Uniket Retard 50 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Uniket retard 50 mg prolonged-release tablets

isosorbide mononitrate

Read the entire 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, consult 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Uniket Retard

3. How to take Uniket Retard

4. Possible adverse effects

5. Storage of Uniket Retard

6. Contents of the pack and other information

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

Uniket Retard belongs to a group of medicines called organic nitrates, which relax the muscle in blood vessels, widening arteries and veins. This improves blood circulation, reducing the workload of the heart and its oxygen requirements.

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 ingredients 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 suffer from severe anemia.

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

? In case of cardiogenic shock (circulatory collapse of cardiac origin), unless diastolic end 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 suffer from obstructive hypertrophic cardiomyopathy (abnormal thickening of the heart muscle).

? If you are concurrently taking medicines containing sildenafil, tadalafil, or vardenafil (medicines used to treat erectile dysfunction), as the effect 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 intended for sudden (acute) attacks of angina pectoris. In such cases, your doctor will likely prescribe another medication.

? If you have reduced filling pressure, for example, acute myocardial infarction, left ventricular failure. Systolic blood pressure should not be allowed to fall below 90 mmHg.

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

? If you suffer from orthostatic hypotension (drop in blood pressure upon standing up).

? If you have conditions associated with increased intracranial pressure (however, to date, increased intracranial pressure has only been observed after intravenous administration of high doses of nitroglycerin).

? Tolerance and cross-tolerance (loss of effectiveness with continued treatment) have been reported with other medications containing nitrate active substances.

? Prolonged treatment with Uniket Retard should not be stopped abruptly, but tapered gradually. Your doctor will advise you how to do this (see also “Instructions for correct administration of the preparation”).

? It is important to take this medicine while sitting down, especially at the beginning of treatment or if you are over 65 years of age.

? If you have slowed gastrointestinal transit, the onset of action of Uniket Retard 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 one or more of these medicines.

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 disorders of the nervous system).

• Sildenafil, tadalafil, vardenafil (used for erectile dysfunction).

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (blood, urine, or other tests), inform your doctor that you are being treated with Uniket Retard, as it may alter test results.

Taking Uniket Retard with food, drinks, and alcohol

Uniket Retard tablets are taken orally, swallowed whole and not chewed, with a glass of water. The tablet may be taken either on an empty stomach or with food (see also "How to take Uniket Retard").

Alcohol must not be consumed during treatment with this medicine, as it could cause a drop in blood pressure.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Uniket Retard should not be taken during the first three months of pregnancy unless, in the strict opinion of the physician, it is absolutely necessary. Therefore, if you are pregnant or think you might be, 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 lactation.

Driving and use of machines

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

Uniket Retard contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Uniket Retard

Follow exactly the instructions for use of Uniket Retard provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The usual dose is 1 tablet once daily in the morning. However, if angina attacks occur mainly at night, the tablet may 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 medication.

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

It is important that treatment with Uniket Retard is started and stopped gradually, and never abruptly. Your doctor will instruct you on how to gradually increase or reduce the dose.

If you feel that the effect 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 any reason, you have taken more Uniket Retard tablets than you should, the following symptoms may occur: rapid decrease in blood pressure, pallor, sweating, weak pulse, increased heart rate (tachycardia), dizziness, headache, 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 reported, followed by 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 lead to increased intracranial pressure with associated cerebral symptoms.

The recommended course of action in case of a possible overdose with Uniket Retard is as follows:

? General measures

• Discontinue administration of the medication.
• In case of a significant drop in blood pressure:
  • place the patient lying down with legs elevated and head tilted downward,
  • if necessary, administer intravenous fluids and oxygen,
  • if shock occurs, admission to an intensive care unit.

? Specific measures

• Increase blood pressure if it is very low.
• Treatment with medications that raise 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 ventilation,
  • hemodialysis (if necessary).

? Resuscitation measures

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

In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service, Telephone 915 62 04 20, stating the name of the medication and the amount taken.

If you forget to take Uniket Retard

If you miss a dose, take the medicine as soon as possible, then continue treatment as prescribed. However, if it is almost time for your next dose, it is better not to take the missed dose and to wait for the next scheduled dose. Do not take a double dose to make up for missed doses.

If you stop treatment with Uniket Retard

If treatment with Uniket Retard is stopped abruptly, a sudden increase in blood pressure may occur. Therefore, prolonged treatments should not be discontinued abruptly, but rather gradually, following your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, Uniket Retard can cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed with Uniket Retard:

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), somnolence, decrease in 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, redness of the skin (rubefaction)), circulatory collapse (sometimes accompanied by decreased heart rate and fainting), worsening of angina pectoris symptoms.

Very rare adverse effects (may affect up to 1 in 10,000 people): muscle pain, stomach burning.

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 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 marked “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Uniket Retard

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

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

Appearance of the product and contents of the package

Uniket Retard is available as white, round, flat prolonged-release tablets with the imprint "UR" on one side.

Each package contains 30 tablets.

Marketing Authorization Holder and Manufacturing Responsible

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the most recent review of this leaflet: August 2016

Detailed and up-to-date information on this medicinal product is available on the website of

the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/