Active ingredients: Paracetamol, Propiphenazone, Caffeine
NEO-OPTALIDON 200 mg + 125 mg + 25 mg coated tablets
Indications Why is Neo Optalidon used? What is it for?
Neo-Optalidon is a medicine containing three active ingredients, paracetamol and propiphenazone, 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, tooth pain, 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.
Contraindications When Neo Optalidon should not be used
Do not take Neo-Optalidon if:
- you are allergic to paracetamol, propiphenazone, caffeine or any of the other ingredients of this medicine (listed in section 6);
- is allergic to other similar substances from a chemical point of view, for example other anti-inflammatories belonging to the same class (eg para-aminophenols, pyrazolones);
- suffer from some blood disorders such as:
- - granulocytopenia (decrease in the number of some blood cells);
- intermittent porphyrias (diseases with alterations of some enzymes); -
- insufficiency of an enzyme called glucose-6-phosphate dehydrogenase (a disease known as favism or bean disease, which causes a decrease in red blood cells);
- severe haemolytic anemia (disease that destroys red blood cells);
- suffer from hepatocellular (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 the age of 12 as it contains caffeine.
Precautions for use What you need to know before taking Neo Optalidon
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 has lasted for more than 12 weeks (chronic rhinitis);
- have chronic "hives (skin rash characterized by the presence of itchy bumps (wheals) that last for 6-12 weeks);
- if you are taking other medicines for inflammation (see “Other medicines and Neo-Optalidon”); in such cases the use of Neo-Optalidon is not recommended.
Interactions Which drugs or foods can change the effect of Neo Optalidon
Other medicines and Neo-Optalidon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, as the simultaneous administration of several medicines can affect their absorption and therefore their effectiveness, and this could also increase the risk of having serious adverse reactions.
In particular, tell your doctor if you are taking:
- hypoglycemic drugs (which lower blood sugar levels) such as acetohexamide, chlorpropamide, tolbutamide;
- anticoagulant drugs such as warfarin (which thin the blood);
- chloramphenicol (against infections) and zidovudine (against viruses);
- rifampicin (for the treatment of tuberculosis);
- cimetidine (for ulcerapeptic);
- phenytoin, lamotrigine, glutethimide, phenobarbital, carbamazepine (against epilepsy);
- NSAIDs and opioids (pain relievers);
- ethinyl estradiol (contained in many birth control pills);
- drugs that affect gastric emptying (e.g. propantheline, metoclopramide, domperidone)
- other drugs containing paracetamol.
If you are taking any of the above medications, your doctor will advise you what to do.
Neo-Optalidon with food, drink and alcohol
Do not take Neo-Optalidon with alcohol as this may interfere with your treatment and / or increase the risk of adverse liver events. Neo-Optalidon contains caffeine. In high doses, caffeine can cause: excitement, difficulty falling asleep (insomnia), shaking of the muscles, vomiting, increased urine output, altered or increased heartbeat (ectopic beats or tachycardia), black spots in the visual field (scotoma). Be careful not to drink too many caffeinated and / or theine-containing drinks while taking Neo-Optalidon.
Warnings It is important to know that:
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, including serious ones, can occur, especially affecting the liver, kidney and blood (see "Other medicines and Neo -Optalidon "and section 4. Possible side effects)
Stop using Neo-Optalidon and consult your doctor:
- if you develop fever, as Neo-Optalidon therapy may not be suitable for your condition;
- if you have chest pain (angina), or notice changes in the skin or mucous membranes, or any other signs of an allergic reaction (see section 4. Possible side effects).
This medicine can affect the results of some laboratory tests, such as tests for measuring uric acid (uricaemia) and blood glucose (blood sugar) in the blood.
Children
Neo-Optalidon should not be given to children under the age of 12, as it contains caffeine
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Neo-Optalidon if you are pregnant or breast-feeding (see "Do not take Neo-Optalidon if")
Driving and using machines
Neo-Optalidon can cause dizziness. Take special care before driving or using machines.
Neo-Optalidon contains:
- sucrose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine;
- hydrogenated peanut oil: do not use if you are allergic to peanuts or soy.
Dosage and method of use How to use Neo Optalidon: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1-2 tablets a day, to be taken with plenty of water or other liquids, and on a full stomach.
The maximum dose is 4 tablets per day. Do not exceed the recommended dose.
Do not take the medicine for more than 3 consecutive days. After 3 days of unsuccessful treatment, if the disorder occurs repeatedly or if you notice any change in its characteristics, consult your doctor.
Senior citizens
It is advisable to follow the minimum dosages indicated above: 1 tablet, 1 times a day, unless otherwise indicated by the doctor.
Children
Neo-Optalidon should not be given to children under the age of 12 as it contains caffeine.
If you forget to take Neo-Optalidon
Do not take a double dose to make up for a forgotten tablet.
Overdose What to do if you have taken an overdose of Neo Optalidon
Seizures or liver problems may occur if you take more Neo-Optalidon than you should.
Also due to the presence of caffeine, high doses of this medicine can cause excitement, insomnia, muscle tremor, nausea, vomiting, increased urine output, altered or increased heartbeat (ectopic beats or tachycardia), black spots in the visual field (scotomas) .
If you take more Neo-Optalidon than you should, tell your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Neo Optalidon
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Neo-Optalidon and see your doctor if you have any of the following:
- rash, redness, itching with spots on the skin (hives), swelling of the face, eyes, lips, difficulty in breathing (larynx edema or asthma), severe allergic reaction (anaphylactic shock);
- severe rash with redness and / or blistering (e.g. erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis);
Tell your doctor if you have the following side effects:
- changes in blood cells: thrombocytopenia (decrease in platelets), leukopenia (decrease in white blood cells), agranulocytosis (marked reduction in granulocytes), anemia (decrease in red blood cells);
- inflammation of the liver (hepatitis) and changes in its functionality;
- inflammation of the kidney (interstitial nephritis), and changes in its function (renal failure), blood in the urine (haematuria), absence of diuresis (anuria);
- upset stomach or intestines;
- dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili”.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition
What Neo-Optalidon contains
The active ingredients are: paracetamol, propiphenazone and caffeine.
One tablet contains: 200 mg of paracetamol, 125 mg of propiphenazone and 25 mg of caffeine.
The other ingredients are: hydroxypropylcellulose; dimethyl silicone oil; crospovidone; hydrogenated vegetable oil; magnesium stearate; titanium dioxide; hydrogenated peanut oil; precipitated silica; macrogol 6000; povidone; sucrose; stearic acid; talc; microcrystalline cellulose; cetyl alcohol; erythrosine (E 127); Arabic gum.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
