1 mg, 2 mg film-coated tablets
tolterodine tartrate
What Tolterodine Sandoz is and what it is used for
Tolterodine Sandoz is used to treat symptoms of overactive bladder, such as:
- difficulty controlling the throwing of water
- need to rush to the toilet without any warning and/or need to go to the toilet frequently.
Tolterodine Sandoz belongs to a group of medicines called antimuscarinic medicines, which allow the muscles in the bladder to relax.
Tolterodine tartrate 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 (hypersensitive) to tolterodine tartrate or any of the other ingredients
- unable to empty the bladder
- have any chronic disease in the intestines with ulcers and inflammation (severe ulcerative colitis )
- have increased pressure in the eyes with reduced vision, which is not under adequate control (uncontrolled narrow-angle glaucoma )
- have a muscle weakness called Myasthenia gravis
- have acute dilation of the colon (toxic megacolon).
Take special care with Tolterodine Sandoz if you
- have difficulty passing water and a weak stream of urine
- have a very swollen and painful stomach, which affects swallowing and digestion
- have problems with kidneys or liver
- See section 3 “How to take Tolterodine Sandoz”.
- have a nerve disorder that sometimes occurs with diabetes and which can lead to diarrhea, impotence, or low blood pressure (autonomic neuropathy )
- have a hiatus hernia (diaphragmatic hernia), where parts of your stomach protrude through the diaphragm
- have or have had severe constipation
- have a particular type of abnormal heartbeat called QT prolongation
- have abnormally low levels of potassium, magnesium, or calcium in your blood
- have a heart rate of fewer than 60 beats per minute
- have any heart disease, such as heart muscle disorder, reduced blood flow to the heart muscle, irregular heartbeat, or heart failure.
Before you start taking this medicine, tell your doctor or pharmacist if any of the above applies to you.
Children under 18 years of age
Tolterodine Sandoz is not recommended for children.
Intake of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines affect or are affected by Tolterodine Sandoz:
- medicines to treat irregular heart rhythms, such as quinidine, procainamide, amiodarone, sotalol
- macrolide antibiotics, such as erythromycin, clarithromycin
- medicines to treat fungal infections, such as ketoconazole, itraconazole
- drugs for the treatment of HIV containing substances with names ending in “-never”
- metoclopramide, cisapride – drugs that increase bowel movements.
Medicines with a similar mode of action (antimuscarinic properties) or medicines with the opposite effect (cholinergic properties) to Tolterodine Sandoz may interact with Tolterodine Sandoz. Examples of this are:
- medicines that dilate the pupils, such as atropine, scopolamine, tropicamide
- medicines that lower the pressure in the eyes, such as carbachol, pilocarpine
- medicines to treat Parkinson’s disease, such as biperiden, bornaprine, medicine, procyclidine, trihexyphenidyl
- medicines to treat spasms in the stomach, bowels, bladder, genitals, or trachea, such as butyl scopolamine, ipratropium, tiotropium
- medicines to treat disorders of the muscles of the bladder and bowels, such as oxybutynin, trospium, solifenacin, darifenacin, and bethanechol.
Pregnancy and breastfeeding
There is insufficient experience from the use of Tolterodine Sandoz during pregnancy. Because Tolterodine Sandoz can harm your unborn baby, you should not use Tolterodine Sandoz if you are pregnant. Tell your doctor right away if you are pregnant, think you are pregnant, or plan to become pregnant.
It is not known whether the active substance in Tolterodine Sandoz is excreted in breast milk. Therefore, you should not use Tolterodine Sandoz if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Tolterodine Sandoz can cause dizziness, fatigue, and blurred vision. Do not drive or use machines if you are affected in this way.
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 sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to take Tolterodine Sandoz
Always take Tolterodine Sandoz as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Tolterodine Sandoz 1 mg:
The usual dose is 2 tablets twice daily.
In case of reduced kidney or liver function or troublesome side effects, the usual dose is 1 tablet twice daily.
Tolterodine Sandoz 2 mg:
The usual dose is 1 tablet twice daily.
In case of reduced kidney or liver function or troublesome side effects, the usual dose is 1 mg* of Tolterodine Sandoz twice daily.
*For this dose, tablets with a smaller amount of active substance are available (Tolterodine Sandoz 1 mg).
How to take Tolterodine Sandoz
Swallow the tablets whole with a glass of water, regardless of the meal, in the morning and evening.
Duration of treatment
This is decided by the attending physician.
Do not stop treatment too soon because you do not see an immediate effect. Your bladder needs time to adjust. Your doctor will evaluate your treatment after 2 – 3 months.
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.
If you forget to take Tolterodine Sandoz
If you forget to take a dose, take it when it is time for the next dose. 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, Tolterodine Sandoz can cause side effects, although not everybody gets them.
You must immediately contact a doctor or visit the nearest emergency department if you experience symptoms of angioedema, such as
- swollen face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Side effects can occur to the following extent:
Very common affects more than 1 in 10 users:
- dry mouth may occur in 35% of patients.
- headache.
Common, affects 1 to 10 users in 100:
- constipation
- abdominal pain
- dizziness
- somnolence
- reduced production of tear fluid, resulting in dry, irritated eyes
- fatigue
- drowsiness
- altered sensation – tingling
- blurred vision
- dizziness
- chest pain
- gases
- vomiting
- diarrhea
- pain or difficulty passing water
- inability to empty the bladder
- dry skin
- palpitation
- bronchial catarrh
- accumulation of fluid in the body which causes swollen hands, ankles, and/or feet
- weight gain.
Uncommon affects 1 to 10 users in 1,000:
- allergic reactions
- heartburn
- nervousness
- impaired memory
- increased heart rate
- irregular heartbeats
- heart failure.
Not known, the frequency cannot be estimated from the available data
- severe allergic reactions that include swelling, especially of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing
- hallucinations
- confusion
- disorientation
- skin redness.
How to store Tolterodine Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister, can, and the carton after Exp or EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
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 film-coated tablet contains 1 mg of tolterodine tartrate. Each film-coated tablet contains 2 mg of tolterodine tartrate.
- Other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate, colloidal anhydrous silicon dioxide, hypromellose, stearic acid, titanium dioxide (E171).
Appearance and package sizes of the medicine
1 mg film-coated tablets :
White to off-white, round, biconvex film-coated tablets marked with “1” on one side.
2 mg film-coated tablets :
White to off-white, round, biconvex film-coated tablets marked with “2” on one side.
The film-coated tablets are packed in Alu/PVC or Alu/PVC/PVDC blisters or packed in HDPE cans with child-resistant closures and inserted in a cardboard box.
Package sizes:
Alu/PVC blisters or Alu/PVC/PVDC blisters: 7, 14, 28, 30, 50, 56, 60, 84, 98 and 100 film-coated tablets
Can: 60 and 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark