Tamsulosin Hydrochloride (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tamsulosin hydrochloride capsules USP 0.4 mg are supplied in high density polyethylene bottles containing hard gelatin capsules with an olive green opaque cap and an orange opaque body. The cap is imprinted with the code “TSL 0.4” in black ink.

7 TABLET in a BOTTLE (53217-159-07)
30 TABLET in a BOTTLE (53217-159-30)
90 TABLET in a BOTTLE (53217-159-90)

Store at 25°C (77°F). Excursions permitted to 15° — 30°C (59° — 86°F) [See USP Controlled Room Temperature].

Keep tamsulosin hydrochloride capsules USP and all medicines out of reach of children.

Repackaged by

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Hypotension

Advise the patient about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when taking tamsulosin hydrochloride capsules USP, and they should be cautioned about driving, operating machinery or performing hazardous tasks [see Warnings and Precautions (5.1)].

  • Drug Interactions

Advise the patient that tamsulosin hydrochloride capsules USP, should not be used in combination with strong inhibitors of CYP3A4 [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

  • Priapism

Advise the patient about the possibility of priapism as a result of treatment with tamsulosin hydrochloride capsules USP and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [see Warnings and Precautions (5.3)].

  • Screening for Prostate Cancer

Prostate cancer and BPH frequently co-exist; therefore, screen patients for the presence of prostate cancer prior to treatment with tamsulosin hydrochloride capsules USP and at regular intervals afterwards [see Warnings and Precautions (5.4)].

  • Intraoperative Floppy Iris Syndrome

Advise the patient when considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloride capsules USP [see Warnings and Precautions (5.5)].

  • Administration

Advise the patient that tamsulosin hydrochloride capsules USP should not be crushed, chewed, or opened [see Dosage and Administration (2)].

  • FDA-approved Patient Labeling

Patient labeling is provided as a tear-off leaflet at the end of this prescribing information.

Manufactured by:
Rottendorf Pharma GmbH
Ennigerloh, Germany
Made in Germany

or

Synthon Hispania, S.L.
Barcelona, Spain
Made in Spain

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised — May 2015

PI-5017-7 (PPI-5018-7)

40-9209

PATIENT INFORMATION

Tamsulosin hydrochloride capsules USP,

0.4 mg

Read the Patient Information that comes with tamsulosin hydrochloride capsules USP before you start taking it and each time you refill your prescription. The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment.

What are tamsulosin hydrochloride capsules USP?

Tamsulosin hydrochloride capsules USP are a prescription alpha-blocker medicine used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition your doctor may refer to as an enlarged prostate.

  • Tamsulosin hydrochloride capsules USP are not for women.
  • Tamsulosin hydrochloride capsules USP are not for children.

Who should not take tamsulosin hydrochloride capsules USP?

Do not take tamsulosin hydrochloride capsules USP if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in tamsulosin hydrochloride capsules USP.

What should I tell my doctor before using tamsulosin hydrochloride capsules USP?

Before taking tamsulosin hydrochloride capsules USP, tell your doctor about all your medical conditions, including:

  • any kidney or liver problems.
  • any history of low blood pressure.
  • any allergies to sulfa or any other medicines.
  • if you are planning to have cataract or glaucoma surgery.

Tell your doctor about all the medicines you take, including:

  • any prescription medicines, including blood pressure medicines.
  • any non-prescription medicines, including vitamins and herbal supplements.

Some of your other medicines may affect the way tamsulosin hydrochloride capsules USP work. Especially tell your doctor if you take a medicine for high blood pressure. You should not take tamsulosin hydrochloride capsules USP if you are already taking certain blood pressure medicines.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take tamsulosin hydrochloride capsules USP?

  • Take tamsulosin hydrochloride capsules USP exactly as prescribed by your doctor.
  • Do not crush, chew, or open tamsulosin hydrochloride capsules USP.
  • Take tamsulosin hydrochloride capsules USP one time each day, about 30 minutes after the same meal each day. For example, you may take tamsulosin hydrochloride capsules USP 30 minutes after dinner each day.
  • If you miss a dose of tamsulosin hydrochloride capsules USP, take it as soon as you remember. If you miss your dose for the whole day, continue with your next dose on your regular schedule. Do not take two doses at the same time.
  • If you stop or forget to take tamsulosin hydrochloride capsules USP for several days, talk with your doctor before starting again.
  • If you take more tamsulosin hydrochloride capsules USP than prescribed, call your doctor right away.

What are the possible side effects of tamsulosin hydrochloride capsules USP?

Possible side effects of tamsulosin hydrochloride capsules USP may include:

  • Decreased blood pressure when changing positions. Tamsulosin hydrochloride capsules USP may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses.

    Symptoms may include:

    • fainting
    • dizziness
    • lightheadedness

Change positions slowly from lying down to sitting up or from a sitting to a standing position until you learn how you react to tamsulosin hydrochloride capsules USP. If you begin to feel dizzy, sit or lie down until you feel better. If the symptoms are severe or do not improve, call your doctor.

  • Allergic reactions. Make your doctor aware of any allergic reactions you may experience while taking tamsulosin hydrochloride capsules USP.

    Allergic reactions may include:

  • rash
  • itching
  • hives

Rare and more serious allergic reactions may also occur. Get medical help right away if you have any of the following reactions:

  • swelling of face, tongue, or throat
  • difficulty breathing
  • blistering of the skin
  • A painful erection that will not go away. Tamsulosin hydrochloride capsules USP can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.
  • Eye problems during cataract or glaucoma surgery. During cataract or glaucoma surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken tamsulosin hydrochloride capsules USP. If you need to have cataract or glaucoma surgery, be sure to tell your surgeon if you take or have taken tamsulosin hydrochloride capsules USP.

Common side effects of tamsulosin hydrochloride capsules USP may include:

  • runny nose
  • dizziness
  • decreased semen

These are not all the possible side effects with tamsulosin hydrochloride capsules USP. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

What should I avoid while taking tamsulosin hydrochloride capsules USP?

Avoid driving, operating machinery, or other dangerous activities, until you know how tamsulosin hydrochloride capsules USP affect you. Tamsulosin hydrochloride capsules USP may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses. See “What are the possible side effects of tamsulosin hydrochloride capsules USP?

How do I store tamsulosin hydrochloride capsules USP?

Store tamsulosin hydrochloride capsules USP at Room Temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C )] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules.

Keep tamsulosin hydrochloride capsules USP and all medicines out of the reach of children.

General information

This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition. Do not give tamsulosin hydrochloride capsules USP to other people, even if they have the same symptoms that you have. It may harm them.

While taking tamsulosin hydrochloride capsules USP, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.

BPH can occur with other more serious conditions, including prostate cancer. Therefore, ask your doctor about screening for prostate cancer prior to treatment with tamsulosin hydrochloride capsules USP and at regular intervals afterwards.

This patient information leaflet summarizes the most important information about tamsulosin hydrochloride capsules USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about tamsulosin hydrochloride capsules USP that is written for health professionals. For more information call Actavis at 1-800-432-8534.

What are the ingredients in tamsulosin hydrochloride capsules USP?

Active Ingredient: tamsulosin hydrochloride

Inactive Ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n -butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac.

Manufactured by:
Rottendorf Pharma GmbH
Ennigerloh, Germany
Made in Germany

or

Synthon Hispania, S.L.
Barcelona, Spain
Made in Spain

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

PPI-5018-7

40-9209

Revised — May 2015

(PPI-41-1188/0515)

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