URAPLEX 20 mg FILM-COATED TABLETS

1. What is Uraplex and what is it used for

The active substance of Uraplex is Trospium Chloride.

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

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

2. What you need to know before taking Uraplex

Do not take Uraplex

• If you are allergic to Trospium Chloride or any of the other ingredients of this medication (listed in section 6).
• If you have urinary retention.
• If you have narrow-angle glaucoma (high tension in the eyes).
• If you have tachyarrhythmia (rapid and sometimes irregular heartbeats).
• 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 old.

Warnings and precautions

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

Since there are no data available in patients with hepatic impairment, the administration of Trospium Chloride is not recommended in these cases.

Trospium Chloride is mainly eliminated through the urine. Significant increases in plasma levels of Trospium Chloride have been observed in patients with severe renal impairment. Therefore, in patients with mild, moderate, or severe renal impairment, caution should be exercised.

Before starting treatment, organic causes of frequent urination, urgent need to urinate, and urge incontinence, such as cardiopathies, kidney diseases, polydipsia (abnormal increase in thirst), or infections or tumors of the urinary organs, should be excluded.

Other medications and Uraplex

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription, especially:

Possible interactions are:

• Potentiation of the effect of drugs with anticholinergic action, such as amantadine (for the treatment of Parkinson's disease), quinidine, and disopyramide (drugs to improve cardiac rhythm disorders), antihistamines (for the treatment of allergies), and tricyclic antidepressants.
• Enhancement of the tachycardic action of beta-sympathomimetics (drugs for the treatment of asthma and other respiratory conditions).
• Decreased efficacy of prokinetic drugs, such as metoclopramide and cisapride.
• Since Trospium Chloride may affect gastrointestinal motility and secretion, it cannot be excluded that the absorption of other drugs administered at the same time may be altered.
• It cannot be excluded that the absorption of Trospium Chloride may be inhibited by drugs such as guar (used to improve certain metabolic disorders, such as diabetes), as well as cholestyramine and colestipol (used to reduce cholesterol in the blood). Therefore, the simultaneous administration of these drugs with Trospium Chloride is not recommended.
• Metabolic interactions of Trospium Chloride with cytochrome P450 enzymes involved in drug metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4) have been investigated in vitro, and no interaction was observed.

No evidence of clinically significant interactions was obtained from clinical trials or the spontaneous reporting system for adverse events.

Pregnancy, breastfeeding, and fertility

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

Uraplex will only be used during pregnancy and breastfeeding after a careful assessment by your doctor of the benefit-risk ratio, as there are insufficient clinical data available. Animal studies have not shown any indications of harmful effects on embryonic/fetal development.

Driving and using machines

In principle, visual accommodation disorders may reduce the ability to use machinery. However, the parameters used to assess driving ability (visual orientation, general reaction capacity, or under stress conditions, concentration, and movement coordination) have not revealed any effect caused by Trospium Chloride.

Uraplex contains sucrose, sodium, lactose, and wheat starch

This medication contains wheat starch, which is equivalent to 438 ppm of gluten, which should be taken into account by celiac patients.

Patient with wheat allergy (other than celiac disease) should not take this medication.

This medication contains sucrose and lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Uraplex

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Unless your doctor tells you otherwise, 1 coated tablet (20 mg of Trospium Chloride) twice a day (equivalent to 40 mg of Trospium Chloride daily) 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 a day or every other day.

The coated tablets should 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 old.

If you take more Uraplex than you should

Contact your doctor or hospital immediately and seek medical help.

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

However, in case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If you forget to take Uraplex

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

Continue treatment without taking the forgotten coated tablet.

If you stop taking Uraplex

Your doctor will indicate the duration of your treatment with Uraplex. Do not stop treatment before, as the expected beneficial results will not be achieved.

The need for continued treatment should be reassessed at regular intervals of 3-6 months.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During treatment with Trospium Chloride, anticholinergic effects such as dry mouth, dyspepsia, and constipation may occur. Other side effects, 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: exanthema.

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 the 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Uraplex

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

Keep the container tightly closed.

Store the container in the outer packaging.

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

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Uraplex

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

Appearance of the product and contents of the pack

Uraplex is presented in a pack of 30 or 60 coated tablets of a yellow-brown color.

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this package leaflet:May 2021

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