Detrusitol Neo 4 mg prolonged-release hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Detrusitol Neo 4 mg prolonged-release hard capsules

(Tolterodine tartrate)

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it may 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 Detrusitol Neo is and what it is used for.
2. What you need to know before taking Detrusitol Neo.
3. How to take Detrusitol Neo.
4. Possible side effects.
5. How to store Detrusitol Neo.
6. Contents of the pack and other information.

1. What Detrusitol Neo is and what it is used for

The active substance in Detrusitol Neo is tolterodine. Tolterodine is a medicine that belongs to a group of medicines called antimuscarinics.

Detrusitol Neo 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 feel a sudden and urgent need to urinate without prior warning and/or you urinate more frequently during the day.

2. What you need to know before taking Detrusitol Neo

Do not take Detrusitol Neo if:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Detrusitol Neo if you think any of the following situations may apply to you:

• If you have difficulty passing urine and/or 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 liver disease.

• If you have 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 have ever experienced reduced intestinal movement or suffer from severe constipation (decreased gastrointestinal motility).

• If you have a significant heart condition such as:

• abnormal heart rhythm (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 levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Other medicines and Detrusitol Neo:

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

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

The use of tolterodine in combination with the following is not recommended:

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

Detrusitol Neo should be used with caution when administered together with:

• certain medicines affecting food transit (containing e.g.: metoclopramide and cisapride).
• medicines used to treat irregular heart rhythm (containing e.g.: amiodarone, sotalol, quinidine, and procainamide).
• other medicines with a similar mode of action to Detrusitol Neo (antimuscarinic properties) or medicines with an opposite mode of action to Detrusitol Neo (cholinergic properties). Consult your doctor if you are unsure.

Taking Detrusitol Neo with food and drink

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

Pregnancy and Breast-feeding

Pregnancy

You should not use Detrusitol Neo if you are pregnant. Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Breast-feeding

It is unknown whether tolterodine is excreted in human breast milk. The use of Detrusitol Neo during breast-feeding is not recommended.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

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

Detrusitol Neo contains sucrose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Detrusitol Neo

Dosage:

Follow exactly the instructions for use of Detrusitol Neo provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is one 4 mg capsule daily, except for 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.

The use of Detrusitol Neo is not recommended in children.

Detrusitol Neo is taken orally. The capsules must be swallowed whole. Do not chew the capsules.

Duration of treatment:

Your doctor will determine the duration of your treatment with Detrusitol Neo. Do not stop treatment prematurely if you do not observe an immediate effect, as your bladder needs time to adapt. Complete the treatment with the 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.

Always consult your doctor if you are considering discontinuing treatment.

Opening the container

Detrusitol Neo may be packaged in blister packs or in a bottle.

If your Detrusitol Neo is in a bottle, to open it, press down on the sealing ring. Then, press down on the cap and, while keeping it pressed, turn it counterclockwise.

If you take more Detrusitol Neo than you should:

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

In case of overdose or accidental ingestion, go to the nearest hospital or contact the Toxicology Information Service, Telephone: 91 562 04 20.

If you forget to take Detrusitol Neo:

If you forget to take 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 usual 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 have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Detrusitol Neo can also have adverse 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.
• Hives and difficulty breathing.

You should also seek medical attention if you experience a hypersensitivity reaction (for example: itching, rash, hives, and difficulty breathing). This occurs uncommonly (less than 1 in 1,000 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 uncommonly (less than 1 in 1,000 patients).

The following adverse effects have been observed during treatment with Detrusitol Neo with the following frequencies:

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

• Dry mouth

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

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

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

• Allergic reactions
• Nervousness
• Tingling 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, redness of the skin, stomach burning, vomiting, angioedema, dry skin, and disorientation. Cases of worsening of dementia symptoms have been reported in patients being treated for dementia.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Detrusitol Neo

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

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

Do not store above 25°C.

Blister packs: Keep the blister pack in the outer carton.

Bottles: Store in the original container.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Detrusitol Neo

The active substance in Detrusitol Neo 4 mg prolonged-release capsules is tolterodine. Each capsule contains 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.

The excipients are:

Capsule contents: sugar granules (containing sucrose and maize starch) [See section 2. Detrusitol Neo contains sucrose (a type of sugar)], hypromellose, Surelease E 7-19040 transparent (containing ethylcellulose, medium-chain triglycerides, oleic acid).

Capsule shell: gelatin and colouring agents.

Colouring agents: indigo carmine (E 132) and titanium dioxide (E 171).

Printing ink: Shellac lac (E 904), titanium dioxide (E171), propylene glycol (E 1520) and simethicone.

Appearance of the product and contents of the pack

Detrusitol Neo consists of prolonged-release capsules designed for once-daily administration.

Detrusitol Neo 4 mg capsules are blue with a symbol and the number "4" printed in white.

Detrusitol Neo is available in the following pack sizes:

Blister packs:

7 prolonged-release capsules (1 strip of 7)

14 prolonged-release capsules (2 strips of 7)

28 prolonged-release capsules (4 strips of 7)

49 prolonged-release capsules (7 strips of 7)

84 prolonged-release capsules (12 strips of 7)

98 prolonged-release capsules (14 strips of 7)

280 prolonged-release capsules (40 strips of 7)

Bottles: containing 30, 90 and 100 capsules.

Hospital packs containing 80, 160 and 320 capsules are also available.

Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Farmasierra Laboratorios, S.L.

Carretera de Inún, km. 26,200

28709 San Sebastian de los Reyes (Madrid)

Spain

Manufacturer:

Pfizer Italia, S.r.l.

63100 Marino del Tronto

Ascoli Piceno, Italy

or

MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Prumyslová 961/16
747 23 Bolatice
Czech Republic

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Detrusitol retard in: Austria, Belgium, Luxembourg, Denmark, Germany, Iceland and Italy.

Detrusitol SR in: Finland, Ireland, Netherlands, Norway and Sweden.

Detrusitol LP in: France.

Detrusitol Neo in: Spain.

Detrusitol XL in: United Kingdom (Northern Ireland).

This leaflet was last approved in December 2022.