URIVESC 20 mg Coated Tablet

Зміст інструкції

1. Urivesc 20 mg coated tablets
2. Urivesc 60 mg prolonged-release hard capsules
   1. WHAT IS URIVESC 60 MG AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URIVESC 60 MG
   3. HOW TO TAKE URIVESC 60 MG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE URIVESC 60 MG
   6. Package Contents and Other Information

Urivesc 20 mg coated tablets

Trospium chloride

because it contains
important information for you.
www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Urivesc 60 mg prolonged-release hard capsules

Trospium chloride

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Urivesc 60 mg is and what it is used for
• 2. What you need to know before you take Urivesc 60 mg
• 3. How to take Urivesc 60 mg
• 4. Possible side effects
• 5. How to store Urivesc 60 mg
• 6. Contents of the pack and other information.

1. WHAT IS URIVESC 60 MG AND WHAT IS IT USED FOR

Urivesc 60 mg is a medicine used to relax the bladder muscles. The
medicine is used for the treatment of symptoms associated with involuntary urine loss
and/or increased frequency of urination and/or urgency to urinate in patients with
overactive bladder.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URIVESC 60 MG

Do not take Urivesc 60 mg

• if you have ever had an allergic reaction to trospium chloride or any of the excipients of Urivesc 60 mg (listed in section 6). (An allergic reaction may be the appearance of a skin rash, itching or shortness of breath).
• if you suffer from any of the following conditions:
• urinary retention, i.e. blockage of the urinary tract,
• the eye disease closed-angle glaucoma,
• abnormal or faster than normal heartbeat,
• myasthenia gravis (a disease that causes muscle fatigue),
• a serious gastrointestinal disease, such as toxic megacolon,
• kidney problems,
• serious liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Urivesc 60 mg if you suffer from
any of the following conditions:

• any type of obstruction of the stomach or intestines,
• impaired urinary flow (e.g. in case of benign prostatic hyperplasia),
• neuropathy, for example nerve damage,
• hiatal hernia associated with reflux esophagitis. The latter is generally associated with heartburn that worsens in a bent or lying position,
• hyperthyroidism,
• any heart condition, such as coronary heart disease or congestive heart failure,
• any liver problems.

Patients with liver disorders
If you have liver disease, talk to your doctor. Patients with severe liver disease should not
take this medicine.

Patients with kidney disorders
If you have kidney disease, talk to your doctor. Patients with kidney disease should not
take this medicine.

Children and adolescents under 18 years of age
DO NOT give Urivesc 60 mg to children and adolescents under 18 years of age.

Other medicines and Urivesc 60 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• certain antidepressants, such as amitriptyline or imipramine
• some medicines for the treatment of asthma that can accelerate the heart rate (e.g. salbutamol)
• other medicines with anticholinergic action (e.g. amantadine - used in the treatment of Parkinson's disease)
• metoclopramide - a medicine used for nausea and vomiting
• medicines containing guar, colestipol or cholestyramine.

Please note that this information may also refer to medicines taken
recently.

Pregnancy and breastfeeding and fertility
Since no experience is available with trospium chloride during pregnancy and
breastfeeding, Urivesc 60 mg should be taken during pregnancy and breastfeeding only
if your doctor considers it absolutely necessary.

Driving and using machines
Even when used as prescribed, this medicine can affect vision and consequently the ability to drive vehicles in road traffic, use machinery or
work may be impaired. Therefore, if you suffer from blurred vision, do not drive
motor vehicles, use machinery, or engage in other dangerous activities.

Urivesc 60 mg contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to some sugars, such as sucrose, contact
them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e.
essentially “sodium-free”.

3. HOW TO TAKE URIVESC 60 MG

Take Urivesc 60 mg following the doctor's instructions exactly. If you have any doubts
consult your doctor or pharmacist.

Usual dose, unless otherwise prescribed by your doctor
Unless otherwise prescribed by your doctor, the usual daily dose is one capsule of
Urivesc 60 mg extended release.

Method of administration
Swallow one extended-release capsule whole with a glass of water. Take the
capsule at least one hour before a meal, on an empty stomach.

Duration of administration
The doctor will determine the duration of treatment.
The need to continue treatment should be checked at regular intervals of 3 - 6 months.
Patients with kidney disease should consult their doctor and not take this medicine.
Patients with liver disease should consult their doctor before taking this
medicine.

If you take more Urivesc 60 mg than you should
So far, no symptoms or signs of intoxication have been reported in humans.
If you have taken more capsules of Urivesc 60 mg than you should, tell your doctor
or pharmacist immediately, who will decide what measures need to be taken.

If you forget to take Urivesc 60 mg
Do not take a double dose to make up for a missed dose. Continue
taking it regularly, as described in the dosage instructions.

If you stop taking Urivesc 60 mg
If you stop taking Urivesc 60 mg before as recommended by your doctor, the
symptoms may reappear. Therefore, take Urivesc 60 mg for the period prescribed by
your doctor. If you wish to stop treatment, consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Urivesc 60 mg can cause side effects, although not everybody gets them.
Following the use of Urivesc 60 mg prolonged-release hard capsules in clinical studies,
the following side effects have been reported:

Very common side effects, may affect more than 1 in 10 people

• Dry mouth

Common side effects, may affect up to 1 in 10 people

• Constipation, nausea, abdominal pain, indigestion,
• dry eyes, dry nose.

Uncommon side effects, may affect up to 1 in 1,000 people

• Flatulence.

Rare side effects, may affect up to 1 in 10,000 people

• difficulty emptying the bladder, urinary retention,
• increased heart rate, palpitations,
• difficulty seeing objects up close,
• skin rashes,
• general feeling of weakness.

Very rare side effects, may affect less than 1 in 10,000 people

• urinary tract infections,
• headache.

Other possible side effects, for which the frequency is not known

• sporadic cases of hallucinations, confusion and agitation have occurred especially in elderly patients and may be favored by neurological disorders and/or other medicines with a similar mechanism of action taken at the same time.

The following side effects have also been reported for trospium (trospium is the active substance of Urivesc 60 mg; it is not known whether these side effects will also occur with the capsules you have been prescribed):
Difficulty breathing, diarrhea, chest pain, mild or moderate increase in certain liver values (serum transaminases), irregular and accelerated heartbeat, joint or muscle pain, dizziness.
The following “very rare” side effects listed below are important and will require immediate intervention if they occur. Stop taking Urivesc 60 mg and
consult your doctor immediately if the following symptoms appear:

• swelling of the face, tongue and trachea, which can cause severe breathing difficulties
• sudden allergic reaction, with shortness of breath, skin rash, wheezing and a drop in blood pressure.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
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 URIVESC 60 MG

Keep this medicine out of the sight and reach of children
Do not use Urivesc 60 mg after the expiry date which is reported on the blister and the container
after EXP.
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not use Urivesc 60 mg if you notice that the packaging is damaged or shows signs of
tampering.
Do not dispose of any medicine in 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 Urivesc 60 mg contains
The active ingredient is: trospium chloride.
Each prolonged-release capsule contains 60 mg of trospium chloride.
The excipients are:
Capsule content: sucrose, corn starch, methylacrylate-methyl methacrylate-methacrylic acid copolymer, sodium dodecyl sulfate, ammonium hydroxide, medium-chain triglycerides, oleic acid, ethyl cellulose, titanium dioxide (E 171), hypromellose, macrogol 400,
polysorbate 80, triethyl citrate, talc
Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), printing ink (shellac gelatin, black iron oxide (E
172), propylene glycol)
See section 2 “Urivesc 60 mg contains sucrose and sodium”.

Description of the appearance of Urivesc 60 mg and package contents
Urivesc 60 mg prolonged-release, hard capsules consist of a white part and an orange part with the inscription SAN 60, and contain white or off-white microspheres.
Urivesc 60 mg is available in packs containing 4 (sample), 7, 10, 14, 28, 30, 56, 60,
84, 90, and 10x28 prolonged-release capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN, Ireland

Manufacturer
Madaus GmbH
51101 Cologne
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark Spasmo-lyt Depot 60 mg
Germany Urivesc
Finland Spasmo-lyt Depot 60 mg
United Kingdom Regurin XL 60 mg prolonged-release capsule, hard
Italy Urivesc 60 mg prolonged-release, hard capsules
Luxembourg Urivesc
Austria Urivesc 60 mg-Retard capsules
Portugal Urivesc
Spain Urivesc 60 mg hard prolonged-release capsules