NEO OPTALIDON 200 mg/125 mg/25 mg Coated tablet

Зміст інструкції

1. What is Neo-Optalidon and what is it used for
2. What you need to know before taking Neo-Optalidon
3. How to take Neo-Optalidon
4. Possible side effects
5. How to store Neo-Optalidon
6. Contents of the pack and other information

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

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist
has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

• 1. What Neo-Optalidon is and what it is used for
• 2. What you need to know before you take Neo-Optalidon
• 3. How to take Neo-Optalidon
• 4. Possible side effects
• 5. How to store Neo-Optalidon
• 6. Contents of the pack and other information

1. What is Neo-Optalidon 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 association.
This medicine is used for the symptomatic treatment of pain (e.g. headache, toothache,
nerve pain, menstrual pain) and fever.
See your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking Neo-Optalidon

Do not take Neo-Optalidon if:

• you are allergic to paracetamol, propyphenazone, caffeine or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other substances with similar chemical properties, for example other anti-inflammatory drugs belonging to the same class (e.g. para-aminophenols, pyrazolones);
• you are allergic to peanuts or soya.
• you suffer from certain blood disorders such as:
• granulocytopenia (decrease in the number of certain blood cells);
• intermittent porphyrias (diseases with alterations of certain enzymes);
• deficiency of an enzyme called glucose-6-phosphate dehydrogenase (disease known as favism or fava bean disease, which causes a decrease in red blood cells);
• severe hemolytic anemia (disease that destroys red blood cells);
• you suffer from hepatocellular insufficiency (insufficient function of the liver cells) or kidney problems;
• you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

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

Warnings and precautions
PAY ATTENTION to not use Neo-Optalidon at high doses or for a long time, or
simultaneously with other drugs containing paracetamol, as adverse reactions may occur,
even serious ones, especially affecting the liver, kidneys and blood (see “Other medicines and Neo-Optalidon”
and section 4. Possible side effects).
Consult your doctor or pharmacist before taking Neo-Optalidon, especially if:

• you have blood disorders or problems with the liver or kidneys;
• you have asthma or inflammation of the nose that lasts more than 12 weeks (chronic rhinitis);
• you have chronic urticaria (skin rash characterized by the presence of itchy wheals that lasts 6-12 weeks);
• you are taking other drugs 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:

• in case of fever, as therapy with Neo-Optalidon 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 sign of an allergic reaction (see section 4. Possible side effects).

During treatment with Neo-Optalidon, immediately inform your doctor if:
If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins
circulate in the blood causing damage to organs) or if you are malnourished, chronic alcoholism or if you are taking
also flucloxacillin (an antibiotic). In patients in these situations, a serious
condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is
used at regular doses for a prolonged period or when paracetamol is taken in association with
flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with
rapid deep breathing, drowsiness, nausea and vomiting.
This medicine can affect the results of some laboratory tests, such as tests for measuring uric acid levels in
the blood (uricemia) and blood sugar levels (glycemia)

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

Other medicines and Neo-Optalidon
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine, as the simultaneous administration of multiple drugs can affect their
absorption and therefore efficacy; moreover, this could increase the risk of having serious adverse reactions.
Inform your doctor or pharmacist if you are taking:

• hypoglycemic drugs (which reduce blood sugar levels) such as acetamide, 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 peptic ulcer);
• phenytoin, lamotrigine, glutethimide, phenobarbital, carbamazepine (against epilepsy);
• NSAIDs and opioids (pain relievers);
• ethinylestradiol (contained in many oral contraceptives);
• drugs that affect gastric emptying (example propantheline, metoclopramide, domperidone)
• other medicines containing paracetamol.
• flucloxacillin (antibiotic), due to a serious risk of alterations of the blood and fluids (called

metabolic acidosis with high anion gap) which must be treated urgently. If you are taking
any of the above-mentioned drugs, your doctor will advise you what to do.

Neo-Optalidon with food, drinks and alcohol
Do not take Neo-Optalidon with alcohol as this may interfere with your treatment and/or increase the
risk of adverse events affecting the liver.
Neo-Optalidon contains caffeine. In high doses, caffeine can cause: excitement, difficulty
falling asleep (insomnia), muscle tremors, vomiting, increased diuresis, changes or increase in heart rate (extrasystole or tachycardia), black spots in the field of vision (scotomas). Be careful not to
take too many drinks containing caffeine and/or theine during treatment with Neo-Optalidon.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Neo-Optalidon if you are pregnant or breastfeeding (see “Do not take Neo-
Optalidon if”).
Do not take Neo-Optalidon if you are pregnant as it may harm the fetus or cause problems
during childbirth.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect your tendency of the mother
and child to bleed and cause a late or prolonged labor. From the 20th week
of pregnancy, NSAIDs can cause kidney problems in the fetus, thus reducing the levels of amniotic fluid that
surrounds the baby (oligohydramnios) or cause narrowing of a blood vessel (ductus arteriosus) in
the baby's heart.

Driving and operating machinery
Neo-Optalidon can cause dizziness. Pay particular attention before driving vehicles or
using machinery.

Neo-Optalidon contains:

• sucrose: if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine;
• hydrogenated peanut oil: if you are allergic to peanuts or soya, do not use this medicine.

3. How to take Neo-Optalidon

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 tablets per 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 doses.
Do not take the medicine for more than 3 consecutive days. After 3 days of treatment without results, if the discomfort recurs or if you notice any change in its characteristics, consult your doctor.

Elderly
It is advisable to adhere to the minimum dosages indicated above: 1 tablet, 1 time a day, unless otherwise indicated by the doctor.

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

If you forget to take Neo-Optalidon
Do not take a double dose to make up for a missed tablet.

If you take more Neo-Optalidon than you should
seizures or liver problems may occur.
Furthermore, due to the presence of caffeine, high doses of this medicine can cause excitement, insomnia, muscle tremors, nausea, vomiting, increased diuresis, alterations or increased heartbeats (extrasystole or tachycardia), black spots in the visual field (scotomas).
If you take more Neo-Optalidon than you should, immediately inform your doctor or go to the nearest hospital.

4. 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 any of the following occur:

• skin rashes, redness, itching with spots on the skin (urticaria), swelling of the face, eyes, lips, difficulty breathing (laryngeal edema or asthma), severe allergic reaction (anaphylactic shock);
• severe skin rashes with redness and/or blister formation (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• frequency not known (cannot be estimated based on available data): serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).

Tell your doctor if you experience any of the following side effects:

• changes in blood cells: 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 changes in its function;
• inflammation of the kidney (interstitial nephritis), and changes in its function (renal failure), blood in the urine (hematuria), absence of diuresis (anuria);
• stomach or intestinal disorders;
• dizziness.

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

5. How to store Neo-Optalidon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Neo-Optalidon contains
The active ingredients are: paracetamol, propyphenazone and caffeine.
One tablet contains: 200 mg of paracetamol, 125 mg of propyphenazone and 25 mg of caffeine.
The other ingredients are: hydroxypropylcellulose; dimethyl silicone oil; crospovidone; hydrogenated vegetable oil;
magnesium stearate; titanium dioxide; hydrogenated peanut oil; anhydrous colloidal silica; macrogol
6000; povidone; sucrose; stearic acid; talc; microcrystalline cellulose; cetyl alcohol; erythrosine (E 127);
gum arabic.

Description of the appearance of Neo-Optalidon and contents of the pack
Neo-Optalidon is available in packs of 8 or 16 film-coated tablets, packaged in opaque PVC/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Perrigo Italia S.r.l., Viale Dell’Arte,25 00144 Roma

Manufacturer
Mipharm S.p.A., Via Quaranta 12, Milano