Ranofren

Package Leaflet: Information for the User

Ranofren, 5 mg, tablets

Ranofren, 10 mg, tablets

Olanzapine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

1. What is Ranofren and what is it used for

Ranofren contains the active substance olanzapine. Ranofren belongs to a group of medicines called antipsychotics and is used to treat:

• Schizophrenia - a disease characterized by hearing, seeing, or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious, and withdrawing from contact with others. The patient may experience depression, anxiety, or tension.
• Moderate to severe manic episodes - disease states whose symptoms are excitement or euphoria.

It has been shown that Ranofren prevents the recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Ranofren

When not to take Ranofren

• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, you should inform your doctor.
• If you have eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting treatment with Ranofren, you should discuss it with your doctor or pharmacist.

• Ranofren is not recommended for use in elderly patients with dementia, as it may cause very serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If you experience such a symptom after taking Ranofren, you should inform your doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, you should contact your doctor immediately.
• In patients taking Ranofren, weight gain has been observed. You should have your weight checked regularly. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Ranofren, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Ranofren and during treatment, your doctor should perform blood tests to determine your blood sugar and lipid levels.
• You should tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

If you have any of the following conditions, you should immediately inform your doctor:

• stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• prostate disorders;
• intestinal obstruction (paralytic ileus);
• liver or kidney disease;
• blood diseases;
• heart disease;
• diabetes;
• seizures;
• if you know that you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urinary medications).

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should inform your doctor.
Routinely, as a precaution, your doctor may check your blood pressure in people over 65 years of age.

Children and adolescents

Ranofren is not intended for use in patients under 18 years of age.

Other medicines and Ranofren

People taking Ranofren may only take other medicines with the consent of their doctor. Taking Ranofren in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor if you are taking:

• medicines used to treat Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Ranofren may be necessary.

Ranofren with alcohol

You should not drink alcohol after taking Ranofren, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Ranofren should not be taken by women who are breastfeeding, as small amounts of the medicine may pass into human milk.
In newborns whose mothers took Ranofren during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing problems, and feeding difficulties. If you notice such symptoms in your baby, you should contact your doctor.

Driving and using machines

Ranofren may cause drowsiness. If drowsiness occurs, you should not drive or operate any machines or devices. You should inform your doctor.

Ranofren contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

Ranofren contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Ranofren

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should ask your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Ranofren. The daily dose of Ranofren is 5 mg to 20 mg. If the symptoms of the disease recur, you should inform your doctor. However, you should not stop taking Ranofren unless your doctor decides to do so.
Ranofren tablets should be taken once a day, as directed by your doctor. You should try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food.
Ranofren tablets should be taken orally. The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Ranofren than recommended

In patients who have taken a higher dose of Ranofren than recommended, the following symptoms have occurred: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and decreased consciousness. Other symptoms include:
severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disorders. You should contact your doctor immediately or go to the hospital if any of these symptoms occur. You should show your doctor the packaging of the tablets.

Missing a dose of Ranofren

As soon as you remember, you should take a tablet. You should not take a double dose to make up for the missed dose.

Stopping treatment with Ranofren

In case of improvement, you should not stop taking the tablets. It is important to take Ranofren for as long as your doctor recommends.
If you suddenly stop taking Ranofren, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Ranofren before stopping treatment.
If you have any further doubts about taking the medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately inform your doctor if you experience:

• abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 patients);
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, you should seek medical attention immediately.
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
• hypersensitivity (e.g., swelling in the mouth and throat, itching, rash) (an uncommon side effect that may affect up to 1 in 100 patients).
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high body temperature, enlarged lymph nodes, elevated liver enzymes, and an increased number of one type of white blood cell (eosinophilia) (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (which may affect more than 1 in 10 patients) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a decrease in heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually resolve on their own, but if they persist, you should inform your doctor.
Common side effects (which may affect up to 1 in 10 patients) include changes in the number of certain blood cells, lipid levels in the blood, and transient increases in liver enzyme activity at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase activity in the blood, increased alkaline phosphatase activity, high gamma-glutamyltransferase activity, increased appetite, dizziness, anxiety, trembling, movement disorders (dyskinesias), constipation, dry mouth, weakness, extreme fatigue, water retention in the body causing swelling of the hands, feet, or ankles, fever, joint pain, and sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects (which may affect up to 1 in 100 patients) include diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma, increased total bilirubin levels, seizures, usually in patients who have had seizures (epilepsy) in the past, muscle stiffness or cramps (including eye movements), restless legs syndrome, speech disorders, stuttering, slow heart rate, prolonged QT interval, sensitivity to sunlight, nosebleeds, drooling, abdominal bloating, memory loss or amnesia, urinary incontinence, difficulty urinating, feeling of urgency to urinate, hair loss, absence or decrease of menstrual periods, changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rarely reported side effects (which may affect up to 1 in 1000 patients):
thrombocytopenia, decreased normal body temperature, malignant neuroleptic syndrome (muscle stiffness, high fever, altered consciousness, instability of the autonomic nervous system), withdrawal symptoms, heart rhythm disorders, sudden death from an unknown cause, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease characterized by a change in skin and white eye color to yellow, muscle disease characterized by unexplained muscle pain and weakness, prolonged and (or) painful erections.
The frequency of the following side effect cannot be estimated from the available data: withdrawal syndrome in newborns.
During treatment with olanzapine in elderly patients with dementia, the following have been reported: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, Ranofren may exacerbate the symptoms of the disease.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ranofren

The medicine should be stored out of sight and reach of children.
You should not take Ranofren after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ranofren contains

• The active substance is olanzapine. Each Ranofren tablet contains 5 mg or 10 mg of olanzapine. Detailed information on the active substance can be found on the packaging of Ranofren.
• Other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium carboxymethylcellulose (Type A).

What Ranofren looks like and contents of the pack

Ranofren 5 mg tablets: round, yellow, biconvex, with a score line on one side.
The tablet can be divided into equal doses.
Ranofren 10 mg tablets: round, yellow, biconvex.
Ranofren tablets are available in cardboard boxes containing 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

{Poland} {Ranofren}
{Spain} {Zolafren}
Date of last revision of the leaflet:01.2024