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INTRODUCTION

TAMSIFLO D is a combination of Dutasteride and Tamsulosin which belongs to the group of medicines called 5-Alpha reductase inhibitors and Alpha-blockers respectively. TAMSIFLO D is used to treat Benign Prostatic Hyperplasia (BPH) in adult men. Benign Prostatic Hyperplasia (also known as enlarged prostate) is a non-cancerous growth of prostate gland, which is predominantly caused by excessive production of a stress hormone called dihydrotestosterone (DHT) in men. Symptoms of BPH includes urinary problems such as difficulty in passing urine, urinary incontinence (unintentional passing of urine), frequent urination at night and sexual dysfunction or painful ejaculation.

Dutasteride acts by reducing the production of dihydrotestosterone, which helps the prostate to shrink and Tamsulosin acts by relaxing the muscles surrounding your prostate gland, making it easier for the urine to pass through, thus rapidly improving the symptoms of BPH. During this therapy, your doctor will regularly monitor your serum prostate-specific Antigen (PSA) levels to detect the incidence of prostate cancer.

Before taking TAMSIFLO D inform your doctor if you have any liver or kidney problems. Both pregnant women and children should avoid handling the leaking medicine, because this medicine has a high potential to get absorbed through your skin and can affect the normal development of a male baby (especially during the first 16 weeks of pregnancy).

Usage of condom during sexual intercourse is recommended among fertile men to avoid conception. TAMSIFLO D is not recommended for use in child or adolescent under 18 years of age. The most common side effects of taking TAMSIFLO D are dizziness, enlargement of breast in men and decreased sex drive. Contact your doctor if any of these symptoms bothers you.

USES OF TAMSIFLO D

  • To treat Benign Prostatic Hyperplasia (BPH) in adult men

HOW TAMSIFLO D WORKS

TAMSIFLO D reduces the symptoms of Benign Prostatic Hyperplasia, where dutasteride works by reducing the production of a stress hormone called dihydrotestosterone and Tamsulosin works by relaxing the muscles surrounding the prostate gland, thus helps in shrinkage of prostate, making it easier for the urine to pass through and relieve the symptoms.

DIRECTIONS FOR USE

Always take TAMSIFLO D as directed by your physician. Take this medicine with or without food, swallow the medicine as a whole and do not crush or chew the medicine. Do not stop taking TAMSIFLO D without informing your doctor.

SIDE EFFECTS OF TAMSIFLO D

COMMON

  • sexual impotence (unable to achieve or maintain an erection)
  • decreased sex drive
  • difficulty in ejaculation
  • gynecomastia (breast enlargement or tenderness)
  • dizziness

UNCOMMON

  • heart failure (signs include shortness of breath, extreme tiredness and swelling in your ankles and legs)
  • low blood pressure on standing
  • weakness or loss of strength
  • headache
  • constipation, diarrhea
  • nausea, vomiting
  • fast heartbeat
  • itchy, blocked, or runny nose
  • skin rash, hives, itching
  • hair loss or hair growth

RARE

  • swelling of the face, eyelids, lips, arms or legs
  • fainting

Stop taking TAMSIFLO D and contact your doctor immediately if you experience any of the following side effects:

  • signs of allergic reaction (such as skin rash, itching, hives, and swelling of face, eyelids, lips, arms, or legs)
  • stevens-johnson syndrome (a severe widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals)

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Avoid consumption of alcohol as it can aggravate your dizziness. If the symptom persists for a longer time, contact your doctor for advice.

Nausea and Vomiting:

Take this medicine with, or just after, a meal or snack and stick to simple meals and do not eat oil rich or spicy food. Consult your doctor if the symptom does not improve.

Headache:

Apply hot or cold-water bag on your head. Try taking rest in a quiet and dark room. Drink tea or coffee. Consult your doctor if the symptom does not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

PREGNANCY

TAMSIFLO D is intended for use only in men. Pregnant women should not come in contact with TAMSIFLO D as it may cause potential abnormalities in male foetus.

BREASTFEEDING

TAMSIFLO D is intended for use only in men, and therefore should not be used in breastfeeding women.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience dizziness while taking TAMSIFLO D.

ALCOHOL

Avoid consumption of alcohol while taking this medicine because it may cause excessive drowsiness. Consult your doctor before taking TAMSIFLO D.

KIDNEY

TAMSIFLO D should be used with caution if you have severe kidney disease. Consult your doctor for advice before taking TAMSIFLO D.

LIVER

TAMSIFLO D is not recommended for use in patients having severe liver disease and it should be used with caution in patients with liver problems. Consult your doctor for advice before taking TAMSIFLO D.

ALLERGY

Do not take TAMSIFLO D if you are allergic to Tamsulosin or Dutasteride and other 5-alpha reductase inhibitors such as finasteride and soya or peanut.

HEART DISEASE

TAMSIFLO D is not recommended for use in patients with low blood pressure (which causes dizziness, lightheadedness, or fainting (orthostatic hypotension)). Consult your doctor for advice before taking TAMSIFLO D.

OTHERS

TAMSIFLO D is not recommended for you, if you:

  • are a woman (because this medicine is for men only)

Before taking TAMSIFLO D, inform your doctor if you have:

  • an upcoming cataract surgery
  • blood test for PSA (Prostate Specific Antigen)

Use in pediatrics:

TAMSIFLO D is not recommended for use in children or adolescents less than 18 years of age. Consult with your doctor for advice before taking TAMSIFLO D.

Use in geriatrics:

TAMSIFLO D should be used with caution in elderly patients above 65 years of age. Consult with your doctor for advice before taking TAMSIFLO D.

INTERACTIONS

A. Drug-Drug Interaction:

Before taking TAMSIFLO D inform to your doctor, if you are taking any of these medicines:

  • other alpha blockers (used to treat enlarged prostate or high blood pressure) such as prazosin, doxazosin, terazosin
  • medicines used to treat erectile dysfunction (Ex. vardenafil, sildenafil and tadalafil)
  • medicines used to treat fungal infections (Ex. itraconazole, ketoconazole or terbinafine)
  • diltiazem or verapamil (used to treat angina or high blood pressure)
  • ritonavir or indinavir (used to treat HIV infections)
  • paroxetine or nefazodone (a medicine used to treat depression)
  • cimetidine (a medicine used to treat stomach ulcers)
  • warfarin (used to treat blood clotting)
  • erythromycin (used to treat bacterial infections)
  • diclofenac (a medicine used to treat pain or inflammation)

Overdosage:

If you or anyone else accidentally take too much of TAMSIFLO D, consult your doctor immediately. Overdosage may cause acute hypotension, nausea, and vomiting.

SYNOPSIS

Drug :  

Dutasteride, Tamsulosin

Pharmacological Category :  

5-Alpha reductase inhibitors, Alpha-blockers

Therapeutic Indication :  

Benign Prostatic Hyperplasia

Dosage Forms :  

Tablet, Capsule

MORE INFORMATION

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

FAQs ABOUT TAMSIFLO D

Can TAMSIFLO D cause prostate cancer?

This medicine can increase the risk of prostate cancer, and so your doctor would regularly monitor your serum prostate specific antigen (PSA) which is used to detect prostate cancer, in order to avoid any untoward side effects.

Can TAMSIFLO D cause infertility?

Yes. This medicine can reduce sperm count, semen volume and movement also it can cause sexual impotence, decreased sex drive or difficulty in ejaculation in men. Consult your doctor if you experience of these side effects.

Can TAMSIFLO D be used for erectile dysfunction?

Yes. This medicine is intended to treat Benign Prostatic Hyperplasia (BPH) and its associated symptoms such as urinary problems and erectile dysfunction or painful ejaculation.

Can TAMSIFLO D cause dizziness?

Yes. TAMSIFLO D can cause dizziness in some people. Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Avoid consumption of alcohol as it can aggravate your dizziness. If the symptom persists for a longer time, contact your doctor for advice.

Is TAMSIFLO D safe to use in patients with liver disease?

TAMSIFLO D is not recommended for use in patients having severe liver disease and it should be used with caution in patients with liver problems. Your doctor will adjust the dose based on the severity of the impairment and will monitor your liver function test periodically during treatment with TAMSIFLO D. Before taking this medicine, inform your doctor if you have any liver disease.

Can TAMSIFLO D be used in children?

TAMSIFLO D is not recommended for use in children or adolescents less than 18 years of age. Consult child’s doctor for advice before taking TAMSIFLO D. Doctor may consider the effective management in treating the condition.

REFERENCES

1. KD. Tripathi. Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page – 303.

2. KD. Tripathi. Antiadrenergic Drugs (Adrenergic Receptor Antagonists) and Drugs for Glaucoma. Essentials of medical pharmacology. Seventh edition. 2013. Page – 142.

3. Peter J. Snyder. Androgens. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1205.

4. GlaxoSmithKline. Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment.  NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2017] [Accessed on 17th August 2021] https://www.clinicaltrials.gov/ct2/show/NCT00090103

5. Konstantinos Dimitropoulos and Stavros Gravas. Fixed-dose combination therapy with dutasteride and tamsulosin in the management of benign prostatic hyperplasia. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2016. [Accessed on 17th August 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4707422/

6. J Miller and TH Tarter. Combination therapy with dutasteride and tamsulosin for the treatment of symptomatic enlarged prostate. NCBI; PMC US National Library of Medicine, National Institute of Health. June 2009. [Accessed on 17th August 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697590/

7. Sibylle Marihart, Mike Harik and Bob Djavan. Dutasteride: A Review of Current Data on a Novel Dual Inhibitor of 5α Reductase. NCBI; PMC US National Library of Medicine, National Institute of Health. 2005. [Accessed on 17th August 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1550785/

8. Glenmark Pharmaceuticals Europe Limited. Laboratorios LEÓN FARMA, SA. Electronic Medicines Compendium (EMC). [Revised in January 2020] [Accessed 17th on August 2021] https://www.medicines.org.uk/emc/files/pil.11336.pdf

9. Dr. Reddy’s Laboratories (UK) Ltd, Laboratorios LEÓN FARMA, SA. Electronic Medicines Compendium (EMC). [Revised in January 2020] [Accessed on 17th August 2021] https://www.medicines.org.uk/emc/files/pil.11304.pdf

10. Cipla Ltd. URIMAX D Tablets (Tamsulosin hydrochloride + Dutasteride). Ciplamed. [Revised in December 2013]. [Accessed on 17th August 2021] https://www.ciplamed.com/content/urimax-d-tablets

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    Country Of Origin
    India
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TAMSIFLO D Tablet 10's

TAMSIFLO D Tablet 10's Mkt: Vasu Organics Pvt Ltd

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