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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

solifenacin succinate / tamsulosin hydrochloride

Read the entire leaflet carefully before you start using this medicine, as 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 others, 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Solifenacin/Tamsulosin Teva 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 filling symptoms and lower urinary tract voiding symptoms caused by bladder-related problems and enlarged prostate (benign prostatic hyperplasia). Solifenacin/Tamsulosin is used when prior treatment with monotherapy for this condition did not adequately relieve symptoms.

When the prostate gland 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 is also affected and contracts spontaneously at times when urination is not desired. This causes filling symptoms such as changes in bladder sensation, urgency (a sudden, strong need to pass urine 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 toilet. Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

2. What you need to know before taking Solifenacin/Tamsulosin Teva

Do not take Solifenacin/Tamsulosin Teva 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, itraconazole). 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, itraconazole). 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 position (upon sitting or standing up); this is known as orthostatic hypotension.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use solifenacin/tamsulosin if:

• you have difficulty passing urine (urinary retention).
• you have any obstruction in the digestive 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 taking medicines that may cause or worsen esophagitis.
• you have a certain type of nerve disorder (autonomic neuropathy).
• you have severe renal disease.
• you have moderate liver disease.

Regular medical check-ups are necessary to monitor the progression of your condition.

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

If you are undergoing or have scheduled 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 discontinue taking this medicine before undergoing eye surgery for cataracts or increased intraocular pressure (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and Solifenacin/Tamsulosin Teva

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 the effects and side effects of both medicines 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 speed up gastrointestinal motility. Solifenacin/tamsulosin may reduce their effect.
• other alpha-blockers (used to lower blood pressure), as they may cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Solifenacin/Tamsulosin Teva 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 (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

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

3. How to take Solifenacin/Tamsulosin Teva

Follow exactly the instructions for use of this medicine as given 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 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 Teva 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, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Solifenacin/Tamsulosin Teva

Take your next dose of solifenacin/tamsulosin at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Solifenacin/Tamsulosin Teva

If you stop taking this medicine, 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 will experience them.

The most serious adverse effect observed infrequently (which may affect up to 1 in 100 men) during treatment with succinate solifenacin/hydrochloride tamsulosin in clinical studies 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 this medicine.

Solifenacin/tamsulosin may cause allergic reactions:

• Uncommon signs of allergic reactions may include skin 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 this medicine must be permanently and immediately discontinued.

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

Frequent adverse 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 exit through the urethra but goes into the bladder (retrograde ejaculation), or that the volume ejaculated is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
• feeling of dizziness (nausea)
• abdominal pain

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

• somnolence
• itching (pruritus)
• skin rash
• urinary tract infection, bladder infection (cystitis)
• disturbance of taste sensation (dysgeusia)
• dry eyes
• dry nose
• reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fluid accumulation in the legs (peripheral edema)
• headache
• rapid or irregular heartbeat (palpitations)
• feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• runny or stuffy nose (rhinitis)
• diarrhea
• vomiting
• tiredness (asthenia)

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

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• feeling of fainting (syncope)
• 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 allergic reaction (erythema multiforme)
• prolonged 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 breathing difficulty, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness)
• decreased appetite
• elevated blood potassium levels (hyperkalemia), which may cause abnormal heart rhythm
• increased pressure in the eyes (glaucoma)
• irregular or abnormal heartbeat (QT interval prolongation, Torsades de Pointes, atrial fibrillation, arrhythmia)
• rapid heart rate (tachycardia)
• difficulty breathing (dyspnea)
• during eye surgery for clouding of the lens (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 floppy during surgery.
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder
• vision disturbance
• nosebleed (epistaxis)
• psychiatric disorders such as confusion (delirium)
• abdominal discomfort

Reporting of adverse effects

If you experience any kind of 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 Teva

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 carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin/Tamsulosin Teva

• 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: high molecular weight polyethylene glycol, colloidal anhydrous silica (E551), magnesium stearate (E470b), calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), low-substituted hydroxypropyl cellulose (E463), hypromellose (E464), red iron oxide (E172), polyethylene glycol, butylated hydroxytoluene (E321).

Nature of the product and contents of the pack

Solifenacin/Tamsulosin Teva 6 mg/0.4 mg modified-release tablets are red, film-coated, round, biconvex tablets marked with “6 04” on one side and with a diameter of 9 mm.

Solifenacin/Tamsulosin Teva is supplied in cardboard boxes containing PA/Aluminium/PVC/Aluminium blisters or in PA/Aluminium/PVC/Aluminium single-dose perforated blisters.

Pack sizes of 30, 50, 90 or 100 tablets (in blisters).

Pack sizes of 30 x 1, 50 x 1, 90 x 1 or 100 x 1 tablets (in single-dose perforated blisters).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.

Swensweg 5, Haarlem,

2031 GA,

The Netherlands

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice,

Poland

Or

Adalvo Limited

Malta Life Sciences Park, Building 1 Level 4

Sir Temi Zamit Buildings

San Gwann Industrial Estate

San Gwann, SGN 3000

Malta

Local representative

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid,

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2023

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