TITENUR

Package Leaflet: Information for the User

Titenur 5 mg film-coated tablets, 10 mg film-coated tablets

solifenacin succinate
Generic medicine
Please read all of this leaflet carefully before you start 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 personally. 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 effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Titenur is and what it is used for
  2. What you need to know before taking Titenur
  3. How to take Titenur
  4. Possible side effects
  5. How to store Titenur
  6. Contents of the pack and other information

1. What Titenur is and what it is used for

The active substance in Titenur belongs to the class of anticholinergics.
These medicines are used to reduce the activity of an overactive bladder. This allows you
to wait longer before going to the bathroom and increases the amount of urine that can be
held in your bladder. Titenur is used to treat the symptoms of a condition called overactive bladder.
These symptoms include: a sudden and strong need to urinate without prior warning, frequent need to urinate, or unintentional loss of urine because you cannot reach the toilet in time.

2. What you need to know before taking Titenur

Do not take Titenur

• if you have difficulty urinating or completely emptying your bladder (urinary retention)
• if you have a serious stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from a muscle disease called myasthenia gravis, which causes extreme weakness in certain muscles
• if you suffer from increased intraocular pressure with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin 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 suffer from severe renal disease or moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of Titenur from the

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body (for example, ketoconazole). Your doctor or pharmacist will inform you about this.
Before starting treatment with Titenur, inform your doctor if you have or have ever had any of the conditions listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Titenur

• If you have difficulty emptying your bladder (bladder obstruction) or have trouble urinating (e.g. reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is very high.
• If you experience gastrointestinal obstructions (constipation).
• If you are at risk of reduced gastrointestinal motility (gastric and intestinal movements). Your doctor will inform you about this possibility.
• If you suffer from severe kidney disease.
• If you have moderate liver disease.
• If you have a stomach hernia (hiatal hernia) or heartburn.
• If you have a nervous system disorder (autonomic neuropathy).

Children and adolescents
Titenur must not be used in children and adolescents under 18 years of age.
Inform your doctor if you have or have ever had any of the conditions listed above before starting treatment with Titenur.
Before starting treatment with Titenur, your doctor will check that there are no other causes for frequent urination (e.g. heart failure (inadequate pumping capacity of the heart) or kidney diseases). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment against specific bacterial infections).
Other medicines and Titenur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking:

• Other cholinergic medicines, as the effectiveness and side effects of both medicines may increase.
• Cholinergics that may reduce the effect of Titenur
• Medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility. Titenur may reduce their effects.
• Medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of Titenur from the body.
• Medicines such as rifampicin, phenytoin, and carbamazepine, which increase the rate of elimination of Titenur from the body.
• Medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Titenur with food and drink
Titenur can be taken at any time, with or without food.
Pregnancy and breastfeeding
You must not use Titenur during pregnancy unless strictly necessary.
Do not use Titenur while breastfeeding, as solifenacin may be excreted in breast milk.
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If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Titenur may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.
Titenur contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Titenur

Instructions for appropriate use
Take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
You should swallow the tablet whole with some liquid. You may take it with or without food,
as you prefer. Do not crush or break the tablets.
The recommended dose is 5 mg daily, unless your doctor tells you to take 10 mg daily.
The 10 mg tablet may be divided into two equal doses.
If you take more Titenur than you should
If you take more Titenur than prescribed, or if a child has accidentally taken Titenur,
contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision,
perception of non-existent objects (hallucinations), overexcitation, seizures (convulsions),
difficulty breathing, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils (mydriasis).
If you forget to take Titenur
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for the next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.
If you stop taking Titenur
If you stop treatment with Titenur, symptoms of overactive bladder may return or worsen. Always consult your doctor if you are considering stopping treatment.
If you have any questions about the use of this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering or peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (an allergic reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin. If angioedema occurs, treatment with Titenur must be stopped immediately and appropriate therapy and/or measures must be initiated.
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Titenur may cause the following side effects:
Very common (may affect more than 1 in 10 people)

• Dry mouth
  Common (may affect up to 1 in 10 people)

• Blurred vision

• Constipation, nausea, indigestion with symptoms such as feeling of abdominal fullness, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infections, bladder infection
• Drowsiness
• Altered taste perception (dysgeusia), dry (irritated) eyes
• Dry nose
• Reflux disease (gastroesophageal reflux), dry throat
• Dry skin
• Difficulty urinating
• Fatigue, fluid accumulation in the lower legs (oedema)

Rare (may affect up to 1 in 1,000 people)

• Accumulation of large amounts of hardened faeces in the colon (faecal impaction)
• Increased volume of urine in the bladder due to inability to empty the bladder (urinary retention)
• Dizziness, headache
• Vomiting
• Itching sensation, rash

Very rare (may affect up to 1 in 10,000 people)

• Hallucinations, confusion
• Allergic rash

Not known (frequency cannot be estimated from the available data)

• Decreased appetite, high levels of potassium in the blood which may cause an abnormal heart rhythm
• Increased intraocular pressure
• Changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat (Torsades de Pointes)
• Voice disorders
• Liver disease
• Muscle weakness
• Kidney disease

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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.
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5. How to store Titenur

Keep this medicine out of the sight and reach of children.
Do not use Titenur after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If the medicine loses its colour or shows signs of deterioration, consult your pharmacist for advice.
Do not dispose of medicines 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 Titenur contains

• The active substance is solifenacin succinate.
  Titenur 5 mg: each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
  Titenur 10 mg: each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other components are:

Tablet core
Monohydrate lactose
Maize starch
Maize starch (partially pregelatinized)
Magnesium stearate
Water for injections

Coating
5 mg
Hypromellose 5cp
Titanium dioxide (E171)
Macrogol 8000
Talc
Yellow iron oxide (E172)
Water for injections

10 mg
Hypromellose 5cp
Titanium dioxide (E171)
Macrogol 8000
Talc
Red iron oxide (E172)
Yellow iron oxide (E172)
Water for injections

Description of the appearance of Titenur and package contents
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Titenur 5 mg: light yellow, round, biconvex film-coated tablets with a diameter of 5.8 mm.
Titenur 10 mg: light pink, round, biconvex film-coated tablets with a score line on one side and flat on the other, with a diameter of 7.9 mm. The tablet can be divided into two equal parts.
Titenur tablets are supplied in blisters containing 10, 20 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
FARMA GROUP S.r.l.
Via Strampelli, 18
63074 San Benedetto del Tronto (AP)
Italy

Manufacturer
Genepharm S.A.
18 km Marathon Avenue
153 51 Pallini Attiki
Greece

This medicinal product is authorized in the European Economic Area countries
under the following trade names:
Portugal: Uriken
Italy: Titenur
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