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

Introduction

Package Leaflet: Information for the User

Solifenacin/Tamsulosin Stadafarma 6 mg/0.4 mg Modified Release Tablets EFG

solifenacin, succinate/tamsulosin, hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 pack

1. What Solifenacin/Tamsulosin Stadafarma is and what it is used for
2. What you need to know before you take Solifenacin/Tamsulosin Stadafarma
3. How to take Solifenacin/Tamsulosin Stadafarma
4. Possible side effects
5. Storage of 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 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 filling symptoms and emptying symptoms of the lower urinary tract caused by bladder problems and by an enlarged prostate (benign prostatic hyperplasia). Solifenacin/tamsulosin is used when previous monotherapy treatment for this condition did not sufficiently relieve the symptoms.

When the prostate gland enlarges, 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 need 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 you need 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 you take Solifenacin/Tamsulosin Stadafarma

Do not take Solifenacin/Tamsulosin Stadafarma if:

• you are allergic to solifenacin or tamsulosin or 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 kidney disease and 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.
• you have moderate liver disease and 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.
• you have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• you have a muscle disease 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 decrease in blood pressure when changing position (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 Solifenacin/Tamsulosin Stadafarma if:

• you have difficulty eliminating fluid (urinary retention).
• you have any obstruction of the digestive system.
• you are at risk of decreased activity of the digestive system (stomach and intestinal movements). Your doctor will inform you if this is the case.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or 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 pressure in the eyes (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 postpone or temporarily interrupt taking this medicine when you are going to undergo eye surgery for cataracts or increased pressure in the eyes (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Using Solifenacin/Tamsulosin Stadafarma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 that 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.
• cholinergics, as they may reduce the effect of solifenacin/tamsulosin.
• medicines such as metoclopramide and cisapride, which may speed up the functioning of the digestive system. 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).

Using Solifenacin/Tamsulosin Stadafarma 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 instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). 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 Stadafarma contains sodium

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

3. How to take Solifenacin/Tamsulosin Stadafarma

Follow exactly the administration instructions of this medicine given 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, depending on your preferences. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin Stadafarma than you should

If you have taken more tablets than you were told to, or if someone else has taken your tablets by mistake, contact your doctor, pharmacist, or hospital immediately for advice.

In case of overdose, your doctor may treat you with activated charcoal; emergency stomach lavage may be useful if performed within one hour of 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.

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

If you forget to take Solifenacin/Tamsulosin Stadafarma

Take your next Solifenacin/Tamsulosin tablet as normal. 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 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 men during treatment with solifenacin/tamsulosin in clinical studies is acute urinary retention, which is 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 be itchy) 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 permanently and immediately discontinued.

If you experience an allergic reaction or a severe skin reaction (e.g. formation of blisters 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 men)

• Dizziness
• Blurred vision
• Dry mouth, indigestion (dyspepsia), constipation, feeling sick (nausea), abdominal pain
• Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra, but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.
• Fatigue

Uncommon side 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 dizzy or weak, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis), dry nose
• Gastroesophageal reflux disease, diarrhea, dry throat, vomiting
• Itching (pruritus), dry skin
• Difficulty urinating
• Fluid buildup in the legs (edema), fatigue (asthenia)

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

• Fainting (syncope)
• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• 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)

• 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 reaction in the skin (erythema multiforme)
• Prolonged and painful erection (usually not during sexual activity) (priapism)

Frequency not known (cannot be estimated from the available data)

• Severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• Decreased appetite, high levels of potassium in the blood (hyperkalemia) that can cause abnormal heart rhythm
• Rapid decrease in consciousness and overall mental function (delirium)
• During eye surgery for cataracts or increased pressure in the eyes (glaucoma), it is possible that the pupil (the black circle in the center of the eye) does not increase in size properly. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, increased pressure in the eyes (glaucoma), vision disturbance
• Irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia), fast heart rate (tachycardia)
• Breathing difficulties (dyspnea), voice disorder, nosebleeds (epistaxis)
• Intestinal obstruction (ileus), abdominal discomfort
• Inflammation of the skin that causes redness and peeling in large areas of the body (exfoliative dermatitis)
• Liver disorder
• Muscle weakness
• Kidney disorder

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 via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side 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 which is stated on the carton and blister after "EXP". The expiry date is the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to 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 ingredients are calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), red iron oxide (E172), magnesium stearate (E470b), macrogol, high molecular weight, colloidal anhydrous silica (E551), titanium dioxide (E171).

Appearance of the product and pack contents

Solifenacin/Tamsulosin Stadafarma 6 mg/0.4 mg tablets are round, biconvex, film-coated, red, and 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 unit-dose blisters containing 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1, or 200x1 modified-release tablets.

Not all 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,

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 last revision of this leaflet:April 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/