Paracetamol Nutra Essential

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Paracetamol Nutra Essential, 325 mg, granule in a sachet

Paracetamolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

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

Paracetamol Nutra Essential contains the active substance paracetamol.
Paracetamol belongs to the pharmacotherapeutic group of analgesics (pain-relieving medications), which also have antipyretic (fever-reducing) effects with weak anti-inflammatory action.
Paracetamol Nutra Essential is used for the symptomatic treatment of mild to moderate pain and fever.
If after 3 days of taking the medicine there is no improvement or the patient feels worse, they should contact a 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 liver function disorders
• if you have acute liver inflammation,
• if you have severe kidney failure
• while taking medications that have an adverse effect on liver function
• if you have severe hemolytic anemia
• while taking MAO inhibitors and for up to 2 weeks after their discontinuation

Warnings and precautions

Consult a doctor or pharmacist before taking Paracetamol Nutra Essential:

• if you have severe kidney or liver function disorders.
• the risk of overdose is higher in people with alcoholic liver damage without signs of cirrhosis.
• if you have chronic alcoholism
• if you have a deficiency of glucose-6-phosphate dehydrogenase
• if you have hemolytic anemia
• if you have Gilbert's syndrome (familial non-hemolytic jaundice).
• if you have anorexia, bulimia, or cachexia, prolonged malnutrition,
• if you have low glutathione reserves in the liver, e.g., appetite disorders, cystic fibrosis, HIV infection, starvation, or sepsis,
• if you have dehydration or hypovolemia.

While taking Paracetamol Nutra Essential, immediately inform your doctor if:
If you have severe diseases, including severe kidney or liver function disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).
There have been reports of a serious condition called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.
Do not exceed the recommended dose.
It is not recommended to take the medicine for a long time or frequently. Do not take other medications containing paracetamol at the same time. Taking a multiple of the daily dose at once can cause severe liver damage; in such a case, there is no loss of consciousness. However, immediate medical attention is necessary. Prolonged use of the medicine without medical supervision can be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, it is not justified to administer another antipyretic medication at the same time, unless the use of paracetamol alone is ineffective.
Caution should be exercised when taking paracetamol in patients with severe kidney failure (creatinine clearance ≤ 30 ml/min) or liver failure (mild and moderate).
The risk of overdose is higher in people with alcoholic liver damage without signs of cirrhosis. Caution should be exercised in cases of chronic alcoholism. In such cases, the total daily dose should not exceed 2 grams.
If you are addicted to alcohol or have liver damage, do not take paracetamol unless prescribed by a doctor. While taking paracetamol, do not consume alcohol. Paracetamol does not enhance the effects of alcohol.
In case of high fever or symptoms of secondary infection or if symptoms persist for more than 3 days, the treatment should be reassessed.
If symptoms worsen or do not improve after 3 days, or if a high fever appears, consult a doctor.
Caution should be exercised when taking paracetamol in dehydrated or chronically malnourished patients. The total dose of paracetamol should not exceed 3 g per day in adults and children with a body weight of at least 50 kg.
Do not take paracetamol unless prescribed by a doctor if you are addicted to alcohol or have liver damage. Also, do not take paracetamol with alcohol. Paracetamol does not enhance the effects of alcohol.
If you are taking other pain-relieving medications containing paracetamol, do not take Paracetamol Nutra Essential without consulting a doctor or pharmacist.
Never take a dose of Paracetamol Nutra Essential that is larger than recommended.
Larger doses do not have a stronger pain-relieving effect, but they can cause severe liver damage. The first symptoms of liver damage appear after several days. Therefore, it is very important to contact a doctor immediately if you have taken Paracetamol Nutra Essential in a dose larger than recommended in this leaflet.
After prolonged, improper use of pain-relieving medications or taking large doses of pain-relieving medications, headaches may occur that do not improve with the use of larger doses of this medicine.
Generally, habitual use of pain-relieving medications, especially combinations of several pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).
Sudden discontinuation of the medicine after prolonged, improper use in large doses of pain-relieving medications may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms. These withdrawal symptoms subside after a few days. Until then, you should avoid further use of pain-relieving medications and not restart them without consulting a doctor.
Do not take Paracetamol Nutra Essential for long periods or in large doses without consulting a doctor or dentist.

Paracetamol Nutra Essential and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, including those available without a prescription.
Medications that may interfere with the action of Paracetamol Nutra Essential:

• probenecid (a medication used to treat gout);
• medications that can potentially damage the liver, such as phenobarbital (sleeping pills), phenytoin, carbamazepine, primidone (antiepileptic medications), and rifampicin (used to treat tuberculosis). Concurrent use of these medications and paracetamol may cause liver damage
• metoclopramide and domperidone (used to treat nausea). These medications may enhance the absorption and accelerate the onset of action of paracetamol.
• medications that slow down gastric emptying. These medications may delay the absorption and onset of action of paracetamol.
• cholestyramine (used to reduce elevated lipid levels in serum). These medications may reduce the absorption and delay the onset of action of paracetamol. Therefore, do not take cholestyramine within the first hour after taking paracetamol.
• medications that reduce blood clotting (oral anticoagulants, especially warfarin).
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

Concomitant administration of paracetamol and AZT (zidovudine, a medication used in HIV infections) increases the tendency to decrease the number of white blood cells (neutropenia). This can disrupt the immune system and increase the risk of infections. Therefore, Paracetamol Nutra Essential can be taken concomitantly with zidovudine only on the advice of a doctor.
Repeated administration of paracetamol for longer than a week increases the tendency to bleeding.
Therefore, long-term use of paracetamol in patients can only be done under medical supervision. Occasional administration of paracetamol does not have a significant effect on the tendency to bleeding.
Effect of paracetamol on laboratory test results
Paracetamol may affect the determination of uric acid and blood sugar levels.

Using Paracetamol Nutra Essential with food, drink, and alcohol

Taking with a meal may delay the effect. While taking Paracetamol Nutra Essential, do not consume alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Pregnancy
Paracetamol Nutra Essential can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible time and as infrequently as possible. If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of administration, consult a doctor or midwife.
Breastfeeding
After oral administration, paracetamol is excreted in small amounts into breast milk. No adverse effects have been reported in breastfed infants. During breastfeeding, therapeutic doses of this medicinal product can be used.

Driving and using machines

Paracetamol Nutra Essential does not affect the ability to drive and use machines.
No studies have been conducted on the effect on the ability to drive and use machines.

Important information about some excipients of 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) 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 some sugars, consult your doctor before taking the medicine.
Aspartame contains a source of phenylalanine, which may be harmful to people with phenylketonuria.
This medicinal product contains sodium in the following amounts: 73.6 mg of sodium per sachet of Paracetamol Nutra Essential. This should be taken into account in patients on a controlled sodium diet.

3. How to take Paracetamol Nutra Essential

Paracetamol Nutra Essential should always be taken exactly as directed in this leaflet. In case of doubt, consult a doctor or pharmacist.
The dose is determined based on the information provided 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, and the total daily dose is 60 mg/kg body weight.
The interval between individual doses should not be less than 4 hours. Do not take Paracetamol Nutra Essential for more 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 (20 kg-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 individual 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 individual doses.
Method of administration
For oral use only. Granules should be taken directly into the mouth (on 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 a body weight below 20 kg. For this group of children, other paracetamol products with a different form and strength are available.
Elderly patients.
No dose adjustment is required in elderly patients.
Patient with liver or kidney function disorders
In patients with liver or kidney function disorders, the dose should be reduced or the intervals between doses prolonged. Consult a doctor or pharmacist.
Chronic alcoholism
Chronic alcohol consumption may lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. Do not exceed the dose of 2 g of paracetamol per day.

Taking a higher dose of Paracetamol Nutra Essential than recommended

In case of overdose of Paracetamol Nutra Essential, contact a doctor or emergency department. Overdose has very serious consequences and can 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.

Missing a 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 a doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Nutra Essential can cause side effects, although not everybody gets them.
The term "rare" means: occurs in 1 to 10 people per 10,000 taking the medicine.
The following rare side effects may occur.

• itching, rash, sweating, petechiae, angioedema (swelling of the face, lips, throat, difficulty breathing), urticaria, edema;
• bleeding;
• abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice;
• acute and chronic pancreatitis (severe abdominal pain, vomiting, bloating, fever, muscle pain, diarrhea, itching); very rare (may affect less than 1 in 10,000 people)
• severe skin reactions (rash with blisters all over the body or ulcers in the mouth, eyes, genitals, and skin, red spots on the body, often in the center of blisters, bursting blisters, large peeling skin patches, weakness, fever, and joint pain).

Other rare side effects

• anemia
• non-hemolytic anemia and bone marrow depression
• thrombocytopenia (reduced platelet count)
• nephropathies and disorders of renal tubular function (kidney diseases)

Frequency of occurrence: "frequency not known" (cannot be estimated from available data)
A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
Paracetamol is a widely used medication, and reports of side effects are rare and usually related to overdose.
Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of prolonged use of the medicine.
If you experience any worsening of side effects or if you experience any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Nutra Essential

Keep out of sight and reach of children.
Do not take Paracetamol Nutra Essential after the expiry date stated on the sachet and carton (marked as EXP). The expiry date refers to the last day of the given month.
No special precautions for storage of the medicinal product are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Nutra Essential contains

Active substance:
paracetamol (Paracetamolum)
1 sachet contains 325 mg of paracetamol.
The medicine also contains:
ethyl cellulose, hypromellose, macrogol 400, calcium carbonate, sodium bicarbonate, citric acid, sodium dihydrogen citrate, aspartame (E 951), glycerol distearate (E 422) type I, mannitol, sodium croscarmellose, sodium carboxymethyl starch type A, silicon dioxide, flavor masking agent (501482 TP0424) containing natural flavoring preparations, flavoring substances identical to natural ones, maltodextrin, sucrose, aspartame (E 951), and acesulfame potassium (E 950);
lemon flavor (502336 TP0551) containing natural flavoring preparations, synthetic flavoring substances, maltodextrin, and alpha-tocopherol (E 307).

What Paracetamol Nutra Essential looks like and contents of the pack

Sachet packaging: paper/LDPE/Aluminum/LDPE with a single dose.
Granules are white to yellowish-white with a lemon odor.
The collective packaging contains 12 or 24 sachets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Nutra Essential OTC, S.L.
C/La Granja 1
28108 Alcobendas (Madrid)
Spain
Phone: +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
Date of last revision of the leaflet: 03/2025