Solifenacin succinate + Tamsulosin hidrohloride Adamed

LEAFLET SUPPLIED WITH THE PACKAGING

Leaflet supplied with the packaging: patient information

Solifenacin succinate + Tamsulosin hydrochloride Adamed, 6 mg+0.4 mg, prolonged-release tablets

prolonged release
solifenacin succinate + tamsulosin hydrochloride
Before taking the medicine, you should carefully read the contents of the leaflet, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Solifenacin succinate + Tamsulosin hydrochloride Adamed and what is it 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 packaging and other information

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

what it is used for
Solifenacin succinate + Tamsulosin hydrochloride Adamed is a combination of two different medicines - solifenacin and tamsulosin - in one tablet. Solifenacin belongs to a group of anticholinergic medicines, and tamsulosin belongs to a group of alpha-adrenergic receptor blockers.
Solifenacin succinate + Tamsulosin hydrochloride Adamed is used in men for the treatment of both moderately and severely symptomatic benign prostatic hyperplasia (BPH), which is a condition where the prostate gland is enlarged. This can cause problems with passing urine.
Solifenacin succinate + Tamsulosin hydrochloride Adamed is used when previous monotherapy treatment has not sufficiently alleviated the symptoms. Benign prostatic hyperplasia can cause problems with urination (symptoms related to passing urine), such as difficulty starting to urinate, difficulty urinating (reduced urine flow), post-micturition dribbling, and a feeling of incomplete emptying of the bladder. At the same time, it can have an adverse effect on the bladder, which contracts involuntarily when the patient does not feel the need to urinate. This can cause symptoms related to urine retention, such as impaired bladder sensitivity, sudden urge to urinate (strong, sudden urge to urinate without prior signs), and the need to urinate more frequently.
Solifenacin reduces unwanted contractions of the bladder 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 Solifenacin succinate + Tamsulosin hydrochloride Adamed

hydrochloride Adamed

When not to take Solifenacin succinate + Tamsulosin hydrochloride Adamed:

• if the patient is allergic to solifenacin or tamsulosin, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is undergoing dialysis,
• if the patient has severe liver disease,
• if the patient has severe kidney disease and is also taking medicines that may slow down the elimination of Solifenacin succinate + Tamsulosin hydrochloride Adamed from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will inform you whether this warning applies to you.
• if the patient has moderate liver disease and is also taking medicines that may slow down the elimination of Solifenacin succinate + Tamsulosin hydrochloride Adamed from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will inform you whether this warning applies to you.
• if the patient has severe gastrointestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis),
• if the patient has a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles,
• if the patient has increased eye pressure (glaucoma) with progressive vision loss,
• if the patient experiences 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 starting treatment with Solifenacin succinate + Tamsulosin hydrochloride Adamed, discuss with your doctor or pharmacist:

• if the patient has difficulty urinating (urinary retention),
• if the patient has gastrointestinal obstruction,
• if the patient is at risk of gastrointestinal obstruction (gastrointestinal motility disorders). The doctor will inform you whether this warning applies to you.
• if the patient has a hernia of the oesophageal hiatus (hiatus hernia) or gastroesophageal reflux disease and is also taking medicines that may cause or worsen oesophagitis,
• if the patient has autonomic 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 progress of the disease for which the patient is being treated.
Solifenacin succinate + Tamsulosin hydrochloride Adamed may affect blood pressure, which can 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 and wait for them to pass.
If the patient is undergoing or is to undergo eye surgery for cataracts or increased eye pressure (glaucoma), they should inform their ophthalmologist about their current, past, or planned use of Solifenacin succinate + Tamsulosin hydrochloride Adamed. The specialist may take appropriate precautions regarding the medicines used and surgical techniques.
Ask your doctor whether you should delay or temporarily stop taking Solifenacin succinate + Tamsulosin hydrochloride Adamed if you are undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

This medicine should not be used in children and adolescents.

Solifenacin succinate + Tamsulosin hydrochloride Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to 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 rate of elimination of Solifenacin succinate + Tamsulosin hydrochloride Adamed from the body,
• other anticholinergic medicines, as the simultaneous use of two medicines of the same type may increase the risk of adverse effects and interactions,
• cholinergic medicines, as they may weaken the effect of Solifenacin succinate + Tamsulosin hydrochloride Adamed,
• medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Solifenacin succinate + Tamsulosin hydrochloride Adamed may weaken their effect.
• 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 can be taken with or without food, as preferred.

Pregnancy, breastfeeding, and fertility

Solifenacin succinate + Tamsulosin hydrochloride Adamed 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 instead 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

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

3. How to take Solifenacin succinate + Tamsulosin hydrochloride Adamed

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult 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.
The tablets should not be crushed or chewed.

Overdose of Solifenacin succinate + Tamsulosin hydrochloride Adamed

In case of overdose or accidental ingestion of the tablets by another person, immediately consult a doctor or pharmacist or go to the hospital for advice.
In case of overdose, the doctor may use 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: dry mouth, dizziness, and blurred vision, perception of non-existent things (hallucinations), excessive stimulation, convulsions (seizures), breathing difficulties, rapid heartbeat (tachycardia), inability to fully or partially empty the bladder or inability to urinate (urinary retention) and/or undesirable decrease in blood pressure.

Missed dose of Solifenacin succinate + Tamsulosin hydrochloride Adamed

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

Stopping treatment with Solifenacin succinate + Tamsulosin hydrochloride Adamed

Stopping treatment with Solifenacin succinate + Tamsulosin hydrochloride Adamed may cause a relapse or worsening of the symptoms associated with the original illness. The intention to stop treatment should always be discussed with a doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solifenacin succinate + Tamsulosin hydrochloride Adamed can cause side effects, although not everybody gets them.
The most serious side effect that has been observed, although not very frequently (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 the patient thinks this applies to them, they should immediately consult a doctor. It may be necessary to stop taking Solifenacin succinate + Tamsulosin hydrochloride Adamed.
After taking Solifenacin succinate + Tamsulosin hydrochloride Adamed, allergic reactions may occur:

• A severe allergic reaction (anaphylactic reaction) of unknown frequency may occur.
• Uncommon symptoms of allergic reactions may include skin rash (which may be itchy) or hives.
• Rarely, swelling of the face, lips, mouth, tongue, or throat may occur, which can cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely during treatment with tamsulosin and very rarely during treatment with solifenacin. If angioedema occurs, Solifenacin succinate + Tamsulosin hydrochloride Adamed should be stopped immediately and not restarted.

If the patient experiences sudden symptoms of allergy or a severe skin reaction (e.g. blistering and peeling of the skin), they should immediately inform their doctor and stop taking Solifenacin succinate + Tamsulosin hydrochloride Adamed. Appropriate treatment and/or other necessary measures should be taken.

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
• dizziness
• blurred vision
• fatigue (tiredness)
• abnormal ejaculation (ejaculation disorders). This means that semen does not come out through the urethra, but instead 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 (feeling sick)
• abdominal pain

Other, uncommon side effects (may affect up to 1 in 100 men)

• sleepiness (drowsiness)
• flushing (redness)
• urinary tract infections, infection (cystitis)
• taste disorders
• dry eyes
• dry nose
• gastroesophageal reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fluid accumulation in the legs (oedema)
• headache
• rapid or irregular heartbeat (palpitations)
• dizziness or weakness, especially when standing up (orthostatic hypotension)
• runny nose or stuffy nose (rhinitis)
• diarrhoea
• 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 large intestine (faecal impaction), intestinal obstruction
• feeling of fainting (loss of consciousness)
• allergic skin reaction that leads to swelling in the tissue just beneath the skin (angioedema)

Very rare side effects (may affect less than 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, nose, or genitals (Stevens-Johnson syndrome)

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

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin succinate + Tamsulosin hydrochloride Adamed

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 stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Solifenacin succinate + Tamsulosin hydrochloride Adamed contains

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

What Solifenacin succinate + Tamsulosin hydrochloride Adamed looks like and contents of the pack

Solifenacin succinate + Tamsulosin hydrochloride Adamed, 6 mg+0.4 mg, prolonged-release tablets are round, biconvex, red, film-coated, with "6 04" engraved on one side.
PA/Aluminium/PVC/Aluminium blister pack 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.
Pieńków, 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 tablets with modified release
France:
VECALMYS 6 mg/0.4 mg, modified-release tablet
Greece:
VALIREM
Italy:
Luracin
Romania:
SOLIFENACIN/TAMSULOZIN ADAMED 6 mg/0.4 mg modified-release tablets
Spain:
Solifenacina/tamsulosina cinfamed 6 mg/ 0.4 mg modified-release tablets EFG
Date of last revision of the leaflet:03.2023