BLERONE XL 4 MG PROLONGED-RELEASE CAPSULES - patient leaflet, side effects, dosage

Blerone XL 4mg prolonged-release capsules

if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

In this leaflet:

• 1. What Blerone XL is and what it is used for

• 2. What you need to know before you take Blerone XL

• 3. How to take Blerone XL

• 4. Possible side effects

• 5. How to store Blerone XL

• 6. Contents of the pack and other information

1. what blerone xl is and what it is used for

The name of your medicine is Blerone XL 4mg prolonged-release capsules (called Blerone XL throughout this leaflet). The active substance in Blerone XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.

Blerone XL is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:

• you are unable to control urination
• you need to rush to the toilet with no advance warning and/or go to the toilet frequently

2. what you need to know before you take blerone xl

Do not take Blerone XL if you:

• are allergic to the active substance or any of the other ingredients in this medicine (listed in section 6).
• are unable to pass urine from the bladder (urinary retention).
• have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated).
• suffer from myasthenia gravis (excessive weakness of the muscles).
• suffer from severe ulcerative colitis (ulceration and inflammation of the colon).
• suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before taking Blerone XL

if you:

• have difficulties in passing urine and/or a poor stream of urine.
• have a gastro-intestinal disease that affects the passage and/or digestion of food.
• suffer from kidney problems (renal insufficiency).
• have a liver condition.
• suffer from neurological disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system).
• have a hiatus hernia (herniation of an abdominal organ).
• ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility).
• have a heart condition such as:

• – an abnormal heart tracing (ECG)

• – a slow heart rate (bradycardia)

• – relevant pre-existing cardiac diseases such as: cardiomyopathy (weak heart muscle), myocardial ischaemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat) and heart failure

• have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.

Other medicines and Blerone XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tolterodine, the active substance of Blerone XL, may interact with other medicinal products.

It is not recommended to use tolterodine in combination with:

• some antibiotics (containing e.g. erythromycin, clarithromycin). ---------

• medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
• medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mode of action to Blerone XL (antimuscarinic properties) or medicines with an opposite mode of action to Blerone XL (cholinergic properties). The reduction in gastric motility caused by antimuscarinics may affect the absorption of other drugs. Ask your doctor if you are unsure.

Blerone XL with food and drink

Blerone XL can be taken before, after or during a meal.

Pregnancy and breast-feeding

If you are pregnant, breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not use Blerone XL when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.

Breast-feeding

It is not known if tolterodine, the active substance of Blerone XL, is excreted in the mother’s breast milk. Breast-feeding is not recommended during administration of Blerone XL.

Driving and using machines

Blerone XL may make you feel dizzy, tired or affect your sight.

If you experience any of these effects then you should not drive your car or operate heavy machinery.

Blerone XL 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.

3. how to take blerone xl

Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults :

The recommended dose is one 4mg prolonged-release hard capsule daily.

Patients with liver or kidney problems:

In patients with liver or kidney problems your doctor may reduce your dose to 2mg Blerone XL daily.

Children:

Blerone XL is not recommended for children.

The prolonged-release hard capsules are for oral use and should be swallowed whole. _______

pupil and inability to urinate or breathe normally. --------

If you forget to take Blerone XL

If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your next dose. In that case, omit the forgotten dose and follow the normal dose schedule.

Do not take a double dose to make up for a forgotten one.

If you stop taking Blerone XL

Your doctor will tell you how long your treatment with Blerone XL will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of prolonged-release capsules prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor.

The benefit of the treatment should be re-evaluated after 2 or 3 months. Always consult your doctor if you are thinking of stopping the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should see your doctor immediately or go to the casualty department if you experience symptoms of:

• severe allergic reaction or angioedema (frequency is not known, cannot be estimated from the available data), such as:

• – swollen face, tongue or pharynx.

• – difficulty in swallowing or breathing.

• – hives, rash, itching.

• heart failure (occurs uncommonly, may affect up to 1 in 100 people), such as:

– chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs.

The following side effects have been observed during treatment with tolterodine with the following frequencies.

Very common (may affect more than 1 in 10 people):

• Dry mouth

Common (may affect up to 1 in 10 people):

• Sinusitis
• Sleepiness
• Dry eyes
• Difficulty with digestion (dyspepsia)
• Abdominal pain
• Painful or difficult urination
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Dizziness
• Headache
• Blurred vision
• Constipation
• Excessive amounts of air or gases in the stomach or the intestine
• Diarrhoea
• Tiredness

Do not store above 30°C

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat blerone xl containsthe active substance in blerone xl 4mg prolonged-release capsules, is 4 mg of tolterodine tartrate, equivalent to 2.74mg of tolterodine.

The other ingredients are:

Lactose monohydrate, cellulose microcrystalline, poly(vinyl acetate), povidone, silica, sodium laurylsulfate, sodium docusate, magnesium stearate, hydroxypropyl­methylcellulo­se Capsule composition: indigo carmine (E132), titanium dioxide (E171), gelatine.

Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, 1,2-propylene glycol

What Blerone XL looks like and contents of the pack

Blerone XL is a hard prolonged-release capsule designed for once daily dosing.

Blerone XL 4mg prolonged-release capsules (19.4×6.9 mm) are light blue opaque-light blue opaque.

Blister packs containing: 7,14,28,49,84­,98 prolonged-release hard capsules

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder :

Zentiva Pharma UK Limited, 12 New Fetter Lane,

London EC4A1JP, United Kingdom

Manufacturer :

Pharmathen S.A, 6, Dervenakion Str., 153 51 Pallini, Attikis, Greece

Or

Pharmathen International S.A, Sapes Industrial Park, Block 5, 69300 Rodopi, Gre­ece

This leaflet was last revised in May 2020

5. How to store Blerone XL

Z0NTIVA

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