Package leaflet: Information for the patient

Lura 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lura is and what it is used for

The active substance of Lura is tamsulosin, a selective antagonist of α1A/α1D adrenergic receptors, which reduces muscle tension in the prostate and urethra. This allows urine to pass more quickly through the urethra, thus facilitating urination. In addition, it reduces the sensation of urinary urgency.
Lura 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 urinary stream), dribbling, urgency, and increased frequency of urination both during the day and at night.

2. What you need to know before taking Lura

Do not take Lura

if you are allergic to the active substance 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;
if you experience fainting due to low blood pressure when changing position (sitting up from lying down or standing up).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lura.

Regular medical check-ups are necessary to monitor the condition for which you are being treated.
Fainting may rarely occur with the use of Lura, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms subside.
If you have severe kidney problems, inform your doctor.
If you are scheduled for, or are on a waiting list for, eye surgery for cataract (clouding of the lens) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or intend to take Lura. The specialist may then take the most appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing eye surgery for cataract or increased eye pressure (glaucoma).
It is possible that tablet residues may be found in the stool.

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 Lura
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, be cautious if you are taking any of the following medicines:

cimetidine (a medicine used to treat stomach acidity);
furosemide (a diuretic), diclofenac (for inflammation and pain), and warfarin (to thin the blood), as they may increase the rate of elimination of Lura;
ketoconazole (used to treat fungal infections), erythromycin (used to treat bacterial infections), or paroxetine (for depression), as they may increase the effect of Lura;
other medicines belonging to the same class (alpha1-adrenergic antagonists), as they may cause a drop in blood pressure.

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

Pregnancy, breastfeeding and fertility
Lura is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. 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 (failed ejaculation). This event is harmless.

Driving and using machines
It has not been demonstrated that Lura impairs the ability to drive vehicles or operate machinery or equipment. However, you should be aware of the possibility that dizziness may occur; in such a case, you should not engage in activities requiring alertness.

Lura contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially 'sodium-free'.

3. How to take Lura

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 one capsule daily, to be taken after breakfast or after the first meal of the
day.
The capsule must be swallowed whole and must not be crushed or chewed, as this could interfere with the modified release of the active substance.
Lura is usually prescribed for long-term use. Effects on the urinary bladder and urination are maintained with long-term treatment with Lura.
If you take more Lura than you should
Taking an excessive dose of Lura may cause an unwanted drop in blood pressure and an increased heart rate, associated with a feeling of weakness.
In case of accidental ingestion/overdose of Lura, contact your doctor immediately or go to the nearest hospital.
If you forget to take Lura
If you forget to take a dose of Lura, you can take it later on the same day. If you miss a day, continue taking the capsule at your usual scheduled time. Do not take a double dose to make up for the missed capsule.
If you stop taking Lura
If treatment with Lura is stopped prematurely, the initial symptoms may reappear. Therefore, continue taking Lura 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 everyone gets them.

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

dizziness, especially when sitting down or standing up;
abnormal ejaculation (ejaculation disorders). This symptom means that seminal fluid does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of seminal fluid is reduced or absent (failure to ejaculate). This event is harmless.

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

headache;
palpitations (the heart beats faster than normal and this can be felt);
reduction in blood pressure, e.g. when standing up quickly from sitting or lying down, often associated with dizziness;
stuffy or runny nose (rhinitis);
constipation, diarrhoea, nausea and vomiting;
weakness (asthenia).

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

fainting (syncope);
sudden localized swelling of soft tissues of the body (e.g. throat and tongue), difficulty breathing with or without itching and skin rash (rush), as often seen in an allergic reaction (angioedema).

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

prolonged and painful erection of the penis (priapism);
skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

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

blurred vision, visual disturbance;
nosebleeds (epistaxis);
severe skin rashes (erythema multiforme, exfoliative dermatitis);
abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnoea);
dry mouth;
if you are about to undergo eye surgery for lens opacity (cataract) or increased eye pressure (glaucoma) and you are already taking or have recently taken Lura, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

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 following website: 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 Lura

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
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 Lura 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. The hard capsule shell is composed of: 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 Lura and package contents
Modified-release hard capsule.
Lura is available in blisters of 20 or 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Ecupharma S.r.l. – Via Mazzini, 20 – 20123 Milan

Manufacturers:
Doppel Farmaceutici S.r.l., Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milan).
Special Product’s Line S.p.A, Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (Frosinone).