TOLTERODINE NEO RATIOPHARM 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tolterodina Neo ratiopharm 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. See section 4.

Contents of the pack

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

1. What is Tolterodina Neo ratiopharm and what is it used for

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

Tolterodina Neo ratiopharm is used for the treatment of the symptoms of overactive bladder. If you have overactive bladder, you may experience:

• that you are not able to control urination voluntarily
• a sudden and urgent need to urinate without prior warning and/or that you urinate more frequently during the day.

2. What you need to know before you take Tolterodina Neo ratiopharm

Do not take Tolterodina Neo ratiopharm

• if you are allergic to 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 properly).
• 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

Consult your doctor or pharmacist before starting to take Tolterodina Neo ratiopharm:

• if you have difficulty emptying your bladder and/or urinate 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 (a condition that affects the nerves that control bodily functions, such as blood pressure, intestinal and sexual function).
• if you have a hiatus hernia (a hernia in an abdominal organ).
• if you have ever noticed a decrease in bowel movements or have severe constipation (decreased gastrointestinal motility).
• if you have heart disease, such as:
• altered heart rhythm (ECG)
• slow heart rate (bradycardia),
• pre-existing heart conditions such as cardiomyopathy (weakness of the heart muscle), myocardial ischemia (decreased blood flow to the heart), arrhythmia (abnormal heart rhythm), heart failure
• if you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Taking Tolterodina Neo ratiopharm with other medicines

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

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

It is not recommended to take 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 ratiopharm should be used with caution when administered in combination with:

• certain medicines that affect the passage of food (e.g. metoclopramide and cisapride).
• medicines for the treatment of irregular heart rhythm (e.g. amiodarone, sotalol, quinidine, and procainamide).
• other medicines that have a similar mode of action to tolterodine (antimuscarinic properties) or medicines that have an opposite mode of action to Tolterodina Neo ratiopharm (cholinergic properties). The reduction in gastric motility produced by antimuscarinic medicines may affect the absorption of other medicines.

Taking Tolterodina Neo ratiopharm with food

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

Pregnancy and breast-feeding

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

Pregnancy

Do not take Tolterodina Neo ratiopharm if you are pregnant.

Breast-feeding

It is not known whether tolterodine is excreted in breast milk. Tolterodina Neo ratiopharm is not recommended during breast-feeding.

Driving and using machines

Tolterodina Neo ratiopharm may make you feel dizzy, tired, or affect your vision. If you experience any of these symptoms, do not drive or operate heavy machinery.

Tolterodina Neo ratiopharm contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Tolterodina Neo ratiopharm

Take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

Adults

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

Use in children

Tolterodina Neo ratiopharm is not recommended for use in children.

Method of administration

The prolonged-release hard capsules are taken orally and should be swallowed whole.

Do not chew the capsules.

Duration of treatment

Your doctor will tell you how long you should take Tolterodina Neo ratiopharm. Do not stop treatment early because you do not see an immediate effect. Your bladder needs time to adapt to this treatment. Finish the treatment with the prolonged-release capsules as prescribed by your doctor. If you do not notice any effect, consult your doctor. The benefit of treatment should be re-evaluated after 2-3 months of use.

If you take more Tolterodina Neo ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

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

If you forget to take Tolterodina Neo ratiopharm

If you forget 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, skip the missed dose and continue with the usual schedule.

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

If you stop taking Tolterodina Neo ratiopharm

Always consult your doctor if you are thinking of stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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.

In addition, you should seek medical attention if you experience a hypersensitivity reaction (e.g. itching, rash, hives, and difficulty breathing). This occurs rarely (may affect up to 1 in 100 people).

Tell your doctor immediately 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 (may affect up to 1 in 100 people).

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

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

• Dry mouth

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

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

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

• Allergic reactions
• Heart failure
• Nervousness
• Irregular heartbeat, palpitations
• Chest pain
• Inability to empty the bladder
• Feeling of tingling in the fingers and toes
• Dizziness
• 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. There have been reports of worsening symptoms of dementia in patients being treated for dementia.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolterodina Neo ratiopharm

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

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.

Do not store above 25°C.

HDPE bottle: the shelf-life after first opening is 200 days.

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 ratiopharm

• The active substance is tolterodine tartrate.

Each prolonged-release hard capsule contains 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose.

Composition of the capsule: indigo carmine (E132), titanium dioxide (E171), and gelatin.

Composition of the internal tablet coating: ethylcellulose, triethyl citrate, ethyl acrylate-methyl methacrylate copolymer, 1,2-propylene glycol.

Appearance and packaging

Tolterodina Neo ratiopharm are prolonged-release hard capsules designed for once-daily administration.

The 4 mg prolonged-release hard capsules of Tolterodina Neo ratiopharm are light blue opaque.

Tolterodina Neo ratiopharm 4 mg prolonged-release hard capsules are available in the following pack sizes:

Blisters of 7, 14, 28, 30, 49, 50, 80, 84, 90, 98, 100, 160, 200, and 280 prolonged-release hard capsules.

HDPE bottles with 30, 60, 100, and 200 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturer

Pharmathen S.A

6, Dervenakion Str.,

153 51 Pallini Attiki

Greece

Or

Pharmathen International S.A

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

Or

Merckle GmbH

Ludwig-Merckle-Strasse, 3

D-89143 Blaubeuren, Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

United Kingdom: Dengaff XL 4 mg prolonged-release capsules

Germany: Tolterodin-CT 4 mg Retardkapseln

Spain: Tolterodina Neo ratiopharm 4 mg cápsulas duras de liberación prolongada EFG

Finland: Tolterodine Teva 4mg depotkapseli, kova

Date of last revision of this leaflet: September 2020

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/)