Flotros 20mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
flotros
20mg film-coated tablets
Trospium chloride
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Flotros 20mg film-coated tablets are and what they are used for
2. Before you take Flotros 20mg film-coated tablets
3. How to take Flotros 20mg film-coated tablets
4. Possible side effects
5. How to store Flotros 20mg film-coated tablets
6. Further information
1. WHAT FLOTROS 20MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Flotros 20mg film-coated tablets are a medicine that relaxes the muscles of the bladder.
Flotros 20mg film-coated tablets are used in patients with a compelling need to urinate (urgency) accompanied by involuntary urine loss (urge incontinence) and/or frequent urination and need to urinate in patients with an overactive bladder (due to unknown causes or neurological disease).
2. BEFORE YOU TAKE FLOTROS 20MG FILM-COATED TABLETS
Do not take Flotros 20mg film-coated tablets:
- if you are allergic (hypersensitive) to trospium chloride or any of the other ingredients of the tablets
- if you suffer from urinary retention, i.e. blockage of the urinary tract
- if you have raised pressure in the eye (narrow angle glaucoma)
- if you have a fast, irregular heartbeat (tachycardic arrhythmia)
- if you have myasthenia gravis, a disorder that causes muscle fatigue
- if you suffer from severe inflammation of the gut (intestines), e.g. severe ulcerative colitis or Crohn's disease
- if you have a severe gastro-intestinal condition, such as toxic megacolon
Take special care with Flotros 20mg film-coated tablets:
- if you have an obstruction in your gut, e.g. a narrowing of the exit from your stomach (pyloric stenosis)
- if you have difficulties in passing urine and/or a poor stream of urine
- if you suffer from neuropathy, i.e. nerve damage
- if you have any heart conditions, such as coronary artery disease or congestive heart failure
- if you have a hiatus hernia or heartburn
- if you have an overactive thyroid gland
Patients with liver problems:
If you have severe liver disease, you should not take Flotros 20mg film-coated tablets.
If you have mild to moderate liver disease, please talk to your doctor.
Patients with kidney problems:
If you have kidney problems, please talk to your doctor.
Your doctor may have to adjust the dose of Flotros 20mg film-coated tablets (see Section 3: "How to take Flotros 20mg film-coated tablets”).
Taking Flotros 20mg film-coated tablets with other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Especially talk to your doctor if you are taking one of the following medicines:
- amantadine (used for the treatment of Parkinson's disease)
- certain medicines used to treat depression called tricyclic antidepressants (e.g. imipramine or amitriptyline)
- medicines to treat asthma, which may accelerate your heart beat (e.g. salbutamol)
- medicines used to treat nausea and vomiting (e.g. metoclopramide or domperidone)
- medicines that contain guar, colestyramine or colestipol
- medicines that contain quinidine or disopyramide (used to treat heart rhythm problems)
- medicines used to treat allergies (antihistamines)
Please note that this information may also apply to medicines that you have used recently.
Pregnancy and breast-feeding:
Your doctor will decide whether you should take this medicine if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
This medicine may cause blurred vision. If you experience this, do not drive or use any tools or machines.
Important information about some of the ingredients of Flotros 20mg film-coated tablets:
This medicinal product 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.
The tablet should be swallowed whole with a glass of water. It should be taken before meals, on an empty stomach.
3. HOW TO TAKE FLOTROS 20MG FILM-COATED TABLETS
Always take Flotros 20mg film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:
1 film-coated tablet twice daily (equal to a daily total of 40mg trospium chloride).
The maximum daily dose is 40mg trospium chloride.
In patients with severe kidney problems, the recommended dosage is 1 film-coated tablet daily or 1 film-coated tablet every other day (equal to a total of 20mg trospium chloride either daily or every other day).
The length of your treatment is determined by your doctor. The need to continue treatment should be evaluated every 3 to 6 months.
Do not give Flotros 20mg film-coated tablets to children of less than 12 years of age.
If you take more Flotros 20mg film-coated tablets than you should:
If you have taken too many Flotros 20mg film-coated tablets you should contact your doctor or go to the nearest hospital emergency department immediately.
If you forget to take Flotros 20mg film-coated tablets:
If you forget to take a tablet, take your next tablet as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking Flotros 20mg film-coated tablets:
Your symptoms may return if you stop taking Flotros 20mg film-coated tablets before told to do so by your doctor. Therefore, you should take Flotros 20mg film-coated tablets 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flotros 20mg film-coated tablets can cause side effects, although not everybody gets them.
The following very rare side effects are important and will require immediate action if you experience them. You should stop taking Flotros 20mg film-coated tablets and see your doctor immediately if the following symptoms occur:
Very rare side effects, affecting fewer than 1 in 10,000 patients:
• swelling of the face, tongue and windpipe, which can cause difficulty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing and sudden dizziness
The following side effects have also been reported:
Very common side effects, affecting more than 1 in 10 people:
dry mouth
Common side effects, affecting fewer than 1 in 10 people:
indigestion, constipation, abdominal pain, nausea
Uncommon side effects, affecting fewer than 1 in 100 people:
wind (flatulence), diarrhoea
Rare side effects, affecting fewer than 1 in 1000 people:
inability to (completely) empty the bladder fast heart beat blurred vision
breathing difficulties (dyspnoea) skin rash chest pain weakness
Very rare side effects (including isolated reports), affecting fewer than 1 in 10,000 people:
fast and irregular heart beat muscle pain, joint pain
changes in blood test results used to monitor the liver
(measured by your doctor)
headache
dizziness
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FLOTROS 20MG FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use 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 medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Flotros 20mg film-coated tablets contain:
The active substance is: trospium chloride 20mg
The other ingredients are:
Tablet core: silica, colloidal anhydrous; lactose monohydrate; cellulose, microcrystalline; sodium starch glycolate (Type A); povidone K25; magnesium stearate;
Tablet film: hypromellose; macrogol 6000; talc; titanium dioxide (E171); saccharin sodium.
What Flotros 20mg film-coated tablets look like and contents of the pack:
Flotros 20mg film-coated tablets are round, white-coloured, film-coated tablets available in packs of 10, 20, 30, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
Manufacturer:
Dr. R. Pfleger Chemische Fabrik GmbH, Dr.-Robert-Pfleger-StraBe 12, D-96052 Bamberg
This medicinal product is authorised in the member states of the EEA under the following names:
Austria: Trospiumchlorid Pfleger 20mg
Denmark: Trospiumchlorid Alternova
Finland: Trospium Verman 20mg
tabletti, kalvopaallysteinen
Germany: Spasmex 20mg Filmtabletten
Ireland: Flotros 20mg Film-Coated Tablets
Italy: Trospio cloruro Pfleger 20mg
United Kingdom: Flotros 20mg Film-Coated Tablets
This leaflet was last approved in 02/2011
207800 002 301709