Orodax

Package leaflet: Information for the user

Orodax 5 mg orodispersible tablets

solifenacin succinate
Equivalent medicine
Please read all of this 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 pass it on to others, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
What Orodax is and what it is used for
What you need to know before taking Orodax
How to take Orodax
Possible side effects
How to store Orodax
Contents of the pack and other information

1. What Orodax is and what it is used for

The active substance of Orodax belongs to the group of anticholinergics. These medicines are used
to reduce the activity of the overactive bladder. This helps delay the need to go to the bathroom
and increases the amount of urine that can be held in your bladder.
Orodax is used to treat the symptoms of overactive bladder. These symptoms include: strong and
sudden urge to urinate without prior warning signs, frequent need to urinate, or leakage because you cannot reach the bathroom in time.

2. What you need to know before taking Orodax

Do not take Orodax:

• if you have difficulty urinating or completely emptying your bladder (urinary retention)
• if you have a serious stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from the muscle disease called myasthenia gravis, which causes 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 mild liver disease and are simultaneously being treated with medicines that may reduce the elimination of Orodax from the body (e.g., ketoconazole). Your doctor or pharmacist will advise you on this.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have difficulty emptying your bladder (=bladder obstruction) or if you experience difficulty in passing urine (e.g., reduced urine flow). The risk of urine accumulation within the bladder (urinary retention) is very high.
• if you have gastrointestinal obstructions (constipation).
• if you are at risk of reduced gastrointestinal motility (gastric and intestinal movements). Your doctor will inform you about this possibility.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have stomach pain (hiatal hernia) or heartburn.
• if you have disorders of the nervous system (autonomic neuropathy).

Children and adolescents

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

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

Before starting treatment with this medicine, your doctor will check that there are no other causes for frequent urination (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 (treatment against specific bacterial infections).

Other medicines and Orodax

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.

It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase.
• cholinergic agents, which may reduce the effectiveness of this medicine.
• medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility, as this medicine may reduce their effectiveness.
• medicines such as ketoconazole, itraconazole, ritonavir, nelfinavir, verapamil, and diltiazem, which decrease the rate of elimination of this medicine from the body.
• medicines such as rifampicin, phenytoin, carbamazepine, which may increase the rate of elimination of Orodax from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the throat (oesophagitis).

Orodax with food and drink

This medicine can be taken with or without food, according to your preference.

Pregnancy and breastfeeding

You must not take this medicine during pregnancy unless strictly necessary.

Do not use this medicine while breastfeeding, as solifenacin may be excreted in human milk.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may cause blurred vision and, occasionally, drowsiness and fatigue. Therefore, avoid driving or operating machinery if you experience these side effects.

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

This medicine contains 0.30 mg of sorbitol per tablet, equivalent to 0.03 mg/g.

3. How to take Orodax

Instructions for appropriate use
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
This medicine is to be taken by mouth. You must suck the tablet until it has completely dissolved. You may take it with or without food, as you prefer.
The recommended dose is 5 mg daily, unless your doctor has instructed you to take 10 mg daily.

1. Remove one blister from the strip by tearing along the perforations.
2. Remove the aluminium foil from the blister by starting at the corner with the printed arrow and peeling back in the direction of the arrow.
3. Completely remove the aluminium foil from the blister so that the tablet becomes accessible. Carefully remove the tablet from the blister. Place the tablet in your mouth and suck it until it has completely dissolved.

If you take more Orodax than you should
If you have taken too much of this medicine or if a child has accidentally taken it, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things not present (hallucinations), over-excitement, epileptic seizures (convulsions), breathing difficulties, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Orodax
If you have forgotten to take a tablet at your usual time, take it as soon as you remember, unless it is almost time for your next dose. Do not take more than one dose per day. If you are unsure, always consult your doctor or pharmacist.

If you stop taking Orodax
If treatment with Orodax is stopped, symptoms of overactive bladder 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience 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 (an allergic reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Orodax). If angioedema occurs, treatment with solifenacin succinate (Orodax) must be stopped immediately and appropriate therapy and/or measures must be initiated.

Orodax 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 infections, bladder infections
• Drowsiness
• Abnormal taste sensation (dysgeusia)
• Dry (irritated) eyes
• Dry nose
• Reflux disease (gastro-oesophageal reflux)
• Dry throat
• Dry skin
• Difficulty urinating
• Fatigue
• Fluid accumulation in the lower leg (oedema)

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

• Accumulation of large amounts of stool in the colon (faecal impaction)
• Increased volume of urine 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)

• Hallucinations, confusion
• Allergic rash

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Orodax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
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.
Do not store above 25°C.

6. Package contents and other information

What Orodax contains

• The active substance is solifenacin succinate 5 mg.
• The other components are polacrilin resin, hypromellose E15 (E464), mannitol (E421), acesulfame potassium (E950), peppermint flavour (contains sorbitol), lactose monohydrate, sodium croscarmellose (E468), menthol flavour, and sodium stearil fumarate.

Description of the appearance of Orodax and pack contents
Orodax 5 mg orodispersible tablets are white to off-white, round, biconvex tablets with bevelled edges, marked “LX1” on one side and smooth on the other side.
Orodax is packaged in blisters containing 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Roma
Italy

Batch Release Responsible
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona 08040
Spain

Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is marketed in other EEA countries under the following names:
Austria: Solifenacin Edest 5 mg Schmelztabletten
Czech Republic: Brisol
Italy: Orodax
Netherlands: VELOXSOL 5 mg orodispergeerbare tabletten
Poland: VELOXSOL, 5 mg, tabletki ulegające rozpadowi w jamie ustnej
Spain: Veloxsol 5 mg comprimidos bucodispersables EFG
Sweden: Veloxsol 5 mg munsönderfallande tablett

Package leaflet: Information for the user

Orodax 10 mg orodispersible tablets

solifenacin succinate
Equivalent medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:
What Orodax is and what it is used for
What you need to know before taking Orodax
How to take Orodax
Possible side effects
How to store Orodax
Contents of the pack and other information

7. What Orodax is and what it is used for

The active substance in Orodax belongs to the group of anticholinergics. These medicines are used
to reduce the activity of the overactive bladder. This helps delay the need to go to the bathroom
and increases the amount of urine that can be held in your bladder.
Orodax is used to treat the symptoms of overactive bladder. These symptoms include: a strong and
sudden urge to urinate without prior warning, frequent need to urinate, or leakage because you cannot
reach the toilet in time.

8. What you need to know before taking Orodax

Do not take Orodax:

• 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 the muscle disease known as myasthenia gravis, which causes 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 mild to moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of Orodax from the body (e.g., ketoconazole). Your doctor or pharmacist will advise you on this.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you experience difficulty emptying your bladder (=bladder obstruction) or have problems passing urine (e.g., reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is very high.
• if you have gastrointestinal obstructions (constipation).
• if you are at risk of reduced gastrointestinal motility (gastric and intestinal movements). Your doctor will advise you on this.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have stomach pain (hiatal hernia) or heartburn.
• if you have disorders of the nervous system (autonomic neuropathy).

Children and adolescents

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

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

Before starting treatment with this medicine, your doctor will check that there are no other causes for frequent urination (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 (treatment against specific bacterial infections).

Other medicines and Orodax

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase.
• cholinergic agents, which may reduce the effectiveness of this medicine.
• medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility, as this medicine may reduce their effectiveness.
• medicines such as ketoconazole, itraconazole, ritonavir, nelfinavir, verapamil, and diltiazem, which decrease the rate of elimination of this medicine from the body.
• medicines such as rifampicin, phenytoin, carbamazepine, which may increase the rate of elimination of Orodax from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the throat (oesophagitis).

Orodax with food and drink

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

Pregnancy and breastfeeding

You must not take this medicine during pregnancy unless strictly necessary.

Do not use this medicine while breastfeeding, as solifenacin may be excreted in human milk.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may cause blurred vision and, occasionally, drowsiness and fatigue. Therefore, avoid driving or operating machinery if you experience these side effects.

Orodax contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

This medicine contains 0.30 mg of sorbitol per tablet, equivalent to 0.03 mg/g.

9. How to take Orodax

Instructions for appropriate use
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine must be taken by mouth. You must suck the tablet until it has completely disintegrated. You may take it with or without food, as preferred.
The recommended dose is 5 mg daily, unless your doctor has instructed you otherwise to take 10 mg daily.

4. Remove one blister from the strip by tearing along the perforations.
5. Remove the aluminium foil from the blister starting at the corner marked with the arrow, peeling it back in the direction of the arrow.
6. Completely remove the aluminium foil from the blister so that the tablet becomes accessible. Carefully remove the tablet from the blister. Place the tablet in your mouth and suck it until it has completely disintegrated.

If you take more Orodax than you should
If you have taken too much of this medicine or if a child has accidentally ingested it, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things not present (hallucinations), over-excitability, epileptic seizures (convulsions), breathing difficulties, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Orodax
If you have forgotten to take a tablet at your usual time, take it as soon as you remember, unless it is almost time for your next dose. Do not take more than one dose per day. If in doubt, always consult your doctor or pharmacist.

If you stop taking Orodax
If you stop treatment with Orodax, symptoms of overactive bladder 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.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience 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 (an allergic reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Orodax). If angioedema occurs, treatment with solifenacin succinate (Orodax) must be stopped immediately and appropriate therapy and/or measures must be initiated.
Orodax may cause the following other 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 infections, bladder infections
• Drowsiness
• Abnormal taste sensation (dysgeusia)
• Dryness (irritation) of the eyes
• Dry nose
• Reflux disease (gastro-oesophageal reflux)
• Dry throat
• Dry skin
• Difficulty in urination
• Fatigue
• Fluid accumulation in the lower leg (oedema)

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

• Accumulation of large amounts of stool in the colon (faecal impaction)
• Increased urine volume 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)

• Hallucinations, confusion
• Allergic rash

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

• Loss of appetite, high levels of potassium in the blood which may cause abnormal heart rhythm
• Increased intraocular pressure
• Changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat
• Voice disorders
• Liver disorders
• Muscle weakness
• Kidney disorders

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store Orodax

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 packaging after EXP. The expiry date refers to the last day of that month.
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.
Do not store above 25°C.

12. Package contents and other information

What Orodax contains

• The active substance is solifenacin succinate 10 mg.
• The other components are polacrilin resin, hypromellose E15 (E464), mannitol (E421), acesulfame potassium (E950), peppermint flavour (contains sorbitol), lactose monohydrate, sodium croscarmellose (E468), menthol flavour and sodium stearyl fumarate.

Description of the appearance of Orodax and contents of the pack
Orodax 10 mg orodispersible tablets are whiteish, round, biconvex tablets with bevelled edges, marked "LX2" on one side and smooth on the other side.
Orodax is packaged in blisters containing 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

Batch release responsible
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona 08040, Spain

This medicinal product is marketed in other EEA countries under the following names:
Austria: Solifenacin Edest 10 mg Schmelztabletten
Czech Republic: Brisol
Italy: Orodax
Netherlands: VELOXSOL 10 mg orodispergeerbare tabletten
Poland: VELOXSOL, 10 mg, tabletki ulegające rozpadowi w jamie ustnej
Spain: Veloxsol 10 mg comprimidos bucodispersables EFG
Sweden: Veloxsol 10 mg munsönderfallande tablett