Genurin

Package leaflet: Information for the patient

Genurin 200 mg film-coated tablets

flavoxate hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult 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 taking 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 Genurin is and what it is 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 organs.
Genurin is used:

• in the treatment of symptoms such as difficulty in urinating (dysuria), urgency to urinate, need to urinate during the night (nocturia), pain above the genital area, urinary frequency and incontinence in diseases of the bladder and prostate (cystitis, cystalgia, prostatitis, urethritis, ureterocystitis, ureterotrigonitis)
• in combination with other medicines, in the treatment of spasms (contractions) due to kidney stones and the ducts transporting urine from the kidneys to the bladder (ureters), due to the use of urinary catheters, after specific diagnostic procedures (cystoscopies), as well as following surgical interventions 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 should know before taking Genurin

Do not take Genurin

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

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

• if you have kidney problems.

Children
Genurin must 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, think you might be pregnant, are planning a pregnancy, or 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 using machines
Do not drive or operate machinery if you experience drowsiness or blurred vision while taking Genurin.
Genurin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Genurin

Take this medicine exactly as directed by 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, taken 3-4 times daily, by oral route.
Do not break the tablet; 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 the missed tablet.

If you stop taking Genurin
If you have any questions about using 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 the following side effects worsen, or if you notice any side effects not listed below, inform your doctor or pharmacist:
Common (may affect up to 1 in 10 people)
Nausea
Uncommon (may affect up to 1 in 100 people)
Drowsiness
Vision impairment
Vomiting, dry mouth, gastric pain and stomach discomfort (dyspepsia)
Skin rash
Rare (may affect up to 1 in 1,000 people)
Urticaria, itching
Inability to completely empty the bladder (urinary retention)
Fatigue
Not known (frequency cannot be estimated from the available data)
Hypersensitivity, anaphylactic reaction, anaphylactic shock
Confusional state
Glaucoma
Fast or irregular heartbeat (palpitations)
Yellowing of the skin and eyes (jaundice), liver disorders, abnormal results in liver function tests (abnormal liver enzymes)
Skin flushing.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help 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 stated on the carton and blister pack. The expiry date refers to the last day of that month.
Do not use this medicine if it appears damaged or if the packaging shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Genurin contains

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

Description of the appearance of Genurin and pack contents
Genurin is available as film-coated tablets.
It is supplied in a pack of 30 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milan, Italy.