Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - olanzapine

Document Subject

Generated Narrative: MedicinalProductDefinition mpbe86a7120b3e7e0f4ee2c7a69bc3ffec

identifier: http://ema.europa.eu/identifier/EU/1/07/427/001 – 28 tablets, per box

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Olanzapine Teva 2.5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-be86a7120b3e7e0f4ee2c7a69bc3ffec

identifier: http://ema.europa.eu/identifier/EU/1/07/427/001 – 28 tablets, per box

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - olanzapine

Attesters

What is in this leaflet

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

Olanzapine Teva contains the active substance olanzapine. Olanzapine Teva belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.

Olanzapine Teva has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.

Do not take Olanzapine Teva

• if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.
• if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).

Warnings and precautions Talk to your doctor or pharmacist before taking Olanzapine Teva.

• The use of Olanzapine Teva in elderly patients with dementia is not recommended as it may have serious side effects.
• Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olanzapine Teva tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.
• Weight gain has been seen in patients taking Olanzapine Teva. You and your doctor should check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Teva. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Teva and regularly during treatment.
• Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.

If you suffer from any of the following illnesses tell your doctor as soon as possible:

• Stroke or mini stroke (temporary symptoms of stroke)
• Parkinson s disease
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or mini stroke.

As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.

Children and adolescents Olanzapine Teva is not for patients who are under 18 years.

Other medicines and Olanzapine Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take use any other medicines.

Only take other medicines while you are on Olanzapine Teva if your doctor tells you that you can. You might feel drowsy if Olanzapine Teva is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).

In particular, tell your doctor if you are taking:

• medicines for Parkinson s disease.
• carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Teva dose.

Olanzapine Teva with alcohol Do not drink any alcohol if you have been given Olanzapine Teva as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Teva can pass into breast milk. The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Teva in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines There is a risk of feeling drowsy when you are given Olanzapine Teva. If this happens do not drive or operate any tools or machines. Tell your doctor.

Olanzapine Teva contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Olanzapine Teva tablets to take and how long you should continue to take them. The daily dose of Olanzapine Teva is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Teva unless your doctor tells you to.

You should take your Olanzapine Teva tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. Olanzapine Teva coated tablets are for oral use. You should swallow the Olanzapine Teva tablets whole with water.

If you take more Olanzapine Teva than you should Patients who have taken more Olanzapine Teva than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.

If you forget to take Olanzapine Teva Take your tablets as soon as you remember. Do not take two doses in one day.

If you stop taking Olanzapine Teva Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine Teva for as long as your doctor tells you. If you suddenly stop taking Olanzapine Teva, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.

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

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

Tell your doctor immediately if you have:

• unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;
• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood. In the early stages 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 will usually pass on its own but if it does not, tell your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males

Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.

Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson's disease Olanzapine Teva may worsen the symptoms.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 25 C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Olanzapine Teva contains

• The active substance is olanzapine. Each Olanzapine Teva 2.5 mg film-coated tablet contains 2.5 mg of the active substance. Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of the active substance. Each Olanzapine Teva 7.5 mg film-coated tablet contains 7.5 mg of the active substance. Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of the active substance. Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of the active substance. Each Olanzapine Teva 20 mg film-coated tablet contains 20 mg of the active substance.
• The other ingredients are: Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), silica colloidal anhydrous, microcrystalline cellulose, magnesium stearate. Tablet coating: hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171). In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains iron oxide red (E172).

What Olanzapine Teva looks like and contents of the pack

Olanzapine Teva 2.5 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed OL 2.5 on one side and plain on the other. Olanzapine Teva 5 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed OL 5 on one side and plain on the other. Olanzapine Teva 7.5 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed OL 7.5 on one side and plain on the other. Olanzapine Teva 10 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed OL 10 on one side and plain on the other. Olanzapine Teva 15 mg film-coated tablet is a light blue, biconvex, oval film-coated tablet, debossed OL 15 on one side and plain on the other. Olanzapine Teva 20 mg film-coated tablet is a pink, biconvex, oval film-coated tablet, debossed OL 20 on one side and plain on the other.

Olanzapine Teva 2.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 film- coated tablets. Olanzapine Teva 5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets. Olanzapine Teva 7.5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets. Olanzapine Teva 10 mg film-coated tablets are available in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x1 film-coated tablets. Olanzapine Teva 15 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56, 70 or 98 film- coated tablets. Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 film- coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands

Manufacturer

Teva Pharmaceutical Works Co. Ltd Pallagi t 4042 Debrecen Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark SanoSwiss UAB Litauen Tlf: +370 70001Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
TEVA HELLAS A.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
TEVA HELLAS A.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.

Detailed information on this medicine is available on the European Medicines Agency web site: