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INTRODUCTION
PAROLYST 12.5MG TABLET contains Paroxetine which belongs to the group of medicines called Selective Serotonin Reuptake Inhibitors. It is used to treat depression and anxiety disorders such as obsessive-compulsive disorder, panic disorders, social anxiety disorder, post-traumatic stress disorder and generalised anxiety disorder.
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.
PAROLYST 12.5MG TABLET should be used in caution with patient having kidney, liver and heart problems. It is not recommended for use in pregnant or breast-feeding woman, consult your doctor for advice before taking the medicine.
PAROLYST 12.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. It should be used with caution in patients above 65 years of age.
The most common side effects of taking PAROLYST 12.5MG TABLET are dizziness, nausea, headache, abnormal dreams or weakness. Consult your doctor if the above symptoms worsens.
USES OF PAROLYST 12.5MG TABLET
Used to treat:
- depression
- obsessive compulsive disorder (OCD)
- panic disorders
HOW PAROLYST 12.5MG TABLET WORKS
PAROLYST 12.5MG TABLET works by inhibiting the reuptake of serotonin (a chemical that acts as a messenger between nerve cells of brain and throughout the body) and increases the levels of serotonin in the brain thus improves mood and physical symptoms of depression and also relieves symptoms of panic disorder, anxiety and obsessive-compulsive disorder.
DIRECTIONS FOR USE
Take PAROLYST 12.5MG TABLET as advised by your physician. Swallow this medicine, 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. Do no stop the medicine without doctor’s advice as it may lead to withdrawal effects.
SIDE EFFECTS OF PAROLYST 12.5MG TABLET
COMMON
- nausea
- dizziness or shaky (tremors)
- somnolence (excess sleepiness)
- asthenia (muscle weakness)
- change in sex drive or sexual function
- left-sided chest pain, pressure or fullness, dizziness, unsteady walking pattern (high cholesterol levels)
- lack of appetite
- insomnia
- abnormal dreams
- headache
- difficulty in concentrating
- agitation, weakness
- blurred vision
- yawning
- dry mouth
- diarrhoea or constipation
- vomiting
- weight gain
- sweating
UNCOMMON
- increase or decrease in blood pressure (feel dizzy or faint when you stand up suddenly)
- faster than normal heartbeat
- lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
- dilated pupils
- feeling confused
- hallucinations (strange visions or sounds)
- an uncontrollable, involuntary passing of urine (urinary incontinence)
- loss of control of blood sugar levels (diabetic patients)
RARE
- abnormal production of breast milk (in women)
- slow heartbeat
- panic attacks
- overactive behaviour or thoughts (mania)
- feeling detached from yourself (depersonalisation)
- irresistible urge to move the legs (Restless Legs Syndrome)
- signs of increased prolactin in blood such as irregular or absent menstrual periods, infertility, milk discharge from the breasts
- menstrual period disorders (including heavy or irregular periods, bleeding between periods and absence or delay of periods
Stop taking PAROLYST 12.5MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- unusual bruising or bleeding including vomiting blood or blood in stools
- difficult urination
- fits (seizures)
- signs of akathisia such as feeling of restlessness, inability to sit or stand still
- signs of low sodium like feeling tired, weak or confused and have achy, stiff or uncoordinated muscles
- allergic reaction like red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, shortness of breath, difficult in swallowing and feel weak or lightheaded resulting in collapse or loss of consciousness
- signs of serotonin syndrome include confusion, restlessness, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles, fast heartbeat
- signs of acute glaucoma such as severe headache, eye pain, nausea and vomiting, blurred vision, eye redness
- signs of stevens johnson syndrome such as widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
- signs of toxic epiderma necrolysis such as widespread rash with blisters and skin peeling on much of the body surface
- signs of liver problems like yellowing of skin, eyes (jaundice)
HOW TO MANAGE SIDE EFFECTS
Nausea or Vomiting:
Take this medicine with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods, sugary snacks and drinks. Talk to your doctor if your symptom is not improving.
Diarrhea:
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.
Headache:
Apply hot or cold-water bag on your head. Try to take rest in a dark and peaceful environment. Drink tea or coffee. Massage with mild pressure on scalp or head. Consult your doctor for advice.
Dizziness:
When you feel dizzy, lie or sit down immediately. If you're experiencing a severe episode of vertigo, lie in a dark and quite place with eyes closed. Vehicle driving should be avoided if you experience frequent dizziness without warning. Talk to your doctor if the symptom worsens.
WARNING & PRECAUTIONS
PREGNANCY
PAROLYST 12.5MG TABLET is not recommended for use in pregnancy unless considered necessary by your physician. Consult your doctor before taking PAROLYST 12.5MG TABLET.
BREASTFEEDING
PAROLYST 12.5MG TABLET may pass into the breast milk, hence it should be used with caution during breastfeeding. Consult your doctor before taking PAROLYST 12.5MG TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you have dizziness, confusion, feeling sleepy or blurred vision. Consult your doctor before taking PAROLYST 12.5MG TABLET.
ALCOHOL
Avoid consumption of alcohol as it may worsen the side effects of PAROLYST 12.5MG TABLET.
KIDNEY
PAROLYST 12.5MG TABLET should be taken with caution in patients with kidney problems. Consult your doctor before taking PAROLYST 12.5MG TABLET.
LIVER
PAROLYST 12.5MG TABLET should be used with caution in patients with liver disease. Consult your doctor before taking PAROLYST 12.5MG TABLET.
ALLERGY
Do not take PAROLYST 12.5MG TABLET if you are allergic to Paroxetine or any other ingredients of this medicine.
HEART DISEASE
PAROLYST 12.5MG TABLET should be taken with caution in patients having heart problems. Before taking PAROLYST 12.5MG TABLET consult with your doctor.
OTHERS
Before taking PAROLYST 12.5MG TABLET, inform your doctor if you:
- have history of seizures
- have episodes of mania (overactive behaviour or thoughts)
- are undergoing electro-convulsive therapy (electrical stimulation of brain)
- have diabetes
- are on low sodium diet
- have glaucoma (pressure in the eye)
Use in pediatrics:
PAROLYST 12.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking PAROLYST 12.5MG TABLET.
Use in geriatrics:
PAROLYST 12.5MG TABLET should be used with caution in elderly patients above 65 years of age as it may lower the sodium level in the blood. Consult your doctor before taking PAROLYST 12.5MG TABLET.
INTERACTIONS
A. Drug-Drug interactions:
- clomipramine, nortriptyline, desipramine, buprenorphine, monoamine oxidase inhibitors including moclobemide and methylthioninium chloride (medicines used to treat depression)
- medicines like thioridazine or pimozide, lithium, risperidone, perphenazine, clozapine (used to treat some psychiatric conditions)
- medicines used to treat pain and inflammation (Ex. aspirin, ibuprofen, celecoxib, etodolac, diclofenac, tramadol, pethidine)
- sumatriptan (used to treat migraine)
- dietary supplement called tryptophan
- mivacurium and suxamethonium (medicine used in anaesthesia)
- fentanyl (medicine used in anaesthesia or to treat chronic pain)
- combination of fosamprenavir and ritonavir (used to treat HIV infection)
- St john’s wort (herbal remedy for depression)
- phenobarbital, phenytoin, sodium valproate or carbamazepine (medicines used to treat epilepsy)
- atomoxetine (used to treat attention deficit hyperactivity disorder)
- procyclidine (used to relieve tremor in Parkinson’s disease)
- warfarin or other anticoagulants (used to thin the blood)
- propafenone, flecainide (used to treat an irregular heartbeat)
- metoprolol (medicine used to treat high blood pressure and heart problems)
- pravastatin (medicine used to treat high cholesterol)
- rifampicin (medicine used to treat TB)
- linezolid (used to treat skin infections)
- tamoxifen (medicine used to treat breast cancer or fertility problem)
Overdosage:
If you or anyone else accidentally takes too much of PAROLYST 12.5MG TABLET, consult your doctor immediately or visit the nearby hospital. The most common symptoms of overdose are fever or uncontrollable tightening of muscles.
SYNOPSIS
| Drug | : | Paroxetine |
| Pharmacological Category | : | Selective Serotonin Reuptake Inhibitors |
| Therapeutic Indication | : | Depression, Obsessive compulsive disorder (OCD), Panic disorder |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep PAROLYST 12.5MG TABLET out of reach of children
- Store at room temperature
FAQs ABOUT PAROLYST 12.5MG TABLET
How does PAROLYST 12.5MG TABLET works?
PAROLYST 12.5MG TABLET works by inhibiting the reuptake of serotonin (a chemical that acts as a messenger between nerve cells of brain and throughout the body) and increases the levels of serotonin in the brain thus improves mood and physical symptoms of depression and also relieves symptoms of panic disorder, anxiety and obsessive-compulsive disorder.
Do I need to be careful while taking PAROLYST 12.5MG TABLET if I am a diabetic?
Yes, you need to be careful while taking PAROLYST 12.5MG TABLET if you are a diabetic. It may alter your blood sugar levels and your dose of insulin or antidiabetic medicines may need dose adjustment. Talk to your doctor regarding this and keep a regular check on your blood sugar levels.
Does PAROLYST 12.5MG TABLET be taken by patients with liver and kidney disease?
PAROLYST 12.5MG TABLET should be used with caution in patients having liver disease and kidney problems. Consult your doctor before taking PAROLYST 12.5MG TABLET.
Is PAROLYST 12.5MG TABLET is recommended for children?
PAROLYST 12.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before giving PAROLYST 12.5MG TABLET to children.
Does PAROLYST 12.5MG TABLET cause sleepiness?
Severe sleepiness and excess sleep duration, induced by this medicine are generally considered as one of the common side effects. Consult your doctor for advice.
REFERENCES
1. KD. Tripathi. Antidepressants and Anti-Anxiety Drugs. Essentials of medical pharmacology. Eighth edition. 2019. Page –487-489.
2. Robert M. Nevels, Samuel T. Gontkovsky and Bryman E. Williams. Paroxetine—The Antidepressant from Hell? Probably Not, But Caution Required. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. March 2016. [Accessed 24th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5044489/
3. Corrado Barbui, MD, Toshiaki A. Furukawa, MD and Andrea Cipriani, MD. Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. January 2008. [Accessed 24th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2211353/
4. Farmaceutisch Analytisch Laboratorium Duiven B.V (FAL Duiven B.V). Electronic Medicines Compendium (EMC). [Revised on November 2021] [Accessed 24th May 2022] https://www.medicines.org.uk/emc/files/pil.9600.pdf
5. GlaxoSmithKline. U.S. Food & Drug Administration [Revised in June 2008] [Accessed 24th May 2022] http://accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf
AUTHOR DETAILS
Written By Dr. Janet.C, Pharm.D
Last updated on 22 Oct 2022 | 09:27 AM(IST)
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