Package leaflet: Information for the patient

Tamsunorm Combi, 6 mg + 0.4 mg, modified-release tablets
Solifenacin succinate + Tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Tamsunorm Combi is and what it is used for
What you need to know before taking Tamsunorm Combi
How to take Tamsunorm Combi
Possible side effects
How to store Tamsunorm Combi
Contents of the pack and other information

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

Tamsunorm Combi is a combination of two different medicines: solifenacin and tamsulosin in a single 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 for the treatment of both moderate and severe lower urinary tract symptoms related to urine storage and voiding caused by bladder problems and enlarged prostate (benign prostatic hyperplasia). Tamsunorm Combi is used when previous treatment with monotherapy for this condition has not sufficiently relieved symptoms.
Enlargement of the prostate gland may lead to problems with urination (voiding symptoms), such as difficulty starting to pass urine, difficulty in passing urine (reduced urine stream), post-micturition dribbling, and a sensation of incomplete bladder emptying. At the same time, it adversely affects the bladder, which contracts spontaneously even when the patient does not feel the need to urinate. This leads to storage symptoms such as bladder hypersensitivity, urgency (a sudden, strong need to pass urine without prior warning), and increased frequency of urination.
Solifenacin reduces unwanted bladder contractions and increases the amount of urine the bladder can hold. Therefore, you can wait longer before going to the toilet. Tamsulosin allows free flow of urine through the urethra, making it easier to urinate.

2. Important information before using Tamsunorm Combi

When not to use Tamsunorm Combi:

if the patient is allergic to solifenacin or tamsulosin, or any of the other ingredients of this medicine (listed in section 6),
if the patient is undergoing kidney dialysis,
if the patient has severe liver disease,
if the patient has severe kidney disease and is simultaneously taking medicines that may delay the elimination of Tamsunorm Combi from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will advise whether this warning applies to the patient.
if the patient has moderate liver disease and is simultaneously taking medicines that may delay the elimination of Tamsunorm Combi from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will advise whether this warning applies to the patient.
if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis),
if the patient has a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles,
if the patient has increased pressure of fluid in the eye (glaucoma) with progressive loss of vision,
if the patient experiences fainting due to a drop in blood pressure when changing body position (when standing up to a sitting or upright position), known as orthostatic hypotension.

The patient should inform the doctor if any of the above conditions apply.
Warnings and precautions
Before starting treatment with Tamsunorm Combi, discuss the following with the doctor or
pharmacist:

if the patient is unable to pass urine (urinary retention),
if the patient has gastrointestinal obstruction,
if the patient is at risk of reduced gastrointestinal motility (movement of the stomach and intestines). The doctor will inform the patient whether this warning applies.
if the patient has severe stomach pain (hiatal hernia) or heartburn and/or is taking medicines that may cause or worsen oesophagitis,
if the patient has nervous system disorders (autonomic neuropathy),
if the patient has severe kidney disease,
if the patient has moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which the patient is being treated.
Tamsunorm Combi may affect blood pressure, which may cause dizziness, a feeling of emptiness in the head, or in rare cases fainting (orthostatic hypotension).
If any of these symptoms occur, the patient should sit or lie down until the symptoms subside.
If the patient is undergoing or is scheduled for eye surgery due to cataract or elevated intraocular pressure (glaucoma), inform the ophthalmologist about current or past use of Tamsunorm Combi, or if the patient plans to use this medicine in the future. The specialist doctor may take appropriate precautions regarding medications and surgical techniques. Please ask the doctor whether the patient should delay or temporarily discontinue Tamsunorm Combi before undergoing eye surgery for cataract or elevated intraocular pressure (glaucoma).
Children and adolescents
This medicine must not be used in children and adolescents.
Tamsunorm Combi and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor about the use of the following medicines:

medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which reduce the rate of elimination of Tamsunorm Combi from the body,
other anticholinergic medicines, as taking two medicines of the same type may increase the effect and side effects of both medicines,
cholinergic medicines, as they may reduce the effect of Tamsunorm Combi,
medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Tamsunorm Combi may reduce their effect.
other alpha-adrenergic receptor blockers, due to the risk of unwanted lowering of blood pressure,
medicines such as bisphosphonates, which may cause or worsen oesophagitis.

Tamsunorm Combi with food and drink
Tamsunorm Combi may be taken with food or between meals, according to the patient's preference.
Pregnancy, breastfeeding and effects on fertility
Tamsunorm Combi is not indicated for use in women.
Cases of abnormal ejaculation (ejaculation disorders) have been reported in men. This means that semen does not exit externally through the urethra but instead flows backward into the bladder (retrograde ejaculation), the volume of semen is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.
Driving and operating machinery
Tamsunorm Combi may cause dizziness, blurred vision, fatigue, and less frequently, somnolence. Patients experiencing these symptoms should not drive or operate machinery.

3. How to use Tamsunorm Combi

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
The maximum daily dose is one tablet taken orally containing 6 mg of solifenacin
and 0.4 mg of tamsulosin. The medicine can be taken with food or between meals.
Do not crush or chew the tablets.
Taking more Tamsunorm Combi than prescribed
If more tablets than recommended have been taken, or if the tablets have been accidentally ingested by
another person, contact a doctor or pharmacist immediately or go to a hospital
for advice.
In case of overdose, the doctor may administer activated charcoal. In an emergency,
gastric lavage may also be helpful if performed within 1 hour
after the overdose. Do not induce vomiting.
Symptoms of overdose may include, among others: dry mouth, dizziness and blurred vision,
perception of non-existent things (hallucinations), excessive excitation, seizures
(convulsions), difficulty breathing, rapid heartbeat (tachycardia), inability to
completely or partially empty the bladder or inability to urinate
(urinary retention) and (or) undesirable lowering of blood pressure.
Missing a dose of Tamsunorm Combi
Take the next dose of Tamsunorm Combi at the usual time. Do not take a double dose
to make up for a missed dose.
Stopping treatment with Tamsunorm Combi
Discontinuing treatment with Tamsunorm Combi may cause a recurrence or worsening of symptoms
related to the original condition. Any intention to discontinue treatment should always be discussed
with a doctor.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Tamsunorm Combi can cause adverse reactions, although not everyone will experience them.

The most serious adverse reaction observed not very frequently (may occur in no more than 1 in 100 men) during treatment with solifenacin succinate and tamsulosin hydrochloride in clinical trials is acute urinary retention, meaning sudden inability to pass urine. If a patient suspects this condition, they should immediately consult a doctor. Discontinuation of Tamsunorm Combi may be necessary.

Allergic reactions may occur after administration of Tamsunorm Combi:
Severe allergic reaction (anaphylactic reaction) occurring with unknown frequency.

Not very common allergic symptoms may include skin rash (which may be itchy) or urticaria.
Rarely occurring symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, Tamsunorm Combi should be immediately discontinued and must not be restarted.

If a patient experiences sudden allergic symptoms or a severe skin reaction (e.g. blistering and peeling of the skin), the doctor should be informed immediately and treatment with Tamsunorm Combi should be stopped. Appropriate treatment and (or) other necessary measures should be initiated.

Very common adverse reactions (may occur in more than 1 in 10 men)

Dry mouth.

Common adverse reactions (may occur in no more than 1 in 10 men)

Constipation
Indigestion (dyspepsia)
Dizziness
Blurred vision
Fatigue (tiredness)
Abnormal ejaculation (ejaculation disorders). This means that semen does not exit through the urethra but flows backward into the bladder (retrograde ejaculation), semen volume is reduced, or ejaculation does not occur (anejaculation).
This phenomenon is harmless.
Nausea
Abdominal pain.

Other, not very common adverse reactions (may occur in no more than 1 in 100 men)

Somnolence (drowsiness)
Itching (pruritus)
Urinary tract infection, infection (inflammation) of the urinary bladder
Taste disturbances
Dry eyes
Dry nose
Gastroesophageal reflux disease (gastroesophageal reflux)
Dry throat
Dry skin
Difficulty in passing urine
Fluid accumulation in the lower legs (oedema)
Headache
Fast or irregular heartbeat (palpitations)
Dizziness or weakness, especially when standing up (orthostatic hypotension)
Catarrh or blocked nose (nasal mucosal inflammation)
Diarrhoea
Nausea (vomiting)
Fatigue (asthenia).

Rare adverse reactions (may occur in no more than 1 in 1,000 men)

Accumulation of hard stool in the large intestine (faecal impaction), colon obstruction
Feeling of fainting (loss of consciousness)
Skin allergy leading to swelling in the tissue just beneath the skin surface (angioedema).

Very rare adverse reactions (may occur in no more than 1 in 10,000 men)

Hallucinations, disorientation
Allergic skin reactions (erythema multiforme)
Prolonged and painful penile erection (usually not during sexual activity) (priapism)
Rash, inflammation, and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genital organs (Stevens-Johnson syndrome).

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

Decreased appetite
High potassium levels in the blood (hyperkalaemia), which may cause heart rhythm disturbances
Increased intraocular pressure (glaucoma)
Irregular or unusual heartbeat (QT interval prolongation, Torsade de Pointes ventricular tachycardia, atrial fibrillation, arrhythmia)
Rapid heartbeat (tachycardia)
Shortness of breath (dyspnoea)
During eye surgery due to lens clouding (cataract) or elevated intraocular pressure (glaucoma), the pupil (black area in the center of the eye) may not dilate properly. In addition, the iris (colored part of the eye) may become floppy during surgery.
Voice disorders
Liver function disorders
Muscle weakness
Kidney function disorders
Vision disorders
Nosebleeds
Delirium
Intestinal obstruction
Discomfort in the abdominal cavity
Severe skin allergy causing peeling of the outer layer of skin (exfoliative dermatitis).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tamsunorm Combi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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.
Other components: microcrystalline cellulose, high molecular weight polyethylene glycol, polyethylene glycol, colloidal anhydrous silica, magnesium stearate, calcium hydrogen phosphate, silicified microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hypromellose, iron oxide red (E172).

What Tamsunorm Combi looks like and contents of the pack
Tamsunorm Combi 6 mg + 0.4 mg coated tablets are red, round, biconvex, with a diameter of 9 mm, and have the imprint "6 04" on one side.
The tablets are packed in blisters made of PA/Aluminium/PVC/Aluminium foil, placed in cardboard boxes containing 10 or 30 tablets. Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Croatia: Semquest