RANOLTERIL 2 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ranolteril, 1 mg, Film-Coated Tablets
3. Ranolteril, 2 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
4. What is Ranolteril and What is it Used for
5. Important Information Before Taking Ranolteril
   1. When Not to Take Ranolteril
   2. Warnings and Precautions
   3. Ranolteril and Other Medications
   4. Ranolteril with Food and Drink
   5. Pregnancy and Breastfeeding
   6. Driving and Operating Machines
   7. Ranolteril Contains Sodium
6. How to Take Ranolteril
   1. Taking a Higher Dose of Ranolteril than Recommended
   2. Missing a Dose of Ranolteril
   3. Stopping Ranolteril Treatment
7. Possible Undesirable Effects
   1. Reporting Undesirable Effects
8. How to Store Ranolteril
9. Package Contents and Other Information
   1. What Ranolteril Contains
   2. What Ranolteril Looks Like and What the Package Contains
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder:
   5. Manufacturer/Importer:
   6. This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the Following Names:
   7. Date of Last Revision of the Package Leaflet: December 2022

Package Leaflet: Information for the Patient

Ranolteril, 1 mg, Film-Coated Tablets

Ranolteril, 2 mg, Film-Coated Tablets

Tolterodine Tartrate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Ranolteril and What is it Used for
• 2. Important Information Before Taking Ranolteril
• 3. How to Take Ranolteril
• 4. Possible Undesirable Effects
• 5. How to Store Ranolteril
• 6. Package Contents and Other Information

1. What is Ranolteril and What is it Used for

The Active Substance of the Medication is Tolterodine. Tolterodine Belongs to a Group of Medicinal Products Called Antimuscarinic Agents.
Tolterodine is Used to Treat Symptoms of Overactive Bladder. Patients with Overactive Bladder may have Difficulty Controlling Urination, Feel a Sudden Need to Urinate, and (or) Urinate Frequently.

2. Important Information Before Taking Ranolteril

When Not to Take Ranolteril

• If the Patient is Allergic to Tolterodine or any of the Other Ingredients of this Medication (Listed in Section 6)
• If the Patient has Difficulty Urinating (Urinary Retention)
• If the Patient has Uncontrolled Narrow-Angle Glaucoma (High Eye Pressure with Vision Loss that is not Properly Treated)
• If the Patient has Myasthenia Gravis(Significant Muscle Weakness)
• If the Patient has Severe Ulcerative Colitis (Ulceration and Inflammation of the Colon)
• If the Patient has Toxic Megacolon (Severe Colon Expansion).

Warnings and Precautions

• If the Patient Experiences Difficulty Urinating and (or) has a Weak Urine Stream
• In Patients with Stomach and Intestinal Diseases that Affect the Movement of Food and (or) Digestion
• If the Patient has Kidney Problems (Renal Insufficiency)
• In Patients with Liver Disease
• If the Patient has Nerve Disorders that Affect Blood Pressure, Intestines, or Sexual Function (Any Autonomic Neuropathy)
• In Patients with Hiatal Hernia (Protrusion of an Organ in the Abdominal Cavity)
• In Patients who have Slower Intestinal Movements or Suffer from Severe Constipation (Decreased Gastrointestinal Motility)
• If the Patient has Heart Problems, such as:
• Abnormal Heart Function Test Results (ECG)
• Slow Heart Rate (Bradycardia)
• Pre-Existing Heart Diseases, such as:
• Cardiomyopathy (Heart Muscle Weakness);
• Myocardial Ischemia (Reduced Blood Flow to the Heart);
• Arrhythmia (Irregular Heartbeat);
• Heart Failure.
• In Case of Abnormally Low Potassium (Hypokalemia), Calcium (Hypocalcemia), or Magnesium (Hypomagnesemia) Levels in the Blood

Before Taking Tolterodine, Consult a Doctor or Pharmacist if there is a Suspicion that the Patient has any of the Above Symptoms.

Ranolteril and Other Medications

Inform the Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take.
Tolterodine, the Active Substance of Ranolteril, may Interact with Other Medicinal Products.
It is not Recommended to Take 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.

Caution should be Exercised when Taking Ranolteril in Combination with:

• Medications that Affect Food Passage (Containing, for Example, Metoclopramide and Cisapride)
• Medications 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 Medications with an Opposite Mechanism of Action to Tolterodine (Cholinergic Agents). In Case of Doubt, Consult a Doctor.

Ranolteril with Food and Drink

This Medication can be Taken Before, During, or After Meals.

Pregnancy and Breastfeeding

Pregnancy
Women who are Pregnant should not Take Tolterodine. Women must Immediately Inform their Doctor if they are Pregnant, Think they may be Pregnant, or Plan to Become Pregnant.
Breastfeeding
It is not Known if Ranolteril Passes into Breast Milk. Breastfeeding is not Recommended while Taking Tolterodine.
Before Taking any Medication, Consult a Doctor or Pharmacist.

Driving and Operating Machines

Ranolteril may Cause Dizziness, Fatigue, or Affect Vision; this may Impact the Ability to Drive and Operate Machines.

Ranolteril Contains Sodium

This Medication Contains Less than 1 mmol of Sodium (23 mg) per Tablet, which means the Medication is Considered "Sodium-Free".

3. How to Take Ranolteril

Dosage
This Medication should be Taken as Directed by the Doctor. In Case of Doubt, Consult a Doctor or Pharmacist.
The Usual Dose of the Medication is one 2 mg Tablet Taken Twice a Day, Except for Patients with Impaired Kidney or Liver Function or those who Experience Troublesome Undesirable Effects. In such Cases, the Doctor may Reduce the Dose to one 1 mg Tablet Twice a Day.
Ranolteril is not Recommended for Use in Children.
Tablets should be Taken Orally and Swallowed Whole.
Duration of Treatment
The Doctor will Inform the Patient how Long the Treatment with Ranolteril will Last. Do not Stop the Treatment Prematurely due to the Lack of Immediate Effect of the Medication. The Bladder Needs Time to Respond to the Treatment. Complete the Treatment Course Prescribed by the Doctor.
Consult a Doctor if there is no Improvement after Completing the Treatment.
The Benefits of the Treatment should be Reassessed after 2 or 3 Months.
If the Patient Considers Stopping the Treatment, they should Always Discuss it with their Doctor.

Taking a Higher Dose of Ranolteril than Recommended

If the Patient has Taken a Larger Number of Tablets than Recommended or Someone Else has Taken them, Inform a Doctor or Pharmacist Immediately.
In Case of Tolterodine Overdose, the Following Symptoms have been Reported:

• Severe Central Anticholinergic Effects (e.g., Hallucinations, Significant Excitement)
• Seizures and Significant Excitement
• Respiratory Failure
• Tachycardia
• Urinary Retention
• Pupil Dilation
• QT Interval Prolongation

Missing a Dose of Ranolteril

Do not Take a Double Dose to Make up for a Missed Dose. If the Patient has Forgotten 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 this Case, Skip the Missed Dose and Take the Next Dose at the Usual Time.

Stopping Ranolteril Treatment

In Case of Further Doubts about the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Ranolteril can Cause Undesirable Effects, although not Everybody gets them.
Immediately Contact a Doctor or Go to the Hospital Emergency Department if the Following Symptoms of Angioedema Occur:

• Swelling of the Face, Tongue, or Throat
• Difficulty Swallowing
• Hives and Difficulty Breathing.

Also, Inform a Doctor if the Following Allergic Reactions Occur (e.g., Itching, Rash, Hives, Difficulty Breathing). These Symptoms are not Very Common (Less than 1 in 100 Patients).
Immediately Contact a Doctor or Go to the Hospital Emergency Department if the Following Occur:

• Chest Pain, Difficulty Breathing, or Easy Fatigue (even at Rest), Difficulty Breathing at Night, Swelling of the Legs.

These may be Symptoms of Heart Failure. These Symptoms are not Very Common (Less than 1 in 100 Patients).
During Tolterodine Treatment, the Following Undesirable Effects have been Observed with the Following Frequency:

Very Common (Occurring in more than 1 in 10 Patients) Undesirable Effects are:

• Dry Mouth
• Headache

Common(Occurring in Less than 1 in 10 Patients) Undesirable Effects are:

• Bronchitis
• Dizziness
• Drowsiness
• Dry Eyes
• Blurred Vision
• Abdominal Pain
• Vertigo
• Palpitations
• Dry Skin
• Indigestion
• Constipation
• Fatigue (Nausea)
• Pain or Difficulty During
• Weight Gain
• Chest Pain
• Vomiting
• Difficulty Emptying the Bladder
• Diarrhea
• Numbness or Tingling in Fingers and Toes
• Excess Gas in the Stomach or Intestines
• Excess Fluid in the Body Leading to Swelling (e.g., of the Ankles)

Uncommon(Occurring in Less than 1 in 100 Patients) Undesirable Effects are:
urination
body

• Allergic Reactions
• Nervousness
• Irregular Heartbeat
• Fast Heart Rate
• Heart Failure
• Heartburn
• Memory Disorders

Additional Undesirable Effects Reported after the Medication was Placed on the Market Included Severe Allergic Reactions, Confusion, Hallucinations (Seeing, Hearing, Feeling, Tasting, or Smelling Things that do not Exist), Sudden Redness of the Face, Angioedema, and Disorientation. There have also been Reports of Worsening Dementia in Patients with Dementia being Treated.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist.
Undesirable Effects can be Reported Directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Ranolteril

Store the Medication in a Place that is not Visible and not Accessible to Children.
Do not Use this Medication after the Expiration Date Stated on the Label or Carton after EXP. The Expiration Date is the Last Day of the Specified Month.
This Medicinal Product does not Require any Special Storage Conditions.

6. Package Contents and Other Information

What Ranolteril Contains

The Active Substance of the Medication is 1 mg of Tolterodine Tartrate, which Corresponds to 0.68 mg of Tolterodine.
The Active Substance of the Medication is 2 mg of Tolterodine Tartrate, which Corresponds to 1.37 mg of Tolterodine.
Other Ingredients are:
Core: Microcrystalline Cellulose, Sodium Carboxymethylcellulose (Type A), Magnesium Stearate, Colloidal Anhydrous Silica.
Coating: Hypromellose, Titanium Dioxide (E171), Macrogol 8000, Talc.

What Ranolteril Looks Like and What the Package Contains

Ranolteril 1 mg Tablets are White to Off-White, Round with a Diameter of Approximately 6.35 mm, Biconvex, Film-Coated, with the Marking "S16" Engraved on one Side, and no Marking on the Other Side.
Ranolteril 2 mg Tablets are White to Off-White, Round with a Diameter of Approximately 6.35 mm, Biconvex, Film-Coated, with the Marking "S042" Engraved on one Side, and no Marking on the Other Side.
The Following Package Sizes of Ranolteril 1 mg and Ranolteril 2 mg Film-Coated Tablets are Available:
Blisters Containing:

• 14 Tablets (1 Blister of 14 Tablets)
• 20 Tablets (2 Blisters of 10 Tablets)
• 28 Tablets (2 Blisters of 14 Tablets)
• 30 Tablets (3 Blisters of 10 or 2 Blisters of 15 Tablets)
• 56 Tablets (4 Blisters of 14 Tablets)
• 60 Tablets (6 Blisters of 10 or 4 Blisters of 15 Tablets)
• 90 Tablets (9 Blisters of 10 or 6 Blisters of 15 Tablets)

Not all Package Sizes may be Available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw

Manufacturer/Importer:

Accord Healthcare Polska Sp.z o.o.
Lutomierska 50 Street
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands

This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the Following Names:

Date of Last Revision of the Package Leaflet: December 2022