Prospect: information for the user

Solifenacina TecniGen 5 mg film-coated tablets EFG

Solifenacin succinate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

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

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

-If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Solifenacina TecniGen

3. How to take Solifenacina TecniGen

4. Possible adverse effects

5. Storage of Solifenacina TecniGen

6. Contents of the package and additional information

The active ingredient of this medication 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 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 prior warning, having to urinate frequently or having urine leakage due to not reaching the bathroom in time.

Do not take Solifenacina TecniGen:

• 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 of ulcerative colitis)
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles
• if you have high eye pressure with gradual loss of vision (glaucoma)
• if you are allergic to solifenacina or any of the other components of this medication (listed in section 6)
• 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 this medication from the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

- 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 obstruction of the digestive system (constipation).

- if you have a risk of decreased activity of the digestive system (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 disorder (autonomic neuropathy).

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

Before starting treatment with this medication, your doctor will assess whether there are other causes that explain 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

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

Other medications and Solifenacina TecniGen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 elimination rate of solifenacina from the body.

- medications such as rifampicin, phenytoin, and carbamazepine, which can increase the elimination rate of solifenacina from the body.

- medications such as bisphosphonates, which can cause or worsen esophagitis.

Taking Solifenacina TecniGen with food and drinks

This medication 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.

Pregnancy

You should not use this medication if you are pregnant, unless it is absolutely necessary.

Breastfeeding

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

Driving and operating machinery

Solifenacina may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Solifenacina TecniGen contains lactose

This medication contains lactose. If your doctor has told you that you have a hereditary intolerance to certain sugars, consult with them before taking this medication.

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

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

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

If you take more Solifenacina TecniGen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forgot to take Solifenacina TecniGen

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 have any doubts, consult your doctor or pharmacist always.

If you interrupt treatment with Solifenacina TecniGen

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Angioedema (allergy on the skin resulting in inflammation that occurs in the tissue beneath the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.If angioedema appears,the treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or measures must be taken.

This medicine 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, 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 (reflux)

- dry throat

- dry skin

- difficulty urinating

- fatigue

- accumulation of fluid in the lower extremities (edema)

Rare (may affect up to 1 in 1000 people)

- accumulation of a large amount of hardened feces in the large intestine (fecal impaction)

- urinary retention (inability to empty the bladder)

- dizziness, headache

- vomiting

- itching, skin rash

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

- hallucinations, confusion

- allergic skin eruption.

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

- decreased appetite, high levels of potassium in the blood that may cause an abnormal heart rhythm.

- increased eye pressure

- changes in heart electrical activity (ECG), irregular heartbeats, palpitations, rapid heart rate.

- voice disorder

- liver disorder

- muscle weakness

- kidney 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Solifenacina TecniGen

- The active ingredient is solifenacin succinate

Cada comprimido recubierto contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin

- The other components are:

Core: cornstarch, lactose monohydrate, hypromellose, magnesium stearate.

Coating: talc, titanium dioxide (E171), macrogol, iron oxide yellow (E172) and hypromellose

Appearance of the product and content of the container

Coated tablets with a film coating, circular, convex and yellow in color.

Solifenacina TecniGen coated tablets EFG are supplied in blisters of 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega, 28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2 Abrunheira, 2710-089 Sintra

Portugal

Last revision date of this leaflet: August 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es