NEOOPTALIDON 200 MG + 125 MG + 25 MG COATED TABLETS 8 TABLETS IN PVC/AL BLISTER

Name
NEO-OPTALIDON 200 mg+125 mg+25 mg coated tablets
Paracetamol + Propyphenazone + Caffeine


What is it and what is it used for?
Neo-Optalidon is a medicine containing three active ingredients, paracetamol and propyphenazone, which reduce fever and pain, and caffeine, which is a classic component of this type of combination.

This medicine is used for the symptomatic treatment of pain (e.g. headache, toothache, nerve pain, menstrual pain) and fever.

Talk to 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 Neo-Optalidon if:
• are allergic to paracetamol, propyphenazone, caffeine or any of the other ingredients of this medicine (listed in section 6);
• is allergic to other chemically similar substances, for example other anti-inflammatories belonging to the same class (e.g. para-aminophenols, pyrazolones);
• is allergic to peanuts or soy;
• suffers from certain blood diseases such as:
- granulocytopenia (decrease in the number of some blood cells);
- intermittent porphyrias (diseases with alterations of some enzymes);
- deficiency of an enzyme called glucose-6-phosphate dehydrogenase (a disease known as favism or fava bean disease, which causes a decrease in red blood cells);
- severe hemolytic anemia (a disease that destroys red blood cells);
• suffer from hepatocellular insufficiency (insufficient function of liver cells) or kidney failure;
• are pregnant or breast-feeding (see "Pregnancy and breast-feeding").

Neo-Optalidon should not be given to children under 12 years of age, because it contains caffeine.


Warnings and precautions
Be CAREFUL not to use Neo-Optalidon at high doses or for a long time, or at the same time as other medicines containing paracetamol, as adverse reactions, even serious ones, may occur, especially affecting the liver, kidneys and blood (see "Other medicines and Neo-Optalidon" and section 4. Possible side effects).

Talk to your doctor or pharmacist before taking Neo-Optalidon, especially if:
• have blood disorders or liver or kidney problems;
• have asthma or inflammation of the nose that lasts for more than 12 weeks (chronic rhinitis);
• have chronic hives (a rash characterized by itchy raised bumps (wheals) that lasts for 6-12 weeks);
• if you are taking other medicines against inflammation (see "Other medicines and Neo-Optalidon"); in these cases the use of Neo-Optalidon is not recommended.

Stop treatment with Neo-Optalidon and consult your doctor:
• if you experience fever, as Neo-Optalidon therapy may not be suitable for your condition;
• if you have chest pain (angina), or notice changes in your skin or mucous membranes, or any other signs of an allergic reaction (see section 4. Possible side effects).

During treatment with Neo-Optalidon, tell your doctor immediately if:
If you have serious illnesses, including severe kidney failure 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). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

This medicine may affect the results of some laboratory tests, such as tests to measure uric acid (uricemia) and blood sugar (glycemia) in the blood.

Children
Neo-Optalidon should not be given to children under 12 years of age, because it contains caffeine.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Neo-Optalidon and contact your doctor if you experience any of the following conditions:
• skin rashes, redness, itching with spots on the skin (hives), swelling of the face, eyes, lips, difficulty breathing (larynx edema or asthma), severe allergic reaction (anaphylactic shock);
• severe skin rashes with redness and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• frequency not known (cannot be estimated from the available data): serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Tell your doctor if you have the following side effects:
• blood cell changes: thrombocytopenia (decrease in platelets), leukopenia (decrease in white blood cells), agranulocytosis (significant reduction in granulocytes), anemia (decrease in red blood cells);
• inflammation of the liver (hepatitis) and alterations in its functionality;
• inflammation of the kidney (interstitial nephritis), and alterations in its functionality (renal failure), blood in the urine (hematuria), absence of diuresis (anuria);
• stomach or intestinal disorders;
• dizziness.

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.