Package leaflet: Information for the user

BOTAM 0.4 mg modified release capsules

Tamsulosin hydrochloride
Equivalent medicine
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 pass it on to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See Section 4.

Contents of this leaflet:

What BOTAM is and what it is used for
What you need to know before taking BOTAM
How to take BOTAM
Possible side effects
How to store BOTAM
Contents of the pack and other information

1. What BOTAM is and what it is used for

BOTAM contains as its active substance tamsulosin, an alpha-adrenoceptor blocker that
relaxes the smooth muscle of the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by prostate enlargement
(benign prostatic hyperplasia). By relaxing the smooth muscle, it allows easier passage of
urine and thus improves urination.

2. What you need to know before taking BOTAM

Do not take BOTAM if:

you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6);
you suffer from low blood pressure upon standing (orthostatic hypotension);
you have severe liver problems (hepatic insufficiency).

Warnings and precautions:
Talk to your doctor or pharmacist before taking BOTAM:

if you experience dizziness or weakness, especially after standing up. Tamsulosin may lower blood pressure, causing these symptoms. In such cases, you should sit or lie down until symptoms disappear;
if you have severe kidney problems;
if you are scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma). You may develop a condition affecting the eyes called intraoperative floppy iris syndrome (see section 4, Possible side effects). Inform your ophthalmologist if you are currently taking or have previously taken tamsulosin hydrochloride. In such cases, the specialist may take appropriate precautions regarding the medication and surgical techniques to be used. Ask your doctor whether you should delay or temporarily stop taking this medicine before undergoing cataract or glaucoma surgery.
Before starting treatment with tamsulosin, your doctor should examine you to confirm that your symptoms are indeed caused by an enlarged prostate.

Children and adolescents
Do not administer this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and BOTAM
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those without a prescription.

Tamsulosin may affect the action of other medicines, and conversely, other medicines may affect the action of tamsulosin. Therefore, it is important to inform your doctor if you are taking:

medicines to lower blood pressure (e.g., verapamil and diltiazem);
medicines for the treatment of HIV (e.g., ritonavir or saquinavir);
medicines for the treatment of fungal infections (e.g., ketoconazole, itraconazole, voriconazole, or fluconazole);
medicines affecting blood coagulation (e.g., warfarin);
anti-inflammatory medicines (e.g., diclofenac);
medicines for the treatment of infections (e.g., erythromycin, clarithromycin);
immunosuppressants (e.g., cyclosporine).

Taking Botam together with other medicines belonging to the same class (α1-adrenoreceptor antagonists) may cause a drop in blood pressure.

Taking BOTAM with food and drink
You should take tamsulosin with a glass of water after breakfast or after the first meal of the day.

Fertility, pregnancy and breastfeeding
BOTAM is not indicated for use in women.

In men, ejaculation abnormalities (ejaculation disorders) have been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (inadequate ejaculation).

Driving and using machines
There is no information available on the effects of tamsulosin on the ability to drive vehicles or operate machinery. You should bear in mind that this medicine may cause dizziness and confusion; therefore, drive or operate machinery only if you feel well.

3. How to take BOTAM

Take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The usual dose is one capsule daily, taken after breakfast or after the first meal of the day.
Swallow the capsule whole with a glass of water, while sitting or standing upright (not lying down).
It is important not to break or crush the capsule, so as not to interfere with the release of
tamsulosin.
If you have renal impairment or mild to moderate hepatic insufficiency, your doctor will prescribe
the normal dose of tamsulosin.
If you take more BOTAM than you should
If you take more tamsulosin than you should, your blood pressure may suddenly drop and
you may experience dizziness, weakness, fainting, vomiting, and diarrhea.
Lie down to minimize the effects of low blood pressure and consult your doctor, who may
administer medicines to restore your blood pressure and fluid levels to normal, and monitor
your body functions.
If necessary, your doctor may empty your stomach and give you a laxative to eliminate any
tamsulosin not yet absorbed into the bloodstream.
If you forget to take BOTAM
Do not take a double dose to make up for the missed dose. Simply take the next dose at your
usual time.
If you stop taking BOTAM
When treatment with tamsulosin is stopped earlier than planned, the original symptoms may
return. Therefore, use tamsulosin for the full duration indicated by your doctor, even if the
symptoms appear to have already disappeared.
Always consult your doctor if you are considering stopping the treatment.
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.
Do not take BOTAM and contact your doctor immediately if any of the following side effects occur:

Common side effects (may affect up to 1 in 10 people)

Dizziness,
Ejaculation disorders.

Uncommon side effects (may affect up to 1 in 100 people)

Headache
Awareness of heartbeat (palpitations)
Drop in blood pressure upon standing causing dizziness, sensation of emptiness in the head or fainting (orthostatic hypotension)
Nasal swelling and irritation (rhinitis)
Constipation
Diarrhoea
Nausea
Vomiting
Rash
Hives (urticaria)
Feeling of weakness (asthenia)
Itching.

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

Sudden swelling of one or more of the following parts: hands, feet, lips, tongue, throat, which may cause difficulty breathing and/or itching, rash due to an allergic reaction (angioedema);
Fainting (syncope).

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

Pain during erection (priapism).
Skin rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

Side effects with unknown frequency (frequency cannot be estimated from available data)

Blurred vision
Visual impairment
Epistaxis (nosebleed)
Dry mouth
Severe skin rashes (erythema multiforme, exfoliative dermatitis).
During eye surgery due to lens opacity (cataract) or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate sufficiently and the iris (the coloured circular part of the eye) may flutter during surgery. For further information, see section 2, Warnings and precautions.
Irregular abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnoea).
Retrograde ejaculation; absent ejaculation.

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 the website:
“www.agenziafarmaco.gov.it/it/responsabili". By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BOTAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the blister after
'Exp'.
The expiry date refers to the last day of that month.
Store the blisters in the original packaging. Keep the container tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BOTAM contains
The active substance is tamsulosin hydrochloride 0.4 mg.
The other components are:
Microcrystalline cellulose, Methacrylic acid – ethyl acrylate copolymer (1:1), Polysorbate 80, Sodium lauryl sulfate, Triacetin, Talc, Calcium stearate.
Capsule shell: titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of BOTAM and contents of the pack
Modified-release capsules.
Supplied in packs with PVC/Al thermoformed blisters in a printed cardboard carton: 20 capsules.

Marketing Authorization Holder
S.F. Group S.r.l., Via Tiburtina 1143 – 00156 Rome

Manufacturer
FAMAR ITALIA, Via Zambeletti, 25 – Baranzate (Milan);
DOPPEL FARMACEUTICI S.r.l., Via Volturno, 4820089 Quinto de’Stampi - Rozzano (Milan);
SPECIAL PRODUCT’S LINE, Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (Frosinone)