UNISERT 100 Tablet 10?s Allschoolabs -

Description

INTRODUCTION
UNISERT 100 TABLET contains Sertraline which belongs to the group of medicines called Selective Serotonin re-uptake Inhibitors. It is used to treat depression, panic disorder, social anxiety disorder, post-traumatic stress disorder and obsessive-compulsive disorder. It is also used to prevent recurrent depression in adults and treat obsessive compulsive disorder in children and adolescents aged 6-17 years old.
Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest. It is also called major depressive disorder or clinical depression, it affects how you feel, think and behave and can lead to a variety of emotional and physical problems.
Anxiety disorder is known as mental health disorder with feelings of anxiety or fear. You may also experience physical signs of anxiety, such as a pounding heart and sweating. Obsessive compulsive disorder and panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).
UNISERT 100 TABLET is not recommended for use in patients with angle closure glaucoma (eye disorder) and liver disease (such as mild, moderate or severe liver impairment).
Before taking UNISERT 100 TABLET, inform your doctor if you have suicidal thoughts, epilepsy or a history of seizures, schizophrenia, heart disease (such as prolonged QT interval, fast heart rhythm) and kidney disease (such as mild, moderate or severe renal impairment).
UNISERT 100 TABLET is not recommended for use in pregnant and breastfeeding women. It should be used with caution in children and adolescents (below 18 years of age). Your doctor will give the right dose depends on your child?s age, body weight and disease condition.
The most common side effects of taking UNISERT 100 TABLET are dizziness, sleepiness, headache, diarrhea, dry mouth, shaking and abnormal taste. Consult your doctor if any of the above side effects worsen.
USES OF UNISERT 100 TABLET
It is used to treat:
Depression and prevents recurrence of depression

Panic disorder

Social anxiety disorder

Post-traumatic stress disorder

Obsessive-compulsive disorder

HOW UNISERT 100 TABLET WORKS
UNISERT 100 TABLET works by increasing the levels of serotonin (a chemical messenger in the brain) that improves mood and physical symptoms of depression thus providing relief from symptoms of post-traumatic stress, obsessive-compulsive and panic disorder in affected individuals.
DIRECTIONS FOR USE
Take UNISERT 100 TABLET as advised by your physician. Do not crush or chew the medicine. Swallow the medicine with a glass of water. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF UNISERT 100 TABLET

COMMON

Insomnia

Dizziness

Tremor, shaking

Indigestion

Excess sweating

Sleepiness

Headache

Diarrhoea

Nausea

Dry mouth

Weakness

Cold chest

Sore throat

Runny nose

Decreased or increased appetite

Anxiety, depression, agitation

Decreased sexual interest

Nervousness

Nightmares

Teeth grinding

Muscular movement problems (such as moving a lot, spasms, tense muscles, difficulty walking and stiffness and involuntary movements of muscles)

Numbness and tingling

Lack of attention

Abnormal taste

Visual disturbances

Ringing in ears

Palpitations

Hot flush

Yawning

Constipation

Abdominal pain

Back, joint and muscle pain

Menstrual irregularities

Erectile dysfunction

Malaise

Chest pain

Fever

UNCOMMON

Gastroenteritis

Ear infection or pain

Hypothyroidism

Edema

Low thyroid hormones

Suicidal thoughts or behavior

Psychotic disorder

Thinking abnormal, lack of caring

Hallucination

Paranoia (feeling of being persecuted)

Amnesia

Migraine

Convulsion

Dizziness while standing up

Abnormal coordination

Speech disorder

Enlarged pupils

Fast heartbeat, heart problem

Bleeding problems (stomach bleeding)

High blood pressure

Flushing, blood in urine

Shortness of breath

Nosebleed

Swallowing or breathing difficulty

Wheezing

Tarry stools

Tooth or tongue disorder

Inflammation of the oesophagus

Tongue problem

Hemorrhoids

Increased saliva

Difficulty

Eye swelling

Hair loss

Purple spots on skin

Skin problem with blisters, face oedema, cold sweat, dry skin

Osteoarthritis

Muscle twitching or cramps

Unable to urinate (problem urinating)

Urinary incontinence

Excessive vaginal bleeding

Vaginal hemorrhage

Swelling in legs

Chills

Difficulty walking

Thirst

Increase in liver enzyme levels

RARE

Signs of diverticulitis (inflammation or infection in one/more small pouches of digestive tract) such as pain, fever, abdominal tenderness, constipation

Swollen lymph glands

Decrease in clotting cells

Decrease in white blood cells

Severe allergic reaction

Endocrine problems

High cholesterol

Diabetes

Increase or decrease in blood sugar

Drug dependence

Sudden severe headache (sign of reversible cerebral vasoconstriction syndrome)

Sensory disturbance

Glaucoma, double vision

Light hurts eye, blood in the eye

Light-headedness

Progressive scarring of lung tissue (Interstitial Lung Disease)

Closing up of throat

Difficulty talking

Breathing slow

Mouth ulceration

Pancreatitis

Problems with liver function

Serious liver function problems

Skin oedema

Hair texture abnormal

Skin odour abnormal

Hair rash

Breakdown of muscle tissue

Bone disorder

Breast discharge

Dry vaginal area

Genital discharge

Red painful penis and foreskin

Breast enlargement

Hernia

Drug tolerance decreased

Problems with clotting

Relaxation of blood vessels procedure
Stop taking UNISERT 100 TABLET and contact your doctor immediately if you experience any of the following side effects:
Signs of hyponatremia (low sodium level) such as nausea, vomiting, headache and confusion

Itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips (signs of allergic reaction)

Signs of stevens Johnson syndrome /toxic epidermal necrolysis (rare life-threatening skin reaction) such as severe skin rash that causes blisters on mouth and tongue

Signs of serotonin syndrome (condition marked by high secretion of serotonin) such as agitation, confusion, high temperature and blood pressure, diarrhea, excessive sweating and rapid heartbeat

Yellow skin and eyes which may mean liver damage

Ideas of harming or killing yourself (suicidal thoughts)

Feelings of restlessness and are not able to sit or stand still

Seizures

Manic episodes

HOW TO MANAGE SIDE EFFECTS
Dizziness:
If you feel dizzy, keep your eyes closed sit or lie down. Do not drive or operate machinery. Consult your doctor if the above symptoms did not improve.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Consult your doctor if the symptom did not improve.
Diarrhea:
Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhoea. Consult your doctor if the symptom did not improve.
Fatigue:
Get enough?sleep and exercise on regular basis. Take part in relaxing activities and drink enough fluids to stay hydrated.
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.
Nausea & Vomiting:
Take this medicine with or just after meals. Stick to simple meals. Avoid eating oily rich or spicy foods. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS

PREGNANCY
UNISERT 100 TABLET should be used with caution during pregnancy only if it is clearly necessary. Consult your doctor before taking UNISERT 100 TABLET.
BREASTFEEDING
UNISERT 100 TABLET should be used with caution in breast-feeding women. Consult your doctor before taking UNISERT 100 TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines as UNISERT 100 TABLET can influence your ability to drive or operate machines. Consult your doctor before taking UNISERT 100 TABLET.
ALCOHOL
Avoid consumption of alcohol while taking UNISERT 100 TABLET. Consult your doctor before taking UNISERT 100 TABLET.
KIDNEY
UNISERT 100 TABLET should be used with caution in patients with kidney problems such as mild, moderate or severe renal impairment. Consult your doctor before taking the medicine.
LIVER
UNISERT 100 TABLET is not recommended for use in patients with mild, moderate or severe hepatic impairment. It should be used with caution in patients with other liver diseases. Consult your doctor before taking UNISERT 100 TABLET.
ALLERGY
Do not take UNISERT 100 TABLET if you are allergic to Sertraline or to any of the other ingredients of this medicine.
HEART DISEASE
UNISERT 100 TABLET should be used with caution in patients with heart disease, prolonged QT interval and Torsade de Pointes (fast heart rhythm), family history of QT prolongation (heart rhythm disorder), low heart rate. Consult your doctor before taking UNISERT 100 TABLET.
OTHERS
UNISERT 100 TABLET is not recommended for use if you:
Have angle closure glaucoma
Before taking UNISERT 100 TABLET, inform your doctor if you:
Suffer from sexual dysfunction

Have suicidal thoughts

Have epilepsy

Have suffered from schizophrenia or manic-depressive illness (bipolar disorder)

Have serotonin syndrome such as agitation or restlessness, sleeplessness, confusion

Have signs of low sodium level in your blood

Have diabetes

Have a history of bleeding disorders

Are undergoing electroconvulsive therapy (a type of medical treatment used in patients with severe major depression or bipolar disorder)

Have signs of low potassium levels ?

Have signs of low magnesium levels
Use in pediatrics:
UNISERT 100 TABLET should be used with caution in children and adolescents with obsessive compulsive disorder. Your doctor will give the right dose depends on your child?s age, body weight and disease condition. Consult your doctor before taking the medicine.
Use in geriatrics:
UNISERT 100 TABLET should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking the medicine.
INTERACTIONS
A. Drug-Drug interactions:
Before taking UNISERT 100 TABLET, inform your doctor if you are taking:
Verapamil, diltiazem, flecainide, propafenone (used to treat high blood pressure, chest pain or regulate the rate and rhythm of the heart)

Monoamine oxidase inhibitors used to treat depression (Ex. selegiline, moclobemide, linezolid)

Pimozide (used to treat mental disorders such as psychosis)

Acetylsalicyclic acid, ibuprofen (used to treat pain, fever and inflammation)

Warfarin (used in treatment of blood clotting disorders)

Amphetamines (used to treat attention deficit hyperactivity disorder, narcolepsy and obesity)

St. john?s wort (herbal medicine used for depression)

Tryptophan (used to help the body make its own protein)

Tramadol (used to treat severe pain)

Fentanyl, suxamethonium and mivacurium (anaesthesia)

Sumatriptan (used to treat migraines)

Diazepam (sedatives)

Phenytoin, phenobarbital, carbamazepine (used to treat epilepsy)

Tolbutamide (used to treat diabetes)

Lansoprazole, pantoprazole, rabeprazole, cimetidine, omeprazole (used to treat stomach acid, ulcers and heartburn)

Lithium (used to treat mania and depression)

Amitriptyline, nefazodone, fluoxetine, fluvoxamine nortriptyline (used to treat depression)

Perphenazine, olanzapine and levomepromazine (used to treat schizophrenia and other mental disorders)

Rifampicin, telithromycin, erythromycin, clarithromycin (used to treat bacterial infections)

Ketoconazole, posaconazole, voriconazole, fluconazole, itraconazole (used to treat fungal infections)

Medicines used to treat HIV (Ex. ritonavir, telaprevir)

Aprepitant (used to prevent nausea and vomiting after an operation or chemotherapy)

Antipsychotics (used to treat psychological disorders) Ex. amitriptyline

Antibiotics (used to treat bacterial infections) Ex. azithromycin, cefixime

Metamizole (used to treat pain and fever)
B. Drug-Food interaction:
Avoid drinking grapefruit juice while taking UNISERT 100 TABLET as it may increase the level of medicine in the body.
Over dosage:
If you or anyone else accidentally takes too much of UNISERT 100 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are drowsiness, nausea, vomiting, rapid heart rate, shaking, agitation, dizziness, unconsciousness, seizures, high/low blood pressure, agitation, confusion or sleeplessness.
SYNOPSIS

Drug :?? Sertraline

Pharmacological Category :?? Selective serotonin re-uptake inhibitor

Therapeutic Indication :??
Depression and prevents recurrence of depression, Panic disorder, social anxiety disorder, Post-traumatic stress disorder, Obsessive Compulsive Disorder (OCD)
Dosage Forms :?? Tablet

MORE INFORMATION

Keep UNISERT 100 TABLET out of reach of children

Store at room temperature

FAQs ABOUT UNISERT 100 TABLET
I have a history of seizures, can I take UNISERT 100 TABLET?
Seizures can make disease condition abnormal. So, before taking UNISERT 100 TABLET, inform your doctor if you have history of seizures or if you are using any medicines for seizures.
Can I drive after taking UNISERT 100 TABLET?
Do not drive or operate any heavy machines as UNISERT 100 TABLET can influence your ability to drive or operate any machines. Consult your doctor before taking UNISERT 100 TABLET.
How much dose of UNISERT 100 TABLET can I take in a day?
Take UNISERT 100 TABLET as advised by your physician. Do not crush or chew the medicine. Swallow the medicine with a glass of water. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Will I feel dizzy after taking UNISERT 100 TABLET?
Yes, you may feel dizzy after taking UNISERT 100 TABLET because dizziness is the most common side effect that occurs associated with the use of the medicine. If you feel dizzy, keep your eyes closed sit or lie down. Do not drive or operate machinery. Consult your doctor if the symptom did not improve.
What are the side effects of UNISERT 100 TABLET?
The most common side effects of taking UNISERT 100 TABLET are insomnia, dizziness, tremor, indigestion, excess sweating, sleepiness and headache. Consult your doctor if any of the symptom worsens.
REFERENCES
1. K.D.Tripathi, Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs. Essentials of medical pharmacology. Seventh edition. 2013 Page 461.
2. Andrea Cipriani,Teresa La Ferla,Toshi A Furukawa, Alessandra Signoretti, Atsuo Nakagawa,?Rachel Churchill, Hugh McGuire and?Corrado Barbui. Sertraline versus other antidepressive agents for depression. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. [Revised in April 2010] [Accessed on 30th May 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4163971/
3. Almatica Pharma LLC. Food and Drug Administration (FDA) [Revised in October 2021] [Accessed on 30th May 2022]?https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215133s000lbl.pdf
4. ZENTIVA k. s. Electronic Medicines Compendium (EMC) [Revised in March 2021] [Accessed on 30th May 2022]?https://www.medicines.org.uk/emc/files/pil.11992.pdf
5. Haupt Pharma Latina S.r.l. Electronic Medicines Compendium (EMC) [Revised in February 2021] [Accessed on 30th May 2022]?https://www.medicines.org.uk/emc/files/pil.2835.pdf
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