Uraplex 20mg Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
20mg coated tablets
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 Uraplex is and what it is used for
2. Before you take Uraplex
3. How to take Uraplex
4. Possible side effects
5. How to store Uraplex
6. Further information
1. WHAT URAPLEX IS AND WHAT IT IS USED FOR
Uraplex is a medicine used for the relaxation of the 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).
2. BEFORE YOU TAKE URAPLEX
Do not take Uraplex
- If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of Uraplex (An allergic reaction can be a rash, itchiness or shortness of breath). For the list of ingredients in Uraplex, please see section 6.
- If you suffer from any of the following:
• urinary retention, i.e. blockage of the urinary tract,
•the eye condition narrow-angle glaucoma,
• abnormal/faster than normal heart beats,
• myasthenia gravis (a disorder that causes muscle fatigue),
• a severe gastro-intestinal condition, such as toxic megacolon.
Take special care with Uraplex
If you suffer from any of the following:
- any type of stomach or bowel obstruction,
- difficulties in passing urine and/or a poor stream of urine (male prostate disorders),
- neuropathy ie. nerve damage,
- a hernia of the diaphragm with inflammation of the oesophagus due to reflux of gastric acid
(a hiatus hermia associated with reflux oesophagitis). This is usually associated with heartburn which worsens on bending or lying down,
- an overactive thyroid,
- any heart conditions, such as coronary artery disease or congestive heart failure,
- any liver problems,
- any kidney problems.
If any of the above apply to you, it is important that you speak to your doctor or pharmacist before taking Uraplex and they will decide what to do.
Patients with liver disorders
You should not take Uraplex 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.
Patients with kidney disorders
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 For patients with kidney disorders).
Children under the age of 12 years
Do not give Uraplex to children under the age of 1 2 years.
Taking 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.
Inform your doctor in particular if you are taking any of the following medicines:
- certain medicines for the treatment of abnormal sadness (depression), e.g. amitriptyline or Imlpramine
- medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)
- other medicines with anticholinergic action (such as those used to treat Parkinson's disease, asthma and stomach cramps)
- medicines for the stimulation of motility of the gastro-intestinal tract which are used to treat impaired gastric emptying or complaints due to reflux of gastric acid (reflux disease), e.g. metoclopramlde
- medicines containing the substances guar, colestipol or cholecystramine which should not be taken simultaneously with Uraplex. Please note that this information may also apply to medicines that you have used recently.
Taking Uraplex with food and drink
As high fat diets can affect the action of Uraplex, the medicine should be taken before meals on an empty stomach. Pregnancy and breast-feeding
Please tell your doctor if you are pregnant, think you might be pregnant, or are breast-feeding. Your doctor will decide if this medicine is suitable for you.
Driving and using machines
Uraplex can cause blurred vision. If you experience this, do not drive or use any tools or machines.
Important information about some of the ingredients of Uraplex
This product contains lactose (milk sugar) and sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
This product also contains wheat starch. If you suffer from wheat allergy (different from coeliac disease) you should not take this product. Uraplex is suitable for patients with coeliac disease.
3. HOW TO TAKE URAPLEX
Always take Uraplex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual dose unless otherwise prescribed by your doctor
Unless otherwise prescribed by your doctor, the usual daily dose for adults and children over the age of 1 2 years is one Uraplex tablet taken twice daily (equivalent to 40 mg of trospium chloride daily).
Method of administration
Swallow one tablet whole with a glass of water. Take the tablet before a meal on an empty stomach.
Duration of treatment
Your doctor will determine the duration of treatment. The need for continued treatment should be checked by your doctor at regular intervals of 3—6 months.
For patients with kidney disorders
If your kidney function is slightly to moderately impaired, no dose adjustment of Uraplex 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.
If you take more Uraplex than you should
If you have taken too much Uraplex you should contact your doctor or go to the nearest hospital casualty department immediately.
If you forget to take Uraplex
If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than two tablets in one day (unless prescribed otherwise).
If you stop taking Uraplex
Your symptoms may return if you stop the intake of Uraplex before recommended by your doctor. Therefore, you should take Uraplex 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.
| A. POSSIBLE SIDE EFFECTS
Like all medicines, Uraplex can cause side effects, although not everybody gets them.
The side effects occurring most frequently are typical for this kind of medicine and comprise dry mouth, dyspepsia and constipation.
The following side effects below are serious and will require immediate action if you experience them. You should stop taking Uraplex and see your doctor immediately if the following symptoms occur:
• swelling of the face, tongue and windpipe which can cause great difficulty in breathing (affects less than 1 user in 1 0,000)
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure (frequency unknown)
• serious reactions with severe blistering and peeling of the skin and/or mucous membranes like for example in the lips, eyes, mouth, nose, and genitals. This may be accompanied by a fever and chills, aching muscles and generally feeling unwell (frequency unknown).
The following side effects have been reported for Uraplex:
Very common side effects, affects more than 1 user in 10
• dryness of the mouth.
Common side effects, affects 1 to 10 users In TOO
• constipation, nausea, abdominal pain, indigestion (dyspepsia).
Uncommon side effects, affects 1 to TO users in 1,000
• fast heart rate (tachycardia),
• headache,
• flatulence, diarrhoea,
• chest pain.
Rare side effects, affects 1 to 10 users in 10,000
• dizziness,
• difficulty emptying of the bladder, urinary retention,
• difficulty seeing objects close-up,
• rash,
• joint and muscle pains.
Other possible side effects, for which the frequency Is not known
• accelerated and irregular heart rate (tachyarrhythmia),
• difficulty in breathing,
• itchiness, nettle-rash (hives),
• general feeling of weakness (asthenia),
• slight to moderate increase of certain liver values (serum transaminases),
• sporadic cases of hallucination, confusion and agitation have occured mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs with a similar mechanism of action taken at the same time.
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.
| 5. HOW TO STORE URAPLEX
Keep out of the reach and sight of children.
Do not use Uraplex after the expiry date which is stated on the carton and the blisterfoil after EXP. The expiry date refers to the last day of that month.
Storage conditions
This medicinal product does not require any special storage conditions.
Do not use Uraplex if you notice that the pack or any of the tablets are damaged.
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 Uraplex contains
The active substance is trospium chloride
Each coated tablet contains 20 mg trospium chloride.
The other ingredients are:
Tablet core: Wheat starch, microcrystalline cellulose, lactose monohydrate, povidone (K29-32), croscarmellose sodium, stearic acid, talc.
Tablet coating: Sucrose, carmellose sodium, talc, silica colloidal anhydrous, calcium carbonate (El 70), macrogol 8000, titanium dioxide (E 1 71), iron oxide hydrate yellow (E 1 72), white beeswax, camauba wax.
Note for diabetics: one coated tablet corresponds to 0.06 g carbohydrate (equivalent to 0.005 bread units).
What Uraplex looks like and contents of the pack
Uraplex tablets are brownish-yellow, glossy coated tablets with a diameter of approximately 7 mm.
Uraplex is available in packs containing 2, 20, 28, 30, 50, 56, 60, 90, 1 OO, 120, 150, 200, 500, 600, 1 000, 1200 and 2000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Madaus GmbH
51101 Cologne, Germany
This leaflet was last approved in August 2011
Uraplex is a registered trade mark of Madaus GmbH.