Urizia 6/0.4 mg, Urizia Solifenacin Succinate/Tamsulosin Hydrochloride 6 mg/0.4 mg Modified Release Tablets
What Arizona Is And What Urizia Used For?
Arizona is a combination of two different medicines, called solifenacin and tamsulosin, in one tablet. Solifenacin belongs to a group of medicines called anticholinergics, and tamsulosin belongs to a group of medicines called alpha-blockers.
Arizona is used in men to treat moderate to severe incontinence and lower urinary tract symptoms caused by bladder problems and prostate enlargement ( benign prostatic hyperplasia ). Arizona is used when previous treatment with a single drug for these complaints has not provided sufficient symptom relief.
As the prostate grows, it can cause:
- Difficulty urinating (vomiting symptoms)
- Obstruction (difficulty starting to urinate)
- Difficulty voiding (poor urine flow)
- Dribbling
- A feeling of incomplete bladder emptying
The bladder is affected at the same time and contracts spontaneously at times when you do not want to urinate. This causes various difficulties in keeping tight, such as:
The sensation of the bladder changing:
- Urinary urgency (without warning, you suddenly feel like you need to pass water)
- Needing to pass water more often.
Solifenacin reduces the unwanted contractions of your bladder, and more urine can be retained in the bladder. You can therefore wait longer before you need to go to the toilet. Tamsulosin makes it easier for urine to pass through the urethra and makes it easier to throw up.
Solifenacin and tamsulosin found in Urizia may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or healthcare professional for further questions, and always follow their instructions.
What Do You Need To Know Before You Use Urizia?
Do Not Use Urizia
- If you are allergic to solifenacin, tamsulosin, or any of the other ingredients of this medicine (listed in section 6).
- If you are undergoing kidney dialysis.
- If you have severe liver disease.
- If you suffer from a severe kidney disease AND at the same time are treated with medicines that can reduce the excretion of Urizia from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). If so, the doctor or pharmacist has informed you of this.
- If you suffer from a moderate liver disease AND at the same time are treated with medicines that can reduce the excretion of Urizia from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). If so, the doctor or pharmacist has informed you of this.
- If you have severe stomach or intestinal problems (including toxic megacolon, a complication associated with ulcerative colitis ).
- If you suffer from a muscle disease called myasthenia gravis, which can cause extreme weakness in specific muscles.
- If you suffer from increased pressure in the eyes ( glaucoma also called glaucoma ), with gradually reduced vision.
- This is called orthostatic hypotension if you suffer from fainting due to low blood pressure when changing position (when sitting up from lying down or standing up).
Tell your doctor if any of these conditions apply to you.
Warnings And Precautions:
Talk to your doctor or pharmacist before using Urizia:
- If you cannot pass water ( urinary retention ).
- If you have strictures in the gastrointestinal tract.
- If there is a risk that your digestive system works more slowly (stomach and bowel movements). If so, your doctor has informed you of this.
- If you have a hernia in the diaphragm ( hiatus hernia) or heartburn or are simultaneously taking medicines that can cause or worsen the inflammation of the esophagus ( oesophagitis ).
- If you suffer from a particular nerve disease (autonomic neuropathy ).
- If you suffer from severe kidney disease.
- If you suffer from moderate liver disease.
Regular medical examinations are necessary to monitor the progress of the condition you are being treated for. Arizona can affect your blood pressure, making you feel dizzy, faint, or in rare cases, cause you to faint ( orthostatic hypotension ). You should sit or lie down if you notice these symptoms until they disappear.
Suppose you are undergoing or have planned eye surgery due to clouding of the lens (cataracts) or increased eye pressure ( glaucoma, also called glaucoma ).
In that case, you should inform your eye doctor that you have previously used, are using, or will use Urizia. The ophthalmologist can then take appropriate measures regarding your medication and surgical techniques.
Ask your doctor if you should postpone or temporarily stop taking medicine when you have surgery for a cloudy lens ( cataract ) or increased pressure in the eye ( glaucoma ).
Children And Young People:
Do not give this medicine to children and adolescents.
Other Medicines And Urizia:
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. It is essential to tell your doctor if you are using:
- Medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine reduce the rate at which Urizia is eliminated from the body.
- Other anticholinergic medicines, as the effects and side effects of both medicines, can be enhanced if you take two medicines of the same type.
- Cholinergic medicines may reduce the effect of Urizia.
- Medicines such as metoclopramide and cisapride make the stomach and intestines work faster. Arizona can reduce its effectiveness.
- Other alpha-blocking agents may cause unwanted lowering of blood pressure.
- Medicines such as bisphosphonates can cause or worsen the inflammation of the esophagus ( oesophagitis ).
Arizona With Food And Drink:
Arizona can be taken with or without food, according to your preference.
Pregnancy, Breastfeeding, And Fertility:
Arizona is not intended for use in women. Abnormal ejaculation (ejaculation) has been reported in men (ejaculatory disorder).
This means that the seminal fluid does not leave the body via the urethra but instead enters the bladder (so-called retrograde ejaculation) or that the ejaculation volume is smaller or absent (absence of ejaculation).
This phenomenon is harmless.
Driving Ability And Use Of Machinery:
Arizona can cause dizziness, blurred vision, fatigue, and, in rare cases, sleepiness. Avoid driving or using machines if you are bothered by these side effects.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How To Take Urizia?
- Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- The maximum daily dose is one tablet containing 6 mg solifenacin and 0.4 mg tamsulosin, which should be taken orally. It can be taken with or without food, as you prefer. Do not crush or chew the tablet.
If You Have Taken Too Much Urizia:
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Your doctor can give you activated charcoal in case of a possible overdose. Emergency gastric pumping may be valuable if done within 1 hour of overdose. Do not induce vomiting. Overdose symptoms may include:
- Dry mouth
- Dizziness
- Blurred vision
- Experiencing things that are not there (hallucinations)
- Affect mood (hyperactivity)
- Seizures (convulsions)
- Difficulty breathing
- Heart palpitations ( tachycardia )
- Inability to fully or partially empty the bladder or throwing up water ( urinary retention ) and an unwanted drop in blood pressure.
If You Forget To Take Urizia?
Take the next tablet as usual. Do not take a double dose to make up for a missed tablet.
If You Stop Taking Urizia:
If you stop taking Urizia, your previous problems may come back or get worse. Always consult your doctor if you are considering stopping treatment. Contact your doctor or pharmacist if you have further questions about this medicine.
Possible Urizia Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. The most serious side effect seen in less common cases (may affect up to 1 in 100 men) during treatment with Urizia in clinical studies are acute urinary retention, which means a sudden inability to pass water.
If you think you have, you should see a doctor immediately. You may need to stop taking Urizia. Allergic reactions may occur with Urizia:
- Less common signs of allergic reactions may include skin rash (which may itch) or hives ( urticaria ).
- Rare symptoms include swelling of the face, lips, mouth, tongue, or throat and may cause difficulty swallowing or breathing ( angioedema ). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, treatment with Urizia should be stopped immediately and not restarted.
If you experience an allergic or severe skin reaction (such as blistering and peeling), tell your doctor immediately and stop using Urizia. Appropriate treatment/action should then be taken.
Common side effects (may affect up to 1 in 10 people)
- Dry mouth
- Constipation
- Indigestion ( dyspepsia )
- Dizziness
- Blurred vision
- Fatigue
- Abnormal ejaculation (ejaculation disorder). This means that the seminal fluid does not leave the body via the urethra but instead enters the bladder (so-called retrograde ejaculation) or that the ejaculation volume is smaller or absent (absence of ejaculation). This phenomenon is harmless.
- Nausea
- Abdominal pain
Other less common side effects (may affect up to 1 in 100 people)
- Somnolence
- Itching ( pruritus )
- Urinary tract infection, infection of the bladder ( cystitis )
- Altered taste ( dysgeusia )
- Dry eyes
- Dry nasal mucous membranes
- Reflux disease (acid reflux)
- Dry throat
- Dry skin
- Difficulty throwing water
- Accumulation of fluid in the lower part of the legs ( edema )
- Headache
- Fast or uneven heartbeats ( palpitations )
- Feeling dizzy or weak, especially when standing up ( orthostatic hypotension )
- Runny or stuffy nose ( rhinitis )
- Diarrhea
- Vomiting
- Fatigue ( asthenia )
Rare side effects (may affect up to 1 in 1,000 people)
- Accumulation of a large amount of hard stool in the colon
- Feeling faint ( syncope )
- Skin allergy that causes swelling in the tissue just below the surface of the skin ( angioedema )
Very rare side effects (may affect up to 1 in 10,000 people)
- Hallucinations, confusion
- Allergic skin reactions (erythema multiforme)
- Prolonged and painful erection (usually not during sexual activity) (priapism)
- Skin rash, inflammation, and blistering of the skin and mucous membranes of the lips, eyes, mouth, nostrils, or genitals ( Stevens-Johnson syndrome )
Frequency not known (cannot be estimated from available data)
- Reduced appetite
- High potassium levels in the blood ( hyperkalemia ) can cause abnormal heart rhythms.
- Increased pressure in the eyes ( glaucoma )
- Irregular or abnormal heartbeats ( QT prolongation, torsade de pointes, atrial fibrillation, arrhythmia )
- Faster heartbeat ( tachycardia )
- Shortness of breath ( dyspnea )
- During an eye operation, in case of clouding of the lens ( cataract ) or case of increased pressure in the eye ( glaucoma ), the pupil size (the black ring in the center of the eye) cannot be increased as much as needed. Even the iris (the colored part of the eye) can become limp during surgery.
- Voice trouble
- Liver problems
- Muscle weakness
- Kidney problems
- Impaired vision
- Epistaxis ( epistaxis )
How to store Urizia?
- Keep this medicine out of sight and reach of children.
- Use before the expiry date stated on the carton and blister card after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
- Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information:
Contents Declaration
- The active substances are solifenacin succinate and tamsulosin hydrochloride.
- Other ingredients are mannitol (E421), maltose, macrogol, magnesium stearate (E470b), butylhydroxytoluene (E321), colloidal silicon dioxide, anhydrous (E551), hypromellose (E464), iron oxide, red (E172).
Appearance And Package Sizes Of The Medicine:
- Arizona 6 mg/0.4 mg are round, red film-coated tablets imprinted with “6/0.4”.
- Urizia-modified- release tablets are available in aluminum blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 tablets.
- Not all packs may be available.
Marketing Authorization Holder And Manufacturer:
Marketing Authorisation Holder:
Astellas Pharma a/s
Arne Jacobsen’s Allé 15
2300 Copenhagen S
Denmark
Manufacturer:
Astellas Pharma Europe BV
Hogemaat 2
7942 JG Meppel
Netherlands
This medicine is approved in the European Economic Area under the names:
Austria, Greece, Ireland, Luxembourg, Slovakia, Spain, United Kingdom, Netherlands: Vesomni
Belgium: Vesomni 6 mg/0.4 mg tabletten met gereguleerde afgifte
Czech Republic: Urizia 6 mg/0.4 mg
Denmark, Finland, Norway, Sweden: Urizia