INTRODUCTION

DUOFLO is a combination of Solifenacin and Tamsulosin which belongs to the group of medicines called Urinary antispasmodics and Alpha blockers respectively. It is used to manage lower urinary tract symptoms (such as overactive bladder, incomplete voiding, painful urination, slow or scanty urine or frequent urination at night) associated with Benign Prostatic Hyperplasia (BPH; enlarged prostate) or other bladder problems.

Tamsulosin is an alpha-1 adrenergic blocker. It acts by relaxing the muscles surrounding the bladder and the prostate. Solifenacin is a muscarinic receptor antagonist. It acts by stopping the contraction of smooth muscles surrounding the bladder. As a result, they collectively increase the capacity of the bladder to hold urine for a longer time and regulate proper urine flow.

Before taking DUOFLO, inform your doctor if you have any liver, kidney, or heart problems. You should also inform your doctor if you are scheduled for any eye surgery while taking DUOFLO as a precaution.

DUOFLO is not recommended for use in patients with severe bowel diseases, myasthenia gravis (muscle disease) or glaucoma (an eye disorder). It is not suitable for use in children and adolescents (aged below 18 years).

The most common side effects of DUOFLO are dry mouth, constipation, indigestion, dizziness, blurred vision, tiredness, ejaculation disorders, nausea, and stomach pain. These side effects are usually temporary and are reversible once therapy is stopped. However, consult your doctor if they bother you.

USES OF DUOFLO

• Used in adults to manage moderate to severe urinary symptoms associated with bladder problems or begin prostate hyperplasia

HOW DUOFLO WORKS

DUOFLO improves urinary symptoms where both solifenacin and tamsulosin acts by blocking the actions of certain chemicals (noradrenaline and acetylcholine) in the body that causes abnormal contraction of muscles surrounding the bladder and the prostate. Tamsulosin acts by relaxing the muscles surrounding the bladder and prostate and solifenacin acts by stopping the contraction of smooth muscles surrounding the bladder. Collectively they reduce the symptoms associated with BPH and makes the bladder to hold urine for a longer period.

DIRECTIONS FOR USE

Take DUOFLO as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. DUOFLO can be taken with or without food. 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 DUOFLO

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting:

Take DUOFLO with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

Diarrhea:

Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not take any anti-diarrheal medicines to manage diarrhea on your own. Consult your doctor if your diarrhea persists for a prolonged period.

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.

Constipation:

Eat plenty of fibre rich foods such as fresh fruits, vegetables, and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

Blurred vision:

Close your eyes and relax. Do not strain your eyes by looking at mobile phones, laptops, or television. Avoid driving or operating any heavy tools or machines while your vision is blur. Consult your doctor if you experience blurred vision for a prolonged period.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before taking DUOFLO, inform your doctor if you are taking any of the following:

• medicines used to manage fungal infections (Ex. ketoconazole, itraconazole)
• medicines used to manage bacterial infections (Ex. erythromycin)
• medicines used to manage viral infections (Ex. ritonavir, nelfinavir)
• medicines used to manage high blood pressure (Ex. verapamil, diltiazem)
• medicine used to manage depression (Ex. paroxetine)
• other anticholinergic medicines (used to increased heart rate, reduce body secretions and increase body movements) Ex. ipratropium, atropine
• medicines used to manage reflux disease (Ex. metoclopramide and cisapride)
• other alpha-blockers (used to manage high blood pressure and prostate diseases) Ex. prazosin
• medicines such as bisphosphonates used to prevent bone loss

Overdosage:

If you or anyone else accidentally took more DUOFLO, consult your doctor immediately or visit the nearby hospital straight away. Symptoms of overdose might include dry mouth, dizziness, blurred vision, hallucinations, excitement, seizures, breathing difficulty, increased heart rate, inability to empty the bladder or pass urine and decrease in blood pressure.

SYNOPSIS

MORE INFORMATION

• Keep DUOFLO out of reach of children
• Store DUOFLO at room temperature

FAQs ABOUT DUOFLO

Can DUOFLO cause dizziness?

Yes. DUOFLO 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 while you are feeling dizzy. Consult your doctor if your dizziness worsens.

What precautions do I need to follow while taking DUOFLO?

DUOFLO is not recommended for use in patients with severe stomach or bowel condition like ulcerative colitis. It is also not suitable for use in patients with myasthenia gravis (muscle disease) glaucoma (an eye disorder) or severe low blood pressure. It should be used with caution in patients with urinary retention (inability to pass urine), nerve problems, or hernia. Inform your doctor if you have any upcoming eye surgery while undergoing management with DUOFLO.

How and when should I take DUOFLO?

Take DUOFLO as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. [GBNKEYEORD] can be taken with or without food. Your doctor will decide right time of administration for you after analysing your health condition.

Can DUOFLO be used to manage prostate cancer?

No, DUOFLO is not meant to manage prostate cancer. It is used in men to manage moderate to severe urinary symptoms of lower urinary tract (such as sudden uncontrollable urge to urinate, incomplete emptying of bladder, painful urination, slow or scanty urine or frequent urination at night) associated with bladder problems or begin prostate hyperplasia.

Does DUOFLO cause any side effects?

Yes, DUOFLO may cause certain side effects like dry mouth, constipation, indigestion, dizziness, blurred vision, tiredness, ejaculation disorders, nausea, inability to urinate and stomach pain. These side effects are usually temporary and are reversible once therapy is stopped. However, consult your doctor if they bother you.

How long will it take for DUOFLO to start working?

DUOFLO starts to work within 4-7 hours of administration. However, it may take up to 4 weeks to reach its maximum effects, and so take this medicine regularly without fail. Consult your doctor if any of the symptom worsens or if the symptoms are not relived even after taking DUOFLO for a prolonged period.

Will DUOFLO affect fertility?

No. DUOFLO does not affect fertility.  It improves moderate to severe urinary symptoms associated with bladder problems or begin prostate hyperplasia by relaxing the smooth muscles surrounding the bladder and prostate.

Is DUOFLO safe?

DUOFLO should be taken under medical supervision. At normal prescribed doses, it might cause few side effects like dry mouth, constipation, indigestion, dizziness, blurred vision, tiredness, ejaculation disorders, nausea, and stomach pain. These side effects are usually temporary and are reversible once therapy is stopped. However, consult your doctor if they bother you.

How long will DUOFLO take to manage my disease?

It may take up to 4 weeks for DUOFLO to show the results. However, this period varies from person to person based on their disease condition. Consult your doctor if your symptoms are not relived even after taking DUOFLO for a prolonged period.

What to do if I forgot to take DUOFLO?

If you forgot to take a dose of DUOFLO take it as soon as you remember. However, if it is time to take the next dose, skip the missed dose and take the next dose at regular times. Do not take a double dose to compensate a missed dose.

Will taking a higher dose of DUOFLO be more effective?

No. Do not take a higher dose of DUOFLO than the prescribed one without consulting your doctor. Taking a higher dose of DUOFLO may not be beneficial. Instead, it can cause serious side effects. If the prescribed dose is not effective for you, consult your doctor. Your doctor may prescribe a suitable higher dose or suggest an alternative therapy after evaluating your disease condition.

REFERENCES

1. K.D. Tripathi. Drugs Acting on ANS Essentials of pharmacology. Seventh edition, 2013. Page – 118, 142.

2. Konstantinos Dimitropoulos and Stavros Gravas Solifenacin/tamsulosin fixed-dose combination therapy to manage lower urinary tract symptoms in patients with benign prostatic hyperplasia. NCBI; PMC US National Library of Medicine, National Institute of Health. March 2015 [Accessed on 4th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372012/

3. Astellas Pharma Ltd Electronic Medicines Compendium (EMC) [Revised in November 2019] [Accessed on 4th May 2022] https://www.medicines.org.uk/emc/files/pil.5245.pdf

4. Cipla Ltd. Solifenacin/tamsulosin [Revised in October 2018] [Accessed on 4th May 2022] https://www.ciplamed.com/content/duoflo-combipack