2 mg and 4 mg prolonged-release capsules, hard
tolterodine tartrate
What Tolterodine STADA is and what it is used for
The active substance in Tolterodine Stada is tolterodine. Tolterodine belongs to a class of drugs called antimuscarinic drugs.
Tolterodine Stada 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 Stada may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tolterodine STADA
Do not use Tolterodine STADA
- are allergic (hypersensitive) to tolterodine or any of the other ingredients of this medicine (listed in section 6)
- have difficulty emptying the bladder ( urinary retention )
- have untreated angle-closure glaucoma (increased pressure in the eye leading to reduced vision)
- suffer from myasthenia gravis (severe muscle weakness)
- suffer from severe ulcerative colitis (ulcers and inflammation of the large intestine)
- suffers from toxic megacolon ( acute pronounced dilation of the large intestine).
Warnings and precautions
Talk to your doctor before taking Tolterodine Stada if you:
- have difficulty passing water and/or a weak stream of urine
- have gastrointestinal problems that affect the passage of food and/or digestion
- suffer from any kidney disease (impaired kidney function)
- have any liver disease
- suffer from any nerve disorder that affects your blood pressure, bowel, or sexual function ( neuropathy of the autonomic nervous system )
- have a hiatus hernia (diaphragmatic hernia)
- have ever had problems emptying your bowels or suffered from severe constipation (decreased bowel movements)
- have any heart disease such as:
- an abnormal electrocardiogram ( ECG )
- slow heart rate ( bradycardia )
- or 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), heart failure
- have abnormally low levels of potassium ( hypokalemia ), calcium ( hypocalcemia ), or magnesium ( hypomagnesemia ) in the blood.
Other medicines and Tolterodine STADA
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Tolterodine, the active substance in Tolterodine Stada, can be affected by and/or affect other medicines.
Therefore, it is not recommended to take tolterodine at the same time as:
- certain antibiotics (containing eg erythromycin, clarithromycin)
- medicines used to treat fungal infections (containing eg ketoconazole, and itraconazole)
- medicines used to treat HIV.
Tolterodine should be used with caution when taken at the same time as:
- medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
- medicines to treat irregular heart activity (containing eg amiodarone, sotalol, quinidine, procainamide )
- other medicines with a similar mechanism of action to Tolterodine Stada (antimuscarinic properties) or medicines with the opposite mechanism of action to Tolterodine Stada (cholinergic properties). The decrease in gastric motility caused by the antimuscarinic may affect the absorption of other drugs. Ask your doctor if you are unsure.
Tolterodine STADA with food, drink, and alcohol
Tolterodine Stada can be taken before, after, or during meals.
Pregnancy, breastfeeding, and fertility
Pregnancy
You should not use Tolterodine Stada if you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.
Breast-feeding
It is unknown whether tolterodine, the active substance in Tolterodine Stada, passes into breast milk. Breastfeeding is not recommended when using Tolterodine Stada.
Ask your doctor or pharmacist before taking any medicine.
Driving ability and use of machinery
Tolterodine Stada can make you feel dizzy, or tired or affect your vision. Your ability to drive or operate machinery may be affected.
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 STADA contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to use Tolterodine STADA
Dosage:
Always take this medicine 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 kidney or liver problems
For patients with a kidney or liver problem, the doctor can lower the dose by one to 2 mg of Tolterodine Stada daily.
Mode of administration
The hard prolonged-release capsules are for oral use and should be swallowed whole.
Do not chew the capsules.
Treatment time
Your doctor will tell you how long the treatment with Tolterodine Stada 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 tablets 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 Stada is not recommended for children.
If you have used too much Tolterodine STADA
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, excitement (elation), faster than normal heartbeat, pupil dilation, and inability to urinate or breathe normally.
If you forget to use Tolterodine STADA
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. In that case, you follow the usual dosage schedule instead.
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine 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 Stada with the following frequency:
Very common side effects ( may affect more than 1 in 10 users):
- dry mouth
Common side effects ( may affect up to 1 in 10 users):
- sinusitis
- somnolence
- dry eyes
- digestive problems ( dyspepsia )
- abdominal pain
- pain or difficulty passing water
- fluid accumulation in the body that causes swelling (such as the ankles)
- dizziness
- headache
- blurred vision
- constipation
- weather tensions
- diarrhea
- fatigue
Uncommon side effects ( may affect up to 1 in 100 users)
- allergic reactions
- nervousness
- palpitation
- inability to empty the bladder
- dizziness
- heart failure
- irregular heart rate
- chest pains
- an ant crawling in fingers and toes
- 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 Tolterodine STADA should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label/box.
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 in Tolterodine Stada 2 mg prolonged-release capsule is 2 mg tolterodine tartrate, corresponding to 1.37 mg tolterodine.
The active substance in Tolterodine Stada 4 mg prolonged-release capsule is 4 mg tolterodine tartrate, corresponding to 2.74 mg tolterodine.
Other ingredients are:
Lactose monohydrate, microcrystalline cellulose, poly (vinyl acetate), povidone, silicon dioxide, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropyl methylcellulose. Capsule shell: indigo carmine (E132), titanium dioxide (E171), gelatin, quinoline yellow (E104)
Inner tablet coating:
Ethylcellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, 1,2-propylene glycol.
Appearance and package sizes of the medicine
Tolterodine Stada is a hard prolonged-release capsule, designed to be dosed once a day.
Tolterodine Stada 2 mg prolonged-release capsules are opaque green – opaque green.
Tolterodine Stada 4 mg prolonged-release capsules are light blue opaque – light blue opaque.
Tolterodine Stada 2 mg prolonged-release capsules are available in the following pack sizes:
Blister packs containing: 28, 30, or 100 prolonged-release capsules
Cans containing 30 or 100 capsules.
Tolterodine Stada 4 mg prolonged-release capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 56, 84, 98, 100, 112 or 126 prolonged-release capsules
Cans containing 30 or 100 capsules.
Not all pack sizes may be marketed.
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Pharmathen SA, Dervenakion 6, 153 51 Pallini Attiki, Greece
Pharmathen International SA, Industrial Park Sapes, Block 5, 69300 Rodopi, Greece
Eurogenerics NV, Heizel Esplanade B22, 1020 Brussels, Belgium
LAMP SAN PROSPERO SpA, via della Pace, 25/A, 41030 San Prospero (Modena) Italy
PharmaCoDane ApS, Marielundvej 46 A, 2730 Herlev, Denmark
Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark