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

Introduction

Package Leaflet: Information for the User

Solifenacin/Tamsulosin TecniGen6 mg/0.4 mgmodified-release tablets EFG

solifenacin, succinate/tamsulosin, hydrochloride

Read the package leaflet carefully before you start taking 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 TecniGen and what is it used for
2. What you need to know before you take Solifenacin/Tamsulosin TecniGen
3. How to take Solifenacin/Tamsulosin TecniGen
4. Possible side effects
5. Storage of Solifenacin/Tamsulosin TecniGen
6. Contents of the pack and further information

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

Solifenacin/Tamsulosin TecniGen 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 TecniGen 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 TecniGen is used when previous treatment with monotherapy 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), dribbling, 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 warning), 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 TecniGen

Do not take Solifenacin/Tamsulosin TecniGen 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 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.
• you have moderate liver disease AND 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.
• 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 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 use solifenacin/tamsulosin 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 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 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 undergoing eye surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Other medicines and Solifenacin/Tamsulosin TecniGen

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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 can be intensified if you are taking two medicines of the same type.
• cholinergic medicines, as they can reduce the effect of solifenacin/tamsulosin.
• medicines such as metoclopramide and cisapride, which can speed up the functioning of the digestive tract. Solifenacin/tamsulosin may reduce their effect.
• other alpha-blockers, as they can cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Taking Solifenacin/Tamsulosin TecniGen with food, drinks, and alcohol

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.

3. How to take Solifenacin/Tamsulosin TecniGen

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are 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 preferences. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin TecniGen than you should

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

In case of overdose, your doctor may treat you with activated charcoal; emergency stomach washout may be useful if performed within one hour of 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, 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Solifenacin/Tamsulosin TecniGen

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 TecniGen

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 other questions about 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 can 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 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 men)

• Dry mouth
• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• 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.
• Feeling of nausea
• Abdominal pain

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

• 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 runny nose (rhinitis)
• Diarrhea
• Vomiting
• Fatigue (asthenia)

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

• 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 men)

• Hallucinations, confusion
• Allergic reaction in the skin (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 pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Fast heart rate (tachycardia)
• Breathing difficulties (dyspnea)
• During eye surgery for cataracts or increased pressure in the eye (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 through the Spanish Pharmacovigilance System for Human Use Medicines: 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 TecniGen

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 and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Solifenacin/Tamsulosin TecniGenThe active substances are solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg.

The other ingredients are microcrystalline cellulose, high molecular weight macrogol, anhydrous colloidal silica, magnesium stearate, anhydrous calcium hydrogen phosphate, silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), low-substituted hydroxypropylcellulose, and coating material: hypromellose, macrogol, and red iron oxide (E172).

Appearance of the product and pack contents

Solifenacin/tamsulosin tablets are film-coated, modified-release tablets. They are round, 9 mm in diameter, biconvex, and red, marked with "6 04" on one side.

The tablets are available in PA/aluminum/PVC/aluminum blister packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avenida de Bruselas, 13, 3rd floor, Edificio América, Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice, Poland

or

Atlantic Pharma – Produções Farmacêuticas S.A.,

Rua da Tapada Grande, nº 2, Abrunheira,

2710 – 089 Sintra, Portugal

or

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria,

2565-187 Dois Portos, Portugal

Date of last revision of this leaflet: October 2022

Other sources of information

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/