Solifenacin Doc Generici

Package leaflet: Information for the patient

SOLIFENACINA DOC 5 mg, film-coated tablets, 10 mg, film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What SOLIFENACINA DOC is and what it is used for

The active substance of SOLIFENACINA DOC belongs to the group of anticholinergics. These medicines
are used to reduce the activity of the overactive bladder. This allows you to wait longer before needing
to go to the toilet and increases the amount of urine that your bladder can hold.
SOLIFENACINA DOC is used to treat the symptoms of a condition called overactive bladder.
These symptoms include: a sudden, strong urge to urinate without warning, needing to urinate frequently, or wetting yourself because you cannot reach the toilet in time.

2. What you need to know before taking SOLIFENACINA DOC

Do not take SOLIFENACINA DOC:

• if you have difficulty urinating or completely emptying your bladder (urinary retention)
• if you have a serious stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles
• if you have increased intraocular pressure with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or to 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 simultaneously being treated with medicines that may reduce the elimination of solifenacin from your body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this applies. Inform your doctor if you have or have ever had any of the above-mentioned conditions before starting treatment with SOLIFENACINA DOC.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking SOLIFENACINA DOC:

• if you have problems emptying your bladder (= bladder obstruction) or if you experience difficulty in passing urine (e.g., weak urine stream). The risk of urine accumulation in the bladder (urinary retention) is significantly higher.
• if you have gastrointestinal obstructions (constipation).
• if you are at risk of low gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies.
• if you suffer from severe kidney disease.
• if you have moderate liver disease.
• if you have stomach pain (hiatal hernia) or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Children and adolescents
SOLIFENACINA DOC must not be used in children or adolescents under 18 years of age.
Inform your doctor if you have or have ever had any of the above-mentioned conditions before starting treatment with SOLIFENACINA DOC.
Before starting SOLIFENACINA DOC, your doctor will assess whether there are other causes for your frequent need to urinate (e.g., heart failure (inadequate ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment against specific bacterial infections).

Other medicines and SOLIFENACINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effects and side effects of both medicines may be increased.
• cholinergic agents, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Solifenacin may reduce their effect.
• drugs such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of SOLIFENACINA DOC from the body.
• drugs such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• drugs such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

SOLIFENACINA DOC with food and drink
SOLIFENACINA DOC may be taken with or without food, according to your preference.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must not use SOLIFENACINA DOC during pregnancy unless clearly necessary.

Breastfeeding
Do not use SOLIFENACINA DOC while breastfeeding, as solifenacin may pass into breast milk.

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

SOLIFENACINA DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take SOLIFENACINA DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must swallow the tablet whole with liquid. It can be taken with or without food, according to your
preference. Do not crush the tablets.
The usual dose is 5 mg once daily, unless your doctor has instructed you to take 10 mg
daily.
If you take more SOLIFENACINA DOC than you should
If you have taken too much SOLIFENACINA DOC or if a child has accidentally ingested
SOLIFENACINA DOC, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perception of things that are not present (hallucinations), over-excitement, epileptic seizures (convulsions), difficulty breathing, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils (mydriasis).
If you forget to take SOLIFENACINA DOC
If you forget to take a dose at your 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.
If you stop taking SOLIFENACINA DOC
If you stop treatment with SOLIFENACINA DOC, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you suffer an allergic reaction or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (a skin allergy causing swelling just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.
If angioedema occurs, treatment with SOLIFENACINA DOC must be immediately discontinued and appropriate measures and/or therapies must be initiated.

SOLIFENACINA DOC may cause the following additional 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 bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infection, bladder infection
• Drowsiness
• Altered taste perception (dysgeusia)
• Dry (irritated) eyes
• Nasal dryness
• Gastro-oesophageal reflux disease (acid reflux), dry throat
• Dry skin
• Difficulty in urination
• Fatigue, fluid accumulation in the lower legs (oedema)

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

• Accumulation of large amounts of hardened faeces in the colon (faecal impaction)
• Urine retention in the bladder due to inability to empty the bladder (urinary retention)
• Dizziness, headache
• Vomiting
• Itching, rash

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

• Hallucination, confusion
• Allergic skin rash

Not known (frequency cannot be estimated from the available data)

• Decreased appetite, high levels of potassium in the blood which may cause heart rhythm abnormalities
• Increased intraocular pressure
• Changes in the heart's electrical activity (ECG), irregular heartbeat, awareness of heartbeat, rapid heartbeat
• Voice disorder
• Liver disorders
• Muscle weakness
• Kidney disorders

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLIFENACIN DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SOLIFENACINA DOC contains

• The active substance is solifenacin succinate.
  SOLIFENACINA DOC 5 mg: Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
  SOLIFENACINA DOC 10 mg: Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other components of SOLIFENACINA DOC 5 mg are:
  Tablet core: maize starch, monohydrate lactose, hypromellose, and magnesium stearate.
  Film coating: hypromellose, talc, titanium dioxide (E171), macrogol, and yellow iron oxide (E172).
• The other components of SOLIFENACINA DOC 10 mg are:
  Tablet core: maize starch, monohydrate lactose, hypromellose, and magnesium stearate.
  Film coating: hypromellose, talc, titanium dioxide (E171), macrogol, and red iron oxide (E172).

Description of the appearance of SOLIFENACINA DOC and package contents

SOLIFENACINA DOC 5 mg are yellow, round, biconvex film-coated tablets.
SOLIFENACINA DOC 10 mg are light pink, round, biconvex film-coated tablets.
SOLIFENACINA DOC 5 mg film-coated tablets are supplied in blisters of 10 and 30 tablets.
SOLIFENACINA DOC 10 mg film-coated tablets are supplied in blisters of 20 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names
Italy: SOLIFENACINA DOC
Portugal: Solifenacina DOC