Package Insert: Information for the Patient

Dolak Retard 60 mg

Prolonged-Release Tablets

Isosorbide Mononitrate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isDolak Retardand for what it is used

2. What you need to know before starting to takeDolak Retard

3. How to takeDolak Retard

4. Possible adverse effects

5. Storage ofDolak Retard

6. Contents of the package and additional information

Dolak Retardbelongs to a group of medications called nitrates, which relax the muscle tissue of blood vessels, widening arteries and veins. This allows for an improvement in blood circulation, reducing cardiac workload.

Dolak Retard is indicated for the treatment and prevention of angina pectoris.

Do not take Dolak Retard

• if you are allergic to isosorbide mononitrate, isosorbide dinitrate, or any of the other components of this medication (listed in section 6);
• in case of shock, cardiac-circulatory collapse, very low blood pressure (maximum less than 90 mm Hg) or acute myocardial infarction;
• if you have severe anemia, head trauma, or cerebral hemorrhage;
• if you are taking any medication that contains sildenafil (medications used for erectile dysfunction). For more information, consult your doctor or pharmacist.

Dolak Retard is not indicated for the relief of sudden attacks of angina pectoris. Your doctor may have prescribed another medication for these cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dolak Retard.

If you have low blood pressure (hypotension) or other heart problems, you must always inform your doctor of these and any other health problems you may have.

Children and adolescents

The use of Dolak Retard in children is not recommended because its safety and efficacy have not been established in this population group.

Other medications and Dolak Retard

Inform your doctor or pharmacist if you are using, 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 or more of them.

Due to the possibility of potentiation of the hypotensive effect, caution should be exercised in the concomitant administration with antihypertensives (e.g., calcium channel blockers, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptics, or tricyclic antidepressants. With alcohol, in addition to hypotension, the decrease in reaction capacity may be accentuated.

The action of this medication on the heart may be altered if used concomitantly with preparations containing sildenafil for erectile dysfunction.

Interference with diagnostic tests

If you are to undergo any diagnostic test (blood, urine...), inform your doctor that you are being treated with Dolak Retard, as it may alter the results.

Nitrates may produce false-negative reactions in the determination of serum cholesterol by the Zlatkis-Zak method.

Taking Dolak Retard with food and beverages

Do not take this medication with alcohol, as it potentiates the vasodilatory effect of isosorbide mononitrate, which may cause a rapid decrease in blood pressure.

Pregnancy and lactation

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

Pregnancy

Dolak Retard should not be taken during the first trimester of pregnancy, unless, at the strict medical judgment, the benefit justifies the possible risks.

Lactation

Dolak Retard should not be used during lactation, as it is unknown whether it passes into breast milk.

Driving and operating machinery

Observe your response to the medication, as in some cases it may produce a decrease in reflexes at usual doses. If so, refrain from driving and operating hazardous machinery. This may be accentuated with concomitant ingestion of alcohol.

Dolak Retard 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 this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Remember to take your medication.

The recommended dose is 1 tablet once a day, in the morning. If the angina crisis occurs mainly at night, administration can be made at night, before going to bed.

In some patients, it may be necessary to increase the dose, recommending a single daily dose to avoid the appearance of tolerance to the preparation.

The Dolak Retard tablet is scored and can be divided into 2 equal halves. Do not crush or chew and should be taken with a sufficient amount of liquid (a glass of water).

The absorption of isosorbide mononitrate is not affected by the ingestion of food.

It is advisable to take this medication while seated, especially at the beginning of treatment, if you are taking high doses or if you are elderly.

Your doctor will indicate the duration of your treatment with Dolak Retard. Do not stop treatment prematurely, as a sudden increase in blood pressure may occur.

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

If you estimate that the action of Dolak Retard is too strong or too weak, inform your doctor or pharmacist.

If you take more Dolak Retard than you should

If you have taken Dolak Retard more than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional

The main symptom to expect is hypotension. A stomach lavage will be performed.

Generally, it is enough to keep the patient lying down with their legs elevated to correct the drop in blood pressure. If other symptoms of intoxication appear, the appropriate corrective treatment will be established.

If you forgot to take Dolak Retard

In case of forgetting a dose, take the medication as soon as possible and continue 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 dose.

If you interrupt treatment with Dolak Retard

If treatment with Dolak Retard is interrupted abruptly, a sudden increase in blood pressure may occur. Therefore, prolonged treatments should not be interrupted abruptly, but gradually, following the instructions received from your doctor.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

In certain cases, especially with high doses, or at the beginning of treatment, it may produce orthostatic hypotension (dizziness when standing up). This effect may be potentiated by the consumption of alcoholic beverages. In particularly sensitive patients, hypotension may lead to syncope, which could be confused with acute myocardial infarction symptoms.

Other secondary effects are: headache, flushing or sensation of facial heat, dizziness, palpitations, fatigue. In general, all these effects, like hypotension, resolve by continuing treatment or, in any case, by reducing the dose. Like other nitrates, isosorbide mononitrate may cause, in rare cases, skin eruptions and/or exfoliative dermatitis.

Occasionally, and especially when used for the first time, gastrointestinal discomforts, such as nausea and/or vomiting, may appear.

A blood alteration (metahemoglobin formation) may occur, particularly in patients with metahemoglobinreductase deficiency or abnormal hemoglobin structure.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about 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 this medicationafter the expiration date that appears on the packaging 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 medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Dolak Retard

• The active principle is isosorbide mononitrate. Each prolonged-release tablet contains 60 mg of isosorbide mononitrate.
• The other components (excipients) are: Diffutab Base “A”, povidone, lactose, tribasic calcium phosphate, macrogol, cornstarch, magnesium stearate, colloidal silicon dioxide, silicagel.

Appearance of the product and contents of the packaging

Dolak Retardis presented in the form of prolonged-release tablets, white, oval, and scored. Each package contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Alfasigma España, S.L.Avda.Diagonal, 490 - 08006 Barcelona

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.Avenida de Madrid 82 28802 Alcalá de Henares, Madrid

Date of the last review of this leaflet: November 2021

Other sources of information

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