Leaflet: information for the user

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

Tolterodine tartrate

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

2. What you need to know before starting to take Tolterodina Neo Kern Pharma

3. How to take Tolterodina Neo Kern Pharma

4. Possible side effects

5. Storage of Tolterodina Neo Kern Pharma

6. Contents of the pack and additional information

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

Tolterodina Neo Kern Pharma 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 your urine 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 take Tolterodina Neo Kern Pharma

• If you are allergic (hypersensitive) to the active ingredient tolterodina or to any of the other components of this medication (listed in section 6).
• If you are unable to urinate from the bladder (urinary retention).
• If you have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of visual field, not being adequately treated).
• If you have myasthenia gravis (excessive muscle weakness).
• 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

• 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 (decreased gastrointestinal motility).
• If you have a relevant 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 (alteration of heart rhythm)
• heart failure

• If you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Consult your doctor, pharmacist, or nurse before starting to take Tolterodina Neo Kern Pharma.

Use of Tolterodina Neo Kern Pharma with other medications

Tolterodina, the active ingredient of Tolterodina Neo Kern Pharma, 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 for the treatment of HIV.

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

• some 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 Tolterodina Neo Kern Pharma (antimuscarinic properties) or medications that have an opposite mode of action to Tolterodina Neo Kern Pharma (cholinergic properties). Consult your doctor if you are unsure.

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

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

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

Pregnancy, breastfeeding, and fertility

You should not use Tolterodina Neo Kern Pharma if you are pregnant.

The excretion of tolterodina in breast milk is unknown. It is not recommended to use Tolterodina Neo Kern Pharma during breastfeeding.

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

Driving and operating machinery

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

Tolterodina Neo Kern Pharma contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 4 mg capsule per day, except in patients with liver or kidney disease, or in cases of bothersome side effects, in which case your doctor may reduce your dose to one 2 mg capsule per day.

Your doctor will indicate the duration of your treatment with Tolterodina Neo Kern Pharma. The benefit of treatment should be reevaluated after 2-3 months of use.

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

Use in children and adolescents

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

If you take more Tolterodina Neo Kern Pharma than you should

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

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.

If you forget to take Tolterodina Neo Kern Pharma

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, wait until the next scheduled dose and take it at the usual time. Continue taking the capsules as directed by your doctor.

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

If you interrupt treatment with Tolterodina Neo Kern Pharma

Do not stop treatment unless you see an immediate effect, as your bladder needs time to adapt to it. Finish the treatment with the prescribed prolonged-release capsules by your doctor. If you do not notice any effect, consult your doctor.

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

Like all medications, Tolterodina Neo Kern Pharma may cause side effects, although not everyone will experience 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 an allergic reaction (for example: itching, rash, urticaria, and difficulty breathing). This occurs infrequently (up to 1 in 100 patients).

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 infrequently (up to 1 in 100 patients).

The following side effects have been observed during treatment with Tolterodina Neo Kern Pharma with the following frequencies.

The very frequent side effects (more than 1 in 10 patients) are:

• Dry mouth.
• Headache.

The frequent side effects (up to 1 in 10 patients) are:

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

The infrequent side effects (up to 1 in 100 patients) are:

• Allergic reactions.
• Nervousness.
• Tingling in the fingers of the hands and feet.
• Dizziness.
• Palpitations, heart failure, irregular heartbeat.
• Inability to empty the bladder.
• Chest pain.
• Memory alteration.

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

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

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tolterodina Neo Kern Pharma

• The active ingredient is tolterodina. Each capsule contains 4 mg of tolterodina tartrate corresponding to 2.74 mg of tolterodina.

• 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), copolymer of methacrylic acid and ethyl acrylate (1:1) and propylene glycol (E 1520). The capsule components are gelatin (E 441), indigo carmine (E-132) and titanium dioxide (E-171).

Appearance of the product and content of the container

Tolterodina Neo Kern Pharma are prolonged-release capsules designed for the administration of one capsule per day.

The hard prolonged-release capsules of 4 mg are blue in color

Each container contains 28 prolonged-release capsules, packaged in PVC/PE/PVDC/Aluminum blisters.

Holder of the marketing authorization

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Athens (Greece)

Ó

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

Last review date of this leaflet: July 2012

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/.