Leaflet: information for the user

Uronid 200 mg film-coated tablets

Flavoxato hydrochloride

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, ask 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.

1.What Uronid is and what it is used for

2.What you need to know before you start taking Uronid

3.How to take Uronid

4.Possible side effects

5Storage of Uronid

6.Contents of the pack and additional information

What is Uronid

Uronid belongs to a group of medications that relieve and prevent muscle spasms. Uronid contains an antispasmodic that works by inhibiting contractions in the urinary tract, thereby reducing urinary symptoms and associated pain.

What is Uronid used for

Uronid is indicated for the treatment of urinary symptoms such as: Difficulty starting urination (intermittent urination), sudden need to urinate (urinary urgency), intense and uncontrollable urge to urinate (frequency), even at night (nocturia), suprapubic vesical pain and involuntary loss of urine (incontinence).

Do not take Uronid

• if you are allergic to flavoxate hydrochloride or to any of the other ingredients of this medication (listed in section 6)
• if you have a gastrointestinal disease that affects normal food transit (obstruction)

• if you suffer from intestinal bleeding.
• if you have difficulty swallowing due to muscle weakness (achalasia)
• if you are unable to completely empty your bladder (urinary retention)
• if you are being treated for a condition known as glaucoma
• if you have a disease that causes generalized muscle fatigue and weakness (myasthenia gravis)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Uronid:

• if you have altered renal function.

Children

Uronid should not be used in children under 12 years of age.

Taking Uronid with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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.

The safety of this medication in pregnancy and breastfeeding has not been established. It is not recommended to use this medication if you are pregnant or breastfeeding.

Driving and operating machinery

Do not drive or operate machinery if you experience drowsiness or blurred vision while taking Uronid.

Uronid contains Lactose

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

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

Use in adults

The recommended daily dose is 1 film-coated tablet of 200 mg every 6-8 hours (3 or 4 times a day) taken orally.

Do not break the tablet, swallow it whole preferably with a glass of water.

Tablets should be taken after meals to prevent nausea.

If you take more Uronid than you should

If you have taken more Uronid than you should, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forget to take Uronid

Do not worry if you have forgotten to take a dose, take the next dose when it is due. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Uronid

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Consult your doctor or pharmacist if any of the adverse effects worsen or if you experience any adverse effect not listed below:Frequent Adverse Effects (may affect up to 1 in 10 patients)

Nausea

Less Frequent Adverse Effects (may affect up to 1 in 100 patients)

Drowsiness

Visual disturbances

Vomiting, dry mouth, stomach pain, heavy digestion (dyspepsia)

Rash

Rare (may affect up to 1 in 1000 patients)

Urticaria, pruritus

Inability to completely empty the bladder (urinary retention)

Fatigue

Unknown Frequency (cannot be estimated from available data)

Hypersensitivity, anaphylactic reaction, anaphylactic shock

Confusion

Glaucoma

Irregular or rapid heartbeats (palpitations)

Yellowing of the skin and eyes (jaundice), liver disorder, abnormal liver function test results (abnormal liver enzyme)

Redness of the skin

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require special conservation conditions.

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

Do not use this medication after the expiration date that appears on the box and the blister pack. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that it is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Uronid

• The active ingredient is flavoxate hydrochloride. Each film-coated tablet contains 200 mg of flavoxate hydrochloride.
• The other components are:

Core excipients:

Lactose

Povidone (E-1201)

Modified carboxymethylcellulose (E-466)

Talc (E-533b)

Magnesium stearate (E-572)

Colloidal silica (E-551)

Microcrystalline cellulose (E-460)

Coating excipients:

Hydroxypropylmethylcellulose

Polyethylene glycol 300

Titanium dioxide (E-171)

Polyethylene glycol 6000

Magnesium stearate (E-572)

Appearance of the product and content of the packaging

Uronid 200 mg film-coated tablets are presented in the form of homogeneous film-coated tablets of white color, in PVC/Al blisters, in containers containing 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Casen Recordati, S.L

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza) Spain

Responsible for manufacturing

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Last review date of this leaflet: December 2017

Other sources of information

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