TOLTERODINE NEO COMBIX 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tolterodina Neo Combix 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Tolterodina Neo Combix and what is it used for
2. What you need to know before taking Tolterodina Neo Combix
3. How to take Tolterodina Neo Combix
4. Possible side effects
5. Storage of Tolterodina Neo Combix
6. Package contents and additional information

1. What is Tolterodina Neo Combix and what is it used for

The active substance of Tolterodina Neo Combix is tolterodine. Tolterodine is a medication that belongs to the group of medications known as antimuscarinics.

Tolterodina Neo Combix is used to treat the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may notice that:

• you are unable to control urination voluntarily
• you feel a sudden and urgent need to urinate without prior warning and/or that you urinate more frequently during the day.

2. What you need to know before taking Tolterodina Neo Combix

Do not takeTolterodina Neo Combix if:

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

Warnings and precautions

Be particularly careful with Tolterodina Neo Combix

• if you have difficulty urinating and/or urinate with a weak or slow stream.
• if you have a gastrointestinal disorder that affects the passage and/or digestion of food.
• if you have kidney problems (renal insufficiency).
• if you have liver disease.
• if you have neuronal disorders that affect your blood pressure, intestinal function, or sexual function (any autonomic nervous system neuropathy).
• if you have a hiatal hernia (hernia in an abdominal organ).
• if you ever notice a decrease in bowel movements or have severe constipation (decreased gastrointestinal motility).
• if you have significant heart disease, such as:
• • abnormal heart rhythm (ECG)
  • slow heart rate (bradycardia)
  • pre-existing heart diseases, such as:
  • • cardiomyopathy (heart muscle weakness)
    • myocardial ischemia (decreased blood flow to the heart)
    • arrhythmia (abnormal heart rhythm)
    • heart failure.
• if you have abnormally low blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

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

Interaction ofTolterodina Neo Combixwith other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Tolterodine, the active substance of Tolterodina Neo Combix, may interact with other medications.

The use of tolterodine in combination with the following is not recommended:

• certain antibiotics (containing, for example, erythromycin and clarithromycin).
• medications used to treat fungal infections (containing, for example, ketoconazole and itraconazole).
• medications for the treatment of HIV.

Tolterodina Neo Combix should be used with caution when administered in combination with:

• certain medications that affect food transit (containing, for example, metoclopramide and cisapride).
• medications for the treatment of irregular heart rhythm (containing, for example, amiodarone, sotalol, quinidine, and procainamide).
• other medications that have a similar mode of action to tolterodine (antimuscarinic properties) or medications that have an opposite mode of action to tolterodine (cholinergic properties). The reduction in gastric motility caused by antimuscarinics may affect the absorption of other medications. Consult your doctor if you are unsure.

Tolterodina Neo Combixwith food, drink, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should not use Tolterodina Neo Combix if you are pregnant. Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding

It is not known whether tolterodine is excreted in breast milk. The use of Tolterodina Neo Combix is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Tolterodina Neo Combix may make you feel dizzy, tired, or affect your vision; your ability to drive or operate machinery may be impaired.

Tolterodina Neo Combix contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Tolterodina Neo Combix

Recommended dose:

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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.

Patient with liver or kidney problems

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

Children

The use of Tolterodina Neo Combix is not recommended in children.

If you take moreTolterodina Neo Combixthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

The symptoms of an overdose include hallucinations, excitement, accelerated heart rate, dilated pupils, and inability to urinate or breathe normally.

If you forget to takeTolterodina Neo Combix

If you forget to take the dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with the usual schedule.

Do not take a double dose to make up for missed doses.

If you stop taking Tolterodina Neo Combix

Your doctor will indicate the duration of treatment with Tolterodina Neo Combix. Do not stop treatment because you do not see an immediate effect. Your bladder needs time to adapt to it. Finish the treatment with the prolonged-release capsules prescribed by your doctor. If you do not notice any effect, consult your doctor.

The benefit of treatment should be reevaluated after 2-3 months of use. Always consult your doctor if you are thinking of stopping treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Tolterodina Neo Combix can cause side effects, although not everyone will experience them.

You should consult your doctor immediately or go to the emergency department if you experience symptoms of angioedema, such as:

• Swelling of the face, tongue, or pharynx
• Difficulty swallowing
• Hives and difficulty breathing

In addition, you should 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).

Inform your doctor or go to the emergency department if you experience:

• Chest pain, difficulty breathing, or fatigue (even at rest), 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):

• Dry mouth

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, skin redness, stomach burning, vomiting, angioedema, and dry skin, as well as disorientation. There have been reports of worsening symptoms of dementia in patients being treated for dementia.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Tolterodina Neo Combix

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

Do not store above 30°C.

Do not use Tolterodina Neo Combix after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofTolterodina Neo Combix

The active substance is tolterodine tartrate. Each capsule contains 4 mg of tolterodine tartrate (equivalent to 2.74 mg of tolterodine).

The other components are: lactose monohydrate, microcrystalline cellulose (E460i), polyvinyl acetate, sodium docusate (E470a), magnesium stearate (E470b), hypromellose (E464), capsule (indigo carmine -E132-, titanium dioxide -E171-, gelatin), coating agent (ethyl cellulose -E462-, triethyl citrate -E1505-, methacrylic acid-ethyl acrylate copolymer, 1,2-propylene glycol -E1520-).

Appearance of the product and package contents

Light blue hard gelatin capsules containing 4 white, round, and biconvex coated tablets.

PVC/PE/PVDC-Aluminum blisters.

Packages containing 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Pharmaten S.A.

Dervenakion 6

Pallini 15351

Attiki

Greece

or

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Date of the last revision of this package leaflet: December 2016

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