Solifenacin Viso Farmaceutica 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacin Viso Farmacéutica 5 mg film-coated tablets EFG

Solifenacin succinate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Solifenacin Viso Farmacéutica is and what it is used for

The active substance solifenacin belongs to the group of anticholinergic medicines. 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.

Solifenacin 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 leaking urine because you cannot reach the toilet in time.

2. What you need to know before starting to take Solifenacin Viso Farmacéutica

Do NOT take Solifenacin Viso Farmacéutica

• 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 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 also being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the conditions listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking solifenacin

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty passing urine (e.g. weak urine stream). 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 intestinal movements). Your doctor will inform you if this applies to you.
• 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 known as autonomic neuropathy.

Inform your doctor before starting treatment with solifenacin if any of the above circumstances 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 for certain bacterial infections).

Children and adolescents

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

Other medicines and Solifenacin Viso Farmacéutica

Tell 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. Consult your doctor to determine if your medication belongs to this group.
• cholinergic agents, as they may reduce the effect of solifenacin. Consult your doctor to determine if your medication belongs to this group.
• medicines such as metoclopramide or cisapride, which increase digestive system activity. Solifenacin may reduce their effect.
• medicines such as ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infections), and verapamil, diltiazem (medicines used to treat high blood pressure and heart conditions). These medicines decrease the rate of elimination of solifenacin from the body.
• medicines such as rifampicin (a medicine used to treat tuberculosis and other bacterial infections) and phenytoin, carbamazepine (medicines used to treat epilepsy). These 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). Consult your doctor to determine if your medication belongs to this group.

Taking Solifenacin Viso Farmacéutica with food and drink

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

Pregnancy, breastfeeding and fertility

You must not use solifenacin if you are pregnant unless absolutely necessary. Do not use solifenacin during breastfeeding, as solifenacin may pass into breast milk.

If you are pregnant or breastfeeding, 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.

Solifenacin Viso Farmacéutica contains lactose monohydrate

If your doctor has informed you that you have a hereditary intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Solifenacin Viso Farmacéutica

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

You must swallow the tablet whole with a liquid, for example, a glass of water. It may be taken with or without food, according to your preference. Do not crush the tablets.

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

Use in children and adolescents

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

If you take more Solifenacin Viso Farmacéutica than you should

If you have taken too much solifenacin or if a child has accidentally ingested solifenacin, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Tel. 91 562 04 20).

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), pronounced excitement, seizures, breathing difficulties, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Solifenacin Viso Farmacéutica

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. Do not take a double dose to make up for a missed dose.

If you stop taking Solifenacin Viso Farmacéutica

If you stop taking this medicine, 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 will experience them.

Stop taking SolifenacinViso Farmacéutica and seek immediate medical attention if you notice any of the following adverse effects

• if you suffer an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin)
• angioedema (an allergic skin reaction causing swelling in the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin.

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 stomach heaviness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• somnolence
• 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 (may affect up to 1 in 1,000 people)

• accumulation of a large amount of hardened feces in the colon (fecal impaction)
• urine retention 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 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 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Viso Farmacéutica

This medicine does not require any special storage conditions.

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 use this medicine if the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacina Viso Farmacéutica

The active substance is solifenacin succinate.

Each film-coated tablet contains 5 mg of solifenacin succinate.

The other components are:

Tablet core: maize starch, lactose monohydrate, hypromellose (E464), and magnesium stearate.

Film coating: hypromellose (E464), macrogol, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of Solifenacina Viso Farmacéutica and contents of the pack

Solifenacina Viso Farmacéutica 5 mg film-coated tablets are round, light yellow tablets, with "390" engraved on one side of the tablet.

Solifenacina Viso Farmacéutica 5 mg film-coated tablets are supplied in blisters of 10, 30, 50, 90, or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

S.C. Zentiva S.A.
Bd. Theodor Pallady nr 50
032266 Bucuresti
Romania

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in member states under the following names:

Date of the most recent review of this leaflet: August 2017