Sulotam

Patient Information Leaflet

SULOTAM 0.4 mg modified-release hard capsules

tamsulosin hydrochloride
Equivalent medicinal product
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 SULOTAM is and what it is used for

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

2. What you need to know before taking SULOTAM

Do not take SULOTAM

• if you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of soft body tissues (e.g. throat or tongue), breathing difficulties and/or itching and skin rash (angioedema);
• if you have severe liver problems (severe hepatic insufficiency);
• if you experience dizziness and fainting upon standing, 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 caution and inform your doctor in the following cases:

• if you have severe kidney problems;
• if you are scheduled for eye surgery (cataract or glaucoma), as complications may occur (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 other conditions that may cause the same symptoms as benign prostatic hyperplasia (enlarged prostate).
These tests include digital rectal examination and a blood test to determine the level of prostate-specific antigen (PSA). Your doctor will evaluate your symptoms and their possible causes. If in doubt, ask your doctor for further information.
During treatment with this medicine, as with other medicines of this type, you may experience faintness due to low blood pressure. At the first signs of dizziness or weakness, you should sit or lie down until symptoms subside.
Children and adolescents
The use of this medicine is not indicated in children and adolescents under 18 years of age.
Other medicines and SULOTAM
Inform 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 may accelerate the elimination of tamsulosin from the body, reducing its effectiveness;
• warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, reducing its effectiveness;
• ketoconazole, a medicine used to treat fungal skin infections. This medicine may increase the effect of tamsulosin;
• paroxetine, a medicine used to treat depression. This medicine may increase the effect of tamsulosin;
• other medicines similar to tamsulosin (alpha-1A adrenergic receptor blockers). The combination may lower blood pressure (hypotension);
• medicines that increase tamsulosin levels 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 intended for male use only and must not be taken by women.
Clinical studies and post-marketing data have shown ejaculation disorders in patients treated with tamsulosin for short and long periods.
This means that seminal fluid does not exit the body through the urethra but enters the bladder (retrograde ejaculation) or that the volume of ejaculation is reduced or absent (absence of ejaculation).
This event is harmless.
Driving and using machines
The use of SULOTAM should not affect the ability to drive or operate machinery.
However, you should be aware that dizziness and vertigo may occur; in such cases, avoid driving or operating machinery.
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 exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule daily, taken in the morning after breakfast or after the
first meal of the day.
Swallow the capsule whole with some water, without chewing or crushing it.
Use in patients with mild to moderate renal or hepatic impairment
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, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may 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 on the
same day after eating something. If the day has already passed, simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for a forgotten dose.
If you stop taking SULOTAM
When treatment with SULOTAM is stopped prematurely, initial symptoms may reappear. Therefore, continue taking SULOTAM for the full duration prescribed by your doctor, even if your symptoms have already disappeared. Always consult your doctor if you think this treatment should be discontinued.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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;
• sensation of rapid heartbeat (palpitations);
• dizziness when standing up, due to a drop in blood pressure (orthostatic hypotension);
• nasal irritation (rhinitis);
• constipation, diarrhoea, nausea and vomiting;
• skin irritation such as rash and urticaria, itching;
• feeling of weakness (asthenia).

Rare (may affect up to 1 in 1,000 people):

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

Very rare (may affect up to 1 in 10,000 people):

• severe skin inflammation with blistering on lips, eyes, mouth, nose or genitals (Stevens-Johnson syndrome);
• painful, prolonged and involuntary erection requiring immediate medical treatment (priapism).

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

• blurred vision and other vision problems;
• nosebleeds (epistaxis);
• dry mouth;
• multiple skin rashes (erythema multiforme);
• inflamed, dry or peeling skin (exfoliative dermatitis);
• changes in heart rhythm (atrial fibrillation, arrhythmia, tachycardia);
• breathing difficulties (dyspnoea);
• a condition called “intraoperative floppy iris syndrome” (IFIS), in which the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy. This may cause complications if you undergo eye surgery (cataract or glaucoma surgery).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the packaging after "EXP".
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SULOTAM contains

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triacetin, talc, calcium stearate.
• Components of the outer capsule shell: 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, 30 or 40 modified-release hard capsules in blisters.
Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EBERLIFE FARMACEUTICI S.p.A., Via G. Porzio snc, 80143 Naples, Italy
Manufacturer
Special Product’s Line S.p.A, Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (Frosinone)