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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

solifenacina/tamsulosina cinfamed 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 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What solifenacina/tamsulosina cinfamed is and what it is used for

2. What you need to know before taking solifenacina/tamsulosina cinfamed

3. How to take solifenacina/tamsulosina cinfamed

4. Possible side effects

5. How to store solifenacina/tamsulosina cinfamed

6. Contents of the pack and other information

1. What solifenacin/tamsulosin cinfamed is and what it is used for

Solifenacin/tamsulosin cinfamed 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 cinfamed is used in men to treat both moderate to severe filling symptoms and voiding symptoms of the lower urinary tract caused by bladder-related problems and by enlargement of the prostate (benign prostatic hyperplasia). Solifenacin/tamsulosin cinfamed is used when prior 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 feeling 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 urinate without prior 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 may be able to wait longer before needing 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 starting to use solifenacin/tamsulosin cinfamed

Do not usesolifenacin/tamsulosin cinfamedif:

• you are allergic to solifenacin or tamsulosin or to any of the other components 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 cinfamed 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 at the same time are being treated with medicines that may reduce the elimination of solifenacin/tamsulosin cinfamed 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 upon changing position (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 cinfamed 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 diaphragm tear (hiatal hernia) or heartburn and/or are simultaneously 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 the condition for which you are being treated.

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

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

Use in children and adolescents

Do not administer this medicine to children or adolescents.

Other medicines andsolifenacin/tamsulosin cinfamed

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use 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 cinfamed is eliminated from the body.
• other anticholinergic medicines, since the effects and adverse 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 cinfamed.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Solifenacin/tamsulosin cinfamed 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).

Solifenacin/tamsulosin cinfamedwith food and drink

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

Pregnancy, breastfeeding, and fertility

Solifenacin/tamsulosin cinfamed is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory disturbance) has been reported. 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.

Driving and using machines

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

3. How to use solifenacin/tamsulosin cinfamed

Follow exactly the instructions for use of this medicine provided 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, according to your preference. Do not crush or chew the tablet.

If you take more solifenacin/tamsulosin cinfamed 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take solifenacin/tamsulosin cinfamed

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

If you stop taking solifenacin/tamsulosin cinfamed

If you stop taking solifenacin/tamsulosin cinfamed, your original symptoms may reappear 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 cinfamed 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, contact your doctor immediately. You may need to stop taking solifenacin/tamsulosin cinfamed.

Solifenacin/tamsulosin cinfamed may cause allergic reactions:

• A severe allergic reaction (anaphylactic reaction) may occur, although the frequency is unknown.
• 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 cinfamed must be immediately and permanently 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 cinfamed. Appropriate treatment and/or measures should be applied.

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

• Dry mouth

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

• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculated semen 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)
• Urinary tract infection, bladder infection (cystitis)
• Disturbance of taste sensation (dysgeusia)
• Dry eyes
• Nasal dryness
• Gastroesophageal reflux disease (gastroesophageal reflux)
• Dry throat
• Dry skin
• Difficulty urinating
• Fluid accumulation in the lower parts of the legs (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 hardened feces in the large intestine (fecal impaction), colon obstruction
• 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)
• 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 available data)

• Decreased appetite
• High levels of potassium in the blood (hyperkalemia), which may cause abnormal heart rhythm
• Increased eye pressure (glaucoma)
• Irregular or abnormal heartbeat (prolongation of QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heart rate (tachycardia)
• Difficulty breathing (dyspnea)
• 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 floppy during surgery.
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder
• Vision disturbance
• Nosebleed (epistaxis)
• Delirium
• Intestinal disorder (ileus)
• Abdominal discomfort
• Severe skin allergy causing skin peeling (exfoliative dermatitis)

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 Medicinal Products: 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 cinfamed.

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 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. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of solifenacin/tamsulosin cinfamed

• The active substances are: solifenacin succinate and tamsulosin hydrochloride.

Each modified-release tablet contains 6 mg of solifenacin succinate, corresponding to 4.5 mg of solifenacin, and 0.4 mg of tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin.

• The other components are microcrystalline cellulose; macrogol; anhydrous colloidal silica; magnesium stearate; calcium hydrogen phosphate; silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica); low-substituted hydroxypropyl cellulose; hypromellose; iron oxide red (E172).

Nature of the product and pack size

Solifenacin/tamsulosin cinfamed: 6 mg/0.4 mg tablets are round (9 mm in diameter), biconvex, red, film-coated, marked with «6 04» on one side.

Blister packs made of PA/aluminum/PVC/aluminum in an outer carton containing 10, 30, 60 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta 31620 Huarte (Navarra) - Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Date of the most recent review of this leaflet: June 2022

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88509/P_88509.html

QR code to: https://cima.aemps.es/cima/dochtml/p/88509/P_88509.html