Package leaflet: Information for the patient

TAMLIC 0.4 mg modified-release hard capsules

Tamsulosin hydrochloride
Generic medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could 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:

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

1. What TAMLIC is and what it is used for

TAMLIC 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, thereby facilitating the passage of urine (urination) and decreasing the sensation of urinary urgency.
TAMLIC is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (reduced urine flow), dribbling, urgency, and increased frequency of urination both during the day and at night.

2. What you need to know before taking TAMLIC

Do not take TAMLIC:

if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
if you have experienced sudden localized swelling of soft body tissues (e.g. throat or tongue), breathing difficulties and/or itching and skin rash after taking medicines (drug-induced angioedema);
if you have severe liver problems;
if you suffer from dizziness or fainting upon standing, caused by a drop in blood pressure (orthostatic hypotension).

Warnings and precautions
Talk to your doctor or pharmacist before taking TAMLIC.
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 due to cataract or increased eye pressure (glaucoma). Complications may occur (see section "Possible side effects"). Inform your doctor if you have previously taken, are currently taking, or are due to take TAMLIC. This way, the specialist doctor will assess the necessary measures to take before surgery.

Before starting treatment with TAMLIC, and periodically during treatment, your doctor will perform some simple tests to rule out other conditions that may cause the same symptoms as an enlarged prostate (benign prostatic hyperplasia). These tests include digital rectal examination and, if necessary, a blood test to determine the level of prostate-specific antigen (PSA).
Your doctor will evaluate your symptoms and their possible causes.
During treatment with this medicine, as with other medicines of this type, your blood pressure may decrease and you may rarely experience fainting. At the first signs of dizziness or weakness, you should sit or lie down until symptoms disappear.
During treatment, you may notice capsule residues in your stools.

Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.

Other medicines and TAMLIC
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 reduce blood pressure (hypotension);
medicines that increase tamsulosin blood levels by reducing its elimination (strong and moderate CYP3A4 inhibitors).

Pregnancy, breastfeeding and fertility
TAMLIC is not indicated for use in women.
In men, ejaculation disorders have been reported, such as semen not being expelled from the body through the urethra but entering the bladder (retrograde ejaculation), or reduced or absent ejaculate volume (anejaculation).

Driving and operating machinery
The use of TAMLIC should not affect your ability to drive or operate machinery. However, you should be aware of the possibility of experiencing dizziness; in such case, avoid driving or operating machinery.

3. How to take TAMLIC

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Use in adults
The recommended dose is 1 capsule daily, taken 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 kidney or liver problems
No dose adjustment is required (see section “Do not take TAMLIC”).
Use in children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
If you take more TAMLIC than you should
If you (or someone else) have taken an excessive dose of TAMLIC or if you think a child may have
taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Overdose may cause a marked drop in blood pressure and increased heart rate, associated with a feeling of weakness.
If you forget to take TAMLIC
If you forgot to take the capsule after the first meal of the day, take it later on the same
day. 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 TAMLIC
When treatment with Tamlic is stopped prematurely, the initial symptoms may reappear.
Therefore, continue taking Tamlic for the full duration prescribed by your doctor, even if your symptoms
have already improved. Always consult your doctor if you think this treatment should be discontinued.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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 (abnormal ejaculation), in which semen does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or the volume of semen is reduced or absent (failure to ejaculate);

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

headache;
sensation of rapid heartbeat (palpitations);
dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
nasal irritation (rhinitis);
constipation, diarrhoea, nausea and vomiting;
skin irritation such as rash, urticaria and 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, and which can be life-threatening (angioedema).

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

severe skin inflammation with blister formation 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;
severe skin rashes (erythema multiforme, exfoliative dermatitis);
changes in heart rhythm (atrial fibrillation, arrhythmia, tachycardia);
difficulty breathing (dyspnoea);
following eye surgery for clouding of the lens (cataract) or increased eye pressure (glaucoma), a condition called "intraoperative floppy-iris syndrome" (IFIS) has been reported, in which the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 TAMLIC

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 TAMLIC 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), indigo carmine (E 132), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of TAMLIC and contents of the pack
Packs of 20 and 30 modified-release hard capsules in PVC/AL blisters.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – Episcopia (Potenza) – Italy.
Manufacturer
Famar Italia S.p.A. - Via Zambeletti, 25 – 20021 Baranzate (Milan).
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)