Olanzapine STADA – Olanzapine uses, dose and side effects


2.5 mg, 5 mg, 7.5 mg, 10 mg film-coated tablets

What Olanzapine STADA is and what it is used for

Olanzapine Stada contains the active substance olanzapine. Olanzapine Stada belongs to the group of drugs neuroleptics and is used to treat the following conditions:

  • Schizophrenia, a disease with symptoms such as hearing, seeing or feeling something that does not exist, delusions, unusual suspicion and withdrawal. People with this disease may also feel depressed, anxious or tense.
  • Moderate to severe manic episodes, a condition with symptoms such as arousal and euphoria .

Olanzapine Stada prevents recurrence of these symptoms in patients with bipolar disorder who have responded to olanzapine treatment in the manic phase.

Olanzapine contained in Olanzapine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Olanzapine STADA

Do not use Olanzapine STADA

  • if you are allergic to olanzapine, peanuts, soy or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself as a rash, itching , swollen face, swollen lips or difficulty breathing. If this happens, consult your doctor
  • if you have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and cautions

Talk to your doctor or pharmacist before taking Olanzapine Stada.

  • The use of Olanzapine Stada in elderly patients with dementia is not recommended as it may cause serious side effects .
  • Drugs of this type can cause abnormal movements of the face or tongue. Contact your doctor if this happens.
  • This type of medicine can also cause a combination of fever, shortness of breath, sweating, muscle stiffness and drowsiness. These side effects are extremely rare, but if they do occur, contact your doctor immediately.
  • Weight gain has occurred in patients taking Olanzapine Stada. You and your doctor should check your weight regularly. Consider referral to a dietitian or help with a diet list if necessary.
  • High blood sugar and high blood fat levels ( triglycerides and cholesterol ) have been reported in patients taking Olanzapine Stada. Your doctor should take blood tests to check your blood sugar and blood fats before you start taking Olanzapine Stada and then at regular intervals during treatment.
  • Tell your doctor if you or anyone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.

You must tell your doctor if you suffer from any of the following diseases:

  • stroke or mild form of stroke (temporary symptoms of stroke )
  • Parkinson’s disease
  • prostate problem
  • intestinal upset (paralytic ileus )
  • liver or kidney disease
  • blood disease
  • heart disease
  • diabetes
  • seizures
  • if you know you may be salt deficient due to prolonged severe diarrhea and vomiting or using diuretics ( diuretics ).

For dementia patients, the doctor should be informed if the patient has had a stroke or a milder form of stroke.

If you are over 65, your blood pressure should be checked regularly by your doctor.

Children and young people

Olanzapine Stada is not for use in patients under 18 years of age.

Other medicines and Olanzapine STADA

Only take other medicines during Olanzapine Stada treatment if your doctor advises you to do so. Along with the following medicines, drowsiness may occur medicines for depression and anxiety and sleeping pills (sedatives).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must tell your doctor if you are taking:

  • medicines for Parkinson’s disease
  • carbamazepine (for epilepsy and mood stabilizers), fluvoxamine (for depression) or ciprofloxacin ( antibiotics ) – it may be necessary to adjust your Olanzapine Stada dose .

Olanzapine STADA with food, drink and alcohol

Do not drink alcohol during treatment with Olanzapine Stada, as it may cause drowsiness with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine if you are breastfeeding, as small amounts of Olanzapine Stada may pass into breast milk.

In newborns whose mothers have taken Olanzapine Stada during the last trimester (the last three months of pregnancy), the following symptoms may occur tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to contact your doctor.

Driving and using machines

There is a risk that you will feel drowsy when using Olanzapine Stada. If this happens, do not drive or use any tools or machines and consult your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Olanzapine STADA contains lactose and soy lecithin

Olanzapine Stada contains lactose .

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Olanzapine Stada contains soy lecithin.

If you are allergic to peanuts or soy, do not take this medicine.

How to take Olanzapine STADA

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will tell you how many Olanzapine Stada tablets to take and how long to take them. The dose of Olanzapine Stada is between 5 mg and 20 mg per day.

Contact your doctor if symptoms return but do not stop taking the medicine unless your doctor tells you to.

You should take Olanzapine Stada once a day. Try to take the tablets at the same time each day either at mealtime or between meals. The tablets should be taken by mouth and swallowed whole with water.

If you use more Olanzapine STADA than you should 

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

Patients who have taken too much Olanzapine Stada have experienced the following symptoms: rapid heart rate, agitation/aggression, speech difficulties, involuntary movement disorders (especially in the face or tongue), and loss of consciousness. Other symptoms may include acute confusion, seizures ( epilepsy ), coma, a combination of fever, shortness of breath, sweating, muscle stiffness, drowsiness or drowsiness, slow breathing, difficulty breathing, high or low blood pressure, abnormal heart rhythm. Contact your doctor or hospital immediately if you experience any of the listed symptoms. Take the remaining tablets with you.

If you forget to use Olanzapine STADA

Take your tablets as soon as you remember. Do not take two doses on the same day.

If you stop using Olanzapine STADA

It is important that you follow your doctor’s instructions and do not stop taking the medicine because you feel better.

If you suddenly stop taking Olanzapine Stada, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea, and vomiting. Your doctor may recommend that you reduce the dose gradually before stopping treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you get:

  • involuntary movement disorders (a common side effect that can affect up to 1 in 10 users) especially in the face or tongue
  • blood clots in the veins (a less common side effect that can affect up to 1 in 100 people) especially in the legs (symptoms are swelling, pain and redness on the legs). The blood clots can be transported to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
  • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or drowsiness (the frequency of this side effect can not be calculated from the available data).

Very rare side effects include severe allergic reactions such as drug reactions with eosinophilia and systemic symptoms (DRESS). DRESS initially appears with flu-like symptoms with rash on the face and then by more widespread rash, fever, enlarged lymph nodes, elevated levels of liver enzymes seen in blood tests, and elevated levels of a type of white blood cell ( eosinophils ).

Very common side effects (may affect more than 1 user in 10) include:

  • weight gain
  • somnolence
  • increased levels of prolactin in the blood.

At the beginning of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This often disappears by itself. If not, contact your doctor.

Common side effects (may affect up to 1 in 10 people) include:

  • changes in levels of blood cells and lipids and at the beginning of treatment, temporarily increased number of liver enzymes
  • increased blood sugar and urine levels
  • elevated levels of uric acid and creatinine phosphokinase in the blood
  • increased appetite, dizziness
  • restlessness, tremors
  • movement difficulties (dyskinesia), constipation
  • dry mouth , rash
  • impotence
  • extreme fatigue
  • fluid retention leading to swelling of the hands, ankles or feet
  • fever, joint pain
  • sexual problems such as decreased sexual drive in men and women or erection problems in men.

Uncommon side effects (may affect up to 1 in 100 people) include:

  • hypersensitivity (eg swelling of the mouth and throat, itching , rash)
  • diabetes or exacerbation of diabetes, sometimes associated with ketoacidosis (ketones in the blood and urine) or coma
  • seizures, generally with known susceptibility to seizures ( epilepsy )
  • muscle stiffness or spasms (including eye movements)
  • ant crawls and feeling of restlessness in the legs at rest (restless legs)
  • speech difficulties
  • stuttering
  • slow heartbeat
  • sensitivity to sunlight
  • bleeding from the nose
  • stretched abdomen
  • dreglande
  • memory loss or forgetfulness
  • urinary incontinence.
  • difficulty urinating
  • hair loss
  • missed or reduced menstruation
  • breast changes in men and women such as abnormal breast milk production or abnormal enlargement.

Rare (may affect up to 1 in 1,000 people) include:

  • lowering of the normal body temperature
  • abnormal heart rhythm
  • sudden, unexplained death
  • inflammation of the pancreas that led to severe stomach pain, fever and malaise
  • liver disease that manifests itself in yellowing of the skin and whites of the eyes
  • muscle disease that manifests itself in unexplained aches and pains
  • prolonged and / or painful erection .

When taking olanzapine, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, increased tendency to fall, extreme fatigue, visual hallucinations, increased body temperature, reddening of the skin, and difficulty walking. Some deaths have been reported in this specific patient group.

For patients with Parkinson’s disease, Olanzapine Stada may worsen the symptoms.

How to store Olanzapine STADA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Blister pack:

Store in the original package. Sensitive to light. Moisture sensitive.

Tablet jars

Store in the original package. Close the jar tightly. Sensitive to light. Moisture sensitive.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is olanzapine. Each tablet contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of the active substance. The exact amount is stated on your Olanzapine Stada package.
  • Other ingredients are; Tablet core: Anhydrous lactose , microcrystalline cellulose, crospovidone, magnesium stearate. Tablet coating: Polyvinyl alcohol, Titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum (E415).

What the medicine looks like and contents of the pack

Film-coated tablet 2.5 mg:

Round, biconvex, white, film-coated tablet, 6 mm in diameter, with the print “O” on one side.

Film-coated tablet 5 mg:

Round, biconvex, white, film-coated tablet, 8 mm in diameter, with the print “O1” on one side.

Film-coated tablet 7.5 mg:

Round, biconvex, white, film-coated tablet, 9 mm in diameter, with the print “O2” on one side.

Film-coated tablet 10 mg:

Round, biconvex, white, film-coated tablet, 10 mm in diameter, with the print “O3” on one side.

Pack sizes blister:

Olanzapine STADA 2.5 mg film-coated tablets: 7, 10, 28, 30 and 98 film-coated tablets or 7×1, 10×1, 28×1, 30×1 and 98×1 film-coated tablets in perforated unit dose blisters.

Olanzapine STADA 5 mg film-coated tablets: 7, 10, 28, 30, 50, 56, 84, 98 and 112 film-coated tablets or 7×1, 10×1, 28×1, 30×1, 50×1, 56×1, 84×1, 98×1 and 112×1 fi

lm-coated tablets in perforated unit dose blisters.

Olanzapine STADA 7.5 mg film-coated tablets: 7, 28, 56, 60, 84, 98 and 112 film-coated tablets or 7×1, 28×1, 56×1, 60×1, 84×1, 98×1 and 112×1 film-coated tablets in perforated unit dose blisters.

Olanzapine STADA 10 mg film-coated tablets: 7, 10, 28, 30, 50, 56, 60, 84, 98 and 112 film-coated tablets or 7×1, 10×1, 28×1, 30×1, 50×1, 56×1, 60×1, 84×1, 98×1 and 112×1 film-coated tablets in perforated unit dose blisters.

Pack sizes can:

Olanzapine STADA 2.5 mg film-coated tablets: 30, 100, 500 film-coated tablets.

Olanzapine STADA 5 mg film-coated tablets: 30, 100, 500 film-coated tablets.

Olanzapine STADA 7.5 mg film-coated tablets: 30, 100, 500 film-coated tablets.

Olanzapine STADA 10 mg film-coated tablets: 30, 100, 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel


Other manufacturers

Sanico NV

Industrial Zone, Veedijk 59

2300 Turnhout


Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev


Leave a Reply