Tamisten 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package 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 you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet Contents

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

1. What Tamisten is and what it is used for

The active substance in Tamisten belongs to the group of anticholinergic medicines. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine your bladder can hold.

Tamisten is used to treat symptoms of overactive bladder syndrome. These symptoms include a sudden, strong urge to urinate without prior warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before taking Tamisten

Do not take Tamisten:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (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 of certain muscles.
• if you have increased 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 also being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this applies.

Before starting treatment with Tamisten, inform your doctor if you have or have had any of the conditions listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamisten:

• if you have problems emptying your bladder (bladder obstruction) or difficulty urinating (e.g. weak urine stream). 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 reduced activity of the digestive system (stomach and intestinal movements). Your doctor will have informed you if this applies.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have gastroesophageal reflux or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Before starting treatment with Tamisten, inform your doctor if you have or have had any of the conditions listed 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 (inadequate pumping capacity of the heart) 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 must not be used in children or adolescents under 18 years of age (see section 3).

Other medicines and Tamisten

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines may increase.
• cholinergics, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide or cisapride, which increase digestive system activity. Solifenacin may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate at which solifenacin is eliminated from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate at which solifenacin is eliminated from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Tamisten with food and drink

Tamisten can be taken with or without food, according to your preference.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Tamisten during pregnancy unless absolutely necessary.

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

Driving and using machines

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

3. How to take Tamisten

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Use in children and adolescents

Tamisten must 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Symptoms in case of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), marked excitement, seizures, breathing difficulty, increased heart rate (tachycardia), urine retention 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 almost time for your 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 medicine, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 (a skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. In case of angioedema, treatment with solifenacin (Tamisten) must be immediately discontinued and appropriate therapy and/or measures must be initiated.

Solifenacin may cause the following adverse 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 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 (irritated) eyes.
• dryness of the nasal passages.
• reflux disease (gastroesophageal reflux).
• dry throat.
• dry skin.
• difficulty urinating.
• fatigue.
• fluid accumulation in the lower limbs (edema).

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

• accumulation of a large amount of hardened feces in the colon (fecal impaction).
• urine retention 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 the available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamisten

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

Do not use this medicine after the expiry date stated on the carton, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Point in the pharmacy. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tamisten

• The active substance 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 components are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172) (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 pack

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

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

The pack contains transparent PVC/PVDC-Alu blisters and cold-form aluminum blisters with aluminum peelable lid, available in pack sizes of 10, 20, 30, 50, 60, 90, and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Medochemie Ltd
1-10 Constantinoupoleos street
3011 Limassol,
Cyprus

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Átika Pharma
Calle Viera y Clavijo, 30, 2º
35002 Las Palmas de Gran Canaria, Las Palmas
Spain

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

Date of the most recent review of this leaflet: June 2021.