Leaflet: information for the user

UNiket 40 mg tablets

isosorbide mononitrate

Read this leaflet carefully before starting to take the 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 should not be given to other people, 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).

1.- What is Niket and for what it is used

2.- What you need to know before starting to take Niket

3.- How to take Niket

4.- Possible side effects

5.- Storage of Niket

6.- Contents of the pack and additional information

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

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

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 final diastolic 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 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 medication is not indicated for sudden (acute) attacks of angina pectoris. In these cases, your doctor may have prescribed another medication.

?If you have a decrease in filling pressure, for example, acute myocardial infarction, left ventricular failure. Avoid reducing systolic pressure 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).

?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 the intravenous administration of high doses of nitroglycerin).

?Tolerance and cross-tolerance (loss of efficacy due to prolonged treatment) have been described with other medications that have nitrate as their active ingredient.

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

?It is essential that the administration of this medication be performed while 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 old) is not recommended.

Other medications and Uniket

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

Especially important to inform your doctor if you take 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 to undergo any diagnostic test (blood, urine, or other analysis), inform your doctor that you are being treated with Uniket, as it may alter the results.

Uniket with food, drinks, and alcohol

The Uniket tablet is administered orally, and should be swallowed whole and 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, alcohol should not be taken, as it may cause a decrease in blood pressure.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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, at strict medical discretion, it is absolutely necessary. Therefore, if you are pregnant or think you may be, 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 lactation.

Driving and operating machinery

Observe your response to the medication, as in some cases, your ability to drive vehicles or operate machinery may be reduced due to a decrease in your reflexes, which may be exacerbated if you consume alcohol at the same time. Therefore, do not drive or operate potentially hazardous machinery until you have checked how you tolerate the medication.

Uniket contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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

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

The maximum recommended dose for this medication is 120 mg (3 tablets per day). Your doctor, however, 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

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

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

It is essential to start and end treatment with Uniket gradually and never abruptly. Your doctor will indicate the way to increase or decrease the dose gradually.

If you estimate that 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 any reason you took more Uniket tablets than you should, the following symptoms may appear: rapid decrease in blood pressure, pallor, 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 reutilize the protein (hemoglobin) used for oxygen transport) and cyanosis (blue 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 increased intracranial pressure with cerebral symptoms.

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

?General measures

- Stop administering the medication.

- In case of a significant drop in blood pressure:

- place the patient lying down, with the legs elevated and the head inclined downward,

- 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 very low.

- Treatment with medications that increase blood pressure (vasopressors), (only in patients who do not respond to fluid administration).

- Treatment of methemoglobinemia:

- vitamin C, methylene blue, or toluidine blue,

- oxygen (if necessary)

- assisted respiration,

- hemodialysis (if necessary)

?Resuscitation measures

- In case of signs of cardiac arrest, initiate resuscitation measures immediately.

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

If you forgot to take Uniket

In case of forgetting a dose, take the medication as soon as possible, continuing 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 compensate for the missed doses.

If you interrupt treatment with Uniket

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

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

Like all medications, Uniket may produce adverse effects, although not all people will experience them.

The following adverse effects have been observed with Uniket:

?Very Common Adverse Effects(may affect more than 1 in 10 people): headache.

?Common Adverse Effects(may affect up to 1 in 10 people):increased heart rate (tachycardia), dizziness (including postural dizziness), drowsiness, decreased blood pressure upon standing (orthostatic hypotension), feeling of weakness (asthenia).

?Uncommon Adverse Effects(may affect up to 1 in 100 people):nausea, vomiting, skin allergic reactions (for example, rash, skin redness (rubefaction), circulatory collapse (sometimes accompanied by decreased heart rate and fainting), increased symptoms of angina pectoris.

?Very Rare Adverse Effects(may affect up to 1 in 10,000 people): muscle pain, stomach burning.

?Unknown Frequency(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 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 for Pharmacovigilance of Medicines for Human Use:https://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.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the Sigre point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Uniket

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

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

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last review of this leaflet: August 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/