TOLTERODINE NEO KERN PHARMA 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tolterodina Neo KERN PHARMA 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Tolterodina Neo Kern Pharma and what is it used for
2. What you need to know before you 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 other information

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

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

Tolterodina Neo Kern Pharma is used for the treatment of the symptoms of overactive bladder. If you have an overactive bladder, you may notice that:

• you are not able to control your urine normally
• you have a sudden and urgent need to urinate, and/or you urinate more often during the day.

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

Do not take Tolterodina Neo Kern Pharma

• if you are allergic (hypersensitive) to the active substance tolterodine or any of the other ingredients of this medicine (listed in section 6).
• if you are unable to empty your bladder (urinary retention).
• if you have uncontrolled narrow-angle glaucoma (high eye pressure with loss of vision, which is not being treated adequately).
• if you have myasthenia gravis (excessive weakness in the muscles).
• 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 emptying your bladder and/or urinating 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 autonomic neuropathy (nerve damage that affects your blood pressure, intestinal or sexual function).
• if you have a hiatus hernia (a hernia in an abdominal organ).
• if you ever notice a decrease in bowel movements or suffer from severe constipation (decreased gastrointestinal motility).
• if you have significant heart disease such as:

• abnormal heart rhythm (ECG)
• slow heart rate (bradycardia)
• pre-existing heart conditions such as:
• cardiomyopathy (weakness in the heart muscle)
• myocardial ischaemia (decreased blood flow to the heart)
• arrhythmia (abnormal heart rhythm)
• heart failure

• if you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.

Consult your doctor, pharmacist or nurse before taking Tolterodina Neo Kern Pharma.

Using Tolterodina Neo Kern Pharma with other medicines

Tolterodine, the active substance of Tolterodina Neo Kern Pharma, may interact with other medicines.

It is not recommended to use tolterodine in combination with:

• certain antibiotics (e.g. erythromycin and clarithromycin)
• medicines used to treat fungal infections (e.g. ketoconazole and itraconazole)
• medicines used to treat HIV.

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

• certain medicines that affect the movement of food (e.g. metoclopramide and cisapride)
• medicines used to treat irregular heart rhythm (e.g. amiodarone, sotalol, quinidine and procainamide)
• other medicines that have a similar mode of action to Tolterodina Neo Kern Pharma (antimuscarinic properties) or medicines that have an opposite mode of action to Tolterodina Neo Kern Pharma (cholinergic properties). Consult your doctor if you are unsure.

Tell your doctor or pharmacist that you are taking or have recently taken or might take any other medicines.

Using Tolterodina Neo Kern Pharma with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

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

It is not known if tolterodine is excreted in breast milk. Tolterodina Neo Kern Pharma is not recommended during breast-feeding.

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Tolterodina Neo Kern Pharma contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Tolterodina Neo Kern Pharma

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

In case of doubt, consult your doctor or pharmacist again.

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

Your doctor will tell you how long you should take Tolterodina Neo Kern Pharma. The benefit of treatment should be re-evaluated after 2-3 months of using it.

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tolterodina Neo Kern Pharma

If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, wait until your next dose and take it at the usual time. In this case, continue taking the capsules as your doctor has told you.

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

If you stop taking Tolterodina Neo Kern Pharma

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

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

4. Possible side effects

Like all medicines, Tolterodina Neo Kern Pharma can cause side effects, although not everybody gets them.

You should consult your doctor immediately if you notice symptoms of angioedema such as:

• Swelling of the face, tongue or throat.
• 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 (in up to 1 in 100 patients).

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

• Chest pain, difficulty breathing or tiredness (even at rest), difficulty breathing at night, swelling of the legs. These may be symptoms of heart failure. This occurs rarely (in 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 common side effects (affecting more than 1 in 10 patients) are:

• Dry mouth.
• Headache.

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

• Sinusitis.
• Dizziness, somnolence, headache.
• Dry eyes, blurred vision.
• Difficulty digesting food (dyspepsia), constipation, abdominal pain, excessive gas in the stomach or intestine.
• Pain or difficulty urinating.
• Tiredness.
• Swelling due to fluid accumulation (e.g. in the ankles).
• Diarrhoea.

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

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

Additional reactions reported 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 have been reported in patients being treated for dementia.

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

5. Storage of Tolterodina 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 which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tolterodina Neo Kern Pharma

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

• The other ingredients are microcrystalline cellulose (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 - ethyl acrylate copolymer (1:1) and propylene glycol (E 1520). The capsule ingredients are gelatin (E 441), indigo carmine (E-132) and titanium dioxide (E-171).

Appearance of the product and pack contents

Tolterodina Neo Kern Pharma are prolonged-release capsules designed for once-daily administration.

The 4 mg prolonged-release hard capsules are blue

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

Marketing authorisation 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 last revision of this leaflet: July 2012

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.