Efflosomyl Xl 2 Mg Prolonged-Release Capsules Hard
Package leaflet: Information for the user Efflosomyl XL 2 mg prolonged-release capsules, hard
tolterodine tartrate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Efflosomyl XL is and what it is used for
2. What you need to know before you take Efflosomyl XL
3. How to take Efflosomyl XL
4. Possible side effects
5. How to store Efflosomyl XL
6. Contents of the pack and other information
1. W hat Efflosomyl XL is and what it is used for
The active substance in Efflosomyl XL is tolterodine tartrate. Tolterodine belongs to a class of medicinal products called antimuscarinics.
Efflosomyl XL is used in adults and the elderly 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 or 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 Efflosomyl XL Do not take Efflosomyl XL
- if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6)
- if you are unable to pass urine from the bladder (urinary retention)
- if you have high pressure in the eyes with loss of eyesight that is not being adequately treated (uncontrolled narrow-angle glaucoma)
- if you suffer from excessive weakness of the muscles (myasthenia gravis)
- if you suffer from severe ulceration and inflammation of the colon (severe ulcerative colitis)
- if you suffer from acute widening of the colon (toxic megacolon).
Warnings and precautions
Talk to your doctor or pharmacist before taking Efflosomyl 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 neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
- have a hiatal hernia (a hernia in the upper part of stomach)
- ever experience decreased bowel movements or suffer from severe constipation (decreased gastrointestinal motility)
- have a heart condition such as:
■ an abnormal heart tracing (ECG)
■ a slow heart rate (bradycardia)
■ have a pre-existing heart disease 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.
Talk to your doctor or pharmacist before starting your treatment with Efflosomyl XL if you think any of these might apply to you.
Other medicines and Efflosomyl XL
Tolterodine tartate, the active substance of Efflosomyl XL, may interact with other medicinal products.
It is not recommended to take this medicine in combination with:
• some antibiotics (e.g. erythromycin, clarithromycin)
• medicinal products used for the treatment of fungal infections (e.g. ketoconazole, itraconazole)
• medicinal products used for the treatment of HIV.
Efflosomyl XL should be used with caution when taken in combination with:
• medicines that affect the passage of food (e.g. metoclopramide and cisapride);
• medicines for the treatment of irregular heartbeat (e.g. amiodarone, sotalol, quinidine, procainamide);
• other medicines with a similar mode of action to Efflosomyl XL (antimuscarinic properties) or medicines with an opposite mode of action to Efflosomyl XL (cholinergic properties). Ask your doctor if you are unsure.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Taking Efflosomyl XL with food and drink Efflosomyl XL can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not take Efflosomyl XL when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to have a baby.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Efflosomyl XL is not recommended for mothers who are breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or operate machinery whilst taking Efflosomyl XL as it may make you feel dizzy, tired or affect your sight.
Efflosomyl XL contains sucrose (a type of sugar)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Efflosomyl XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 4 mg capsule daily. For patients who have a kidney or a liver condition or troublesome side effects, your doctor may reduce your dose to one 2 mg capsule daily.
Use in Children
Efflosomyl XL is not recommended for children.
The capsules should be swallowed whole with a glass of water with or without food. Do not chew the capsules.
Duration of treatment
Your doctor will tell you how long your treatment with Efflosomyl XL will last. Your bladder will need some time to adapt. Do not stop treatment early because you do not see an immediate effect. Finish the course of 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.
If you take more Efflosomyl XL than you should
If you or somebody else takes too many capsules, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.
Signs of overdose to look for are: hallucinations, severe excitation, convulsions, increased heart beat, shortness of breath, difficulty to pass urine or widening of pupils.
If you forget to take Efflosomyl 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 dose.
If you stop taking Efflosomyl XL
Do not stop taking this medicine unless your doctor advises you to stop.
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 hospital emergency department if you experience symptoms of angioedema such as:
• swollen face, tongue, throat
• difficulty to swallow
• hives and difficulty in breathing
You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives or difficulty breathing). This occurs uncommonly (occurs in less than 1 in 100 patients).
Tell your doctor immediately or go to the hospital emergency department if you notice any of the following:
• chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs.
These may be symptoms of heart failure. This occurs uncommonly (occurs in less than 1 in 100 patients).
The following side effects have been observed during treatment with Efflosomyl XL with the following frequencies.
Very common side effects (may affect more than 1 in 10 patients)
• dry mouth
Common side effects (may affect up to 1 in 10 patients)
• sinusitis
• dizziness, sleepiness, headache
• dry eyes, blurred vision
• difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine
• painful or difficult urination
• tiredness
• extra fluid in the body causing swelling (e.g. in the ankles)
• diarrhoea
Uncommon side effects (may affect up to 1 in 100 patients)
• allergic reactions
• nervousness
• sensation of pins and needles in the fingers and toes
• feeling of spinning, dizziness (vertigo)
• palpitations, heart failure, irregular heartbeat
• inability to empty the bladder
• chest pain
• memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Efflosomyl XL
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicine 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 information What Efflosomyl XL contains
The active substance is tolterodine tartrate. Each prolonged-release capsule contains 2 mg tolterodine tartrate which is equivalent to 1.37 mg of tolterodine.
The other ingredients are sugar spheres (sucrose and maize starch), ethylcellulose (E462), hypromellose (E464) and talc (E553b). The capsule shell contains indigo carmine (E132), yellow iron oxide (E172), titanium dioxide (E171) and gelatin (E441). The printing ink contains shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide.
What Efflosomyl XL looks like and contents of the pack
Efflosomyl XL 2 mg prolonged-release capsules are green opaque hard-shell gelatin capsules filled with white to off-white beads. The capsules are marked with MYLAN over 3402 in black ink on both parts of the capsule.
Your medicine is packed in perforated unit dose or in standard blisters containing 28x1 or 10, 14, 20, 28, 30, 60, 84, 90, 98 and 100 prolonged-release capsules, and in bottles containing 30, 100, 250 and 500 prolonged-release capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Mylan Hungary Kft., Mylan utca 1, Komarom, 2900, Hungary This leaflet was last revised in April 2013
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