TOLTERODINE NEO SANDOZ 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tolterodine Neo Sandoz 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

1. What is Tolterodine Neo Sandoz and what is it used for
2. What you need to know before you take Tolterodine Neo Sandoz
3. How to take Tolterodine Neo Sandoz
4. Possible side effects
5. Storage of Tolterodine Neo Sandoz
6. Contents of the pack and other information

1. What is Tolterodine Neo Sandoz and what is it used for

The active substance of Tolterodine Neo Sandoz is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinics.

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

• that you are not able to control urination,
• a sudden and urgent need to urinate, and/or that you need to urinate more often during the day.

2. What you need to know before you take Tolterodine Neo Sandoz

Do not take Tolterodine Neo Sandoz

• if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6),
• if you are unable to empty your bladder (urinary retention),
• if you have uncontrolled narrow-angle glaucoma (high eye pressure with loss of vision, which is not being treated),
• if you have myasthenia gravis (excessive weakness in the muscles),
• if you have severe ulcerative colitis (ulceration and inflammation in the colon),
• if you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have difficulty emptying your bladder and/or a weak urine stream,
• if you have a gastrointestinal disorder which affects the passage and/or digestion of food,
• if you have kidney problems (renal insufficiency),
• if you have liver disease,
• if you have autonomic neuropathy (a condition which affects the nerves that supply the internal organs),
• if you have hiatal hernia (a condition where part of the stomach slips through a tear in the diaphragm),
• if you have decreased gastrointestinal motility (a condition where the movement of food through the digestive tract is slowed),
• if you have any significant cardiac disease, such as:
• • altered cardiac rhythm (ECG),
  • slow heart rate (bradycardia),
  • pre-existing heart diseases such as cardiomyopathy (weakness in the heart muscle), myocardial ischaemia (reduced blood flow to the heart), arrhythmia (abnormal heart rhythm), heart failure,
• if your potassium levels in the blood are abnormally low (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia).

Consult your doctor or pharmacist before starting to take Tolterodine Neo Sandoz if you think any of these conditions apply to you.

Taking Tolterodine Neo Sandoz with other medicines

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

Tolterodine, the active substance of Tolterodine Neo Sandoz, may interact with other medicines.

It is not recommended to use tolterodine in combination with:

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

Tolterodine should be used with caution when administered in combination with:

• certain medicines which affect the passage of food (e.g. metoclopramide and cisapride),
• medicines for the treatment of irregular heart rhythm (e.g. amiodarone, sotalol, quinidine and procainamide), other medicines which have a similar mode of action to tolterodine (antimuscarinic properties) or medicines which have an opposite mode of action to tolterodine (cholinergic properties).

The reduction of gastric motility caused by antimuscarinics may affect the absorption of other medicines. Consult your doctor if you are unsure.

Using Tolterodine Neo Sandoz with food and drink

Tolterodine Neo Sandoz can be taken before, during or after a meal.

Pregnancy and breast-feeding

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.

Pregnancy

Do not take Tolterodine Neo Sandoz if you are pregnant. Inform your doctor immediately if you are pregnant or think you might be or if you are planning to become pregnant.

Breast-feeding

It is not known if tolterodine is excreted in breast milk. Breast-feeding is not recommended during treatment with Tolterodine Neo Sandoz.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Tolterodine Neo Sandoz may make you feel dizzy, tired or affect your vision; your ability to drive or operate machinery may be affected.

Tolterodine Neo Sandoz contains lactose and sodium

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

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

3. How to take Tolterodine Neo Sandoz

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

The prolonged-release hard capsules are taken orally and should be swallowed whole. Do not chew the capsules.

Adults

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

Patients with liver or kidney problems

In patients with liver or kidney problems, your doctor may reduce your dose to one 2 mg capsule per day.

Children

Tolterodine is not recommended for use in children.

If you take more Tolterodine Neo Sandoz than you should

If you or anyone else has taken too many prolonged-release hard capsules, contact your doctor or pharmacist immediately. Symptoms of overdose include: hallucinations, excitement, rapid heart rate, dilated pupils and inability to urinate or breathe normally.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Tolterodine Neo Sandoz

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time for the next dose. In this case, wait and take the next dose at the usual time. Continue taking the capsules as your doctor has told you.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Tolterodine Neo Sandoz

Your doctor will tell you how long you should take Tolterodine Neo Sandoz. Do not stop treatment early if you do not see an immediate effect. Your bladder needs time to adapt to this. Finish the treatment with the 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 reassessed 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 if you experience symptoms of angioedema such as:

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

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

Tell your doctor or pharmacist if you experience:

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

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

The following side effects have been observed during treatment with Tolterodine Neo Sandoz with the following frequencies:

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

• dry mouth.

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

• sinusitis,
• drowsiness,
• dry eyes,
• difficulty digesting food (dyspepsia),
• abdominal pain,
• difficulty or pain when urinating,
• swelling due to fluid accumulation (e.g. in the ankles),
• dizziness,
• headache,
• blurred vision,
• constipation,
• excessive air or gas in the stomach or intestine,
• diarrhoea,
• fatigue.

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

• allergic reactions,
• nervousness,
• palpitations,
• inability to empty the bladder,
• vertigo,
• heart failure,
• irregular heart rhythm,
• chest pain,
• finger or toe cramps,
• memory impairment.

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

5. Storage of Tolterodine Neo Sandoz

Keep this medicine out of the sight and reach of children.

Do not use Tolterodine Neo Sandoz after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Shelf-life after first opening:

HDPE bottle: 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 to protect the environment.

6. Contents of the pack and other information

Composition of Tolterodine Neo Sandoz

• The active substance is tolterodine tartrate. Each hard capsule contains 4 mg of tolterodine tartrate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, colloidal anhydrous silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose, indigo carmine (E132), titanium dioxide (E171), gelatin, ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer (1:1) and 1,2-propylene glycol.

Appearance and packaging

Light blue opaque hard capsules containing four white, round and biconvex coated tablets.

The prolonged-release hard capsules are packaged in Alu/PVC/PE/PVDC blisters or HDPE bottles with a child-resistant closure, in a cardboard box.

Package sizes:

Blisters of 7, 14, 28, 30, 49, 50, 56, 60, 80, 84, 90, 98, 100, 112, 160, 280, 320 prolonged-release hard capsules.

HDPE bottles of 30, 60, 100 and 200 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Pharmaten, S.A.

6, Dervenakion Str., 153 51

Pallini, Attiki

Greece

Or

Pharmathen International S.A.

Sapes Industrial Park Block 5,

69300 Rodopi

Greece

Salutas Pharma GmbH

Otto-von-Guericke Allee 1,

39179, Barleben

Germany

or

Lek Pharmaceuticals dd

Verovskova 57,

1526 Ljubljana

Slovenia

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Tolterodin - 1 A Pharma 4 mg Hartkapseln, retardiert

Belgium: Tolterodin Sandoz 4 mg capsules met verlengde afgifte, hard

Denmark: Tolterodine “Sandoz”

Finland: Tolterodine Sandoz 4 mg, depotkapselit, kovat

United Kingdom: Inconex XL 4 mg, Prolonged-release Capsules, hard

Greece: Tolterodine/Sandoz 4 mg, καψ?κια παρατεταμ?νης αποδ?σμευσης, σκληρ?

Netherlands: Tolterodinetartraat Sandoz retard 4 mg, harde capsules met verlengde afgifte

Ireland: Tolusitol 4 mg Prolonged-Release Capsules, Hard

Iceland: Tolterodine Sandoz 4 mg, forðahylki, hörð

Malta: Inconex XL 4mg, prolonged release capsules, hard

Norway: Tolterodine Sandoz 4 mg depotkapsler, harde

Sweden: Tolterodine Sandoz 4 mg, depotkapslar, hårda

This leaflet was approved in March 2020