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INTRODUCTION
FREXT 50MG TABLET contains Fluvoxamine which belongs to the group of medicines called Selective serotonin reuptake inhibitors (SSRIs). It is used in the treatment of depression (mood disorder that causes a persistent feeling of sadness and loss of interest) and obsessive-compulsive disorder (OCD).
Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
Along with this treatment, your doctor might ask you to make certain lifestyle changes such as quitting alcohol, reducing caffeine intake.
Before taking FREXT 50MG TABLET, inform your doctor if you had cardiac arrest, have bleeding problems, kidney, liver problems, epilepsy, diabetes, mania, electroconvulsive therapy, and glaucoma.
Avoid caffeine intake while taking FREXT 50MG TABLET as it can worsen the symptoms. FREXT 50MG TABLET is not recommended if you are pregnant unless your doctor considers it necessary.
FREXT 50MG TABLET should be used with caution in breastfeeding women as it will pass through the milk. Your doctor will give the right dose depends on your child’s age, body weight and health condition.
The most common side effects of FREXT 50MG TABLET are anxiety, constipation, diarrhea, difficulty sleeping, dizziness and headache. Consult your doctor if any of the above side effects worsens.
USES OF FREXT 50MG TABLET
- Used to treat depression and obsessive-compulsive disorder (OCD)
HOW FREXT 50MG TABLET WORKS
FREXT 50MG TABLET belongs to selective serotonin reuptake inhibitors (SSRI) antidepressants. It works by increasing the levels of serotonin, a chemical messenger in the brain. This improves mood and physical symptoms of depression and also relieves symptoms of obsessive-compulsive disorders.
DIRECTIONS FOR USE
Take FREXT 50MG TABLET as advised by your physician. Swallow the medicine with water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF FREXT 50MG TABLET
COMMON
- agitation, anxiety
- constipation
- indigestion
- diarrhea
- difficulty sleeping
- dizziness
- dry mouth
- faster heartbeat
- feeling drowsy (lethargy)
- feeling unwell (malaise)
- headache
- loss of appetite
- nervousness
- stomach pain
- sweating
- tremor, muscle weakness (asthenia)
- vomiting
UNCOMMON
- allergic skin reactions (along with swelling of face, lip or tongue, rash, itching)
- confusion
- delayed ejaculation
- dizziness when standing up too quickly
- hallucinations
- lack of co-ordination
- muscle or joint pain
- aggression
RARE
- convulsions
- liver complaints
- mania (feeling of over-excitement)
- sensitivity to sunlight
Stop taking FREXT 50MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- distressing thoughts or experiences like thoughts of self-harm
- sweating, muscle spasms, instability, confusion or extreme agitation
- stiff muscles, high temperature and confusion (neuroleptic malignant syndrome)
- feel tired, weak, or confused and have painful, stiff, or uncontrolled muscles
- severe skin reactions like skin rashes or redness, including rash, starting on the extremities, usually on both sides of the body and evolving into concentric circles that resemble a target (erythema multiforme), widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (toxic epidermal necrolysis)
- unusual bruising or purple patches appear on your skin, blood in vomit or stool
HOW TO MANAGE SIDE EFFECTS
Vomiting:
Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly.
Diarrhoea:
Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor.
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.
Headache:
Avoid bright lights and apply cold compress. Try to rest and relax. If the symptom does not improve, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
FREXT 50MG TABLET is not recommended for use if you are pregnant unless your doctor considers it necessary, particularly in the last 3 months of pregnancy. Consult your doctor before taking it.
BREASTFEEDING
Your doctor will decide whether to discontinue breastfeeding or taking FREXT 50MG TABLET as it may pass through the breast milk affecting the baby. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or use heavy machines while taking FREXT 50MG TABLET if it makes you sleepy.
ALCOHOL
Do not drink alcohol while taking FREXT 50MG TABLET as it can make you sleepy and unsteady.
KIDNEY
FREXT 50MG TABLET should be used with caution if you have any kidney problems, your doctor will adjust the dose according to your age, body weight and disease condition. Consult your doctor before taking it.
LIVER
FREXT 50MG TABLET should be used with caution if you have any liver problems, your doctor will adjust the dose according to your age, body weight and disease condition. Consult your doctor before taking it.
ALLERGY
Do not take FREXT 50MG TABLET if you are allergic to Fluvoxamine or to any ingredients of this medicine.
HEART DISEASE
FREXT 50MG TABLET should be used with caution in patients who recently had a heart attack. Consult your doctor before taking.
OTHERS
Before taking FREXT 50MG TABLET, inform your doctor if you:
- have epilepsy
- have a history of bleeding problems
- have diabetes
- having treatment with electroconvulsive therapy (ECT)
- had mania (feeling of over-excitement)
- have glaucoma (high pressure in eye)
- had thoughts of self-harm
Use in pediatrics:
This medicine is not recommended for children and adolescents under 18 years unless they are being treated for obsessive compulsive disorder (OCD). Your doctor will give the right dose depends on your child’s age, body weight and disease condition. Consult your doctor for advice.
Use in geriatrics:
Your doctor will decide the correct dose and duration of FREXT 50MG TABLET for you depending upon your age, body weight and disease condition. Consult your doctor before taking.
INTERACTIONS
A. Drug-Drug interactions:
Before taking FREXT 50MG TABLET, inform your doctor if you are taking any of the following medicine:
- tizanidine (muscle relaxant)
- St John’s Wort, other herbal medicines
- benzodiazepines, tricyclic antidepressants, neuroleptic, lithium, tryptophan, monoamine oxidase inhibitor (moclobemide), pimozide, serotonin reuptake inhibitor (citalopram) (to treat depression and psychotic condition)
- aspirin (acetylsalicylic acid) or aspirin-like medicines (to treat pain and inflammation)
- ciclosporin (to reduce activity of the immune system)
- methadone (for pain and withdrawal symptoms)
- mexiletine (to treat abnormal heart rhythms)
- phenytoin or carbamazepine (to treat epilepsy)
- propranolol (to treat high blood pressure and heart conditions)
- ropinirole (for Parkinson’s disease)
- to treat migraines, such as sumatriptan
- terfenadine (to treat allergies)
- sildenafil (to treat erectile dysfunction)
- theophylline (to treat asthma and bronchitis)
- tramadol (painkiller)
- clopidogrel, warfarin, nicoumalone (to prevent blood clots)
B. Drug-Food interaction:
If you drink a lot of tea, coffee, and soft drinks with caffeine, you may have symptoms such as hands shaking, feeling sick, fast heart rate (palpitations), restlessness and difficulty sleeping (insomnia). If you lower caffeine intake, these symptoms might disappear.
Overdosage:
If you or anyone else accidentally takes too much of FREXT 50MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, diarrhea and feeling drowsy or dizzy.
SYNOPSIS
| Drug | : | Fluvoxamine |
| Pharmacological Category | : | Selective serotonin re-uptake inhibitors (SSRI) |
| Therapeutic Indication | : | Depression and Obsessive-compulsive disorder |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep FREXT 50MG TABLET out of reach of children
- Do not store above 25°C
FAQs ABOUT FREXT 50MG TABLET
Can I stop taking FREXT 50MG TABLET if I feel better?
No, consult your doctor before stopping FREXT 50MG TABLET completely. This is done because sudden discontinuation may cause withdrawal symptoms. These symptoms include anxiety, irritability, mood swings, feeling restlessness, changes in sleep habits, headache, sweating, nausea, dizziness, electric shock-like sensations, and confusion.
Can FREXT 50MG TABLET make you sleepy?
Yes, a common side effect of FREXT 50MG TABLET is sleepiness. It may also affect your ability to think clearly or react quickly. Avoid driving or operating heavy machinery until and unless you know how it affects you.
Can FREXT 50MG TABLET be crushed?
No, do not crush chew or break FREXT 50MG TABLET. Swallow it with a glass of water and consult your doctor for further instructions.
Is it safe to consume alcohol while taking FREXT 50MG TABLET?
Avoid consumption of alcohol while taking this medicine, as it can increase the risk of side effects such as dizziness, drowsiness, and difficulty in concentration. Avoid activities that require mental alertness like driving vehicles or operating heavy machines.
Can FREXT 50MG TABLET be taken during pregnancy?
It is not recommended for use during pregnancy as it may harm your foetus. Consult your doctor if you are pregnant.
REFERENCES
1. KD Tripathi. Drugs Used in Mental Illness Antidepressant and Antianxiety Drugs. Essentials of Medical Pharmacology. Eighth Edition.2019. Page –488-489.
2. Mylan Products Ltd, Electronic Medicines Compendium (EMC). [Revised in October 2021] [Accessed on 21st May 2022] https://www.medicines.org.uk/emc/files/pil.1169.pdf
3. Jazz Pharmaceuticals. U.S. Food and Drug Administration. [Revised in May 2011] [Accessed on 21st May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s003lbl.pdf
4. Jazz Pharmaceuticals. U.S. Food and Drug Administration. [Revised in December 2007] [Accessed on 21st May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf
5. Fluvoxamine. Mayoclinic. [Revised in February 2018] [Accessed on 21st May 2022] https://www.mayoclinic.org/diseases-conditions/depression/symptoms-causes/syc-20356007
AUTHOR DETAILS
Written By Dr. Janet.C, Pharm.D
Last updated on 25 Nov 2022 | 05:30 PM(IST)
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