Prospecto: information for the user

solifenacina/tamsulosina cinfamed 6 mg/0.4 mg modified-release EFG tablets

solifenacina succinate/tamsulosina hydrochloride

Read this prospectus carefully before starting to use this medication because it contains important information for you.

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

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

-This medication has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is solifenacina/tamsulosina cinfamed and what is it used for

2What you need to know before starting to use solifenacina/tamsulosina cinfamed

3.How to use solifenacina/tamsulosina cinfamed4.Possible adverse effects

5.Storage of solifenacina/tamsulosina cinfamed

6.Contents of the package and additional information

Solifenacina/tamsulosina cinfamedis 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.

Solifenacina/tamsulosina cinfamedis 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). Solifenacina/tamsulosina cinfamedis used when previous monotherapy treatment for this condition did not adequately relieve symptoms.

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.

No usesolifenacina/tamsulosina cinfamedif:

-is allergic to solifenacina or to tamsulosina or to any of the other components of this medication (listed in section 6).

-is undergoing renal dialysis.

-has severe liver disease.

-has severe kidney disease and is being treated with medications that can decrease the elimination ofsolifenacina/tamsulosina cinfamedfrom the body (for example, ketoconazol, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this is the case.

-has moderate liver disease and is being treated with medications that can decrease the elimination ofsolifenacina/tamsulosina cinfamedfrom the body (for example, ketoconazol, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this is the case.

-has a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).

-has a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles.

-has increased pressure in the eyes (glaucoma), with gradual loss of vision.

-experiences dizziness 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 usesolifenacina/tamsulosina cinfamedif:

-you have difficulty eliminating urine (urinary retention).

-you have any obstruction of the digestive system.

-you are at 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 heartburn and/or if, at the same time, you are taking medications that can cause or worsen esophagitis.

-you have a certain type of nervous system disease (autonomic neuropathy).

-you have severe kidney disease.

-you have moderate liver disease.

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

Solifenacina/tamsulosina cinfamedmay 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 or have scheduled 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 usesolifenacina/tamsulosina cinfamed. 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).

Use in children and adolescents

Do not administer this medication to children and adolescents.

Other medications andsolifenacina/tamsulosina cinfamed

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, which reduce the rate at whichsolifenacina/tamsulosina cinfamedis 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 ofsolifenacina/tamsulosina cinfamed.

-medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system.solifenacina/tamsulosina cinfamedmay reduce its 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).

Solifenacina/tamsulosina cinfamedwith food and drinks

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

Pregnancy, breastfeeding, and fertility

Solifenacina/tamsulosina cinfamedis 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 that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

Solifenacina/tamsulosina cinfamedmay cause dizziness, blurred vision, fatigue, and, less frequently, drowsiness.If you experience these adverse effects, do not drive or operate machinery.

Follow exactly the administration instructions of this medication 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 solifenacina and 0.4 mg of tamsulosina, taken orally. It can be taken with or without food, according to your preferences. Do not crush or chew the tablet.

If you take more solifenacina/tamsulosina cinfamed than you should

If you have taken more tablets than indicated, or if another person takes your tablets by accident, contact your doctor, pharmacist, or hospital immediately for advice.

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.

Overdose symptoms may include: dry mouth, dizziness, and blurred vision, seeing things that are not there (hallucinations), over-excitement, seizures, 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.

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

If you forget to take solifenacina/tamsulosina cinfamed

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

If you interrupt treatment with solifenacina/tamsulosina cinfamed

If you stop taking solifenacina/tamsulosina cinfamed, your initial symptoms may reappear or worsen. Always consult your doctor if you are considering interrupting treatment.

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

Like all medications, solifenacina/tamsulosina cinfamed can cause side effects, although not everyone will experience them.

The most serious side effect observed with low frequency (affecting up to 1 in 100 men) during treatment with solifenacina/tamsulosina 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 solifenacina/tamsulosina cinfamed.

Solifenacina/tamsulosina cinfamed may cause allergic reactions:

-A severe allergic reaction (anaphylactic reaction) may occur with unknown frequency.

-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, which may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported in rare cases with tamsulosina and in very rare cases with solifenacina. In the event of angioedema, treatment with solifenacina/tamsulosina cinfamed should be discontinued immediately and definitively.

If you experience an allergic crisis or a severe skin reaction (such as blistering and skin peeling), you should inform your doctor immediately and stop using solifenacina/tamsulosina cinfamed. Appropriate treatment and/or measures should be applied.

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

-Dry mouth

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

-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.

-Feeling of dizziness (nausea)

-Abdominal pain

Other less common side effects (may affect up to 1 in 100 men)

-Drowsiness

-Itching (pruritus)

-Urinary tract infection, bladder infection (cystitis)

-Taste disorder (dysgeusia)

-Dry eyes

-Nasal dryness

-Gastroesophageal reflux disease (GERD)

-Sore throat

-Dry skin

-Difficulty urinating

-Fluid accumulation in the lower legs (edema)

-Headache

-Irregular or rapid heartbeat (palpitations)

-Feeling of 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 1000 men)

-Accumulation of a large amount of hardened feces in the large intestine (fecal impaction), colon obstruction

-Feeling of fainting (syncope)

-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)

-Long-lasting 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, nose, or genitals (Stevens-Johnson syndrome)

Unknown frequency (cannot be estimated from available data)-Loss of appetite

-Elevated potassium levels in the blood (hyperkalemia) that may cause abnormal heart rhythm

-Increased pressure in the eyes (glaucoma)

-Irregular or abnormal heartbeat (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 pressure in the eye (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

-Vision disorder

-Nosebleed (epistaxis)

-Delirium

-Intestinal disorder (ileus)

-Abdominal discomfort

-Severe skin allergy that causes skin peeling (dermatitis exfoliativa)

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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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 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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of solifenacina/tamsulosina cinfamed

- The active principles are: solifenacin succinate and tamsulosin hydrochloride.

Cada comprimido de liberación modificada contiene 6 mg de succinato de solifenacina, que corresponden a 4,5 mg de solifenacina y 0,4 mg de hidrocloruro de tamsulosina, que corresponden a 0,37 mg de tamsulosina.

- The other components are microcrystalline cellulose; macrogol; anhydrous colloidal silica; magnesium stearate; calcium hydrogen phosphate; microcrystalline cellulose silicified (microcrystalline cellulose and anhydrous colloidal silica); low-substitution hydroxypropyl cellulose; hypromellose; red iron oxide (E172).

Appearance of the product and contents of the package

Solifenacina/tamsulosina cinfamed: the 6 mg/0.4 mg tablets are round (9 mm in diameter), biconvex, red, coated with a film, and engraved with "6 04" on one face.

Blister of PA/aluminum/PVC/aluminum in an outer box containing 10, 30, 60, or 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta 31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Last review date of this leaflet: June 2022

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information on the following internet address: https://cima.aemps.es/cima/dochtml/p/88509/P_88509.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88509/P_88509.html