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RESTONORM PLUS Tablet 15's
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INTRODUCTION
RESTONORM PLUS TABLET is a combination of Risperidone and Trihexyphenidyl which belongs to a group of medicines called Atypical antipsychotics and Anticholinergics, respectively. It is used to treat schizophrenia, and acute manic episodes in affected individuals. Schizophrenia is a serious mental disorder that affects a person's ability to think, feel/behave clearly. Acute manic episode is a manic phase of bipolar I disorder which is defined as an extremely unstable or irritable mood along with excess activity or energy level in affected individuals.
[GBKEYWORD] is not recommended for use in patients allergic to Risperidone, and/or Trihexyphenidyl. Before taking RESTONORM PLUS TABLET, inform your doctor if you have or ever had a stroke, involuntary movements of the tongue, mouth and face, Parkinson’s disease (brain disorder), dementia ( loss of cognitive functioning such as thinking, remembering, and reasoning), epilepsy, myasthenia gravis ( muscle weakness), tardive dyskinesia (neurological disorder), heart, kidney, and/or liver problems.
RESTONORM PLUS TABLET is not recommended for use in pregnant women unless it is clearly necessary. It is also not recommended for use in breastfeeding women. The medicine is also not indicated for use in children and adolescents (aged below 18 years) and is advised to be used with caution in elderly patients (aged 65 years and above) after consulting the doctor.
The most common side effects of taking RESTONORM PLUS TABLET are difficulty falling/staying asleep, common cold symptoms, sinus infection, diarrhea, indigestion, and/or dry mouth. Consult your doctor if any of these symptoms gets worse.
USES OF RESTONORM PLUS TABLET
- Treats schizophrenia (serious mental disorder)
- Treats acute manic episodes (bipolar disorder)
HOW RESTONORM PLUS TABLET WORKS
RESTONORM PLUS TABLET is used to treat schizophrenia and acute manic episodes, where Risperidone improves mood, thoughts and behavior by decreasing the levels of dopamine and serotonin (chemical messengers) in the brain, and Trihexyphenidyl improves muscle control and reduces stiffness in Parkinson's disease (brain disorder) by decreasing the level of acetylcholine (chemical messenger) in the brain, thus improving the symptoms.
DIRECTIONS FOR USE
Take RESTONORM PLUS TABLET as advised by your physician. Swallow RESTONORM PLUS TABLET with a glass of water and do not chew or crush 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 RESTONORM PLUS TABLET
COMMON
- difficulty falling or staying asleep
- signs of Parkinson's disease (brain disorder) such as slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement “freezing up” and then restarting, a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face
- feeling sleepy, or less alert
- headache
- pneumonia (serious illness of lung)
- infection of the chest (bronchitis)
- common cold symptoms
- sinus infection
- signs of urinary tract infection such as strong urge to urinate, burning sensation while urination
- ear infection such as ear pain, trouble sleeping, loss of balance
- feeling like if having flu
- signs of hyperprolactinemia (high prolactin levels) in men such as breast swelling, difficulty in getting or maintaining erections, decreased sexual desire or other sexual dysfunction. In women signs might include breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle or fertility problems
- weight gain
- increased appetite
- decreased appetite
- sleep disorder
- irritability
- depression
- anxiety
- restlessness
- signs of dystonia (muscle disorder) such as abnormal movements of the eyes, mouth, tongue or jaw
- dizziness
- dyskinesia (a muscle disorder marked by uncontrolled, involuntary muscle movement) such as repetitive, spastic or writhing movements, or twitching
- tremor (shaking)
- signs of eye infections such as blurry vision, or pink eye
- rapid heart rate
- high blood pressure
- shortness of breath
- sore throat
- cough
- nose bleeds
- stuffy nose
- abdominal pain or discomfort
- vomiting
- nausea
- constipation
- diarrhea
- indigestion
- dry mouth
- toothache
- rash, skin redness
- muscle spasms
- bone or muscle ache
- back pain
- joint pain
- incontinence (lack of control) of urine
- swelling of the body, arms or legs
- chest pain
- weakness
- dryness of mouth
- nervousness
UNCOMMON
- infection of the breathing passages
- bladder infection
- eye infection
- tonsillitis (swollen tonsils)
- fungal infection of the nails
- single area of san infection confined to skin
- an infection confined to a part of the body
- viral infection
- skin inflammation caused by mites
- anemia (decrease in red blood cells)
- allergic reaction
- diabetes or worsening of diabetes
- high blood sugar
- excessive drinking of water
- weight loss
- loss of appetite resulting in malnutrition
- low body weight
- elated mood (mania)
- confusion
- decreased sexual drive
- nervousness
- nightmares
- loss of consciousness
- low level of consciousness
- restless urge to move parts of your body
- balance disorder
- abnormal coordination
- disturbance in attention
- problems with speech
- loss or abnormal sense of taste
- low sensation of skin to touch and pain
- tingling, pricking, or numbness sensation of skin
- oversensitivity of the eyes to light
- dry eye
- increased tears
- redness of the eyes
- sensation of spinning (vertigo)
- ringing in the ears
- ear pain
- a fluttering or pounding feeling in your chest
- low blood pressure
- low blood pressure upon standing
- flushing
- pneumonia caused by inhaling food, lung congestion, congestion of breathing passages, crackle lung sounds, wheezing, voice disorder, breathing passage disorder
- infection of stomach or intestine
- stool incontinence, very hard stool
- difficulty while swallowing
- excessive passing of gas or wind
- signs of allergic skin reactions such as red rash, itching skin
- hair loss
- signs of skin infections such as thickening of skin, dry skin, skin discolouration, acne, flaky, itchy scalp or skin, skin disorder, skin lesion
- abnormal posture
- joint stiffness
- joint swelling
- muscle weakness
- neck pain
- frequent passing of urine
- inability to pass urine
- pain when passing urine
- erectile dysfunction
- ejaculation disorder
- signs of menstrual problems such as loss of menstrual periods, missed menstrual periods or other problems with your cycle (females)
- development of breasts in men
- leakage of milk from the breasts, breast pain, breast discomfort
- discharge from vagina
- sexual dysfunction
- swelling of the face, eyes, lips, or mouth
- chills
- change in the way you walk
- feeling thirsty
- feeling unwell
- chest discomfort
- feeling out of sorts
- discomfort
RARE
- infection
- sleepwalking
- sleep-related eating disorder
- low blood sugar
- lack of emotion
- inability to reach orgasm
- not moving or responding while awake (catatonia)
- blood vessel problems in the brain such as stroke, aneurysms
- coma due to uncontrolled diabetes
- shaking of the head
- problems related movement of eyes, eye rolling, eyelid margin crusting
- eye problems during cataract surgery
- intraoperative floppy iris syndrome (IFIS) (a complication that occurs during cataract surgery)
- dangerously excessive intake of water
- irregular heartbeat
- trouble breathing during sleep (sleep apnoea)
- fast or shallow breathing
- pancreatitis (inflammation of the pancreas)
- a blockage in the bowels
- swollen tongue
- chapped lips
- rash on skin related to drug
- dandruff
- delay in menstrual periods
- enlargement of the breast glands, discharge from the breasts
- hardening of the skin
- low body temperature
- coldness in arms and legs
- symptoms of drug withdrawal such as anxiety, fatigue, sweating, vomiting, depression
- signs of jaundice such as yellowing of the skin and the eyes
Stop taking RESTONORM PLUS TABLET and contact your doctor if you experience any of the following side effects:
- signs of stroke such as dementia, sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time
- signs of tardive dyskinesia (neurological disorder) such as twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
- involuntary rhythmic movements of the face, mouth, and tongue
- convulsion (fits)
- fainting
- atrial fibrillation (an abnormal heart rhythm)
- slow heart rate
- signs of blood clots in the veins, especially in the legs such as swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing
- signs of neuroleptic malignant syndrome (life threatening neurological disorder) such as fever muscle stiffness, sweating or a lowered level of consciousness
- signs of priapism (sexual disorder) such as prolonged or painful erection in man
- signs of severe allergic reaction such as fever, swollen mouth, face, eyelids, lip or tongue, shortness of breath, itching, skin rash
- drop in blood pressure
- glaucoma (increased pressure within the eyeball)
- rhabdomyolysis (condition of breakdown of muscle fibers and pain in muscles)
- dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
- lightness in chest
- difficult swallowing
- restlessness
- agitation
- confusion
- delusion (loss of sense of reality)
- hallucinations
- difficulty in sleeping
- false sense of well being
- immediate or short-term memory loss
- worsening of myasthenia gravis
- large pupils
- lack of near vision
- eye discomfort
- increased sensitivity to light
- faster heartbeat
- being sick
- dry and redness of skin or skin rashes
- inability to pass urine
- difficulty while passing urine
- thirst
- fever
HOW TO MANAGE SIDE EFFECTS
Constipation
Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate treatments for constipation.
Diarrhea
Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.
Dizziness Or Drowsiness
Try to rest and relax and get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Limit your consumption of alcohol, as it can aggravate your dizziness. Consult and inform your doctor if the symptom does not improve.
Headache
If RESTONORM PLUS TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Paracetamol is safe to be taken with RESTONORM PLUS TABLET. Headaches should usually go away after the first week of taking RESTONORM PLUS TABLET. If headaches last more than a week or severe, inform your doctor.
Indigestion
Try to have smaller and more frequent meals and eat and drink slowly. Try to reduce consumption of tea, coffee, cola or alcohol and lose weight if you are obese. Avoid smoking and don’t have rich, spicy or fatty foods. Consult and inform your doctor if the symptom does not improve.
Nausea And Vomiting
Try to take RESTONORM PLUS TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.
WARNING & PRECAUTIONS
PREGNANCY
Monitoring requiredRESTONORM PLUS TABLET is not recommended for use in pregnant women unless it is clearly necessary. It should be used with caution in pregnant women during the third trimester period since the medicine might cause side effects such as shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding in newborn babies. Consult your doctor before taking RESTONORM PLUS TABLET.
BREASTFEEDING
ContraindicatedRESTONORM PLUS TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking RESTONORM PLUS TABLET.
DRIVING AND USING MACHINES
Use with CautionRESTONORM PLUS TABLET might cause dizziness, tiredness, mild nausea, and vision problems. If you experience these side effects, try to avoid driving or operating heavy machines. Consult your doctor before taking RESTONORM PLUS TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking RESTONORM PLUS TABLET. Consult your doctor before taking RESTONORM PLUS TABLET.
KIDNEY
Use with CautionRESTONORM PLUS TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking RESTONORM PLUS TABLET.
LIVER
Use with CautionRESTONORM PLUS TABLET should be used with caution in patients with liver problems. Consult your doctor before taking RESTONORM PLUS TABLET.
ALLERGY
ContraindicatedRESTONORM PLUS TABLET is not recommended for use if you are allergic to Risperidone or Trihexyphenidyl, or any other ingredients of this medicine.
HEART DISEASE
Consult your doctorConsult your doctor before taking RESTONORM PLUS TABLET, if you have heart problems such as irregular heart rhythm.
OTHERS
Before taking RESTONORM PLUS TABLET, inform your doctor if you:
- have stroke due to high blood pressure, cardiovascular disease or blood vessel problems in brain
- have experienced involuntary movements of the face, mouth, and tongue
- have or ever had neuroleptic malignant syndrome (life threatening neurological disorder) with symptoms such as high temperature, muscle stiffness, sweating or a lowered level of consciousness
- have Parkinson’s disease (brain disorder)
- dementia ( loss of cognitive functioning such as thinking, remembering, and reasoning)
- are diabetic
- had an epilepsy
- you have or ever had a prolonged or painful erection
- have problems controlling your body temperature or overheating
- have hyperprolactinemia (high level of prolactin)
- have a tumor dependent on prolactin hormone
- or someone else in your family has a history of blood clots
- have glaucoma
- high blood pressure
- have prostate problems
- have trouble passing urine
- have stomach ulcer
- have severe heartburn
- have acid indigestion
- have any other digestive disorders
- have myasthenia gravis ( muscle weakness)
- have tardive dyskinesia (neurological disorder)
Use in Pediatrics:
RESTONORM PLUS TABLET is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking RESTONORM PLUS TABLET.
Use in Geriatrics:
RESTONORM PLUS TABLET should be used with caution in elderly patients (aged 65 years or above). It is not recommended for use in elderly patients suffering from dementia due to stroke. Medical treatment should be sought straight away if signs of stroke such as sudden change in mental state or sudden weakness or numbness of face, arms or legs, especially on one side, or slurred speech, even for a short period of time are noticed. Consult your doctor before taking RESTONORM PLUS TABLET.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking RESTONORM PLUS TABLET, inform your doctor, if you are taking any of the following medicine:
- medicines that work on your brain such as to help you calm down Ex. benzodiazepines
- medicines used for pain such as opiates (Ex. oxycodone, fentanyl, buprenorphine)
- medicines used for allergy such as antihistamines (Ex. brompheniramine, cetirizine, chlorpheniramine)
- medicines that may change the electrical activity of your heart, such as medicines used for malaria, heart rhythm problems (Ex. quinidine), allergies (antihistamines), some antidepressants (Ex.fluoxetine, citalopram, sertraline) or other medicines for mental problems
- medicines that cause a slow heartbeat Ex. amiodarone, flecainide, propafenone
- medicines that cause low blood potassium such as diuretics Ex. chlorthalidone, hydrochlorothiazide, metolazone
- medicines used to treat elevated blood pressure Ex. amlodipine, felodipine, isradipine
- medicines for Parkinson’s disease (brain disorder) Ex. levodopa
- diuretics (medicines used for heart problems or swelling of parts of your body due to a build up of too much fluid) Ex. furosemide, chlorothiazide
- medicines that increase the activity of the central nervous system such as psychostimulants Ex. methylphenidate
- rifampicin (medicine used for treating some infections)
- carbamazepine, phenytoin (medicines used for epilepsy)
- phenobarbital (medicine used to control seizures)
- quinidine (medicine used for certain types of heart disease)
- antidepressants (medicines used for depression) Ex. paroxetine, fluoxetine, tricyclic antidepressants
- medicines used to treat high blood pressure such as beta blockers Ex. atenolol, bisoprolol, carvedilol
- phenothiazines (medicines used to treat psychosis or to calm down) Ex. chlorpromazine, thioridazine, fluphenazine, mesoridazine, perphenazine
- cimetidine, ranitidine (medicines used for stomach acidity)
- itraconazole, ketoconazole (medicines used for treating fungal infections)
- certain medicines used in the treatment of HIV/AIDS Ex. ritonavir
- verapamil (medicine used to treat high blood pressure and/or abnormal heart rhythm)
- sertraline, fluvoxamine (medicines used to treat depression and other psychiatric disorders)
- aspirin (medicine used for fever and to relieve mild to moderate pain from headaches, toothaches)
- monoamine oxidase inhibitors (medicines used for depression) Ex. moclobemide, tranylcypromine
- disopyramide (medicine used for irregular heartbeat)
- amantadine (medicine used for viral infections)
- nefopam (medicine used as a painkiller)
- metoclopramide or domperidone (medicine used to treat and prevent nausea and vomiting)
- parasympathomimetics (medicines used in the treatment of urinary retention) Ex. neostigmine, bethanechol
Overdosage:
If you or anyone else accidentally takes too much of RESTONORM PLUS TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are feeling sleepy or tired, or having abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, or having abnormal heartbeats or fits.
SYNOPSIS
| Drug | : | Risperidone, Trihexyphenidyl |
| Pharmacological Category | : | Atypical antipsychotics, Anticholinergics |
| Therapeutic Indication | : | Schizophrenia (a serious mental disorder), acute manic episodes (bipolar disorder) |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep the medicine out of reach in children
- Store RESTONORM PLUS TABLET at room temperature
FAQs ABOUT RESTONORM PLUS TABLET
Q. What RESTONORM PLUS TABLET is used for?
A. RESTONORM PLUS TABLET is used to treat schizophrenia, and acute manic episodes. Schizophrenia is a serious mental disorder that affects a person's ability to think, feel and behave clearly which results in impairred daily functioning in a person. Acute manic episode is a manic phase of bipolar I disorder which is defined as an extremely unstable or irritable mood characterized by excessive rapid thought and speech, reckless behavior and feeling of invincibility.
Q. Can RESTONORM PLUS TABLET be used in elderly patients?
A. Yes, RESTONORM PLUS TABLET can be used but with caution in elderly patients (aged 65 years and above). It is not recommended for use in elderly patients suffering from dementia due to stroke. Medical treatment should be sought straight away if signs of stroke such as sudden change in mental state or sudden weakness or numbness of face, arms or legs, especially on one side, or slurred speech, even for a short period of time are noticed. Consult your doctor before taking RESTONORM PLUS TABLET.
Q. What side effects are seen with RESTONORM PLUS TABLET?
A. The most common side effects of taking RESTONORM PLUS TABLET are difficulty falling/staying asleep, common cold symptoms, sinus infection, diarrhea, indigestion, and/or dry mouth. Consult your doctor if any of these symptoms worsens.
Q. Is it safe to drive after taking RESTONORM PLUS TABLET?
A. RESTONORM PLUS TABLET might cause dizziness, tiredness, mild nausea, and vision problems. If you experience any such side effects, then try to avoid driving or operating heavy machines.
Q. What happens if you take more RESTONORM PLUS TABLET than your required dose?
A. If you or anyone else accidentally takes too much of RESTONORM PLUS TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are feeling sleepy or tired, or having abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, or having abnormal heartbeats or fits.
REFERENCES
1. KD. Tripathi. Antiparkinsonian Drugs & Drugs Used in Mental Illness: Antipsychotic and Antimanic Drugs. Seventh edition. 2013. Page – 433 & 441.
2. Rovi Pharmaceuticals Laboratories. Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients with Acute Schizophrenia (PRISMA-3). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2022] [Accessed on 20th May 2022] https://clinicaltrials.gov/ct2/show/NCT03160521
3. GlaxoSmithKline. Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects with Advanced Parkinson's Disease. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in January 2022] [Accessed on 20th May 2022] https://clinicaltrials.gov/ct2/show/NCT00823836
4. Shawn E. McNeil; Jonathan R. Gibbons; Mark Cogburn. Risperidone. NIH National Library of Medicine, National center for biotechnology information. January2022 [Accessed on 20th May 2022] https://www.ncbi.nlm.nih.gov/books/NBK459313/
5. Talha N. Jilani; Sarah Sabir; Sandeep Sharma. NIH National Library of Medicine, National center for biotechnology information. February 2022 [Accessed on 20th May 2022] https://www.ncbi.nlm.nih.gov/books/NBK519488/
6. Balkanpharma – Dupnitsa AD. Electronic medicines compendium (EMC). [Revised in May 2021] [Accessed on 20th May 2022] https://clinicaltrials.gov/ct2/show/NCT00823836
7. Thornton & Ross Limited. Electronic medicines compendium (EMC). [Revised in July 2016] [Accessed on 20th May 2022] https://www.medicines.org.uk/emc/files/pil.5271.pdf
USEFUL DIAGNOSTIC TESTS
- Magnetic resonance imaging (MRI)
- Computed tomography (CT scan)
AUTHOR DETAILS
Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 30 Jan 2023 | 09:30 AM(IST)
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