Solifenacin Tarbis 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacin Tarbis 10 mg film-coated tablets EFG

Solifenacin succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Solifenacina Tarbis is and what it is used for

The active substance in Solifenacina Tarbis belongs to the group of anticholinergics. These medicines are used to reduce the activity of an 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.

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

2. What you need to know before starting Solifenacin Tarbis

Do not take Solifenacin Tarbis

• if you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6)
• if you have difficulty passing urine or emptying your bladder completely (urinary retention)
• if you have a serious stomach or bowel condition (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 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 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 solifenacin, inform your doctor if you have or have ever had any of the conditions mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine:

• if you have difficulty emptying your bladder (= bladder obstruction) or problems passing urine (e.g. 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 increased risk of reduced activity of the digestive system (stomach and bowel movements). Your doctor will inform you if this applies.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Children and adolescents

Solifenacin must not be used in children or adolescents under 18 years of age.

Inform your doctor before starting treatment with solifenacin if any of the above-mentioned conditions have ever applied to you.

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your need to urinate frequently (for example, 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 against certain bacterial infections).

Taking Solifenacin Tarbis with other medicines

Inform 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 could increase.
• Cholinergic agents, as they may reduce the effect of solifenacin.
• Medicines such as metoclopramide or cisapride, which increase the activity of the digestive system. Solifenacin may reduce their effect.
• Medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of solifenacin from the body.
• Medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• Medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Tarbis with food and drink

Solifenacin may be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

You must not use solifenacin if you are pregnant unless absolutely necessary.

Do not use solifenacin during breast-feeding, as solifenacin may pass into breast milk.

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

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 operate machinery.

3. How to take Solifenacin Tarbis

Instructions for proper use

Follow exactly the instructions given by your doctor for taking this medicine.

If in doubt, consult your doctor or pharmacist again.

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.

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

If you take more Solifenacin Tarbis than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms 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 accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Solifenacin Tarbis

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. Never take more than one dose per day.

If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Tarbis

If you stop taking solifenacin, 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 suffer an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or nurse 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. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or measures must be taken.

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 feeling of stomach heaviness, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort

Uncommon adverse effects (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• dry nasal passages
• reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the lower limbs (edema)

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

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

Very rare adverse effects (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 which may cause an abnormal heart rhythm.
• increased eye pressure
• changes in the heart's electrical activity (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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Tarbis

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

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin Tarbis

• The active substance is solifenacin succinate: 10 mg.
• The other components are povidone, corn starch, sodium carboxymethyl potato starch (type A), anhydrous calcium hydrogen phosphate, magnesium stearate, Opadry White (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, and talc), and iron oxide red (E172).

Appearance of the medicinal product and contents of the pack

Solifenacin Tarbis 10 mg tablets are rough, cylindrical, biconvex, pale pink tablets without a score line, marked with the logo “S1” on one side.

Solifenacin Tarbis 10 mg tablets are supplied in blisters containing 30 tablets.

Marketing Authorization Holder

Tarbis Farma, S.L.
Gran Vía Carlos III, 94
08028 Barcelona (Spain)

Manufacturer

LABORATORIOS CINFA, S.A.
C/Olaz-Chipi, 10 - Polígono Industrial Areta
31620 Huarte-Pamplona (Navarra)

Date of the most recent revision of this leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/