DOLAK RETARD 60 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information Leaflet

Dolak Retard 60 mg

prolonged-release tablets

Isosorbide mononitrate

Read this 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, ask 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, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dolak Retard is and what it is used for
2. What you need to know before taking Dolak Retard
3. How to take Dolak Retard
4. Possible side effects
5. Storage of Dolak Retard
6. Package contents and additional information

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

Dolak Retard belongs to a group of medicines called nitrates, which relax the muscle of the blood vessels, widening arteries and veins. This allows for improved blood circulation, reducing cardiac workload.

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

2. What you need to know before taking Dolak Retard

Do not take Dolak Retard

• if you are allergic to isosorbide mononitrate, isosorbide dinitrate, or any of the other ingredients of this medicine (listed in section 6);
• in case of shock, cardiocirculatory 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 medicine that contains sildenafil (medicines 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 has probably prescribed another medicine 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 should always inform your doctor of these and any other conditions you may have.

Children and adolescents

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

Other medicines and Dolak Retard

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, 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 of them.

Due to the possibility of potentiation of the hypotensive effect, caution should be exercised when administering Dolak Retard concomitantly with antihypertensives (e.g., calcium antagonists, 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 effect of this medicine on the heart may be altered if used concomitantly with preparations containing sildenafil for erectile dysfunction.

Interference with diagnostic tests

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

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

Taking Dolak Retard with food and drinks

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

Pregnancy and breastfeeding

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

Pregnancy

Dolak Retard should not be taken during the first trimester of pregnancy, unless, in the strict opinion of the doctor, the benefit justifies the potential risks.

Breastfeeding

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

Driving and using machines

Observe your response to the medication, as it may produce a decrease in reflexes at usual doses. If this is the case, avoid driving and operating hazardous machinery. This effect may be accentuated with concomitant alcohol consumption.

Dolak Retard contains lactose

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

3. How to take Dolak Retard

Follow the administration instructions of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

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

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

The absorption of isosorbide mononitrate is not affected by food intake.

It is advisable to take this medicine while sitting, 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 before, as it may cause a sudden increase in blood pressure.

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

If you think the effect 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 more Dolak Retard than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

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

Usually, 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 initiated.

If you forget to take Dolak 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 forgotten dose and wait for the next one.

Do not take a double dose to make up for the forgotten dose.

If you stop treatment with Dolak Retard

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

In certain cases, especially with high doses or at the beginning of treatment, it may cause 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 symptoms of acute myocardial infarction.

Other side effects are: headache, facial flushing or feeling of heat, dizziness, palpitations, fatigue. Usually, all these effects, like hypotension, disappear with continued treatment or, in any case, with a decrease in dose. Like other nitrites, isosorbide mononitrate may occasionally cause skin rashes and/or exfoliative dermatitis.

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

A blood disorder (methemoglobin formation) may occur, particularly in patients with methemoglobin reductase deficiency or abnormal hemoglobin structure.

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dolak Retard

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), potassium acesulfame (E950), magnesium stearate, and mint flavor

Appearance of the product and package contents

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one of the faces.

They are presented in packages containing 15 and 30 sucking tablets.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma España S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es