Zylanza

Olanzapine.

ZYLANZA 5 mg or 10 mg are yellow to pale yellow, round, biconvex orodispersible tablets embossed on one side with '5' for 5 mg strength and '10' for 10 mg strength.
Each ZYLANZA orodispersible tablet contains either 5 mg or 10 mg of olanzapine.
Excipients/Inactive Ingredients: The other ingredients are: Calcium carbonate, Maize starch pregelatinised, Maize starch, Lactose monohydrate (spray dried), Crospovidone (type A), Aspartame, Magnesium stearate.

ZYLANZA contains the active substance olanzapine. ZYLANZA belongs to a group of medicines called antipsychotics.

ZYLANZA is used to treat the following conditions: Schizophrenia, a disease with symptoms such as hallucinations, mistaken beliefs, unusual suspiciousness, and becoming withdrawn (people with this disease may also feel depressed, anxious or tense); Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
ZYLANZA has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.

This medicine should always be taken exactly as prescribed.
The daily dose of ZYLANZA is between 5 mg and 20 mg. Patients should consult their physician if symptoms return, but they should not stop taking ZYLANZA unless instructed to do so.
ZYLANZA tablets should be taken once a day following physician's advice. The tablets should be taken at the same time each day. It does not matter whether they are taken with or without food.
ZYLANZA orodispersible tablets are for oral use.
ZYLANZA tablets break easily, so they should be handled carefully. The tablets should not be handled with wet hands as they may break up.
1. The blister strip should be held at the edges and one blister cell should be separated from the rest of the strip by gently tearing along the perforations around it.
2. The backing should be carefully peeled off.
3. The tablet should be gently pushed out.
4. The tablet should be put in the mouth. It will dissolve directly in the mouth, so that it can be easily swallowed.
The tablet can also be placed in a full glass or cup of water, orange juice, apple juice, milk or coffee. This mixture should be stirred. With some drinks, the mixture may change colour and possibly become cloudy. It should be consumed straight away.
Forgotten intake of ZYLANZA: The tablets should be taken as soon as they are remembered. Two doses should not be taken in one day.
Stopping intake of ZYLANZA: Patients should not stop taking the tablets just because they feel better. It is important to carry on taking ZYLANZA for as long as prescribed.
If intake of ZYLANZA is suddenly stopped, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. It may be suggested to reduce the dose gradually before stopping treatment.

Patients who have taken more ZYLANZA 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.

ZYLANZA should not be taken by patients with: allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in Description) (an allergic reaction may be recognised as rash, itching, swollen face, swollen lips or shortness of breath); previous diagnosis of eye problems such as certain kinds of glaucoma.

Patients should be assessed before taking ZYLANZA.
Medicines of this type may cause unusual movements mainly of the face or tongue. Patients should be assessed if this happens after ZYLANZA has been given.
Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, immediate medical attention is necessary.
Weight gain has been seen in patients taking ZYLANZA. Weight should be checked regularly. A referral to a dietician or help with a diet plan should be considered if necessary.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYLANZA. Blood tests should be performed to check blood sugar and certain fat levels before initiating treatment with ZYLANZA and regularly during treatment.
The physician should know if patients or someone else in their family have a history of blood clots, as medicines like these have been associated with the formation of blood clots.
The physician should know as soon as possible if patients suffer from any of the following illnesses: Stroke or "mini" stroke (temporary symptoms of stroke); Parkinson's disease; Prostate problems; Paralytic ileus; Liver or kidney disease; Blood disorders; Heart disease; Diabetes; Seizures; Salt depletion as a result of prolonged severe diarrhoea and vomiting or usage of diuretics.
If patients suffer from dementia, they or their carer/relative should inform the physician if they have ever had a stroke or "mini" stroke.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis. Olanzapine should be discontinued if DRESS is suspected.
ZYLANZA contains aspartame: Patients who cannot take phenylalanine should note that ZYLANZA contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.
ZYLANZA contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine before consulting their physician.
Driving and using machines: There is a risk of feeling drowsy when being treated with ZYLANZA. If this happens, patients should not drive or operate any tools or machines.
Use in Pregnancy: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. ZYLANZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Children: ZYLANZA is not for patients who are under 18 years.
Use in the Elderly: The use of ZYLANZA in elderly patients with dementia is not recommended as it may have serious side effects.
As a routine precaution, blood pressure may be monitored if patients are over 65 years.

If patients are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby, they should be advised before taking this medicine.
This medicine should not be given when breast-feeding, as small amounts of ZYLANZA can pass into breast milk.
The following symptoms may occur in newborn babies of mothers who have used ZYLANZA in the last trimester: shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If the baby develops any of these symptoms, patients may need to contact their physician.

Like all medicines, ZYLANZA can cause side effects, although not everybody gets them.
Immediate medical attention is necessary in case of: 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; 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.
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 or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; 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 on blood tests and an increase in a type of white blood cells (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, ZYLANZA may worsen the symptoms.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed. Side effects can also be reported directly via the national reporting system. By reporting side effects, patients can help provide more information on the safety of this medicine.

Other medicines and ZYLANZA: Other medicines should only be taken while on ZYLANZA if advised by the physician. Drowsiness may occur if ZYLANZA is taken in combination with antidepressants or tranquillisers.
Physicians should know if patients are taking, have recently taken or might take any other medicines, particularly: medicines for Parkinson's disease; carbamazepine, fluvoxamine or ciprofloxacin. It may be necessary to change the ZYLANZA dose.
ZYLANZA with alcohol: Alcohol should not be consumed with ZYLANZA, as together with alcohol it may cause drowsiness.

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

ZYLANZA should be stored in its original pack, in order to protect against light and moisture.

Antipsychotics

N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics

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