Solifenacin succinate/tamsulosin hydrochloride Zentiva 6 mg/0.4 mg modified release tablets

• 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 signs of illness 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).

1. What Solifenacin succinate/Tamsulosin hydrochloride is and what it is used for
2 What you need to know before you use Solifenacin succinate/Tamsulosin hydrochloride
3. How to use Solifenacin succinate/Tamsulosin hydrochloride
4. Possible side effects
5. How to store Solifenacin succinate/Tamsulosin hydrochloride
6. Contents of the pack and other information

• are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• are undergoing kidney dialysis.
• have a severe liver disease.
• suffer from severe kidney disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Solifenacin succinate/ Tamsulosin hydrochloride from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole).
  Your doctor or pharmacist will have informed you if this is the case.
• suffer from moderate liver disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Solifenacin succinate/ Tamsulosin hydrochloride from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole).
  Your doctor or pharmacist will have informed you if this is the case.
• have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis).
• suffer from a muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles.
• suffer from increased pressure in the eyes (glaucoma), with gradual loss of eye sight.
• suffer from fainting due to reduced blood pressure when changing posture (going to sit up or stand up); this is called orthostatic hypotension.

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

Talk to your doctor or pharmacist before using Solifenacin succinate/Tamsulosin hydrochloride if:

• you have an inability to pass water (urinary retention).
• you have some obstruction of the digestive system.
• you are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case.
• you have a stomach tear (hiatus hernia) or heartburn and/or if, at the same time, you are taking medicines that can cause or worsen oesophagitis.
• you suffer from a certain type of nervous disease (autonomic neuropathy).
• you suffer from severe kidney disease.
• you suffer from moderate liver disease.

Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.

Solifenacin succinate/Tamsulosin hydrochloride can affect your blood pressure which can make you feel dizzy, light headed or rarely can make you faint (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they disappear.

If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eyes (glaucoma), please inform your eye specialist that you have previously used, are using or are planning to use Solifenacin succinate/ Tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye (glaucoma).

Do not give this medicine to children and adolescents.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

• medicines like ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine which decrease the rate at which Solifenacin succinate/Tamsulosin hydrochloride is removed from the body.
• other anticholinergic medicines, as effects and side effects of both medications can be enhanced if you are taking two medicines of the same type.
• cholinergics, as they can reduce the effect of Solifenacin succinate/Tamsulosin hydrochloride.
• medicines like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin succinate/Tamsulosin hydrochloride can reduce their effect.
• other alpha-blockers, as this may cause an unwanted decrease in blood pressure.
• medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

Solifenacin succinate/Tamsulosin hydrochloride can be taken with or without food, according to your preference.

Solifenacin succinate/Tamsulosin hydrochloride is not indicated for use by women.

In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure).

This phenomenon is harmless.

Solifenacin succinate/Tamsulosin hydrochloride might cause dizziness, blurred vision, tiredness and, uncommonly, sleepiness. If you suffer from these side effects, do not drive or operate machinery.

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 immediately for advice.

In case of an overdose your doctor may treat you with activated charcoal; emergency stomach washout may be useful if performed within 1 hour of overdose.

Do not induce vomiting.

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

Take your next tablet of Solifenacin succinate/ Tamsulosin hydrochloride as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Solifenacin succinate/Tamsulosin hydrochloride, your original complaints may return or worsen. Always consult your doctor, if you are considering stopping the treatment.

• Sleepiness (somnolence)
• Itching (pruritus)
• Urinary tract infection, bladder infection (cystitis)
• Impaired sense of taste (dysgeusia)
• Dry eyes
• Dry nose
• Reflux disease (gastro-oesophageal reflux)
• Dry throat
• Dry skin
• Difficulty in passing urine
• Accumulation of fluid in the lower legs (oedema)
• Headache
• Fast or uneven heartbeat (palpitations)
• Feeling dizzy or weak especially when you stand up (orthostatic hypotension)
• Runny or blocked nose (rhinitis)
• Diarrhoea
• Being sick (vomiting)
• Tiredness (asthenia)

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

• Lodging of a large amount of hardened stool in the large intestine (faecal impaction)
• Feeling faint (syncope)
• Skin allergy that results in the swelling that occurs in the tissue 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 reaction (Erythema multiforme)
• Long-lasting and painful erection (usually not during sexual activity) (priapism)
• Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome)

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

• Decreased appetite
• High levels of blood potassium (hyperkalaemia) which can cause abnormal heart rhythm
• Increased pressure in the eyes (glaucoma)
• Irregular or unusual heart beat (QT prolongation, Torsade de Pointes, atrial fibrillation, arrhythmia)
• Faster heartbeat (tachycardia)
• Shortness of breath (dyspnoea)
• During an operation of the eye for cloudiness 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 coloured part of the eye) may become floppy during surgery.
• Voice disorder
• Liver disorder
• Muscle weakness
• Renal disorder
• Impaired vision
• Nose bleeds (epistaxis)

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• The active substances are 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride.
• The other ingredients are cellulose, microcrystalline; macrogol; silica, colloidal anhydrous (E551); magnesium stearate (E470b); dibasic calcium phosphate anhydrous (E341); silicified microcrystalline cellulose; low-substituted hydroxypropyl cellulose (E463); hypromellose (E464); iron oxide red (E172).

Solifenacin succinate/Tamsulosin hydrochloride Zentiva 6 mg/0.4 mg tablets are round, biconvex, red, filmcoated tablets, debossed with “6 0.4” on one side.

Carton box containing PA/Aluminium/PVC/Aluminium blisters.

Pack sizes of 30 and 100 tablets.

Not all pack sizes may be marketed.

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