Tolterodine Neo Combix 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tolterodine Neo Combix 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 as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet:

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

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

The active substance in Tolterodine Neo Combix is tolterodine. Tolterodine is a medicine that belongs to a group of medicines called antimuscarinics.

Tolterodine 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 voluntarily control your urine
• you experience a sudden and urgent need to urinate without prior warning and/or an increased number of times you urinate during the day.

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

Do not take Tolterodine Neo Combix if:

• you are allergic to tolterodine or to any of the other components of Tolterodine Neo Combix (listed in section 6).
• you are unable to empty urine from the bladder (urinary retention).
• you have uncontrolled narrow-angle glaucoma (increased intraocular pressure with visual field loss that is not being adequately treated).
• you have myasthenia gravis (excessive muscle weakness).
• you suffer from severe ulcerative colitis (ulceration and inflammation in the colon).
• you suffer from toxic megacolon (acute dilation of the colon).

Warnings and precautions

Take special care with Tolterodine Neo Combix

• if you have difficulty passing urine and/or have a weak or slow urinary stream.
• if you have a gastrointestinal disorder affecting the passage and/or digestion of food.
• if you have kidney problems (renal insufficiency).
• if you have liver disease.
• if you suffer from neurological disorders affecting your blood pressure, intestinal or sexual function (any neuropathy of the autonomic nervous system).
• if you have hiatal hernia (herniation of an abdominal organ).
• if you ever notice reduced intestinal movement or suffer from severe constipation (decreased gastrointestinal motility).
• if you have a significant heart condition such as:
  • abnormal heart rhythm (ECG)
  • slow heart rate (bradycardia)
  • pre-existing heart diseases such as:
    • cardiomyopathy (weakening of the heart muscle)
    • myocardial ischemia (reduced blood flow to the heart)
    • arrhythmia (irregular 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 Tolterodine Neo Combix if you think any of these situations may apply to you.

Interaction of Tolterodine Neo Combix with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Tolterodine, the active substance in Tolterodine Neo Combix, may interact with other medicines.

The use of tolterodine in combination is not recommended with:

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

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

• certain medicines affecting gastrointestinal transit (containing e.g.: metoclopramide and cisapride).
• medicines for the treatment of irregular heart rhythm (containing e.g.: 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 tolterodine (cholinergic properties). The reduction in gastric motility caused by antimuscarinics may affect the absorption of other medicines. Consult your doctor if you are unsure.

Tolterodine Neo Combix with food, drink and alcohol

Tolterodine Neo Combix may be taken before, during or after a meal.

Pregnancy and breastfeeding

Pregnancy

You must not use Tolterodine 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 unknown whether tolterodine is excreted in breast milk. The use of Tolterodine Neo Combix during breastfeeding is not recommended.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Tolterodine Neo Combix may cause dizziness, tiredness, or affect your vision; your ability to drive or operate machinery may be impaired.

Tolterodine Neo Combix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tolterodine Neo Combix

Recommended dose:

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Prolonged-release hard capsules are taken orally and must be swallowed whole. Do not chew the capsules.

Adults

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

Patients 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 Tolterodine Neo Combix is not recommended in children.

If you take more Tolterodine Neo Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose include hallucinations, excitement, increased heart rate, dilated pupils, and inability to urinate or breathe normally.

If you forget to take Tolterodine Neo Combix

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 that case, skip the missed dose and continue with your regular schedule.

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

If you stop taking Tolterodine Neo Combix

Your doctor will advise you on the duration of treatment with Tolterodine Neo Combix. Do not discontinue treatment because you do not observe an immediate effect. Your bladder needs time to adapt to it. Complete the course of prolonged-release capsules as prescribed by your doctor. If you notice no improvement, consult your doctor.

The benefit of treatment should be re-evaluated after 2–3 months of use. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Tolterodina Neo Combix may produce adverse 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

You should also seek medical attention if you experience a hypersensitivity reaction (for example: itching, rash, hives, and difficulty breathing). These occur infrequently (affecting 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 infrequently (affecting up to 1 in 100 people).

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

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

• Dry mouth

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

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

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

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

5. Storage of Tolterodine Neo Combix

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use Tolterodine Neo Combix after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

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

Appearance of the product and contents of the container

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

PVC/PE/PVDC-Aluminum blisters.

Packaging 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 most recent review of this leaflet: December 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/