Solifenacin and tamsulosin Mylan

Package leaflet: Information for the user

Solifenacina e Tamsulosin Mylan 6 mg/0.4 mg modified-release tablets

solifenacin succinate/tamsulosin hydrochloride
Equivalent medicine
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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Solifenacina e Tamsulosin Mylan is and what it is used for
2. What you need to know before taking Solifenacina e Tamsulosin Mylan
3. How to take Solifenacina e Tamsulosin Mylan
4. Possible side effects
5. How to store Solifenacina e Tamsulosin Mylan
6. Contents of the pack and other information

1 What Solifenacina e Tamsulosin Mylan is and what it is used for
Solifenacina e Tamsulosin Mylan 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.
Solifenacina e Tamsulosin Mylan is used in men to treat moderate to severe filling and voiding symptoms of the lower urinary tract caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Solifenacina e Tamsulosin Mylan is used for this condition when previous monotherapy treatments have not adequately resolved the symptoms.
An enlarged prostate can cause urinary problems (voiding symptoms) such as hesitancy (difficulty starting urination), difficulty urinating (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 causes filling symptoms such as changes in bladder sensation, urgency (a sudden, strong desire to urinate without prior warning signs) and the need to urinate more frequently.
Solifenacin reduces involuntary bladder contractions and increases the amount of urine the bladder can hold. This helps delay the need to urinate. Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

2 What you need to know before taking Solifenacina e Tamsulosin Mylan
Do not use Solifenacina e Tamsulosin Mylan:

• 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 Solifenacina e Tamsulosin Mylan 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 disease AND are simultaneously being treated with medicines that can reduce the elimination of Solifenacina e Tamsulosin Mylan 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 disease called myasthenia gravis, which causes extreme weakness of certain muscles.
• if you have increased intraocular pressure (glaucoma), with gradual loss of vision.
• if you suffer from fainting due to a drop in blood pressure when changing position (sitting or standing up), called orthostatic hypotension.

Inform your doctor if you have any of the conditions listed above.
Warnings and precautions
Consult your doctor or pharmacist before taking Solifenacina e Tamsulosin Mylan:

• if you have difficulty passing urine (urinary retention).
• if you have obstructions in the digestive system.
• if you are at risk of slowed digestive system (gastric and intestinal movements). Your doctor will advise you about this possibility.
• if you have a stomach tear (hiatal hernia) or heartburn and/or are taking other medicines that may cause or worsen oesophagitis.
• if you have a certain type of nervous system disorder (autonomic neuropathy).
• if you have severe kidney disease.
• if you have moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which you are being treated.
Solifenacina e Tamsulosin Mylan may alter blood pressure and may cause dizziness, mental confusion or rarely fainting (orthostatic hypotension). If you experience any of these symptoms, sit or lie down until they disappear.
If you are scheduled for or on a waiting list for eye surgery for cataract or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously used, are currently using or plan to use solifenacin succinate/tamsulosin hydrochloride. 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 cataract or increased eye pressure (glaucoma).
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Solifenacina e Tamsulosin Mylan
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 reduce the rate at which Solifenacina e Tamsulosin Mylan is eliminated 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 effect of Solifenacina e Tamsulosin Mylan.
• medicines such as metoclopramide and cisapride, which speed up the digestive system. Solifenacina e Tamsulosin Mylan may reduce their effect.
• other alpha-blockers, as this may cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates that may cause or worsen inflammation of the throat (oesophagitis).

Solifenacina e Tamsulosin Mylan with food and drinks
Solifenacina e Tamsulosin Mylan may be taken with or without food, as preferred.
Pregnancy, breastfeeding and fertility
The use of Solifenacina e Tamsulosin Mylan in women is not indicated.
In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen 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
Solifenacina e Tamsulosin Mylan may cause dizziness, blurred vision, tiredness and, uncommonly, drowsiness. Avoid driving or operating machinery if you experience these side effects.
Solifenacina e Tamsulosin Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
3 How to take Solifenacina e Tamsulosin Mylan
Take this medicine 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. You may take Solifenacina e Tamsulosin Mylan with or without food, as preferred. Do not crush or chew the tablet.
If you take more Solifenacina e Tamsulosin Mylan than you should
If you have taken more tablets than recommended, or if someone else has accidentally taken your tablets, contact a doctor, pharmacist or hospital immediately.
In case of overdose, the doctor may treat you with activated charcoal; gastric lavage may be useful if performed within one hour of the overdose. Do not induce vomiting.
Symptoms of overdose may include: dry mouth, dizziness, blurred vision, perception of non-existent objects (hallucinations), over-excitement, seizures, breathing difficulties, increased heart rate (tachycardia), difficulty completely or partially emptying the bladder or difficulty urinating (urinary retention) and/or an undesirable drop in blood pressure.
If you forget to take Solifenacina e Tamsulosin Mylan
Take the next tablet of Solifenacina e Tamsulosin Mylan at your regular time. Do not take a double dose to make up for the missed tablet.
If you stop taking Solifenacina e Tamsulosin Mylan
If you stop treatment with Solifenacina e Tamsulosin Mylan, your symptoms may recur or worsen. Always consult your doctor if you intend to stop treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most serious side effect observed in clinical studies with Solifenacina e Tamsulosin Mylan, occurring with uncommon frequency (may affect up to 1 in 100 men), is acute urinary retention, which is a sudden difficulty in urinating. If you think you are experiencing this effect, contact your doctor immediately. You may need to stop using Solifenacina e Tamsulosin Mylan.
Allergic reactions may occur with solifenacin succinate/tamsulosin hydrochloride:

• Uncommon signs 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 swallowing and breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, Solifenacina e Tamsulosin Mylan must be stopped immediately and must not be used again.

If an allergic attack or a severe skin reaction occurs (e.g. blistering and peeling of the skin), you must immediately inform your doctor and stop using solifenacin succinate/tamsulosin hydrochloride. Appropriate therapies and/or measures must be taken.
Common side effects (may affect up to 1 in 10 men)

• dizziness
• blurred vision
• dry mouth, indigestion (dyspepsia), constipation, feeling unwell (nausea), abdominal pain
• abnormal ejaculation (ejaculatory disorder). This means that semen 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.
• tiredness (fatigue)

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

• urinary tract infection, bladder infection (cystitis)
• drowsiness, impaired sense of taste (dysgeusia), headache
• dry eyes
• fast or irregular heartbeat (palpitations)
• feeling dizzy or weak, especially when standing up (orthostatic hypotension)
• blocked or runny nose (rhinitis), dry nose
• reflux disease (gastro-oesophageal reflux), diarrhoea, dry throat, feeling unwell (vomiting)
• itching, dry skin
• difficulty urinating
• fluid accumulation in the lower leg (oedema), tiredness (asthenia)

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

• feeling faint (syncope)
• accumulation of large amounts of faeces in the colon (faecal impaction)
• skin allergy causing 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 rash, inflammation and blistering of the skin and/or mucosa of lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome), skin allergic reaction (erythema multiforme)
• prolonged and painful erection (usually not occurring during sexual activity) (priapism)

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

• serious allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• reduced appetite, elevated potassium levels in the blood (hyperkalaemia) which may cause abnormal heart rhythm
• rapid decrease in awareness and general mental functioning (delirium)
• during eye surgery for cataract or increased eye pressure (glaucoma), the pupil (the black circle in the middle of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become flaccid during surgery and increased pressure in the eyes (glaucoma) and impaired vision may occur
• irregular or unusual heartbeat (QT prolongation, torsade de pointes, atrial fibrillation, arrhythmia), fast heartbeat (tachycardia)
• shortness of breath (dyspnoea), voice disorder, nosebleed (epistaxis)
• intestinal obstruction (ileus), abdominal discomfort
• liver disease
• skin inflammation causing redness and peeling over large areas of the body (exfoliative dermatitis)
• muscle weakness
• kidney disease

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult 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. Reporting side effects can help provide more information on the safety of this medicine.
5 How to store Solifenacina e Tamsulosin Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and 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 no longer used. This will help protect the environment.
6 Contents of the pack and other information
What Solifenacina e Tamsulosin Mylan 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 calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), iron oxide red (E172), magnesium stearate (E470b), macrogol, high molecular weight macrogol, colloidal anhydrous silica, titanium dioxide (E171).

Description of the appearance of Solifenacina e Tamsulosin Mylan and contents of the pack
Solifenacina e Tamsulosin Mylan are film-coated, red, round, biconvex tablets, with “T7S” engraved on one side.
Solifenacina e Tamsulosin Mylan is available in blisters containing 30, 90, 100 or 200 modified-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan S.p.A. Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturers:
Synthon Hispania S.L. C/ Castelló, nº1, Sant Boi de Llobregat 08830 Barcelona, Spain
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
Synthon s.r.o. Brněnská 32/čp. 597, 678 01 Blansko, Czech Republic