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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

solifenacin succinate/tamsulosin hydrochloride

Read the entire 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, 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Solifenacina/tamsulosina 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.

Solifenacina/tamsulosina is used in men to treat both moderate to severe storage symptoms and lower urinary tract voiding symptoms caused by bladder-related problems and enlarged prostate (benign prostatic hyperplasia). Solifenacina/tamsulosina is used when previous treatment with monotherapy for this condition has not provided adequate symptom relief.

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 storage 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 that your bladder can hold. Therefore, you can 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 Viatris

Do not take Solifenacin/Tamsulosin Viatris 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 at the same time are 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 at the same time are 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 suffer from 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

Talk to your doctor or pharmacist before taking solifenacin/tamsulosin 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 stomach tear (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen esophagitis.
• you suffer from a certain type of nerve disorder (autonomic neuropathy).
• you have severe kidney disease.
• you have moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which you are 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 are undergoing eye surgery due to clouding of the lens (cataracts) or increased pressure in the eye (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 lens clouding (cataracts) or increased eye pressure (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and Solifenacin/Tamsulosin Viatris

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

It is especially important that you 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.
• medicines such as diclofenac and warfarin, which may increase the rate at which solifenacin/tamsulosin is eliminated from the body.
• other anticholinergic medicines, since 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 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 worsen inflammation of the esophagus (esophagitis).

Taking Solifenacin/Tamsulosin Viatris 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 instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

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

Solifenacin/Tamsulosin Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Solifenacin/Tamsulosin Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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 may be taken with or without food, according to your preference. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin Viatris 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 Viatris

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

If you stop taking Solifenacin/Tamsulosin Viatris

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, solifenacin/tamsulosin may 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, seek immediate medical attention. 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 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 immediately inform your doctor and stop using solifenacin/tamsulosin. Appropriate treatment and/or measures should be applied.

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

• Dizziness
• Blurred vision
• Dry mouth, indigestion (dyspepsia), constipation, feeling of nausea, abdominal pain
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or 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)
• Drowsiness, taste disturbance (dysgeusia), headache
• Dry eyes
• Fast or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or stuffy nose (rhinitis), dry nose
• Gastroesophageal reflux disease (gastro-oesophageal reflux), diarrhea, dry throat, nausea (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 faint (syncope)
• Accumulation of a large amount of hardened stool 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), skin allergic 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)
• Loss of appetite, elevated blood potassium levels (hyperkalemia) which may cause abnormal heart rhythm
• Rapid decrease in consciousness and general mental function (delirium)
• During eye surgery for 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, increased eye pressure (glaucoma), vision disturbances
• Irregular or abnormal heartbeat (QT interval prolongation, Torsades de Pointes, atrial fibrillation, arrhythmia), rapid heartbeat (tachycardia)
• Difficulty breathing (dyspnea), voice disorder, nosebleed (epistaxis)
• Intestinal obstruction (ileus, colon obstruction), abdominal discomfort
• Liver disorder
• Abnormal liver function test
• Skin inflammation causing redness and peeling over large areas of the body (exfoliative dermatitis)
• Muscle weakness
• Kidney disorder

Reporting of adverse effects

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

5. Storage of Solifenacin/Tamsulosin Viatris

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

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

Blister packs should be stored below 25°C.

Bottles should be stored below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, 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 Viatris

• 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), high molecular weight polyethylene glycol, polyethylene glycol, colloidal anhydrous silica, titanium dioxide (E171).

Appearance of the product and contents of the pack

Solifenacin/Tamsulosin Viatris: red, round, biconvex, film-coated modified-release tablets marked “T7S” on one side.

It is available in blister packs containing 30, 90, 100 or 200 tablets, or in perforated unit-dose blisters containing 30 x 1, 90 x 1 or 100 x 1 modified-release tablets, or in HDPE bottles of 150 ml containing 200 modified-release tablets with a child-resistant screw cap made of polypropylene and containing 2 g of desiccant.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Synthon Hispania S.L.
Calle De Castelló 1
08830 Sant Boi De Llobregat
Spain

or

Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

or

Synthon, s.r.o.
Brnenská 32/cp. 597
678 01 Blansko
Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Belgium: Solifenacine/Tamsulosine Viatris 6 mg/0.4 mg tabletten met gereguleerde afgifte
Croatia: Solifenacinsukcinat/tamsulozinklorid Viatris 6 mg/0,4 mg tablete s prilagodenim oslobadanjem
Spain: Solifenacina/Tamsulosina Viatris 6 mg/0,4 mg comprimidos de liberación modificada EFG
Italy: Solifenacina e Tamsulosin Viatris
Luxembourg: Solifenacine/Tamsulosine Viatris 6 mg/0.4 mg comprimés à libération modifiée
Netherlands: Solfenacinesuccinaat/Tamsulosinehydrochloride Viatris 6 mg/0,4 mg tabletten met gereguleerde afgifte
Portugal: Solifenacina + Tansulosina Mylan
Czech Republic: Solifenacin/Tamsulosin Viatris

Date of the most recent review of this leaflet: November 2024

Other sources of information

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