UNIKET RETARD 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Uniket Retard 50 mg prolonged-release tablets

isosorbide mononitrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

2.- What you need to know before you take Uniket Retard

3.- How to take Uniket Retard

4.- Possible side effects

5.- Storage of Uniket Retard

6.- Contents of the pack and further information

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

Uniket Retard 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 an improvement in blood circulation, reducing the heart's workload and its oxygen needs.

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

2. Before taking Uniket Retard

Do not take Uniket Retard

? If you are allergic to isosorbide mononitrate, to organic nitrates in general, or to 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 filling 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 increase in the thickness 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 Retard 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 will probably prescribe another medicine for you.

? If you have a decrease in filling pressure, for example, 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 an increase in 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 continued treatment) have been described with other medicines that have nitrates as the active substance.

? It is important that prolonged treatments with Uniket Retard are not interrupted abruptly, but gradually. Your doctor will indicate how to do it (see also “Instructions for the correct administration of the preparation”).

? It is important that the administration of this medicine is carried out while you are sitting, especially at the beginning of treatment or if you are over 65 years old.

? If you have slowed gastrointestinal transit and are taking Uniket Retard, the action of the medicine may be delayed.

Children and adolescents

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

Other medicines and Uniket Retard

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, 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 any 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 tests, urine tests, or others), inform your doctor that you are being treated with Uniket Retard, as it may alter the results.

Taking Uniket Retard with food, drinks, and alcohol

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

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

Uniket Retard 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 Retard is administered to a breastfeeding mother. The 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 also consume alcohol. Therefore, do not drive or use potentially hazardous machinery until you have checked how you tolerate the medicine.

Uniket Retard contains lactose

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

3. How to take Uniket Retard

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

Uniket Retard is not indicated as initial treatment for the treatment and prevention of angina pectoris. For this, your doctor will have previously prescribed another medicine with a lower dose of isosorbide mononitrate (the active substance of Uniket Retard), such as Uniket 20 mg. Consult your doctor or pharmacist if you have doubts.

The normal dose is 1 tablet once a day, in the morning. However, if the angina crisis occurs mainly at night, the tablet can be taken at night, before going to bed.

Instructions for the correct administration of the preparation

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

Your doctor will indicate the duration of your treatment with Uniket Retard 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 Retard gradually and never abruptly. Your doctor will indicate how to gradually increase or decrease the dose.

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

If you take more Uniket Retard than you should

If, for some reason, you took more Uniket Retard 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 appearance of rapid breathing, anxiety, loss of consciousness, and cardiac arrest. It cannot be ruled out that an overdose of Uniket Retard 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 Retard is as follows:

? General measures

• Interrupt the administration of the medicine.
• In case of significant decrease in blood pressure:
• place the patient lying down, with legs elevated and head tilted downwards,
• if necessary, administration of fluids intravenously and oxygen,
• if shock appears, admission 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 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, telephone 915 62 04 20, indicating the name of the medicine and the amount taken.

If you forget to take Uniket Retard

In case of forgetting 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 missed dose and wait for the next one. Do not take a double dose to make up for the missed doses.

If you stop treatment with Uniket Retard

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uniket Retard can cause side effects, although not everybody gets them.

The following side effects have been observed with Uniket Retard:

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 (flushing)), 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 the 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's (AEMPS) online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Uniket Retard

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

No special storage conditions are required.

Do not use Uniket Retard after the expiry date stated on the packaging and blister after “EXP”. The expiry 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 you have any doubts, 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 Retard

The active substance is isosorbide mononitrate. Each tablet contains 50 mg of isosorbide mononitrate.

The other components (excipients) are: lactose monohydrate, hypromellose, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, povidone, talc, glycerol palmitostearate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and contents of the pack

Uniket Retard is presented in the form of white, round, flat prolonged-release tablets with the mark “UR” printed on one side.

Each pack contains 30 tablets.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last revision of this 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/