TOLTERODINE PHARMATHEN 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tolterodina Pharmathen 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

Read all of this leaflet carefully before you start taking 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Tolterodina Pharmathen and what is it used for
2. What you need to know before you take Tolterodina Pharmathen
3. How to take Tolterodina Pharmathen
4. Possible side effects

5 Storage of Tolterodina Pharmathen

1. Contents of the pack and further information

1. What is Tolterodina Pharmathen and what is it used for

The active substance of Tolterodina Pharmathen is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinics.

Tolterodina Pharmathen is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may experience:

• urge incontinence - you may leak urine before you can get to the toilet
• urgency - you may feel that you need to urinate immediately sometimes with little or no warning
• frequency - you may need to urinate more often than usual

2. What you need to know before you take Tolterodina Pharmathen

Do not takeTolterodina Pharmathen

• if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6)
• if you have difficulty passing urine (urinary retention)
• if you have an uncontrolled narrow-angle glaucoma (high pressure in the eye with loss of vision, which is not being treated)
• if you have myasthenia gravis (excessive weakness of the muscles)
• if you have severe ulcerative colitis (inflammation of the gut)
• if you have toxic megacolon (a very enlarged colon)

Warnings and precautions

Consult your doctor or pharmacist before taking Tolterodina Pharmathen:

• if you have difficulties in passing urine and/or a weak urine stream
• if you have a gastrointestinal disorder affecting the passage and/or digestion of food, such as severe constipation
• if you have kidney problems (renal insufficiency)
• if you have liver disease
• if you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any autonomic neuropathy)
• if you have a hiatal hernia (a hernia where part of the stomach slips up into the chest)
• if you have reduced bowel movements or severe constipation
• if you have a heart condition, such as:

• altered heart rhythm (ECG)
• slow heart rate (bradycardia)
• pre-existing heart conditions such as cardiomyopathy (weakness of the heart muscle), myocardial ischaemia (reduced blood flow to the heart), arrhythmia (abnormal heart rhythm), heart failure

• if you have low levels of potassium, calcium or magnesium in your blood

Consult your doctor or pharmacist before starting treatment with Tolterodina Pharmathen if you think any of these may apply to you.

Other medicines and Tolterodina Pharmathen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tolterodine, the active substance of Tolterodina Pharmathen, may interact with other medicines.

It is not recommended to use tolterodine in combination with:

• certain antibiotics (e.g. containing erythromycin and clarithromycin)
• medicines used for the treatment of fungal infections (e.g. containing ketoconazole and itraconazole)
• medicines for the treatment of HIV

Tolterodina Pharmathen should be used with caution when administered in combination with:

• certain medicines that affect the movement of food through the stomach and intestines (e.g. containing metoclopramide and cisapride)
• medicines for the treatment of irregular heartbeats (e.g. containing amiodarone, sotalol, quinidine and procainamide)
• other medicines with a similar mode of action to tolterodine (antimuscarinic properties) or medicines with an opposite mode of action to Tolterodina Pharmathen (cholinergic properties). The reduction in gastric motility produced by antimuscarinic agents may affect the absorption of other medicines. Consult your doctor if you are unsure.

Taking Tolterodina Pharmathen with food and drink

Tolterodina Pharmathen can be taken before, during or after a meal.

Pregnancy and breast-feeding

Pregnancy

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.

Breast-feeding

It is not known if tolterodine is excreted in breast milk. Tolterodina Pharmathen is not recommended during breast-feeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Tolterodina Pharmathen may make you feel dizzy, tired or affect your vision. If you experience any of these symptoms, do not drive or operate machinery.

Tolterodina Pharmathen contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Tolterodina Pharmathen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Tolterodina Pharmathen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The prolonged-release hard capsules are taken by mouth and should be swallowed whole.

Do not chew the capsules.

Adults:

The usual dose is one 4 mg prolonged-release hard capsule per day.

Patient with liver or kidney problems:

In patients with liver or kidney problems, your doctor may reduce the dose to 2 mg of tolterodine per day.

Use in children and adolescents:

Tolterodina Pharmathen is not recommended for use in children.

If you take more Tolterodina Pharmathen than you should

If you have taken too much Tolterodina Pharmathen, contact your doctor or pharmacist immediately or go to the nearest hospital casualty department. Take the medicine pack with you. Symptoms of overdose may include hallucinations, excitement, increased heart rate, dilated pupils and difficulty urinating or breathing normally.

If you forget to take Tolterodina Pharmathen

If you forget to take your dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and continue with your normal dose schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tolterodina Pharmathen

Your doctor will tell you how long you should take Tolterodina Pharmathen. Do not stop treatment early because you do not see an immediate effect. Your bladder needs time to adapt to this medicine. Complete the course of prolonged-release hard capsules as prescribed by your doctor. If you do not notice any effect, consult your doctor.

The benefit of treatment should be re-evaluated after 2-3 months of use. Always consult your doctor if you are thinking of stopping 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, this medicine can cause side effects, although not everybody gets them.

You should contact your doctor immediately or go to the casualty department if you experience symptoms of angioedema such as:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives and difficulty breathing

You should also seek medical attention if you experience a hypersensitivity reaction (e.g. itching, rash, hives and difficulty breathing). This occurs rarely (affects up to 1 in 100 people).

Tell your doctor immediately or go to the casualty department if you experience:

• chest pain, difficulty breathing or tiredness (even when resting), difficulty breathing at night, swelling of the legs

These may be symptoms of heart failure. This occurs rarely (affects up to 1 in 100 people).

The following side effects have been observed during treatment with tolterodine, with the following frequencies:

Very common side effects(may affect more than 1 in 10 people):

Common side effects(may affect up to 1 in 10 people):

Uncommon side effects(may affect up to 1 in 100 people):

Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach upset, vomiting, angioedema and dry skin, and disorientation. There have been reports of worsening of 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 the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolterodina Pharmathen

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 carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

HDPE bottle: the shelf-life after first opening is 200 days.

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 protect the environment.

6. Contents of the pack and further information

Composition of Tolterodina Pharmathen

• The active substance of Tolterodina Pharmathen 4 mg prolonged-release hard capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose.

Composition of the capsule: Indigo carmine (E132), titanium dioxide (E171) and gelatin.

Composition of the inner tablet coating: Ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer (1:1), propylene glycol.

Appearance and packaging

Tolterodina Pharmathen are prolonged-release hard capsules designed for once daily administration.

The 4 mg prolonged-release hard capsules of Tolterodina Pharmathen are blue opaque.

Tolterodina Pharmathen 4 mg prolonged-release hard capsules are available in the following pack sizes:

Blister packs of 7, 14, 28, 49, 56, 84 and 98 prolonged-release hard capsules.

Bottles of 30, 100 and 200 capsules

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Pharmathen S.A.,

6 Dervenakion str.,

15351 Pallini, Attiki,

Greece

Manufacturer

Pharmathen S.A.

6, Dervenakion Str.,

153 51 Pallini Attiki

Greece

or

Pharmathen International S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

or

Apotex Nederland B.V.

Archimedesweg 2

2333 CN Leiden

Netherlands

Date of last revision of this leaflet: November 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).