Tolterodine Neo Kern Pharma 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tolterodine Neo KERN PHARMA 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

Read the entire 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 or pharmacist.
• 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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

1. What Tolterodine Neo Kern Pharma is and what it is used for

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

Tolterodine Neo Kern Pharma 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 urination
• 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 Kern Pharma

Do not take Tolterodine Neo Kern Pharma

• If you are allergic (hypersensitive) to the active substance tolterodine or to any of the other ingredients of this medicine (listed in section 6).
• If you are unable to empty urine from the bladder (urinary retention).
• If you have uncontrolled narrow-angle glaucoma (increased intraocular pressure with visual field loss, not adequately treated).
• If you have myasthenia gravis (excessive muscle weakness).
• If you have severe ulcerative colitis (ulceration and inflammation of the colon).
• If you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

• 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 a liver disease.

• If you suffer from neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic neuropathy).

• If you have hiatal hernia (herniation of an abdominal organ).

• If you ever notice reduced intestinal movements or suffer from severe constipation (decreased gastrointestinal motility).

• If you have a significant heart condition such as:

• abnormal heart recording (ECG)

• slow heart rate (bradycardia)

• pre-existing heart diseases such as:

• cardiomyopathy (weakness 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, pharmacist, or nurse before starting to take Tolterodine Neo Kern Pharma.

Use of Tolterodine Neo Kern Pharma with other medicines

Tolterodine, the active ingredient in Tolterodine Neo Kern Pharma, may interact with other medicines.

The use of tolterodine is not recommended in combination 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 Kern Pharma should be used with caution when administered in combination with:

• certain medicines affecting food 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 Neo Kern Pharma (antimuscarinic properties) or medicines with an opposite mode of action to Tolterodine Neo Kern Pharma (cholinergic properties). Consult your doctor if you are unsure.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Use of Tolterodine Neo Kern Pharma with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

You must not use Tolterodine Neo Kern Pharma if you are pregnant.

It is unknown whether tolterodine is excreted in breast milk. The use of Tolterodine Neo Kern Pharma is not recommended during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Tolterodine Neo Kern Pharma contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Tolterodine Neo Kern Pharma

Follow exactly the instructions for administration of this medicine as given by your doctor.

If in doubt, please consult your doctor or pharmacist again.

The recommended dose is one 4 mg capsule daily, except in patients with hepatic or renal disease, or those experiencing bothersome side effects, in which case your doctor may reduce your dose to one 2 mg capsule daily.

Your doctor will determine the duration of your treatment with Tolterodine Neo Kern Pharma. The benefit of treatment should be re-evaluated after 2-3 months of use.

Tolterodine Neo Kern Pharma is taken orally. The capsules must be swallowed whole. Do not chew the capsules.

Use in children and adolescents

Tolterodine Neo Kern Pharma is not recommended for use in children.

If you take more Tolterodine Neo Kern Pharma than you should

If you or anyone takes too many prolonged-release capsules, contact your doctor or pharmacist immediately.

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 medicine and the amount ingested.

If you forget to take Tolterodine Neo Kern Pharma

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. In this case, continue taking the capsules as directed by your doctor.

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

If you stop taking Tolterodine Neo Kern Pharma

Do not stop treatment prematurely if you do not observe an immediate effect, as your bladder needs time to adapt. Complete the course of prolonged-release capsules as prescribed by your doctor. If you notice no effect, consult your doctor.

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

4. Possible adverse effects

Like all medicines, Tolterodina Neo Kern Pharma can cause adverse effects, although not everyone experiences them.

You should consult your doctor immediately if you notice 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 (for example: itching, rash, urticaria and breathing difficulty). This occurs infrequently (up to 1 in 100 patients).

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 (up to 1 in 100 patients).

The following adverse effects have been observed during treatment with Tolterodina Neo Kern Pharma, with the frequencies listed below.

Very common adverse effects (occurring in more than 1 out of 10 patients) are:

• Dry mouth.
• Headache.

Common adverse effects (occurring in up to 1 out of 10 patients) are:

• Sinusitis.
• Dizziness, somnolence, headache.
• Dry eyes, blurred vision.
• Difficulty in digestion (dyspepsia), constipation, abdominal pain, excessive air or gas in the stomach or intestines.
• Pain or difficulty when urinating.
• Fatigue.
• Swelling due to fluid accumulation (e.g., in the ankles).
• Diarrhea.

Uncommon adverse effects (occurring in up to 1 in 100 patients) are:

• Allergic reactions.
• Nervousness.
• Pins and needles in the fingers and toes.
• Dizziness.
• Palpitations, heart failure, irregular heartbeat.
• Inability to empty the bladder.
• Chest pain.
• Memory impairment.

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

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

5. Storage of Tolterodine Neo Kern Pharma

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

Store below 30°C.

Do not use this medicine 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 containers and medicines at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tolterodine Neo Kern Pharma

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

• The other components are microcelac (lactose monohydrate and microcrystalline cellulose (E 460 i)), polyvinyl acetate, povidone (E 1201), sodium lauryl sulfate, silica, hypromellose (E 464), sodium docusate, magnesium stearate (E 470 b), ethylcellulose (E 462), triethyl citrate (E 1505), methacrylic acid and ethyl acrylate copolymer (1:1), and propylene glycol (E 1520). The components of the capsule shell are gelatin (E 441), indigo carmine (E 132), and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Tolterodine Neo Kern Pharma are prolonged-release capsules intended for once-daily administration.

The 4 mg prolonged-release hard capsules are blue in colour.

Each pack contains 28 prolonged-release capsules, packed in PVC/PE/PVDC/Aluminium blisters.

Marketing Authorization Holder

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Athens (Greece)

Or

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300 (Greece)

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus, 72, 08228, Terrassa, Barcelona

Date of the most recent review of this leaflet: July 2012

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/.