SOLIFENACIN TECNIGEN 5 mg FILM-COATED TABLETS

2. What you need to know before you take Solifenacin TecniGen

Do not take Solifenacin 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 pressure in the eyes, with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other ingredients of this medicine (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 medicines that may decrease the elimination of this medicine from the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting treatment with this medicine:

• if you have problems emptying your bladder (= bladder obstruction) 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 hiatus hernia or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

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

Before starting treatment with this medicine, your doctor will assess whether there are other causes that explain your need to urinate frequently (e.g. heart failure (insufficient pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment against certain bacterial infections).

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Solifenacin TecniGen

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

It is especially important that you tell your doctor if you are taking:

• other anticholinergic medicines, the activity and side effects of both medicines could increase.
• cholinergics, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide or cisapride, which make the digestive system work faster. 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 esophagus (esophagitis).

Taking Solifenacin TecniGen with food and drinks

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Do not use this medicine during breast-feeding, 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.

Solifenacin TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Solifenacin TecniGen

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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, unless your doctor tells you to take 10 mg per day.

If you take more Solifenacin TecniGen than you should

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

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), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin 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, always consult your doctor or pharmacist.

If you stop taking Solifenacin TecniGen

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Angioedema (allergy in the skin that results in inflammation that occurs in the tissue 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.

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 a feeling of heaviness in the stomach, abdominal pain, belching 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
• 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 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 the 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin TecniGen

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Solifenacin TecniGen

• the active substance is solifenacin succinate

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

• the other ingredients are:

Core: corn starch, lactose monohydrate, hypromellose, magnesium stearate.

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

Appearance and packaging

Film-coated tablets, circular, convex and yellow in color.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Date of last revision of this leaflet: August 2018

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