Tolterodine Neo Ratiopharm 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tolterodine Neo ratiopharm 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tolterodina Neo ratiopharm is and what it is 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 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 taking Tolterodine Neo ratiopharm

Do not take Tolterodine Neo ratiopharm

• if you are allergic to tolterodine or to any of the other ingredients of this medicine (listed in section 6).
• if you are unable to empty urine from your bladder (urinary retention).
• if you have uncontrolled narrow-angle glaucoma (increased intraocular pressure with visual field loss that is not being 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

Talk to your doctor or pharmacist before taking Tolterodine Neo ratiopharm:

• if you experience 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 have neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic nervous system neuropathy).
• if you have a hiatal hernia (herniation of an abdominal organ).
• if you frequently experience reduced intestinal movement or suffer from severe constipation (decreased gastrointestinal motility).
• if you have heart disease, such as:
  • abnormal heart rhythm (ECG changes)
  • slow heart rate (bradycardia),
  • pre-existing heart conditions such as: cardiomyopathy (weakened 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).

Taking Tolterodine Neo ratiopharm with other medicines

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

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

The concomitant use of tolterodine is not recommended with:

• certain antibiotics (containing, for example: erythromycin and clarithromycin).
• medicines used to treat fungal infections (containing, for example: ketoconazole and itraconazole).
• medicines used to treat HIV.

Tolterodine Neo ratiopharm should be used with caution when administered together with:

• certain medicines affecting food transit (containing, for example: metoclopramide and cisapride).
• medicines used to treat irregular heart rhythm (containing, for example: 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 Neo ratiopharm (cholinergic properties). The reduction in gastric motility caused by antimuscarinic medicines may affect the absorption of other medicines.

Taking Tolterodine Neo ratiopharm with food

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

Pregnancy and breastfeeding

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

Pregnancy

You must not take Tolterodine Neo ratiopharm if you are pregnant.

Breastfeeding

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

Driving and using machines

Tolterodine Neo ratiopharm may cause dizziness, tiredness, or affect your vision. If you experience any of these symptoms, you must not drive or operate heavy machinery.

Tolterodine Neo ratiopharm contains lactose and sodium

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

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

3. How to take Tolterodine Neo ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

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, the doctor may reduce the dose to 2 mg of tolterodine per day.

Use in children

The use of Tolterodine Neo ratiopharm is not recommended in children.

Method of administration

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

Do not chew the capsules.

Duration of treatment

Your doctor will determine the duration of treatment with Tolterodine Neo ratiopharm. Do not stop treatment prematurely just because you do not observe an immediate effect. Your bladder needs time to adapt. Complete the full course of treatment with prolonged-release capsules as prescribed by your doctor. If you notice no effect, consult your doctor. The benefit of treatment should be re-evaluated after 2–3 months of use.

If you take more Tolterodine Neo ratiopharm 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, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include hallucinations, excitement, rapid heartbeat, pupil dilation, and inability to urinate or breathe normally.

If you forget to take Tolterodine Neo ratiopharm

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 the missed dose.

If you stop treatment with Tolterodine Neo ratiopharm

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, this medicine can cause 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 breathing difficulty). This occurs infrequently (may affect up to 1 in 100 people).

Inform your doctor immediately 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 (may affect 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):

• 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 urinating
• Diarrhea
• Swelling due to fluid accumulation (e.g., in the ankles)
• Fatigue

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

• Allergic reactions
• Heart failure
• Nervousness
• Irregular heartbeat, palpitations
• Chest pain
• Inability to empty the bladder
• Tingling sensation in the fingers of the hands and feet
• Dizziness
• 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.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolterodine Neo ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container and the blister pack. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tolterodine 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 components are: monohydrate lactose, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose.

Capsule composition: indigo carmine (E132), titanium dioxide (E171) and gelatin.

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

Appearance of the product and contents of the pack

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

The Tolterodine Neo ratiopharm 4 mg prolonged-release hard capsules are opaque light blue in colour.

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

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

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

Only some 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, 1st Floor

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 medicinal product 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 the most recent review of this leaflet: September 2020

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