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MORVESIN 400 MICROGRAM SR CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Morvesin 400 microgram SR Capsules
Tamsulosin hydrochloride

Read all of this leaflet carefully before you
start using 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. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet:
1. What Morvesin is and what it is used for
2. What you need to know before you take
Morvesin
3. How to take Morvesin
4. Possible side effects
5. How to store Morvesin
6. Contents of the pack and other information

1. WHAT MORVESIN IS AND WHAT IT
IS USED FOR

The active substance of Morvesin is tamsulosin.
This is an alpha-1-receptor blocker that reduces
the ability to contract the muscles in the prostate
and urethra. As a result, the urethra, which runs
through the prostate, is less constricted so that
urinating is easier. In addition, it diminishes
sensations of urge.

Morvesin is used by men for the treatment of
complaints in the lower urinary tract that occur in
benign prostate enlargement. These complaints
may include difficulty urinating (poor stream),
dribbling, urgency and having to urinate frequently
at night as well as during the day.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE MORVESIN

Do not take Morvesin
• If you are allergic (hypersensitive) to tamsulosin
or any of the other ingredients of Morvesin.
• If you have a serious liver problems if you suffer
from fainting due to reduced blood pressure
when changing posture (going to sit or stand up).

Warnings and precautions
• Periodic medical examinations are necessary to
monitor the development of the condition you
are being treated for.
• If you suffer from a serious kidney problems.
• In rare cases during the use of Morvesin,
fainting may occur on sitting up straight or
standing. If you start to feel dizzy or weak you
must lie down or sit down until it has passed.
• Before therapy with Morvesin is initiated, you
should be evaluated by your doctor in order to
exclude the presence of other conditions which
can cause the same symptoms as benign
(harmless) prostate enlargement. Your doctor
will likely to examine your prostate gland
manually (done by hands) to detect
abnormalities and may measure a chemical
substance produced by the prostate (prostate
specific antigen, PSA) in your blood before
treatment and at regular intervals afterwards.
• In rare occasions, severe allergic reaction with
swelling of the face, lips, tongue and throat
which may cause difficulty in breathing,
speaking or swallowing (angio-oedema) may
occur. If this happens, you should stop taking

Morvesin immediately and contact your doctor.
• If you are undergoing or have been scheduled
for eye surgery because of cataract (cloudiness
of the lens) or increased pressure in the eye
(glaucoma), please inform your eye specialist
before the operation that you are using or have
previously used, are using, or are planning to
use tamsulosin. This is because Morvesin may
cause complications during the surgery which
can be managed if your specialist is prepared in
advance
Consult your doctor if the above-mentioned
warning is applicable to you, or has been in the
past.
Children
Do not give this medicine to children or
adolescent under 18 years because it does not
work in this population.

Other medicines and Morvesin
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you
are taking:
• Medicines that lower your blood pressure such
as verapamil and diltiazem.
• Medicines to treat HIV such as ritonavir or
indinavir.
• Medicines to treat a fungal infection such as
ketaconazole or itraconazole.
• Other alpha blockers such as doxazosin,
indoramin, prazosin or alfuzosin.
• Erythromycin, an antibiotic used to treat
infections.

Taking Morvesin with food and drink
You should take the capsule after breakfast, or the
first meal of the day.
Pregnancy, breast-feeding and fertility
Morvesin is not intended for use by women.
In men, abnormal ejaculation has been reported
(ejaculation disorder). This means that the semen
does not leave the body via the urethra, but
instead goes into the bladder (retrograde
ejaculation) or the ejaculation volume is reduced
or absent (ejaculation failure). This phenomenon
is harmless.
Driving and using machines
There is no evidence that Morvesin affects the
ability to drive or to operate machinery or
equipment. You should take into account the
possibility that Morvesin may cause dizziness. In
that case you should not drive vehicles and/or
operate machinery that requires concentration.

3. HOW TO TAKE MORVESIN
Always take Morvesin exactly as your doctor has
told you to. You should check with your doctor or
pharmacist if you are not sure. The usual
recommended dose is one capsule per day taken
orally. Take the capsule after breakfast, or the first
meal of the day. Swallow the capsule whole with
some water while standing or sitting (not lying
down). Do not chew or break the capsule.
Usually, Morvesin is prescribed for long periods of
time. The effects on the bladder and on urination
are maintained during long-term treatment with
Morvesin.
Follow these instructions unless otherwise
indicated by your doctor. Remember to take your
medication. Your doctor will indicate the duration
of your treatment with Morvesin.
Continued on the next page >>

If you take more Morvesin than you should
If you take more Morvesin than you should,
consult your doctor or pharmacist or go to the
local hospital accident and emergency department
immediately and take this leaflet and any other
remaining capsules.
Symptoms of Morvesin overdose may include
dizziness, fainting and headache.
If you forget to take Morvesin
If you forget to take your daily Morvesin after
breakfast or first meal of the day, you can take it
later the same day after another meal. If you miss
a whole day, just continue to take your normal
daily dose the next day after breakfast or first
meal of the day. Do not take a double dose to
make up for the dose that you missed.
If you stop taking Morvesin
If the treatment with Morvesin is stopped earlier
than recommended, then the original symptoms
may return. For this reason, use Morvesin for the
duration of your treatment, as recommended by
your doctor even though your symptoms may,
have disappeared.
Always consult your doctor if you are considering
to stop taking the medicine.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Morvesin can cause side
effects, although not everybody gets them.

Contact your doctor or hospital immediately if
you notice any of the following rare serious
side effects (it may be an allergic reaction):
rash, itching, inflamed or reddened skin
(especially affecting the whole body); swelling of
the face, lips, tongue or throat which may cause
difficulty in swallowing or breathing
(angio-oedema).
The following side effects have been reported
during the use of Tamsulosin Hydrochloride:
Common (may affect up to 1 in 10 people)
• dizziness, abnormal ejaculation.

Uncommon (may affect up to 1 in 100 people)
• headache
• feeling your heart beat
• orthostatic hypotension (experience dizziness
caused by low blood pressure after sitting or
standing up)
• runny or blocked nose (rhinitis)
• feeling sick and being sick, diarrhoea and
constipation
• allergic reactions such as skin rash, itching and
local inflammation
• weakness.
Rare (may affect up to 1 in 1,000 people)
• fainting
• generalized hives

Very rare (may affect up to 1 in 10,000 people)
• priapism (persistent and painful erection of the
penis without sexual stimulus which requires
immediate medical attention)
• serious illness with blistering of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome)

Not known (Frequency cannot be estimated from
the available data)
Vision blurred, visual impairment, bleeding from
the nose, rash, inflammation and blistering of the
skin (erythema multiforme, dermatitis exfoliative),
irregular heart beat, faster heart beat, shortness of
breath, dry mouth.
If you may undergo a cataract or glaucoma
surgery while you are taking or have taken
tamsulosin, your pupil may not correctly dilate and
the iris (the coloured part of the eye) may become
floppy (see also
section “Take special care with Morvesin”.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE MORVESIN
Keep out of the sight and reach of children.
Store below 30ºC.

Do not use Morvesin after the expiry date which is
stated on the carton box after EXP.: The expiry
date refers to the last day of that month.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION

What Morvesin contains
The active substance is tamsulosin
hydrochloride.
Each capsules contains 0.4 mg tamsulosin
hydrochloride.

The other ingredients are:
Content of the capsules: microcrystalline cellulose
(E460), Polyacrylate, Metacrylic acid-ethyl
acrylate copolymer (1:1), polysorbate 80 (E433),
sodium laurilsulfate, talc (E553b), colloidal
anhydrous silica (E551).

The capsule shell contains gelatine (E441), patent
blue V (E131), titanium dioxide (E171), yellow red
and black iron oxide (E172).

What Morvesin looks like and contents of the
pack
Morvesin are light green/yellow capsules. The
capsules contain white to slightly yellowish pellets.

Morvesin is packed in blisters.
The capsules may be packed in the following pack
sizes:
Carton box with blister(s) containing: 10, 20, 28,
30, 50, 56, 60, 90 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia
or

Salutas Pharma GmbH,
Otto von Guericke Allee 1,
39179 Barleben,
Germany
or

Lek S.A.,
Ul. Domaniewska 50C,
02-672 Warzawa,
Poland.

This leaflet is last revised in 03/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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