2 mg and 4 mg prolonged-release capsules, hard
tolterodine tartrate
What Tolterodine Teva is and what it is used for
The active substance in Tolterodine Teva is tolterodine. Tolterodine belongs to a class of drugs called antimuscarinic drugs.
Tolterodine Teva is used to treat symptoms of overactive bladder. If you have an overactive bladder, you may experience that:
- you have difficulty controlling the throwing up of water
- you need to rush to the toilet without any warning and/or go to the toilet frequently.
Tolterodine contained in Tolterodine Teva may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Tolterodine Teva
Do not use Tolterodine Teva
- if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6)
- if you have difficulty emptying your bladder ( urinary retention )
- if you have uncontrolled narrow-angle glaucoma (increased pressure in the eye leading to reduced vision, which is not under optimal control)
- if you suffer from myasthenia gravis (severe muscle weakness)
- if you suffer from severe ulcerative colitis (ulcers and inflammation of the large intestine)
- if you suffer from toxic megacolon ( acute pronounced dilation of the colon).
Warnings and precautions
Talk to your doctor or pharmacist before using Tolterodine Teva
- if you have difficulty passing water and/or a weak stream of urine
- if you have gastrointestinal problems that affect the passage of food and/or digestion
- if you suffer from any kidney disease (impaired kidney function)
- if you have any liver disease
- if you suffer from any nerve disorder that affects your blood pressure, bowel, or sexual function ( neuropathy in the autonomic nervous system )
- if you have a hiatus hernia (diaphragmatic hernia)
- if you have ever had problems with emptying your bowels or suffered from severe constipation (decreased bowel movements)
- if you have any heart disease such as:
- an abnormal electrocardiogram ( ECG )
- slow heart rate ( bradycardia )
- have previously had problems with the heart such as cardiomyopathy (weak heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heart activity), or heart failure
- If you have abnormally low levels of potassium ( hypokalaemia ), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.
Other medicines and Tolterodine Teva
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Tolterodine, the active substance in Tolterodine Teva, can be affected by and/or affect other medicines.
Therefore, it is not recommended to take tolterodine at the same time as:
- certain antibiotics (eg, erythromycin, clarithromycin)
- medicines used to treat fungal infections (eg ketoconazole, itraconazole)
- medicines used to treat HIV.
Tolterodine Teva should be used with caution when taken at the same time as:
- medicines that affect the passage of food (eg metoclopramide and cisapride)
- drugs to treat irregular heartbeat (eg amiodarone, sotalol, quinidine, procainamide )
- other medicines with a similar mechanism of action to Tolterodine Teva (antimuscarinic properties) or medicines with the opposite mechanism of action to Tolterodine Teva (cholinergic properties). The reduction of gastric motility (bowel movements) caused by antimuscarinic drugs may affect the absorption of other drugs.
Tolterodine Teva with food
Tolterodine Teva can be taken before, after, or during meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You should not take Tolterodine Teva if you are pregnant.
Breastfeeding
It is unknown whether tolterodine, the active substance in Tolterodine Teva, passes into breast milk. Breastfeeding is not recommended when using Tolterodine Teva.
Driving ability and use of machinery
Tolterodine Teva may make you feel dizzy, or tired or affect your vision. If you experience any of these effects, do not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tolterodine Teva contains lactose and sodium
If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before you start using this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release capsule, i.e. it is almost “sodium-free”.
How to use Tolterodine Teva
Always use Tolterodine Teva as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Adults
The usual dose is one 4 mg prolonged-release capsule daily.
Patients with liver or kidney disorders
For patients with a kidney or liver coma, the doctor may lower the dose by one to one 2 mg Tolterodine Teva prolonged-release capsule daily.
Use for children
Tolterodine Teva is not recommended for children.
Mode of administration
The prolonged-release capsules must be swallowed whole. The prolonged-release capsules must not be chewed.
Treatment time
Your doctor will tell you how long treatment with Tolterodine Teva will last. Do not stop treatment earlier because you will not see an immediate effect. Your bladder needs some time to adjust. Therefore, you must complete your treatment with prolonged-release capsules that your doctor has prescribed. If you have not had any effect after finishing the treatment, talk to your doctor. The treatment benefit must be evaluated again after 2 or 3 months.
Use for children
Tolterodine Teva is not recommended for children.
If you have used too much Tolterodine Teva
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Overdose symptoms include hallucinations, euphoria, a faster than normal heartbeat, pupil dilation, and inability to urinate or breathe normally.
If you forget to use Tolterodine Teva
If you have forgotten a dose when you usually take it, you can take it as soon as you remember if it is not soon time for the next dose. If so, skip the missed dose and follow the regular dosing schedule instead.
Do not take a double dose to make up for a missed dose.
If you stop using Tolterodine Teva
Always consult your doctor if you are considering stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Tolterodine Teva can cause side effects, although not everybody gets them.
You should immediately contact a doctor or go to the emergency department if you experience signs of angioedema such as:
- swollen face, tongue, and throat
- swallowing difficulties
- hives and difficulty breathing.
You should also see a doctor if you experience hypersensitivity (such as itching, skin rash, hives, or difficulty breathing). Such reactions are less common (may affect up to 1 in 100 users).
Contact a doctor immediately or seek emergency care if you experience the following symptoms:
- chest pains, breathing difficulties, pronounced fatigue (even at rest), breathing difficulties at night, and swollen legs.
These symptoms may be signs of heart failure, which is less common (may affect up to 1 in 100 people).
The following side effects have been observed during treatment with Tolterodine Teva with the following frequency:
Very common side effects ( affects more than 1 in 10 users):
- dry mouth.
Common side effects ( may affect up to 1 in 10 patients):
- sinusitis
- dizziness, drowsiness, headache
- dry eyes, blurred vision
- digestive problems ( dyspepsia ), constipation, abdominal pain, tension
- pain or difficulty passing water
- diarrhea
- fluid accumulation in the body causing swelling (eg in the ankles)
- fatigue.
Uncommon side effects ( may affect up to 1 in 100 users):
- allergic reactions
- heart failure
- concern
- irregular heart rate, palpitations
- chest pains
- inability to empty the bladder
- an ant crawling in fingers and toes
- dizziness
- memory impairment.
Other side effects that have been reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushing, heartburn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening dementia symptoms in patients treated for dementia.
How to store Tolterodine Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label/carton after EXP.
The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
HDPE can: Shelf life after first opening is 200 days.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tolterodine tartrate.
One prolonged-release capsule, hard, contains 2 mg of tolterodine tartrate, corresponding to 1.37 mg of tolterodine.
One prolonged-release capsule, hard, contains 4 mg of tolterodine tartrate, corresponding to 2.74 mg of tolterodine.
Other ingredients are:
Lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, silicon dioxide, sodium lauryl sulfate, docusate sodium, magnesium stearate, hydroxypropyl methylcellulose.
2 mg
The capsule consists of indigo carmine (E132), quinoline yellow (E104), titanium dioxide (E171), and gelatin.
4 mg
The capsule consists of indigo carmine (E132), titanium dioxide (E171), and gelatin.
The inner tablet’s coating consists of ethyl cellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, and propylene glycol.
Appearance and package sizes of the medicine
Tolterodine Teva is a hard prolonged-release capsule, designed to be dosed once a day.
Tolterodine Teva 2 mg prolonged-release capsules, hard, are opaque, and green.
Tolterodine Teva 4 mg prolonged-release capsules, hard, are opaque, and light blue.
Tolterodine Teva 2 mg and 4 mg prolonged-release capsules, hard 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 capsules, hard.
HDPE cans containing: 30, 60, 100, and 200 prolonged-release capsules, hard.
Not all pack sizes may be marketed.
Manufacturer
Pharmathen SA, Pallini Attiki, Greece
Pharmathen International SA, Rodopi, Greece
Portfarma ehf, Reykjavík, Iceland
Paradox Healthcare Ltd, Paola, Malta
Pharmacare Premium Ltd, Birzebbugia, Malta
TEVA Pharmaceutical Works Private Limited Company, Debrecen, Hungary
Pharmachemie BV, Haarlem, The Netherlands
Teva Operations Poland Sp. zoo, Krakow, Poland
Merckle GmbH, Blaubeuren, Germany
Teva Pharma BV, Haarlem, The Netherland