Prospecto:Information for the Patient

Tamisten 5 mg Film-Coated Tablets

Tamisten 10 mg Film-Coated Tablets

Solifenacin Succinate

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenif they are not listed in this prospectus. See section 4.

1.What is Tamisten and for what it is used

2.What you need to knowbeforestarting totake Tamisten

3.How to take Tamisten

4.Possible adverse effects

5Storage of Tamisten

6.Contents of the package and additional information

The active ingredient of Tamisten belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to use the restroom and increases the amount of urine that your bladder can hold.

Tamisten is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, having to urinate frequently or experiencing urine leakage due to not reaching the restroom in time.

Do not take Tamisten:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you have difficulty urinating or emptying your bladder completely (urinary retention).
• if you have a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis).
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness in certain muscles.
• if you have high eye pressure with gradual loss of vision (glaucoma).
• if you are undergoing renal dialysis.
• if you have severe liver disease.
• if you have severe kidney disease or moderate liver disease and are being treated with medications that can reduce the elimination of solifenacina from the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

Inform your doctor before starting treatment with Tamisten if you have or have had any of the diseases mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamisten:

• if you have difficulty emptying your bladder (bladder obstruction) or urinating (e.g. weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any digestive system obstruction (constipation).
• if you have a risk of decreased digestive system activity (gastrointestinal motility). Your doctor will have informed you if this is the case.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Inform your doctor before starting treatment with Tamisten if you have or have had any of the diseases mentioned above.

Before starting treatment with Tamisten, your doctor will assess whether there are other causes for your need to urinate frequently (e.g. heart failure or kidney disease).

If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Children and adolescents

Tamisten should not be used in children or adolescents under 18 years old (see section 3).

Other medications and Tamisten

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. It is especially important to inform your doctor if you are taking:

• other anticholinergic medications, the activity and adverse effects of both medications may increase.
• cholinergic medications, which can reduce the effect of solifenacina.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of solifenacina from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of solifenacina from the body.
• medications such as bisphosphonates, which may cause or worsen esophagitis.

Taking Tamisten with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use Tamisten if you are pregnant unless it is absolutely necessary.

Do not use Tamisten during breastfeeding as solifenacina may pass into breast milk.

Driving and operating machines

Solifenacina may cause blurred vision and, occasionally, drowsiness or fatigue. If you experience any of these adverse effects, do not drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

Swallow the tablet whole with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

Use in children and adolescents

Tamisten should not be used in children or adolescents under 18 years old.

If you take more Tamisten than you should

If you have taken too much Tamisten or if a child has taken Tamisten accidentally, contact your doctor or pharmacist immediately, orcall the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. The symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urinary retention, and dilated pupils (mydriasis).

If you forget to use Tamisten

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take the next dose.

Do not take a double dose to compensate for the missed doses. If you have any doubts, consult your doctor or pharmacist always.

If you interrupt treatment with Tamisten

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Consult your doctor always if you are thinking of interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin),you must inform your doctor or pharmacist immediately.

Angioedema (allergy on the skin that results in inflammation that occurs in the tissue under the surface of the skin) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.In the case of angioedema, treatment with solifenacin (Tamisten) must be stopped immediately and appropriate therapy and/or measures must be initiated.

Solifenacin may cause the following 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 feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort.

Uncommon(may affect up to 1 in 100 people):

• urinary tract infection, bladder infection.
• drowsiness.
• abnormal taste perception (dysgeusia).
• dry eyes (irritated).
• nasal dryness.
• gastroesophageal reflux disease (GERD).
• dry throat.
• dry skin.
• difficulty urinating.
• fatigue.
• lower extremity edema (fluid accumulation).

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

• large amounts of hardened feces accumulated in the large intestine (fecal impaction).
• urine accumulation in the bladder due to inability to empty the bladder (urinary retention).
• dizziness, headache.
• vomiting.
• itching, skin rash.

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

• hallucinations, confusion.
• allergic skin eruption.

Unknown frequency(frequency cannot be estimated from available data):

• decreased appetite, high potassium levels in the blood that may cause abnormal heart rhythm.
• increased eye pressure.
• changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat.
• voice disorder.
• liver disorder.
• muscle weakness.
• renal disorder.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box,after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the Pharmacy Take-Back Point. In this way, you will help protect the environment.

Composition ofTamisten

• The active ingredient issuccinato de solifenacina. Each tablet contains 5 mg or 10 mg of succinato de solifenacina, equivalent to 3.8 mg or 7.5 mg of solifenacina, respectively.
• The other components aremicrocrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E 172) (only for the 5 mg dose) and red iron oxide (E172) (only for the 10 mg dose).

Appearance of the product and contents of the package

Tamisten 5 mg tablets are yellow-coated, round, biconvex tablets with a diameter of 6 mm.

Tamisten 10 mg tablets are red-coated, round, biconvex tablets with a diameter of 8 mm.

The package contains transparent PVC/PVDC-Alu blisters and aluminum foil blisters with a cold-formed aluminum foil and a pressure-opening aluminum foil of 10, 20, 30, 50, 60, 90, 100 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol,

Cyprus

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2021.