SOLIFENACIN KRKA 10 mg FILM-COATED TABLETS

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

Do not takeSolifenacin Krka

• If you are allergic to solifenacin or 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 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 being treated with medicines that may decrease the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

Before starting treatment with Solifenacin Krka, tell 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 Solifenacin Krka.

• If you have a problem 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 have a 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 an autonomic nervous disorder (autonomic neuropathy).

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

Before starting treatment with Solifenacin Krka, your doctor will assess whether there are other causes for your frequent need to urinate (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

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

Other medicines andSolifenacinKrka

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 may 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).

TakingSolifenacinKrkawith food and drinks

Solifenacin Krka can be taken with or without food, as you prefer.

Pregnancy and breast-feeding

Do not use Solifenacin Krka if you are pregnant unless it is absolutely necessary. Do not use Solifenacin Krka 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 have a baby, ask your doctor or pharmacist for advice before taking 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 use machines.

Solifenacin Krkacontains lactose

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

3. How to take Solifenacin Krka

Instructions for correct use

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

If you take moreSolifenacinKrkathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional. 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 takeSolifenacinKrka

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.

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 Solifenacin Krka

If you stop taking this medicine, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Solifenacin Krka and seek medical attention immediately if you notice any of the following side effects:

• angioedema (allergy in the skin that results in inflammation that occurs in the tissue that is under the surface of the skin) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Solifenacin Krka 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, 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 eyes (irritated).
• dryness of the nasal passages.
• gastroesophageal reflux disease (gastroesophageal reflux), dry throat.
• dry skin.
• difficulty urinating.
• fatigue, accumulation of fluid 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Krka

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 other information

Composition ofSolifenacin Krka

• The active substance is solifenacin succinate.

Solifenacin Krka 5 mg film-coated tablets: each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

Solifenacin Krka 10 mg film-coated tablets: each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.

• The other ingredients are:

Core of the tablet: lactose monohydrate, povidone, and magnesium stearate.

Coating of the tablet: hypromellose, talc, titanium dioxide (E171), triacetin, and red iron oxide (E172) (only for the 10 mg dose)

See section 2 "Solifenacin Krka contains lactose"

Appearance and packaging

Solifenacin Krka 5 mg film-coated tablets

Film-coated tablets, white to white-brown, round, slightly convex with beveled edges. Tablet diameter: 7.5 mm.

Solifenacin Krka 10 mg film-coated tablets

Film-coated tablets, white-pink, round, slightly convex with beveled edges. Tablet diameter: 7.5 mm.

Available in boxes with blisters of 10, 20, and 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: July 2023

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