Paracetamol is a medicine to relieve pain and reduce fever (analgesic and antipyretic).
Nideran Paracetamol is used to relieve mild to moderate pain and/or fever in adults and children aged 10 years or older (or weighing more than 33 kg).

Do not take Nideran Paracetamol
• if you are allergic 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 Nideran Paracetamol:
• if you have kidney problems
• if you have heart or lung disease
• if you have liver problems or are taking medicines that affect liver function
• if you have anaemia (a reduction in red blood cells, which may make the skin pale yellow, cause weakness or shortness of breath)
• if you regularly drink excessive amounts of alcohol. Chronic alcoholics should not exceed 2 grams of paracetamol in any 24-hour period.
• if you are taking other medicines containing paracetamol, as they can severely damage the liver
• if you have asthma and are sensitive to acetylsalicylic acid (aspirin)

You should not use paracetamol frequently and over a long period of time, as prolonged or frequent use may cause liver problems. Talk to your doctor or pharmacist if you intend to take paracetamol over a long period of time.

Do not use Nideran Paracetamol without talking to a doctor if you have problems with alcohol or if you have liver damage. Do not take Nideran Paracetamol with alcohol. The effect of alcohol is not boosted by taking Nideran Paracetamol.

Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose does not increase pain relief; instead, it can cause serious liver damage. Symptoms of liver damage usually appear after a few days. Therefore, it is very important that you contact your doctor as soon as possible if you take more than the recommended dose.

In case of high fever or signs of infection, after more than 3 days of treatment, or if pain persists after more than 5 days of treatment, you should contact your doctor.

Children
Do not give to children under 10 years of age. For children under 10 years of age, consult your doctor or pharmacist as there are other forms with dosages better suited to this age group.

Other medicines and Nideran Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take other medicines containing paracetamol.

Nideran Paracetamol may affect or be affected by some other medicines. Tell your doctor or pharmacist if you are taking:
• metoclopramide or domperidone (used to treat nausea (feeling unwell) or vomiting (feeling sick)
• cholestyramine (used to lower blood cholesterol). This medicine should be taken at least one hour before or after taking paracetamol
• warfarin and other medicines used to thin the blood, if you need to take a painkiller every day for a long period of time
• medicines used to increase the elimination of urine (loop diuretics such as furosemide)
• probenecid (used to treat gout)
• medicines that induce liver enzymes, such as rifampicin (used to treat infections) and medicines to treat epilepsy such as barbiturates, phenytoin, carbamazepine, primidone
• lamotrigine (for the treatment of epilepsy), since paracetamol may reduce its effect
• propranolol (used to treat high blood pressure and heart rhythm disorders)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disease (metabolic acidosis with increased anion gap) which must be treated urgently and which can occur particularly in the case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are taken.

Nideran Paracetamol can affect the results of some laboratory tests, such as tests for uric acid and blood sugar.

Nideran Paracetamol with food and alcohol
The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day - beer, wine, liquor, etc. daily) may cause liver damage.
Taking this medicine with food does not alter its effectiveness.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, paracetamol can be used during pregnancy. The lowest possible dose that reduces pain and/or fever should be taken and it should be used for the shortest time possible. Contact your doctor if the pain and/or fever does not subside, or if you need to take the medicine more often.
Although paracetamol is excreted in breast milk in small amounts, no side effects have been reported in breast-fed infants. Paracetamol can be used during breast-feeding at the recommended doses.

Driving and using machines
Paracetamol has no or negligible influence on the ability to drive and use machinery.

Nideran Paracetamol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is practically ‘sodium-free’.

Always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist.

The treatment should be started at the lowest effective dose.

The recommended dose is:

Patients with impaired kidney or liver function
The dose should be reduced in patients with impaired kidney or liver function, or the interval between doses should be prolonged. In patients with severe kidney impairment the dosing interval for Nideran Paracetamol must be at least 8 hours. Ask your doctor or pharmacist for advice.

Follow the instructions given here, unless your doctor has given you other instructions.

Talk to your doctor or pharmacist if you feel that this medicine is too strong or too weak.

If you take more Nideran Paracetamol than you should
If you have taken more paracetamol than you should, contact your doctor or pharmacist immediately. There is a risk of liver damage, even if you feel well.
To avoid liver damage, it is important that your doctor can start treatment as soon as possible (preferably within 10-12 hours after an overdose).
Symptoms of overdose may include: nausea (feeling unwell), vomiting (feeling sick), anorexia (loss of appetite), yellowing of the skin and eyes (jaundice), abdominal pain and risk of kidney or liver damage. In this case, the patient should go to the hospital immediately.
Patients taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Nideran Paracetamol

Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause undesirable effects, although not everybody experiences them.
This medicine may cause the following side effects:

Rare (may affect up to 1 in 1,000 people): discomfort, drop in blood pressure (hypotension) and increase in blood transaminase levels.
Very rare (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (drop in blood sugar). Very rare cases of serious skin reactions have been reported.

Paracetamol can cause liver damage when taken at high doses or in long-term treatment.

Reporting undesirable effects
If you experience any undesirable effects, including possible undesirable effects not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report undesirable effects directly to INFARMED, I.P. using the contact information indicated below. By reporting undesirable effects, you can help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram (preferably)
or at the following addresses:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicine Helpline: 800222444 (free)
Email: farmacovigilancia@infarmed.pt

What Nideran Paracetamol contains
The active substance is paracetamol
The other components are sodium starch glycolate (Type A), purified water, pregelatinised starch, povidone K30 (E1201), stearic acid (E570), crospovidone (E1202).

What Nideran Paracetamol looks like and contents of the pack
Nideran Paracetamol is a white, biconvex, round tablet with PA engraved on one side, 11.0 ± 0.5 mm in diameter.
Nideran Paracetamol is available in blister packs of 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Towa Pharmaceutical, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
or
SAG Manufacturing S.L.U
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750 Madrid
Spain

Detailed and up-to-date information about this medicine is available by scanning the 2D code included on the packaging with a smartphone. The same information is also available at the following website address: https://www.tolifeotc.com/nideran2.

This insert was last revised in February 2024.