Package Insert: Information for the User

Tolterodine Neo Combix 4 mg Extended-Release Hard Capsules EFG

Tolterodine Tartrate

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

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

1. What is Tolterodine Neo Combix and how is it used

2. What you need to know before starting to take Tolterodine Neo Combix

3. How to take Tolterodine Neo Combix

4. Possible adverse effects

5. Storage of Tolterodine Neo Combix

6. Contents of the package and additional information

The active ingredient of Tolterodina Neo Combix is tolterodina. Tolterodina is a drug that belongs to the group of medications known as antimuscarinics.

Tolterodina Neo Combix is used for the treatment of 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 increase the number of times you urinate during the day.

Do not takeTolterodina Neo Combix if:

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

Warnings and precautions

Be especially careful with Tolterodina Neo Combix

• If you have difficulty urinating and/or weak or slow urine flow.
• 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 neurological disorders that affect your blood pressure, intestinal function, or sex (any autonomic nervous system neuropathy).
• If you have hiatal hernia (hernia in an abdominal organ).
• If you ever notice a decrease in intestinal movement or have severe constipation (gastrointestinal motility decrease).
• If you have a relevant heart disease, such as:
• • Abnormal heart rhythm (ECG)
  • Slowed heart rate (bradycardia)
  • Pre-existing heart diseases, such as:
  • • Cardiomyopathy (heart muscle weakness)
    • Myocardial ischemia (decreased blood flow to the heart)
    • Arrhythmia (alteration of 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.

Tolterodina Neo Combix interactions with other medications

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

Tolterodina, the active ingredient in Tolterodina Neo Combix, may interact with other medications.

Tolterodina should not be used in combination with:

• Some antibiotics (containing, for example, erythromycin and clarithromycin).
• Medications used to treat fungal infections (containing, for example, ketoconazole and itraconazole).
• Medications used to treat HIV.

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

• Some medications that affect food transit (containing, for example, metoclopramide and cisapride).
• Medications used to treat irregular heart rhythm (containing, for example, amiodarone, sotalol, quinidine, and procainamide).
• Other medications with a similar mode of action to tolterodina (antimuscarinic properties) or medications with an opposite mode of action to tolterodina (cholinergic properties). The reduction of gastric motility caused by antimuscarinics may affect the absorption of other medications. Consult your doctor if unsure.

Tolterodina Neo Combix with food, drink, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

The excretion of tolterodina in breast milk is unknown. Tolterodina Neo Combix is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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 a certain sugar intolerance, consult with them before taking this medication.

Recommended Dose:

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Adults

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

Patients with liver or kidney problems

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

Children

Tolterodina Neo Combix is not recommended for use 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The symptoms of an overdose include hallucinations, excitement, rapid heartbeat, dilated pupils, and inability to urinate or breathe normally.

If you forgot to takeTolterodina Neo Combix

If you forgot 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, omit the missed dose and continue with your regular schedule.

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

If you interrupt treatment with Tolterodina Neo Combix

Your doctor will indicate the duration of treatment with Tolterodina Neo Combix. Do not stop treatment because you do not observe an immediate effect. Your bladder needs time to adapt to this.

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 questions about the use of this medication, ask your doctor or pharmacist.

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

You should consult your doctor immediately or go to the emergency service 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 an allergic reaction (for example: itching, rash, urticaria, and difficulty breathing). This occurs with low frequency (affects up to 1 in 100 people).

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

• Chest pain, difficulty breathing, or fatigue (even at rest), difficulty breathing at night, leg inflammation.

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

The following side effects have been observed during treatment with tolterodina with the following frequencies.

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

• Dry mouth

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

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

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and skin dryness and disorientation. Cases of worsening dementia symptoms in patients being treated for dementia have been reported.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

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

Do not store at a temperature above30°C.

Do not use Tolterodina Neo Combix after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines that you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Tolterodina Neo Combix

The active ingredient 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), hydroxypropylmethylcellulose (E464), capsule (indigo carmine -E132-, titanium dioxide -E171-, gelatin), coating agent (ethylcellulose -E462-, triethyl citrate -E1505-, copolymer of methacrylic acid-ethyl acrylate, 1,2-propylene glycol -E1520-).

Appearance of the product and contents of the packaging

Hard gelatin capsules of light blue color containing 4 white, round, and biconvex coated tablets.

PVC/PE/PVDC-Aluminum blisters.

Packages containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz, 2. Building 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: December 2016

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/