PROLET 50 Tablet 15's
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Introduction About PROLET 50 TABLET
PROLET 50 TABLET contains Primidone which belongs to the group of medicines called Antiepileptics. It is used in the management of epilepsy, seizures (fits) and involuntary shaking movements (essential tremors).
Epilepsy is the disturbed nerve cell activity in the brain, causing seizures or periods of unusual behaviour, sensations and sometimes loss of consciousness. Your doctor may advise you to take Vitamin D supplementation (in case of long-term management).
PROLET 50 TABLET is not recommended for use in patients having porphyria. PROLET 50 TABLET should be used with caution in patients having lung, liver, kidney and problems. PROLET 50 TABLET should be used with caution during pregnancy only if clearly necessary and it is not recommended in breastfeeding woman.
Your doctor will prescribe the right dose of PROLET 50 TABLET for your child depending on their age, body weight and health condition. PROLET 50 TABLET should be used with caution in elderly patients.
PROLET 50 TABLET might make you have thoughts of killing or harming yourself. Contact your doctor immediately if you feel such symptoms. The most common side effects of taking PROLET 50 TABLET are lack of energy, visual disturbances, rolling eyes, disorders in coordination, nausea, etc. Consult your doctor for advice if any of these worsen or doesn’t improve.
Uses Of PROLET 50 TABLET
Manage:
- Epilepsy
- Seizures (fits)
- Involuntary shaking movements (essential tremors)
How PROLET 50 TABLET Works
PROLET 50 TABLET reduces the seizure or fits by enhancing the inhibitory action of GABA which is a neurotransmitter (nerve chemical) that reduces the excitability and abnormal activity of the nerve cells in brain.
How to use PROLET 50 TABLET
Take PROLET 50 TABLET as advised by your physician. Swallow with a glass of water and do not crush or chew it. Your doctor will decide the correct dose and duration of PROLET 50 TABLET for you depending upon your age, body weight and health condition. Do not stop taking PROLET 50 TABLET unless your doctor advises you to stop.
Side Effects Of PROLET 50 TABLET
Common
- apathy or lack of energy
- visual disturbances, rolling eyes
- disorders in coordination
- nausea
Uncommon
- headache
- feeling of spinning (vertigo)
- vomiting
- allergic skin reaction
Rare
- anaemia, decreased white blood cells or platelets (fever, infections, bleeding or development of lymph nodes felt as lumps underneath the skin mostly in armpits, neck and groin)
- mood swings
- pain in bone or joint, Dupuytren’s contracture (thickening of fibrous tissue in the palm of the hand causing one or more fingers to draw back)
- osteomalacia (softened bone due to vitamin D deficiency)
- signs of exfoliative dermatitis (generalised redness and peeling of the skin),
- signs of lupus erythematosus such as inflammation of various parts of the body including the skin, joints, lungs, kidneys, heart and liver
- signs of elevated levels of liver enzymes (gamma GT, alkaline phosphatase) like fever, stomach pain, dark urine, jaundice
Stop taking PROLET 50 TABLET and contact your doctor immediately if you experience any of the following side effects:
- increased frequency of fits or occurrence of different types of seizure
- thoughts of killing or harming self
- skin rashes (Ex. Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome) characterized by reddish target like spots or circular patches with central blisters on the body, ulcers occurring in the throat, mouth, nose, genitals and conjunctivitis (red and swollen eyes)
How To Manage Side Effects
Vomiting:
Drink clear or ice-cold drinks. eat light, bland foods and avoid fried, oily or sweet foods. If symptom persists, contact your doctor.
Nausea:
Take PROLET 50 TABLET with or just after meals. Stick to simple meals. Avoid eating rich or spicy food. If symptom persists, contact your doctor.
Headache:
Apply hot or cold-water bag on your head. Take enough rest in a quiet environment and don’t involve yourself in any exertional activities. apply pain relieving balm in the forehead. If symptom persists, contact your doctor.
Warning & Precautions
Pregnancy
PROLET 50 TABLET should be used during pregnancy only if clearly necessary. Women should use appropriate contraceptive methods while taking PROLET 50 TABLET. Your doctor may adjust your dose and prescribe you supplements such as Vitamin K. Consult your doctor before taking it.
Breastfeeding
PROLET 50 TABLET is not recommended in breastfeeding woman as it passes through mother’s milk and causes sleepiness in the baby. Consult your physician before taking it.
Driving and Using Machines
Do not drive or operate any machines if you feel sleepy after taking PROLET 50 TABLET.
Alcohol
Avoid consumption of alcohol while taking PROLET 50 TABLET as it may react with this medicine.
Kidney
PROLET 50 TABLET should be used with caution in patients having kidney problems. Consult your doctor for advice.
Liver
PROLET 50 TABLET should be used with caution in patients having liver problems. Consult your doctor for advice.
Allergy
Do not take PROLET 50 TABLET if you are allergic to Primidone, Phenobarbital or any of the other ingredients of this medicine.
Lungs
PROLET 50 TABLET should be used with caution in patients having respiratory problems. Consult your doctor for advice.
Others
PROLET 50 TABLET is not recommended for use if you:
- or any of your family members have porphyria (disorder of certain chemical substances build up in body which are related to red blood cells)
Use in Pediatrics:
Your doctor will prescribe the right dose of PROLET 50 TABLET for your child depending on their age, body weight and health condition.
Use in Geriatrics:
PROLET 50 TABLET should be used with caution in elderly patients. Your doctor might lower your dose. Consult your doctor for advice.
Interactions
A. Drug - Drug interactions:
Before taking PROLET 50 TABLET, inform your doctor if you are taking any of the following medicines:
- other medicines used to manage epilepsy and other types of fiits (Ex. phenytoin, valproic acid, felbamate, perampanel, carbamazepine, oxcarbazepine, lamotrigine, tiagabine, stiripentol, zonisamide)
- medicines used to manage blood clots (Ex. acenocoumarol, phenindione, fluindione, warfarin, apixaban, rivaroxaban, dabigatran or ticagrelor)
- medicines used to induce sleep (Ex. phenobarbital, alprazolam)
- medicines used to manage severe pain (Ex. morphine, methadone, oxycodone, fentanyl)
- medicines used to manage infections (Ex. metronidazole, telithromycine, doxycycline)
- medicines used for asthma (Ex. theophylline, montelukast)
- hormonal medicines used to manage pregnancy (Ex. oral contraceptive pill, progestatives, estroprogestatives, ulipristal)
- levothyroxine (used to maintain thyroid hormone levels)
- medicines used to manage heart conditions or high blood pressure (Ex. quinidine, amlodipine, dronedarone, bosentan, ivabradine, nimodipine, macitentan, ranolazine, propafenone, propranolol, atenolol)
- medicines used to manage autoimmune disorders and transplant rejection (Ex. cyclosporine, sirolimus, tacrolimus, everolimus)
- medicines used to manage depression or mental illness (Ex. tricyclic antidepressants, lurasidone, lamotrigine, quetiapine, mianserin, sertraline, St. John’s wort)
- medicines used for inflammatory and autoimmune conditions (Ex. prednisolone, mometasone)
- medicines used in cancer management (Ex. etoposide, cyclophosphamide, abiraterone, eribuline, axitinib, ifosfamide, crizotinib, bosutinib, dabrafenib, erlotinib, dasatinib, gefitinib, imatinib, nilotinib, lapatinib, pazopanib, sorafenib,lapatinib, sunitinib, regorafenib, vemurafenib, vandetanib, vismodegib, ceritinib, cabozantinib, ibrutinib, ponatinib, olaparib, carbazitaxel, procarbazine, docetaxel, irinotecan)
- medicines used to manage tuberculosis (Ex. delamanid, bedaquiline)
- quinine (used to manage malaria)
- medicines used for viral infections like HIV infection or hepatitis c (Ex. boceprevir, daclatasvir, cobicistat, dasabuvir, lopinavir, dolutegravir, maraviroc, telaprevir ombitasvir, paritaprevir, nelfinavir, rilpivirine, simeprevir, nelfinavir, sofosbuvir)
- medicines used to manage fungal infections (Ex. voriconazole, itraconazole, albendazole, posaconazole)
- vitamin B9 (used to manage folate deficiency)
- deferasirox (used to reduce excessive iron deposition)
- ivacaftor (used to manage cystic fibrosis)
- medicines used for parasitic infections (Ex. albendazole, praziquantel)
Overdosage:
If you or anyone else accidentally take too much of PROLET 50 TABLET, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Primidone |
| Pharmacological Category | : | Anticonvulsants |
| Therapeutic Indication | : | Epilepsy, Seizures, Essential tremors |
| Dosage Forms | : | Tablets |
More Information
- Keep PROLET 50 TABLET out of reach of children
- Store PROLET 50 TABLET below 25°C
FAQs About PROLET 50 TABLET
What if I miss a dose of PROLET 50 TABLET?
If you miss a dose of PROLET 50 TABLET, take it as soon as you remember. However, skip that dose if it's almost time for the next one. Do not take PROLET 50 TABLET two times to make up for the missed dose.
Can I stop taking PROLET 50 TABLET on my own if I start to feel better?
Do not stop taking PROLET 50 TABLET suddenly on your own, as it may lead to increased risk of seizures and withdrawal symptoms. Continue to take this medicine, as long as your doctor tells you to do so and he may gradually reduce it to avoid withdrawal symptoms.
Is PROLET 50 TABLET safe for breast-feeding women?
No, PROLET 50 TABLET is not recommended in breastfeeding woman as it passes through mother’s milk and causes sleepiness in the baby. Consult with your physician before taking.
Do I need to be aware of any serious side effects while taking PROLET 50 TABLET?
Some serious side effects of PROLET 50 TABLET includes thoughts of killing or harming yourself, increased frequency of seizures or occurrence different types of seizure, rash or skin problems. Contact your doctor or go to the nearest hospital immediately if you feel such symptoms.
Does PROLET 50 TABLET causes vomiting?
Yes, PROLET 50 TABLET may cause vomiting in some people. Take PROLET 50 TABLET with or just after meals. Stick to simple meals. Avoid eating spicy foods, oil rich or sugary snacks and drinks. Drinking too much liquid along with your meals can be avoided, drink slowly in between meals. Consult your doctor if your symptom worsens.
References
1. KD. Tripathi. Antiepileptics. Essentials of medical pharmacology. Eighth edition. 2019. Page – 443.
2. Elisabetta Patorno, Robert J. Glynn, Sonia Hernandez-Diaz, Jerry Avorn, Peter M. Wahl, Rhonda L. Bohn, Daniel Mines, Jun Liu, Sebastian Schneeweiss. Risk of Ischemic Cerebrovascular and Coronary Events in Adult Users of Anticonvulsant Medications in Routine Care Settings. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. August 2013. [Accessed on 16th September 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828795/
3. L J Findley, L Cleeves and S Calzetti. Primidone in essential tremor of the hands and head: a double blind controlled clinical study. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. September 1985. [Accessed on 16th September 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1028493/
4. Primidone. NIH National Library of Medicine, National center for biotechnology information. PubChem. September 2022. [Accessed on 16th September 2022]. https://pubchem.ncbi.nlm.nih.gov/compound/Primidone
5. Recipharm Limited. Electronic Medicines Compendium (EMC). [Revised in December 2021]. [Accessed on 16th September 2022]. https://www.medicines.org.uk/emc/files/pil.2941.pdf
6. Bausch Health Companies Inc. U.S. Food & Drug Administration (USFDA). [Revised in October 2020]. [Accessed on 16th September 2022]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf
7. Tasmed. EPIAD. Primidone Tablet. [Accessed on 16th September 2022]. https://tasmedlab.com/allproduct/epiad/#indications
Useful Diagnostic Tests
- Electroencephalogram (EEG)
Author Details
