ORODAX 5 mg Orodispersible Tablet

Зміст інструкції

1. ORODAX 5 mg orodispersible tablets
   1. What is ORODAX and what is it used for
   2. What you need to know before taking ORODAX Do not take ORODAX
   3. How to take ORODAX
   4. Possible side effects
   5. How to store ORODAX
   6. Contents of the pack and other information
2. ORODAX 10 mg orodispersible tablets
   1. What is ORODAX and what is it used for?
   2. What you need to know before taking ORODAX Do not take ORODAX
   3. How to take ORODAX
   4. Possible side effects
   5. How to store ORODAX
   6. Package contents and other information

ORODAX 5 mg orodispersible tablets

solifenacin succinate
Generic medicine

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, 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, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take ORODAX
How to take ORODAX
Possible side effects
How to store ORODAX
Contents of the pack and other information

1. What is ORODAX and what is it used for

The active substance of ORODAX belongs to the group of anticholinergics. These medications are used
to reduce the activity of an overactive bladder. This allows delaying the need to go to the bathroom
and increases the amount of urine that can be contained within your bladder.
ORODAX is used to treat the symptoms of an overactive bladder. These symptoms include: strong
and sudden urge to urinate without preceding signals, frequent need to urinate or wetting
because you are unable to reach the bathroom in time.

2. What you need to know before taking ORODAX Do not take ORODAX

• if you have an impairment of urination or complete emptying of the bladder (urinary retention)
• if you have a severe problem with your stomach or intestines (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from a muscle disease defined as myasthenia gravis, which causes extreme weakness of some muscles
• if you suffer from increased eye pressure, with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• if you are undergoing renal dialysis
• if you suffer from severe liver disease
• if you suffer from severe kidney disease or mild liver disease and are simultaneously treated with medicines that can reduce the elimination of ORODAX from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you about this.

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

Warnings and precautions
Consult your doctor or pharmacist before taking ORODAX
if you experience difficulty emptying your bladder (=bladder obstruction) or if you have
difficulty passing urine (e.g., reduced urine flow). The risk of urine accumulation
inside the bladder (urinary retention) is very high
if you have obstructions of the digestive system (constipation)
if you have a risk of reduced gastrointestinal motility (gastric and intestinal movements). Your
doctor will inform you about this possibility
if you suffer from severe kidney disease
if you suffer from 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
ORODAX should not be used in children or adolescents under 18 years of age.
Before starting treatment with ORODAX, tell your doctor or pharmacist if you have or have ever had any of the conditions listed above.
Before starting treatment with ORODAX, the doctor will ensure that there are no other causes that
lead to the need to urinate frequently (e.g., heart failure (insufficient
ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your
doctor will prescribe you an antibiotic (treatment for specific bacterial infections).

Other medicines and ORODAX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
It is especially important to tell your doctor if you are taking:
other anticholinergic drugs, as the effectiveness and side effects of both drugs
may increase
cholinergics that may reduce the effectiveness of ORODAX
drugs, such as metoclopramide and cisapride, that stimulate the motility of the gastrointestinal tract,
as ORODAX may reduce their effectiveness
drugs, such as ketoconazole, itraconazole (medicines used to treat fungal infections),
ritonavir, nelfinavir (medicines used to treat HIV infections), verapamil and diltiazem
(medicines used to treat high blood pressure and heart disease), which decrease the
rate of elimination of this medicine from the body
drugs, such as rifampicin, phenytoin, carbamazepine, which can increase the rate of
elimination of ORODAX from the body
drugs such as bisphosphonates which may cause or worsen inflammation of the esophagus
(esophagitis).

ORODAX with food and drink
This medicine can be taken with or without food, at your discretion.

Pregnancy and breastfeeding
You should not take this medicine if you are pregnant unless it is strictly
necessary.
Do not use this medicine if you are breastfeeding, as solifenacin may be excreted in human milk.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
ORODAX may cause blurred vision and, rarely, 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 intolerance to certain sugars,
contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is essentially
“sodium-free”.

3. How to take ORODAX

Instructions for proper use
Take this medicine following exactly the instructions of 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 can take it with or without food, as you prefer.
The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per
day.

If you take more ORODAX than you should
If you have taken too much ORODAX or if a child has accidentally taken ORODAX, consult
your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness
and blurred vision, perception of non-existent objects (hallucinations), over-excitation, epileptic
seizures, breathing problems, increased heart rate (tachycardia), accumulation of

• 1. Remove a blister from the strip by tearing along the perforations.
• 2. Remove the aluminum foil on the blister starting from the corner with the arrow printed on it and lifting it in the direction of the arrow.
• 3. Completely remove the aluminum foil on the blister so that the tablet is accessible. Carefully remove the tablet from the blister. Put the tablet in your mouth and suck it until it has completely disintegrated.

urine 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 the usual time, you should take it as soon as you remember, unless
it is time to take the 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 taking ORODAX, the symptoms of
overactive bladder may reappear or worsen. Always consult your doctor if you are considering stopping the
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 everybody gets them.
If you experience an allergic reaction or a serious skin reaction (for example, blistering and
peeling of the skin), you should inform your doctor or pharmacist immediately.
Angioedema (an allergic reaction that consists of swelling of the tissue just below the
skin surface) with obstruction of the airways (difficulty breathing) has been reported in some
patients treated with solifenacin succinate (ORODAX). If angioedema occurs, treatment with
solifenacin succinate (ORODAX) should be discontinued immediately and appropriate therapy and/or
measures should be instituted.
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 feeling of fullness, abdominal pain,
belching, nausea and heartburn (dyspepsia), discomfort in the stomach.
Uncommon (may affect up to 1 in 100 people)
Urinary tract infections, bladder infections
Drowsiness
Abnormal taste perception (dysgeusia)
Dryness (irritation) of the eyes
Dry nose
Reflux disease (gastro-oesophageal reflux)
Dry throat
Dry skin
Difficulty with urination
Fatigue
Fluid retention in the lower leg (edema)
Rare (may affect up to 1 in 1,000 people)
Accumulation of large amounts of stool in the colon (fecal impaction)
Increased amount of urine in the bladder caused by the 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 available data)
Decreased appetite, high levels of potassium in the blood which can cause abnormal heart
rhythm
Increased eye pressure
Changes in heart electrical activity (ECG), irregular heartbeat, feeling of
palpitations, fast heartbeat
Voice disorders
Liver disorders
Muscle weakness
Kidney disorders

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting
system at
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 which is stated on the pack after SCAD. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Do not store at a temperature above 25°C

6. Contents of the pack and other information

What ORODAX contains

• The active ingredient is solifenacin succinate 5 mg.
• The other ingredients are polyacrylic resin, hypromellose E15 (E464), mannitol (E421) sucralose (E955), peppermint aroma, lactose monohydrate, sodium croscarmellose (E468), menthol aroma and sodium stearyl fumarate.

Description of the appearance of ORODAX and contents of the pack
ORODAX 5 mg orodispersible tablets are round, white, biconvex, with the number 5 imprinted on one side.
ORODAX are packaged in blisters of 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L.
VIALE ALCIDE DE GASPERI, 165/B, 95127 CATANIA

Release Batch Responsible
Idifarma Desarrollo Farmacéutico, S.L
Pol Mocholi C/ Noáin, 1
31110 Noáin (Navarre)
Spain

This medicinal product is marketed in other EEA countries under the following
names:
Spain: VELOXSOL
France: VELOXSOL
Germany: VELOXSOL
Poland: VELOXSOL
Sweden: Veloxsol
Italy: ORODAX
Czech Republic: Solifenacin Edest
Austria: VELOXSOL
Netherlands: VELOXSOL

ORODAX 10 mg orodispersible tablets

solifenacin succinate
Generic medicine

Read 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take ORODAX
How to take ORODAX
Possible side effects
How to store ORODAX
Contents of the pack and other information

7. What is ORODAX and what is it used for?

The active substance of ORODAX belongs to the group of anticholinergics. These medications are used
to reduce the activity of an overactive bladder. This allows delaying the need to go to the bathroom
and increases the amount of urine that can be contained within your bladder.
ORODAX is used to treat the symptoms of an overactive bladder. These symptoms include: strong
and sudden urge to urinate without preceding signals, the need to urinate frequently, or wetting
because you are unable to reach the bathroom in time.

8. What you need to know before taking ORODAX Do not take ORODAX

• if you have an impairment of urination or complete emptying of the bladder (urinary retention)
• if you have a serious problem with your stomach or intestines (including toxic megacolon, a complication associated with ulcerative colitis)
• if you suffer from a muscle disease called myasthenia gravis, which causes extreme weakness of some muscles
• if you suffer from increased eye pressure, with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• if you are undergoing renal dialysis
• if you suffer from severe liver disease
• if you suffer from severe kidney disease or mild liver disease and are simultaneously treated with medicines that can reduce the elimination of ORODAX from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you about this.

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

Warnings and precautions
Consult your doctor or pharmacist before taking ORODAX
if you experience difficulty emptying the bladder (=bladder obstruction) or if you have
difficulty passing urine (e.g., reduced urine flow). The risk of urine accumulation
inside the bladder (urinary retention) is very high
if you have obstructions of the digestive system (constipation)
if you have a risk of reduced gastrointestinal motility (gastric and intestinal movements). Your
doctor will inform you about this possibility
if you suffer from severe kidney disease
if you suffer from 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
ORODAX should not be used in children or adolescents under 18 years of age.
Before starting treatment with ORODAX, tell your doctor or pharmacist if you have or have ever had any of the conditions listed above.
Before starting treatment with ORODAX, the doctor will ascertain that there are no other causes that
lead to the need to urinate frequently (e.g., heart failure (insufficient
ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your
doctor will prescribe you an antibiotic (treatment for specific bacterial infections).

Other medicines and ORODAX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
It is especially important to inform your doctor if you are taking:
other anticholinergic drugs, as the effectiveness and side effects of both drugs
may increase
cholinergics that may reduce the effectiveness of ORODAX
medicines, such as metoclopramide and cisapride, that stimulate the motility of the gastrointestinal tract,
as ORODAX may reduce their effectiveness
medicines, such as ketoconazole, itraconazole (medicines used to treat fungal infections),
ritonavir, nelfinavir (medicines used to treat HIV infections), verapamil and diltiazem
(medicines used to treat high blood pressure and heart disease), 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
(esophagitis).

ORODAX with food and drink
This medicine can be taken at any time, with or without food.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant unless it is strictly
necessary.
Do not use this medicine if you are breastfeeding, as solifenacin may be excreted in human milk.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
ORODAX may cause blurred vision and, rarely, 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 your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is essentially
“sodium-free”.

9. How to take ORODAX

Instructions for proper use
Take this medicine following exactly the instructions of 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 can take it with or without food, as you prefer.
The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per
day.

If you take more ORODAX than you should
If you have taken too much ORODAX or if a child has accidentally taken ORODAX, consult
immediately a doctor or pharmacist.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness
and blurred vision, perception of non-existent objects (hallucinations), over-excitation, convulsions

• 4. Remove a blister from the strip by tearing along the perforations.
• 5. Remove the aluminum foil on the blister starting from the corner with the printed arrow and lifting it in the direction of the arrow.
• 6. Completely remove the aluminum foil on the blister so that the tablet is accessible. Carefully remove the tablet from the blister. Put the tablet in your mouth and suck it until it is completely disintegrated.

epileptic seizures, breathing problems, increased heart rate (tachycardia), urine retention in the bladder (urinary retention) and pupil dilation (mydriasis).

If you forget to take ORODAX
If you have forgotten to take a tablet at the usual time, you should take it as soon as you remember, unless
it is time to take the 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 taking ORODAX, the symptoms of
overactive bladder may reappear or worsen. Always consult your doctor if you are considering stopping the
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 gets them.
If you experience an allergic attack or a serious skin reaction (for example, blistering and
peeling of the skin), you should inform your doctor or pharmacist immediately.
Angioedema (an allergic reaction consisting of swelling of the tissue just below the
skin surface) with obstruction of the airways (difficulty breathing) has been reported in some
patients treated with solifenacin succinate (ORODAX). If angioedema occurs, treatment with
solifenacin succinate (ORODAX) should be discontinued immediately and appropriate therapy and/or
measures should be instituted.
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 feeling of abdominal fullness, abdominal
pain, belching, nausea and heartburn (dyspepsia), discomfort in the stomach.
Uncommon (may affect up to 1 in 100 people)
Urinary tract infections, bladder infections
Drowsiness
Abnormal taste perception (dysgeusia)
Dry (irritated) eyes
Dry nose
Reflux disease (gastro-esophageal reflux)
Dry throat
Dry skin
Difficulty with urination
Fatigue
Fluid retention in the lower leg (edema)
Rare (may affect up to 1 in 1,000 people)
Accumulation of large amounts of stool in the colon (fecal impaction)
Increased amount of urine in the bladder caused by the 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 available data)
Decreased appetite, high levels of potassium in the blood which can cause abnormal heart
rhythm
Increased eye pressure
Changes in heart electrical activity (ECG), irregular heartbeat, feeling of
palpitations, fast heartbeat
Voice disorders
Liver disorders
Muscle weakness
Kidney disorders

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting
system at
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 pack after SCAD. The expiry date refers to the last day of that month.
Do not throw away any medicine in the water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Do not store at a temperature above 25°C

12. Package contents and other information

What ORODAX contains

• The active ingredient is solifenacin succinate 10 mg.
• The other ingredients are polyacrylic resin, hypromellose E15 (E464), mannitol (E421) sucralose (E955), peppermint aroma, lactose monohydrate, sodium croscarmellose (E468), menthol aroma and sodium stearyl fumarate.

Description of the appearance of ORODAX and package contents
ORODAX 10 mg orodispersible tablets are round, white, biconvex.
ORODAX are packaged in blisters of 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
FARMITALIA INDUSTRIA CHIMICO FARMACEUTICA S.R.L.
VIALE ALCIDE DE GASPERI, 165/B, 95127 CATANIA

Release batch responsible
Idifarma Desarrollo Farmacéutico, S.L
Pol Mocholi C/ Noáin, 1
31110 Noáin (Navarre)
Spain

This medicinal product is marketed in other EEA countries with the following
names:
Spain: VELOXSOL
France: VELOXSOL
Germany: VELOXSOL
Poland: VELOXSOL
Sweden: Veloxsol
Italy: ORODAX
Czech Republic: Solifenacin Edest
Austria: VELOXSOL
Netherlands: VELOXSOL