SOLIFENACIN HEC PHARM 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Hec Pharm 5 mg film-coated tablets EFG

solifenacin succinate

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

• Keep this package 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Solifenacin Hec Pharm and what is it used for
2. What you need to know before taking Solifenacin Hec Pharm
3. How to take Solifenacin Hec Pharm
4. Possible side effects
5. Storage of Solifenacin Hec Pharm
6. Package contents and additional information

1. What is Solifenacin Hec Pharm and what is it used for

The active substance of this medication 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 that your bladder can hold.

This medication is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, needing to urinate frequently, or having urine leaks because you cannot reach the bathroom in time.

2. What you need to know before taking Solifenacin Hec Pharm

Do not take Solifenacin Hec Pharm

• 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 high pressure in the eyes, with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other components of this medication (listed in section 6)
• if you have severe kidney disease or are undergoing renal dialysis
• if you have moderate or severe liver disease
• if you are receiving treatment with medications that may decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with this medication, 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 this medication

• 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 have an increased risk of decreased activity of the digestive system (movements of the stomach and intestine). Your doctor will inform you if this is the case.
• if you have a hiatal hernia or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents

Solifenacin HEC Pharm should not be used in children or adolescents under 18 years of age.

Inform your doctor before starting treatment with this medication if any of the above circumstances have occurred to you.

Before starting treatment with this medication, 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).

Other medications and Solifenacin Hec Pharm

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 this medication.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. This medication 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 this medication from the body.
• medications such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Solifenacin HEC Pharm with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

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

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.

Driving and using machines

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

Solifenacin HEC Pharm contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Solifenacin HEC Pharm

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

You should swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. Do not crush the tablets.

The usual dose is 5 mg per day, for which other presentations are available. The dose will be 10 mg per day when your doctor decides that you need this higher dose.

If you take more Solifenacin HEC Pharm than you should

If you have taken too much solifenacin or if a child has accidentally taken this medication, contact your doctor or pharmacist immediately.

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).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Solifenacin HEC Pharm

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. Never take more than one dose per day. If you are unsure, consult your doctor or pharmacist.

If you stop taking Solifenacin HEC Pharm

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

If you have any other questions about the use of 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), you should inform your doctor immediately.

Angioedema (allergy in the skin that results in inflammation under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate should be discontinued immediately and appropriate treatment and/or measures should be taken.

Solifenacin may cause these 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 a feeling of stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon side effects (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
• fluid accumulation in the lower limbs (edema)

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

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

Very rare side 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 potassium levels 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, perception of one's own heartbeat, 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Solifenacin Hec Pharm

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

Do not use this medication after the expiration date shown on the packaging or blister after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin HEC Pharm

• The active substance is solifenacin succinate.

Each film-coated tablet contains 5 mg of solifenacin succinate, which is equivalent to 3.8 mg of solifenacin.

• The other components are:

Tablet core: anhydrous lactose (see warnings in section 2), hypromellose E5-LV, magnesium stearate, microcrystalline cellulose, and anhydrous colloidal silica.

Tablet coating: monohydrate lactose (see warnings in section 2), hypromellose 2910, titanium dioxide, and triacetin.

Appearance of Solifenacin HEC Pharm and package contents

Solifenacin HEC Pharm 5 mg film-coated tablets are white or almost white, round, film-coated tablets with "Y7" engraved on one side and smooth on the other.

Solifenacin HEC Pharm 5 mg film-coated tablets are available in blisters of 10, 30, 50, or 90 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17

10963 Berlin

Germany

Manufacturer

Formula Pharmazeutische und chemische

Entwicklungs GmbH

Goerzallee 305b

14167 Berlin

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet:October 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/