Patient leaflet - REGURIN XL 60 MG PROLONGED-RELEASE CAPSULES
Regurin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
The name of your medicine is Regurin XL 60mg prolonged-release capsules but will be referred to as Regurin XL throughout this leaflet.
What is in this leaflet:
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1. What Regurin XL is and what it is used for
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2. What do you need to know before you take Regurin XL
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3. How to take Regurin XL
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4. Possible side effects
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5. How to store Regurin XL
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6. Contents of the pack and other 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 urinary 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 urinary bladder.
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2. What do you need to know 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 this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath.). 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Regurin XL
if you suffer from any of the following:
- any type of stomach or bowel obstruction,
- an impaired urine flow (e.g. in the case of benign tissue growth of the male prostate),
- neuropathy, i.e. nerve damage,
- a 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.
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.
Other medicines and Regurin XL
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Inform your doctor in particular if you are taking any of the following medicines:
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– certain anti-depressants e.g. amitryptiline or imipramine
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– some medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)
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– other medicines with anticholinergic action (e.g. amantadine – used to treat Parkinson’s disease)
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– metoclopramide – medicine used for nausea and vomiting
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– 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 and fertility
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
Even when used as directed, this medicine can affect vision so that the ability to actively participate in road traffic, operate machines or work may be impaired. Therefore, do not drive motor vehicles, operate machines or perform other hazardous activities if you are suffering from blurred vision.
Regurin XL contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicine.
This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say it is essentially ‘sodium-free’.
3. how to take regurin xl
Always take this medicine exactly as your doctor has told you. 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 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
No symptoms and signs of intoxication in humans have been reported to date.
If you have taken too much Regurin XL you should inform immediately a doctor or pharmacist who will decide on further measures.
If you forget to take Regurin XL
Do not take a double dose to make up for a forgotten dose. Continue with the regular intake as described in the dosage directions.
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, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for Regurin XL prolonged-release capsules, hard 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.
Other possible side effects, for which the frequency is not known
- sporadic cases of hallucination, confusion and agitation have occurred 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.
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.
- 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.
5. how to store regurin xl
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not take the capsules after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
If the capsule becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
Do not take Regurin XL if you notice that the package has been damaged or shows signs of tampering.
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. contents of the pack and other information
What Regurin XL contains
The active ingredient in the Regurin XL is trospium chloride.
Each hard capsule contains 60mg trospium chloride.
The other ingredients are:
Capsule contents: sucrose, corn starch, methyl acrylate-methyl methacrylate-methacrylic acid copolymer, ammonium hydroxide, medium chain triglycerides, oleic acid, ethylcellulose, titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80, triethyl citrate, 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), propylene glycol).
What Regurin XL looks like and contents of the pack
Regurin XL consists of a white-coloured and an orangecoloured part imprinted with ‘SAN 60’ and contains white to off-white pellets.It is available in pack size of 28 capsules.
Manufactured by: Meda Pharma GmbH,1110 Vienna, Austria. OR
MADAUS GmbH, 51101 Cologne, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Regurin® XL 60mg prolonged-release capsules;
PL 18799/2962
Leaflet date: 20.04.2021 POM I
Regurin is a registered trademark of MADAUS GmbH.
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