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RELTID XL 4MG PROLONGED RELEASE CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Reltid XL 4mg Prolonged Release Capsules
Tolterodine tartrate
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you:

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
What is in this leaflet:
1.
What Reltid XL 4mg Prolonged Release Capsules are and what it they are used for
2.
Before you take Reltid XL 4mg Prolonged Release Capsules
3.
How to take Reltid XL 4mg Prolonged Release Capsules
4.
Possible side effects
5.
How to store Reltid XL 4mg Prolonged Release Capsules
6.
Further information

1. What Reltid XL 4mg Prolonged Release Capsules are and what they are used for
The active substance in Reltid XL 4mg Prolonged Release Capsules is tolterodine. Tolterodine
belongs to a class of medicinal products called antimuscarinics.
Reltid XL 4mg Prolonged Release Capsules are used for the treatment of the symptoms of
overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:

you are unable to control urination

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 Reltid XL 4mg Prolonged Release Capsules
Do not take Reltid XL 4mg Prolonged Release Capsules:

if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in
Reltid XL 4mg Prolonged Release Capsules (see section 6 for a list of the ingredients)

if you are unable to pass urine from the bladder (urinary retention)

if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with
loss of eyesight that is not being adequately treated)

if you suffer from myasthenia gravis (excessive weakness of the muscles)

if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
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if you suffer from a toxic megacolon (acute dilatation of the colon).

Take special care with Reltid XL 4mg Prolonged Release Capsules

If you have difficulties in passing urine and/or a poor stream of urine.

If you have a gastro-intestinal disease that affects the passage and/or digestion of food.

If you suffer from kidney problems (renal insufficiency).

If you have a liver condition.

If you suffer from neurological disorders that affect your blood pressure, bowel or
sexual function (any neuropathy of the autonomic nervous system).

If you have a hiatus hernia (herniation of an abdominal organ).

If you ever experience decreased bowel movements or suffer from severe
constipation (decreased gastro-intestinal motility).

If you 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),
myocardial ischaemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat)
and heart failure

If you have abnormally low levels of potassium (hypokalaemia), calcium
(hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.

Talk to your doctor or pharmacist before starting your treatment with Reltid XL 4mg Prolonged
Release Capsules if you think any of these might apply to you.
Other medicines and Reltid XL 4mg Prolonged Release Capsules
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Tolterodine, the active substance of Reltid XL 4mg Prolonged Release Capsules, may interact with
other medicinal products.
It is not recommended to use tolterodine in combination with:

some antibiotics (containing e.g. erythromycin, clarithromycin)

medicinal products used for the treatment of fungal infections (containing e.g.
ketoconazole, itraconazole)

medicinal products used for the treatment of HIV
Reltid XL 4mg Prolonged Release Capsules should be used with caution when taken in
combination with:

medicines that affect the passage of food (containing e.g. metoclopramide and
cisapride)

medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol,
quinidine, procainamide

other medicines with a similar mode of action to Reltid XL 4mg Prolonged Release Capsules
(antimuscarinic properties) or medicines with an opposite mode of action to Reltid XL 4mg
Prolonged Release Capsules (cholinergic properties). The reduction in gastric motility caused by
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antimuscarinics may affect the absorption of other drugs. Ask your doctor if you are unsure.
Taking Reltid XL 4mg Prolonged Release Capsules with food and drink
Reltid XL 4mg Prolonged Release Capsules can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use Reltid XL 4mg Prolonged Release Capsules w hen you are pregnant. Tell your
doctor immediately if you are pregnant, think you are pregnant or are planning to become
pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Reltid XL 4mg Prolonged Release Capsules,
is excreted in the mother’s breast milk. Breast-feeding is not recommended during
administration of Reltid XL 4mg Prolonged Release Capsules.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Reltid XL 4mg Prolonged Release Capsules may make you feel dizzy, tired or affect your sight.
If you experience any of these effects then you should not drive your car or operate heavy
machinery.
Reltid XL 4mg Prolonged Release Capsules contain 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.
3. How to take Reltid XL 4mg Prolonged Release Capsules
Dosage:
Always take Reltid XL 4mg Prolonged Release Capsules exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
The prolonged-release hard capsules are for oral use and should be swallowed whole.
Do not chew the capsules.
Adults:
The usual dose is one 4 mg prolonged-release hard capsule daily.
Patients with liver or kidney problems:
In patients with liver or kidney problems your doctor may reduce your dose to 2 mg Tolterodine
daily.
Children:
Reltid XL 4mg Prolonged Release Capsules are not recommended for children.
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If you have taken more Reltid XL 4mg Prolonged Release Capsules than you should:
If you or somebody else takes too many prolonged-release capsules, contact your doctor or
pharmacist immediately. Symptoms in case of overdose include hallucinations, excitation, a
heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.
If you forget to take Reltid XL 4mg Prolonged Release Capsules:
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.
Duration of treatment Your doctor will tell you how long your treatment with Reltid XL 4mg
Prolonged Release Capsules 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 prolongedrelease 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 any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Reltid XL 4mg Prolonged Release Capsules 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:

swollen face, tongue or pharynx

difficulty to swallow

hives and difficulty in breathing
You should also seek medical attention if you experience a hypersensitivity reaction (for
example itching, rash, hives, difficulty breathing). This occurs uncommonly (occurs in less than 1
in 100 patients).
Tell your doctor immediately or go to the casualty department if you notice any of the following:

chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing
at night, swelling of the legs.
These may be symptoms of heart failure. This occurs uncommonly (occurs in less than 1 in
100 patients).
The following side effects have been observed during treatment with Reltid XL 4mg Prolonged
Release Capsules with the following frequencies.
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Very common side effects (occurs in more than 1 in 10 patients) are:


Dry mouth

Common side effects (occurs in less than 1 in 10 patients) are:






Sinusitis
Sleepiness
Dry eyes
Difficulty with digestion
(dyspepsia)
Abdominal pain






Dizziness
Headache
Blurred vision
Constipation



excessive amounts of air or gases
in the stomach or the intestine
Diarrhoea
Tiredness




Painful or difficult urination

Extra fluid in the body causing •
swelling (e.g. in the ankles)
Uncommon side effects (occurs in less than 1 in 100 patients) are:





Allergic reactions
Nervousness
Palpitations
Inability to empty the bladder








Vertigo



Heart failure
Irregular heartbeat
Chest pain
Sensation of pins and needles in
the fingers and toes
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.
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.

5. How to store Reltid XL 4mg Prolonged Release Capsules
Keep Reltid XL 4mg Prolonged Release Capsules out of the reach and sight of children.
Do not use Reltid XL 4mg Prolonged Release Capsules after the expiry date which is stated on
the label/carton. The expiry date refers to the last day of that month.
Do not store above 25°C
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

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6. Further information
What Reltid XL 4mg Prolonged Release Capsules contains
The active substance in Reltid XL 4mg Prolonged Release Capsules, hard is 4 mg of tolterodine
tartrate, equivalent to 2.74 mg of tolterodine.
The other ingredients are:
Lactose monohydrate, cellulose microcrystalline, poly(vinyl acetate), povidone, silica, sodium
laurilsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose Capsule
composition: indigo carmine (E132), titanium dioxide (E171), gelatin
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate
copolymer, 1,2-Propylene glycol
What Reltid XL 4mg Prolonged Release Capsules looks like and contents of the pack
Reltid XL 4mg Prolonged Release Capsule is a hard prolonged-release capsule designed for once
daily dosing.
Reltid XL 4mg Prolonged Release Capsules are light blue-opaque-light blue opaque.

Reltid XL 4mg Prolonged Release Capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 49, 84, 98 prolonged-release capsules
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Pharmathen S.A
6, Dervenakion str.,
153 51 Pallini
Attiki, Greece
Manufacturer:
Pharmathen S.A
6, Dervenakion Str.,
153 51 Pallini Attiki
Greece
Pharmathen International S.A
Sapes Industrial Park
Block 5, 69300
Rodopi
Greece
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Portfarma ehf
Borgartúni 26,
105 Reykjavík
Iceland
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate,
Birzebbugia
BBG 3000
Malta

This leaflet was last revised in 06/2013

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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