Package leaflet: Information for the patient

OPTALIDON, coated tablets

OPTALIDON, suppositories
Propyphenazone, Butalbital, Caffeine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, 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:

What OPTALIDON is and what it is 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

1. What OPTALIDON is and what it is used for

OPTALIDON is a medicine containing three active substances: propyphenazone, which acts against fever and
pain; butalbital and caffeine, which enhance the pain-relieving effect of the medicine through different mechanisms. Butalbital also has a calming (sedative) effect.
This medicine is used for relief of pain, for example in headaches, toothache, muscle or joint pain, and menstrual pain.

2. What you need to know before taking OPTALIDON

Do not take OPTALIDON if:

you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to other similar active substances, such as other anti-inflammatory drugs;
you suffer from certain blood disorders, such as:
- granulocytopenia (reduction in the number of certain white blood cells);
- porphyria (diseases involving alterations in certain enzymes);
- deficiency of an enzyme called glucose-6-phosphate dehydrogenase (known as favism or "fava bean disease", which causes a reduction in red blood cells);
you have taken excessive doses (overdose or intoxication) of alcohol, painkillers (analgesics), or drugs acting on the brain (hypnotics and psychotropics);
you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

OPTALIDON must not be administered to children and adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking OPTALIDON if:

you are elderly or feel very weak (debilitated);
you have liver or kidney problems;
you have gastrointestinal diseases.

Stop treatment and consult your doctor:

if you develop fever, as treatment with OPTALIDON may not be suitable for your condition;
if you experience chest pain (angina), or notice skin or mucous membrane changes, or any other sign of allergic reaction (see section 4).

BE CAREFUL
Do not exceed the recommended dose of OPTALIDON or take it for prolonged periods, because:

butalbital contained in OPTALIDON may lead to dependence, resulting in the need to progressively increase the dosage;
propyphenazone contained in OPTALIDON may cause adverse reactions, especially affecting the blood (see section 4).

Children and adolescents under 18 years of age
OPTALIDON must not be administered to children and adolescents under 18 years of age (see section "Do not take OPTALIDON if").
Other medicines and OPTALIDON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, because taking multiple medicines together may affect their absorption and therefore their effectiveness; this could also increase the risk of serious adverse reactions.
In particular, inform your doctor if you are taking:

medicines acting on the central nervous system (psychotropic drugs), such as anxiolytics, antidepressants, barbiturates, or other sedatives;
hypoglycemic agents (which reduce blood sugar levels), such as acetazolamide, chlorpropamide, tolbutamide;
anticoagulant medicines such as warfarin (which thin the blood);
phenytoin (for epilepsy);
hormonal contraceptives.

If you are taking any of the medicines listed above, inform your doctor, who will advise you on what to do.
OPTALIDON with food, drinks and alcohol
Do not consume alcohol during treatment with OPTALIDON, as it may interfere with your treatment and increase the sedative effect of butalbital.
OPTALIDON contains caffeine. In high doses, caffeine may cause: excitement, difficulty falling asleep (insomnia), muscle tremors, vomiting, increased urination, changes or increased heart rate (extrasystoles or tachycardia), dark spots in the visual field (scotomas).
Rarely, in predisposed individuals, symptoms of caffeine-induced hyperexcitability may occur.
Be careful not to consume too many beverages containing caffeine and/or theine during treatment with OPTALIDON.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or 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 complications during childbirth.
NSAIDs can cause kidney and heart problems in the fetus. They may affect the bleeding tendency of both mother and baby and may cause delayed or prolonged labour. From week 20 of pregnancy, NSAIDs may cause kidney problems in the fetus, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
Do not take Optalidon if you are breastfeeding.
Driving and using machines
OPTALIDON may cause drowsiness, dizziness, sedation, and confusion, impairing the mental and/or physical abilities required to perform tasks such as driving a vehicle and/or operating machinery.
Therefore, do not use Optalidon before driving or operating machinery.
OPTALIDON, coated tablets contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
OPTALIDON suppositories contain the excipient sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take OPTALIDON

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
1-2 coated tablets, several times a day, up to a maximum of 6 tablets per day. Take OPTALIDON with water or other liquids and with food, without chewing the tablets;
or
1 suppository, several times a day, up to a maximum of 2-3 suppositories per day.
Do not exceed the recommended doses. If symptoms recur frequently or if you notice any change in their characteristics, consult your doctor.

Use in the elderly
It is advisable to consult your doctor before taking OPTALIDON, as a reduction of the above-mentioned doses may be necessary.

Use in children and adolescents under 18 years of age
OPTALIDON must 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 the missed dose.

If you take more OPTALIDON than you should
Symptoms may include nausea, vomiting, headache, mental confusion, dizziness resembling coma (obnubilation, drowsiness, comatose state), accompanied by breathing difficulties (bradypnea, tracheobronchial obstruction), and low blood pressure (arterial hypotension), signs of a neurovegetative syndrome.

In addition, due to the presence of caffeine, high doses of this medicine may cause overstimulation with excitement, insomnia, muscle tremors, nausea, vomiting, increased urination (diuresis), heart rhythm disturbances or increased heartbeat (extrasystoles or tachycardia), and dark spots in the visual field (scotomas).

If you take more OPTALIDON than you should, contact your doctor immediately or go to the nearest hospital, as appropriate supportive measures may be necessary.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Stop taking OPTALIDON and contact your doctor immediately if you experience any of the following symptoms due to an allergic reaction:

skin and mucous membrane rashes, redness, itching with skin lesions (urticaria), facial swelling, swelling of the eyes, lips, breathing difficulties, sudden drop in blood pressure (anaphylactic reactions).

Inform your doctor if you experience any of the following adverse reactions:

blood cell abnormalities: leucopenia (reduction in white blood cells), agranulocytosis (marked decrease in granulocytes);
kidney inflammation (interstitial nephritis) or changes in kidney function (renal failure), blood in the urine (haematuria);
nausea, vomiting and abdominal pain;
drowsiness, sedation, dizziness, vertigo, confusion;
muscle coordination disturbances (ataxia), involuntary eye movements (nystagmus);
excitation, difficulty falling asleep (insomnia), irritability, increased heart rate (tachycardia).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide further 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 special storage conditions.
OPTALIDON suppositories: do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What OPTALIDON contains
The active substances are: propyphenazone, butalbital and caffeine.
OPTALIDON coated tablets
One tablet contains: 125 mg of propyphenazone, 50 mg of butalbital and 25 mg of caffeine.
Other components: hydroxypropyl cellulose, magnesium stearate, pregelatinized maize starch,
sucrose, talc, arabic gum, erythrosine,
OPTALIDON suppositories
One suppository contains: 375 mg of propyphenazone, 150 mg of butalbital and 75 mg of caffeine.
Other components: sunset yellow FCF (E110), erythrosine, semisynthetic solid glycerides, purified water.
Description of the appearance of OPTALIDON and contents of the pack
OPTALIDON coated tablets are available in packs of 25 tablets.
OPTALIDON suppositories are available in packs of 6 suppositories.
Marketing Authorization Holder
Perrigo Italia S.r.l., Viale dell’Arte, 25 – 00144 Rome
Manufacturer
Mipharm S.p.A., Via Quaranta 12 – 20141 Milan
February 2023