Tamnic 400 micrograms Modified-release Capsules, hard

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Tamsulosin hydrochloride

Предлага се от:

Clonmel Healthcare Ltd

АТС код:

G04CA; G04CA02

INN (Международно Name):

Tamsulosin hydrochloride

дозиране:

400 microgram(s)

Лекарствена форма:

Modified-release capsule, hard

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Alpha-adrenoreceptor antagonists; tamsulosin

Статус Оторизация:

Marketed

Дата Оторизация:

2006-04-28

Листовка

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMNIC 400 MICROGRAMS MODIFIED-RELEASE CAPSULES, HARD
Tamsulosin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Tamnic 400 micrograms is and what it is used for
2. What you need to know before you take Tamnic 400 micrograms
3. How to take Tamnic 400 micrograms
4. Possible side effects
5. How to store Tamnic 400 micrograms
6. Contents of the pack and other information
1. WHAT TAMNIC 400 MICROGRAMS IS AND WHAT IT IS USED FOR
Tamsulosin is an α
1A
-adrenoreceptor blocker. It relaxes the muscles in the prostate and
urinary tract.
Tamsulosin is prescribed to alleviate urinary symptoms caused by an
enlarged prostate (benign
prostatic hyperplasia). By relaxing the muscle it enables a more
easily pass of urine and helps
urination.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMNIC 400 MICROGRAMS
DO NOT TAKE TAMNIC 400 MICROGRAMS IF YOU:
•
Are allergic to tamsulosin or any of the other ingredients of this
medicine listed in section 6
[symptoms may include: swelling of your face and throat (angioedema)].
•
Have a history of a fall in blood pressure on standing up, which
causes dizziness, light-
headedness or fainting.
•
Have severe liver problems.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Tamnic 400 micrograms:
•
Experience dizziness or light-headedness, especially after standing
up. Tamnic 400 micrograms
may lower your blood pressure, causing these symptoms. You should sit
or lie down un

Данни за продукта

Health Products Regulatory Authority
23 October 2020
CRN009WTY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamnic 400 micrograms Modified-release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.4 mg of tamsulosin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release capsule, hard.
Orange/olive-green capsule.
The capsules contain white to off-white pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lower urinary tract symptoms (LUTS) associated with benign prostatic
hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One capsule a day after breakfast or the first meal of the day. The
capsule is swallowed whole with a glass of water while
standing or sitting (not lying down). The capsule should not be broken
or pulled apart as this may have an effect on the release
of the long-acting active ingredient.
Paediatric population
The safety and efficacy of tamsulosin in children < 18 years have not
been established. Currently available data are described in
section 5.1.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance, including drug-induced
angioedema, or to any of the excipients listed in
section 6.1.

A history of orthostatic hypotension.

Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
1
-adrenoceptors antagonists, a reduction in blood pressure can occur in
individual cases during treatment with
tamsulosin, as a result of which, rarely, syncope can occur. At the
first signs of orthostatic hypotension (dizziness, weakness),
the patient should sit or lie down until the symptoms have
disappeared.
The patient should be examined before commencement of therapy with
tamsulosin to exclude the presence of other
conditions that can produce similar symptoms to those of BPH. The
prostate should be examined via the rectum and, if
necessary, the PSA count determined prior to commencement of treatment
and again later at regular in