Solifenacin succinate + tamsulosin hydrochloride adamed

PACKAGE LEAFLET

Package leaflet: information for the patient

Solifenacin succinate + Tamsulosin hydrochloride Adamed, 6 mg+0.4 mg, modified-release tablets
solifenacin succinate + tamsulosin hydrochloride
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Solifenacin succinate + Tamsulosin hydrochloride Adamed is and what it is used for
2. Important information before taking Solifenacin succinate + Tamsulosin hydrochloride Adamed
3. How to take Solifenacin succinate + Tamsulosin hydrochloride Adamed
4. Possible side effects
5. How to store Solifenacin succinate + Tamsulosin hydrochloride Adamed
6. Contents of the pack and other information

1. What Solifenacin succinate + Tamsulosin hydrochloride Adamed is and what it is used for

Solifenacin succinate + Tamsulosin hydrochloride Adamed is a combination of two different medicines – solifenacin and tamsulosin – in a single tablet. Solifenacin belongs to a group of medicines called anticholinergics, while tamsulosin belongs to a group of medicines known as alpha-adrenergic receptor blockers.
Solifenacin succinate + Tamsulosin hydrochloride Adamed is used in men to treat both moderate and severe lower urinary tract symptoms related to urine storage and voiding caused by bladder problems and enlargement of the prostate gland (benign prostatic hyperplasia).
Solifenacin succinate + Tamsulosin hydrochloride Adamed 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 flow), post-micturition dribbling, and a sensation of incomplete bladder emptying. At the same time, this may adversely affect the bladder, which contracts spontaneously when the patient does not feel the need to urinate. This leads to symptoms related to urine storage, 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 facilitates the free flow of urine through the urethra, making urination easier.

2. Important information before taking Solifenacin succinate + Tamsulosin hydrochloride Adamed

Do not take Solifenacin succinate + Tamsulosin hydrochloride Adamed:

• if you are allergic to solifenacin or tamsulosin, or to 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 simultaneously taking medicines that may delay the elimination of Solifenacin succinate + Tamsulosin hydrochloride Adamed from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you whether this warning applies to you,
• if you have moderate liver disease and are simultaneously taking medicines that may delay the elimination of Solifenacin succinate + Tamsulosin hydrochloride Adamed from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you whether this warning applies to you,
• if you have severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis),
• if you have a muscle disease called myasthenia gravis, which may cause significant muscle weakness,
• if you have increased intraocular pressure (glaucoma) with progressive vision loss,
• if you experience fainting due to a drop in blood pressure upon changing body position (when standing up from a sitting or lying position), known as orthostatic hypotension.

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

Warnings and precautions

Before starting treatment with Solifenacin succinate + Tamsulosin hydrochloride Adamed, discuss with your doctor or pharmacist if:

• you have inability to pass urine (urinary retention),
• you have gastrointestinal obstruction,
• you are at risk of delayed gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you whether this warning applies to you,
• you have a hiatal hernia or heartburn (gastroesophageal reflux) and/or you are taking medicines that may cause or worsen oesophagitis,
• you have nervous system disorders (autonomic neuropathy),
• you have severe kidney disease,
• you have moderate liver disease.

Regular medical check-ups are necessary to monitor the progress of the condition being treated.
Solifenacin succinate + Tamsulosin hydrochloride Adamed may affect blood pressure, which may cause dizziness, a feeling of emptiness in the head, or, rarely, 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 scheduled to undergo cataract surgery or surgery due to increased intraocular pressure (glaucoma), inform your ophthalmologist that you are currently taking, have previously taken, or plan to take Solifenacin succinate + Tamsulosin hydrochloride Adamed. The specialist may take appropriate precautions regarding medications and surgical techniques.
Ask your doctor whether you should delay or temporarily discontinue taking this medicine if you are undergoing cataract surgery or surgery due to increased eye pressure (glaucoma).

Children and adolescents
This medicine must not be used in children and adolescents.

Solifenacin succinate + Tamsulosin hydrochloride Adamed and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

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

Taking Solifenacin succinate + Tamsulosin hydrochloride Adamed with food and drink
Solifenacin succinate + Tamsulosin hydrochloride Adamed may be taken with or without food, according to your preference.

Pregnancy, breastfeeding and fertility
Solifenacin succinate + Tamsulosin hydrochloride Adamed 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 the body through the urethra but flows backward into the bladder (retrograde ejaculation), semen volume is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.

Driving and operating machinery
Solifenacin succinate + Tamsulosin hydrochloride Adamed may cause dizziness, blurred vision, fatigue, and, less frequently, somnolence. Patients experiencing these symptoms should not drive or operate machinery.

3. How to use Solifenacin succinate + Tamsulosin hydrochloride Adamed

This medicine should always be taken as directed by a doctor 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 may be taken with food or between meals. Tablets must not be crushed or chewed.

Taking more Solifenacin succinate + Tamsulosin hydrochloride Adamed than prescribed

If more tablets than recommended are taken, or if someone else accidentally takes the tablets, contact a doctor or pharmacist immediately or go to 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 of 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 drop in blood pressure.

Missing a dose of Solifenacin succinate + Tamsulosin hydrochloride Adamed

Take the next dose of Solifenacin succinate + Tamsulosin hydrochloride Adamed at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Solifenacin succinate + Tamsulosin hydrochloride Adamed

Stopping treatment with Solifenacin succinate + Tamsulosin hydrochloride Adamed 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 side effects

Like all medicines, Solifenacin succinate + Tamsulosin hydrochloride Adamed may cause side effects, although not everyone experiences them.

The most commonly reported side effect observed infrequently (may occur in less than 1 in 100 men) during clinical trials with solifenacin succinate and tamsulosin hydrochloride is acute urinary retention, meaning sudden inability to pass urine. If a patient suspects this condition, they should contact their doctor immediately. It may be necessary to stop taking Solifenacin succinate + Tamsulosin hydrochloride Adamed.

Allergic reactions may occur after taking Solifenacin succinate + Tamsulosin hydrochloride Adamed:

• A severe allergic reaction (anaphylactic reaction) may occur, frequency unknown.
• Infrequent allergic symptoms 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). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, treatment with Solifenacin succinate + Tamsulosin hydrochloride Adamed must be stopped immediately 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), they should contact their doctor immediately and stop taking Solifenacin succinate + Tamsulosin hydrochloride Adamed. Appropriate treatment and/or other necessary measures should be initiated.

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

• dry mouth

Common side effects (may affect less than 1 in 10 men)

• constipation
• indigestion
• dizziness
• blurred vision
• fatigue (tiredness)
• abnormal ejaculation (ejaculation disorders). This means semen does not exit through the urethra but 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.
• nausea (feeling sick)
• abdominal pain

Other, less common side effects (may affect less than 1 in 100 men)

• somnolence (drowsiness)
• itching (pruritus)
• urinary tract infection, bladder infection (cystitis)
• taste disturbances
• dry eyes
• dry nose
• gastroesophageal reflux disease (acid reflux)
• dry throat
• dry skin
• difficulty passing urine
• fluid accumulation in the lower legs (oedema)
• headache
• fast or irregular heartbeat (palpitations)
• dizziness or weakness, especially when standing up (orthostatic hypotension)
• cold symptoms or blocked nose (nasal mucosa inflammation)
• diarrhoea
• nausea (vomiting)
• fatigue (asthenia)

Rare side effects (may affect less than 1 in 1,000 men)

• accumulation of large amounts of hard stool in the large intestine (faecal impaction), colon obstruction
• feeling faint (loss of consciousness)
• skin allergy leading to swelling in the tissue just beneath the skin surface (angioedema)

Very rare side effects (may affect less 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 (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, ventricular tachycardia of the torsade de pointes type, atrial fibrillation, arrhythmia)
• rapid heartbeat (tachycardia)
• shortness of breath
• during cataract surgery or surgery due to elevated intraocular pressure (glaucoma), the pupil (black area in the center of the eye) may not dilate properly. Additionally, 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 disorders (intestinal obstruction)
• abdominal discomfort
• severe skin allergy causing skin peeling (toxic epidermal necrolysis).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the responsible entity.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Solifenacin succinate + Tamsulosin hydrochloride Adamed

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 term "EXP". The expiry date refers to the last day of the indicated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

What Solifenacin succinate + Tamsulosin hydrochloride Adamed 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 free solifenacin base, and 0.4 mg of tamsulosin hydrochloride, equivalent to 0.37 mg of free tamsulosin base.
  The other ingredients are 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, and iron oxide red (E172).

What Solifenacin succinate + Tamsulosin hydrochloride Adamed looks like and contents of the pack
Solifenacin succinate + Tamsulosin hydrochloride Adamed 6 mg + 0.4 mg tablets are round, 9 mm in diameter, biconvex, coated, red tablets, with the imprint “6 04” on one side.
Packaged in PA/Aluminium/PVC/Aluminium blisters in a cardboard box containing 10, 30, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńsków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: +48 22 732 77 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:
Poland: Solifenacin succinate + Tamsulosin hydrochloride Adamed
Austria: Solifenacin +Tamsulosin Adamed
Bulgaria: Urifenacin
Croatia: Tancer 6 mg/0.4 mg tablete s prilagođenim oslobađanjem
France: VECALMYS 6 mg/0.4 mg, comprimé à libération modifiée
Greece: VALIREM
Italy: Luracin
Romania: SOLIFENACIN/TAMSULOZIN ADAMED 6 mg/0.4 mg comprimate cu eliberare modificată
Spain: Solifenacina/tamsulosina cinfamed 6 mg/0.4 mg comprimidos de liberación modificada EFG