The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 23218/0254.
Fesoterodine fumarate 4 mg prolonged-release tablets, Fesoterodine fumarate 8 mg prolonged-release tablets
Fesoterodine fumarate 4 mg prolonged-release tablets
Fesoterodine fumarate 8 mg prolonged-release tablets
1. What Fesoterodine fumarate is and what it is used for
2. What you need to know before you take Fesoterodine fumarate
3. How to take Fesoterodine fumarate
4. Possible side effects
5. How to store Fesoterodine fumarate
6. Contents of the pack and other information
Fesoterodine fumarate contains an active substance called fesoterodine fumarate, and is a so called antimuscarinic treatment which reduces the activity of an overactive bladder and it is used in adults to treat the symptoms.
Fesoterodine fumarate treats the symptoms of an overactive bladder such as
Fesoterodine may not always be suitable for you. Talk to your doctor before taking Fesoterodine fumarate, if any of the following apply to you:
Heart problems: Talk to your doctor if you suffer from any of the following conditions
Do not give this medicine to children and adolescents below 18 years of age because it is yet to be established whether it would work for them and whether it would be safe.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you whether you can take Fesoterodine fumarate with other medicines.
Please inform your doctor if you are taking medicines according to the following list. Taking them at the same time as fesoterodine may make side effects such as dry mouth, constipation, difficulty in completely emptying your bladder or drowsiness more serious or occur more often.
Please also inform your doctor if you are taking any of the following medicines:
You should not take Fesoterodine fumarate if you are pregnant, as the effects of fesoterodine on pregnancy and the unborn baby are not known.
It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with Fesoterodine fumarate.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Fesoterodine fumarate can cause blurred vision, dizziness, and sleepiness. If you experience any of these effects, do not drive or use any tools or machines.
Fesoterodine fumarate contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Fesoterodine fumarate contains 72 mg Fructose in each tablet.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended starting dose of Fesoterodine fumarate is one 4 mg tablet a day. Based on how you respond to the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.
You should swallow your tablet whole with a glass of water. Do not chew the tablet. Fesoterodine fumarate can be taken with or without food.
To help you remember to take your medicine, you may find it easier to take it at the same time every day.
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice immediately. Show them your pack of tablets.
If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than one tablet in one day. Do not take a double dose to make up for a forgotten tablet.
Do not stop taking Fesoterodine fumarate without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking Fesoterodine fumarate.
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.
Serious allergic reactions including angioedema occurred rarely. You should stop taking Fesoterodine fumarate and contact your doctor immediately if you develop swelling of the face, mouth or throat.
Very common (may affect more than 1 in 10 people)
You may get a dry mouth. This effect is usually mild or moderate. This may lead to a greater risk of dental caries. Therefore, you should brush your teeth regularly twice daily and see a dentist when in doubt.
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects 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 the blister after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Fesoterodine fumarate 4 mg
Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
Fesoterodine fumarate 8 mg
Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
The tablet core: Fructose, Lactose monohydrate, Microcrystalline cellulose, Hypromellose K100M Premium (type 2208), Hypromellose K4M (type 2208), Glycerol dibehenate, talc.
The coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (4000), talc, indigo carmine aluminum lake.
Fesoterodine fumarate 4 mg prolonged-release tablets are blue elliptical, biconvex and debossed with “F4” on one side and plain on the other side.
Fesoterodine fumarate 8 mg prolonged-release tablets are dark blue elliptical, biconvex and debossed with “F8” on one side and plain on the other side.
Fesoterodine fumarate is available in blister packs of 14, 28, 30, 56, 84, 98 and 100 prolonged-release tablets.
Please note that not all the above pack sizes may be marketed.
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
This leaflet was last revised in February, 2022