Solifenacin/tamsulosin Stadapharma 6 mg/0.4 mg modified-release tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the user

Solifenacin/Tamsulosin Stadafarma 6 mg/0.4 mg modified-release tablets EFG

solifenacin succinate/tamsulosin hydrochloride

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Solifenacin/Tamsulosin Stadafarma is and what it is used for
2. What you need to know before taking Solifenacin/Tamsulosin Stadafarma
3. How to take Solifenacin/Tamsulosin Stadafarma
4. Possible side effects
5. How to store Solifenacin/Tamsulosin Stadafarma
6. Contents of the pack and other information

1. What Solifenacin/Tamsulosin Stadafarma is and what it is used for

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

Solifenacin/tamsulosin is used in men to treat both moderate to severe storage symptoms and voiding symptoms of the lower urinary tract caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Solifenacin/tamsulosin is used when prior treatment with monotherapy for this condition has not provided adequate symptom relief.

When the prostate enlarges, urinary problems (voiding symptoms) may occur, such as delayed urination (difficulty starting to pass urine), reduced urine flow (weak stream), dribbling, and a sensation of incomplete bladder emptying. At the same time, the bladder may also be affected and contracts spontaneously at times when urination is not desired. This causes storage symptoms such as changes in bladder sensation, urgency (a sudden, strong need to urinate without warning), and increased frequency of urination.

Solifenacin reduces involuntary contractions of the bladder and increases the amount of urine your bladder can hold. Therefore, you may be able to wait longer before needing to go to the bathroom. Tamsulosin allows urine to pass more easily through the urethra and helps urination.

2. What you need to know before using Solifenacin/Tamsulosin Stadafarma

Do not use Solifenacin/Tamsulosin Stadafarma if:

• you are allergic to solifenacin or tamsulosin, or to any of the other ingredients of this medicine (listed in section 6).
• you are undergoing renal dialysis.
• you have severe liver disease.
• you have severe renal disease and are simultaneously being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this applies.
• you have moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazol). Your doctor or pharmacist will inform you if this applies.
• you have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• you have a muscle disorder 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 drop in blood pressure when changing posture (sitting or standing up); this is known as orthostatic hypotension.

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

Warnings and precautions

Consult your doctor or pharmacist before starting Solifenacin/Tamsulosin Stadafarma if:

• you have difficulty passing urine (urinary retention).
• you have any obstruction of the gastrointestinal tract.
• you are at risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies.
• you have a diaphragmatic tear (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen esophagitis.
• you have a certain type of nervous system disorder (autonomic neuropathy).
• you have severe renal disease.
• you have moderate liver disease.

Periodic medical check-ups are necessary to monitor the progression of the condition being treated.

Solifenacin/tamsulosin may affect blood pressure, which could cause dizziness, lightheadedness, or rarely, fainting (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down until they subside.

If you are scheduled for or undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are currently using, or plan to use solifenacin/tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily interrupt treatment with this medicine prior to undergoing eye surgery for lens opacity (cataracts) or increased intraocular pressure (glaucoma).

Children and adolescents

Do not administer this medicine to children or adolescents.

Use of Solifenacin/Tamsulosin Stadafarma with other medicines

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

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

• 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 their effects and adverse effects may be intensified when taking two medicines of the same type.
• cholinergics, as they may reduce the effect of solifenacin/tamsulosin.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Solifenacin/tamsulosin may reduce their effect.
• other alpha-blockers, as they may cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates, which may cause or exacerbate inflammation of the esophagus (esophagitis).

Use of Solifenacin/Tamsulosin Stadafarma with food and drink

Solifenacin/tamsulosin may be taken with or without food, according to your preference.

Pregnancy, breastfeeding, and fertility

Solifenacin/tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and use of machines

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

Solifenacin/Tamsulosin Stadafarma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to use Solifenacin/Tamsulosin Stadafarma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, 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, depending on your preference. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin Stadafarma than you should

If you have taken more tablets than prescribed, or if someone else accidentally takes your tablets, 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 helpful if performed within one hour of the overdose. Do not induce vomiting.

Symptoms of overdose may include: dry mouth, dizziness and blurred vision, seeing things that are not there (hallucinations), over-excitability, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Solifenacin/Tamsulosin Stadafarma

Take your next tablet of Solifenacin/Tamsulosin at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Solifenacin/Tamsulosin Stadafarma

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most serious adverse effect observed infrequently (affecting up to 1 in 100 men) during clinical studies with solifenacin/tamsulosin is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing this, contact your doctor immediately. You may need to stop taking solifenacin/tamsulosin.

Solifenacin/tamsulosin may cause allergic reactions:

• Uncommon signs of allergic reactions may include rash (which may be itchy) 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 rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with solifenacin/tamsulosin must be permanently and immediately discontinued.

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

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

• Dizziness
• Blurred vision
• Dry mouth, indigestion (dyspepsia), constipation, sensation of dizziness (nausea), abdominal pain
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but goes into the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless
• Tiredness (fatigue)

Uncommon adverse effects (may affect up to 1 in 100 men)

• Urinary tract infection, bladder infection (cystitis)
• Somnolence, disturbance of taste sensation (dysgeusia), headache
• Dry eyes
• Rapid or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis), dry nose
• Gastroesophageal reflux disease (gastroesophageal reflux), diarrhea, dry throat, vomiting
• Itching (pruritus), dry skin
• Difficulty urinating
• Fluid accumulation in the legs (edema), tiredness (asthenia)

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

• Feeling of fainting (syncope)
• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Skin allergy causing swelling in the tissue beneath the skin surface (angioedema)

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

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

Frequency not known (cannot be estimated from available data)

• Severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• Decreased appetite, elevated blood potassium levels (hyperkalemia) which may cause abnormal heart rhythm
• Rapid decrease in consciousness and overall mental function (delirium)
• During eye surgery for lens clouding (cataracts) or increased eye pressure (glaucoma), the pupil (the black circle in the center of the eye) may not dilate properly. In addition, the iris (the colored part of the eye) may become flaccid during surgery, increased eye pressure (glaucoma), vision disturbances
• Irregular or abnormal heartbeat (QT interval prolongation, Torsades de Pointes, atrial fibrillation, arrhythmia), rapid heart rate (tachycardia)
• Breathing difficulty (dyspnea), voice disorder, nosebleed (epistaxis)
• Intestinal obstruction (ileus), abdominal discomfort
• Skin inflammation causing redness and peeling over large areas of the body (exfoliative dermatitis)
• Liver disorder
• Muscle weakness
• Kidney disorder

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin/Tamsulosin Stadafarma

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

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin/Tamsulosin Stadafarma

• The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride.
• The other components are calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), red iron oxide (E172), magnesium stearate (E470b), macrogol high molecular weight, macrogol, colloidal anhydrous silica (E551), titanium dioxide (E171).

Nature of the product and pack contents

Solifenacin/Tamsulosin Stadafarma 6 mg/0.4 mg tablets are round, biconvex, film-coated red tablets, marked with “T7S” on one side.

Solifenacin/Tamsulosin Stadafarma is available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release tablets, or in perforated unit-dose blisters containing 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1 or 200x1 modified-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Synthon Hispania S.L.,

C/ Castelló, nº1,

Sant Boi de Llobregat,

08830 Barcelona, Spain

or

Synthon BV,

Microweg 22,

6545 CM Nijmegen,

The Netherlands

or

Synthon s.r.o.,

Brnenská 32/cp. 597,

678 01 Blansko,

Czech Republic

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Date of the most recent revision of this leaflet: April 2023

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