Інструкція із застосування OPTALIDON
Зміст інструкції
- What is OPTALIDON and what is it used for
- What you need to know before taking OPTALIDON
- How to take OPTALIDON
- Possible side effects
- How to store OPTALIDON
- Contents of the pack and other information
OPTALIDON, coated tablets
OPTALIDON, suppositories
Propifenazone, Butalbital, Caffeine
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What OPTALIDON is and what it is used for
- 2. What you need to know before you take OPTALIDON
- 3. How to take OPTALIDON
- 4. Possible side effects
- 5. How to store OPTALIDON
- 6. Contents of the pack and other information
1. What is OPTALIDON and what is it used for
OPTALIDON is a medicine containing three active ingredients: propyphenazone, which acts against fever and pain; butalbital and caffeine which, through different mechanisms, increase the analgesic effect of the drug. Butalbital also has a calming (sedative) effect.
This medicine is used for pain relief, for example in cases of headache, toothache, muscle or joint pain, menstrual pain.
2. What you need to know before taking OPTALIDON
Do not take OPTALIDON if:
- you are allergic to the active ingredients, or to any of the other ingredients of this medicine (listed in section 6);
- you are allergic to other active substances similar to these, such as, for example, other anti-inflammatory drugs;
- you suffer from certain blood disorders such as:
- granulocytopenia (decrease in the number of certain white blood cells);
- porphyria (diseases with alterations of certain enzymes);
- insufficiency of an enzyme called glucose-6-phosphate dehydrogenase (disease known as favism or fava bean disease, which causes a decrease in red blood cells);
- you have taken excessive doses (overdose or intoxication) of alcohol, pain medications (analgesics) or drugs that act on the brain (hypnotics and psychotropics);
- you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
OPTALIDON should not be administered to children and adolescents under 18 years of age.
Warnings and precautions
Consult your doctor or pharmacist before taking OPTALIDON if:
- you are elderly or feel very weak (debilitated);
- you have problems with the liver or kidneys;
- you have abdominal diseases.
Stop treatment and consult your doctor:
- in case of fever, as therapy with 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).
PAY ATTENTION
Do not exceed the dose of OPTALIDON and do not take it for long periods, because:
- the butalbital contained in OPTALIDON can cause habituation with a resulting need to gradually increase the dosage;
- the propyphenazone contained in OPTALIDON can cause adverse reactions, especially affecting the blood (see section 4).
Children and adolescents under 18 years of age
OPTALIDON should not be administered to children and adolescents under 18 years of age (see
section “Do not take OPTALIDON if”).
Other medicines and OPTALIDON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because the simultaneous administration of multiple drugs can affect their
absorption and therefore efficacy; moreover, this could increase the risk of having serious adverse reactions.
In particular, tell your doctor if you are taking:
- medicines that act on the central nervous system (psychotropic drugs), such as, for example, anxiolytics, antidepressants, barbiturates or other sedatives;
- hypoglycemic drugs (which reduce blood sugar levels) such as acetohexamide, chlorpropamide, tolbutamide;
- anticoagulant drugs such as warfarin (which thin the blood);
- phenytoin (for epilepsy);
- hormonal contraceptives.
If you are taking any of the above medicines, tell your doctor who will advise you what to do.
OPTALIDON with food, drinks and alcohol
Do not drink alcohol during therapy with OPTALIDON as this may interfere with your treatment
increasing the sedative effect of butalbital.
OPTALIDON contains caffeine. In high doses, caffeine can cause: excitement, difficulty
falling asleep (insomnia), muscle tremors, vomiting, increased diuresis, changes or increase in
heartbeats (extrasystole or tachycardia), black spots in the visual field (scotomas).
Rarely, in predisposed individuals, symptoms of caffeine hyperstimulation may occur.
Be careful not to consume too many drinks containing caffeine and/or theine during treatment with
OPTALIDON.
Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take 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 to
bleed, both mother and baby, 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
surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus
arteriosus) in the baby's heart.
Do not take Optalidon if you are breastfeeding.
Driving and operating machinery
OPTALIDON can cause drowsiness, dizziness, sedation, dizziness, impairing mental and/or physical ability
necessary to perform activities such as driving a vehicle and/or operating machinery.
Therefore, do not use Optalidon before driving a vehicle or operating machinery.
OPTALIDON, coated tablets contains sucrose. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.
OPTALIDON suppositories contain the excipient yellow sunset FCF (E110) which may cause allergic
reactions
3. How to take OPTALIDON
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
1-2 coated tablets, several times a day for a maximum of 6 tablets per day. Take OPTALIDON
with water or other liquids, and on a full stomach, without chewing the tablets;
or
1 suppository, several times a day for a maximum of 2-3 suppositories per day.
Do not exceed the recommended doses. If the disorder occurs repeatedly or if you notice any change
in its characteristics, consult your doctor.
Use in the elderly
It is advisable to consult your doctor before taking OPTALIDON, as a
reduction of the above dosages may be necessary.
Use in children and adolescents under 18 years of age
OPTALIDON should not be administered to children and adolescents under 18 years of age (see
section “Do not take OPTALIDON if”).
If you forget to take OPTALIDON
Do not take a double dose to make up for a forgotten dose.
If you take more OPTALIDON than you shouldnausea, vomiting, headache, mental confusion
may occur, as well as dizziness even similar to coma (obnubilation, stupor, comatose state) accompanied by
difficulty breathing (bradypnea, tracheobronchial obstruction) and low blood pressure
(arterial hypotension), signs of a neurovegetative syndrome.
Furthermore, due to the presence of caffeine, high doses of this medicine may cause
hyperstimulation with excitement, insomnia, muscle tremors, nausea, vomiting, increased diuresis,
alterations or increase in heartbeats (extrasystole or tachycardia), black spots in the visual field
(scotomas).
If you take more OPTALIDON than you should, inform your doctor immediately or go to the nearest
hospital as appropriate supportive measures may be necessary.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking OPTALIDON and contact your doctor immediately if any of the following conditions occur due to allergy:
- skin and mucous membrane rashes, redness, itching with spots on the skin (urticaria), swelling of the face, eyes, lips, difficulty breathing, sudden drop in blood pressure (anaphylactic reactions).
Tell your doctor if you experience any of the following side effects:
- changes in blood cells: leukopenia (decrease in white blood cells), agranulocytosis (significant reduction in granulocytes);
- inflammation of the kidney (interstitial nephritis) or changes in its function (renal insufficiency), blood in the urine (hematuria);
- nausea, vomiting and abdominal pain;
- drowsiness, sedation, dizziness, vertigo, confusion;
- disorders of muscle coordination (ataxia), involuntary eye movements (nystagmus);
- excitation, difficulty falling asleep (insomnia), irritability, increased heart rate (tachycardia).
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 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 OPTALIDON
Keep this medicine out of the sight and reach of children.
OPTALIDON coated tablets: this medicine does not require any particular storage conditions.
OPTALIDON suppositories: do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”. The expiry date refers to the last day of that month.
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 OPTALIDON contains
The active ingredients are: propyphenazone, butalbital and caffeine.
OPTALIDON coated tablets
One tablet contains: 125 mg of propyphenazone, 50 mg of butalbital and 25 mg of caffeine.
The other ingredients are: hydroxypropylcellulose, magnesium stearate, pregelatinized corn starch,
sucrose, talc, gum arabic, erythrosine,
OPTALIDON suppositories
One suppository contains: 375 mg of propyphenazone, 150 mg of butalbital and 75 mg of caffeine.
The other ingredients are: sunset yellow FCF (E110), erythrosine, solid semisynthetic glycerides, purified water.
Description of the appearance of OPTALIDON and contents of the pack
OPTALIDON coated tablets is available in packs of 25 tablets.
OPTALIDON suppositories is available in packs of 6 suppositories.
Marketing Authorisation Holder
Perrigo Italia S.r.l., Viale -Dell’Arte, 25 – -00144 Roma
Manufacturer
Mipharm S.p.A., Via Quaranta 12 – 20141 Milano
February 2023

- Країна реєстрації
- Лікарська формаCoated tablet, 25
- Код АТХN02BB74
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до OPTALIDONЛікарська форма: Oral drops, solution, 500 MG/ MLДіюча речовина: Метамизол натрияВиробник: ABC FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Injectable solution, 1 G/2 MLДіюча речовина: Метамизол натрияВиробник: OPELLA HEALTHCARE ITALY S.R.L.Потрібен рецептЛікарська форма: Oral drops, solution, 500 MG/MLДіюча речовина: Метамизол натрияПотрібен рецепт
Аналоги OPTALIDON в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог OPTALIDON у Україна
Аналог OPTALIDON у Іспанія
Лікарі онлайн щодо OPTALIDON
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на OPTALIDON онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
OPTALIDON не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у OPTALIDON — propyphenazone, combinations with psycholeptics. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
OPTALIDON виробляється компанією PERRIGO ITALIA S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування OPTALIDON з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати OPTALIDON у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (propyphenazone, combinations with psycholeptics) включають METAMITSOLO SODIKO ABK, NOVALJINA, PIRALJIN. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















