol Nutra Essential
4. Possible side effects
5. How to store Paracetamol Nutra Essential
6. Contents of the pack and other information

1. What Paracetamol Nutra Essential is and what it is used for

Paracetamol Nutra Essential contains paracetamol as the active substance.
Paracetamol belongs to the pharmacotherapeutic group of analgesics (painkillers), which also act as antipyretics (fever-reducing agents), with weak anti-inflammatory activity.
The medicinal product Paracetamol Nutra Essential is indicated for symptomatic relief of mild to moderate pain and fever.
If there is no improvement after 3 days of treatment or if you feel worse, contact your doctor.

2. Important information before taking Paracetamol Nutra Essential

Do not take Paracetamol Nutra Essential

• if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol Nutra Essential (listed in section 6),
• if you have severe impairment of liver function,
• if you have acute hepatitis,
• if you have severe renal failure,
• during concomitant use with drugs that have adverse effects on liver function,
• if you have severe haemolytic anaemia,
• during concomitant use with MAO inhibitors and within 2 weeks after their discontinuation.

Warnings and precautions

Consult your doctor or pharmacist before taking Paracetamol Nutra Essential:

• if you have severe renal or hepatic impairment,
• the risk of overdose is higher in individuals with alcoholic liver damage without cirrhotic features,
• if you suffer from chronic alcoholism,
• if you have glucose-6-phosphate dehydrogenase deficiency,
• if you have haemolytic anaemia,
• if you have Gilbert’s syndrome (familial non-haemolytic jaundice),
• if you have anorexia, bulimia or cachexia, or long-term malnutrition,
• if you have low glutathione reserves in the liver, e.g. due to eating disorders, cystic fibrosis, HIV infection, starvation or wasting, sepsis,
• if you are dehydrated or have hypovolaemia.

While taking Paracetamol Nutra Essential, contact your doctor immediately if:
You have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).
Cases of a serious condition called metabolic acidosis (an imbalance in blood and body fluids) have been reported in patients taking paracetamol regularly for prolonged periods or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Do not exceed the recommended dose.
Long-term or frequent use of this medicine is not recommended. Do not take other medicines containing paracetamol at the same time. Taking multiple daily doses at once may cause severe liver damage; unconsciousness may not occur. However, immediate medical help is required. Prolonged use without medical supervision may be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, there is no justification for simultaneously administering another antipyretic unless paracetamol alone is ineffective.

Exercise caution when using paracetamol in patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) or hepatic impairment (mild to moderate).
The risk of overdose is higher in individuals with alcoholic liver damage without cirrhotic features. Exercise caution in cases of chronic alcoholism. In such cases, the total daily dose should not exceed 2 grams.
If you are alcohol-dependent or have liver damage, do not use paracetamol unless prescribed by a doctor. Do not consume alcohol while taking paracetamol. Paracetamol does not enhance the effects of alcohol.

If high fever occurs, signs of secondary infection develop, or symptoms persist beyond 3 days, reassess the ongoing treatment.
If symptoms worsen or do not resolve after 3 days, or if high fever develops, consult your doctor.
Exercise caution when taking paracetamol in dehydrated or chronically malnourished individuals. The total daily dose of paracetamol should not exceed 3 g in adults and children weighing at least 50 kg.

Do not take paracetamol unless prescribed by a doctor if you are alcohol-dependent or have liver damage. Do not take paracetamol simultaneously with alcohol. Paracetamol does not enhance the effects of alcohol.

If you are taking other analgesics containing paracetamol, do not take Paracetamol Nutra Essential without prior consultation with your doctor or pharmacist.
Never take Paracetamol Nutra Essential in a dose higher than recommended.
Higher doses do not provide stronger pain relief but may cause severe liver damage. Initial symptoms of liver damage may appear after several days. Therefore, it is very important to contact your doctor immediately if you have taken Paracetamol Nutra Essential in a dose higher than recommended in this leaflet.

After long-term, inappropriate use of analgesics or taking them in high doses, headaches may occur that do not resolve with higher doses of this medicine.

Generally, habitual use of analgesics, especially combinations of several analgesic substances, may lead to permanent kidney damage with risk of renal failure (analgesic nephropathy).

Sudden discontinuation after long-term, inappropriate use of analgesics in high doses may cause headaches, weakness, muscle pain, restlessness and autonomic symptoms. These withdrawal symptoms resolve within a few days. During this time, avoid further use of analgesics and do not restart them without consulting your doctor.

Do not take Paracetamol Nutra Essential for long periods or in high doses without consulting your doctor or dentist.

Paracetamol Nutra Essential and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

Medicines that may interfere with the action of Paracetamol Nutra Essential:

• probenecid (used in the treatment of gout (gouty arthritis));
• drugs potentially harmful to the liver, e.g. phenobarbital (sleeping tablets), phenytoin, carbamazepine, primidone (antiepileptic drugs) and rifampicin (used in the treatment of tuberculosis). Concomitant use of these drugs with paracetamol may cause liver damage;
• metoclopramide and domperidone (used to treat nausea). These drugs may enhance the absorption and accelerate the onset of action of paracetamol;
• drugs that delay gastric emptying. These drugs may delay the absorption and onset of action of paracetamol;
• cholestyramine (used to reduce elevated serum lipid levels). These drugs may reduce absorption and delay the onset of action of paracetamol. Therefore, cholestyramine should not be taken within the first hour after paracetamol administration;
• anticoagulant drugs (oral anticoagulants, especially warfarin);
• flucloxacillin (an antibiotic), due to the serious risk of disturbances in blood and body fluids (called metabolic acidosis), which require urgent treatment (see section 2).

Concomitant administration of paracetamol and AZT (zidovudine, a drug used in HIV infections) increases the tendency to decreased white blood cell count (neutropenia). This may impair immune system function and increase the risk of infection. Therefore, Paracetamol Nutra Essential may be taken concomitantly with zidovudine only on a doctor's recommendation.

Repeated use of paracetamol for longer than one week increases the tendency to bleeding. Therefore, long-term use of paracetamol should only occur under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency.

Effect of paracetamol on laboratory test results
Paracetamol may affect the measurement of blood uric acid and blood glucose levels.

Taking Paracetamol Nutra Essential with food, drink and alcohol
Taking with food may delay its effect. Do not consume alcohol while taking Paracetamol Nutra Essential.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy
Paracetamol Nutra Essential may be given to pregnant women if necessary. Use the lowest effective dose that adequately relieves pain or reduces fever, and take the medicine for the shortest possible duration and as infrequently as possible. If pain is not relieved or fever does not subside, or if increased dosing frequency is required, consult your doctor or midwife.

Breastfeeding
After oral administration, paracetamol is excreted in small amounts into breast milk. No adverse effects on breastfed infants have been reported. Therapeutic doses of this medicinal product may be used during breastfeeding.

Driving and operating machinery
Paracetamol Nutra Essential does not affect the ability to drive or operate machinery. No studies on the effect on driving and operating machinery have been conducted.

Important information about certain excipients in Paracetamol Nutra Essential:
Each sachet contains 15.35 mg of aspartame (E 951), providing 8.68 mg of phenylalanine, 73.6 mg of sodium, glucose (trace amounts) derived from potato maltodextrin, and 4.86 mg of sucrose.
This medicinal product contains glucose (a component of maltodextrin) and sucrose.
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Aspartame is a source of phenylalanine, which may be harmful to individuals with phenylketonuria.
This medicinal product contains sodium in the following amount: 73.6 mg of sodium per sachet of Paracetamol Nutra Essential. This should be taken into account in patients on a sodium-controlled diet.

3. How to take Paracetamol Nutra Essential

Paracetamol Nutra Essential should always be taken exactly as described in this leaflet. If in doubt, consult your doctor or pharmacist.

The dose is determined based on the information in the table below. The dose of Paracetamol Nutra Essential depends on age and body weight; the single dose is 10 mg/kg body weight every 4 hours or 15 mg/kg body weight every 6 hours, with a total daily dose of 60 mg/kg body weight.
The interval between doses should not be less than 4 hours. Do not use Paracetamol Nutra Essential for longer than three days without a doctor's recommendation.

Sachet 325 mg

| Body weight (age) | Single dose [sachet] | Maximum daily dose [sachets] | |-------------------|------------------------|-------------------------------| | 20 kg – 40 kg (6–12 years) | 325 mg paracetamol (1 sachet) | 1300 mg paracetamol (4 sachets) | | > 40 kg (adolescents over 12 years and adults) | 650 mg paracetamol (2 sachets) | 2600 mg paracetamol (8 sachets) |

Children aged 6 to 12 years (body weight 20–40 kg)
325 mg (1 sachet) every 4–6 hours, maximum 1300 mg (4 sachets) paracetamol per day. Maintain at least a 4-hour interval between doses.

Adults and adolescents over 12 years (body weight >40 kg)
650 mg (2 sachets) every 4–6 hours, maximum 2600 mg (8 sachets) paracetamol per day. Maintain at least a 4-hour interval between doses.

Method of administration
For oral use only. The granules should be taken directly into the mouth (onto the tongue) and swallowed without water.

Do not take Paracetamol Nutra Essential after a meal.

Special patient groups

Children
Do not use in children under 6 years of age or with body weight below 20 kg. Other paracetamol products with different formulations and strengths are available for this age group.

Elderly patients
Dose adjustment is not required in elderly patients.

Patients with hepatic or renal impairment
In patients with hepatic or renal impairment, the dose should be reduced or the intervals between doses extended. Consult your doctor or pharmacist.

Chronic alcoholism
Chronic alcohol consumption may lower the toxic threshold of paracetamol. In these patients, the interval between doses should be at least 8 hours. Do not exceed a daily dose of 2 g paracetamol.

Overdose of Paracetamol Nutra Essential
In case of overdose of Paracetamol Nutra Essential, contact your doctor or emergency department immediately. Overdose has very serious consequences and may even lead to death.
Even if you feel well, immediate treatment is necessary due to the risk of delayed severe liver damage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.

Missed dose of Paracetamol Nutra Essential
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Nutra Essential can cause side effects, although not everyone experiences them.
The term "rare" means: occurs in 1 to 10 people per 10,000 treated.

Possible rare side effects may include:

If any of the following symptoms occur, stop treatment and contact your doctor immediately:

• itching, rash, sweating, purpura, angioedema (swelling of the face, lips, throat, breathing difficulties), urticaria, oedema;
• bleeding;
• abdominal pain, diarrhoea, nausea, vomiting, liver failure, liver necrosis, jaundice;
• acute and chronic pancreatitis (severe abdominal pain, vomiting, bloating, fever, muscle pain, diarrhoea, itching); very rare (may affect less than 1 in 10,000 people);
• severe skin reactions (rash with blisters all over the body or erosions in the mouth, eyes, genital organs and skin, red spots on the body, often with blisters in the centre, bursting blisters, large peeling skin sheets, weakness, fever and joint pain).

Other rare side effects:

• anaemia;
• non-haemolytic anaemia and bone marrow suppression;
• thrombocytopenia (reduced platelet count);
• nephropathies and tubular renal function disorders (kidney diseases).

Frequency of occurrence: "frequency not known" (cannot be estimated from available data).
A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Paracetamol is a widely used medicine, and reports of side effects are rare and usually associated with overdose.
Nephrotoxic effects are rare; no association with therapeutic doses has been reported, except in cases of long-term use.

If any of the side effects worsen or if you experience any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Paracetamol Nutra Essential

Keep this medicine out of the sight and reach of children.
Do not use Paracetamol Nutra Essential after the expiry date stated on the sachet and the cardboard
package (marked as EXP). The expiry date refers to the last day of the specified month.
No special storage precautions are required for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Nutra Essential contains
Active substance:
paracetamol (Paracetamolum)
Each sachet contains 325 mg of paracetamol.

Other ingredients include:
ethylcellulose, hypromellose, macrogol 400, calcium carbonate, sodium bicarbonate, citric acid,
disodium hydrogen citrate, aspartame (E 951), glycerol distearate (E 422) type I, mannitol,
sodium croscarmellose, sodium carboxymethyl starch type A, amorphous silica, flavour-masking agent
and odour agent (501482 TP0424) containing natural flavouring preparations, nature-identical
flavouring substances, maltodextrin, sucrose, aspartame (E 951), and potassium acesulfame (E 950);
lemon flavour (502336 TP0551) containing natural flavouring preparations, synthetic flavouring
substances, maltodextrin, and alpha-tocopherol (E 307).

What Paracetamol Nutra Essential looks like and contents of the packaging
Single-dose sachet: paper/LDPE/aluminium/LDPE laminate.
White to yellowish-white granules with a lemon scent.
The pack contains 12 or 24 sachets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Nutra Essential OTC, S.L.
C/La Granja 1
28108 Alcobendas (Madrid)
Spain
Tel. +34 916 612 335

Manufacturer
Farmalider S.A.
C/ Aragoneses, 2
28108 Alcobendas (Madrid)
Spain

Biofabri S.L.
A Relva, s/n, O Porriño
36400 Pontevedra
Spain