Solifenacin medreg

Package leaflet: Information for the patient

Solifenacin Medreg, 5 mg, film-coated tablets
Solifenacin Medreg, 10 mg, film-coated tablets
Solifenacini succinas
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Solifenacin Medreg is and what it is used for

The active substance in Solifenacin Medreg belongs to a group of medicines called anticholinergics (cholinolytics). These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between urinations and increases the amount of urine the bladder can hold.
Solifenacin Medreg is used to treat the symptoms of overactive bladder. These symptoms include urgency, which is a sudden, compelling need to urinate, frequency of urination, and urge incontinence, where the patient is unable to reach the toilet in time.

2. Important information before taking Solifenacin Medreg

When not to take Solifenacin Medreg:

• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6),
• if the patient is unable to pass urine or empty the bladder (urinary retention),
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis),
• if the patient suffers from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles,
• if the patient has increased intraocular pressure with gradual loss of vision (narrow-angle glaucoma),
• if the patient is undergoing dialysis,
• if the patient has severe liver function impairment,
• if the patient with severe kidney disease or moderate liver disease is also taking medications that may delay elimination of Solifenacin Medreg from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Solifenacin Medreg, inform your doctor if any of the above conditions are present or have occurred in the past.

Warnings and precautions

Before starting to take Solifenacin Medreg, discuss with your doctor or pharmacist:

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher,
• if the patient suffers from gastrointestinal tract motility disorders (constipation),
• if there is a risk of slowed gastrointestinal motility (peristalsis, stomach and intestinal movements). Your doctor will provide further information on this,
• if the patient has severe kidney function impairment,
• if the patient has moderate liver function impairment,
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn,
• if the patient has disorders of the nervous system (autonomic neuropathy). Symptoms of autonomic neuropathy vary depending on which part of the autonomic nervous system is affected. They may include: dizziness, fainting, irregular heartbeat, drop in blood pressure upon sudden change to upright position, abnormal sweating, visual disturbances, digestive problems, urinary problems, sexual dysfunction, exercise intolerance, burning sensation.

Consult your doctor, even if the above warnings relate to current or past conditions, before starting treatment with Solifenacin Medreg.

Before initiating treatment with Solifenacin Medreg, your doctor will evaluate whether there are other causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood effectively, or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Children and adolescents

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

Solifenacin Medreg with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with Solifenacin Medreg may increase both therapeutic effects and adverse reactions of both drugs,
• cholinergic receptor agonists, as they may reduce the effectiveness of Solifenacin Medreg,
• drugs enhancing gastrointestinal motility, such as metoclopramide and cisapride, as Solifenacin Medreg may reduce their effectiveness,
• drugs such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may slow down the metabolism of Solifenacin Medreg in the body,
• drugs such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Solifenacin Medreg in the body,
• drugs such as bisphosphonates, as they may cause or worsen esophagitis.

Solifenacin Medreg with food and drink

Solifenacin Medreg can be taken during meals or independently of meals, according to patient preference.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Solifenacin Medreg must not be used during pregnancy unless the doctor considers it absolutely necessary.

Solifenacin Medreg must not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and operating machinery:

Solifenacin Medreg may cause blurred vision and occasionally drowsiness or fatigue. If these adverse effects occur, the patient should not drive or operate any machinery.

Solifenacin Medreg contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before using Solifenacin Medreg.

3. How to take Solifenacin Medreg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The usual dose is 5 mg once daily, unless your doctor has recommended a dose of 10 mg.
The tablet should be swallowed whole with liquid. Solifenacin Medreg can be taken during or independently of meals,
according to patient preference. Do not crush the tablets.

Taking more Solifenacin Medreg than recommended
If you have taken too many Solifenacin Medreg tablets, or if a child has accidentally swallowed the medicine,
contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and visual disturbances, hallucinations,
excessive excitement, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), excessive urine retention
in the bladder (urinary retention), and dilated pupils.

If you miss a dose of Solifenacin Medreg
If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next scheduled dose.
Do not take the medicine more than once a day. If you are unsure, consult your doctor or pharmacist.

Stopping Solifenacin Medreg
If you stop taking Solifenacin Medreg, symptoms of overactive bladder may return or worsen. Always consult your doctor
before discontinuing treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering
and peeling of the skin), a doctor or pharmacist should be informed immediately.
Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface),
including swelling of the airways (difficulty breathing), has been reported in some patients taking solifenacin succinate (Solifenacin Medreg). If angioedema occurs, treatment with solifenacin succinate (Solifenacin Medreg) should be stopped immediately and appropriate treatment and/or corrective measures should be initiated.
Solifenacin Medreg may cause other adverse effects listed below:
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, dyspepsia with symptoms such as bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), gastric discomfort.

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection, cystitis,
• somnolence,
• taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux disease (acid reflux),
• dry throat,
• dry skin,
• difficulty in urination,
• fatigue,
• swelling of the lower limbs.

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

• faecal impaction; colonic obstruction,
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

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

• hallucinations, disorientation,
• urticaria.

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

• decreased appetite, increased blood potassium levels which may lead to cardiac arrhythmias,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat (torsade de pointes), palpitations, tachycardia,
• voice disorders,
• hepatic function abnormalities,
• muscle weakness,
• renal function disorders,
• abdominal discomfort, intestinal obstruction (lack of intestinal motility which may lead to intestinal obstruction),
• extensive redness and peeling of the skin,
• delirium.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Solifenacin Medreg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Solifenacin Medreg contains

• The active substance is solifenacin succinate.
  Solifenacin Medreg 5 mg, coated tablets: Each tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
  Solifenacin Medreg 10 mg, coated tablets: Each tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• Other ingredients are:
  Tablet core: Lactose monohydrate, spray-dried lactose monohydrate, maize starch, talc, magnesium stearate.
  Tablet coating:
  Solifenacin Medreg 5 mg, coated tablets: Opadry yellow OY 32823 (hypromellose 6cP (E 464), titanium dioxide (E 171), polyethylene glycol 400, iron oxide yellow (E 172), iron oxide red (E 172)).
  Solifenacin Medreg 10 mg, coated tablets: Opadry white 03B28796 (hypromellose 6cP (E 464), titanium dioxide (E 171), polyethylene glycol 400), Opadry brown 02F23883 (hypromellose 5cP (E 464), titanium dioxide (E 171), polyethylene glycol 6000, iron oxide yellow (E 172), iron oxide red (E 172)).

What Solifenacin Medreg looks like and contents of the pack
Solifenacin Medreg 5 mg: Yellow, round, biconvex coated tablet, approximately 6 mm in diameter.
Solifenacin Medreg 10 mg: Pink, round, biconvex coated tablet, approximately 7 mm in diameter.
The coated tablets are packed in aluminium/OPA/aluminium/PVC blisters in a cardboard carton.
Pack sizes: 10, 20, 30, 50, 60, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medreg s.r.o.
Na Florenci 2116/15, Nové Město
110 00 Prague 1
Czech Republic

Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia