OPTALIDON 500 mg/75 mg SUPPOSITORIES

Introduction

Patient Information Leaflet

Optalidon 500 mg/75mg suppositories Propyphenazone, anhydrous caffeine

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 10 days.

Contents of the Leaflet

1. What Optalidon is and what it is used for
2. What you need to know before taking Optalidon
3. How to take Optalidon
4. Possible side effects
5. Storage of Optalidon
6. Package contents and additional information

1. What Optalidon is and what it is used for

Optalidon is a medicine that contains two active ingredients in combination: propyphenazone for pain, and caffeine, which has a stimulating effect on the nervous system, for somnolence.

It is indicated for adults and children over 12 years old, for the relief of mild or moderate pain, such as headache, toothache, and menstrual pain.

You should consult a doctor if it worsens or does not improve after 10 days.

2. What you need to know before taking Optalidon

Do not useOptalidon

• If you are allergic to propyphenazone or caffeine, or to any of the other components of this medicine (listed in section 6).
• If you are allergic to medicines that contain metamizole, phenylbutazone, or other components of the pyrazolone group.
• If you are allergic to medicines that contain aminophylline, dyphylline, oxtriphylline, theobromine, theophylline, or other components of the xanthine group.
• If you have experienced allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing) when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• If you have blood disorders (granulocytopenia, agranulocytosis).
• If you have any metabolic disease such as porphyria (a rare, usually hereditary disorder in which a large amount of porphyrin is eliminated in feces and urine) or congenital glucose-6-phosphate dehydrogenase deficiency.
• If you have severe liver, kidney, or heart disease (renal, hepatic, or cardiac insufficiency).
• If you have an anxiety disorder.
• If you have an active gastroduodenal ulcer.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Optalidon.

Do not exceed the recommended dose in the Posology section, nor use it for more than 10 days. Consult your doctor or pharmacist before starting to use Optalidon if:

• you have hypertension,
• you have a gastroduodenal ulcer,
• you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis).

If the pain persists, worsens, or other symptoms appear, especially fever or mouth ulcers, treatment should be discontinued immediately and your doctor consulted.

Caffeine may increase blood glucose levels.

In people with sleep disorders, it is recommended not to take this medicine in the hours before bedtime to avoid possible insomnia.

Athletes should be informed that this medicine contains a component that may result in a positive doping test.

Children and adolescents

It should not be administered to children under 12 years old.

Other medicines and Optalidon

Taking Optalidon with other medicines.

Inform your doctor or pharmacist if you are taking or using, have taken or used recently, or may need to take or use any other medicine. In particular, if you are taking any of the following medicines, it may be necessary to modify the dose of one of them or interrupt treatment:

• oral anticoagulants (medicines used to "thin" the blood and prevent clot formation) such as warfarin,
• barbiturics (medicines used to treat seizures),
• antihistamines (used to reduce the symptoms of allergic reactions),
• lithium (reducing its therapeutic effect).

Using Optalidon with food and beverages and alcohol

It is recommended to limit the use of products that contain caffeine when being treated with this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should not be taken during pregnancy or breastfeeding without consulting a doctor.

Do not take Optalidon if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and that of the fetus to bleed and make labor longer than expected. You should not take Optalidon during the first 6 months of pregnancy unless it is absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, Optalidon may cause kidney problems in the fetus, which can lead to low levels of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more days, your doctor may recommend additional monitoring.

Driving and using machines

Do not drive or operate hazardous machinery, as this medicine can cause drowsiness or decreased reaction time at the recommended doses.

3. How to take Optalidon

Follow the administration instructions for this medicine indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.

Rectal route.

The recommended dose is 1 suppository per day. The maximum dose will be 2 suppositories per day.

Always use the lowest effective dose. Administration of the preparation is subject to the appearance of pain. As it disappears, this medication should be discontinued.

Instructions for correct administration of the preparation

If the suppository is too soft to insert, cool it in the refrigerator for 30 minutes or put it under cold running water before removing the plastic wrapper or after if necessary to prevent it from softening.

Use in children and adolescents

It should not be used in children under 12 years old.

If you use more Optalidon than you should

Symptoms of overdose are: abdominal pain, nausea, vomiting, drowsiness, excitement, convulsions, and coma.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Telephone: (91)-562.04.20), indicating the medicine and the amount ingested.

If you forget to use Optalidon

Do not use a double dose to make up for forgotten doses.

If you stop treatment with Optalidon

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

They are not usually observed at the recommended doses. In hypersensitive subjects, very rare cutaneous allergic reactions have been observed: redness or itching, skin alterations with blister formation, urticaria, or shock. In this case, treatment should be discontinued and a doctor consulted. Occasionally, dizziness, nausea, nervousness, difficulty sleeping, rapid heartbeats, or gastrointestinal irritation may appear.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Optalidon

Keep this medicine out of the sight and reach of children. No special storage conditions are required.

Do not use this medicine after the expiration date shown on the label and carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Optalidon

Per suppository:

The active ingredients are propyphenazone (DCI) 500 mg, anhydrous caffeine 75 mg.

The other components (excipients) are yellow iron oxide, red iron oxide, Sorbitan laurate (Span 20), and suppository mass.

Appearance of the product and package contents

Package with 6 suppositories.

Marketing authorization holder

Perrigo España S.A.

Pza de Xavier Cugat 2 Edificio D planta 1 08174 Sant Cugat del Valles

Barcelona, Spain

Manufacturer

MIPHARM S.P.A.,

Via B. Quaranta, 12, 1-201 40, Italy

Date of the last revision of this leaflet: 12/2022

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.