2 mg hard
prolonged-release capsules of tolterodine tartrate
What Tolterodine Sandoz is and what it is used for
The active substance in Tolterodine Sandoz is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinics.
Tolterodine Sandoz is used to treating symptoms of overactive bladder. If you have an overactive bladder, you may experience that:
- you have difficulty controlling urination (urination)
- you have to rush to the toilet without warning and/or go to the toilet frequently.
Tolterodine contained in Tolterodine Sandoz 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 take Tolterodine Sandoz
Do not take Tolterodine Sandoz
- 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 that leads to reduced vision and is not under adequate 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 dilation of the colon).
Warnings and precautions
Talk to your doctor or pharmacist before taking Tolterodine Sandoz.
- 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 suffer from any liver disease
- if you suffer from any neurological disorder that affects your blood pressure, your bowel function, or your sexual function ( neuropathy of the autonomic nervous system )
- if you have a hiatal hernia (diaphragmatic hernia)
- if you ever have problems emptying your bowels or suffer from constipation (decreased bowel movements)
- if you suffer from any heart disease, for example:
- an abnormal electrocardiogram ( ECG )
- low heart rate ( bradycardia )
- or previously had heart problems, eg: cardiomyopathy (weak heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat), and heart failure
- if you have abnormally low levels of potassium ( hypokalaemia ), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.
Talk to your doctor or pharmacist before taking Tolterodine Sandoz if any of the above apply to you.
Other medicines and Tolterodine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tolterodine, the active substance in Tolterodine Sandoz, can be affected by and/or affect other medicines.
Therefore, taking Tolterodine Sandoz 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 Sandoz should be used with caution when taken at the same time as:
- medicines that affect the passage of food (eg metoclopramide and cisapride)
- medicines for the treatment of irregular heartbeats (containing e.g. amiodarone, sotalol, quinidine, procainamide ), other medicines with a similar mechanism of action to Tolterodine Sandoz (antimuscarinic properties), or medicines with the opposite mechanism of action to Tolterodine Sandoz (cholinergic properties). Decreased bowel movements caused by antimuscarinic drugs may affect the absorption of other drugs. Ask your doctor if you are unsure.
Tolterodine Sandoz with food and drink
Tolterodine Sandoz can be taken before, after, or during meals.
Pregnancy and breastfeeding
Pregnancy
You should not use Tolterodine Sandoz if you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.
A mining
It is unknown whether tolterodine, the active substance in Tolterodine Sandoz, passes into breast milk. Breastfeeding is not recommended while using Tolterodine Sandoz.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Tolterodine Sandoz may make you dizzy, tired, or affect your vision. If you experience any of these side effects, you should not drive or operate heavy 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. A 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 Sandoz contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard prolonged-release capsule , i.e. it is almost “sodium-free”.
How to take Tolterodine Sandoz
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The hard prolonged-release capsules should be taken orally and swallowed whole.
Do not chew the capsules.
Adults :
The usual dose is one 4 mg hard prolonged-release capsule daily.
Patients with liver or kidney problems:
For patients with liver or kidney problems, the doctor may reduce the dose by one to 2 mg of Tolterodine Sandoz daily.
Children
Tolterodine Sandoz is not recommended for children.
If you have taken too much Tolterodine Sandoz
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. Symptoms of overdose are e.g. hallucinations, excitement, faster than a usual heartbeat, dilation of the pupils, and inability to pass water (urinate) or breathe normally.
If you forget to take Tolterodine Sandoz
If you have forgotten to take a dose when you usually take it, you can take it as soon as you remember, unless it is almost time for the next dose. In that case, you should skip the missed dose and instead follow the usual dosing schedule.
Do not take a double dose to make up for a missed dose.
If you stop taking Tolterodine Sandoz
Your doctor will tell you how long you will be treated with Tolterodine Sandoz. Do not stop treatment prematurely if you do not notice an immediate effect. Your bladder may need some time to adjust. Take all extended-release capsules as prescribed by your doctor. If you have not noticed any effect when the treatment is over, talk to your doctor.
The benefit of the treatment should be evaluated again after 2–3 months. 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, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately or seek emergency care if you experience signs of angioedema, such as:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
You should also see a doctor if you experience a hypersensitivity reaction (eg itching, rash, hives, 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 any of the following:
- chest pains, breathing difficulties or pronounced fatigue (even when resting), breathing difficulties at night, 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 Sandoz 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 (urinating)
- Fluid accumulation in the body causes swelling (eg in the ankles)
- Dizziness
- Headache
- Blurred vision
- Constipation
- Large amounts of air or gases in the stomach or intestines
- Diarrhea
- Fatigue
Uncommon side effects ( may affect up to 1 in 100 users):
- Allergic reactions
- Concern
- Palpitation
- Inability to empty the bladder
- Dizziness
- Heart failure
- Irregular heartbeats
- Chest pains
- Tingling in fingers and toes
- Impaired memory
Other side effects that have been reported are 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 Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton after Ex. Date. or EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC.
Shelf life after first opening:
HDPE can: 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. Each hard prolonged-release capsule contains 2 mg tolterodine tartrate.
- Other ingredients are lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, anhydrous colloidal silicon dioxide, sodium lauryl sulfate, docusate sodium, magnesium stearate, hydroxypropyl methylcellulose, indigo carmine (E132), quinoline yellow (E104), titanium dioxide (E171), gelatin, ethyl cellulose, triethyl citrate, methacrylic acid -ethyl acrylate copolymer, 1,2-propylene glycol.
Appearance and package sizes of the medicine
Opaque green-opaque green hard gelatin capsules containing two white, round, biconvex, tablets.
The hard prolonged-release capsules are packed in Alu/PVC/PE/PVDC blisters or packed in HDPE cans with child-resistant closures and inserted in a cardboard box.
Package sizes:
Blister pack: 7, 14, 28, 30, 49, 50, 56, 80, 84, 90, 98, 100, 112, 160, 280 and 320 hard prolonged-release capsules.
Can: 30, 60, 100, and 200 hard prolonged-release capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder :
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer :
Pharmathen International SA, Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
or
Pharmathen SA, Dervenakion St. 6, 15351 Pallini, Attikis, Greece
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179, Barleben, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia