Ranolazine ranolteril

Package leaflet: Information for the patient

Ranolteril, 1 mg, film-coated tablets
Ranolteril, 2 mg, film-coated tablets
Tolterodini tartras
Please read all of this leaflet carefully before 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ranolteril is and what it is used for
2. Important information before taking Ranolteril
3. How to take Ranolteril
4. Possible side effects
5. How to store Ranolteril
6. Contents of the pack and other information

1. What Ranolteril is and what it is used for

The active substance in Ranolteril is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinics.
Tolterodine is used to treat the symptoms of overactive bladder syndrome. Patients with overactive bladder syndrome may have difficulty controlling urination, feel a sudden need to go to the toilet, and (or) need to urinate frequently.

2. Important information before using Ranolteril

When not to use Ranolteril

• If the patient is allergic to tolterodine or to any of the other ingredients of this medicine (listed in section 6)
• If the patient has difficulty in emptying urine from the bladder (urinary retention)
• If the patient has uncontrolled narrow-angle glaucoma (high pressure in the eye with loss of vision that is not adequately treated)
• If the patient has myasthenia gravis (severe muscle weakness)
• If the patient has severe ulcerative colitis (ulceration and inflammation of the colon)
• If the patient has toxic megacolon (severe dilation of the colon)

Warnings and precautions

• If the patient experiences difficulty in passing urine and/or has a weak urine stream
• In patients with stomach or intestinal disorders affecting the movement of food and/or digestion
• If the patient has kidney problems (renal failure)
• In patients with liver disease
• If the patient has neurological disorders affecting blood pressure, intestines, or sexual function (any autonomic neuropathy)
• In patients with hiatal hernia (protrusion of an organ into the chest cavity)
• In patients whose intestinal movements are slowed or who suffer from severe constipation (reduced gastrointestinal motility)
• If the patient has heart-related conditions such as:
  • abnormal results of heart function tests (ECG)
  • slow heart rate (bradycardia)
  • previous heart diseases such as:
    • cardiomyopathy (weakening of the heart muscle)
    • myocardial ischaemia (reduced blood flow to the heart)
    • arrhythmia (irregular heartbeat)
    • heart failure
• In case of abnormally low blood levels of potassium (hypokalaemia), calcium (hypocalcaemia), or magnesium (hypomagnesaemia)

Before starting treatment with tolterodine, consult a doctor or pharmacist if you suspect that the patient has any of the above-mentioned conditions.

Ranolteril and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Tolterodine, the active substance in Ranolteril, may interact with other medicinal products.

Do not use Ranolteril in combination with:

• certain antibiotics (containing, for example, erythromycin, clarithromycin)
• medicinal products used to treat fungal infections (containing, for example, ketoconazole, itraconazole)
• medicinal products used to treat HIV infection

Use Ranolteril with caution when used together with:

• medicines affecting gastrointestinal transit (containing, for example, metoclopramide, cisapride)
• medicines used to treat irregular heartbeat (containing, for example, amiodarone, sotalol, quinidine, procainamide)
• other medicinal products with a similar mechanism of action to tolterodine (antimuscarinic agents) or with an opposing mechanism of action (cholinergic agents). If in doubt, consult your doctor.

Ranolteril with food and drink

This medicine can be taken before, during, or after meals.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant should not take tolterodine. Women must inform their doctor immediately if they are pregnant, suspect they may be pregnant, or plan to become pregnant.

Breastfeeding
It is not known whether Ranolteril passes into breast milk. Breastfeeding is not recommended during treatment with tolterodine.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Ranolteril may cause dizziness, fatigue, or affect vision; this may impair the ability to drive or operate machinery.

Ranolteril contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Ranolteril

Dosage
This medicine should be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual dose is one 2 mg tablet taken twice daily, except in patients with impaired
renal or hepatic function or in those experiencing troublesome adverse effects. In such
cases, the doctor may reduce the dose to one 1 mg tablet twice daily.
Ranolteril is not recommended for use in children.
The tablets are for oral use and should be swallowed whole.

Duration of treatment
Your doctor will inform you how long the treatment with Ranolteril should last. Do not stop
treatment prematurely due to the lack of immediate effect. The urinary bladder requires
time to respond to treatment. Complete the full course of treatment as prescribed by your doctor.
Contact your doctor if there is no improvement after completing the treatment.
The benefits of treatment should be re-evaluated after 2 or 3 months.
If a patient is considering stopping treatment, this should always be discussed with the doctor.

Overdose of Ranolteril
If a patient has taken more tablets than recommended, or if someone else has taken the medicine,
inform a doctor or pharmacist immediately.
In cases of tolterodine overdose, the following symptoms have been reported:

• Severe central anticholinergic effects (e.g., hallucinations, marked agitation)
• Seizures and pronounced excitation
• Respiratory failure
• Tachycardia
• Urinary retention
• Mydriasis (pupil dilation)
• QT interval prolongation

Missed dose of Ranolteril
Do not take a double dose to make up for a missed dose. If a patient forgets to take a dose at the
usual time, they should take it as soon as they remember, unless it is almost time for the next dose.
In that case, the missed dose should be skipped and the next dose taken at the usual time.

Stopping Ranolteril
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

You should immediately contact your doctor or go without delay to a hospital emergency department if symptoms of angioedema occur, such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria (hives) and breathing difficulties.

You should also consult your doctor if allergic reactions occur (for example, itching, rash, urticaria, breathing difficulties). These symptoms occur uncommonly (in fewer than 1 in 100 patients).

You should immediately contact your doctor or go without delay to a hospital emergency department if any of the following occur:

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

These may be symptoms of heart failure. These symptoms occur uncommonly (in fewer than 1 in 100 patients).

The following adverse reactions have been observed during treatment with tolterodine, with the frequencies listed below.

Very common (occurring in more than 1 in 10 patients) adverse reactions include:

• Dry mouth
• Headache

Common (occurring in fewer than 1 in 10 patients) adverse reactions include:

• Bronchitis – Dizziness – Somnolence
• Dry eyes – Blurred vision – Abdominal pain
• Sensation of spinning – Palpitations – Dry skin
• Indigestion – Constipation – Fatigue (dyspepsia)
• Pain or difficulty when urinating – Weight gain – Chest pain
• Vomiting – Inability to empty the bladder
• Diarrhea
• Tingling sensation in fingers and toes
• Excess gas in stomach or intestines
• Fluid retention leading to swelling (e.g. ankles)

Uncommon (occurring in fewer than 1 in 100 patients) adverse reactions include:

• Allergic reactions – Nervousness – Irregular heartbeat
• Rapid heartbeat – Heart failure – Heartburn
• Memory disturbances

Additional adverse reactions reported after the medicine was marketed include severe allergic reactions, confusion, hallucinations (seeing, hearing, feeling, tasting or smelling things that are not real), sudden flushing of the face, angioedema and disorientation. Cases of worsening dementia have also been reported in patients being treated for dementia.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ranolteril

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage conditions.

6. Contents of the pack and other information

What Ranolteril contains
The active substance is 1 mg of tolterodine tartrate, equivalent to 0.68 mg of tolterodine.
The active substance is 2 mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
The other ingredients are:
Core: microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate,
colloidal anhydrous silica.
Coating: hypromellose, titanium dioxide (E171), macrogol 8000, talc.

What Ranolteril looks like and contents of the pack
Ranolteril 1 mg tablets are white to off-white, round, approximately 6.35 mm in diameter,
biconvex, film-coated, with the imprint "S16" on one side and no marking on the other side.
Ranolteril 2 mg tablets are white to off-white, round, approximately 6.35 mm in diameter,
biconvex, film-coated, with the imprint "S042" on one side and no marking on the other side.

The following pack sizes of Ranolteril 1 mg and Ranolteril 2 mg film-coated tablets are available:
Blister packs containing:

• 14 tablets (1 blister with 14 tablets)
• 20 tablets (2 blisters with 10 tablets each)
• 28 tablets (2 blisters with 14 tablets each)
• 30 tablets (3 blisters with 10 tablets each or 2 blisters with 15 tablets each)
• 56 tablets (4 blisters with 14 tablets each)
• 60 tablets (6 blisters with 10 tablets each or 4 blisters with 15 tablets each)
• 90 tablets (9 blisters with 10 tablets each or 6 blisters with 15 tablets each)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw, Poland

Manufacturer/Importer:
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht, Netherlands

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