URONID 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Uronid 200 mg Film-Coated Tablets

Flavoxate Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Uronid and what is it used for
2. What you need to know before you take Uronid
3. How to take Uronid
4. Possible side effects

5 Storage of Uronid

1. Contents of the pack and further information

1. What is Uronid and what is it used for

What is Uronid

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

What Uronid is 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).

2. What you need to know before you take Uronid

Do not take Uronid

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

• if you have intestinal bleeding.
• if you suffer from muscular inability to swallow (achalasia)
• if you are unable to completely empty your bladder (urinary retention)
• if you are being treated for the eye disease known as glaucoma
• if you have a disease that causes fatigue and generalized muscle 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of this medicine in pregnancy and breast-feeding has not been established. It is not recommended to use this medicine if you are pregnant or breast-feeding.

Driving and Using Machines

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

Uronid contains Lactose

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

3. How to take Uronid

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

Adult Use

The recommended daily dose is 1 film-coated tablet of 200 mg every 6-8 hours (3 or 4 times a day) 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, or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine 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 forgotten doses.

If you stop taking Uronid

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult your doctor or pharmacist if any of the side effects get serious or if you notice any side effects not listed in this leaflet: Common side effects (may affect up to 1 in 10 people)

Nausea

Uncommon side effects (may affect up to 1 in 100 people)

Drowsiness

Visual disturbances

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

Rash

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

Urticaria, pruritus

Inability to completely empty the bladder (urinary retention)

Fatigue

Frequency not known (cannot be estimated from the available data)

Hypersensitivity, anaphylactic reaction, anaphylactic shock

Confusion

Glaucoma

Rapid or irregular heartbeats (palpitations)

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

Redness of the skin

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Uronid

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.

Do not use this medicine if you notice it is damaged or shows signs of having been tampered with.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Uronid

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

Core excipients:

Lactose

Povidone (E-1201)

Carboxymethylcellulose (E-466)

Talc (E-533b)

Magnesium stearate (E-572)

Colloidal silica (E-551)

Microcrystalline cellulose (E-460)

Coating excipients:

Hypromellose

Polyethylene glycol 300

Titanium dioxide (E-171)

Polyethylene glycol 6000

Magnesium stearate (E-572)

Appearance and Packaging of the Product

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza) Spain

Manufacturer

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Date of the last revision of this leaflet: December 2017

Other Sources of Information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/