Patient leaflet - Tolterma XL 4 mg prolonged-release capsules hard
1. What Tolterma XL is and what it is used for
The active substance in this medicine is tolterodine.
Tolterodine belongs to a class of medicines called antimuscarinics.
This medicine is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:
Ÿ you are unable to control urination,
Ÿ you need to rush to the toilet with no advance warning and/or go
to the toilet frequently.
2. What you need to know before you take Tolterma XL
Do not take this medicine:
Ÿ if you are allergic (hypersensitive) to tolterodine or any of the
other ingredients in this medicine (listed in section 6).
Ÿ if you are unable to pass urine from the bladder (urinary retention) Ÿ if you have an uncontrolled narrow-angle glaucoma (high pressure
in the eyes with loss of eyesight that is not being adequately treated)
Ÿ if you suffer from myasthenia gravis (excessive weakness of the
muscles)
Ÿ if you suffer from severe ulcerative colitis (ulceration and
inflammation of the colon)
Ÿ if you suffer from a toxic megacolon (acute dilatation of the
colon).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
Ÿ have difficulties in passing urine and/or a poor stream of urine
Ÿ have a gastro-intestinal disease that affects the passage and/or
digestion of food
Ÿ suffer from kidney problems (renal insufficiency) Ÿ have a liver condition
Ÿ suffer from neuronal disorders that affect your blood pressure,
bowel or sexual function (any neuropathy of the autonomic nervous system)
Ÿ have a hiatal hernia (herniation of an abdominal organ)
- myocardial ischaemia (reduced blood flow to the heart) Ÿ ever experienced decreased bowel movements or suffered from
severe constipation (decreased gastro-intestinal motility) Ÿ have a heart condition such as:
§ an abnormal heart tracing (ECG);
§ a slow heart rate (bradycardia);
§ relevant pre-existing cardiac diseases such as:
cardiomyopathy (weak heart muscle)
- arrhythmia (irregular heartbeat)
- and heart failure
Ÿ some antibiotics (containing e.g. erythromycin, clarithromycin) Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Ÿ have abnormally low levels of potassium (hypokalaemia), calcium
(hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.
Other medicines and Tolterma XL
Tolterodine, the active substance of this medicine, may interact with other medicines.
This medicine can be taken before, after or during a meal. It is not recommended to use this medicine in combination with:
Ÿ medicines used for the treatment of fungal infections (containing e.g. ketoconazole, itraconazole)
Ÿ medicines used for the treatment of HIV.
This medicine should be used with caution when taken in combination with:
Ÿ medicines that affect the passage of food (containing e.g.
metoclopramide and cisapride)
Ÿ medicines for the treatment of irregular heartbeat (containing e.g.
amiodarone, sotalol, quinidine, procainamide)
Ÿ other medicines with a similar mode of action to this medicine
(antimuscarinic properties) or medicines with an opposite mode of action to this medicine (cholinergic properties). Ask your doctor if you are unsure.
Tolterma XL with food and drink
Pregnancy and breast-feeding
Pregnancy
You should not use this medicine when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant.
It is not known if tolterodine, the active substance of this medicine, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of this medicine. Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.
Tolterma XL contains sucrose
This medicine contains sucrose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
3. How to take Tolterma XL
Dosage
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is one 4 mg prolonged-release capsule daily, except for patients who have a kidney or a liver condition or troublesome side effects, in which case your doctor may reduce your dose to one 2 mg capsule daily.
This medicine is not recommended for children.
The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.
Duration of treatment
Your doctor will tell you how long your treatment with this medicine will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of prolonged-release capsules prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor.
The benefit of the treatment should be re-evaluated after 2 or 3 months.
Always consult your doctor if you are thinking of stopping the treatment.
If you have taken more of this medicine than you should
If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.
If you forget to take this medicine
If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your next dose. In that case, omit the forgotten dose and follow the normal dose schedule.
Do not take a double dose to make up for a forgotten one.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see your doctor immediately or go to the casualty department if you experience symptoms of angioedema such as:
Ÿ swollen face, tongue or pharynx
Ÿ difficulty to swallow
Ÿ hives and difficulty in breathing
rest), difficulty breathing at night, swelling of the legs. You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing). This occurs uncommonly (may affect up to 1 in 100 people).
Tell your doctor immediately or go to the casualty department if you notice any of the following:
Ÿ chest pain, difficulty breathing or getting tired easily (even at
These may be symptoms of heart failure. This occurs uncommonly (may affect up to 1 in 100 people).
The following side effects have been observed during treatment with this medicine with the following frequencies.
Common side effects (may affect up to 1 in 10 people) are: Very common side effects (may affect more than 1 in 10 people) are:
excessive amounts of air or gases in the stomach or the intestine Ÿ Dry mouth
Ÿ Sinusitis
Ÿ Extra fluid in the body causing swelling (e.g. in the ankles) Ÿ Dizziness, sleepiness, headache
Ÿ Dry eyes, blurred vision
Ÿ Difficulty in digestion (dyspepsia), constipation, abdominal pain,
Ÿ Painful or difficult urination
Uncommon side effects (may affect up to 1 in 100 people) are: Ÿ Tiredness
Ÿ Diarrhoea
Ÿ Allergic reactions
Ÿ Nervousness
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Ÿ Sensation of pins and needles in the fingers and toes Ÿ Vertigo
Ÿ Palpitations, heart failure, irregular heartbeat
Ÿ Inability to empty the bladder
Ÿ Chest pain
Ÿ Memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tolterma XL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What this medicine contains
The active substance is tolterodine tartrate
2 mg: Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37mg tolterodine.
4 mg: Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74mg tolterodine.
The other ingredients are:
Capsule contents: Sugar spheres (containing sucrose and maize starch), hydroxypropylmethyl cellulose, talc, ethylcellulose dispersion Type B.
Capsule shell: Gelatin and sodium lauryl sulfate.
Colourants:
2 mg: Iron oxide yellow (E172), iron oxide red (E172), titanium dioxide(E171), FD & C Blue 1(E133)
4 mg: Iron oxide red (E172), titanium dioxide (E171), FD & C Blue 1 (E133)
Printing ink: Shellac (E904), dehydrated alcohol (E1510), isopropyl alcohol, butyl alcohol, propylene glycol (E1520), strong ammonia solution (E527), potassium hydroxide (E525), titanium Dioxide (E171).
What this medicine looks like and contents of the pack
This medicine is a hard prolonged-release capsule designed for once daily dosing.
2 mg: Blue green cap/ Blue green body size "4" capsule containing off white to slight yellowish extended release pellets with 'L 32' on cap and '2' on body imprinted with white ink.
4 mg: Blue cap/ Blue body size "3" capsule containing off white to slight yellowish extended release pellets with 'L 33' on cap and '4' on body imprinted with white ink.
This medicines 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:
Cold formed blister packs: Blister pack comprises of Aluminium foil and cold form laminate.
Pack sizes: 28, 49, 50, 56, 98 capsules.
Wynyard, Billingham, TS22 5TB, United Kingdom Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
PL 34771/0212-0213