SULOTAM 0.4 mg Modified-release hard capsule

Зміст інструкції

1. SULOTAM 0.4 mg modified-release hard capsules
   1. What is SULOTAM and what is it used for
   2. What you need to know before you take SULOTAM
   3. How to take SULOTAM
   4. Possible side effects
   5. How to store SULOTAM
   6. Contents of the pack and other information

SULOTAM 0.4 mg modified-release hard capsules

tamsulosin hydrochloride
Generic medicine

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is SULOTAM and what is it used for

SULOTAM contains the active ingredient tamsulosin, belonging to the class of medicines called
alpha 1 adrenergic receptor antagonists, which work by reducing muscle tension in the prostate and
urethra, facilitating the passage of urine (urination) and decreasing the sensation of urgency to
urinate.
SULOTAM is used in men for the treatment of lower urinary tract symptoms associated with
an enlarged prostate (benign prostatic hyperplasia). These disorders may include
difficulty urinating (reduced stream), dribbling, urgency and increased frequency of
urination both during the day and at night.

2. What you need to know before you take SULOTAM

Do not take SULOTAM

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden local swelling of soft tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema);
• if you suffer from severe liver problems (severe hepatic insufficiency);
• if you experience a feeling of dizziness and fainting when you stand up, caused by a drop in blood pressure (orthostatic hypotension).

Warnings and precautions
Talk to your doctor or pharmacist before taking SULOTAM.
Take this medicine with cautionand inform your doctor in the following cases:

• if you suffer from severe kidney problems;
• if you are going to undergo eye surgery (cataract and glaucoma), because complications may arise (see section “Possible side effects”).

Before starting treatment with SULOTAM, and periodically during treatment, your doctor will likely perform some simple tests to rule out the presence of other conditions that
can cause the same symptoms as benign prostatic hyperplasia (enlarged prostate).
These tests include a digital rectal examination and a blood test to determine the level
of prostate-specific antigen (PSA). The doctor will assess your symptoms and their possible causes. If
you have any doubts, ask your doctor for all the information.
During treatment with this medicine, as with other medicines of this type, you may
experience a feeling of fainting due to a drop in blood pressure. At the first signs
of dizziness or weakness, you should sit or lie down until they disappear.

Children and adolescents
The use of this medicine is not indicated in children and adolescents up to 18 years of age.

Other medicines and SULOTAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• diclofenac, used to treat pain and inflammation. This medicine can accelerate the elimination of tamsulosin from the body, reducing its effectiveness;
• warfarin, a medicine used to prevent blood clotting. This medicine can accelerate the elimination of tamsulosin from the body, reducing its effectiveness;
• ketoconazole,a medicine used to treat skin infections caused by fungi. This medicine can increase the effect of tamsulosin;
• paroxetine, a medicine used to treat depression. This medicine can increase the effect of tamsulosin;
• other medicines similar to tamsulosin (alpha 1A adrenoceptor blockers). The combination may lower blood pressure (hypotension);
• medicines that increase the levels of tamsulosin in the blood (strong CYP3A4 inhibitors).

SULOTAM with food and drink
SULOTAM should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
SULOTAM is for exclusive use by men and should not be taken by women.
Clinical and post-marketing studies have shown ejaculatory disorders in patients treated
for short and long periods with tamsulosin.
This means that the seminal fluid does not exit the body through the urethra but enters the bladder
(retrograde ejaculation) or that the volume of ejaculate is reduced or absent (anejaculation).
This event is harmless.

Driving and using machines
The use of SULOTAM should not affect the ability to drive vehicles and use
machinery. However, you should be aware of the possibility of dizziness and vertigo; in
such cases, avoid driving vehicles.

SULOTAM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take SULOTAM

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended doseis 1 capsule a day to be taken in the morning, after breakfast or after the
first meal of the day.
Swallow the capsule whole with a little water, without chewing or crushing it.

Use in patients with mild to moderate reduced renal and hepatic function
No dose adjustment is required.

If you take more SULOTAM than you should
If you (or someone else) have taken an excessive dose of SULOTAM or if you think a child may
have taken this medicine, inform your doctor immediately or go to the Emergency Room
of the nearest hospital.
An overdose can cause a severe drop in blood pressure.

If you forget to take SULOTAM
If you have forgotten to take the capsule after the first meal of the day, take it later in the
same day after eating something. If the day has already passed, simply
continue to take your daily capsule as prescribed. Do not take a double doseto make up for
a missed dose.

If you stop taking SULOTAM
When treatment with SULOTAM is stopped prematurely, the initial symptoms may reappear.
Therefore, continue to take SULOTAM for the entire period of time prescribed by your doctor,
even if your symptoms have already disappeared. Always consult your doctor if you believe this therapy
should be stopped.
If you have any doubts about 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 everyone will experience them.
Contact your doctor if you experience any of the following side effects:

Common(may affect up to 1 in 10 people):

• dizziness;
• ejaculation disorders.

Uncommon(may affect up to 1 in 100 people):

• headache;
• feeling of a fast heartbeat (palpitations);
• feeling of lightheadedness when standing up, due to a drop in blood pressure (orthostatic hypotension);
• nasal irritation (rhinitis);
• constipation, diarrhea, nausea and vomiting;
• skin irritation such as rash and hives, itching;
• feeling of weakness (asthenia).

Rare(may affect up to 1 in 1000 people):

• feeling of fainting (syncope);
• allergic reaction characterized by swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing, which can be life-threatening (angioedema).

Very rare(may affect up to 1 in 10000 people):

• severe skin inflammation with blister formation on lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome);
• involuntary, painful and prolonged erection that requires immediate medical treatment (priapism).

Frequency not known(the frequency cannot be estimated from the available data):

• blurred vision and other visual problems;
• nosebleeds (epistaxis);
• dry mouth;
• multiple skin rashes (erythema multiforme);
• inflamed, dry or flaky skin (exfoliative dermatitis);
• irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia);
• difficulty breathing (dyspnea);
• a condition called “intraoperative floppy iris syndrome” (IFIS), where the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy. This can cause complications if you need to undergo eye surgery (cataract or glaucoma).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store SULOTAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SULOTAM contains

• The active ingredient is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triacetin, talc, calcium stearate.
• The components of the external capsule are: gelatin, titanium dioxide (E 171), indigotine (E 132), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of SULOTAM and contents of the pack
Each pack contains 20 modified-release hard capsules, in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
EBERLIFE FARMACEUTICI S.p.A., Via G. Porzio snc, 80143 Napoli, Italy

Manufacturer
Special Product’s Line S.p.A, Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (Frosinone)