Zoltazen 6 mg./0.4 mg. 30 tablets

1. What Zoltazen is and what it is used for

Zoltazen is a combination of two different medicines known as 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.

Zoltazen is used in men to treat moderate to severe storage symptoms and lower urinary tract symptoms caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia (BPH)). This medicine is used when previous treatment with a single medicine for this condition has not relieved the symptoms adequately.

As the prostate grows, this can lead to urinary problems (voiding symptoms) such as hesitancy (difficulty starting to urinate), difficulty urinating (a thin stream), dribbling and a feeling of incomplete emptying of the bladder. At the same time, the bladder is also affected and contracts spontaneously when you do not want to urinate. This leads to symptoms of storage such as changes in bladder sensitivity, urgency (having a strong, sudden urge to urinate without warning) and more frequent urination.

Solifenacin reduces involuntary contractions of your bladder and increases the amount of urine that the bladder can store. You may therefore wait longer before going to the toilet. Tamsulosin allows urine to pass more easily through the urethra and makes it easier to urinate.

2. What you need to know before you use Zoltazen

Do not use Zoltazen:

if you are allergic to solifenacin or 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 severe kidney disease and if you are being treated at the same time with medicines that may reduce the removal of Zoltazen from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.

if you suffer from moderate liver disease AND if you are being treated at the same time with medicines that may reduce the removal of Zoltazen from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.

if you have severe stomach or intestinal disease (including toxic megacolon, a complication associated with ulcerative colitis).

if you suffer from a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles.

if you have increased pressure in the eye (glaucoma) with gradual loss of vision,

if you feel sick due to low blood pressure when you change your position (when you sit or stand up); this is called orthostatic hypotension.

Tell your doctor if you think any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before using Zoltazen:

if you are unable to urinate (urinary retention),

if you have any obstruction of the digestive system,

if you are at risk of your digestive system being slowed down (stomach and intestinal movements). Your doctor will inform you if this is the case.

if you have a stomach problem (hiatal hernia) or heartburn and/or if you are taking medicines at the same time that can cause or worsen oesophagitis.

if you have a certain type of nerve disease (autonomic neuropathy).

if you have severe kidney disease.

if you have moderate liver disease.

You should have regular medical check-ups to monitor the progress of the condition you are being treated for.

This medicine may affect your blood pressure, which may make you feel dizzy, light-headed or, rarely, you may feel sick (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they have passed.

If you are undergoing or are scheduled to have eye surgery for clouding of the lens (cataract) or increased pressure in the eye (glaucoma), please tell your eye doctor that you have taken or are taking or plan to take Zoltazen. The specialist can then take the necessary precautions in relation to the treatment and surgical techniques to be undertaken. Talk to your doctor about whether or not you should delay or temporarily stop taking this medicine until you have surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and Zoltazen

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

It is especially important to tell your doctor if you are using:

medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem and

aroxetine, which reduce the rate at which Zoltazen is removed from the body.

other anticholinergic medicines, because the effects and side effects of both medicines may be increased if you take two medicines of the same type.

cholinergics, because they may reduce the effect of Zoltazen.

medicines such as metoclopramide and cisapride, which cause the digestive system to work faster. Zoltazen may reduce their effect.

other alpha-blockers (used to lower blood pressure), because this may lead to an unwanted decrease in blood pressure.

medicines such as bisphosphonates, which may cause or worsen inflammation of the gullet (oesophagitis).

Zoltazen with food and drink

Zoltazen can be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

Zoltazen is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that semen does not leave the body through the urethra but instead enters the bladder (retrograde ejaculation) or the volume of the ejaculate is reduced or absent (an ejaculation). This phenomenon is harmless.

Driving and using machines

This medicine may cause dizziness, blurred vision, tiredness and, uncommonly, drowsiness. If you experience these side effects, do not drive or use machines.

3. How to use Zoltazen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The maximum daily dose is one tablet containing 6 mg solifenacin and 0.4 mg tamsulosin, taken by mouth. The medicine can be taken with or without food, according to your preference. Do not crush or chew the tablet.

If you take more Zoltazen than you should

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately.

In case of overdose, your doctor may give you activated charcoal; immediate gastric lavage may be helpful if done within 1 hour of the overdose. Do not induce vomiting.

Symptoms of overdose may include: dry mouth, dizziness and blurred vision; seeing things that are not there (hallucinations), excessive excitability, fits (convulsions), difficulty breathing, increased heart rate (tachycardia), inability to completely or partially empty your bladder or to pass urine (urinary retention) and/or an unwanted decrease in blood pressure.

If you forget to take Zoltazen

Take your next Zoltazen tablet as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Zoltazen

If you stop taking Zoltazen, your original symptoms may return or get worse. Always consult your doctor if you are considering stopping treatment.

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

4. Possible side effects

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

The most serious side effect that has been seen uncommonly (may affect up to 1 in 100 men) during treatment with solifenacin succinate/tamsulosin hydrochloride in clinical studies is acute urinary retention, which is a sudden inability to pass urine. If you think you may have these symptoms, consult a doctor immediately. You may need to stop taking Zoltazen.

Allergic reactions that may occur with Zoltazen:

Uncommon symptoms of allergic reactions may include skin rash (which may be itchy) or hives (urticaria).

Rare symptoms include swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, this medicine should be stopped immediately and not restarted.

If you experience an allergic attack or severe skin reaction (e.g. blistering and peeling of the skin), you should inform your doctor immediately and stop using this medicine. Appropriate therapy and/or measures should be taken.

Other side effects:

Common side effects (may affect up to 1 in 10 men)

dry mouth

constipation

indigestion (dyspepsia)

dizziness

blurred vision

tiredness (fatigue)

abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body through the urethra but instead goes into the bladder (retrograde ejaculation) or the volume of the ejaculate is reduced or absent (ejaculation disorder). This phenomenon is harmless,

nausea

stomach pain

Other uncommon side effects (may affect up to 1 in 100 men)

sleepiness (somnolence)

itching (pruritus)

rash

urinary tract infection, bladder infection (cystitis)

impaired sense of taste (dysgeusia)

dry eyes

dry nose

reflux disease (gastroesophageal reflux)

dry throat

dry skin

difficulty passing urine

fluid accumulation in the lower limbs (peripheral oedema)

headache

fast or uneven heartbeats (palpitations)

feeling dizzy or weak, especially when standing up (orthostatic hypotension)

runny or blocked nose (rhinitis)

diarrhoea

nausea (vomiting)

tiredness (asthenia)

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

buildup of large amounts of hardened stool in the large intestine (faecal impaction)

fainting (syncope)

skin allergy that leads to swelling affecting the tissues just below the surface of the skin (angioedema)

Very rare side effects (may affect up to 1 in 10,000 men)

hallucinations, confusion

allergic skin reactions (erythema multiforme)

prolonged and painful erection (usually not during sexual activity) (priapism)

inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages and genitals (Stevens-Johnson syndrome)

Not known (frequency cannot be estimated from the available data)

anaphylactic reaction (sudden, severe allergic reaction with difficulty breathing, swelling, dizziness, fast heart rate, sweating and loss of consciousness)

decreased appetite

high levels of potassium in the blood (hyperkalemia), which can cause an abnormal heart rhythm

increased pressure in the eye (glaucoma)

irregular or unusual heart rhythm (QT prolongation, Torsade de Pointes, atrial fibrillation, arrhythmia)

fast heart rate (tachycardia)

shortness of breath (dyspnea)

during eye surgery for clouding of the lens (cataract) or for increased pressure in the eye (glaucoma), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the colored part of the eye) may dilate during the surgery,

voice disorder

liver disorder

muscle weakness

kidney disorder

impaired vision

nosebleeds (epistaxis)

psychiatric disorders such as confusion (delirium)

abdominal discomfort.

5. How to store Zoltazen

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zoltazen contains

The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride.

The other ingredients are: macrogol, high molecular weight; silica, colloidal anhydrous (E551); magnesium stearate (E470b); calcium hydrogen phosphate (E341); cellulose, microcrystalline (E460); hydroxypropylcellulose, partially substituted (E463); hypromellose (E464); red iron oxide (E172); macrogol; butylhydroxytoluene (E321).

What Zoltazen looks like and contents of the pack

Zoltazen 6 mg/0.4 mg modified-release tablets are round, biconvex, red, film-coated tablets, debossed with "6 04" on one side, and with a diameter of approximately 9 mm.

Zoltazen tablets are available in a carton containing

PA/aluminium/PVC/aluminium blisters or PA/aluminium/PVC/aluminium unit dose blisters.

Packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets (in blisters).

Packs containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 90 x 1, 100 x 1 or 200 x 1 tablets (in single-dose blisters)

Not all pack sizes may be marketed.