Tolterodine Neo Aurovitas 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tolterodine Neo Aurovitas 4 mg prolonged-release hard capsules EFG

Tartrate of tolterodine

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Tolterodine Neo Aurovitas is and what it is used for

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

Tolterodine 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 Aurovitas

Do not take Tolterodine Neo Aurovitas

• 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 the bladder (urinary retention).
• if you have uncontrolled narrow-angle glaucoma (increased intraocular pressure with loss of visual field, which 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 starting Tolterodine Neo Aurovitas if:

• you experience difficulty passing urine and/or have a weak or slow urinary stream.
• you have a gastrointestinal disorder affecting the passage and/or digestion of food.
• you have kidney problems (renal impairment).
• you have liver disease.
• you have neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic neuropathy).
• you have a hiatal hernia (herniation of an abdominal organ).
• you ever experience reduced intestinal movement or suffer from severe constipation (decreased gastrointestinal motility).
• you have heart disease, such as:
  • abnormal heart rhythm (ECG).
  • slow heart rate (bradycardia).
  • pre-existing heart conditions such as: cardiomyopathy (weakening of the heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat), heart failure.
• you have abnormally low blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

Taking Tolterodine Neo Aurovitas with other medicines

Tell 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 Aurovitas, may interact with other medicines.

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

• 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 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 heartbeat (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 (cholinergic properties). Consult your doctor if you are unsure.

Taking Tolterodine Neo Aurovitas with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

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

Pregnancy

You must not use tolterodine if you are pregnant. Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breast-feeding

It is unknown whether tolterodine, the active ingredient in Tolterodine Neo Aurovitas, is excreted in breast milk. The use of tolterodine during breast-feeding is not recommended.

Driving and using machines

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

Tolterodine Neo Aurovitas contains lactose

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

This medicine contains less than 1 mmol of sodium (23 mg) per 4 mg capsule; essentially "sodium-free".

3. How to take Tolterodine Neo Aurovitas

Dosage:

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Do not chew the capsules.

Adults:

The recommended dose is one prolonged-release hard capsule of 4 mg daily.

Patients with liver or kidney problems

In patients with liver or kidney problems, the doctor may reduce the dose to 2 mg of tolterodine daily.

Use in children and adolescents

The use of tolterodine is not recommended in children.

If you take more Tolterodine Neo Aurovitas 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, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Tolterodine Neo Aurovitas

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 a missed dose.

If you stop taking Tolterodine Neo Aurovitas

Your doctor will advise you on the duration of treatment with tolterodine. Do not stop treatment prematurely just because you do not observe an immediate effect. Your bladder needs time to adapt. Complete the course of 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.

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 experiences 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.

Additionally, seek medical attention if you experience a hypersensitivity reaction (for example: itching, rash, hives, and difficulty breathing). This occurs infrequently (affects up to 1 in 100 people).

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

• chest pain, shortness of breath, or fatigue (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs infrequently (affects 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, 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 retention (e.g., in the ankles).
• Diarrhea.

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

• Allergic reactions.
• Nervousness.
• Palpitations, heart failure, irregular heartbeat.
• Inability to empty the bladder.
• Tingling sensation in the fingers and toes.
• Dizziness.
• 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 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolterodine Neo Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tolterodine NeoAurovitas

• The active substance in Tolterodine NeoAurovitas 4 mg prolonged-release hard capsules is 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. Coating composition of the internal tablet: ethylcellulose, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, 1,2-propylene glycol.

Appearance of the product and contents of the pack

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

Tolterodine NeoAurovitas 4 mg prolonged-release hard capsules are opaque light blue in colour.

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

Blister packs containing 7, 14, 28, 30, 49, 56, 60, 84, 98 and 100 prolonged-release hard capsules.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

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

Date of the most recent revision of this leaflet: September 2018

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