SOLIFENACIN/TAMSULOSIN CINFA 6 mg/0.4 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

solifenacin/tamsulosin cinfa 6 mg/0.4 mg modified-release tablets EFG

solifenacin, succinate/tamsulosin, hydrochloride

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is solifenacin/tamsulosin cinfa and what is it used for
2. What you need to know before taking solifenacin/tamsulosin cinfa
3. How to take solifenacin/tamsulosin cinfa
4. Possible side effects
5. Storage of solifenacin/tamsulosin cinfa
6. Contents of the pack and further information

1. What is solifenacin/tamsulosin cinfa and what is it used for

Solifenacin/tamsulosin cinfa is a combination of two different medicines called solifenacin and tamsulosin in one tablet. Solifenacin belongs to a group of medicines called anticholinergics and tamsulosin belongs to a group of medicines called alpha-blockers.

Solifenacin/tamsulosin is used in men to treat both moderate to severe symptoms of filling and emptying the lower urinary tract caused by bladder problems and by an enlarged prostate (benign prostatic hyperplasia). Solifenacin/tamsulosin is used when previous monotherapy for this condition did not sufficiently relieve the symptoms.

When the prostate gland gets bigger, it can cause urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and a feeling of incomplete emptying of the bladder. 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 notice), and having to urinate more frequently.

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

2. What you need to know before taking solifenacin/tamsulosin cinfa

Do not take solifenacin/tamsulosin cinfa:

• If you are allergic to solifenacin, tamsulosin, or any of the other ingredients of this medicine (listed in section 6).

if you are undergoing renal dialysis.

• If you have severe liver disease.
• If you have severe kidney disease AND if, at the same time, you are being treated with medicines that may decrease the elimination of solifenacin/tamsulosin from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• If you have moderate liver disease AND if, at the same time, you are being treated with medicines that may decrease the elimination of solifenacin/tamsulosin from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). 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 eye pressure (glaucoma) with gradual loss of vision.
• If you experience fainting due to a decrease in blood pressure when changing posture (when sitting or standing up); this is called orthostatic hypotension.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacin/tamsulosin cinfa if:

• you have difficulty eliminating fluid (urinary retention).
• you have any obstruction of the digestive tract.
• you are at risk of decreased activity of the digestive tract (stomach and intestine movements). Your doctor will inform you if this is the case.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or if, at the same time, you are taking medicines that may cause or worsen esophagitis.
• you have a certain type of nerve 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 for which you are being treated.

Solifenacin/tamsulosin 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 going to undergo or have scheduled eye surgery due to cataracts or increased eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are using, or plan to use solifenacin/tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should delay or temporarily interrupt taking this medicine when undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Other medicines and solifenacin/tamsulosin cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which reduce the rate at which solifenacin/tamsulosin is eliminated from the body.
• other anticholinergic medicines, as the effects and side effects of both medicines may be intensified if you are taking two medicines of the same type.
• cholinergic medicines, as they may reduce the effect of solifenacin/tamsulosin.
• medicines such as metoclopramide and cisapride, which may speed up the functioning of the digestive tract. Solifenacin/tamsulosin may reduce their effect.
• other alpha-blockers, as they may cause an undesirable decrease in blood pressure.
• medicines such as bisphosphonates, which may cause or exacerbate esophagitis.

Using solifenacin/tamsulosin cinfa with food and drinks

Solifenacin/tamsulosin can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

Solifenacin/tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not released through the urethra but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

Solifenacin/tamsulosin may cause dizziness, blurred vision, fatigue, and less frequently, drowsiness. If you experience these side effects, do not drive or use machines.

Solifenacin/tamsulosin cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per unit dose; it is essentially "sodium-free".

3. How to take solifenacin/tamsulosin cinfa

Follow the instructions for administration of this medicine exactly 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 more solifenacin/tamsulosin cinfa than you should

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

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

In case of overdose, your doctor may treat you with activated charcoal; emergency stomach 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-excitability, convulsions, difficulty breathing, increased heart rate (tachycardia), inability to empty the bladder completely or partially or to urinate (urinary retention), and/or undesirable increase in blood pressure.

If you forget to take solifenacin/tamsulosin cinfa

Take your next solifenacin/tamsulosin cinfa tablet as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking solifenacin/tamsulosin cinfa

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

If you have any further questions on 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.

The most serious side effect that has been observed with a frequency of less than 1 in 100 patients during treatment with solifenacin/tamsulosin in clinical studies is acute urinary retention, which consists of a sudden inability to urinate. If you think you may have this, go to your doctor immediately. You may need to stop taking solifenacin/tamsulosin.

Solifenacin/tamsulosin may cause allergic reactions:

• Uncommon signs of allergic reactions may include skin rash (which may itch) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with solifenacin/tamsulosin should be stopped immediately and definitively.

If you experience an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), you should inform your doctor immediately and stop using solifenacin/tamsulosin. Treatment and/or measures should be applied.

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

• Dry mouth
• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.
• Feeling of nausea
• Abdominal pain

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

• Drowsiness
• Itching (pruritus)
• Urinary tract infection, bladder infection (cystitis)
• Taste disorder (dysgeusia)
• Dry eyes
• Dry nose
• Gastroesophageal reflux disease
• Dry throat
• Dry skin
• Difficulty urinating
• Fluid accumulation in the legs (edema)
• Headache
• Fast or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Nasal congestion or obstruction (rhinitis)
• Diarrhea
• Vomiting
• Fatigue (asthenia)

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

• A large amount of hardened feces accumulating in the large intestine (fecal impaction)
• 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 patients)

• Hallucinations, confusion
• Allergic skin reaction (erythema multiforme)
• Prolonged and painful erection (usually not during sexual activity) (priapism)
• Skin rash, 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 the available data)

• Decreased appetite
• High levels of potassium in the blood (hyperkalemia) that can cause abnormal heart rhythm
• Increased eye pressure (glaucoma)
• Abnormal heart rhythm or anomaly (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Fast heart rate (tachycardia)
• Breathing difficulties (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) may not increase in size properly. 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)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of solifenacin/tamsulosin cinfa

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Contents of the pack and further information

Composition of solifenacin/tamsulosin cinfa

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

Appearance of the product and contents of the pack

The solifenacin/tamsulosin cinfa 6 mg/0.4 mg tablets are film-coated, red, round, biconvex (approximately 9 mm) and marked with "T7S" on one side.

Solifenacin/tamsulosin cinfa tablets are available in blister packs or PA/Al/PVC-Al containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

Synthon Hispania S.L.

C/ Castelló, nº1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen, Gelderland

Netherlands

or

Synthon s.r.o.

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

Date of last revision of this leaflet: August 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.