Zolafren 2.5 mg hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Zolafren 2.5 mg hard capsules EFG
olanzapine
Read all of this 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 only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Zolafren is and what it is used for
- What you need to know before taking Zolafren
- How to take Zolafren
- Possible side effects
- How to store Zolafren
- Contents of the pack and other information
1. What Zolafren is and what it is used for
Zolafren belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:
- Schizophrenia, a disorder whose symptoms include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
- Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.
Zolafren has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.
2. What you need to know before taking Zolafren
Do not take Zolafren:
- If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
- If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).
Warnings and precautions
Talk to your doctor or pharmacist before starting Zolafren.
-
The use of Zolafren is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
-
Medicines of this type may cause unusual movements, especially of the face or tongue. If this happens after taking Zolafren, inform your doctor.
-
Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.
-
Weight gain has been observed in patients taking Zolafren. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a dietitian.
-
Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Zolafren. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Zolafren and regularly during treatment.
-
If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with blood clot formation.
If you have any of the following conditions, inform your doctor as soon as possible:
- Stroke or transient ischemic attack (temporary stroke-like symptoms).
- Parkinson's disease
- Prostate problems
- Intestinal blockage (paralytic ileus)
- Liver or kidney disease
- Blood disorders
- Heart disease
- Diabetes
- Seizures
- If you think you may have loss of body salts due to prolonged severe diarrhea and vomiting, or due to the use of diuretic medicines (water tablets)
If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.
Children and adolescents
Patients under 18 years of age must not take Zolafren.
Other medicines and Zolafren
Only use other medicines together with Zolafren if your doctor authorizes it. You may feel increased drowsiness if Zolafren is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, tell your doctor if you are taking:
- Medication for Parkinson's disease.
- Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Zolafren may need to be adjusted.
Use of Zolafren with alcohol
Do not drink alcohol while taking Zolafren, as it may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Zolafren may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Zolafren during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
There is a risk of drowsiness while taking Zolafren. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Zolafren contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Zolafren
Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how many Zolafren capsules to take and for how long. The daily dose of Zolafren ranges between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Zolafren unless your doctor tells you to do so.
You should take your Zolafren capsules once daily, as directed by your doctor. Try to take the capsules at the same time each day. You may take them with or without food. Zolafren hard capsules are for oral administration. You must swallow the capsules whole with water.
If you take more Zolafren than you should
Patients who have taken more Zolafren than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the pack with the capsules.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Zolafren
Take your capsule as soon as you remember. Do not take a double dose to make up for missed doses.
If you stop taking Zolafren
Do not stop treatment simply because you feel better. It is very important to continue taking Zolafren for as long as your doctor instructs.
If you stop taking Zolafren suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping 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 will experience them.
Contact your doctor immediately if you have:
- unusual movements (a common adverse effect that may affect up to 1 in 10 people), especially of the face or tongue.
- blood clots in the veins (an uncommon adverse effect that may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
- a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from available data).
Very common adverse effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor.
Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, and temporary increases in liver enzymes at the beginning of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; weakness; excessive fatigue; fluid retention causing swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.
Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. mouth and throat swelling, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the breast gland in men and women such as abnormal production of breast milk or abnormal growth.
Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and whites of the eyes; muscle disorder presenting as unexplained muscle pain, and prolonged and/or painful erection.
Very rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes seen in blood tests, and increased levels of a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.
Zolafren may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Zolafren
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage temperature.
Zolafren should be stored in its original packaging to protect it from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE collection point. 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 Zolafren
- The active substance is olanzapine. Each capsule contains 2.5 mg of the active ingredient.
- The other components are: microcrystalline cellulose (type 112), lactose monohydrate, magnesium stearate, gelatin, titanium dioxide (E171), and black iron oxide (E172).
Appearance of the product and contents of the pack
Zolafren 2.5 mg are hard gelatin capsules of size 3, containing 2.5 mg of olanzapine, with a white body and grey cap.
They are supplied in PA-Aluminum-PVC/Aluminum blisters in packs of 28 or 56 capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Laboratorios, S.L.U.
c/de las Rosas de Aravaca, 31-2nd floor
28023 Aravaca (Madrid), Spain
Manufacturer
Adamed Pharma S.A.
Ul. Marszalka Jozefa Pilsudskiego 5
95-200 Pabianice, Poland
This medicinal product is authorized in the Member States of the European Economic Area
under the following names
Country | Medicine Name |
Spain | Zolafren 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg hard capsules EFG |
Date of the most recent review of this leaflet: October 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/