UNIKET 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

U

isosorbide mononitrate

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to 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 side effects not listed in this package leaflet (see section 4).

Contents of the Package Leaflet:

1. What Uniket is and what it is used for

2. What you need to know before taking Uniket

3. How to take Uniket

4. Possible side effects

5. Storage of Uniket

6. Contents of the pack and further information

1. What Uniket is and what it is used for

Uniket belongs to a group of medicines called organic nitrates, which relax the muscle of the blood vessels, widening the arteries and veins. This allows for improved blood circulation, reducing the heart's workload and its oxygen needs.

This medicine is indicated for the treatment and prevention of angina pectoris.

2. What you need to know before taking Uniket

Do not take Uniket

? If you are allergic to isosorbide mononitrate, organic nitrates in general, or any of the other components of this medicine (listed in section 6).

? If you have very low blood pressure (systolic blood pressure below 90 mmHg).

? In case of acute circulatory failure (shock, collapse)

? If you have severe anemia.

? In case of severe hypovolemia (decrease in total blood volume).

? In case of cardiogenic shock (circulatory collapse of cardiac origin), unless a diastolic blood pressure is maintained with adequate measures.

? If you have constrictive pericarditis (inflammation of the pericardium that compresses the heart).

? In case of cardiac tamponade (acute compression of the heart).

? If you have hypertrophic obstructive cardiomyopathy (abnormal thickening of the heart muscle).

? If you are taking medicines that contain sildenafil, tadalafil, or vardenafil (medicines used to treat erectile dysfunction), as the action of Uniket on the heart may be altered.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Uniket Retard

? This medicine is not indicated for sudden (acute) attacks of angina pectoris. In these cases, your doctor has probably prescribed another medicine for you.

? If you have a decrease in filling pressure, such as acute myocardial infarction, left ventricular failure. The reduction of systolic blood pressure below 90 mmHg should be avoided.

? If you have aortic and/or mitral stenosis (narrowing of the heart valves).

? If you have orthostatic hypotension (decrease in blood pressure when standing up).

? If you have diseases associated with increased intracranial pressure (however, so far, only an additional increase in intracranial pressure has been observed after intravenous administration of high doses of nitroglycerin).

? Tolerance and cross-tolerance (loss of efficacy due to continuous treatment) have been described with other medicines that have nitrates as the active ingredient.

? It is essential that prolonged treatments with Uniket are not interrupted abruptly, but gradually. Your doctor will indicate how to do it (see also “3. How to take Uniket”).

? It is crucial that the administration of this medicine is done while you are seated, especially at the beginning of treatment or if you are over 65 years old.

Children and adolescents

The efficacy and safety of use in children have not been established. Therefore, the use of Uniket in children and adolescents (under 18 years) is not recommended.

Other medicines and Uniket

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

It is especially important that you inform your doctor if you are taking any of the following medicines:

? Beta-blockers, calcium antagonists, diuretics, ACE inhibitors (used to treat high blood pressure).

? Vasodilators (used in heart and blood vessel diseases).

? Tricyclic antidepressants (for the treatment of depression).

? Neuroleptics (used in nervous system diseases).

? Sildenafil, tadalafil, vardenafil (used in erectile dysfunction).

Interference with diagnostic tests

If you are going to have any diagnostic tests (blood, urine, or other tests), inform your doctor that you are being treated with Uniket, as it may alter the results.

Taking Uniket with food, drinks, and alcohol

The Uniket tablet is administered orally, and you should swallow it whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water). The tablet can be taken both on an empty stomach and with food (see also “3. How to take Uniket”).

During treatment with this medicine, you should not drink alcohol, as it may cause a decrease in blood pressure.

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.

Consult your doctor or pharmacist before using any medicine.

Uniket should not be taken during the first three months of pregnancy unless, in the strict opinion of the doctor, it is absolutely necessary. If you are pregnant or think you may be pregnant, inform your doctor as soon as possible.

Cautious use is advised if Uniket is administered to a breastfeeding mother. Currently available information is insufficient to determine the risk during breastfeeding.

Driving and using machines

Observe your response to the medication, as it may reduce your ability to drive vehicles or operate machinery due to a decrease in your reflexes, which could be enhanced if you consume alcohol at the same time. Therefore, do not drive or operate potentially hazardous machinery until you have verified how you tolerate the medicine.

Uniket contains lactose

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 Uniket

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

The normal dose is 1 tablet, 2 or 3 times a day (80 to 120 mg per day), according to the needs of each patient.

The maximum recommended dose for this medicine is 120 mg (3 tablets per day). However, your doctor will indicate how you should take the medicine and how many tablets you should take each day.

Instructions for the correct administration of the preparation

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water). Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Uniket and may also adjust the dose if necessary. Do not change the dose indicated by your doctor, and do not stop treatment without consulting your doctor first, as it may be harmful to your health.

It is essential that you start and stop treatment with Uniket gradually and never abruptly. Your doctor will indicate how to gradually increase or decrease the dose.

If you think the action of Uniket is too strong or too weak, inform your doctor or pharmacist.

If you take more Uniket than you should

If, for some reason, you took more Uniket tablets than you should, the following symptoms may appear: rapid decrease in blood pressure, paleness, sweating, weak pulse, increased heart rate (tachycardia), dizziness, headache, feeling of weakness, nausea, vomiting, and diarrhea.

In patients treated with organic nitrates, cases of methemoglobinemia (a blood disorder in which the body cannot reuse the protein (hemoglobin) used for oxygen transport) and cyanosis (bluish discoloration of the skin and mucous membranes) have been described, with subsequent appearance of rapid breathing, anxiety, loss of consciousness, and cardiac arrest. It cannot be ruled out that an overdose of Uniket may cause this adverse reaction.

Very high doses may cause an increase in intracranial pressure with cerebral symptoms.

The procedure in case of a possible overdose of Uniket is as follows:

? General measures

• Discontinue administration of the medicine.
• In case of a significant decrease in blood pressure:
• place the patient in a lying position, with legs elevated and head tilted downwards,
• if necessary, administer fluids intravenously and oxygen,
• if shock occurs, admit the patient to an intensive care unit.

? Special measures

• Increase blood pressure if it is too low.
• Treatment with medicines that increase blood pressure (vasopressors), (only in patients who do not respond to fluid administration).
• Treatment of methemoglobinemia:
• vitamin C, methyl blue, or toluidine blue,
• oxygen (if necessary)
• assisted breathing,
• hemodialysis (if necessary)

? Resuscitation measures

• In case of signs of cardiorespiratory arrest, start resuscitation measures immediately.

In case of overdose or accidental ingestion, you can also call the Toxicology Information Service. Phone 915 62 04 20, indicating the name of the medicine and the amount taken.

If you forget to take Uniket

In case you forget a dose, take the medicine as soon as possible, continuing the treatment as prescribed. However, when the next dose is near, it is better not to take the forgotten dose and wait for the next one. Do not take a double dose to make up for the forgotten doses.

If you stop treatment with Uniket

If you stop treatment with Uniket abruptly, a sudden increase in blood pressure may occur. Therefore, it is recommended that prolonged treatments are not interrupted abruptly, but gradually, following the instructions received from your doctor.

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

4. Possible side effects

Like all medicines, Uniket can cause side effects, although not everyone will experience them.

The following side effects have been observed with Uniket:

? Very common side effects (may affect more than 1 in 10 people): headache.

? Common side effects (may affect up to 1 in 10 people): increased heart rate (tachycardia), dizziness (including postural dizziness), somnolence, decrease in blood pressure when standing up (orthostatic hypotension), feeling of weakness (asthenia).

? Uncommon side effects (may affect up to 1 in 100 people): nausea, vomiting, allergic skin reactions (e.g., rash, skin redness (rubefaction)), circulatory collapse (sometimes accompanied by a decrease in heart rate and fainting), increase in angina pectoris symptoms.

? Rare side effects (may affect up to 1 in 10,000 people): muscle pain, heartburn.

? Frequency not known (cannot be estimated from available data): exfoliative dermatitis (widespread skin peeling that usually causes itching, skin redness, and hair loss), decrease in blood pressure (hypotension).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Uniket

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

No special storage conditions are required.

Do not use Uniket after the expiration date stated on the packaging and blister after “EXP”. The expiration date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Uniket

The active ingredient is isosorbide mononitrate. Each tablet contains 40 mg of isosorbide mononitrate.

The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, potato starch, talc, anhydrous colloidal silica, aluminum stearate, and magnesium stearate.

Appearance of the product and pack contents

Uniket is presented in the form of white, round, flat tablets with a cross-shaped notch on one side and the imprint “40” on the other side. It is available in packs of 20 and 40 tablets.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last revision of this package leaflet: August 2016

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/