NIROLEX FEVER DOL*20CPR 500MG

What it is and what it is used for
NIROLEX FEVER AND PAIN contains the active ingredient paracetamol belonging to a group of medicines known as analgesics and antipyretics, as they act by relieving pain (analgesic action) and lowering body temperature in case of fever (antipyretic action).
NIROLEX FEVER AND PAIN is used to reduce fever and provide relief from mild to moderate pain.
You should contact your doctor if you do not feel better or if you feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not take NIROLEX FEVER AND PAIN:
- If you are allergic (hypersensitive) 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 NIROLEX FEVER AND PAIN. Never exceed the recommended dose.

Stop treatment and contact your doctor immediately if you experience allergic reactions (see paragraph "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 (a hereditary disease that presents with yellowing of the skin), liver failure or acute hepatitis;
- if you are taking other medicines that alter liver function (See also paragraph “Other medicines and NIROLEX FEVER AND PAIN”);
- if you suffer from haemolytic anemia, characterized by destruction of red blood cells in the blood;
- if you have a rare hereditary disease characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase.

In such conditions NIROLEX FEVER AND PAIN must be administered only under medical supervision, if necessary, reducing the dose or prolonging the interval between individual administrations.

Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take other products containing paracetamol at the same time since if paracetamol is taken in high doses, serious adverse reactions may occur. Prolonged use of medicines that act by relieving pain (analgesics), especially at high doses, can induce headaches, which should not be treated with increasing doses of the medicine.
In case of prolonged use, the doctor will have to subject you to checks to monitor the functionality of the liver and kidneys and the relationship between the various elements of the blood (blood crasis).

Do not take higher doses than recommended because a higher dose can 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”).
Suddenly stopping taking pain-relieving medicines after a prolonged period of incorrect use at high doses may cause headaches, fatigue, muscle pain, nervousness and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not start taking them again without consulting your doctor.

You should contact your doctor if your symptoms persist for more than 3 days, get worse, or develop new symptoms, or if you experience redness or swelling.

Taking this medicine may alter the results of some laboratory tests such as the measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood. Therefore, tell the testing center that you are being treated with NIROLEX FEVER AND PAIN before having blood tests.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets 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 can cause problems in breathing and swallowing (angioedema), reduction in blood pressure, breathing problems (dyspnoea), rash, erythema, increased sweating and hives. If you experience allergic reactions, stop treatment with this medicine and contact your doctor immediately;
- nausea;
- increase in liver enzymes (transaminases).

Very rare (may affect up to 1 in 10,000 people):
- reduction of platelets (thrombocytopenia), white blood cells (leukopenia), granulocytes (agranulocytopenia), red blood cells (anaemia) and all cells (pancytopenia) in the blood;
- bronchospasm (more likely in subjects with a history of bronchial asthma or allergy).

Not known (frequency cannot be estimated from the available data):
- drug rash, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis);
- changes in liver function, inflammation of the liver (hepatitis), liver damage, including serious damage (see also the section “If you use more NIROLEX FEVER AND PAIN than you should”);
- kidney problems (acute renal failure, interstitial nephritis), presence of blood in the urine (hematuria), absence of urine elimination (anuria);
- stomach and intestinal disorders;
- dizziness (vertigo).

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