BOTAM 0.4 mg Modified-release hard capsules

Зміст інструкції

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

BOTAM 0.4 mg modified-release capsules

Tamsulosin hydrochloride

Generic medicine
Read this leaflet carefully before using 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 BOTAM is and what it is used for
• 2. What you need to know before you take BOTAM
• 3. How to take BOTAM
• 4. Possible side effects
• 5. How to store BOTAM
• 6. Contents of the pack and other information

1. What is BOTAM and what is it used for

BOTAM contains tamsulosin as its active ingredient, an alpha-adrenergic receptor blocker that
relaxes the muscles of the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by prostate enlargement
(benign prostatic hyperplasia). By relaxing the muscles, it allows for easier passage
of urine and therefore facilitates urination.

2. What you need to know before you take BOTAM

Do not take BOTAM if:

• you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6)
• you suffer from low blood pressure when changing to an upright position;
• 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 this case, you should sit or lie down until the symptoms disappear;
• If you suffer from severe kidney problems.;
• If you are going to undergo surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma). A condition affecting the eyes called iris flag syndrome may occur (see section 4, Possible side effects); Inform your ophthalmologist if you are using or have used tamsulosin hydrochloride in the past. In this case, the specialist may take appropriate precautions regarding the drug and surgical techniques

to be applied. Ask your doctor if you should postpone or temporarily interrupt taking
this medicine before undergoing surgery for cataracts
(clouding of the lens) or increased eye pressure (glaucoma).
Before starting therapy with tamsulosin, your doctor must examine you to verify that your
symptoms are actually caused by an enlarged prostate.

Children and Adolescents
Do not give this medicine to children or adolescents under 18 years of age because it is not effective
in this population.

Other medicines and BOTAM
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those available without a prescription.
Tamsulosin can affect the action of other medicines and these, in turn, can
affect the action of tamsulosin. Therefore, it is important to inform your doctor if you are
taking:

• medicines for lowering 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 for blood clotting (e.g. warfarin);
• anti-inflammatory drugs (e.g. diclofenac);
• medicines for the treatment of infections (e.g. erythromycin, clarithromycin);
• immunosuppressants (e.g. cyclosporine).

Taking Botam with other medicines belonging to the same class (alpha 1-adrenergic receptor antagonists) can cause a decrease in blood pressure.

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

Fertility, pregnancy and breastfeeding
BOTAM is not indicated in women.
In men, abnormalities in ejaculation (ejaculation disorders) have been reported. This means
that semen does not come out through the urethra but through the bladder (retrograde ejaculation) or that
the volume of ejaculate is reduced or absent (insufficient ejaculation).

Driving and using machines
There is no information on the effects of tamsulosin on the ability to drive vehicles and
operate machinery. You should consider that this medicine can cause dizziness
and confusion, so drive or operate machinery only if you feel well.

3. How to take BOTAM

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The usual doseis one capsule a day to be taken after breakfast or after the first
meal of the day.
Swallow the capsule whole with a glass of water, in a sitting or upright position (not lying down).
It is important that you do not break or crush the capsule, in order not to interfere with the release of
tamsulosin.
If you suffer from renal impairment or mild to moderate hepatic insufficiency, your doctor will make
you take 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 drop suddenly and
you may experience dizziness, weakness, fainting, vomiting and diarrhoea.
Lie down to minimize the effects of low blood pressure and consult your doctor, who may administer
medicines to restore normal blood pressure values
and fluid levels, and monitor your body functions.
If necessary, your doctor may have your stomach emptied and administer a laxative to eliminate
all tamsulosin that has not yet entered the bloodstream.

If you forget to take BOTAM
Do not take a double dose to make up for a missed dose. Simply take
the next dose at the usual time.

If you stop taking BOTAM
When treatment with tamsulosin is stopped prematurely, the original disorders
may recur. Therefore, use tamsulosin for the entire time indicated by your doctor even if the
disorders may already seem to have disappeared.
Always consult your doctor if you think about stopping therapy.
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 everybody gets them.
Do not take BOTAM and contact your doctor immediately if any of the following 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
• Feeling of heartbeats (palpitations)
• Low blood pressure when standing up which causes dizziness, lightheadedness or fainting (orthostatic hypotension)
• Nasal congestion and irritation (rhinitis)
• Constipation
• Diarrhoea
• Nausea
• Vomiting
• Skin rash
• Hives
• Feeling of weakness (asthenia)
• Itching.

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

• Sudden swelling of one or all of the following: hands, feet, lips, tongue, throat which can 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)

• Painful 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
• Impaired vision
• Epistaxis (nosebleed)
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• During an ophthalmic surgical intervention due to lens opacity (cataract) or increased eye pressure (glaucoma), a condition called Iris Flag Syndrome (IFS) may occur: the pupil may dilate insufficiently and the iris (the coloured circular part of the eye) may ripple during the intervention. For further information, see section 2, Warnings and precautions.
• Abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), shortness of breath (dyspnea).
• Retrograde ejaculation; absent ejaculation.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
“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 indicated on the packaging 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 in wastewater 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 BOTAM contains
The active ingredient is tamsulosin hydrochloride 0.4 mg.
The other ingredients 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), indigotine (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
They are supplied in packs with heat-sealed PVC/Al blisters in a lithographed cardboard box, 20
capsules.

Marketing Authorisation 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)