UNIKET 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Uniket 20 mg Tablets

Isosorbide Mononitrate

Read the package leaflet carefully before starting to take this medication, 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 medication 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Uniket and what is it 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 is Uniket and what is it used for

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

This medication 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 medication (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 appropriate 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 medications that contain sildenafil, tadalafil, or vardenafil (medications used to treat erectile dysfunction), as Uniket's action on the heart may be altered.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Uniket

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

? If you have a decrease in filling pressure, such as acute myocardial infarction, left ventricular failure. The systolic blood pressure should not be reduced below 90 mmHg.

? 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 medications 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 this (see also "Instructions for the correct administration of the preparation").

? It is essential that the administration of this medication is done while sitting, 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 is not recommended in children and adolescents (under 18 years old).

Other medications and Uniket

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription, homeopathic products, 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 medications:

? 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, swallowed without chewing with the help of 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 medication, do not consume 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 medication.

Consult your doctor or pharmacist before using any medication.

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

Caution 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 because, in some cases, your ability to drive vehicles or use machines may be reduced due to a decrease in your reflexes, which could be increased if you consume alcohol at the same time. Therefore, do not drive or use potentially hazardous machinery until you have verified how you tolerate the medication.

Uniket contains lactose

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

3. How to take Uniket

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

The following scheme is recommended for correct dosing:

• Day 1 and 2 of treatment: half a tablet 2 times a day.
• Day 3 and 4 of treatment: 1 tablet 2 times a day
• From day 4 of treatment onwards: 1 tablet 2 or 3 times a day

The maximum recommended daily dose for this medication is 60 mg (3 tablets per day). However, your doctor will indicate how you should take the medication and how many tablets you should take each day.

Instructions for the correct administration of the preparation

The Uniket tablet, or its part, should be swallowed without chewing with a sufficient amount of liquid (e.g., a glass of water). Remember to take your medication.

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 increase or decrease the dose gradually.

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 you have taken 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 (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 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

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

? Special measures

• Increase blood pressure if it is too low.
• Treatment with medications that increase blood pressure (vasopressors), (only in patients who do not respond to fluid administration).
• Treatment of methemoglobinemia:
• vitamin C, methylthioninium chloride or toluidine blue,
• oxygen (if necessary)
• assisted respiration,
• 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 medication and the amount taken.

If you forget to take Uniket

If you forget a dose, take the medication 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 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, 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 100 people): increased heart rate (tachycardia), dizziness (including postural dizziness), somnolence, decreased 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 decreased heart rate and fainting), increased symptoms of angina pectoris.

? 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), decreased blood pressure (hypotension).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Uniket

Keep this medication out of 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. 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 20 mg of isosorbide mononitrate.

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

Appearance of the product and contents of the pack

Uniket is presented in the form of white, round, flat tablets with a score line on one face and the imprint "20" on the other face. The score line allows the tablet to be divided into two equal halves and facilitates swallowing.

Available in packs of 40 and 80 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/