FLUZAPINE Tablet 10's

INTRODUCTION

FLUZAPINE TABLET is a combination of Fluoxetine and Olanzapine which belongs to the group of medicines called Antidepressants and Antipsychotics respectively. It is used to treat depression associated with bipolar disorder in adults who are not responding to treatment with other medicines.

Bipolar disorder (also known as manic depression) is a mental disorder characterized by alternative episodes of mania (sudden unusual extreme sense of happiness) and depression. FLUZAPINE TABLET can be taken with or without meals. While taking FLUZAPINE TABLET avoid consumption of alcohol as it may make you feel drowsier.

Before taking this medicine inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have bleeding problems, parkinsonism, fits, mania, dementia, diabetes, blood clots or severe dehydration as a precaution.

Do not take FLUZAPINE TABLET without consulting your doctor if you are pregnant or breastfeeding. The most common side effects of taking FLUZAPINE TABLET are problems in attention, dry mouth, constipation, sleepiness, dizziness while standing up, tiredness, increased hunger, weight gain, shakiness, increased bloods sugar or cholesterol levels, blurred vision and decreased sex drive. Consult your doctor if any of these side effects worsens.

You must also inform your doctor immediately if you experience worsening of depression along with suicidal thoughts or having severe muscle stiffness, shakiness, fever and/or chest pain as a precaution.

USES OF FLUZAPINE TABLET

• Treats depression associated with bipolar disorder in adults

HOW FLUZAPINE TABLET WORKS

FLUZAPINE TABLET works by regulating the release and uptake of certain chemical messengers (dopamine and serotonin) within the brain that affects thoughts, emotions, body movements and behaviour. As a result, it improves your ability to think, controls your emotions and stabilizes your mental health.

DIRECTIONS FOR USE

Take FLUZAPINE TABLET as advised by your physician. It can be taken with or without meals.

Swallow the medicine with a glass of water. Do not crush or chew the medicine.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and mental state.

Do not stop taking FLUZAPINE TABLET without consulting your doctor, even if you feel better during the mid-way of therapy.

SIDE EFFECTS OF FLUZAPINE TABLET

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Consult your doctor if your dizziness worsens.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

Nausea:

Take FLUZAPINE TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

WARNING & PRECAUTIONS

PREGNANCY

FLUZAPINE TABLET should be used with caution in pregnant women. Your doctor will decide whether you should use this medicine or not after evaluating the benefits and risks of the therapy.

BREASTFEEDING

FLUZAPINE TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk to the nursing infant. Therefore, consult your doctor before taking it.

DRIVING AND USING MACHINES

Do not drive or operate any machines if your ability is affected by FLUZAPINE TABLET.

ALCOHOL

Avoid consumption of alcohol while taking FLUZAPINE TABLET as it might make you feel drowsy or sleepy.

KIDNEY

FLUZAPINE TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

LIVER

FLUZAPINE TABLET should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.

ALLERGY

Do not take FLUZAPINE TABLET if you are allergic to fluoxetine or olanzapine.

HEART DISEASE

FLUZAPINE TABLET should be used with caution in patients with heart problems (such as heart attack). Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking FLUZAPINE TABLET, inform your doctor if you are taking any of the following medicine:

• medicine used to treat depression like monoamine oxidase inhibitors (Ex. tranylcypromine, moclobemide iproniazid, nialamide, isocarboxazid, toloxatone), fluvoxamine, lithium, selegiline, amitriptyline, imipramine, bupropion, St. John’s wort
• other medicines used to treat psychiatric disorders (such as pimozide, haloperidol, risperidone, thioridazine)
• linezolid (a medicine used to treat bacterial infection)
• methylthioninium chloride (a medicine used to treat high methaemoglobin in blood)
• medicines used to reduce anxiety and to induce sleep (such as alprazolam, midazolam, clonazepam, nitrazepam)
• medicines used to treat parkinsonism (such as levodopa, amantadine)
• carbamazepine, phenytoin (medicines used to treat epilepsy)
• ciprofloxacin (a medicine used to treat bacterial infection)
• medicines used for blood thinning (such as heparin, warfarin)
• tamoxifen (a medicine used to treat cancer)
• diuretics (used to reduce edema and blood pressure) such as hydrochlorothiazide, furosemide
• medicines used to treat allergic reactions (such as azelastine, cyproheptadine, mequitazine)
• medicines used for pain relief (such as tramadol, ibuprofen, diclofenac)
• medicines used to treat migraine headache (such as sumatriptan)
• tryptophan (a medicine used to treat mental illness)
• medicines used to treat abnormal heart rhythm and other heart problems (such as digoxin, quinidine, amiodarone, diltiazem, amlodipine, metoprolol, flecainide, propafenone, nebivolol or encainide)
• medicines used to treat bacterial infection (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine)
• medicines used to treat malaria (such as mefloquine, chloroquine, halofantrine)
• desmopressin (a medicine used to treat diabetes insipidus)
• atomoxetine (a medicine used to treat ADHD)
• buprenorphine (an opioid analgesic medication)

B. Drug-Food interactions:

FLUZAPINE TABLET can be taken with or without meals.

Overdosage:

If you or anyone else accidentally took more FLUZAPINE TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include racing heartbeat, agitation, problems with speech, unusual movements (especially of the face or tongue), confusion, fits, fever, sweating, muscle stiffness, drowsiness, sleepiness, slow heartbeat, abnormal heart rate, nausea and vomiting.

SYNOPSIS

MORE INFORMATION

• Keep FLUZAPINE TABLET out of reach of children
• Store FLUZAPINE TABLET at room temperature

FAQs ABOUT FLUZAPINE TABLET

Q: What is the use of FLUZAPINE TABLET?

A: FLUZAPINE TABLET is used to treat depression associated with bipolar disorder in adults who are not responding to treatment with other medicines.

Q: How FLUZAPINE TABLET works?

A: FLUZAPINE TABLET works by regulating the release and uptake of certain chemical messengers (dopamine and serotonin) within the brain that affects thoughts, emotions, body movements and behaviour. As a result, it improves your ability to think, controls your emotions and stabilizes your mental health.

Q: What is the best time to take FLUZAPINE TABLET?

A: Take FLUZAPINE TABLET approximately at the same time each day. You can take FLUZAPINE TABLET either in the morning or in the evening as per doctor’s instructions. Taking it at the same time each day will have the best effect and it would also help you remember your daily dose.

Q: Can FLUZAPINE TABLET cause weight gain?

A: Yes. Weight gain is one of the common side effects of taking FLUZAPINE TABLET. If this side effect bothers you, contact your doctor.

Q: Will FLUZAPINE TABLET reduce my sex drive?

A: Yes. FLUZAPINE TABLET may affect your sexual life. It may decrease sex drive or cause problems in orgasm, ejaculation or erection. Therefore, consult your doctor if you experience any such symptoms.

Q: Will the use of FLUZAPINE TABLET make you feel sleepy or tired?

A: Yes, FLUZAPINE TABLET can make your feel sleepy, drowsy or tired. Do not drive or handle heavy machines or tool if you feel drowsy or sleepy. Avoid consumption of alcohol as it can aggravate your drowsiness.

Q: Can FLUZAPINE TABLET be used in children?

A: FLUZAPINE TABLET is generally not recommended for use in children and adolescents (aged below 18 years). Therefore, consult your doctor before administration.

Q: What to do if I forget to take a dose of FLUZAPINE TABLET?

A: If you forget to take a dose of FLUZAPINE TABLET, take it as soon as you remember. However, if it is time to take the next dose, skip the missed dose and take the next one at regular times. Do not take a double dose of FLUZAPINE TABLET to compensate a missed dose, as it could lead to toxicity.

Q: Will taking a higher dose of FLUZAPINE TABLET than the prescribed one be beneficial?

A: No, taking a higher dose of FLUZAPINE TABLET will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

Q: Can I stop taking FLUZAPINE TABLET once my symptoms subside?

A: No. Do not stop taking FLUZAPINE TABLET without consulting your doctor even if you feel better during the mid-way of the therapy. You may feel better after 2 weeks of therapy with FLUZAPINE TABLET, but it might take several weeks for you to experience complete benefits. Also, sudden discontinuation of therapy may cause withdrawal symptoms such as nausea, vomiting, sweating, lack of sleep, anxiety and abnormal dreams.

Q: Can FLUZAPINE TABLET be taken daily?

A: Yes. FLUZAPINE TABLET can be taken daily as per your doctor’s instruction. However, if you are doubtful, consult your doctor.

Q: How long does it take for FLUZAPINE TABLET to work?

A: It may take several weeks for FLUZAPINE TABLET to heal your condition. Therefore, continue to take FLUZAPINE TABLET for the stipulated duration recommended by your doctor without any interruption.

Q: How to take FLUZAPINE TABLET?

A: Take FLUZAPINE TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. FLUZAPINE TABLET can be taken with or without meals.

Q: Is FLUZAPINE TABLET safe to use in pregnancy?

A: FLUZAPINE TABLET should be used in pregnant women only if considered necessary by the physician. Therefore, consult your doctor before taking. Studies have shown the onset of certain withdrawal symptoms (such as shaking, weakness, sleepiness, breathing problems and difficulty in feeding) in babies born to women taking FLUZAPINE TABLET during their pregnancy.

Q: What are the common side effects of taking FLUZAPINE TABLET?

A: The most common side effects of taking FLUZAPINE TABLET are problems in attention, dry mouth, constipation, sleepiness, dizziness while standing up, tiredness, increased hunger, weight gain, shakiness, increased bloods sugar or cholesterol levels, blurred vision and decreased sex drive. Consult your doctor if any of these side effects worsens.

REFERENCES

1. KD. Tripathi. Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs. Essentials of Medical Pharmacology. 7th Edition. Page – 461.

2. Elizabeth Brunner, Mauricio Tohen, Olawale Osuntokun, John Landry and Michael E Thase. Efficacy and Safety of Olanzapine/Fluoxetine Combination vs Fluoxetine Monotherapy Following Successful Combination Therapy of Treatment-Resistant Major Depressive Disorder. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. May 2014. [Accessed on 21st January 2023]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4207330/

3. Milpharm Limited. Olanzapine tablets. Electronic Medicines Compendium. [Revised in December 2022]. [Accessed on 21st January 2023]. https://www.medicines.org.uk/emc/files/pil.3071.pdf

4. Brown & Burk UK Ltd. Fluoxetine 20mg Hard Capsules. Electronic Medicines Compendium. [Revised in September 2021]. [Accessed on 21st January 2023]. https://www.medicines.org.uk/emc/files/pil.10658.pdf

5. Endo Ventures Ltd. Fluoxetine 10 mg Film-coated Tablets. Electronic Medicines Compendium. [Revised in January 2021]. [Accessed on 21st January 2023]. https://www.medicines.org.uk/emc/files/pil.9338.pdf

6. Eli Lilly and Company. SYMBYAX (olanzapine and fluoxetine hydrochloride) capsule for oral use. U.S. Food and Drug Administration. [Revised in August 2011]. [Accessed on 21st January 2023]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s33lbl.pdf

7. Central Drugs Standard Control Organization. Olanzapine 5mg/10mg+ Fluoxetine HCl eq. to Fluoxetine 20mg/20mg tablet. February 2003. [Accessed on 21st January 2023]. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/dciApprovedfdc.pdf

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 25 Jan 2023 | 03:38 PM(IST)