Patient leaflet - SOLIFENACIN SUCCINATE 1 MG / ML ORAL SOLUTION
Instructions for Use:
- Open the bottle: press the cap and turn it anti clock wise (figure 1)
- Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
- Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
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- Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
- Turn the bottle the right way up (figure 6A).
Remove the syringe from the adaptor (figure 6B).
- Close the bottle with the plastic screw cap.
- Empty the contents of the syringe into your mouth.
- Wash the syringe with water (figure 7).
If you take more Solifenacin Succinate than you should
If you have taken too much Solifenacin Succinate or if a child has accidentally taken Solifenacin Succinate, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations), over- excitability, seizures (convulsions), difficulty breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and dilated pupils (mydriasis).
If you forget to take Solifenacin Succinate
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose. Never take more than one dose per day. If you are in doubt, always consult your doctor or pharmacist.
If you stop taking Solifenacin Succinate
If you stop taking this medicine your symptoms of overactive bladder may return or worsen. Always consult your doctor, if you are considering stopping the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing) has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued immediately and appropriate therapy and/or measures should be taken.
Solifenacin Succinate 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 abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort
Uncommon (may affect up to 1 in 100 people)
- urinary tract infection, bladder infection
- sleepiness, impaired sense of taste (dysgeusia) dry (irritated) eyes
- dry nasal passages
- reflux disease (gastro-oesophageal reflux), dry throat
- dry skin
- difficulty in passing urine
- tiredness, accumulation of fluid in the lower legs (oedema)
Rare (may affect up to 1 in 1,000 people)
- lodging of a large amount of hardened stool in the large intestine (faecal impaction)
- build up 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 blood potassium which can cause abnormal heart rhythm
- increased pressure in the eyes
- changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, faster heart beat
- voice disorder
- liver disorder
- muscle weakness
- renal disorder
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
- 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 carton and label after EXP. The expiry date refers to the last day of that month.
- Store below 30oC in the original container.
- Discard any remaining medicine after 30 days of first opening of the bottle.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Solifenacin Succinate contains
- The active substance is solifenacin succinate.
Each ml of oral solution contain 1 mg of Solifenacin Succinate, corresponding to 0.76 mg Solifenacin.
- The other ingredients are sodium benzoate (E211), sucralose (E955), liquid maltitol (E965), peppermint flavour, citric acid monohydrate (E330), purified water.
What Solifenacin Succinate looks like and contents of the pack
Solifenacin Succinate is a clear, colorless oral solution with peppermint flavour.
This medicine is supplied in 150 ml amber colored bottle with a tamper evident child resistant closure and a 5 ml oral syringe (graduated at every 0.5 ml equivalent to 0.5mg) with adaptor, packed in a carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Name and address Brillpharma Limited, 6 Sovereign Park, Luton, LU4 8EL, United Kingdom
Email:
Manufacturer:
Wave Pharma Limited, 4th floor, Cavendish House, 369 Burnt Oak Broadway, Edgware, HA8 5AW, United Kingdom
Solifenacin Succinate 1mg/ml Oral Solution; PL 40496/0004
This leaflet was last revised in August 2019
To request a copy of this leaflet in Braille, large print or audio format then please contact the marketing authorisation holder at the address (or email) above.
V2 21–08–19 D0
160 mm
160 mm