Tolterodine Tartrate 2Mg Film-Coated Tablets Tolterodine Tartrate

Package leaflet: Information for the user Tolterodine tartrate 2mg Film-coated Tablets Tolterodine tartrate

Read all of this leaflet carefully before you • have a heart condition such as: start taking this medicine because it contains - an abnormal heart tracing (ECG); important information for you. - a slow heart rate (bradycardia); • Keep this leaflet. You may need to read it again. - relevant pre-existing cardiac diseases such as: • If you have any further questions, ask your doctor - cardiomyopathy (weak heart muscle) - myocardial ischaemia (reduced blood flow to the or pharmacist heart) • This medicine has been prescribed for you only. - arrhythmia (irregular heartbeat) Do not pass it on to others. It may harm them, - and heart failure even if their signs of illness are the same as yours. • have abnormally low levels of potassium • If you get any side effects, talk to your doctor or (hypokalaemia), calcium (hypocalcaemia) or pharmacist. This includes any possible side effects magnesium (hypomagnesaemia) in your blood not listed in this leaflet. See section 4. Other medicines and Tolterodine Tartrate Tell your doctor if you are taking, have recently taken or What is in this leaflet: might take any other medicines. 1 What Tolterodine Tartrate is and what it is Tolterodine, the active substance of Tolterodine Tartrate, used for may interact with other medicinal products. 2 What you need to know before you take Tolterodine Tartrate It is not recommended to use tolterodine in combination 3 How to take Tolterodine Tartrate with: 4 • some antibiotics (containing e.g. erythromycin, Possible side effects clarithromycin) 5 How to store Tolterodine Tartrate • medicinal products used for the treatment of fungal 6 Contents of the pack and other infections (containing e.g. ketoconazole, itraconazole) information • medicinal products used for the treatment of HIV. Tolterodine Tartrate should be used with caution when 1 What Tolterodine Tartrate is and what it is taken in combination with: used for • medicines that affect the passage of food (containing The active substance in Tolterodine Tartrate is e.g. metoclopramide and cisapride) tolterodine. Tolterodine belongs to a class of medicinal • medicines for the treatment of irregular heartbeat products called antimuscarinics. (containing e.g. amiodarone, sotalol, quinidine, Tolterodine Tartrate is used for the treatment of the procainamide) symptoms of overactive bladder syndrome. If you have • other medicines with a similar mode of action to overactive bladder syndrome, you may find that: Tolterodine Tartrate (antimuscarinic properties) • you are unable to control or medicines with an opposite mode of action to urination, Tolterodine Tartrate (cholinergic properties). Ask your • you need to rush to the doctor if you are unsure. toilet with no advance warning and/or go to the Tolterodine Tartrate with food and drink toilet frequently. Tolterodine Tartrate can be taken before, after or during a meal.

Pregnancy and breast-feeding Pregnancy 2 You should not use Tolterodine Tartrate when you What you need to know before you take are pregnant. Tell your doctor immediately if you are Tolterodine Tartrate pregnant or breast-feeding, think you may be pregnant Do not take Tolterodine Tartrate if you: or are planning to have a baby, ask your doctor or • are allergic to tolterodine or any of the other pharmacist for advice before taking this medicine. ingredients of this medicine (listed in section 6) • are unable to pass urine from the bladder (urinary Breast-feeding retention) It is not known if tolterodine, the active substance of • have an uncontrolled narrow-angle glaucoma (high Tolterodine Tartrate, is excreted in the mother’s breast pressure in the eyes with loss of eyesight that is not milk. Breast-feeding is not recommended during being adequately treated) administration of Tolterodine Tartrate. • suffer from myasthenia gravis (excessive weakness of the muscles) Driving and using machines • suffer from severe ulcerative colitis (ulceration and Tolterodine Tartrate may make you feel dizzy, tired inflammation of the colon) or affect your sight; your ability to drive or operate • suffer from a toxic megacolon (acute dilatation of the machinery may be affected. colon).

Warnings and precautions 3 How to take Tolterodine Tartrate Talk to your doctor or pharmacist before taking Dosage Tolterodine Tartrate if you: Always take this medicine exactly as your doctor or • have difficulties in passing urine and/or a poor stream pharmacist has told you. Check with your doctor or of urine pharmacist if you are not sure. • have a gastro-intestinal disease that affects the passage and/or digestion of food The recommended dose is one 2 mg tablet twice • suffer from kidney problems (renal insufficiency) daily, except for patients who have a kidney or a liver • have a liver condition condition or troublesome side effects in which case your • suffer from neuronal disorders that affect your blood doctor may reduce your dose to one 1 mg tablet twice pressure, bowel or sexual function (any neuropathy of daily. the autonomic nervous system) • have a hiatal hernia (herniation of an abdominal Tolterodine Tartrate is not recommended for children. organ) • ever experience decreased bowel movements or suffer The tablets are for oral use and should be swallowed from severe constipation (decreased gastro-intestinal whole. motility) Continued top of next column Continued over page BBBA5081

Tolterodine Tartrate 2mg Film-coated Tablets PIL - UK

approved for print/date Item number: BBBA5081 Colours Non Printing Colours 1. Black 1. Profile Originator: S.Anson Dimensions: 170 x 330 2. 2. Origination Date: 11.06.19 Min Body Text Size: 8pt Revision Date: 15-07-19 Supplier: Specifar S.A. 3. 3. Revised By: RH 4. 5. Proof Round Technical Date sent: 11.06.19 6. 03 Approval Date received: 28-06-19 [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 Duration of treatment Reporting of side effects Your doctor will tell you how long your treatment with If you get any side effects, talk to your doctor, Tolterodine Tartrate will last. Do not stop treatment pharmacist or nurse. This includes any possible side early because you do not see an immediate effect. Your effects not listed in this leaflet. You can also report side bladder will need some time to adapt. Finish the course effects directly via the Yellow Card Scheme at: of tablets prescribed by your doctor. If you have not www.mhra.gov.uk/yellowcard or search for MHRA Yellow noticed any effect by then, talk to your doctor. Card in the Google Play or Apple App Store. By reporting side effects you can help provide more The benefit of the treatment should be re-evaluated information on the safety of this medicine. after 2 or 3 months. If you take more Tolterodine Tartrate than you should 5 How to store Tolterodine Tartrate If you or somebody else takes too many tablets, contact Keep this medicine out of the sight and reach of your doctor or pharmacist immediately. children. If you forget to take Tolterodine Tartrate Do not use this medicine after the expiry date which is If you forget to take a dose at the usual time, take it as stated on the label/carton. The expiry date refers to the soon as you remember unless it is almost time for your last day of that month. next dose. In that case, omit the forgotten dose and No special precautions for storage. follow the normal dose schedule. Do not take a double dose to make up for a forgotten Do not throw away any medicines via wastewater or dose. household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will If you stop taking Tolterodine Tartrate help protect the environment. Always consult your doctor if you are thinking of stopping the treatment. If you have any further questions on the use of this 6 Contents of the pack and other information medicine, ask your doctor or pharmacist. What Tolterodine Tartrate contains The active substance in Tolterodine Tartrate 2mg tablets is 2mg of tolterodine tartrate, equivalent to 1.37mg of 4 Possible side effects tolterodine. Like all medicines, this medicine can cause side effects, The other ingredients are: Cellulose, microcrystalline, although not everybody gets them. calcium hydrogen phosphate dihydrate, sodium starch You should see your doctor immediately or go to the glycolate (Type B), magnesium stearate, silica colloidal casualty department if you experience symptoms of anhydrous angioedema, such as: Film coating: Opadry white 20A28334 consisting of: • swollen face, tongue or pharynx Hydroxypropyl cellulose (E463), hypromellose 3cP • difficulty to swallow (E464), talc (E5553b), titanium dioxide (E171). • hives and difficulty in breathing What Tolterodine Tartrate looks like and You should also seek medical attention if you experience contents of the pack a hypersensitivity reaction (severe allergic reaction) (for Tolterodine Tartrate 2mg film-coated tablets are white, example itching, rash, hives, difficulty breathing). This round, biconvex, film-coated tablets, bearing a breakline occurs uncommonly (may affect up to 1 in 100 people). on one side, having a diameter of 6.0mm approximately. Tell your doctor immediately or go to the casualty Tolterodine Tartrate 2 mg tablets are available in the department if you notice any of the following: following pack sizes: • chest pain, difficulty breathing or getting tired easily Blister packs containing; (even at rest), difficulty breathing at night, swelling of - 10 tablets the legs. - 20 tablets These may be symptoms of heart failure. This occurs - 28 tablets uncommonly (may affect up to 1 in 100 people). - 30 tablets - 56 tablets The following side effects have been observed during - 60 tablets treatment with Tolterodine Tartrate with the following - 100 tablets frequencies. Very common side effects (may affect more than 1 in Not all pack sizes may 10 people) are: be marketed. • Dry mouth • Headache Marketing Authorisation Holder Common side effects (may affect up to 1 in 10 people) Accord, Barnstaple, EX32 8NS, UK are: • Bronchitis Manufacturer • Dizziness, sleepiness, sensation of pins and needles in Specifar S.A., 1,28 Octovriou str., 123 51 Ag. Varvara, the fingers and toes Athens, Greece • Dry eyes, blurred vision • Vertigo • Palpitations This leaflet was last revised in June 2019 • Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in If you would like a the stomach or the intestine, vomiting • Dry skin leaflet with larger text, • Painful or difficult urination, inability to empty the please contact bladder • Tiredness, chest pain, extra fluid in the body causing 01271 385257. swelling (e.g. in the ankles) • Increased weight • Diarrhoea Uncommon side effects (may affect up to 1 in 100 people) are: • Allergic reactions • Nervousness • Increased heart rate, heart failure, irregular heartbeat • Heart burn • Memory impairment Additional reactions reported include severe allergic reactions, confusion, hallucinations, flushed skin, angioedema and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.

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Tolterodine Tartrate 2mg Film-coated Tablets PIL - UK