Ranofren

Package leaflet: Information for the user

Ranofren, 5 mg, tablets
Ranofren, 10 mg, tablets
Olanzapinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
• If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Ranofren is and what it is used for

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

• schizophrenia – a disorder in which the patient hears, sees, or senses things that do not exist in reality, holds beliefs that are not based in reality, is excessively suspicious, and withdraws from contact with others. The patient may also experience depression, anxiety, or tension.
• moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

Ranofren has been shown to prevent recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment during a manic episode.

2. Important information before taking Ranofren

When not to take Ranofren

• if the patient is allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial swelling, swollen lips or difficulty breathing. If such symptoms occur, inform the doctor immediately.
• if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Ranofren, discuss this with your doctor or pharmacist.

• Ranofren is not recommended for elderly patients diagnosed with dementia, as it may cause very serious adverse effects.
• Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Ranofren, inform your doctor.
• Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation. If such symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking Ranofren. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients taking Ranofren. Before starting and during treatment with Ranofren, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform the doctor if the patient or a family member has a history of blood clots, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the doctor immediately:

• stroke or "mini" stroke (transient ischemic attack);
• Parkinson's disease;
• prostate gland disorders;
• intestinal obstruction (paralytic);
• liver or kidney disease;
• blood disorders;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they may have lost body salts due to prolonged, severe diarrhoea and vomiting (nausea with vomiting) or use of diuretics (water tablets).

If the patient has dementia and has ever had a stroke or "mini" stroke, this should be reported (by the patient or caregiver) to the doctor.
As a precautionary measure, doctors may routinely monitor blood pressure in patients 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
Patients taking Ranofren should use other medicines only with the doctor's approval. Taking Ranofren together with antidepressants, sedatives or sleeping medicines may cause drowsiness.
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

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

Ranofren and alcohol
Do not drink alcohol while taking Ranofren, as this medicine combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before taking this medicine. Breastfeeding women should not take Ranofren, as small amounts of the medicine may pass into human milk.

Newborns whose mothers took Ranofren during the third trimester (last three months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor.

Driving and operating machinery
Ranofren may cause drowsiness. If drowsiness occurs, the patient should not drive or operate any machinery or equipment. Inform the doctor.

Ranofren contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

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

3. How to take Ranofren

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Ranofren. The daily dose of Ranofren ranges from 5 mg to 20 mg. If symptoms reappear, inform your doctor. However, do not stop taking Ranofren unless your doctor advises you to do so.
Ranofren tablets should be taken once daily, as directed by your doctor. Try to take the medicine at the same time each day. It does not matter whether the tablets are taken during or outside of meals.
Ranofren tablets are for oral use. Swallow the tablet whole with water.

Taking more Ranofren than prescribed
In patients who have taken more than the recommended dose of Ranofren, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the facial muscles and tongue), and reduced level of consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or somnolence, decreased respiratory rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical attention or go to a hospital if any of these symptoms occur. Show the doctor the medicine packaging.

Missed dose of Ranofren
Take the tablet as soon as you remember. Do not take a double dose to make up for a missed dose.

Stopping Ranofren treatment
Do not discontinue taking the tablets if you start feeling better. It is important to continue taking Ranofren for as long as your doctor has prescribed.
If Ranofren is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment completely.

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 will experience them.
You should contact your doctor immediately if any of the following occur:

• abnormal movements, especially of the face or tongue (a commonly reported adverse reaction which may affect up to 1 in 10 patients);
• blood clots in the veins (an uncommonly reported adverse reaction which may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, redness of the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, seek medical advice immediately.
• occurrence together of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this adverse reaction cannot be determined from available data).
• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash) (an uncommonly reported adverse reaction which may affect up to 1 in 100 patients).
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, flu-like symptoms initially occur with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and increased levels of one type of white blood cell (eosinophilia) (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (which may affect more than 1 in 10 patients) include
increased body weight, drowsiness, and increased blood prolactin levels. In the early stages of
treatment, dizziness or fainting (with slowed heart function) may occur, particularly when rising from a lying or sitting position. These symptoms usually resolve on their own, but if they persist, you should inform your doctor.
Common adverse reactions (which may affect up to 1 in 10 patients) include changes in the count of
certain blood cells, blood lipid levels, and transient increases in liver enzyme activity at the beginning of treatment, increased blood and urine glucose levels, increased blood uric acid levels and creatine phosphokinase activity, increased alkaline phosphatase activity, high gamma-glutamyltransferase activity, increased appetite, dizziness, restlessness, tremor, movement disorders (dyskinesias), constipation, dryness of the oral mucosa, rash, loss of strength, extreme fatigue, fluid retention leading to 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 adverse reactions (which may affect up to 1 in 100 patients) include
diabetes or worsening of existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma, increased total bilirubin concentration, seizures, usually in patients who previously experienced seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart function, QT interval prolongation, photosensitivity, nosebleeds, hypersalivation, abdominal distension, memory loss or amnesia, urinary incontinence, difficulty urinating, sensation of bladder pressure, hair loss, absence or reduction of menstruation, breast changes in men and women such as lactation outside the breastfeeding period or unusual breast enlargement.
Rarely reported adverse reactions (which may affect up to 1 in 1000 patients):
thrombocytopenia, decreased body temperature, neuroleptic malignant syndrome
(muscle rigidity, high fever, altered mental status, autonomic instability), withdrawal symptoms, cardiac arrhythmias, sudden unexplained death, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease manifesting as yellowing of the skin and whites of the eyes, muscle disease presenting as unexplained muscle aches and pain, prolonged and/or painful erection.
Adverse reactions with unknown frequency include withdrawal syndrome in newborns.
During olanzapine treatment in elderly patients diagnosed with dementia, the following may occur:
stroke, pneumonia, urinary incontinence, falls, extreme fatigue, 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 worsen symptoms of adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ranofren

Keep this medicine out of sight and reach of children.
Do not use Ranofren after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Ranofren contains

• The active substance is olanzapine. Each Ranofren tablet contains 5 mg or 10 mg of olanzapine. Additional information on the amount of active substance is provided on the Ranofren packaging.
• Other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium carboxymethyl starch (Type A).

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
{Poland} {Ranofren}
{Spain} {Zolafren}