Patient leaflet - REGURIN XL 60 MG PROLONGED-RELEASE CAPSULES HARD
What is in this leaflet:
1. What Regurin XL 60 mg is and what it is used for
2. What do you need to know before you take Regurin XL 60 mg
3. How to take Regurin XL 60 mg
4. Possible side effects
5. How to store Regurin XL 60 mg
6.
1. what regurin xl 60 mg is and what it is used for
Regurin XL 60 mg is a medicine used for the relaxation of themuscles 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.
2. What do you need to know before you take Regurin XL 60 mg
Do not take Regurin XL 60 mg
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– If you have ever had an allergic reaction to trospium chloride orany 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 60mg
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 60 mg to children under 18 years of age.
Other medicines and Regurin XL 60 mg
Please tell your doctor or pharmacist if you are taking or haverecently taken or might take any other medicines.
Inform your doctor in particular if you are taking any of thefollowing 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 – medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicinesthat 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 60 mg should be taken during pregnancy and breast-feeding only if your doctorconsiders it absolutely necessary.
Driving and using machines
Even when used as directed, this medicine can affect vision sothat 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 60 mg contains sucrose and sodium
If you have been told by your doctor that you have an intoleranceto some sugars, such as sucrose, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) percapsule, that is to say it is essentially ‘sodium-free’
3. how to take regurin xl 60 mg
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 60 mg prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass ofwater. 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 regularintervals of 3 – 6 months.
Patients with a kidney disorder should consult their doctor andnot take this medicine.
Patients with a liver disorder should consult their doctor beforetaking this medicine.
If you take more Regurin XL 60 mg than you should
No symptoms and signs of intoxication in humans have beenreported to date.
If you have taken too much Regurin XL 60 mg you should informimmediately a doctor or pharmacist who will decide on further measures.
If you forget to take Regurin XL 60 mg
Do not take a double dose to make up for a forgotten dose. Continue with the regular intake as described in the dosagedirections.
If you stop taking Regurin XL 60 mg
Your symptoms may return if you stop taking Regurin XL 60 mg before recommended by your doctor. Therefore, you should take Regurin XL 60 mg 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, askyour doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, althoughnot everybody gets them.
The following side effects have been reported for Regurin XL 60mg 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 haveoccurred 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 60 mg; it is not known if these side effects will also occur with the capsules thatyou have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderateincrease of certain liver values (serum transaminases), fast irregular heartbeat, joint or muscle pains, dizziness.
The following “very rare” side effects below are important and willrequire immediate action if you experience them. You should stop taking Regurin XL 60 mg 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.
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 thisleaflet. You can also report side effects directly via the Yellow Card Scheme at:r search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information onthe safety of this medicine.
5. how to store regurin xl 60 mg
Keep out of the sight and reach of children.
Do not use this medicine 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 medicine does not require any special storage conditions.
Do not use this medicine if you notice that the package has been damaged or has apparently been tampered with.
If your capsules show any signs of deterioration or discolouration, consult your pharmacist for advice. If damagedplease tell your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help to protect the environment.
6. contents of the pack and other information
What Regurin XL 60 mg contains
The active substance is trospium chloride.
Each prolonged-release capsule contains 60 mg trospiumchloride.
The other ingredients are:
Capsule contents: Sucrose, Maize starch, Methyl acrylatemethylmethacrylate-methacrylic acid-copolymer, Sodium dodecyl sulphate, Ammonium hydroxide, Medium chain triglycerides, Oleic acid, Ethyl cellulose, Titanium dioxide (E 171), Hypromellose, Macrogol 400, Polysorbate 80, Triethyl citrate and Talc.
Capsule shell: Gelatin, Titanium dioxide (E 171), Yellow ironoxide (E 172), Red iron oxide (E 172), Printing ink (Shellac, Black iron oxide (E172) and Propylene glycol).
What Regurin XL 60 mg looks like and contents of the pack
Regurin XL 60 mg capsules consist of a white and orange capsule, imprinted with SAN 60 and contains white to cream coloured pellets.
Regurin XL 60 mg capsules are available in blister packs of 30 capsules.
Manufactured by: Madaus GmbH, 51101 Cologne.
Procured from within the EU. Product License Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.Repackaged by: Maxearn Limited, Unit 29, Oakhill TradingEstate, Devonshire Road, Worsley, Manchester, M28 3PT.
PL 20774/2457 POM
Regurin XL 60 mg prolonged-release capsules,hard
Date of Preparation: 20th September 2021
Regurin is a registered trademark.
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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471269
L-01–2457–01