Tamsunorm Combi

Package Leaflet: Information for the Patient

Tamsunorm Combi, 6 mg + 0.4 mg, modified-release tablets

Solifenacin succinate + Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tamsunorm Combi and what is it used for
• 2. Important information before taking Tamsunorm Combi
• 3. How to take Tamsunorm Combi
• 4. Possible side effects
• 5. How to store Tamsunorm Combi
• 6. Contents of the pack and other information

1. What is Tamsunorm Combi and what is it used for

Tamsunorm Combi is a combination of two different medicines: 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-adrenergic receptor blockers.

Tamsunorm Combi is used in men to treat moderate to severe symptoms of benign prostatic hyperplasia (enlargement of the prostate gland), which cause problems with the flow of urine. Tamsunorm Combi is used when previous treatment with monotherapy has not alleviated the symptoms sufficiently.

Benign prostatic hyperplasia can cause problems with urination (urinary symptoms), such as difficulty starting urination, difficulty urinating (reduced urine flow), post-micturition dribbling, and a feeling of incomplete emptying of the bladder. At the same time, it has an adverse effect on the bladder, which contracts involuntarily when the patient does not feel the need to urinate.

This leads to the occurrence of symptoms related to urine storage, such as bladder sensitivity disorders, sudden urge to urinate (strong, sudden desire to urinate without prior signs), and the need to urinate more frequently.

Solifenacin reduces unwanted bladder contractions and increases the amount of urine that the bladder can hold. Therefore, you can wait longer before going to the toilet. Tamsulosin allows for a smooth flow of urine through the urethra, making it easier to urinate.

2. Important information before taking Tamsunorm Combi

When not to take Tamsunorm Combi:

• if you are allergic to solifenacin or tamsulosin, or any of the other ingredients of this medicine (listed in section 6),
• if you are undergoing dialysis,
• if you have severe liver disease,
• if you have severe kidney disease and are taking medicines that may delay the elimination of Tamsunorm Combi from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this warning applies to you.
• if you have moderate liver disease and are taking medicines that may delay the elimination of Tamsunorm Combi from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this warning applies to you.
• if you have severe stomach or intestinal disorders (including toxic megacolon, a complication of ulcerative colitis),
• if you have a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles,
• if you have increased eye pressure (glaucoma) with progressive vision loss,
• if you experience fainting spells caused by a drop in blood pressure when changing body position (when standing up or sitting up), which is called orthostatic hypotension.

Tell your doctor if you think any of the above conditions apply to you.

Warnings and precautions

Before taking Tamsunorm Combi, discuss with your doctor or pharmacist:

• if you have difficulty urinating (urinary retention),
• if you have intestinal obstruction,
• if you have a risk of delayed bowel movement (gastrointestinal motility). Your doctor will inform you if this warning applies to you.
• if you have a hiatus hernia or gastroesophageal reflux disease and are taking medicines that may cause or worsen esophageal inflammation,
• if you have autonomic nervous system disorders (autonomic neuropathy),
• if you have severe kidney disease,
• if you have moderate liver disease.

Regular medical check-ups are necessary to monitor the progression of the disease for which you are being treated.

Tamsunorm Combi may affect blood pressure, which can cause dizziness, a feeling of emptiness in the head, or, in rare cases, fainting (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down until they pass.

If you are undergoing or are going to undergo eye surgery for cataracts or increased eye pressure (glaucoma), tell your ophthalmologist about your current or past use of Tamsunorm Combi, or if you plan to use it in the future. The specialist doctor may take appropriate precautions regarding the medications and surgical techniques used. Ask your doctor if you should delay or temporarily stop taking Tamsunorm Combi in case of eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

This medicine should not be used in children and adolescents.

Tamsunorm Combi and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

In particular, inform your doctor about the use of the following medicines:

• medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which reduce the elimination of Tamsunorm Combi from the body,
• other anticholinergic medicines, as there is a possibility of increased action and side effects of both medicines when two medicines of the same type are taken,
• cholinergic medicines, as they may weaken the action of Tamsunorm Combi,
• medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Tamsunorm Combi may weaken their action.
• other alpha-adrenergic receptor blockers, due to the possibility of undesirable blood pressure lowering,
• medicines such as bisphosphonates, which may cause or worsen esophageal inflammation.

Tamsunorm Combi with food and drink

Tamsunorm Combi can be taken with or without food, according to the patient's preference.

Pregnancy, breastfeeding, and fertility

Tamsunorm Combi is not indicated for use in women.

There have been reports of abnormal ejaculation (ejaculation disorders) in men. This means that semen does not come out through the urethra but flows back into the bladder (retrograde ejaculation), the semen volume is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.

Driving and using machines

Tamsunorm Combi may cause dizziness, blurred vision, fatigue, and, less often, sleepiness. Patients who experience these symptoms should not drive or operate machinery.

3. How to take Tamsunorm Combi

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken orally. The medicine can be taken with or without food.

Do not crush or chew the tablets.

What to do if you take more Tamsunorm Combi than you should

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

In the event of an overdose, your doctor may administer activated charcoal. In an emergency, gastric lavage may also be helpful if performed within 1 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), excessive excitement, convulsions (seizures), difficulty breathing, rapid heartbeat (tachycardia), inability to fully or partially empty the bladder or inability to urinate (urinary retention), and (or) undesirable decrease in blood pressure.

What to do if you forget to take Tamsunorm Combi

Take the next tablet of Tamsunorm Combi at the usual time. Do not take a double dose to make up for the forgotten dose.

What to do if you stop taking Tamsunorm Combi

Stopping Tamsunorm Combi may cause a relapse or worsening of the symptoms associated with the original condition. The intention to stop treatment should always be discussed with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsunorm Combi can cause side effects, although not everybody gets them.

The most serious side effect that has been observed, although not very often (may occur in less than 1 in 100 men), during treatment with solifenacin succinate and tamsulosin hydrochloride in clinical trials, is acute urinary retention, which means sudden inability to urinate. If you think this situation applies to you, you should see your doctor immediately. It may be necessary to stop taking Tamsunorm Combi.

After taking Tamsunorm Combi, allergic reactions may occur:

• A severe allergic reaction (anaphylactic reaction) with an unknown frequency.
• Uncommon symptoms of allergic reactions may include skin rash (which may be itchy) or hives.
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema). Rarely, during treatment with tamsulosin and very rarely during treatment with solifenacin, angioedema has been reported. If angioedema occurs, you should stop taking Tamsunorm Combi immediately and not restart it.

If you experience sudden symptoms of an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), you should tell your doctor immediately and stop taking Tamsunorm Combi. You should receive appropriate treatment and (or) other necessary measures.

Very common side effects (may affect more than 1 in 10 men)

• dry mouth.

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

• constipation
• indigestion (dyspepsia)
• dizziness
• blurred vision
• fatigue (tiredness)
• abnormal ejaculation (ejaculation disorders). This means that semen does not come out through the urethra but flows back into the bladder (retrograde ejaculation), the semen volume is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.
• nausea (nausea)
• abdominal pain.

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

• drowsiness (somnolence)
• itching (pruritus)
• urinary tract infection, cystitis
• taste disorders
• dry eyes
• dry nose
• gastroesophageal reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fluid accumulation in the legs (edema)
• headache
• rapid or irregular heartbeat (palpitations)
• dizziness or weakness, especially when standing up (orthostatic hypotension)
• runny nose or stuffy nose (rhinitis)
• diarrhea
• vomiting (vomiting)
• fatigue (asthenia).

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

• accumulation of a large amount of hard stool in the intestine (fecal impaction), intestinal obstruction
• feeling of fainting (loss of consciousness)
• skin allergy that leads to swelling in the tissue just beneath the skin surface (angioedema).

Very rare side effects (may affect up to 1 in 10,000 men)

• hallucinations, disorientation
• allergic skin reactions (erythema multiforme)
• prolonged and painful erection of the penis (usually not during sexual activity) (priapism)
• rash, inflammation, and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).

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

• decreased appetite
• high potassium levels in the blood (hyperkalemia), which can cause heart rhythm disorders
• increased eye pressure (glaucoma)
• irregular or abnormal heartbeat (QT interval prolongation, Torsade de Pointes-type ventricular tachycardia, atrial fibrillation, arrhythmia)
• rapid heartbeat (tachycardia)
• shortness of breath (dyspnea)
• in the case of eye surgery for cataracts or increased eye pressure (glaucoma), the pupil (the black area in the center of the eye) may not dilate properly. Additionally, the iris (the colored part of the eye) may become flaccid during surgery.
• voice disorders
• liver function disorders
• muscle weakness
• kidney function disorders
• vision disorders
• nosebleeds
• delirium (delirium)
• intestinal obstruction
• feeling of discomfort in the abdominal cavity
• severe skin allergy causing peeling of the skin (exfoliative dermatitis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamsunorm Combi

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 that month.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tamsunorm Combi contains

• The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacin succinate, equivalent to 4.5 mg of solifenacin, and 0.4 mg of tamsulosin hydrochloride, equivalent to 0.37 mg of tamsulosin.
• The other ingredients are: microcrystalline cellulose, high molecular weight macrogol, macrogol, colloidal anhydrous silica, magnesium stearate, calcium hydrogen phosphate, siliconized microcrystalline cellulose, low-substituted hydroxypropylcellulose, hypromellose, red iron oxide (E172).

What Tamsunorm Combi looks like and contents of the pack

Tamsunorm Combi 6 mg + 0.4 mg modified-release tablets are red, round, biconvex, 9 mm in diameter, and have the symbol "6 04" embossed on one side.

Blisters of PA/Aluminum/ PVC/Aluminum foil in a cardboard box containing 10 or 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Tel.: +48 17 865 51 00

Manufacturer

Adamed Pharma S.A.

ul. Marszałka J. Piłsudskiego 5

95-200 Pabianice

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

Croatia: Semquest

Date of last revision of the leaflet:December 2023