LURA 0.4 MG Модифицированные капсулы с контролируемым высвобождением

Содержание инструкции

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

Lura 0.4 mg extended-release hard capsules

tamsulosin hydrochloride
Generic medicine

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

1. What is Lura and what is it for

The active ingredient of Lura is tamsulosin, a drug with selective antagonist action on α1A/ α 1D adrenoreceptors
which reduces muscle tension in the prostate and urethra. This allows urine to
pass more quickly through the urethra, facilitating urination. In addition, it decreases the
sensation of urgency to urinate.
Lura is used in men for the treatment of lower urinary tract symptoms associated with an
enlarged prostate (benign prostatic hyperplasia). These disorders can include difficulty
urinating (reduced stream), dripping, 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 ingredient 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), difficulty breathing and/or itching and rash (angioedema);
• if you suffer from severe liver problems;
• if you experience fainting due to a drop in 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.

• Periodic medical check-ups are necessary to monitor the development of the condition you are being treated for.
• Rarely, with the use of Lura, fainting may occur, as well as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until they disappear.
• If you suffer from severe kidney problems, tell your doctor.
• If you are to undergo or are on the waiting list for eye surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma). Inform the ophthalmologist if you have previously taken, are taking or intend to take Lua. The specialist may consequently adopt the most appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor if you should postpone or temporarily suspend treatment with this medicine before undergoing eye surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma). It is possible that residues of the tablet may be found in the stool.

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

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

• cimetidine (a medicine to treat stomach acidity);
• furosemide (diuretic), diclofenac (for inflammation and pain) and warfarin (to thin the blood), as they may increase the rate of elimination of Lura;
• ketoconazole (for the treatment of fungal infections), erythromycin (for the treatment of bacterial infections) or paroxetine (for depression), as they may increase the effect of Lura;
• other medicines belonging to the same class (alpha1-adrenoceptor 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 in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that the
semen does not exit the body through the urethra but enters the bladder (retrograde ejaculation) or that the volume of ejaculate is reduced or absent (anejaculation). This event is
harmless.

Driving and operating machinery
It has not been demonstrated that Lura alters the ability to drive vehicles or operate machinery or
equipment. However, you should be aware of the possibility that dizziness may occur, in which case
you should not engage in activities that require attention.

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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule a day 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 because this
could interfere with the modified release of the active substance.
Normally Lura is prescribed for long periods of time. The effects on the urinary bladder and on
urination are maintained following long-term treatment with Lura.

If you take more Lura than you should
Taking an excessive dose of Lura may induce an unwanted drop in blood pressure and
an increase in heart rate, associated with a feeling of weakness.
In case of accidental ingestion/taking of an excessive dose of Lura, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Lura
If you have forgotten to take a dose of Lura you can take it later in the same day. If you have
missed a day, continue to take the capsule of the day at the usual scheduled time. Do not take a
double dose to compensate for the forgotten capsule.

If you stop taking Lura
When treatment with Lura is stopped prematurely, the initial symptoms may reappear.
Therefore, continue to take Lura for the entire period of time prescribed by your doctor, even if your
symptoms have already disappeared. Always consult your doctor if you believe that this therapy should be
interrupted.
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.

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

• dizziness, particularly when getting up when sitting or standing;
• abnormal ejaculation (ejaculation disorders). This symptom means that the 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 (anorgasmia). This event is harmless.

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

• headache;
• palpitations (the heart beats faster than normal and is also noticeable);
• reduction in blood pressure, e.g. when getting up quickly from sitting or lying down, often associated with dizziness;
• nasal congestion or runny nose (rhinitis);
• constipation, diarrhea, nausea and vomiting;
• weakness (asthenia).

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

• fainting (syncope);
• sudden localized swelling of the soft tissues of the body (e.g. of the throat and tongue), difficulty breathing with or without itching and rash (rush), as often occurs 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 available data):

• blurred vision, impaired vision;
• nosebleeds (epistaxis);
• severe skin rashes (erythema multiforme, exfoliative dermatitis);
• abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), shortness of breath (dyspnea);
• dry mouth;
• if you are about to undergo eye surgery for cataracts or increased pressure in the eye (glaucoma) and are already taking or have recently taken Lura, the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during surgery.

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 or 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 at a temperature not exceeding 30 °C.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Lura contains

• The active ingredient 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 is formed by: 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 contents of the pack
Modified-release hard capsule
Lura is available in blister packs of 20 capsules.

Marketing Authorisation Holder:
Ecupharma S.r.l. – Via Mazzini, 20 – 20123 Milano

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