TAMISTEN 5 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

Tamisten 5 mg film-coated tablets EFG

Tamisten 10 mg film-coated tablets EFG

Solifenacin succinate

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Tamisten and what is it used for
2. What you need to know before taking Tamisten
3. How to take Tamisten
4. Possible side effects

5 Conservation of Tamisten

1. Package contents and additional information

1. What is Tamisten and what is it used for

The active ingredient of Tamisten belongs to the group of anticholinergics. These medications are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine 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 warning, having to urinate frequently, or having urine leaks because you cannot reach the bathroom in time.

2. What you need to know before taking Tamisten

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 muscular disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• if you have high pressure in the eyes, 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 may decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

Before starting treatment with Tamisten, inform your doctor if you have or have had any of the above-mentioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamisten:

• if you have problems emptying your bladder (obstruction of the bladder) or urinating (e.g., a weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any obstruction of the digestive system (constipation).
• if you are at risk of decreased activity of the digestive system (movements of the stomach and intestine). 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 a hiatal hernia or heartburn.
• if you have an autonomic nervous disorder (autonomic neuropathy).

Before starting treatment with Tamisten, inform your doctor if you have or have had any of the above-mentioned diseases.

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

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

Children and adolescents

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

Other medications and Tamisten

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

• other anticholinergic medications, as the activity and side effects of both medications may increase.
• cholinergic medications, as they may reduce the effect of solifenacin.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of solifenacin from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of solifenacin from the body.
• medications such as bisphosphonates, which may cause or worsen esophageal inflammation (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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and using machines

Solifenacin may cause blurred vision and, sometimes, drowsiness or fatigue. If you experience any of these side effects, do not drive or use machines.

3. How to take Tamisten

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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, as you prefer. Do not crush the tablets.

Use in children and adolescents

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

If you take more Tamisten than you should

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

If you forget to take 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 make up for forgotten doses. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Tamisten

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

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

4. Possible side effects

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

If you suffer an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or pharmacist immediately.

Angioedema (allergic reaction in the skin that results in inflammation under the skin's surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. In case of angioedema, treatment with solifenacin (Tamisten) should be discontinued immediately, and appropriate therapy and/or measures should 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 a feeling of stomach heaviness, abdominal pain, belching, nausea, and heartburn (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).
• dryness of the nasal passages.
• gastroesophageal reflux disease (GERD)
• dry throat.
• dry skin.
• difficulty urinating.
• fatigue.
• accumulation of fluid in the lower limbs (edema).

Rare(may affect up to 1 in 1000 people):

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction).
• accumulation of urine 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 rash.

Frequency not known(frequency cannot be estimated from available data):

• decreased appetite, high levels of potassium in the blood that can cause an abnormal heart rhythm.
• increased pressure in the eyes.
• changes in the electrical activity of the heart (ECG), irregular heartbeats, palpitations, rapid heartbeat.
• voice disorder.
• liver disorder.
• muscle weakness.
• kidney disorder.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Tamisten

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the box, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre collection point in the pharmacy. This will help protect the environment.

6. Package contents and additional information

Composition ofTamisten

• The active ingredient is solifenacin succinate. Each tablet contains 5 mg or 10 mg of solifenacin succinate, equivalent to 3.8 mg or 7.5 mg of solifenacin, respectively.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, 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 package contents

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

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

The package contains transparent PVC/PVDC-Alu blister packs and aluminum blister packs with a push-through opening, containing 10, 20, 30, 50, 60, 90, or 100 tablets.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Medochemie Ltd

1-10 Constantinoupoleos street

3011 Limassol,

Cyprus

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Spanish branch

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this leaflet: June 2021.