INTRODUCTION ABOUT GARDENAL 60MG TABLET

GARDENAL 60MG TABLET contains Phenobarbitone which belongs to the group of medicines called Barbiturates. It is used in the management of epilepsy to reduce the number and severity of fits. It is used to manage all forms of epilepsy except absence seizures (also called petit mal seizures in children).

Epilepsy is a chronic disease of the brain characterized by repeated seizures (brief episodes of involuntary movement that may involve a part of the body (partial) or the entire body (generalized) accompanied by loss of consciousness and bladder or bowel function).

Avoid consumption of alcohol while taking GARDENAL 60MG TABLET as it interferes with the action of this medicine. GARDENAL 60MG TABLET is not recommended for use in patients with porphyria, addison’s disease, breathing problems, kidney and liver problems.

GARDENAL 60MG TABLET should be used with caution during pregnancy only if clearly advised by the doctor. GARDENAL 60MG TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking it.

GARDENAL 60MG TABLET should be used with caution in children. It should be used with caution in elderly patients (aged 65 years and above). Specific serious side effects include thoughts of harming or killing yourself, consult your physician immediately if you experience any such side effects. The side effect of taking GARDENAL 60MG TABLET include drowsiness. Consult your physician if any of the side effects worsen.

USES OF GARDENAL 60MG TABLET

• Manage epilepsy

HOW GARDENAL 60MG TABLET WORKS

GARDENAL 60MG TABLET works by acting on the GABA-A receptors and increases the activity of GABA, a natural chemical messenger helps to suppress the abnormal activity of nerve cells triggering seizures. Thus, helps to manage seizures effectively.

DIRECTIONS FOR USE

Take GARDENAL 60MG TABLET as advised by your physician. Swallow the medicine with water and do not crush or chew the medicine. Dose and duration will be decided by your physician depending upon your age, body weight and disease condition.

Do not stop taking GARDENAL 60MG TABLET without consulting your doctor. Sudden cessation of this medicine may develop withdrawal effects such as sleeplessness, anxiety, tremor, dizziness, headache, nausea, fits and delirium.

SIDE EFFECTS OF GARDENAL 60MG TABLET

UNCOMMON

• drowsiness

RARE

• confusion
• paradoxical CNS reactions (hyperactivity, anxiety in children)
• excitement
• restlessness in elderly

Stop taking GARDENAL 60MG TABLET and contact your doctor immediately if you experience any of the following side effects:

• symptoms of allergic reaction such as skin rash or hives, itching, swelling of the face, lips or neck causing severe difficulty in breathing
• symptoms of antiepileptic hypersensitivity syndrome include fever, rash, yellowing of the eyes and skin (hepatitis) and swollen glands
• symptoms of potential life-threatening skin rashes such as stevens-johnson syndrome, toxic epidermal necrolysis include rash may progress to widespread blisters or peeling of the skin, reddish spots or circular patches with central blisters on the trunk, ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), accompanied by flu-like symptoms

HOW TO MANAGE SIDE EFFECTS

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating machinery if you feel drowsiness. Avoid alcohol consumption as it aggravates drowsiness. Consult your doctor if drowsiness worsens.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

GARDENAL 60MG TABLET should be used with caution in pregnancy only if considered clearly necessary. Women in the reproductive age should use effective contraception while being managed with this medicine and after 2 months after taking this medicine. Consult your doctor before taking it.

BREASTFEEDING

Contraindicated

GARDENAL 60MG TABLET is not recommended for use in breastfeeding women as the medicine will pass into the breast milk and may harm the baby. Consult your doctor before taking it.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or operate any machines after taking GARDENAL 60MG TABLET as it may impair the mental or physical abilities required to drive or operate machinery.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking GARDENAL 60MG TABLET as it interferes with the action of this medicine.

KIDNEY

Contraindicated

GARDENAL 60MG TABLET is not recommended for use in patients with kidney problems. Consult your doctor before taking it.

LIVER

Contraindicated

GARDENAL 60MG TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take GARDENAL 60MG TABLET if you are allergic to phenobarbitone, other barbiturates (such as amobarbital) or any other ingredients of this medicine.

LUNGS

Consult your doctor

GARDENAL 60MG TABLET is not recommended for use in patients with breathing problems. It should be used with caution in patients with any problems in the lungs. Consult your doctor before taking it.

USE IN PEDIATRICS

Use with Caution

GARDENAL 60MG TABLET should be used with caution in children. Your child’s doctor may adjust the dose based on child’s body weight. Consult your child’s doctor for advice.

USE IN GERIATRICS

Use with Caution

GARDENAL 60MG TABLET should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking it.

OTHERS

GARDENAL 60MG TABLET is not recommended for use if you have:

• porphyria (a genetic or inherited disorder which affects the skin or nervous system)
• addison’s Disease (condition affecting the adrenal glands)

Before taking GARDENAL 60MG TABLET inform your doctor if you:

• have a history of alcohol or drug addiction
• have severe or long-term pain
• need to take blood or urine test
• intolerance to some sugars

INTERACTIONS

A. Drug-Drug Interactions:

Before taking GARDENAL 60MG TABLET, inform your doctor if you are taking any of the following medicines:

• disopyramide and quinidine (used to manage irregular heartbeats)
• chloramphenicol, doxycycline, telithromycin (used to manage bacterial infections)
• metronidazole, itraconazole, posaconazole, voriconazole, griseofulvin (used to manage fungal infections)
• rifampicin (used to manage tuberculosis)
• abacavir, amprenavir, doultegravir, tenofovir, lopinavir, indinavir, darunavir, nelfinavir and saquinavir (used to manage viral infections)
• warfarin (medicine used for thinning the blood)
• mianserin, paroxetine, amitriptyline, fluoxetine, moclobemide or dosulepin, st. john’s wort (hypericum perforatum) an herbal remedy (used to manage depression)
• clonazepam, oxcarbazepine, phenytoin, sodium valproate, carbamazepine, lamotrigine, tiagabine, ethosuximide and vigabatrin (used to manage epilepsy)
• chlorpromazine, thioridazine, haloperidol, aripiprazole and clonazepam (used to manage various mental illness)
• felodipine, isradipine, nicardipine, verapamil, diltiazem, nimodipine, nifedipine, metoprolol, timolol and propranolol (used to manage high blood pressure and heart problems)
• digitoxin or eplerenone (medicines used to manage certain heart conditions)
• ciclosporin (used for management of organ transplant rejection)
• corticosteroids such as hydrocortisone, cortisone, dexamethasone and prednisolone (used to manage pain and inflammation)
• folic acid or vitamin d (supplements)
• irinotecan (used to manage colon or rectal cancer)
• toremifene (used to manage breast cancer)
• gestrinone (used to manage endometriosis)
• methadone, morphine (used to manage severe pain or drug addiction)
• oral contraceptives (used to manage pregnancy)
• tibolone (used to manage osteoporosis)
• liothyronine or levothyroxine (used to manage hypothyroidism)
• montelukast or theophylline (used to manage asthma, COPD)
• tropisetron and aprepitant (used to manage nausea and vomiting following chemotherapy)
• memantine (used to manage dementia)
• methylphenidate (used to manage attention deficit disorder)
• phenylbutazone (used to manage spondylitis)
• cimetidine (used to manage ulcers)
• fluvoxamine (used to manage obsessive-compulsive disorder)
• herbal medicines used for sedation (Ex. chamomile, kava kava, valerian)
• lorazepam (used to manage anxiety)

Overdosage:

If you or anyone else accidentally take too much of GARDENAL 60MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose includes drowsiness, speech difficulties, jerky eye and body movements, loss of inhibition, reduced reflex response, loss of muscle control during movement and when swallowing, heart problems or heart attacks, low body temperature, low blood pressure, breathing difficulties and coma.

SYNOPSIS

MORE INFORMATION

• Keep GARDENAL 60MG TABLET out of sight and reach of children
• Store GARDENAL 60MG TABLET below 25°C