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

• you are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• you are having kidney dialysis.
• you suffer from severe kidney disease AND if, at the same time, you are being treated with medicines that may decrease the removal of solifenacin/tamsulosin from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will have told you if this is the case.
• you have severe liver disease.
• you suffer from moderate liver disease AND if, at the same time, you are being treated with medicines that may decrease the removal of solifenacin/tamsulosin from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will have told you if this is the case.
• you have a severe stomach or bowel condition (including toxic megacolon, a complication of ulcerative colitis).
• you suffer from a muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles.
• you suffer from increased pressure in the eyes (glaucoma), with gradual loss of eye sight.
• you suffer from dizziness, lightheadedness or fainting when going to sit up or stand up due to reduced blood pressure; 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 this medicine 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 told 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 bisphosphonates (for osteoporosis), that can cause or worsen inflammation of the food pipe (oesophagitis).
• you suffer from type of nervous disease called autonomic neuropathy.
• you suffer from severe kidney disease.
• you suffer from moderate liver disease.

• You will need regular medical examinations to check the development of the condition you are being treated for.
• Vecit can reduce your blood pressure, which can make you feel dizzy, light headed or rarely can make you faint when going to sit up or stand up (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down until they disappear.
• If you are having or due to have eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eyes (glaucoma), please tell your eye specialist that you have previously used, are using or are planning to use Vecit. The specialist can then take precautions with medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when having eye surgery for a cataract or 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/ tamsulosin is removed from the body.
• other anticholinergic medicines, as effects and side effects of both medications can be increased if you are taking two medicines of the same type.
• cholinergics, as they can reduce the effect of Vecit.
• medicines like metoclopramide and cisapride, which make the digestive system work faster (Vecit can reduce their effect).
• other alpha-blockers, as this may cause an unwanted decrease in blood pressure.
• medicines such as bisphosphonates for osteoporosis, that can cause or worsen inflammation of the food pipe (oesophagitis).

This medicine can be taken with or without food, as you prefer.

Vecit is not for use by women.

In men, abnormal ejaculation has been reported. This means that the semen does not leave the body via the urethra (the tube that carries urine from the bladder to the outside of the body), but instead goes into the bladder or the ejaculation volume is reduced or absent. This is harmless.

Vecit 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.

Do not try to make yourself sick.

Symptoms of overdose may include: dry mouth, dizziness, and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures, difficulty breathing, increased heart rate, 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 as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking this medicine, your original complaints may return or worsen. If you are considering stopping the treatment, always consult your doctor,

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 at: 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: silicified microcrystalline cellulose type 90HD (microcrystalline cellulose and colloidal silicon dioxide); dibasic calcium phosphate anhydrous (E341); low-substituted hydroxypropyl cellulose (E463); magnesium stearate (E470b); macrogol 7.000.000; Cellulose, microcrystalline type 200; colloidal anhydrous silica (E551); magnesium stearate (E470b); hypromellose 6MPas (E464); macrogol 8000; iron oxide red (E172).

Vecit Modified-release Tablets are round, biconvex, red, film-coated tablets, debossed with “6 04” on one side.

Vecit Modified-release Tablets are available in PA/Aluminium/ PVC/Aluminium blister packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected].