Leaflet: information for the user

Uraplex 20 mg coated tablets

trospium chloride

Read this leaflet carefully before you start taking this medicine, because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6.Contents of the pack and additional information

The active ingredient of Uraplex is trospium chloride.

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

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

Do not take Uraplex

• If you are allergic to trospium chloride or any of the other components of this medication (listed in section 6).
• If you have urinary retention.
• If you have narrow-angle glaucoma (high eye pressure).
• If you have tachyarrhythmia (rapid and 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 gastrointestinal tract disorders such as pyloric stenosis (narrowing of the pylorus, the opening between the stomach and small intestine).
• If you have urinary flow obstruction, with a risk of urinary retention.
• If you have autonomic neuropathy.
• If you have hiatal hernia associated with gastroesophageal reflux.
• When an increase in heart rate may be counterproductive, such as in patients with hyperthyroidism, coronary disease, and congestive heart failure.

Since there are no data available in patients with liver insufficiency, it is not recommended to administer trospium chloride in these cases.

Trospium chloride is primarily eliminated by the urine. Significant increases in plasma trospium chloride levels have been observed in patients with severe renal insufficiency. Therefore, caution should be exercised in patients with mild, moderate, or severe renal insufficiency.

Before starting treatment, the underlying causes of frequent urination, urgent need to urinate, and urinary incontinence, such as cardiovascular disease, renal disease, polydipsia (excessive thirst), or urinary tract infections or tumors, should be excluded.

Other medications and Uraplex

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

The possible interactions are:

• Potentiation of the effect of anticholinergic drugs such as amantadine (for Parkinson's disease), quinidine, and disopyramide (drugs to improve cardiac rhythm disorders), antihistamines (for allergies), and tricyclic antidepressants.
• Intensification of the taquicardizant action of beta-sympathomimetics (drugs for asthma and other respiratory conditions).
• Decrease in the efficacy of prokinetic drugs (drugs to improve intestinal transit) such as metoclopramide and cisapride.
• Since trospium chloride may affect gastrointestinal motility and secretion, it cannot be ruled out that the absorption of other drugs administered at the same time may be altered.
• It cannot be ruled out 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 blood cholesterol). Therefore, it is not recommended to administer these drugs simultaneously with trospium chloride.
• In vitro investigations of the metabolic interactions of trospium chloride with the cytochrome P450 enzymes involved in drug metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4) did not show any interactions.

No clinically significant interactions were observed in clinical trials or in the spontaneous reporting system of adverse events.

Pregnancy, lactation, and fertility

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

Uraplex will only be used during pregnancy and lactation after a careful risk-benefit assessment by your doctor, as there are not enough clinical data available. Animal studies have not shown any indications of harmful effects on the embryo/fetus.

Driving and operating machinery

Visual accommodation disorders may reduce the ability to use machinery. However, the parameters used to evaluate driving ability (visual orientation, general reaction time, or under stress, concentration, and movement coordination) have not shown any effects caused by trospium chloride.

Uraplex contains saccharose, sodium, lactose, and wheat starch

This medication 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) should not take this medication.

This medication contains saccharose and lactose. If your doctor has indicated 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".

Follow exactly the administration instructions for this medication as 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) 2 times a day (equivalent to 40 mg of trospium chloride per day) orally.

The recommended dose in patients with severe renal impairment (creatinine clearance between 10 and 30 ml/min/1.73 m 2 ) 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, with an empty stomach.

Use in children

The safety and efficacy have not been established in children under 12 years.

If you take more Uraplex than you should

Immediately contact your doctor or hospital and seek medical help.

In case of overdose, anticholinergic effects such as visual disturbances, rapid heart rate, dry mouth, and skin redness would occur. These symptoms can be treated with a cholinergic agonist 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 Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If you forgot to take Uraplex

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

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

If you interrupt treatment with Uraplex

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

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

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

Like all medicines, this medicine may 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, 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)

Neurological 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)

Neurological disorders: dizziness.

Eye disorders: visual disturbances.

Skin and subcutaneous tissue disorders: exanthema.

Musculoskeletal and connective tissue disorders: myalgias, arthralgias.

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.

Unknown frequency(cannot be estimated from available data)

Immune system disorders: anaphylaxis.

Neurological 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.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Keep the container perfectly closed.

Store the container in the outer packaging.

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

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Uraplex

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

Appearance of the product and contents of the packaging

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

MADAUS GMBH

Colonia Alle, 15

Colonia 51101

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:May 2021

Further detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/