Patient Information Leaflet: Information for the User

Suloxina 6 mg/0.4 mg modified-release tablets

succinylate solifenacin / hydrochloride tamsulosin
Equivalent medicine
Please read all of 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Suloxina is and what it is used for

Suloxina is a combination of two different medicines called solifenacin and tamsulosin in a single tablet. Solifenacin belongs to a group of medicines known as anticholinergics, and tamsulosin belongs to a group of medicines known as alpha-blockers.
Suloxina is used in men to treat moderate to severe filling symptoms and voiding symptoms of the lower urinary tract caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Suloxina is used for this condition when previous monotherapy treatments have not adequately relieved the symptoms.
An enlarged prostate can cause urinary problems (voiding symptoms), such as hesitancy (difficulty starting urination), difficulty in passing urine (weak stream), dribbling, and a sensation of incomplete bladder emptying. At the same time, the bladder is also involved and contracts spontaneously even when you do not wish to empty it. This leads to filling symptoms such as altered bladder sensation, urgency (a sudden and strong need to urinate without prior warning), and increased frequency of urination.
Solifenacin reduces involuntary contractions of your bladder and increases the amount of urine your bladder can hold. In this way, it helps delay the need to go to the toilet. Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

2. What you need to know before taking Suloxina

Do not take Suloxina

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 renal dialysis.
if you have severe liver disease.
if you have severe kidney disease AND are simultaneously being treated with medicines that can reduce the elimination of Suloxina from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
if you have moderate liver problems AND are simultaneously being treated with medicines that can reduce the elimination of Suloxina from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
if you have a serious stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
if you have the muscle disorder known as myasthenia gravis, which causes extreme weakness of certain muscles.
if you have increased intraocular pressure (glaucoma), with gradual loss of vision.
if you experience fainting due to low blood pressure when changing body position (sitting or standing up), called orthostatic hypotension.

Inform your doctor if you have any of the conditions listed above.
Warnings and precautions
Talk to your doctor or pharmacist before using Suloxina if:

you have difficulty passing urine (urinary retention).
you have obstructions in the digestive system.
you are at risk of reduced gastrointestinal motility (gastric and intestinal movements). Your doctor will advise you about this possibility.
you have stomach pain (hiatal hernia) or heartburn and/or are simultaneously taking medicines that cause or worsen oesophagitis.
you suffer from certain nervous system disorders (autonomic neuropathy).
you have severe kidney disease.
you have moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which you are being treated.
Suloxina may affect blood pressure and may 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 on a waiting list for eye surgery due to cataracts or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or plan to take Suloxina. The specialist may then take appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing eye surgery for cataracts or increased eye pressure (glaucoma).
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Suloxina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor if you are taking:

medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine that decrease the rate of elimination of Suloxina from the body.
other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase if you are taking two medicines of the same type.
cholinergics, which may reduce the effectiveness of Suloxina.
medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility, as Suloxina may reduce their effectiveness.
other alpha-blockers (used to lower blood pressure), as this may cause an unwanted drop in blood pressure.
medicines such as bisphosphonates that may cause or worsen inflammation of the oesophagus (oesophagitis).

Suloxina with food and drinks
Suloxina may be taken with or without food, as you prefer.
Pregnancy, breastfeeding and fertility
Suloxina is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that seminal fluid does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculation is reduced or absent (anejaculation). This event is harmless.
Driving and using machines
Suloxina may cause dizziness, blurred vision, fatigue and, not commonly, somnolence. Avoid driving or operating machinery if you experience these side effects.

3. How to take Suloxina

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, 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. You may take Suloxina with or without food, according to your preference. Do not crush or chew the tablet.
If you take more Suloxina than you should
If you have taken more tablets than recommended, or if someone else has accidentally taken your tablets, consult a doctor, pharmacist, or go to hospital immediately.
In case of overdose, the doctor may treat you with activated charcoal; 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, perception of objects that are not present (hallucinations), over-excitation, seizures, breathing difficulties, increased heart rate (tachycardia), difficulty completely or partially emptying the bladder or difficulty urinating (urinary retention), and/or unwanted drop in blood pressure.
If you forget to take Suloxina
Take the next Suloxina tablet at your regular scheduled time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Suloxina
If you stop treatment with Suloxina, your symptoms may return or worsen.
Always consult your doctor if you intend to discontinue treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Suloxina can cause side effects, although not everyone gets them.

The most serious side effect observed during clinical studies with solifenacin succinate/tamsulosin hydrochloride, occurring uncommonly (may affect up to 1 in 100 men), is urinary retention, which is a sudden difficulty in urinating. If you think you are experiencing this side effect, contact your doctor immediately. You may need to stop taking Suloxina.

Allergic reactions that may occur with Suloxina:

Uncommon symptoms of allergic reactions may include skin rashes (which may be itchy) or hives.
Rare 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. If angioedema occurs, Suloxina must be stopped immediately and must not be taken again.

If you experience an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin), you must contact your doctor immediately and stop taking Suloxina. Appropriate treatment and/or measures must be taken.

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

dry mouth
constipation
indigestion (dyspepsia)
dizziness
blurred vision
fatigue (tiredness)
abnormal ejaculation (ejaculation disorders). This means that semen does not exit through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of semen is reduced or absent (failed ejaculation). This phenomenon is harmless.
feeling unwell (nausea)
abdominal pain

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

drowsiness
itching
skin rash
hives
urinary tract infections, bladder infections (cystitis)
altered taste sensation (dysgeusia)
dry eyes
dry nose
reflux disease (gastroesophageal reflux)
dry throat
dry skin
difficulty urinating (urinary retention, dysuria)
fluid accumulation in the lower legs (peripheral edema)
headache
rapid or irregular heartbeat (palpitations)
feeling dizzy or weak, especially when standing up (orthostatic hypotension)
stuffy or runny nose (rhinitis)
diarrhea
feeling unwell (vomiting)
weakness (asthenia)

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

accumulation of large amounts of feces in the large intestine (fecal impaction), colon obstruction
feeling faint (syncope)
skin allergic reaction involving swelling of the tissue just beneath the skin surface (angioedema)

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

hallucinations, confusion
skin allergic reactions (Erythema multiforme)
prolonged and painful erection (usually not occurring during sexual activity) (priapism)
inflammation, blistering of the skin and/or mucous membranes of the lips, eyes and mouth, nostrils or genitals (Stevens-Johnson syndrome)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

anaphylactic reaction (sudden and severe allergic reaction with breathing difficulties, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness)
decreased appetite
high levels of potassium in the blood (hyperkalemia) which may cause abnormal heart rhythm
increased eye pressure (glaucoma)
abnormal and irregular heartbeat (QT prolongation, torsade de pointes, atrial fibrillation, arrhythmia)
rapid heartbeat (tachycardia)
difficulty breathing (dyspnea)
during eye surgery for lens opacity (cataract) or for increased eye pressure (glaucoma), the pupil (the black circle in the center of your eye) may dilate poorly. Also, the iris (the colored part of your eye) may become floppy during surgery.
voice disorders
liver disorders
abnormal liver function test
muscle weakness
kidney disorders
impaired vision
nosebleeds (epistaxis)
acute confusional state (delirium)
intestinal obstruction (ileus)
abdominal discomfort
redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suloxina

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.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Suloxina contains

The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride.
The other components are: high molecular weight polyethylene glycol (E1521) (contains silicon dioxide and butylated hydroxytoluene (E321)); anhydrous colloidal silica (E551); magnesium stearate (E470b); calcium hydrogen phosphate (E341); microcrystalline cellulose (E460); silicified microcrystalline cellulose; low-substituted hydroxypropylcellulose (E463); hypromellose (E464); iron oxide red (E172); polyethylene glycol (E1521).

Description of the appearance of Suloxina and contents of the pack
Suloxina 6 mg/0.4 mg modified-release tablets are round, biconvex, red, film-coated, with the imprint “6 04” engraved on one side and a diameter of 9 mm.
Suloxina is supplied in a cardboard box containing blisters made of PA/Aluminum/PVC/Aluminum.
Pack size: 30 modified-release tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Nederland: Suloxina 6 mg/0.4 mg tabletten met gereguleerde afgifte
Italy: Suloxina