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Zydalis 20 MG Tablet

Manufactured byZydus Cadila
ContainsTadalafil
Description

Zydalis 20 MG Tablet is used for the treatment of erectile dysfunction (ED), which is also called impotence, in men. Erectile dysfunction is a condition where a man is unable to achieve and/or maintain a penile erection adequate enough for sexual intercourse. It happens when there is a decreased blood flow to the penis. The decreased blood flow may be due to physical complications following an injury or disease or due to some psychological conditions such as anxiety, stress, depression, etc. Chronic lifestyle factors such as obesity, smoking, drinking, etc., could also contribute to ED. ED is strongly age-related, and the occurrence of moderate-to-severe ED could increase two-fold to three-fold between the ages of 40 and 70 years. This medicine relaxes the smooth muscles present in the wall of blood vessels and helps in increasing the flow of blood to the penis. It works well when the underlying cause of erectile dysfunction is physical, psychological, or both. If the underlying cause of erectile dysfunction is psychological, Zydalis 20 MG Tablet may or may not work, based on the severity of the condition. In cases of psychological causes alone or psychological (including lifestyle) and physical causes, it is important to undergo psychological counseling to achieve the best possible effect along with the standard of care which may include Zydalis 20 MG Tablet. This medicine may cause severe side effects such as a prolonged and painful erection that lasts for more than 4 hours, loss of vision in one or both the eyes, hearing impairment, etc. It is recommended to consult a physician immediately in case of such adverse events. NOTE: It is also important to note that this medicine does not offer any protection against sexually transmitted diseases (STDs) such as syphilis, gonorrhea, HIV, etc.; hence, adequate safety measures should be taken while having sexual intercourse.

Side effects

Major & minor side effects for Zydalis 20 MG Tablet

  • Headache
  • Heartburn
  • Nausea
  • Diarrhea
  • Flushing
  • Cough
  • Decrease/loss of vision
  • Change in color vision
  • Decrease/loss of hearing
  • Prolonged and painful erection
  • Dizziness
  • Difficulty in breathing
  • Swelling of face, lips, eyelids, tongue, hands and feet
  • Peeling and blistering of skin

Uses of Zydalis 20 MG Tablet

What is it prescribed for?

  • Erectile Dysfuntion
  • Benign prostatic hyperplasia
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The effect of this medicine can be observed within 30 to 60 minutes of administration of the dose.
  • How long do the effects of this medicine last?
    The effect of this medicine lasts for an average duration of 36-40 hours.
  • Is it safe to consume alcohol while taking this medicine?
    Use of alcohol should be avoided or kept to a minimal level while you are taking this medicine due to the increased risk of severe adverse effects such as dizziness, fainting, flushing, persistent headaches, changes in heart rate, etc.
  • Is this a habit forming medicine?
    No habit forming tendencies were reported.
  • Can this medicine be taken during pregnancy?
    This medicine is not recommended for use in pregnant women.
  • Can this medicine be taken while breast-feeding?
    This medicine is not recommended for use in breastfeeding women.

Allergy

This medicine is not recommended for use in patients with a known allergy to tadalafil or any other inactive ingredients present along with the formulation.

Organic nitrates

This medicine is not recommended for use in patients receiving any other medicines containing nitrates (Eg: Nitroglycerin, Isosorbide etc.) due to the increased risk of serious adverse effects.

Riociguat

This medicine is not recommended for use in patients receiving Riociguat (Popular trade name is Adempas) due to the increased risk of serious adverse effects.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women.

Breast-feeding

This medicine is not recommended for use in breastfeeding women.
General warnings

Hypotension

Consumption of this medicine can cause a mild and short-lasting decrease in blood pressure levels. Caution should be exercised if you are taking any medication for lowering high blood pressure levels. It is advised that you report all your current medicines, including any herbs and supplements, to the doctor before beginning treatment with this medicine.

Other medicines

This medicine is not recommended for use in patients who are receiving medicines such as nitroglycerine, riociguat, etc. due to the increased risk of serious adverse effects. This medicine should be used with caution in patients receiving medicines to treat high blood pressure levels, heart diseases, etc. It is advised that you report the use of all your current medicines, including any herbs and supplements, before starting therapy with this medicine.

Deformation of penis

This medicine should be used with caution in patients having a physical deformity of the penis which may be due to angulation, cavernosal fibrosis or Peyronie's disease. The risk of permanent loss of sexual potency is very high if this medicine is used in patients suffering from these conditions. Replacement with a suitable alternative should be considered based on the patient's clinical condition.

Priapism

This medicine may cause Priapism, a painful erection lasting for more than 4 hours. Patients suffering from sickle cell anemia, multiple myeloma, leukemia, physical deformation of the penis, etc. are at higher risk of priapism. Priapism may result in penile tissue damage as well as permanent loss of sexual potency. Hence, this medicine should be used with extreme caution in patients predisposed to priapism. Any incidence of priapism should be reported to the doctor promptly and emergency medical assistance should be taken.

Loss of hearing

This medicine may cause a sudden decrease in hearing capabilities along with a buzzing or a ringing sound in the ears. Stop the use of this medicine and contact your doctor immediately if such symptoms are experienced. Replacement with a suitable alternative may be necessary in some cases based on the clinical condition.

Loss of vision

This medicine may cause a sudden loss of vision in one or both the eyes. It may also cause impairment in color differentiation capacity. Hence, it should be used with extreme caution in patients suffering from a rare genetic disorder of the retina called retinitis pigmentosa since these patients are at a higher risk of vision loss. Stop the use of this medicine and contact your doctor immediately if such symptoms are experienced. Replacement with a suitable alternative may be necessary in some cases based on the clinical condition.

Heart diseases

This medicine should be used with extreme caution if you have a disease of the heart and blood vessels. It is not recommended for use in patients who have suffered from a heart attack, stroke, or life-threatening arrhythmia within the last 6 months. Use of this medicine is not recommended if your doctor has asked you to not indulge in any sexual activity due to the increased risk of severe adverse effects on the heart.

Risk of adverse effects

The risk of side effects is extremely high in smokers, elderly patients, and patients suffering from conditions including heart diseases, diabetes, high blood pressure levels, high cholesterol levels, etc. Caution should be exercised in such cases and patients should be counseled appropriately. Some side effects like dizziness, numbness, nausea, pain, etc. could occur while having intercourse after taking this medicine. Report any such instances to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Use in children

This medicine is not recommended for use in patients less than 18 years of age since the safety and efficacy of use are not clinically established.

Use only under medical supervision

This medicine may be available over the counter in certain countries; however, you are strongly recommended to consult a doctor before taking this medicine. It should be taken only under the supervision of a qualified healthcare professional.

Counseling

The underlying cause of erectile dysfunction may be physical, psychological, or both. It is important to determine the underlying cause of erectile dysfunction to devise an appropriate plan of treatment. In cases of psychological causes alone or psychological (including lifestyle) and physical causes, it is important to undergo psychological counseling to achieve the best possible effect.

Lifestyle modification

Chronic lifestyle factors such as obesity, smoking, drinking, etc., could also contribute to erectile dysfunction (ED). Patients with ED are advised to follow major lifestyle modifications like quitting smoking and drinking, weight loss, healthy diet, and exercise along with the standard treatment for better improvement in the condition.

Use in females

This medicine is not recommended for use in females.

Missed Dose

This medicine is used as and when required, so the chances of missing a dose are less likely. If you are on a scheduled dosing regimen of this medicine, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not double the dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Use of alcohol should be avoided or kept to a minimal level while you are taking this medicine due to the increased risk of severe adverse effects such as dizziness, fainting, flushing, persistent headaches, changes in heart rate, etc.
Interaction with Medicine

Carbamazepine

Ketoconazole

Phenytoin

Alfuzosin

Disease interactions

Cardiovascular diseases

Report the incidence of any disease of the heart and blood vessels to the doctor. The use of this medicine is not recommended in such patients, especially in patients who are advised to refrain from any sexual activity, due to the increased risk of serious adverse effects on the heart.

Kidney Disease

This medicine should be used with caution in patients suffering from kidney diseases due to the increased risk of severe adverse effects. Close monitoring of kidney function is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Seizure disorders

This medicine should be used with caution in patients suffering from seizure disorders due to the increased risk of severe adverse effects. Close monitoring of the clinical condition, appropriate dose adjustments, or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Priapism

This medicine may cause Priapism, a painful erection lasting for more than 4 hours. Patients suffering from sickle cell anemia, multiple myeloma, leukemia, physical deformation of the penis, etc. are at higher risk of priapism. Priapism may result in penile tissue damage as well as permanent loss of sexual potency. Hence, this medicine should be used with extreme caution in patients predisposed to priapism. Any incidence of priapism should be reported to the doctor promptly and emergency medical assistance should be taken.

Disease of the retina

This medicine is not recommended for use in patients suffering from disorders of the retina where color discrimination is impaired since it may worsen the patient's condition. Replacement with a suitable alternative should be considered based on the patient's clinical condition.

Liver disease

This medicine should be used with caution in patients suffering from liver diseases due to the increased risk of severe adverse effects. Close monitoring of liver function is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.
Food interactions
Information not available.
Lab interactions
Information not available.
Take this medicine exactly as instructed by the doctor. Do not consume it in larger or smaller quantities than recommended. Take this medicine at least 30-60 minutes before sexual activity. It is important to note that when taken for erectile dysfunction, this medicine will not work without sexual stimulation.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Does not cause sleepiness

How it works
This medicine works by relaxing the smooth muscles present in the walls of blood vessels in the penis. This action is limited to particular areas of the body and the flow of blood in these areas is increased. Thus, when there is sexual stimulation, this medicine increases blood flow in the penis, resulting in a successful or improved penile erection and does not show any effect when there is no sexual stimulation.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Phosphodiesterase-5 inhibitors, Impotence agents

Schedule

Schedule H

DailyMed - Tadalafil tablet, coated [Internet]. Dailymed.nlm.nih.gov. 2020 [cited 27 May 2020]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abcb2cda-9b3f-45f6-ad5f-c2370b0dd114

Tadalafil - DrugBank [Internet]. Drugbank.ca. 2017 [cited 23 May 2017]. Available from:

https://www.drugbank.ca/drugs/DB00820

Tadalafil: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2017 [cited 23 May 2017]. Available from:

https://medlineplus.gov/druginfo/meds/a604008.html

Tadalafil 2.5mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc) [Internet]. Medicines.org.uk. 2020 [cited 27 May 2020]. Available from:

https://www.medicines.org.uk/emc/product/10230/smpc
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Information on this page was last updated on 27 May 2020

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