Availability & Expiry
INTRODUCTION
MODULA 5MG TABLET contains Tadalafil which belongs to the group of medicines called Phosphodiesterase type 5 (PDE 5) inhibitors. It is used in adult men to treat erectile dysfunction and urinary symptoms associated with benign prostatic hyperplasia (prostate enlargement causing painful or frequent urination or untentional passing of urine).
Erectile dysfunction (also known as impotence) is a sexual condition where a man cannot sustain a hard erected penis that is required for a normal sexual activity. It happens due to decreased blood flow to the penis.
MODULA 5MG TABLET would help you to get an erection only if you are sexually stimulated. It is not an aphrodisiac (sex-stimulating agent) and therefore cannot be used to induce sexual thoughts or can improve sexual performance/pleasure in healthy men. It is also not suitable for use in healthy men who do not have erectile dysfunction.
It may take around 30 minutes to 1 hour for MODULA 5MG TABLET to start working, therefore take this medicine at least one hour before planning to have sex. Avoid consuming alcohol or grapefruit juice while taking MODULA 5MG TABLET, as it may lead to unwanted side effects.
Before taking MODULA 5MG TABLET, inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any deformity in your penis or have undergone surgical removal of whole or a part of the prostate gland.
MODULA 5MG TABLET is not recommended for use in patients with severely low or high blood pressure and in patients who recently had stroke. The most common side effects of taking MODULA 5MG TABLET are flushing, headache, dizziness, blurred vision and muscle pain. Consult your doctor if any of these side effect troubles you.
You must also inform your doctor if you experience any painful and prolong erection after taking MODULA 5MG TABLET.
USES OF MODULA 5MG TABLET
It is used to treat:
- Erectile dysfunction
- Signs of Benign Prostatic Hyperplasia
HOW MODULA 5MG TABLET WORKS
MODULA 5MG TABLET works by blocking the effects of certain enzymes (PDE5) in the body that limits blood flow to the penis. This relaxes the blood vessels supplying the penis, improves blood flow to the penis and makes it stay erected throughout the process of sexual intercourse.
It also relaxes the smooth muscles surrounding the bladder and prostate gland which improves the flow of urine thereby reducing the unpleasant signs of Benign Prostatic Hyperplasia.
DIRECTIONS FOR USE
Take MODULA 5MG TABLET preferably before meals and at least 1 hour before sexual intercourse or as advised by your physician.
For Tablet: Swallow the medicine with a glass of water. Do not crush or chew the medicine.
For Orally Disintegrating Strip/Flim: Place the medicine inside the mouth until it dissolves on its own. Do not swallow or crush or chew the medicine.
For Granules: Disperse the medicine in the required amount of water as mentioned in the product label. Stir the mixture until it becomes uniform. Consume the medicine immediately after reconstitution.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF MODULA 5MG TABLET
COMMON
- headache
- backpain, muscle pain
- pain in arms and legs
- flushing of the face
- nasal congestion
- indigestion
UNCOMMON
- dizziness
- stomach pain, acidity
- nausea, vomiting
- blurred vision, eye pain
- difficulty in breathing
- blood in urine
- palpitation (racing heartbeat)
- changes in blood pressure (high/low)
- nasal bleeds
- tinnitus (ringing in ears)
- swelling of hands, feet or ankles
- tiredness
RARE
- bleeding from penis
- blood in semen
Stop taking MODULA 5MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- severe allergic reaction (such as wheeziness, difficulty in breathing or dizziness, swelling of the face, lips, eyelids or throat)
- prolonged or painful erection (priapism)
- chest pain
- sudden decline or loss of vision
- decreased hearing or sudden hearing loss
HOW TO MANAGE SIDE EFFECTS
Nausea and Vomiting:
Take MODULA 5MG TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your symptom worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
WARNING & PRECAUTIONS
PREGNANCY
MODULA 5MG TABLET is not suitable for use in women.
BREASTFEEDING
MODULA 5MG TABLET is not suitable for use in women.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness or blurred vision after taking MODULA 5MG TABLET.
ALCOHOL
Avoid consumption of alcohol while taking MODULA 5MG TABLET, as it could temporarily impair your ability to get an erection.
KIDNEY
MODULA 5MG TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
MODULA 5MG TABLET should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.
ALLERGY
Do not take MODULA 5MG TABLET if you are allergic to Tadalafil.
LUNGS
MODULA 5MG TABLET should be used with caution in patients with pulmonary arterial hypertension. Therefore, consult your doctor before taking it.
HEART DISEASE
MODULA 5MG TABLET is not recommended for use in patients with severe heart diseases (such as any recent heart attack). It should be used with caution in patients with other heart diseases. Therefore, consult your doctor before taking it.
OTHERS
MODULA 5MG TABLET is not recommended for use if you:
- recently had stroke (within the last 3 months)
- have severe low blood pressure
- have uncontrollably high blood pressure
- previously had vision loss due to non-arteritic anterior ischaemic optic neuropathy (nerve damage caused due to lack of blood and oxygen supply to the eye)
Before taking MODULA 5MG TABLET inform your doctor if you:
- have sickle cell anaemia (an inherited blood disorder charactrized by low RBC count)
- have cancers of blood (leukaemia) or bone marrow (multiple myeloma)
- have penile deformation
- had any pelvis surgery in the past
- had any surgical removal of all or part of the prostate gland (radical non nerve-sparing prostatectomy)
- have Peyronie’s disease (development of fibrous scar tissue in the penis that causes painful erection)
- have prostate cancer
- have stomach ulcer or bleeding disorder such as haemophilia
- have any type of a rare inherited eye diseases (such as retinitis pigmentosa)
Use in pediatrics:
MODULA 5MG TABLET is not recommended for use in children and adolescents (aged below 18 years). Therefore, consult your doctor before taking it.
Use in geriatrics:
MODULA 5MG TABLET should be used with caution in elderly patients. Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking MODULA 5MG TABLET, inform your doctor if you are taking any of the following medicines such as:
- nitrates or amyl nitrites (used for reliving chest pain) Ex. nitroglycerin, isosorbide dinitrite
- other medicines used to treat erectile dysfunction (Ex. sildenafil)
- alpha blockers (used to treat high blood pressure or benign prostatic hyperplasia) Ex. prazosin, terazosin, tamsulosin
- riociguat (a medicine used to treat increased pressure in the lungs)
- medicines used to treat BPH (Ex. dutasteride, finasteride)
- ketoconazole, itraconazole (used to treat fungal infection)
- protease inhibitors (used to treat HIV infection) Ex. ritonavir, lopinavir
- phenobarbital, phenytoin, carbamazepine (medicines used to treat fits)
- rifampicin, erythromycin, clarithromycin (medicines used for bacterial infections)
B. Drug-Food Interactions:
Avoid consuming grapefruit juice while taking MODULA 5MG TABLET, as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more MODULA 5MG TABLET, consult your doctor or visit the nearby hospital.
SYNOPSIS
| Drug | : | Tadalafil |
| Pharmacological Category | : | Phosphodiesterase-5 inhibitors |
| Therapeutic Indication | : | Erectile Dysfunction, Benign Prostatic Hyperplasia |
| Dosage Forms | : | Tablets, Oral disintegrating strips, Granules |
MORE INFORMATION
- Keep MODULA 5MG TABLET out of sight and reach of children
- Store MODULA 5MG TABLET below 30°C
FAQs ABOUT MODULA 5MG TABLET
How MODULA 5MG TABLET works?
MODULA 5MG TABLET works by blocking the effects of certain enzymes (PDE5) in the body that limits blood flow to the penis. This relaxes the blood vessels supplying the penis, improves blood flow to the penis and makes it stay erected throughout the process of sexual intercourse. It also relaxes the smooth muscles surrounding the bladder and prostate which improves the flow of urine thereby reducing the unpleasant signs of Benign Prostatic Hyperplasia.
What is the use of MODULA 5MG TABLET?
MODULA 5MG TABLET is used to treat erectile dysfunction and BPH in men. It helps men to get and sustain a hard penis which is required for a normal sexual activity. It also reduces the unpleasant urinary symptoms associated with BPH.
Can I take MODULA 5MG TABLET daily?
MODULA 5MG TABLET is generally prescribed as one dose per day. However, your doctor will decide the number of doses per day depending upon your age, body weight and disease condition. Do not take MODULA 5MG TABLET more than once a day without consulting your doctor.
How long does it take for MODULA 5MG TABLET to start working?
It may take around 30 minutes to 1 hour for MODULA 5MG TABLET to start working, therefore take this medicine at least one hour before planning to have sex. This time may vary from person to person depending upon their health condition.
Who can take MODULA 5MG TABLET?
MODULA 5MG TABLET can be used in adult men with erectile dysfunction or BPH. It is not suitable for use in healthy men without erectile dysfunction or in men who are not sexually stimulated. It is also not advisable for use in children or adolescents (aged below 18 years).
Is MODULA 5MG TABLET effective?
Yes. MODULA 5MG TABLET improves penile erection (make penis firm) during sexual intercourse. It acts by relaxing the blood vessels supplying the penis which therefore improves penile blood flow and oxygen supply. It also relaxes the smooth muscles surrounding the bladder and prostate and improves the flow of urine thereby reducing the unpleasant signs of Benign Prostatic Hyperplasia.
Can the use of MODULA 5MG TABLET delay the release of sperms?
No. MODULA 5MG TABLET would only help to get an erection (hard penis) in patients with erectile dysfunction. It does not exerts its effects on sperm release (ejaculation) and therefore cannot be used to prevent premature ejaculation (early release of sperms).
Can healthy men consume MODULA 5MG TABLET to improve sexual performance?
MODULA 5MG TABLET is not an aphrodisiac (sex-stimulating agent). It does not induce sexual thoughts or can improve sexual performance/pleasure in healthy men. It would help you to get an erection only if you are sexually stimulated.
What will happen if I consume a high dose of MODULA 5MG TABLET than prescribed by my doctor?
Do not consume a higher dose of MODULA 5MG TABLET than the one prescribed by your doctor, as it may lead to unwanted side effects. Your doctor will decide the correct dose for you, depending on your age and disease condition. If the prescribed dose, does not help you to get an erection or if your erection does not last long until sexual intercourse, contact your doctor.
Can men taking MODULA 5MG TABLET father a child?
There is no confirmed proof that MODULA 5MG TABLET could affect fertility in men. However, it is better to consult your doctor before planning to have a child if you are taking MODULA 5MG TABLET.
Is MODULA 5MG TABLET safe?
MODULA 5MG TABLET is considered safe at doses prescribed by the physician. However, it may cause few side effects such as headache dizziness, flushing or muscle pain in some individuals. Contact your doctor if they bother you.
Can I consume alcohol while taking MODULA 5MG TABLET?
Avoid consumption of alcohol while taking MODULA 5MG TABLET as it could reduce the effectiveness of MODULA 5MG TABLET.
How long does the effects of MODULA 5MG TABLET would last long?
The effects of MODULA 5MG TABLET would normally last long for 4 hours. However, this time may vary from person to person depending upon their age and health condition. Consult your doctor if the effects of MODULA 5MG TABLET does not last long until sexual intercourse.
What should I do if I miss a dose of MODULA 5MG TABLET?
If you miss a dose of MODULA 5MG TABLET, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and take the next one at regular times. Do not take a double dose of MODULA 5MG TABLET to compensate the missed dose.
What do I do if I take too many tablets of MODULA 5MG TABLET?
In case of over consumption of MODULA 5MG TABLET contact your healthcare practitioner. Symptoms of overdosage may include chest pain, hearing problems or sudden decrease or loss of vision.
Will taking a higher dose of MODULA 5MG TABLET be more effective?
No. Do not take a higher dose of MODULA 5MG TABLET than prescribed by your doctor, as it could lead to toxicity. Always consume the dose prescribed by your doctor. If you feel that the prescribed dose is not working for you, consult your doctor for advice.
Can MODULA 5MG TABLET helps to urinate easily?
MODULA 5MG TABLET helps to regulate the flow of urine by relaxing the smooth muscles surrounding the bladder and prostate. It improves urine flow and reduces pain and discomfort while passing urine.
Can MODULA 5MG TABLET help to dissolve kidney stones?
No. MODULA 5MG TABLET is only used to treat erectile dysfunction or benign prostatic hyperplasia. It cannot dissolve kidney stones. Consult your doctor for advice.
Can the use of MODULA 5MG TABLET cause long-lasting painful penile erection?
Yes. MODULA 5MG TABLET may rarely cause persistent painful penile erection (priapism) which is unrelated to sexual activity. If you experience any such symptom, contact your doctor immediately.
Can MODULA 5MG TABLET stop urine?
In patients with urinary problems (such as unintentional passing of urine or frequent urination), MODULA 5MG TABLET regulates the flow of urine by relaxing the smooth muscles surrounding the bladder and prostate. Therefore, it controls abnormal urinary symptoms (such as difficulty in passing urine or frequent urination).
Can the use of MODULA 5MG TABLET make me feel dizzy?
MODULA 5MG TABLET may cause dizziness in some individuals. If you experience dizziness, try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
REFERENCES
1. KD. Tripathi. Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page – 304.
2. Konstantinos Hatzimouratidis. A review of the use of tadalafil in the treatment of benign prostatic hyperplasia in men with and without erectile dysfunction. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. August 2014. [Accessed on 28th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4054509/
3. Sang-In Park, Su-Hak Heo, Gihwan Kim, Seokhoon Chang, Keon-Hyoung Song, Min-Gul Kim, Eun-Heui Jin, JaeWoo Kim, SeungHwan Lee and Jang Hee Hong. Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. April 2018. [Accessed on 28th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5916261/
4. Cipla (EU) Limited. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 28th October 2022] https://www.medicines.org.uk/emc/files/pil.10231.pdf
5. Eli Lilly and company. U.S. Food & Drug Administration. [Revised in October 2007] [Accessed on 28th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf
6. Central Drugs Standard Control Organization. Tadalafil Tablet 2.5mg/5mg. [Revised inFebruary 2003]. Tadalafil Orally Disintegrating Strip 10mg & 20mg (Additional dosage form). [Revised in July 2014]. Tadalafil 10mg/20mg Tablets. [Revised in September 2003]. [Accessed on 28th October 2022] https://cdscoonline.gov.in/CDSCO/Drugs
7. Powder for Oral Suspension Containing Tadalafil. Google Patents. [Revised in November 2021]. [Accessed on 29th October 2022] https://patents.google.com/patent/US11179338B1/en
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