Leaflet: information for the user

Solifenacina/Tamsulosina Normon 6mg/0.4mg modified-release EFG tablets

solifenacina succinate/tamsulosin hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they 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 leaflet. See section 4.

1.What is Solifenacina/Tamsulosina Normon and what it is used for

2What you need to know before starting to take Solifenacina/Tamsulosina Normon

3.How to take Solifenacina/Tamsulosina Normon

4.Possible side effects

5.Storage of Solifenacina/Tamsulosina Normon

6.Contents of the pack and additional information

Solifenacina/Tamsulosina Normon is a combination of two different medicines called solifenacina and tamsulosina in a tablet. Solifenacina belongs to a group of medicines called anticholinergics and tamsulosina belongs to a group of medicines called alpha-blockers.

Solifenacina/Tamsulosina Normon is 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 an enlarged prostate (benign prostatic hyperplasia). This medicine is used when previous treatment with monotherapy for this condition did not alleviate the 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 take Solifenacina/Tamsulosina Normon

• If you are allergic to solifenacina or tamsulosina or any of the other components of this medication (listed in section6).
• If you are undergoing renal dialysis.
• If you have severe liver disease.
• If you have severe kidney disease and 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.
• If you have moderate liver disease and 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.
• If you have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• If you have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• If you have increased pressure in the eyes (glaucoma), with gradual loss of vision.
• If you experience fainting due to a decrease in blood pressure when changing position (sitting or standing); this is known as 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 take Solifenacina/Tamsulosina Normon:

• If you have difficulty eliminating liquid (urinary retention).
• If you have any obstruction of the digestive system.
• If you are at risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.
• If you have a hiatal hernia or heartburn and/or if, at the same time, you are taking medications that can cause or worsen esophagitis.
• If you have a certain type of nervous system disease (autonomic neuropathy).
• If you have severe kidney disease.
• If you have 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 solifenacina/tamsulosina. The specialist will then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should or should not postpone or interrupt 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 Solifenacina/Tamsulosina Normon

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 its effect.
• Other alpha-blockers (used to reduce blood pressure), as they can cause an undesirable decrease in blood pressure.
• Medications such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Taking Solifenacina/Tamsulosina Normon with food and drinks

Solifenacina/tamsulosina can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

Solifenacina/tamsulosina 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 machines

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

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

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

If you take more Solifenacina/Tamsulosina Normon than you should

If you have taken more tablets than you were instructed to, or if someone else takes your tablets by mistake, 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 completely or partially empty the bladder or to urinate (urinary retention), and/or unwanted increase in blood pressure.

If you forget to take Solifenacina/Tamsulosina Normon

Take your next solifenacina/tamsulosina tablet as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Solifenacina/Tamsulosina Normon

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 medicines, this medicine can 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 with solifenacin succinate/tamsulosin hydrochloride in 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 taking this medicine.

Solifenacin/Tamsulosin may 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 with this medicine should be stopped immediately and definitively.

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 using this medicine. Appropriate treatment and/or measures should be applied.

Other side effects:

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

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

Other side effects of infrequent occurrence (may affect up to 1 in 100 men)

• Drowsiness.
• Itching (pruritus).
• Skin rash.
• 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 (peripheral edema).
• Headache.
• Irregular or rapid heartbeat (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)

• Delusions, confusion.
• Allergic reaction in the skin (erythema multiforme).
• Long-lasting and painful erection (usually not during sexual activity) (priapism).
• Inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

Frequency not known (cannot be estimated from available data)

• Anaphylactic reaction (sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness).
• Decreased appetite.
• Elevated potassium levels in the blood (hyperkalemia) that may cause abnormal heart rhythm.
• Increased eye pressure (glaucoma).
• Irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia).
• Rapid heartbeat (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 sufficiently. 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).
• Psychiatric disorders such as delirium.
• Abdominal discomfort.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Solifenacina/Tamsulosina Normon

-The active principles are solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6mg of solifenacin succinate and 0.4mg of tamsulosin hydrochloride.

-The other components are: high molecular weight macrogol, anhydrous colloidal silica (E551), magnesium stearate (E470b), calcium dihydrogen phosphate (E341), microcrystalline cellulose (E460), microcrystalline cellulose silicified

(colloidal anhydrous silica and microcrystalline cellulose), low-substitution hydroxypropyl cellulose (E463), hypromellose (E464), red iron oxide (E172), macrogol, and butylhydroxytoluene (E321).

Appearance of the product and contents of the package

Solifenacina/Tamsulosina Normon 6mg/0.4mg modified-release tablets are red, round, biconvex, film-coated tablets with "604" engraved on one face and a diameter of 9mm.

Solifenacina/Tamsulosina Normon is available in packages with PA/aluminum/PVC/aluminum blisters or in pre-cut single-dose blisters of PA/aluminum/PVC/aluminum.

Packages of 30tablets (in blisters).

Packages of 30×1tablet (in pre-cut single-dose blisters).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Responsiblefor manufacturing

ADAMED PHARMA S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

O

ADALVO LIMITED

Malta Life Sciences Park, Building 1 Level 4

Sir Temi Zammit Buildings

San Gwann SGN 3000

Malta

This medicine is authorized in themember states of the European Economic Area with the following names:

Spain:Solifenacina/Tamsulosina Normon 6mg/0.4mg modified-release tablets EFG

Revision date of this leaflet: January 2023

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).