Description

Specification

INTRODUCTION
ALZOCIN D TABLET is a combination of Alfuzosin and Dutasteride which belongs to the group of medicines called Alpha-1 adrenergic blockers and 5-Alpha reductase inhibitors respectively. ALZOCIN D TABLET is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adult men with an enlarged prostate.
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.
Before taking ALZOCIN D TABLET inform your doctor if you have low blood pressure, liver, kidney or heart disease as a precaution. During treatment with ALZOCIN D TABLET, your doctor will regularly monitor your serum prostate-specific antigen (PSA) levels to rule out risk of prostate cancer.
Women who are pregnant or think they may be pregnant should not handle the leaked medicine or be exposed to the semen of men taking ALZOCIN D TABLET, as it could cause serious abnormalities in the growing fetus. Usage of condom during sexual intercourse is recommended among fertile men to avoid conception.
Men being treated with?ALZOCIN D TABLET should not donate blood for at least 6 months after their last dose, in order to prevent the exposure of the medicine to pregnant women via blood transfusion. ALZOCIN D TABLET should be used with caution in elderly patients (aged 65 years or above).
The most common side effects of taking ALZOCIN D TABLET are dizziness, fainting, weakness and decreased sex drive or breast enlargement in men. Contact your doctor if any of the side effects worsen.
USES OF ALZOCIN D TABLET

Treat signs and symptoms of benign prostatic hyperplasia (BPH) in adult men

HOW ALZOCIN D TABLET WORKS
ALZOCIN D TABLET effectively reduces the symptoms of BPH, where dutasteride acts by inhibiting the activity of an enzyme called 5-alpha reductase, which is responsible for the conversion of?testosterone into dihydrotestosterone (a stress hormone that causes BPH) and alfuzosin acts by relaxing the muscles surrounding the bladder and prostate by inhibiting the alpha-1 adrenergic receptors of the lower urinary tract. As a result, ALZOCIN D TABLET helps in shrinkage of an enlarged prostate, making it easier for the urine to pass through and provide relief from symptomatic BPH.
DIRECTIONS FOR USE
Take ALZOCIN D TABLET as advised by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Try to take ALZOCIN D TABLET at the same time each day immediately after meals. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.
SIDE EFFECTS OF ALZOCIN D TABLET

COMMON

Dizziness or fainting

Headache, nausea, stomach pain

General weakness or tiredness

Sexual impotence (unable to achieve or maintain an erection), decreased sex drive and difficulty with ejaculation

Gynecomastia (breast enlargement or tenderness in men)

UNCOMMON

Postural hypotension (feeling dizzy, lightheaded or faint while standing up)

Rapid heartbeat

Drowsiness

Diarrhea, dry mouth

Skin rash with itching

Signs of heart failure (shortness of breath, extreme tiredness and swelling in ankles)

Hot flushes

Fluid retention (may cause swollen arms or legs)

Stuffy or runny nose, itching or sneezing

Vision problems

Hair loss (usually from the body) or hair growth

RARE
Stop taking ALZOCIN D TABLET and contact your doctor immediately if you experience any of the following side effects:
Priapism (persistent painful penile erection unrelated to sexual activity)

Chest pain

Severe allergic reactions (such as skin rash with redness and lumps, swelling of face, eyelids, lips, mouth and tongue causing difficulty in breathing or swallowing)

HOW TO MANAGE SIDE EFFECTS
Nausea:
Try to take ALZOCIN D TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if the symptom did not improve.
Diarrhea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.
Headache:
Rest and relax. Drink lot of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.
Skin rash:
Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS

PREGNANCY
Women who are pregnant or can become pregnant should not handle the leaked medicine or be exposed to the semen of men taking ALZOCIN D TABLET, as it could cause serious abnormalities in the growing fetus. Usage of condom during sexual intercourse is therefore recommended in such population as a precaution. Contact your doctor for advice if a pregnant woman gets accidentally exposed to ALZOCIN D TABLET.
BREASTFEEDING
ALZOCIN D TABLET is not indicated to use in breast-feeding women as it is indicated to use only in men.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness, sleepiness, weakness or headache after taking ALZOCIN D TABLET.
ALCOHOL
Avoid consumption of alcohol while taking ALZOCIN D TABLET, as it could make you feel dizzier or weaker.
KIDNEY
ALZOCIN D TABLET should be taken with caution in patients with severe kidney impairment. Consult your doctor before taking ALZOCIN D TABLET.
LIVER
ALZOCIN D TABLET is not recommended for use in patients with moderate to severe liver impairment and it should be used with caution in patients with mild liver impairment. Consult your doctor before taking ALZOCIN D TABLET.
ALLERGY
Talk to your doctor if you are allergic to Alfuzosin or Dutasteride.
HEART DISEASE
ALZOCIN D TABLET should be taken with caution in patients with heart disease (Ex. angina, prolong QT interval). Consult your doctor before taking ALZOCIN D TABLET.
OTHERS
ALZOCIN D TABLET is not recommended for use if you:
Have prostate cancer
Before taking ALZOCIN D TABLET, inform your physician if you:
Have orthostatic hypotension (feeling dizzy or faint while standing up)

Have an upcoming cataract surgery

Are going to have blood test for PSA (Prostate Specific Antigen)
Use in pediatrics:
ALZOCIN D TABLET is not recommended for use in children and adolescents (aged below 18 years). Consult your child?s doctor for advice.
Use in geriatrics:
ALZOCIN D TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking ALZOCIN D TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ALZOCIN D TABLET inform to your doctor, if you are taking any of these medicines:
Medicines used to treat fungal infections (Ex. ketoconazole or itraconazole)

Medicines used to treat high blood pressure and other heart problems (such as nitroglycerin, verapamil, atenolol or diltiazem)

Antibiotics (used to treat bacterial infections) such as troleandomycin and ciprofloxacin

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)

Warfarin (used to prevent formation of blood clots in the body)

Ritonavir (used to treat HIV infection)

Cimetidine (used to treat stomach ulcers)
Overdosage:
If you or anyone else accidentally take too much of ALZOCIN D TABLET, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage include severe hypotension (decrease in blood pressure causing severe dizziness and fainting).
SYNOPSIS

Drug :?? Alfuzosin, Dutasteride

Pharmacological Category :?? Alpha-1 adrenergic blockers, 5-Alpha reductase inhibitors

Therapeutic Indication :?? Benign Prostatic Hyperplasia???????????

Dosage Forms :?? Tablet, Capsule

MORE INFORMATION

Keep ALZOCIN D TABLET out of reach of children

Store at room temperature

FAQs ABOUT ALZOCIN D TABLET
Can the use of ALZOCIN D TABLET cause long-lasting painful penile erection?
Yes, ALZOCIN D TABLET can rarely cause a serious condition called priapism?(persistent painful penile erection unrelated to sexual activity). Stop taking ALZOCIN D TABLET and contact your doctor immediately if you experience persistent painful erections of the penis that is unrelated to sexual activity, because this condition can lead to permanent erectile dysfunction if not treated properly.
Can the use of ALZOCIN D TABLET cause prostate cancer?
Yes, ALZOCIN D TABLET can increase the risk of high-grade prostate cancer in men and so your doctor would regularly monitor your serum prostate specific antigen (PSA) levels. Current clinical findings show that men taking dutasteride develops a serious form of prostate cancer more often than men who are not relied on dutasteride therapy. However, the mechanism behind the incidence of prostate cancer is not clear.
Use of ALZOCIN D TABLET by male individuals affects pregnancy?
Before taking ALZOCIN D TABLET, inform your doctor if you are planning to have a baby, because this medicine can be found in the semen of men taking it. Both pregnant women and women of child-bearing potential must not be exposed to ALZOCIN D TABLET either through direct handling or through semen, because it could cause serious abnormalities to the growing fetus. Usage of condom during sexual intercourse is recommended among fertile men to avoid conception.
Can ALZOCIN D TABLET cause infertility?
Yes, ALZOCIN D TABLET can cause sexual impotence, decreased sex drive or difficulty in ejaculation in men because it reduces the sperm count, semen volume and sperm movement. Consult your doctor if this bothers you.
Can the use of ALZOCIN D TABLET make me feel dizzy?
Yes, ALZOCIN D TABLET 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. However, if you experience severe persistent dizziness and fainting while standing up, please consult your doctor.
What to do If I forget to take ALZOCIN D TABLET?
You should take ALZOCIN D TABLET immediately when you remember. If it is time for your next dose skip the dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
Is ALZOCIN D TABLET safe to use in children?
ALZOCIN D TABLET is not recommended for use in children and adolescents (aged below 18 years). Consult your doctor before taking ALZOCIN D TABLET. If your child experiences any symptoms of difficulty in urination consult child?s doctor immediately.
REFERENCES
1. KD. Tripathi. Antiadrenergic Drugs (Adrenergic Receptor Antagonists) and Drugs for Glaucoma and Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 142-144 & 303.
2.?B Ventimiglia,?S Consoli,?M Serrao,?A Tsirgiotis. Efficacy of dutasteride, alfuzosin or both on Quality of Life in patients with prostatic hyperplasia and BOO.A two-year spontaneous, observational, self-controlled study. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April-June 2008. [Accessed on 28th October 2022]?https://pubmed.ncbi.nlm.nih.gov/21086358/
3.?Mostafa Elhilali,?Mark Emberton,?Haim Matzkin,?R Jeroen A van Moorselaar,?Rudolf Hartung,?Niels Harving,?Antonio Alcaraz,?Guy Vallancien,?ALF-ONE Study Group. Long-term efficacy and safety of alfuzosin 10 mg once daily: a 2-year experience in ?real-life? practice. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 2006. [Accessed on 28th October 2022] https://pubmed.ncbi.nlm.nih.gov/16469018/
4.?Zhongbao Zhou, Shiqiang Song, Zhenli Gao, Jitao Wu, Jiajia Ma and?Yuanshan Cui. The efficacy and safety of dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2019. [Accessed on 28th October 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388756/
5.?R Jeroen A van Moorselaar,?Rudolf Hartung,?Mark Emberton,?Niels Harving,?Haim Matzkin,?Mostafa Elhilali,?Antonio Alcaraz,?Guy Vallancien,?ALF-ONE Study Group. Alfuzosin 10 mg once daily improves sexual function in men with lower urinary tract symptoms and concomitant sexual dysfunction. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 2005. [Accessed on 28th October 2022] https://pubmed.ncbi.nlm.nih.gov/15705088/
6. Sanofi Winthrop Industrie. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 28th October 2022] https://www.medicines.org.uk/emc/files/pil.1475.pdf
7. APL Swift Services (Malta) Limited or Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in August 2019] [Accessed on 28th October 2022] https://www.medicines.org.uk/emc/files/pil.9277.pdf
8. Cipla Ltd. Alfusin D Tablets?(Alfuzosin hydrochloride + Dutasteride). Ciplamed.com. [Revised in December 2013] [Accessed on 28th October 2022] https://www.ciplamed.com/content/alfusin-d-tablets
USEFUL DIAGNOSTIC TESTS

Prostate-specific antigen (PSA) test

PRODUCT DETAILS

Net Qty

1 N

Item Weight

17.5 g

Ingredient

Alfuzosin Hydrochloride 10 MG+DUTASTERIDE 0.5 mg

Hsn Code

30049099

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Additional information

Weight
17.5 g

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