Patient Information Leaflet: Information for the Patient

Cafinitrina 1 mg/25 mg Sublingual Tablets

nitroglycerin/caffeine citrate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Cafinitrinabelongs to a group of medications calledvasodilators used in heart diseases, which increase the flow of blood that reaches the heart and improve its performance when there is less blood flow in the coronary arteries (arteries that carry blood to the heart).

Cafinitrinais administered under the tongue to:

• Treat acute attacks of angina pectoris, which consist of the sudden appearance of chest pain or pressure, although it may be felt in the neck or arm, due to a lack of blood flow in the coronary arteries.
• Prevent chest pain due to angina pectoris when engaging in physical activity or a situation that may trigger said pain.

Do not take Cafinitrina

• If you are allergic to nitroglycerin, nitroglycerin derivatives, and/or caffeine citrate or any other component of this medication (listed in section 6).
• In case of severe anemia, cerebral hemorrhage, or brain injuries with increased intracranial pressure.
• If you have uncorrected decreased total blood volume or very low blood pressure.
• If you have an uncorrected increase in intraocular pressure.
• If you have been diagnosed with obstructive cardiomyopathy (a non-inflammatory heart disease), especially if it is associated with aortic or mitral stenosis or constrictive pericarditis (heart valve problems).
• If you are being treated with sildenafil or other similar medications used to treat erectile dysfunction.
• If you are taking soluble guanylate cyclase stimulators (e.g., riociguat) used to treat pulmonary hypertension, as they increase the risk of hypotension.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cafinitrina:

• If you have ischemic heart failure or severe cerebral ischemia (cardiac or cerebral circulation problems), as decreased oxygen supply may decrease the effect of nitroglycerin.
• If you are being dialyzed, as there is a risk of hypotension.
• If you have incipient glaucoma (eye disease caused by high pressure in the eye), as organic nitrates and nitrites may increase intraocular pressure.
• If you have recently had an acute myocardial infarction or have acute heart failure, as you may require careful medical monitoring.

Be aware that in chronic treatments with high doses, the effects of nitroglycerin may decrease.

Avoid sudden discontinuation of treatment.

Children and adolescents

This medication is not recommended for use.

Other medications and Cafinitrina

• The administration of5-phosphodiesterase inhibitors(sildenafil or other similar medications for erectile dysfunction treatment) or soluble guanylate cyclase stimulators (riociguat) may potentiate the occasional hypotensive effect (decrease in blood pressure) associated with nitroglycerin intake. See section 2 “Do not take Cafinitrina”.
• Avoid using this medication with ergotamine or related medications, as it may decrease the effect of both medications.
• Exercise caution when administering this medication simultaneously with other vasodilators (papaverine, vincamine, etc.), anti-hypertensive medications (e.g., calcium channel blockers, beta-blockers, diuretics, etc.), tricyclic antidepressants, neuroleptics, and alcohol, as they may potentiate the hypotensive effect of nitroglycerin.
• The intake of acetylsalicylic acid and other non-steroidal anti-inflammatory substances (analgesics with anti-inflammatory effects) may decrease the response to nitroglycerin.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Cafinitrina with food, drinks, and alcohol

Avoid consuming alcoholic beverages.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy:

Your doctorwill decide whether you should take or not take Cafinitrina after considering the benefits for the mother and the risk to the fetus.

Breastfeeding::

Your doctor will decide if you need to stop breastfeeding or stop treatment.

Driving and operating machines

Cafinitrina may cause hot flashes, dizziness, or decreased blood pressure, especially at the beginning of treatment. If you experience any of these adverse effects, avoid driving vehicles or operating machines.

Cafinitrina contains saccharose and lactose

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Remember to take your medication.

Insert a tablet into your mouth, chew it immediately without swallowing it and place it under your tongue.

The recommended dose is:

Treatment of acute attacks of angina pectoris

Take 1 tablet at the first symptom or sign of anginal pain. If the pain does not completely disappear, you can repeat the dose three or four times, in short intervals of 10 minutes.

Prevention of painful crisis of angina pectoris

Take 1 tablet, between 5 and 10 minutes before engaging/exposing yourself to activities/situations known to trigger anginal pain.

Your doctor will indicate the duration of your treatment with Cafinitrina

Use in children and adolescents

This medication is not recommended for use.

If you take more Cafinitrina than you should

You may experience a condition of decreased blood pressure, shock, and blue discoloration of the skin.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested. Alternatively, go to the nearest emergency service. Bring this leaflet with you.

If you forgot to take Cafinitrina

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Cafinitrina

Do not stop treatment abruptly, as you may experience a possible withdrawal reaction or rebound effect. In this case, you may experience precipitation of angina pectoris or myocardial infarction. Therefore, it is recommended to gradually reduce the dose over a period of 4-6 weeks.

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 all people will experience them.

Below is a list of adverse effects. It is essential to inform your doctor if you notice any discomfort.

Very Frequent (may affect more than 1 person in every 10):

• Headache

Frequent (may affect up to 1 person in every 10 of every 100):

• Dizziness, drowsiness
• Fast heart rate
• Dizziness when standing up or getting up
• Fatigue
• Low blood pressure

Infrequent (may affect between 1 and 10 people in every 1,000)::

• Syncope
• Worsening of angina pectoris, slow heart rate, blue skin
• Redness of the skin, circulatory insufficiency
• Nausea, vomiting

Very Rare Adverse Reactions (may affect up to 1 person in every 10,000):

• Hemoglobin alteration (methemoglobinemia)
• Restlessness
• Cerebral hypoperfusion
• Respiratory alteration
• Stomach burning, bad breath
• Severe skin reaction (dermatitis exfoliativa), rash

Adverse Effects of Unknown Frequency::

• Dizziness
• Palpitations
• Pallor
• Excessive sweating, urticaria

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 of Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

If you carry a small amount of tablets, use an appropriate container and store them in it without removing them from the blister pack in which each one is included. Avoid carrying the container near the body because the body heat itself can affect the medication.

Unless these precautions are met, the medication will not maintain its activity until the expiration date indicated on the packaging.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.By doing so, you will help protect the environment.

Composition of Cafinitrina

• The active principles are nitroglycerin and caffeine citrate. Each tablet contains 1 mg of nitroglycerin and 25 mg of caffeine citrate.
• The other components are:

• core: s ilica colloid, talc, saccharose, lactose, cornstarch, solid semisynthetic glycerides,
• coating: cornstarch, talc, saccharose, titanium dioxide (E-171) and cera ester E.

Appearance of the product and content of the packaging

Packaging containing 20 sublingual tablets coated with a film in PVC/Aluminum blisters.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Industrias Farmacéuticas Almirall Prodesfarma, S.L.

National Highway II, Km 593

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this prospectus: August 2022

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS) http:// www.aemps.gob.es /