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 25258/0108.
Trospium chloride 20mg film-coated tablets
Trospium chloride 20mg film-coated tablets
1. What Trospium chloride 20mg film-coated tablets are and what they are used for
2. What you need to know before you take Trospium chloride 20mg film-coated tablets
3. How to take Trospium chloride 20mg film-coated tablets
4. Possible side effects
5. How to store Trospium chloride 20mg film-coated tablets
6. Contents of the pack and other information
Trospium chloride 20mg film-coated tablets is a medicine used for the relaxation of the urinary bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and imperative urge of urination in patients with hyperactive bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders).
Talk to your doctor or your pharmacist before taking Trospium chloride 20mg film-coated tablets if you suffer from any of the following :
You should not take Trospium chloride 20mg film-coated tablets if you have a serious liver disorder. If you have a slight to moderate liver impairment, you should talk to your doctor before taking this medicine.
If you have a kidney disorder, you should talk to your doctor before taking this medicine. Your doctor will, if necessary, give you a lower dose (see dosage instructions in Section 3“How to take Trospium chloride 20mg film-coated tablets – Patients with kidney disorders”).
The safety and efficacy of [Name to be completed nationally] in children under 12 years of age has not been established. No data are available.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor in particular if you are taking any of the following medicines:
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
As high fat diets can affect the action of Trospium chloride 20mg film-coated tablets, this medicine should be taken before meals on an empty stomach.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Since there is no experience with trospium chloride during pregnancy and breast-feeding, Trospium chloride 20mg film-coated tablets should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.
This medicine can cause blurred vision. Do not drive motor vehicles, operate machines or perform other hazardous activities if you suffer from blurred vision after taking this medicine.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and children over 12 years of age is one film-coated tablet twice a day (equivalent to 40 mg of trospium chloride per day), unless otherwise prescribed by your doctor.
Patients with kidney disorders
If your kidney function is slightly to moderately impaired, no dose adjustment is required.
In severely impaired kidney function, the dose should be reduced to one tablet once daily or every second day (equivalent to 20 mg of trospium chloride daily or every second day).
You should consult with your doctor about the correct dose for you.
Use in children
Do not give this medicine to children under 12 years of age.
Swallow one film-coated tablet whole with a glass of water. Take the tablet before a meal on an empty stomach.
Your doctor will want to assess your treatment every 3 to 6 months, to decide whether this medicine is still the best one for you.
No symptoms and signs of intoxication in humans have been reported to date.
If you have taken more Trospium chloride 20mg film-coated tablets than the amount prescribed, you should contact a doctor or pharmacist immediately.
If you miss a dose of Trospium chloride 20mg film-coated tablets, simply carry on with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
Your symptoms may return if you stop the intake of Trospium chloride 20mg film-coated tablets before recommended by your doctor. Therefore, you should take this medicine for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects below are serious and will require immediate action if you experience them. Stop taking Trospium chloride 20mg film-coated tablets and see your doctor immediately if the following symptoms occur:
The following side effects have also been reported for Trospium chloride 20mg film-coated tablets:
Very common side effects (affects more than 1 user in 10):
Common side effects (affects 1 to 10 users in 100):
Uncommon side effects (affects 1 to 10 users in 1,000):
Rare side effects (affects 1 to 10 users in 10,000):
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. 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 Trospium chloride 20mg film-coated tablets after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.
Core: Cellulose Microcrystalline, Lactose monohydrate, Maize starch, Povidone, Croscarmellose sodium, Silica Colloidal Anhydrous, Magnesium Stearate;
Coating: Sucrose, Copovidone, Titanium Dioxide (E171), Macrogol 6000, Macrogol 400, Talc, Hypromellose (E464), Iron Oxide Yellow (E172), Iron Oxide Red (E172).
Trospium chloride 20mg film-coated tablets are supplied as:
brownish yellow to light brown, round, biconvex film-coated tablets, debossed with “L” on one side and “l” on other side.
Trospium chloride 20mg film-coated tablets are available in PVC/PVDC-Aluminium blisters of 30, 50, 60, 100 tablets.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member States of the EEA under the following names:
France Trospipharm 20mg comprimé pelliculé
Germany: Trospiumchlorid Glenmark 20mg Filmtabletten
United Kingdom Trospium chloride 20mg film-coated tablets
This leaflet was last revised in 03/2018.