Farpenta

Package leaflet: Information for the user

Farpenta 2.5 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Olanzapine
Please read all of this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Farpenta is and what it is used for

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

• Schizophrenia, a disorder with symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
• Moderate to severe manic episodes, a condition characterised by symptoms of excitement or euphoria.

Farpenta has been shown to be able to prevent the return of these symptoms in patients with bipolar disorder in whom the manic episode has responded to treatment with olanzapine.

2. What you need to know before taking Farpenta

Do not take Farpenta

• if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced this, inform your doctor.
• if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

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

• The use of Farpenta in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after you have been given Farpenta, inform your doctor.
• Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Farpenta. Your doctor will therefore regularly monitor your body weight, with your cooperation. If necessary, consider seeking advice from a dietitian or following a dietary program.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been reported in patients taking Farpenta. Your doctor will therefore arrange for blood tests to monitor your blood sugar and certain blood fat levels before you start taking Farpenta and periodically during treatment.
• Inform your doctor if you or a family member has a history of blood clots, as such medicines have been associated with blood clot formation.

If you suffer from any of the following conditions, inform your doctor as soon as possible:

• Stroke or "mini" strokes (transient ischaemic attacks)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Epileptic seizures
• If you know you may experience excessive loss of salt due to severe and prolonged diarrhoea and vomiting (due to illness) or due to the use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.

Children and adolescents
Farpenta is not indicated for patients under 18 years of age.

Other medicines and Farpenta
During treatment with Farpenta, take other medicines only after obtaining approval from your doctor. You may feel drowsy if Farpenta is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquillisers).
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – as your dose of Farpenta may need to be adjusted.

Farpenta and alcohol
Do not drink any alcoholic beverages during treatment with Farpenta, as taking alcohol together with this medicine may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You should not take this medicine while breastfeeding, as small amounts of Farpenta may pass into breast milk.
The following symptoms may occur in newborns whose mothers have used Farpenta 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, you may need to contact your doctor.

Driving and using machines
When taking Farpenta, there is a risk of experiencing drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Farpenta contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Farpenta

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Farpenta tablets to take and for how long you should continue taking them. The dose of Farpenta ranges from 5 mg to 20 mg daily. If your symptoms return, discuss this with your doctor, but do not stop taking Farpenta unless your doctor tells you to do so.
You should take Farpenta tablets once daily, following your doctor's instructions. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. Farpenta coated tablets are for oral use. Swallow the Farpenta tablets whole with water.

If you take more Farpenta than you should
Patients who have taken more Farpenta than prescribed have experienced the following symptoms: increased heart rate, agitation/aggression, speech problems, unusual movements (especially of the face or 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 somnolence, slowed breathing rate, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if you experience any of the symptoms listed above. Show your doctor the tablet pack.

If you forget to take Farpenta
Take the missed dose as soon as you remember. Do not take a double dose on the same day.

If you stop taking Farpenta
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue Farpenta treatment for as long as your doctor considers necessary.
If you suddenly stop taking Farpenta, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately if any of the following occur:

• unusual movements (a common side effect which may occur in up to 1 in 10 people), mainly of the face or tongue;
• blood clots in the veins (an uncommon side effect which may occur in up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical help;
• a combination of fever, rapid breathing, sweating, muscle stiffness and mental dullness or drowsiness (the frequency of this side effect cannot be determined from the available data).

Very common side 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 feel dizzy or faint (with a slowing of the heartbeat), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats, and in the early stages of treatment, temporary increases in liver enzymes; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased feeling of hunger; 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 dysfunction 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 of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketones in blood and urine) or coma; seizures, usually in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 patients) include: decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease presenting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pains; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as rash on the face subsequently spreading, high temperature, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and walking disorders. In this particular group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, Farpenta may cause worsening of symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Farpenta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not store above 25°C. Keep the product in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Farpenta contains:

• The active substance is olanzapine. Each film-coated tablet of Farpenta 2.5 mg contains 2.5 mg of active substance. Each film-coated tablet of Farpenta 5 mg contains 5 mg of active substance. Each film-coated tablet of Farpenta 7.5 mg contains 7.5 mg of active substance. Each film-coated tablet of Farpenta 10 mg contains 10 mg of active substance. Each film-coated tablet of Farpenta 15 mg contains 15 mg of active substance. Each film-coated tablet of Farpenta 20 mg contains 20 mg of active substance.

• The excipients are: (tablet core) monohydrate lactose, hydroxypropylcellulose, crospovidone (type A), anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate; (coating of the tablet) hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171).

• Additionally, the 15 mg tablets contain indigo carmine (E132) and the 20 mg tablets contain red iron oxide (E172).

Description of the appearance of Farpenta and contents of the pack
Farpenta 2.5 mg film-coated tablet is a white, round, biconvex film-coated tablet with a diameter of approximately 6 mm, marked with "OL 2.5" on one side and smooth on the other.
Farpenta 5 mg film-coated tablet is a white, round, biconvex film-coated tablet with a diameter of approximately 6 mm, marked with "OL 5" on one side and smooth on the other.
Farpenta 7.5 mg film-coated tablet is a white, round, biconvex film-coated tablet with a diameter of approximately 7 mm, marked with "OL 7.5" on one side and smooth on the other.
Farpenta 10 mg film-coated tablet is a white, round, biconvex film-coated tablet with a diameter of approximately 8 mm, marked with "OL 10" on one side and smooth on the other.
Farpenta 15 mg film-coated tablet is a blue, oval, biconvex film-coated tablet with a length of approximately 13 mm and a width of 7.5 mm, marked with "OL 15" on one side and smooth on the other.
Farpenta 20 mg film-coated tablet is a pink, oval, biconvex film-coated tablet with a length of approximately 14 mm and a width of approximately 8 mm, marked with "OL 20" on one side and smooth on the other.
Farpenta 2.5 mg film-coated tablets are available in packs of 28 or 30 film-coated tablets.
Farpenta 5 mg film-coated tablets are available in packs of 28 or 30 film-coated tablets.
Farpenta 7.5 mg film-coated tablets are available in packs of 60 film-coated tablets.
Farpenta 10 mg film-coated tablets are available in packs of 28, 30 or 60 film-coated tablets.
Farpenta 15 mg film-coated tablets are available in packs of 30 film-coated tablets.
Farpenta 20 mg film-coated tablets are available in packs of 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Double-E Pharma, 17 Corrig Road, Sandyford, Dublin 18, Ireland.

Manufacturer:
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom

This leaflet was last approved on {MM/YYYY}.

Patient Information Leaflet: Information for the user

Farpenta 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Olanzapine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms appear to be the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Farpenta is and what it is used for

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

• Schizophrenia, a disorder with symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
• Moderate to severe manic episodes, a condition characterized by symptoms of excitement or euphoria.

Farpenta has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder in whom the manic episode has responded to treatment with olanzapine.

2. What you should know before taking Farpenta

Do not take Farpenta

• if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced this, inform your doctor.
• if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

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

• The use of Farpenta in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this occurs after starting Farpenta, inform your doctor.
• Very rarely, medicines of this type can cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Farpenta. Therefore, your doctor will regularly monitor your body weight, in collaboration with you. If necessary, consider seeking advice from a dietitian or support with a diet program.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been reported in patients taking Farpenta. Accordingly, your doctor will arrange for blood tests to monitor your blood sugar and certain blood fat levels before you start taking Farpenta and periodically during treatment.
• Inform your doctor if you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.

If you have any of the following medical conditions, inform your doctor as soon as possible:

• Stroke or "mini" strokes (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Epileptic seizures
• If you know you may experience excessive loss of salt due to severe and prolonged diarrhoea and vomiting (due to illness) or use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform the doctor if you have previously had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.

Children and adolescents
Farpenta is not indicated for patients under 18 years of age.

Other medicines and Farpenta
During treatment with Farpenta, take other medicines only after authorization from your doctor. You may feel drowsy if Farpenta is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquillisers).
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – as your dose of Farpenta may need to be adjusted.

Farpenta and alcohol
Do not drink any alcoholic beverages during treatment with Farpenta, as taking alcohol together with this medicine may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of Farpenta can pass into breast milk.

The following symptoms may occur in newborns whose mothers have used Farpenta 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, you may need to contact your doctor.

Driving and using machines
When taking Farpenta, you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Important information about some of the excipients in Farpenta
Farpenta contains lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.

Farpenta 5 mg orodispersible tablets also contain 2.25 mg of aspartame (E951).
Farpenta 10 mg orodispersible tablets also contain 4.5 mg of aspartame (E951).
Farpenta 15 mg orodispersible tablets also contain 6.75 mg of aspartame (E951).
Farpenta 20 mg orodispersible tablets also contain 9.0 mg of aspartame (E951).

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.

3. How to take Farpenta

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Farpenta tablets to take and for how long you should continue taking them. The dose of Farpenta ranges from 5 mg to 20 mg per day. If your symptoms reappear, speak to your doctor, but do not stop taking Farpenta unless your doctor tells you to do so.
You should take Farpenta tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. Farpenta orodispersible tablets are for oral use.
Farpenta tablets break easily, so handle them carefully when taking the tablet in your hand. Do not touch the tablets with wet hands, as they may break. Place the tablet in your mouth. It will dissolve directly in the mouth, allowing it to be easily swallowed.
Alternatively, you may also place the tablet in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stir the mixture. With some beverages, the mixture may change colour and become slightly cloudy. Drink it immediately.
If you take more Farpenta than you should
Patients who have taken more Farpenta than prescribed have experienced the following symptoms: increased heart rate, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or somnolence, slowed breathing rate, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if you experience any of the symptoms described above. Show your tablet pack to the doctor.
If you forget to take Farpenta
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking Farpenta
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue Farpenta treatment for as long as your doctor considers necessary.
If you suddenly stop taking Farpenta, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Inform your doctor immediately if any of the following occur:

• unusual movements (a common side effect that may occur in up to 1 in 10 people), mainly affecting the face or tongue;
• blood clots in the veins (an uncommon side effect that may occur in up to 1 in 100 people), especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention;
• a combination of fever, rapid breathing, sweating, muscle stiffness and mental dullness or drowsiness (the frequency of this side effect cannot be determined from available data).

Very common side effects (may occur in 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 slowing of the heart rate), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may occur in up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats, and temporary increases in liver enzymes during the initial stages 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 (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunction such as decreased libido in males and females or erectile dysfunction in males.
Uncommon side effects (may occur in up to 1 in 100 people) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketones in blood and urine) or coma; seizures, usually occurring in individuals with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slowing of the heart rate; sensitivity to sunlight; nosebleeds; abdominal swelling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduced menstrual cycles; and breast-related changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 patients) include decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pain; prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as rash on the face later spreading to other parts of the body, high fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking disorders. In this particular group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, Farpenta may worsen symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Farpenta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. Store the product in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package contents and other information What Farpenta contains:

The active substance is olanzapine.
Each orodispersible tablet of Farpenta 5 mg contains 5 mg of active substance. Each orodispersible tablet of Farpenta 10 mg contains 10 mg of active substance. Each orodispersible tablet of Farpenta 15 mg contains 15 mg of active substance. Each orodispersible tablet of Farpenta 20 mg contains 20 mg of active substance.
The other ingredients are Mannitol, Aspartame (E951), Magnesium stearate, Crospovidone type B, Lactose monohydrate, Hypromellose, Lemon flavour [aroma preparation, maltodextrin, sucrose, gum arabic (E414), glyceryl triacetate (E1518) and alpha-tocopherol (E307)].

Description of the appearance of Farpenta and contents of the pack
Orodispersible tablet is a technical term indicating a tablet that dissolves directly in the mouth, allowing it to be easily swallowed.
Farpenta 5 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 8 mm.
Farpenta 10 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 10 mm.
Farpenta 15 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 11 mm.
Farpenta 20 mg orodispersible tablet is a round, yellow, biconvex tablet with a diameter of 12 mm.
Farpenta 5 mg, 10 mg and 15 mg orodispersible tablets are available in packs of 28 or 30 tablets.
Farpenta 20 mg orodispersible tablets are available in packs of 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder:
Double-E Pharma Ltd., 17 Corrig Road, Sandyford, Dublin 18, Ireland.

Manufacturer:
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary
TEVA PHARMA S.L.U., Poligono Industrial Malpica, c/C, no. 4, 50.016 Zaragoza, Spain
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

This patient information leaflet was last approved in {MM/YYYY}.