Dengaff Xl 4 Mg Prolonged-Release Capsules
Package leaflet: Information for the patient Dengaff XL 4 mg Prolonged-release Capsules
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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet:
1. What Dengaff XL Prolonged-release Capsules are and what they are used for
2. What you need to know before you take Dengaff XL Prolonged-release Capsules
3. How to take Dengaff XL Prolonged-release Capsules
4. Possible side effects
5. How to store Dengaff XL Prolonged-release Capsules
6. Contents of the pack and other information
1. What Dengaff XL Prolonged-release Capsules are and what they are used for
The active substance in Dengaff XL is tolterodine. Tolterodine belongs to a class of medicines called antimuscarinics.
Dengaff 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 Dengaff XL Prolonged-release Capsules Do not take Dengaff XL if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in Dengaff XL (see section 6 for a list of the ingredients)
• 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:
• if you have difficulties in passing urine and/or a poor stream of urine.
• if you have a gastro-intestinal disease that affects the passage and/or digestion of food.
• if you suffer from kidney problems (renal insufficiency).
• if you have a liver condition.
• if you suffer from neurological disorders that affect your blood pressure, bowel or
sexual function (any neuropathy of the autonomic nervous system). if you have a hiatus hernia (herniation of an abdominal organ).
if you ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility). if you 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
if you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.
Other medicines and Dengaff XL
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.
Tolterodine, the active substance of Dengaff XL, may interact with other medicines.
It is not recommended to take tolterodine in combination with:
• some antibiotics (containing e.g. erythromycin, clarithromycin)
• medicines used for the treatment of fungal infections (containing e.g. ketoconazole, itraconazole)
• medicines used for the treatment of HIV
Dengaff XL should be used with caution when taken in combination with:
• 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 Dengaff XL (antimuscarinic properties) or medicines with an opposite mode of action to Dengaff XL (cholinergic properties). The reduction in gastric motility caused by antimuscarinics may affect the absorption of other drugs.
Dengaff XL with food
Dengaff XL can be taken before, after or during a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take Dengaff XL when you are pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Dengaff XL, is excreted in the mother’s breast milk. Breast-feeding is not recommended during administration of Dengaff XL.
Driving and using machines
Dengaff 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.
Dengaff 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 medicines.
3. How to take Dengaff XL Prolonged-release Capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults:
The recommended dose is one 4 mg 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 2 mg Dengaff XL daily.
Use in children:
Dengaff XL is not recommended for children.
Method of administration
The prolonged-release capsules, hard are for oral use and should be swallowed whole.
Do not chew the capsules.
Duration of treatment
Your doctor will tell you how long your treatment with [Tolterodine] 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.
If you have taken more Dengaff XL than you should:
If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. Symptoms in case of overdose include hallucinations, excitation, a heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.
If you forget to take Dengaff 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 Dengaff XL
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 angioedema, such as:
• swollen face, tongue or pharynx
• 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, difficulty breathing). This occurs uncommonly (may affect up to 1 in 100 patients).
Tell your doctor immediately or go to the casualty 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 (may affect up to 1 in 100 people).
The following side effects have been observed during treatment with Dengaff XL with the following frequencies.
Very common side effects (may affect more than 1 in 10 people) are:
• Dry mouth
Common side effects (may affect up to 1 in 10 people) are:
• 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
• Diarrhoea
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Tiredness
Uncommon side effects (may affect up to 1 in 100 people) are:
• Allergic reactions
• Heart failure
• Nervousness
• Irregular heartbeat, palpitations
• Chest pain
• Inability to empty the bladder
• Sensation of pins and needles in the fingers and toes
• Vertigo
• 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.
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: 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 Dengaff XL Prolonged-release Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
Do not store above 25°C
HDPE bottle: Shelf life after first opening is 200 days
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Dengaff XL Prolonged-release Capsules
The active substance in Dengaff XL 4 mg Prolonged-release Capsules is 4 mg of tolterodine tartrate, equivalent to 2,8 mg of tolterodine.
The other ingredients are:
Lactose monohydrate, cellulose microcrystalline, poly(vinyl acetate), povidone, silica, sodium laurilsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose Capsule composition: indigo carmine (E132), titanium dioxide (E171), gelatin
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, 1,2-Propylene glycol
What Dengaff XL Prolonged-release Capsules look like and contents of the pack
Dengaff XL Prolonged-release Capsules , hard designed for once daily dosing.
Dengaff XL Prolonged-release Capsules,hard are light blue-opaque-light blue opaque.
Dengaff XL Prolonged-release Capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 50, 80, 84, 90, 98, 100, 160, 200, 280 prolonged-release HDPE bottle sizes containing: 30, 60, 100, 200 prolonged-release capsules, hard
Not all pack sizes may be marketed
Marketing authorisation holder and manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom
OR*
Manufacturer:
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem The Netherlands
OR*
TEVA UK Ltd
Eastbourne, BN22 9AG, United Kingdom OR*
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
OR*
Portfarma ehf
Borgartuni 26, 105 Reykjavik Iceland
OR*
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate,
Malta
OR*
Pharmadox Healthecare Ltd KW20A Kordin Industrial Park Malta
OR*
BioCentrum Sp. z o.o Bobrzynskiego 14, 30-348 Krako Poland
OR*
Teva Operations Poland Sp. z.o.o Ul. Sienkiewicza 25, 99-300 Kutno Poland
OR*
Teva Operations Poland Sp. z.o.o ul. Mogilska 80. 31-546, Krakow Poland
OR*
Pharmathen International S.A
Sapes Industrial Park, Block 5, 69300 Rodopi
Greece
OR*
Pharmathen S.A
6, Dervenakion Str., 153 51 Pallini, Attikis Greece
* Only the actual site of batch release will appear on the printed version of the leaflet This leaflet was last revised in April 2016 PL 00289/1775