Daital 6 mg/0,4 mg comprimidos de liberaciÓn modificada efg

Label: Information for the User

Daital 6 mg/0.4 mg Modified Release EFG Tablets

Solifenacin succinate/tamsulosin hydrochloride

Read this label carefully before you start taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Daitalis a combination of two different medications called solifenacina and tamsulosina in a tablet. Solifenacina belongs to a group of medications called anticholinergics and tamsulosina belongs to a group of medications called alpha-blockers.

This medicationis used in men to treat both moderate to severe filling symptoms and emptying symptoms of the lower urinary tract caused by problems related to the bladder and by the enlargement of the prostate (benign prostatic hyperplasia).This medicationis used when previous monotherapy treatment for this condition did not alleviate symptoms sufficiently.

When the prostate becomes enlarged, urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and sensation of incomplete bladder emptying may occur. At the same time, the bladder is also affected and contracts spontaneously at times when urination is not desired. This causes filling symptoms such as changes in bladder sensation, urgency (having a strong and sudden desire to urinate without prior warning) and having to urinate more frequently.

Solifenacina reduces involuntary bladder contractions and increases the amount of urine that the bladder can store. Therefore, you can expect to wait longer before having to go to the bathroom. Tamsulosina allows urine to pass more easily through the urethra and facilitates urination.

Do not useDaitalif:

• You are allergic to solifenacina or tamsulosina or any of the other components of this medication (listed in section 6).
• You are undergoing renal dialysis.
• You have a severe liver disease.
• You have a severe kidney disease and, at the same time, are being treated with medications that can reduce the elimination of solifenacina/tamsulosina from the body (for example ketoconazol, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this is the case.
• You have a moderate liver disease and, at the same time, are being treated with medications that can reduce the elimination of solifenacina/tamsulosina from the body (for example ketoconazol, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this is the case.
• You have a severe stomach or intestine condition (including toxic megacolon, a complication associated with ulcerative colitis).
• You have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• You have increased pressure in the eyes (glaucoma), with gradual loss of vision.
• You experience fainting due to a decrease in blood pressure when changing position (sitting or standing); this is called orthostatic hypotension.

Inform your doctor if you think you have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication if:

• You have difficulty eliminating liquid (urinary retention).
• You have any obstruction of the digestive system.
• You have a risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.
• You have a hiatal hernia or stomach burning and/or if, at the same time, you are taking medications that can cause or worsen esophagitis.
• You have a certain type of nervous disease (autonomic neuropathy).
• You have a severe kidney disease.
• You have a moderate liver disease.

Regular medical check-ups are necessary to monitor the development of the condition being treated.

This medication may affect blood pressure, which can cause dizziness, drowsiness, or, rarely, fainting (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they have disappeared.

If you are scheduled to undergo eye surgery due to cataracts or increased pressure in the eyes (glaucoma), please inform your ophthalmologist that you have previously used, are using, or plan to use this medication. The specialist will then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should or should not temporarily stop taking this medication when undergoing eye surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Daital

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are using:

• Medications such as ketoconazol, erythromycin, ritonavir, nelfinavir, itraconazol, verapamil, diltiazem, and paroxetine that reduce the rate at which solifenacina/tamsulosina is eliminated from the body.
• Other anticholinergic medications, as the effects and adverse effects of both medications can be intensified if you are taking two medications of the same type.
• Cholinergic medications, as they can reduce the effect of solifenacina/tamsulosina.
• Medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system. Solifenacina/tamsulosina may reduce their effect.
• Other alpha-blockers, as they can cause an undesirable decrease in blood pressure.
• Medications such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Use of Daital with food and drinks

This medication can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

This medication is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

This medication may cause dizziness, blurred vision, fatigue, and, less frequently, somnolence. If you experience these adverse effects, do not drive or operate machinery.

Daital contains croscarmelosa sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken orally. It can be taken with or without food, according to your preferences. Do not crush or chew the tablet.

If you take moreDaitalthan you should

If you have taken more tablets than you were told to, or if someone else takes your tablets by accident, contact your doctor, pharmacist, or hospital immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

In case of overdose, your doctor may treat you with activated charcoal; emergency gastric lavage may be useful if performed within one hour of the overdose. Do not induce vomiting.

The symptoms of overdose may include: dry mouth, dizziness, and blurred vision, seeing things that are not there (hallucinations), over-excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), inability to fully or partially empty the bladder or to urinate (urinary retention), and/or unwanted increase in blood pressure.

If you forget to takeDaital

Take your next tablet of this medication as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withDaital

If you stop taking this medication, your initial symptoms may reappear or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, solifenacin/tamsulosincan cause side effects, although not everyone will experience them.

The most serious side effect observed with low frequency (which may affect up to 1 in 100 men) during treatment withsolifenacin/tamsulosinin clinical studies is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing it, go to your doctor immediately. You may need to stop takingthis medication.

This medicationmay cause allergic reactions:

• Less common signs of allergic reactions may include skin rash (which may cause itching) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported in rare cases with tamsulosin and in very rare cases with solifenacin. In the event of angioedema, treatment withthis medicationshould be stopped immediately and permanently.

If you experience an allergic crisis or a severe skin reaction (for example, blistering and peeling of the skin), you should inform your doctor immediately, and stop usingthis medication. Appropriate treatment and/or measures should be applied.

Frequent side effects (may affect up to 1 in 10 men)

• Dry mouth
• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• Abnormal ejaculation (ejaculation disorder). This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.
• Nausea
• Abdominal pain

Less frequent side effects (may affect up to 1 in 100 men)

• Drowsiness
• Itching (pruritus)
• Urinary tract infection, bladder infection (cystitis)
• Disorder of the sense of taste (dysgeusia)
• Dry eyes
• Runny nose
• Gastroesophageal reflux disease (GERD)
• Dry throat
• Dry skin
• Difficulty urinating
• Swelling of the legs (edema)
• Headache
• Irregular or abnormal heart rhythm (palpitations)
• Dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis)
• Diarrhea
• Vomiting
• Weakness (asthenia)

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

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Syncope (fainting)
• Allergic reaction in the skin that causes swelling in the tissue under the skin surface (angioedema)

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

• Illusions, confusion
• Allergic reaction in the skin (erythema multiforme)
• Prolonged and painful erection (usually not during sexual activity) (priapism)
• Skin rash, inflammation, and blistering on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome)

Frequency unknown (cannot be estimated from available data)

• Decreased appetite
• Elevated potassium levels in the blood (hyperkalemia) that may cause abnormal heart rhythm
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heart rhythm (prolongation of the QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Fast heart rate (tachycardia)
• Difficulty breathing (dyspnea)
• During eye surgery for cataracts or increased eye pressure (glaucoma), it is possible that the pupil (the black circle in the center of the eye) will not dilate properly. Additionally, the iris (the colored part of the eye) may become flaccid during surgery.
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder
• Visual disturbance
• Nasal bleeding (epistaxis)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister pack after “CAD”. The expiration date is the last day of the month indicated.

Store below 25 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unusedmedicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition ofDaital

• The active principles are solifenacin succinate 6 mg and hydrochloride of tamsulosin 0.4 mg.
• The other components are microcrystalline cellulose, high molecular weight macrogol, magnesium stearate, calcium hydrogen phosphate, anhydrous colloidal silica, sodium croscarmellose, red iron oxide (E-172), coating material [hypromellose, macrogol, red iron oxide (E-172), titanium dioxide (E-171)].

Appearance of the product and content of the container

Daital 6 mg/0.4 mg tablets are round, approximately 9 mm in diameter, biconvex, film-coated, red in color, and marked with “T7S” on one face.

The modified-release tablets of Daital are available in pre-cut, single-dose blisters of oPA/Al/PVC-Aluminum that contain 30 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

Synthon Hispania S.L.

C/ Castelló, nº1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM, Nijmegen

Netherlands

or

Synthon s.r.o.

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

Last review date of this leaflet:

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Sanitary Products(AEMPS)http://www.aemps.gob.es/.