CAFINITRINA 1 mg/25 mg SUBLINGUAL TABLETS

Introduction

Patient Information Leaflet

Cafinitrina 1 mg/25 mg sublingual tablets

nitroglycerin/caffeine citrate

Read this leaflet carefully before starting to take 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What is Cafinitrina and what is it used for

Cafinitrina belongs to a group of medicines called vasodilators used in heart diseases, which increase blood flow to the heart and improve its performance when there is reduced blood flow in the coronary arteries (arteries that carry blood to the heart).

Cafinitrina is administered under the tongue to:

• Treat acute attacks of angina pectoris, which consist of sudden onset of pain or oppression in the chest, although it may be felt in the neck or arm, due to reduced blood flow in the coronary arteries.
• Prevent chest pain due to angina pectoris when physical activity or situations that may trigger such pain are to be undertaken.

2. What you need to know before taking Cafinitrina

Do not take Cafinitrina

• If you are allergic to nitroglycerin, nitroglycerin derivatives, and/or caffeine citrate or any of the other components of this medicine (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 increased intraocular pressure.
• If you have been diagnosed with obstructive cardiomyopathy (a non-inflammatory heart disease), especially if associated with aortic or mitral stenosis or constrictive pericarditis (heart valve problems).
• If you are being treated with sildenafil or other similar-acting medications used for erectile dysfunction.
• If you are taking soluble guanylate cyclase stimulators (e.g., riociguat) used in the treatment of 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 reduced oxygen supply may decrease the effect of nitroglycerin.
• If you are undergoing dialysis, 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 suffered a myocardial infarction or have acute heart failure, as you may require careful medical monitoring.

You should be aware that chronic treatment with high doses may decrease the effects of nitroglycerin.

Sudden discontinuation of treatment should be avoided.

Children and adolescents

This medicine is not recommended for use in this population.

Other medicines and Cafinitrina

• The administration of phosphodiesterase 5 inhibitors (sildenafil or similar medications for erectile dysfunction treatment) or soluble guanylate cyclase stimulators (riociguat) may enhance the occasional hypotensive effect associated with nitroglycerin intake. See section 2 "Do not take Cafinitrina".
• Avoid using this medicine with ergotamine or related medications, as it may decrease the effect of both medicines.
• Caution is recommended if this medicine is administered simultaneously with other vasodilator medications (papaverine, vincamine, etc.), antihypertensives (e.g., calcium channel blockers, beta blockers, diuretics, etc.), tricyclic antidepressants, neuroleptics, and alcohol, as they may enhance the hypotensive effect of nitroglycerin.
• Intake of acetylsalicylic acid and other non-steroidal anti-inflammatory substances (analgesics with anti-inflammatory effects) may decrease the response to nitroglycerin.

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

Taking 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 medicine.

Pregnancy:

Your doctor will decide whether you should take Cafinitrina or not, considering the benefits for the mother and the risks for the fetus.

Breastfeeding

Your doctor will decide whether you should stop breastfeeding or stop treatment.

Driving and using machines

Cafinitrina may cause flushing, dizziness, or decreased blood pressure, especially at the start of treatment. If you experience any of these side effects, avoid driving vehicles or using machines.

Cafinitrina contains sucrose and lactose

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

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

3. How to take Cafinitrina

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

Remember to take your medicine.

Place a tablet in your mouth, chew it immediately without swallowing, 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 angina pain. If the pain does not disappear completely, you can repeat the intake 3 or 4 times, at short intervals of 10 minutes.

Prevention of angina pectoris pain

Take 1 tablet 5 to 10 minutes before undertaking/exposing yourself to activities/situations known to trigger angina pain.

Your doctor will indicate the duration of your treatment with Cafinitrina.

Use in children and adolescents

This medicine is not recommended for use in this population.

If you take more Cafinitrina than you should

A decrease in blood pressure, shock, and bluish discoloration of the skin may occur.

In case of overdose or accidental intake, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Alternatively, go to the nearest emergency department. Bring this leaflet with you.

If you forget to take Cafinitrina

Do not take a double dose to make up for the forgotten dose.

If you stop taking Cafinitrina

Do not stop treatment abruptly, as a possible withdrawal reaction or rebound effect may occur. In such cases, angina pectoris or myocardial infarction may be precipitated. Therefore, it is recommended to gradually decrease the dose over a period of 4-6 weeks.

If you have any further questions 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.

The following is a list of side effects. It is important that you inform your doctor if you notice any discomfort.

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• Fainting
• Worsening of angina pectoris, slow heart rate, bluish skin discoloration
• Redness of the skin, circulatory failure
• Nausea, vomiting

Rare (may affect up to 1 in 1,000 people):

• Hemoglobin alteration (methemoglobinemia)
• Restlessness
• Cerebral hypoperfusion
• Respiratory alteration
• Heartburn, bad breath
• Severe skin reaction (exfoliative dermatitis), rash

Side effects of unknown frequency:

• Dizziness
• Palpitations
• Pallor
• Excessive sweating, urticaria

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cafinitrina

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

Do not store above 25°C.

Do not use this medicine after the expiration date stated on the packaging after "EXP:". The expiration date is the last day of the month indicated.

If you carry a small amount of tablets with you, use a suitable container and store them in it without removing them from the blister pack. Avoid carrying the container near your body, as your body heat may affect the medicine.

If these precautions are not followed, the medicine may not maintain its activity until the expiration date indicated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Cafinitrina composition

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

• core:colloidal silica, talc, sucrose, lactose, cornstarch, semi-synthetic solid glycerides,
• coating:cornstarch, talc, sucrose, titanium dioxide (E-171), and ester wax E.

Product appearance and packaging contents

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

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Industrias Farmacéuticas Almirall Prodesfarma, S.L.

Ctra. Nacional 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

Date of last revision of this leaflet: August 2022

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