Giraxine 5 mg film-coated tablets, Solifenacin Succinate Medreich 5 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Solifenacin Succinate is and what it is used for

The active substance of Solifenacin Succinate belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder.

Solifenacin Succinate is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time.

2. What you need to know before you take Solifenacin Succinate

Do not take Solifenacin Succinate

• if you have an inability to pass water or to empty your bladder completely (urinary retention)
• if you have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles
• if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma)
• if you are allergic to Solifenacin Succinate 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 or moderate liver disease AND at the same time are being treated with medicines that may decrease the removal of Solifenacin Succinate from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case. Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin Succinate starts.

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin Succinate

• if you have trouble emptying your bladder (= bladder obstruction) or have difficulty in passing urine (e.g. a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much higher.
• if you have some obstruction of the digestive system (constipation).
• if 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.
• if you suffer from severe kidney disease.
• if you have moderate liver disease.
• if you have a stomach tear (hiatus hernia) or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents

Solifenacin Succinate is not to be used in children or adolescents under 18 years.

Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin Succinate starts. Before starting Solifenacin Succinate, your doctor will assess whether there are other causes for your need to pass urine frequently (for example heart failure (insufficient pumping power of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe you an antibiotic (a treatment against particular bacterial infections).

Other medicines and Solifenacin Succinate

Please tell your doctor or pharmacist if you are taking or have recently taken or might take other medicines.

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

• other anticholinergic medicines, effects and side effects of both medications can be enhanced.
• cholinergics as they can reduce the effect of Solifenacin Succinate.
• medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin Succinatecan reduce their effect.
• medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin Succinate is broken down by the body
• medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin Succinate is broken down by the body.
• medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

Pregnancy and, breast-feeding and fertility

You should not use Solifenacin Succinate if you are pregnant unless clearly necessary.

Do not use Solifenacin Succinate if you are breast-feeding as solifenacin may get into your breast milk.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Solifenacin Succinate may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery.

Solifenacin Succinate contains lactose.

If you have been told by your doctor that you have anintolerance to some sugars, contact your doctor beforetaking this medicinal product.

3. How to take Solifenacin Succinate

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. You should swallow the whole tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets. The usual dose is 5 mg per day, unless your doctor told you to take 10 mg per day.

If you take more Solifenacin Succinate than you should

If you have taken too much Solifenacin Succinate or if a child has accidentally taken Solifenacin Succinate, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations), over- excitability, seizures (convulsions), difficulty breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and dilated pupils (mydriasis).

If you forget to take Solifenacin Succinate

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose. Never take more than one dose per day. If you are in doubt, always consult your doctor or pharmacist.

MED/GIR/P/03 21.08.17(GW)/11/26.07.19(AK)

If you stop taking Solifenacin Succinate

If you stop taking Solifenacin Succinate, your symptoms of overactive bladder may return or worsen. Always consult yourdoctor, if you are considering stopping the treatment.

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

4. Possible side effects

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

If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or pharmacist immediately. Angioedema (skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing) has been reported in some patients on solifenacin Succinate (Solifenacin Succinate). If angioedema occurs, solifenacin Succinate (Solifenacin Succinate) should be discontinued immediately and appropriate therapy and/or measures should be taken

Solifenacin Succinate may cause the following other side effects:

Very common (may affect more than 1 in 10 people)

• dry mouth

Common (may affect up to 1 in 10 people)

• blurred vision
• constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• sleepiness, impaired sense of taste (dysgeusia)
• dry (irritated) eyes
• dry nasal passages
• reflux disease (gastro-oesophageal reflux), dry throat
• dry skin
• difficulty in passing urine
• tiredness, accumulation of fluid in the lower legs (oedema)

Rare (may affect up to 1 in 1,000 people)

• lodging of a large amount of hardened stool in the large intestine (faecal impaction)
• build up of urine in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, rash

Very rare (may affect up to 1 in 10,000 people)

• hallucinations, confusion
• allergic rash

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

• decreased appetite, high levels of blood potassium which can cause abnormal heart rhythm
• increased pressure in the eyes
• changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, faster heart beat
• voice disorder
• liver disorder
• muscle weakness
• renal disorder

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Solifenacin Succinate

Keep this medicine out of the sight and reach of children.

Do not use Solifenacin Succinate 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. There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Solifenacin Succinate contains

• The active substance is solifenacin Succinate 5 mg or 10 mg.
• The other ingredients are lactose monohydrate, maize starch, hydroxypropyl, magnesium stearate and OPADRY white OY58900 [Hypromellose, Titanium dioxide and Macrogol].

What Solifenacin Succinate looks like and contents of the pack

Solifenacin Succinate 5mg film-coated tablet is a round, white to off-white tablet engraved with ‘’ 5’’ on one side and plain on other side Solifenacin Succinate 10mg film-coated tablet is a round, white to off-white tablet engraved with ‘’10’’ on one side and plain on other side.

Solifenacin Succinate tablets are supplied in blister packs of 10, 20, 30, 50, 90 or 100 tablets.

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names:

Solifenacin Succinate 5mg and 10mg Film-coated Tablets (UK)

Solifenacin Succinate 5mg and 10mg Film-coated Tablets (DK, NO, SE)

This leaflet was last revised in December 2019

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 02088311580 (UK only) Please be ready to give the following information:

Product name Reference number

Solifenacin Succinate 5mg Film-coated Tablets PL 21880/0212

Solifenacin Succinate 10mg Film-coated Tablets PL 21880/0213

Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

E-mail : info@medreich.co.uk

MED/GIR/P/01 30.12.19(VK)