Regurin Xl 60mg Prolonged-Release Capsules Hard
REGURIN® XL
60MG PROLONGED-RELEASE CAPSULES, HARD
(trospium chloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Regurin XL 60mg Prolonged-Release Capsules, Hard but will be referred to as Regurin XL throughout the leaflet.
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 Regurin XL is and what it is used for
2. Before you take Regurin XL
3. How to take Regurin XL
4. Possible side effects
5. How to store Regurin XL
6. Further information
1. What Regurin XL is and what it is used for
Regurin XL is a medicine used for the relaxation of the muscles 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/or urgency of urination in patients with an overactive bladder.
2. Before you take Regurin XL Do not take Regurin XL
■ If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of Regurin XL (An allergic reaction can be a rash, itchiness or shortness of breath.). For the list of ingredients in Regurin XL, 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,
■ problems with your kidneys,
■ severe problems with your liver.
Take special care with Regurin XL
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, i.e. nerve damage,
■ a hernia of the diaphragm with inflammation of the oesophagus due to reflux of gastric acid (hiatus hernia 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.
Talk to your doctor before starting your treatment with Regurin XL if you think any of these might apply to you.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Regurin XL to children under 18 years of age.
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 antidepressants e.g. amitryptiline or imipramine
■ some 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)
■ metoclopramide - medicine used for nausea and vomiting
■ medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you have used recently.
Pregnancy and breast-feeding
Since there is no experience with trospium chloride during pregnancy and breast-feeding, Regurin XL should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Regurin XL 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 Regurin XL
This medicine contains sucrose. If you know that you have an intolerance to certain sugars, please take Regurin XL only after consultation with your doctor.
3. How to take Regurin XL
Please always take Regurin XL 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 is one Regurin XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water. Take the capsule at least one hour before a meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment. The need for continued treatment should be checked at regular intervals of 3 - 6 months.
Patients with a kidney disorder should consult their doctor and not take this medicine.
Patients with a liver disorder should consult their doctor before taking this medicine.
If you take more Regurin XL than you should
If you have taken too much Regurin XL you should contact your doctor or go to the nearest hospital casualty department immediately.
If you forget to take Regurin XL
If you forget to take a capsule, take your capsule as soon as you remember, but do not take more than one capsule in one day. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Regurin XL
Your symptoms may return if you stop taking Regurin XL before recommended by your doctor. Therefore, you should take Regurin XL 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, Regurin XL can cause side effects, although not everybody gets them.
The following "very rare" side effects below are important and will require immediate action if you experience them. You should stop taking Regurin XL and see your doctor immediately if the following symptoms occur:
■ swelling of the face, tongue and windpipe which can cause great difficulty in breathing
■ a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure.
The following side effects have been reported for Regurin XL in clinical trials:
Very common side effects, affects more than 1 user in 10
■ dryness of the mouth.
Common side effects, affects 1 to 10 users in 100
■ constipation, nausea, abdominal pain, indigestion,
■ dry eyes, dry nose.
Uncommon side effects, affects 1 to 10 users in 1,000
■ flatulence.
Rare side effects, affects 1 to 10 users in 10,000
■ difficulty emptying the bladder, urinary retention,
■ fast heart rate, palpitations,
■ difficulty seeing objects close-up,
■ rash,
■ general feeling of weakness.
Very rare side effects, affects less than 1 user in 10,000
■ urinary tract infection,
■ headache.
The following side effects have also been reported for trospium (trospium is the active ingredient of Regurin XL; it is not known if these side effects will also occur with the capsules that you have been prescribed): Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase of certain liver values (serum transaminases), fast irregular heartbeat, joint or muscle pains, dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Regurin XL
■ Keep out of the sight and reach of children.
■ Do not use Regurin XL after the expiry date which is stated on the blister and the container after EXP.
The expiry date refers to the last day of that month.
■ This medicinal product does not require any special storage conditions.
■ Do not use Regurin XL if you notice that the package has been damaged or shows signs of tampering.
■ If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
■ If the capsules become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will tell you what to do.
■ 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 Regurin XL contains
The active substance is trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are:
Capsule contents: sucrose, maize starch, methyl acrylate-methyl methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate, ammonium hydroxide, medium chain triglycerides, oleic acid, ethylcellulose, titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80, triethyl citrate and talc
Capsule shell: gelatin, titanium dioxide (E 171),
Yellow iron oxide (E 172), red iron oxide (E 172), printing ink (shellac, black iron oxide (E 172) and propylene glycol)
What Regurin XL looks like and contents of the pack
Regurin XL are prolonged release capsules having orange cap imprinted with SAN and white body imprinted with 60 in black ink containing white to off-white pellets.
Regurin XL is available in packs of 30, 60, 90 or 100 capsules.
Manufacturer
Manufactured by:
MADAUS GmbH, 51101 Cologne, Germany.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0683 POM
Leaflet issue and revision date (Ref): 13.05.16 Regurin® is a registered trademark of Madaus GmbH.
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