Package Insert: Information for the Patient

Optalido500 mg/75mg Suppositories Propifenazona, Caffeine Anhydrous

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

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

Optalidon?is a medication that contains two active ingredients in association: propifenazon for pain, and caffeine which has a stimulating effect on the nervous system, for drowsiness.

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.

Consult a doctor if it worsens or does not improve after 10 days.

Do not useOptalidon

• If you are allergic to propifenazona or to caffeine, or to any of the other components of this medication (listed in section 6).
• If you are allergic to medications that contain metamizol, phenylbutazona, or other components of the pyrazolones group.
• If you are allergic to medications that contain aminophylline, diprophylline, oxtriphylline, theobromine, theophylline, or other components of the xanthines group.
• If you have presented allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases coughing or wheezing) when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• If you suffer from blood disorders (granulocytopenia, agranulocytosis).
• If you have a metabolic disease such as porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in feces and urine) or congenital deficiency of glucose-6-phosphate dehydrogenase.
• If you have severe liver, kidney, or heart disease (renal, hepatic, or cardiac insufficiency).
• If you have anxiety disorder
• If you have an active gastric or duodenal ulcer.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Optalidon.

Do not exceed the recommended dose in the Posology section, or use it for more than 10 days. Consult your doctor or pharmacist before starting to use Optalidon if:

• you have hypertension,
• you have a gastric or duodenal ulcer,
• if 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 interrupted immediately and your doctor consulted.

Caffeine may elevate blood glucose levels.

In people with difficulty sleeping, it is recommended not to take this medication in the hours leading up to bedtime, to avoid possible insomnia.

Inform athletes that this medication contains a component that may result in a positive analytical test for doping control.

Children and adolescents

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

Other medications and Optalidon

Optalidon with other medications.

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 medication. In particular, if you are taking any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

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

Use of Optalidon with food and beverages and alcohol

It is recommended to limit the use of products containing caffeine while taking this medication.

Pregnancy and lactation and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy or lactation without consulting your doctor.

Do not take Optalidon in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in the fetus. It may affect your tendency and that of the fetus to bleed and make delivery later or longer than expected. Do not take Optalidon during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, Optalidon may cause renal problems in the fetus that may cause 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 operating machinery

Do not drive or operate hazardous machinery as this medication may cause drowsiness or decreased reaction capacity at the recommended doses.

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

Rectal administration.

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

You must always use the lower dose that is effective. The administration of the preparation is subject to the appearance of pain. As this disappears, discontinue this medication.

Instructions for correct administration of the preparation

If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or place it under cold running water before removing the plastic wrapping or afterwards if necessary to prevent softening.

Use in children and adolescents

Do not use in children under 12 years old.

If you use more Optalidon than you should

The 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 medication and the amount ingested.

If you forgot to use Optalidon

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Optalidon

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

These effects are not usually observed at the recommended doses. In hypersensitive individuals, very rarely, allergic skin reactions have been observed: redness or itching, skin alterations with blister formation, urticaria, or shock. In this case, discontinue treatment and consult a doctor. Occasionally, dizziness, nausea, nervousness, difficulty sleeping, rapid heartbeats, or gastrointestinal irritation may appear.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGREcollection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need.By doing so, you will help protect the environment.

Composition of Optalidon

By suppository:

The active principles are propifenazona (DCI) 500 mg, anhydrous caffeine 75 mg.

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

Appearance of the product and content of the packaging

Packaging with 6 suppositories.

Marketing Authorization Holder

Perrigo España S.A

Xavier Cugat 2 Building D, 1st floor 08174 Sant Cugat del Valles

Barcelona Spain

Responsible for Manufacturing

MIPHARM. S.PA,

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

Last review date of this leaflet: 12/2022

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es