Uraplex 20 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Uraplex 20 mg Film-coated Tablets

trospium chloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Uraplex is and what it is used for

2. What you need to know before taking Uraplex

3. How to take Uraplex

4. Possible adverse effects

5. How to store Uraplex

6. Package contents and additional information

1. What Uraplex is and what it is used for

The active substance of Uraplex is trospium chloride.

This product is a urological antispasmodic (a medicine to relax the muscles of the urinary bladder).

Uraplex is used to treat symptoms associated with involuntary loss of urine (wetting clothes) and/or increased urinary frequency and/or urinary urgency in patients with overactive bladder.

2. What you need to know before starting to take Uraplex

Do not take Uraplex

• If you are allergic to trospium chloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have urinary retention.
• If you have narrow-angle glaucoma (high pressure in the eyes).
• If you have tachyarrhythmia (rapid and sometimes irregular heartbeat).
• If you have myasthenia gravis (a disorder characterized by rapid muscle fatigue with exercise).
• If you have a severe gastrointestinal condition, including toxic megacolon (abnormally large dilation of part of the large intestine) and severe ulcerative colitis (inflammatory bowel disease).
• If you are under 12 years of age.

Warnings and precautions

• If you have obstructive gastrointestinal disorders such as pyloric stenosis (narrowing of the pylorus, the opening from the stomach to the small intestine).
• If you have obstruction of urinary flow, with risk of urinary retention.
• If you have autonomic neuropathy.
• If you have hiatal hernia associated with reflux esophagitis.
• When an increase in heart rate may be detrimental, such as in patients with hyperthyroidism, coronary heart disease, or congestive heart failure.

Since data are lacking in patients with hepatic impairment, administration of trospium chloride is not recommended in these cases.

Trospium chloride is primarily eliminated via the urine. Markedly increased plasma levels of trospium chloride have been observed in patients with severe renal impairment. Therefore, caution should be exercised in patients with mild, moderate, or severe renal impairment.

Before starting treatment, organic causes of frequent urination, urgent need to urinate, and urge incontinence should be ruled out, such as heart diseases, kidney diseases, polydipsia (abnormally increased thirst), or infections or tumors of the urinary organs.

Other medicines and Uraplex

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, especially:

Potential interactions include:

• Potentiation of the effect of drugs with anticholinergic action such as amantadine (used to treat Parkinson's disease), quinidine and disopyramide (medicines used to treat cardiac rhythm disorders), antihistamines (used to treat allergies), and tricyclic antidepressants.
• Enhancement of the tachycardia-inducing effect of beta-sympathomimetic drugs (medicines used to treat asthma and other respiratory conditions).
• Reduced efficacy of prokinetic drugs (medicines used to improve intestinal transit) such as metoclopramide and cisapride.
• Since trospium chloride may influence gastrointestinal motility and secretion, the possibility that the absorption of other drugs administered simultaneously may be altered cannot be excluded.
• A reduced absorption of trospium chloride by drugs such as guar (used to improve certain metabolic disorders such as diabetes), as well as colestyramine and colestipol (used to lower blood cholesterol levels), cannot be ruled out. Therefore, simultaneous administration of these drugs with trospium chloride is not recommended.
• Metabolic interactions of trospium chloride have been investigated in vitro with cytochrome P450 enzymes involved in drug metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4), and no interactions were observed.

No evidence of clinically significant interactions has been obtained from clinical trials or from the spontaneous adverse event reporting system.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Uraplex should only be used during pregnancy and lactation after careful assessment by your doctor of the benefit-risk ratio, as sufficient clinical data are not available. Studies conducted in experimental animals have not shown evidence of adverse effects on embryo/fetal development.

Driving and operating machinery

In principle, accommodation-related visual disturbances may reduce the ability to operate machinery. However, parameters used to assess driving capacity (visual orientation, general reaction ability under stress conditions, concentration, and motor coordination) have not revealed any effect caused by trospium chloride.

Uraplex contains sucrose, sodium, lactose, and wheat starch

This medicinal product contains wheat starch, equivalent to 438 ppm of gluten, which should be taken into account by patients with celiac disease.

Patients with wheat allergy (other than celiac disease) must not take this medicinal product.

This medicinal product contains sucrose and lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicinal product.

This medicinal product contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially "sodium-free".

3. How to take Uraplex

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Unless otherwise directed by your physician, 1 coated tablet (20 mg of trospium chloride) twice daily (equivalent to 40 mg of trospium chloride daily), taken orally.

The recommended dose in patients with severe renal impairment (creatinine clearance between 10 and 30 ml/min/1.73 m²) is 1 coated tablet (equivalent to 20 mg of trospium chloride) once daily or on alternate days.

Coated tablets must be swallowed whole, without chewing, with a glass of water before meals, on an empty stomach.

Use in children

Safety and efficacy have not been established in children under 12 years of age.

If you take more Uraplex than you should

Contact your doctor or hospital immediately and seek medical help.

In case of overdose, anticholinergic effects may occur, such as visual disturbances, increased heart rate, dry mouth, and skin flushing. These symptoms can be treated with a parasympathomimetic drug such as neostigmine. In patients with glaucoma, pilocarpine may be applied locally.

However, in case of overdose or accidental ingestion, go to a medical center or contact the Toxicology Information Service at telephone number 915 62 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Uraplex

Do not take a double dose to make up for forgotten doses.

Continue treatment as usual, without needing to take the missed coated tablet.

If you stop treatment with Uraplex

Your doctor will determine the duration of your treatment with Uraplex. Do not discontinue treatment prematurely, as the expected beneficial effects will not be achieved.

The need for continued treatment should be reassessed regularly every 3–6 months.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

During treatment with trospium chloride, anticholinergic effects such as dry mouth, dyspepsia, and constipation may occur. Other adverse effects, listed in order of frequency, are:

Very common (may affect more than 1 in 10 people)

Gastrointestinal system: dry mouth.

Common (may affect up to 1 in 10 people)

Gastrointestinal disorders: dyspepsia, constipation, abdominal pain, nausea.

Uncommon (may affect up to 1 in 100 people)

Nervous system disorders: headache.

Cardiac disorders: tachycardia.

Gastrointestinal disorders: diarrhea, flatulence.

General disorders and administration site conditions: chest pain.

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

Nervous system disorders: dizziness.

Eye disorders: visual disturbances.

Skin and subcutaneous tissue disorders: rash.

Musculoskeletal and connective tissue disorders: myalgia, arthralgia.

Renal and urinary disorders: urinary disorders, urinary retention.

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

Skin and subcutaneous tissue disorders: angioedema.

Frequency not known (cannot be estimated from available data)

Immune system disorders: anaphylaxis.

Nervous system disorders: hallucinations, confusion, and agitation, especially in elderly patients.

Cardiac disorders: tachyarrhythmia.

Respiratory, thoracic and mediastinal disorders: dyspnea.

Skin and subcutaneous tissue disorders: pruritus, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Investigations: asthenia, mild to moderate elevation of serum transaminase levels.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Uraplex

Keep this medicine out of the sight and reach of children.

Keep the container tightly closed.

Store the container in the outer packaging.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated after EXP or CAD.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Uraplex

• The active substance is trospium chloride.
• The other components are: sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate (E-170), titanium dioxide (E-171), palmitic/stearic acid, sodium croscarmellose, povidone, polyethylene glycol 8000, anhydrous colloidal silica, iron hydroxide (E-172), sodium carmellose, white beeswax, carnauba wax.

Appearance of the product and contents of the pack

Uraplex is presented in packs of 30 or 60 yellowish-brown coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

MADAUS GMBH

Colonia Alle, 15

Cologne 51101

Germany

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent revision of this leaflet: May 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/