2 mg, 4 mg prolonged-release capsules, hard
tolterodine tartrate
What Tolterodine Rivopharm is and what it is used for
The active substance in Tolterodine Rivopharm is tolterodine. Tolterodine belongs to a class of drugs called antimuscarinic drugs.
Tolterodine Rivopharm 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 Rivopharm may also be approved to treat other diseases 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 you use Tolterodine Rivopharm
Do not take Tolterodine Actavis
- 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 angle-closure 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 taking Tolterodine Rivopharm 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 in the autonomic nervous system ).
- have a hiatus hernia (diaphragmatic hernia).
- have ever had problems with bowel emptying or suffered from severe constipation (reduced gastrointestinal movements).
- have any heart disease such as:
- an abnormal electrocardiogram ( ECG ).
- slow heart rate ( bradycardia ).
- previous problems with the heart such as cardiomyopathy (weak heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heart activity), and heart failure.
- have abnormally low levels of potassium ( hypokalemia ), calcium ( hypocalcemia ), or magnesium ( hypomagnesemia ) in the blood.
Other medicines and Tolterodine Rivopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tolterodine, the active substance in Tolterodine Rivopharm, can be affected by and/or affect other medicines.
Taking Tolterodine Rivopharm is not recommended 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 Rivopharm should be used with caution when taken at the same time as:
- medicines that affect the passage of food (eg metoclopramide and cisapride).
- medicines to treat irregular heart activity (eg amiodarone , sotalol, quinidine , procainamide ).
- other medicines with a similar mechanism of action as Tolterodine Rivopharm (antimuscarinic properties) or medicines with the opposite mechanism of action as Tolterodine Rivopharm (cholinergic properties). The reduction in bowel movements caused by the antimuscarinic may affect the absorption of other medicines. Ask your doctor if you are unsure.
Tolterodine Actavis with food and drink
Tolterodine Rivopharm 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 Rivopharm if you are pregnant.
Breast-feeding
It is unknown whether tolterodine, the active substance in Tolterodine Rivopharm, passes into breast milk. Breastfeeding is not recommended when using Tolterodine Rivopharm.
Driving ability and use of machinery
Tolterodine Rivopharm may make you feel dizzy, 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 Rivopharm contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
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 use Tolterodine Rivopharm
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage
The hard prolonged-release capsules are for oral use and should be swallowed whole.
Do not chew the capsules.
Adults
The recommended dose is one 4 mg prolonged-release capsule daily.
Patients with kidney or liver problems:
The doctor may lower the dose by one to 2 mg of Tolterodine Rivopharm daily for patients with kidney or liver problems.
Use for children and adolescents:
Tolterodine Rivopharm is not recommended for children.
If you have taken too much Tolterodine Actavis
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, agitation, faster than normal heartbeat, pupil dilation, and inability to throw up water or breathe normally.
If you forget to take Tolterodine Actavis
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 instead follow the usual dosing schedule and ignore the missed dose.
Do not take a double dose to make up for a missed dose.
If you stop taking Tolterodine Actavis
Your doctor will tell you how long the treatment with Tolterodine Rivopharm will last. Do not stop treatment earlier because you will not see an immediate effect. Your bladder needs some time to adjust. Complete the treatment with extended-release capsules as prescribed by your doctor. 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. 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.
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 Rivopharm with the following frequency:
Very common side effects ( may affect more than 1 in 10 users):
- dry mouth
Common side effects ( may affect less than 1 in 10 users):
- sinusitis
- dizziness, drowsiness, headache
- dry eyes, blurred vision
- digestive problems ( dyspepsia ), constipation, abdominal pain, whether tension
- pain or difficulty passing water
- diarrhea
- fluid accumulation in the body that causes swelling (such as the ankles)
- fatigue
Uncommon side effects ( may affect less than 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 Rivopharm
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 in Tolterodine Rivopharm 2 mg prolonged-release capsule, hard is 2 mg tolterodine tartrate, corresponding to 1.37 mg tolterodine.
The active substance in Tolterodin Rivopharm 4 mg prolonged-release capsule, hard 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, docusate sodium, magnesium stearate, hydroxypropyl methylcellulose.
Capsule contents: indigo carmine (E132), quinoline yellow (only 2‑mg) (E104), titanium dioxide (E171), gelatin.
Capsule shell: ethyl cellulose, triethyl citrate, methacrylic acid – ethyl acrylate copolymer, 1, 2- propylene glycol.
Appearance and package sizes of the medicine
Tolterodine Rivopharm is a hard prolonged-release capsule, designed to be dosed once a day.
Tolterodine Rivopharm 2 mg prolonged-release capsules are opaque, and green.
Tolterodine Rivopharm 4 mg prolonged-release capsules are opaque, light blue
Tolterodine Rivopharm 2 mg prolonged-release capsules are available in the following pack sizes:
Blister packs containing: 14, 28, 30, 56, 60, 84, 98, 100 prolonged-release capsules
HDPE cans containing: 30, 100, and 200 capsules
Tolterodine Rivopharm 4 mg prolonged-release capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 56, 60, 84, 98, 100 prolonged-release capsules
HDPE cans containing: 30, 100, and 200 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer
Pharmathen SA
Dervenakion Str. 6
15351 Pallini Attiki
Greece
Pharmathen International SA
Sales Industrial Park
Block 5
69300 Rodopi
Greece
Agent:
SanoSwiss UAB
Lviv 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com