Patient leaflet - Fesoterodine DR. Reddys 8 mg prolonged-release tablets, Teraleve 8 mg prolonged-release tablets
1. What TERALEVE is and what it is used for
- trouble digesting food (dyspepsia)
2. What you need to know before you take TERALEVE
- straining or pain when emptying the bladder (dysuria)
3. How to take TERALEVE
- dizziness
4. Possible side effects
- headache
5. How to store TERALEVE
- pain in the stomach
6. Contents of the pack and other information
- diarrhoea
- feeling sick (nausea)
- What TERALEVE is and what it is used for
- difficulty sleeping (insomnia)
- dry throat
TERALEVE contains an active substance called fesoterodine fumarate, and is a so called antimuscarinic treatment which reduces the activity of an overactive bladder and it is used in adults to treat the symptoms.
Uncommon (may affect up to 1 in 100 people)
- urinary tract infection
TERALEVE treats the symptoms of an overactive bladder such as:
- sleepiness (somnolence)
- not being able to control when you empty your bladder (called urgency incontinence)
- difficulty tasting (dysgeusia)
- suddenly needing to empty your bladder (called urgency)
- vertigo
- having to empty your bladder more often than usual (called increased urinary frequency).
- rash
- What you need to know before you take TERALEVE
- dry skin
- itching
Do not take TERALEVE
- an uncomfortable feeling in the stomach
- if you are allergic to fesoterodine or to peanut or soya or to any of the other ingredients of TERALEVE (listed in
- wind (flatulence)
section 6) (see section 2, “Fesoterodine contains lactose and glycerol”)
- difficulty in completely emptying the bladder (urinary retention)
- if you are not able to completely empty your bladder (urinary retention)
- delay in passing urine (urinary hesitation)
- if your stomach empties slowly (gastric retention)
- extreme tiredness (fatigue)
- if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not under control
- increased heart beat (tachycardia)
- if you have excessive weakness of the muscles (myasthenia gravis)
- palpitations
- if you have ulceration and inflammation of the colon (severe ulcerative colitis)
- liver problems
- if you have an abnormally large or distended colon (toxic megacolon)
- cough
- if you have severe liver problems
- nasal dryness
- if you have kidney problems or moderate to severe liver problems and are taking medicines containing any of the
- throat pain
following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and nefazodone (used to treat depression).
- stomach acid reflux
- blurred vision
Rare (may affect up to 1 in 1,000 people)
Warnings and precautions
- urticaria
TERALEVE may not always be suitable for you. Talk to your doctor before taking TERALEVE, if any of the following apply to you:
- confusion
Reporting of side effects
if you have difficulties in completely emptying your bladder (for example due to prostate enlargement)
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 the Yellow Card Scheme website 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.
- if you ever experience decreased bowel movements or suffer from severe constipation
- if you are being treated for an eye disease called narrow angle glaucoma
- if you have serious kidney or liver problems, your doctor may need to adjust your dose
if you have a disease called autonomic neuropathy which you notice from symptoms such as changes in your blood
pressure or disorders in the bowel or sexual function
if you have a gastrointestinal disease that affects the passage and/or digestion of food
- 5. How to store TERALEVE
if you have heartburn or belching
Keep this medicine out of the sight and reach of children.
if you have an infection of the urinary tract, your doctor may need to prescribe some antibiotics.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”. The expiry date refers to the last day of that month.
Heart problems: Talk to your doctor if you suffer from any of the following conditions:
you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause
this
TERALEVE 4 mg:
you have a slow heart rate (bradycardia)
Do not store above 30°C.
you suffer from heart disease such as myocardial ischaemia (reduced blood flow to the heart muscle), irregular
Store in the original package in order to protect from moisture.
heartbeat or heart failure
TERALEVE 8 mg:
you have hypokalaemia, which is a manifestation of abnormally low levels of potassium in your blood.
This product does not require any special temperature storage conditions.
Children and adolescents
Store in the original package in order to protect from moisture.
Do not give this medicine to children and adolescents below 18 years of age because it is yet to be established whether it would work for them and whether it would be safe.
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 protect the environment.
Other medicines and TERALEVE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you whether you can take TERALEVE with other medicines.
- 6. Contents of the pack and other information
What TERALEVE Tablet contains
Please inform your doctor if you are taking medicines according to the following list. Taking them at the same time as TERALEVE may make side effects such as dry mouth, constipation, difficulty in completely emptying your bladder or drowsiness more serious or occur more often.
The active substance is fesoterodine fumarate.
TERALEVE 4 mg:
Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
- medicines containing the active substance amantadine (used to treat Parkinson’s disease)
certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm and to prevent travel
TERALEVE 8 mg:
sickness like medicines containing metoclopramide
Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
certain medicines used to treat psychiatric diseases, like anti-depressives and neuroleptics.
The other ingredients are:
Please also inform your doctor if you are taking any of the following medicines:
Tablet core: glycerol dibehenate, hypromellose, talc, lactose monohydrate, celullose, microcrystalline. Coating: poly(vinyl alcohol), talc, titanium dioxide, glycerol monocaprylocaprate, sodium laurilsulfate, indigo carmine aluminum lake.
medicines containing any of the following active substances may increase the break-down of fesoterodine and thus
decrease its effect: St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
TERALEVE 8 mg: iron oxid red
medicines containing any of the following active substances may increase the blood levels of fesoterodine: itraconazole
or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used for smoking cessation or to treat depression), quinidine (used to treat arrhythmias) and cinacalcet (used to treat hyperparathyroidism)
What TERALEVE Tablet looks like and the contents of the pack
TERALEVE 4 mg prolonged-release tablets are light blue, oval, biconvex, film-coated tablets with dimensions approximately 13 mm by 6 mm, and engraved on one side with the number ‘4’.
TERALEVE 8 mg prolonged-release tablets are blue, oval, biconvex, film-coated tablets with dimensions approximately 13 mm by 6 mm, and engraved on one side with the number ‘8’.
medicines containing the active substance methadone (used in the treatment of severe pain and abuse problems).
Brand: Dr Reddy’s
Pregnancy and breast-feeding
TERALEVE is available in OPA/Alu/PVC-Alu packs of 7, 14, 28, 30, 56, 84, 98 and 100 prolonged-release tablets.
You should not take TERALEVE if you are pregnant, as the effects of fesoterodine on pregnancy and the unborn baby are not known.
TERALEVE_Fesoterodine
Product Name:
Please note that not all the above pack sizes may be marketed.
Strength:
4 & 8 mg
Marketing Authorisation Holder
It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with TERALEVE.
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom
Film-Coated Tablets
Form:
Manufacturer
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Rontis Hellas, Medical and Pharmaceutical Products S.A, Sorou 38, Maroussi, Attiki, 15125, Greece
Leaflet
Driving and using machines
Pack Size:
This leaflet was last revised in February 2021.
28’s
TERALEVE can cause blurred vision, dizziness, and sleepiness. If you experience any of these effects, do not drive or use any tools or machines.
Country:
UK
TERALEVE contains lactose, glycerol and sodium
Date Created:
08/10/2020
TERALEVE contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
11/03/2021
Date Modified:
TERALEVE contains glycerol which may cause headache, stomach upset and diarrhea.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
- 3. How to take TERALEVE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended starting dose of TERALEVE is one 4 mg tablet a day. Based on how you respond to the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.
You should swallow your tablet whole with a glass of water. Do not chew the tablet. TERALEVE can be taken with or without food.
9 pt
Rontis
To help you remember to take your medicine, you may find it easier to take it at the same time every day.
Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK Dimensions:
If you take more TERALEVE than you should
Project:
NPL
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice immediately. Show them your pack of tablets.
If you forget to take TERALEVE
Process Black
If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than one tablet in one day. Do not take a double dose to make up for a forgotten tablet.
If you stop taking TERALEVE
Do not stop taking TERALEVE without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking fesoterodine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
PC XXXX PC XXXX
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