Dolak Retard 60 mg prolonged-release tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Dolak Retard 60 mg
prolonged-release tablets
Isosorbide mononitrate
Read the entire leaflet carefully before you start taking this medicine, because 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, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Dolak Retard is and what it is used for
- What you need to know before taking Dolak Retard
- How to take Dolak Retard
- Possible side effects
- How to store Dolak Retard
- Contents of the pack and other 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 in the walls of blood vessels, dilating arteries and veins. This improves blood flow and reduces the workload of the heart.
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 to any of the other ingredients of this medicine (listed in section 6);
- in case of shock, cardiocirculatory collapse, very low blood pressure (systolic pressure below 90 mm Hg), or acute myocardial infarction;
- if you have severe anemia, cerebral trauma, or cerebral hemorrhage;
- if you are taking any medicine containing sildenafil (medicines used for erectile dysfunction). For further information, consult your doctor or pharmacist.
Dolak Retard is not indicated for the relief of sudden angina attacks. Your doctor has likely prescribed another medication for such episodes.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Dolak Retard.
If you have low blood pressure (hypotension) or other heart conditions, you must always inform your doctor about these and any other medical conditions you may have.
Children and adolescents
The use of Dolak Retard is not recommended in children, as safety and efficacy have not been established in this population group.
Other medicines and Dolak Retard
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of these medicines.
Due to the possibility of enhanced hypotensive effects, caution should be exercised when administering Dolak Retard concomitantly with antihypertensive agents (e.g., calcium channel antagonists, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptics, or tricyclic antidepressants. With alcohol, in addition to hypotension, a decrease in reaction capacity may be intensified.
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 scheduled to undergo any diagnostic tests (blood, urine analyses, etc.), inform your doctor that you are being treated with Dolak Retard, as it may alter test results.
Nitrates may produce 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 alcohol enhances the vasodilatory effect of isosorbide mononitrate, potentially causing a rapid drop in blood pressure.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you might 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 judgment of the physician, 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 use of machines
Observe your response to the medication, as in some cases it may reduce reflexes even at usual doses. If this occurs, refrain from driving or operating dangerous machinery. This effect may be intensified by concomitant alcohol intake.
Dolak Retard contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Dolak Retard
Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
The recommended dose is 1 tablet once daily in the morning. If angina attacks occur mainly at night, the dose may be taken at night, before going to bed.
In some patients it may be necessary to increase the dose, with a once-daily dose recommended to avoid the development of tolerance to the preparation.
Dolak Retard tablets are scored and can be divided into two equal halves. They must not be crushed or chewed and should be swallowed with sufficient 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 down, especially at the beginning of treatment, if you are taking high doses or if you are elderly.
Your doctor will advise you on how long your treatment with Dolak Retard should last. Do not stop treatment prematurely, as this could lead to a sudden increase in blood pressure.
It is important that you start and stop treatment with Dolak Retard gradually and never abruptly. Your doctor will instruct you on how to gradually increase and decrease the dose.
If you feel that 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.
It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.
The main expected symptom is hypotension. Gastric lavage will be performed.
Generally, it is sufficient to keep the patient lying down with legs elevated to correct the drop in blood pressure. If other symptoms of intoxication occur, appropriate corrective treatment will be initiated.
If you forget to take Dolak Retard
If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and wait until the next scheduled dose.
Do not take a double dose to make up for a missed dose.
If you stop taking Dolak Retard
If treatment with Dolak Retard is stopped abruptly, you may experience a sudden increase in blood pressure. Therefore, prolonged treatments should not be interrupted abruptly but should be discontinued 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, this medicine may cause adverse effects, although not everyone will experience them.
In certain cases, especially with high doses or at the beginning of treatment, orthostatic hypotension (a sensation of dizziness upon standing) may occur. This effect may be enhanced by consumption of alcoholic beverages. In particularly sensitive patients, hypotension may lead to syncope, which could be mistaken for symptoms of acute myocardial infarction.
Other side effects include: headache, facial flushing or sensation of warmth, dizziness, palpitations, fatigue. Generally, all these effects—as with hypotension—subside upon continuing treatment or, if necessary, upon reducing the dose. Like other nitrates, isosorbide mononitrate may rarely cause skin rashes and/or exfoliative dermatitis.
Occasionally, and especially when first used, gastrointestinal discomfort such as nausea and/or vomiting may occur.
A blood disorder (formation of methemoglobin) may occur, particularly in patients with methemoglobin reductase deficiency or with abnormal hemoglobin structure.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Dolak Retard
- The active substance is isosorbide mononitrate. Each prolonged-release tablet contains 60 mg of isosorbide mononitrate.
- The other components (excipients) are: diffutab Base “A”, povidone, lactose, tricalcium phosphate, macrogol, corn starch, magnesium stearate, colloidal silicon dioxide, silicagel.
Appearance of the medicinal product and contents of the container
Dolak Retard is presented as prolonged-release, white, oval, scored tablets. Each container contains 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma España, S.L.
C/ Aribau 195, 4º
08021 Barcelona, Spain
Manufacturer:
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid 82
28802 Alcalá de Henares, Madrid
Date of the most recent revision of this leaflet: November 2021
Other sources of information
Detailed 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/