GENURIN 200 mg Tabletki Powlekane

Treść ulotki

1. Genurin 200 mg film-coated tablets
   1. What is Genurin and what is it used for
   2. What you need to know before taking Genurin
   3. How to take Genurin
   4. Possible side effects
   5. How to store Genurin
   6. Contents of the pack and other information

Genurin 200 mg film-coated tablets

flavoxate hydrochloride

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

• Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Genurin is and what it is used for
• 2. What you need to know before you take Genurin
• 3. How to take Genurin
• 4. Possible side effects
• 5. How to store Genurin
• 6. Contents of the pack and other information

1. What is Genurin and what is it used for

Genurin contains the active substance flavoxate hydrochloride.
It belongs to a group of medicines called “urinary antispasmodics” and works by relaxing the muscles
of the genital and urinary tracts.
Genurin is used:

• in the treatment of symptoms such as: difficulty urinating (dysuria), urge to urinate, need to urinate during nighttime rest (nocturia), pain above the genitals, frequency and urinary incontinence in diseases of the bladder and prostate (cystitis, cystalgia, prostatitis, urethritis, urethrocystitis, urethrotrigonitis)
• together with other medicines, in the treatment of spasms (contractions) due to kidney stones and the ducts that carry urine from the kidneys to the bladder (ureters), the use of urinary catheters and after particular diagnostic tests (cystoscopies), as well as the consequences of surgery on the lower urinary tract
• in the treatment of spasms of the female genital tract such as pelvic pain, menstrual pain (dysmenorrhea) and uterine contractions (uterine hypertonia and dyskinesia).

2. What you need to know before taking Genurin

Do not take Genurin

• if you are allergic to flavoxate hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have a stomach or intestinal disorder that affects the normal passage of food (obstruction)
• if you have bleeding in the stomach or intestines
• if you have an inability to swallow due to muscle weakness (achalasia)
• if you are unable to completely empty your bladder (urinary retention)
• if you are being treated for an eye disease called glaucoma
• if you have a condition that causes general weakness and muscle fatigue (myasthenia gravis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Genurin:

• if you have kidney problems.

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
The safety of this medicine during pregnancy and breastfeeding has not been established. If you are
pregnant or breastfeeding, this medicine is not recommended.

Driving and operating machinery
Do not drive or operate machinery if you experience drowsiness or blurred vision while using Genurin.

Genurin contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Genurin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 film-coated tablet of 200 mg, 3-4 times a day, orally.
Do not break the tablet but swallow it whole, preferably with a glass of water.
The tablets should be taken after a meal to prevent nausea.

If you take more Genurin than you should
If you accidentally take too many Genurin tablets, contact your doctor or
hospital immediately.

If you forget to take Genurin
If you forget a dose, do not worry, take the next dose at the usual time. Do not take a
double dose to make up for a missed tablet.

If you stop taking Genurin
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of these side effects gets serious, or if you notice any side effects not listed below, tell your doctor or pharmacist:

Common(may affect up to 1 in 10 people)
Nausea

Uncommon(may affect up to 1 in 100 people)
Drowsiness
Impaired vision
Vomiting, dry mouth, stomach pain and digestive disorders (dyspepsia)
Skin rash

Rare(may affect up to 1 in 1,000 people)
Hives, itching
Inability to empty the bladder completely (urinary retention)
Fatigue

Not known(frequency cannot be estimated from available data)
Hypersensitivity, anaphylactic reaction, anaphylactic shock
Confusional state
Glaucoma
Fast or irregular heartbeat (known as palpitations)
Yellowing of the skin and eyes (jaundice), liver disorders, abnormal liver function tests (abnormal liver enzymes)
Flushing (of the skin).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Genurin

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package and blister. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice that it is damaged or if the packaging shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Genurin contains

• The active ingredient is flavoxate hydrochloride. Each film-coated tablet contains 200 mg of flavoxate hydrochloride.
• The other ingredients are: Core: lactose monohydrate, sodium carboxymethylcellulose, povidone, talc, magnesium stearate, microcrystalline cellulose. Coating: hypromellose, microcrystalline cellulose, macrogol 6000, macrogol stearate, titanium dioxide (E171), magnesium stearate.

Description of the appearance of Genurin and contents of the pack
Genurin is presented in the form of film-coated tablets.
It is available in packs of 30 tablets in blisters.

Marketing authorisation holder and manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milano.