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FARAMSIL 400 MICROGRAM PROLONGED-RELEASE TABLETS

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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SZ00000LT000

PACKAGE LEAFLET: INFORMATION FOR THE USER

Faramsil 400 microgram Prolonged-release Tablets
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 Faramsil is and what it is used for
2. What you need to know before you take Faramsil
3. How to take Faramsil
4. Possible side effects
5. How to store Faramsil
6. Contents of the pack and other information

1.

What Faramsil is and what it is
used for

Faramsil contains the active substance tamsulosin
hydrochloride, which belongs to a group of
medicines called alpha adrenoceptor blockers.
Faramsil relaxes:
• the muscles in the prostate gland, and
• the tube from the bladder to the outside (the urethra).
This lets urine pass more easily through the urethra,
making it easier to urinate.
Faramsil is for men who have benign prostate
enlargement (benign prostatic hyperplasia, BPH).
This is when the prostate gland increases in size.
This can make it difficult to pass urine. This means
you may have to pass urine often or during the night.
You may also feel that you still need to pass urine
even after having done so. You may also dribble
after passing urine.

2.

What you need to know before you
take Faramsil

Do not take Faramsil if
• you are allergic to tamsulosin or any of the other
ingredients of this medicine (listed in section 6)
• you have a serious liver problem.
• you feel dizzy or faint when you suddenly sit or
stand up.
Warnings and precautions
Talk to your doctor before taking tamsulosin
• if you have a serious kidney problem.
As with other medicines in the same group, dizziness
can occur in individual cases, when taking Faramsil.
If you feel weak or dizzy, when taking Faramsil, you
should sit or lie down straight away until the
symptoms have disappeared.

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Before you start taking Faramsil your doctor may
need to examine you. This is to check that you do
not have another condition with the same symptoms
as BPH. Your doctor may also use a blood test before
you start taking the medicine. These tests may continue
afterwards, to see how the medicine is working.

If you are undergoing eye surgery because of
cloudiness of the lens (cataract) or increased
pressure in the eye (glaucoma), please inform your
eye specialist that you are using or have previously
used tamsulosin. The specialist can then take
appropriate precautions with respect to medication
and surgical techniques to be used. Ask your doctor
whether or not you should postpone or temporarily
stop taking this medicine when undergoing eye
surgery because of a cloudy lens (cataract) or
increased pressure in the eye (glaucoma).
Children
Do not give this medicine to children or adolescents
under 18 years because it does not work in this
population.
Other medicines and Faramsil
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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
Please inform your doctor that you are on Faramsil
before any operation or dental procedure as there is
a potential that your medicine may interfere with the
effects of the anaesthetic.
Faramsil with food and drink
Faramsil can be taken independently of food.
Pregnancy, breast-feeding and fertility
Tamsulosin is not indicated for use in 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
No studies on the effects on the ability to drive and
use machines have been performed. However you
should be aware of the fact that drowsiness, blurred
vision, dizziness and fainting can occur. If you feel
weak or dizzy, do not drive or use machines.
Faramsil contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3.

How to take Faramsil

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure. The recommended dose is one tablet
each day. It can be taken with or without food.
Swallow the tablet whole. Do not crush or chew it.
If you take more Faramsil than you should
• Talk to your doctor or pharmacist or go to the
nearest hospital straight away.
Continued on the next page >>

• Take this leaflet and any of the remaining tablets
with you.
Taking too much Faramsil may make you feel dizzy
or faint and cause headache.
If you forget to take Faramsil
If you forget to take your Faramsil at your usual time,
take it later the same day.
If you miss a whole day, just take your normal tablet
the next day. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Faramsil
If you stop taking Faramsil your original symptoms
may return. You should keep taking Faramsil as
advised by your doctor, even if your symptoms have
gone away. Always talk to your doctor if you are
thinking about stopping taking this medicine.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
You should contact your doctor immediately if
you notice any of the following side effects (it
may be an allergic reaction):
• lumpy skin rash (urticaria)
• swollen feet, hands, lips, tongue or throat and
difficulty breathing.
Stop taking this medicine and see a doctor
straight away if you experience any of the
following symptoms - you may need medical
treatment:
• serious illness with blistering of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome)
• rash, inflammation and blistering of the skin
(erythema multiforme, dermatitis exfoliative)
If you feel weak or dizzy, when taking Faramsil,
you should sit or lie down straight away until the
symptoms have disappeared.
Common (may affect up to 1 in 10 people):
• feeling dizzy
• abnormal ejaculation (ejaculation disorder). This
means that 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.
Uncommon (may affect up to 1 in 100 people):
• headache
• fast or uneven heart beat (palpitations)
• a fall in blood pressure on standing up which
causes dizziness, light-headedness or fainting
• runny or blocked nose
• feeling sick or being sick
• diarrhoea or constipation
• allergic reactions (skin rash, itchy or inflamed skin)
• feeling weak.
Rare (may affect up to 1 in 1,000 people):
• fainting
Very rare (may affect up to 1 in 10,000 people):
• long-lasting and painful erection (priapism),
normally not during sexual activity

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Not known (frequency cannot be estimated from the
available data):
• irregular heart beat, faster heart beat
• shortness of breath
• vision blurred, visual impairment
• bleeding from the nose
• dry mouth

As with other medicines that belong to the same
group (alpha-blockers), Faramsil can also cause
drowsiness, blurred vision, dry mouth or oedema.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the
national reporting system the Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting side
affects you can help provide more information on the
safety of this medicine.

5.

How to store Faramsil

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store in the original package.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6.

Contents of the pack and other
information

What Faramsil contains
• The active substance is 0.4 mg tamsulosin
hydrochloride.
• The other ingredients are:
- Tablet core: cellulose, microcrystalline,
hydroxypropylcellulose, lactose monohydrate,
polyethylene oxide, butylhydroxytoluene,
magnesium stearate, silica, colloidal anhydrous
- Tablet film-coating: hypromellose,
hydroxypropylcellulose, macrogol 400, titanium
dioxide (E171), talc, quinoline yellow (E104),
carmine (E120), iron oxide, black (E172).
What Faramsil looks like and contents of the
pack
Faramsil 400 microgram Prolonged-release Tablets
are brown, round, bi-convex film-coated tablets
marked “0.4” on one side and “SZ” on the other side.
Faramsil is packed in aluminium/aluminium blisters:
10, 14, 20, 28, 30, 50, 56, 60, 80, 90, 100 or 200
film-coated prolonged-release tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d., Verovskova 57, 1526
Ljubljana, Slovenia or
Lek Pharmaceuticals d.d., Trimlini 2D, 9220
Lendava, Slovenia or
Salutas Pharma GmbH, Otto-von-Guericke Allee 1,
39179 Barleben, Germany or
Salutas Pharma GmbH, Dieselstrasse 5, 70839
Gerlingen, Germany or
Lek S.A., Ul. Domaniewska 50C, 02- 672 Warszawa,
Poland.
This leaflet was last revised in 08/2015

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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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