Insomin Forte Tablet 10'S

Introduction About INSOMIN FORTE TABLET

INSOMIN FORTE TABLET contains Nitrazepam which belongs to the group of medicines
called Hypnotic agents. It is used for the short-term management of insomnia
(difficulty in falling asleep). It can also be used in management of a type of
epilepsy called myoclonic seizures (sudden, jerky muscle movements).

INSOMIN FORTE TABLET shortens the time required to fall asleep and lengthens the
duration of the sleep. Take INSOMIN FORTE TABLET only for the duration
recommended by your doctor. Avoid consuming alcohol while taking INSOMIN FORTE
TABLET as it could make you feel dizzier and drowsier.

Before taking INSOMIN FORTE TABLET inform your doctor if you have any lung,
liver, kidney or heart problems. You must also inform your doctor if you have
any muscle problems, depression, anxiety, any psychiatric disorders, epilepsy or
a history of alcoholism or drug abuse as a precaution.

INSOMIN FORTE TABLET is not recommended for use in patients with breathing
difficulties. It is also not suitable for use in pregnant or breastfeeding women
and in children aged below 18 years.

INSOMIN FORTE TABLET may reduce alertness and induce excessive drowsiness in
patients. Therefore, it should not be overdosed or misused by the patients.
Patients must also avoid driving or handling any heavy tools while taking
INSOMIN FORTE TABLET as a precaution.

The most common side effects of taking INSOMIN FORTE TABLET are dizziness,
drowsiness, muscle weakness, feeling unsteady, lack of coordination, reduced
alertness, tiredness and headache. Contact your doctor if any of these side
effect worsens.

You must also inform your doctor immediately if you experience any suicidal
thoughts after taking INSOMIN FORTE TABLET.

Uses Of INSOMIN FORTE TABLET

It is used to manage:

• Insomnia (difficulty in falling asleep)
• Myoclonic seizures (fits causing sudden jerky muscle movements)

How INSOMIN FORTE TABLET Works

INSOMIN FORTE TABLET is a hypnotic medicine. It works by increasing the activity
of certain brain chemicals (GABA) that reduces anxiety, relaxes body muscle and
induces sleep. This produces a calming effect on the brain and shortens the time
required for falling asleep. Additionally, it can also suppress the abnormal
electrical signals in the brain which helps in reducing the onset of seizures.

How to use INSOMIN FORTE TABLET

Take INSOMIN FORTE TABLET as advised by your physician. Swallow the medicine
with a glass of water. Do not chew or crush the medicine.

Your doctor will decide the correct dose and duration of therapy for you
depending upon your age, body weight and health condition.

Do not stop taking INSOMIN FORTE TABLET without consulting your doctor as it may
lead to recurrence of sleep problems or can cause withdrawal symptoms such as
anxiety, nervousness, restlessness, mood changes, confusion, irritability,
sweating, diarrhoea, headaches, muscle weakness, changes in behaviour, numbness
and tingling of the extremities, fits, over-sensitivity to light, noise and
touch and hallucination.

Side Effects Of INSOMIN FORTE TABLET

Common

• dizziness, drowsiness
• feeling unsteady, loss of co-ordination
• lack of emotions
• reduced alertness
• tiredness, double vision
• confusion
• headache
• muscle weakness

Rare

• changes in blood count
• changes in sex drive
• spinning sensation (vertigo)
• breathing problems
• nausea, upset stomach
• difficulty in passing urine

Stop taking INSOMIN FORTE TABLET and consult your doctor immediately if you
experience any of the following side effects such as:

• signs of severe allergic reactions (such as skin rash, itching, swelling of the face, lips, throat or tongue causing difficulty in breathing or swallowing)
• severe skin reactions (such as skin rash with itching and redness, blistering and peeling of skin, skin swelling and inflammation of mucous membrane, skin lesions with a pink/red ring and a pale center which may be itchy, scaly or filled with fluid accomp
• worsening of depression, suicidal thoughts or behavior
• yellowing of skin and whites of the eye (signs of liver problems)
• behavioural changes (such as aggression, excitement, confusion, restlessness, agitation, irritability, rages, hallucinations, nightmares and depression)

How To Manage Side Effects

Nausea:

Take INSOMIN FORTE TABLET with or just after a meal or a snack. Stick to simple
meals. Avoid eating rich or spicy food. Consult your doctor if your nausea
worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines completely while you are feeling dizzy. Do not consume excessive
alcohol, as it could aggravate your dizziness. Consult your doctor if your
dizziness worsens.

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

Warning & Precautions

!### Pregnancy

INSOMIN FORTE TABLET is not recommended for use in pregnant women as it may harm
the growing baby. Therefore, inform your doctor before taking INSOMIN FORTE
TABLET if you are pregnant or think you may be pregnant.

!### Breastfeeding

INSOMIN FORTE TABLET is not recommended for use in breastfeeding women.
Therefore, consult your doctor before taking it.

!### Driving and Using Machines

Do not drive and use heavy machinery while taking INSOMIN FORTE TABLET as it
could reduce alertness and induce drowsiness with poor muscle coordination.

!### Alcohol

Avoid consum
you feel dizzier.

!### Kidney

INSOMIN FORTE TABLET should be used with caution in patients with kidney
problems. Therefore, consult your doctor before taking it.

!### Liver

INSOMIN FORTE TABLET is not recommended for use in patients having severe liver
problems. It should be used with caution in patients with other liver problems.
Therefore, consult your doctor before taking it.

!### Allergy

Do not take INSOMIN FORTE TABLET if you are allergic to Nitrazepam or to any
other benzodiazepines (such as clonazepam, diazepam).

!### Lungs

INSOMIN FORTE TABLET is not recommended for use in patients with severe lung
diseases (such as COPD). It should be used with caution in patients with mild
lung problems. Therefore, consult your doctor before taking it.

!### Heart Disease

INSOMIN FORTE TABLET should be used with caution in patients with heart
problems. Therefore, consult your doctor before taking it.

Others

INSOMIN FORTE TABLET is not recommended for use if you:

• have any breathing difficulties
• have sleep apnea (breathing difficulties during sleep)
• have myasthenia gravis (severe muscle weakness and tenderness)
• have any psychiatric disorders (such as schizophrenia)
• have porphyria (an inherited blood disorder)

Before taking INSOMIN FORTE TABLET, inform your doctor if you:

• are in depression or have a history of depression
• have anxiety or any other mental illnesses
• are alcoholic
• have low albumin levels in blood
• have poor blood supply to the brain
• have epilepsy
• have an history of alcoholism or drug abuse

Use in Pediatrics

INSOMIN FORTE TABLET is not recommended for use in children and adolescents
(aged below 18 years). However, consult your doctor for advice.

Use in Geriatrics

INSOMIN FORTE TABLET should be used with caution in elderly patients as it could
relax the muscles and increase the risk of fall or injuries in such patients.
Therefore, consult your doctor before taking it. Proper dose adjustments and
careful monitoring are required in such patients.

Interactions

A. Drug-Drug Interactions

Before taking INSOMIN FORTE TABLET, inform your doctor if you are taking any of
the following medicines such as:

• other medicines used to manage depress brain such as antidepressants (Ex. fluoxetine, sertraline), hypnotics (Ex. alprazolam, midazolam), neurole
• anaesthetics (used to cause numbness of body parts or loss of consciousness) Ex. lignocaine, sevoflurane
• antihistamines (used to manage allergic symptoms) Ex. cetirizine
• lofexidine (a medicine used to manage withdrawal symptoms of opioids)
• nabilone (a medicine used to manage nausea and vomiting)
• opioid analgesics (used for pain relief) such as morphine, fentanyl, pethidine
• medicines used to manage epilepsy (Ex. phenytoin and phenobarbital)
• rifampicin (a medicine used to manage tuberculosis)
• moxonidine (a medicine used to reduce high blood pressure)
• muscle relaxants (used to reduce muscle spasms) Ex. baclofen, tiz
• erythromycin (a medicine used to manage bacterial infections)
• cimetidine (a medicine used to manage stomach ulcers)

Overdosage:

If you or anyone else accidentally took more INSOMIN FORTE TABLET, consult your
doctor immediately or visit the nearby hospital. Symptoms of overdose might
include drowsiness, confusion, muscle relaxation, lack of coordination,
decreased blood pressure, and extremely slow and/or shallow breathing and pulse.

Synopsis

Drug	:	Nitrazepam
Pharmacological Category	:	Benzodiazepines
Therapeutic Indication	:	Insomnia, Seizure
Dosage Forms	:	Tablet, Capsule

More Information

• Keep INSOMIN FORTE TABLET out of reach of children
• Store INSOMIN FORTE TABLET at room temperature

FAQs About INSOMIN FORTE TABLET

Can INSOMIN FORTE TABLET cause dependency?

INSOMIN FORTE TABLET can also elicit a withdrawl response. Recurrence of sleep
problems, psychological disturbances such as depression, nervousness, tension
and anxiety may also occur, along with mood changes such as irritabiliuty,
restlessness and confusion may also occur. Various physical m
withdrawal include frequent loose stools (diarrhea), headache and muscle
weakness. Hence, it is recommended to take only the prescribed dosage for the
specific amount of time and not to suddenly stop taking INSOMIN FORTE TABLET,
without doctor’s consultation.

Can I drive after taking INSOMIN FORTE TABLET?

No, it is not recommended to drive after taking INSOMIN FORTE TABLET due to
increased tiredness and dizziness, reduced alertness, poor muscular
co-ordination and double vision. Hence INSOMIN FORTE TABLET compromises the
ability to drive, hence should be avoided after taking INSOMIN FORTE TABLET to
manage the hazards.

Is INSOMIN FORTE TABLET addictive?

Yes. INSOMIN FORTE TABLET is addictive in nature. Patients may feel addicted to
this medicine even after using it for a short span of time. Therefore, take
INSOMIN FORTE TABLET only as instructed by your doctor. Avoid overusing or
misusing the medicine.

What is the use of INSOMIN FORTE TABLET?

INSOMIN FORTE TABLET is used in to manage insomnia (sleeplessness) and a type of
epilepsy called myoclonic seizure.

How INSOMIN FORTE TABLET works?

INSOMIN FORTE TABLET is a hypnotic medicine. It works by increasing the activity
of certain brain chemicals (GABA) that reduces anxiety, relaxes body muscle and
induces sleep. This produces a calming effect on the brain and shortens the time
required for falling asleep. Additionally, it can also suppress the abnormal
electrical signals in the brain which helps in reducing the onset of seizures.

How to take INSOMIN FORTE TABLET?

Take INSOMIN FORTE TABLET as advised by your physician. Swallow the medicine
with a glass of water. Do not chew or crush the medicine.

Can I stop taking INSOMIN FORTE TABLET once I started feeling better?

No. Do not stop taking INSOMIN FORTE TABLET without consulting your doctor as it
may make your symptoms re-appear once again or can cause withdrawal symptoms
such as anxiety, nervousness, restlessness, mood changes, confusion,
irritability, sweating, diarrhoea, headaches, muscle weakness, changes in
behaviour, numbness and tingling of the extremities, fits, over-sensitivity to
light, noise and touch and hallucination.

Can I take INSOMIN FORTE TABLET daily?

Take INSOMIN FORTE TABLET as advised by your physician. Your doctor will
evaluate your health condition and suggests whether can you take INSOMIN FORTE
TABLET every day or not.

Will taking a higher dose of INSOMIN FORTE TABLET be more effective?

No. Taking a higher dose of INSOMIN FORTE TABLET will not be effective rather it
would be making you drowsier. Always take the dose prescribed by your doctor. If
the prescribed dose is not effective for you, consult your doctor for advice.
Your doctor might increase the dose or suggest an alternative therapy.

What to do if I forgot to take a dose of INSOMIN FORTE TABLET?

If you forgot to take a dose of INSOMIN FORTE TABLET, take it as soon as you
remember. However, if it is time for the next dose of INSOMIN FORTE TABLET, skip
the missed dose and take the next one regularly. Do not take a double dose of
INSOMIN FORTE TABLET to compensate the missed ones. Consult your doctor for
advice.

What are the side effects of INSOMIN FORTE TABLET?

The most common side effects of taking INSOMIN FORTE TABLET are dizziness,
drowsiness, muscle weakness, feeling unsteady, lack of coordination, reduced
alertness, tiredness and headache. Contact your doctor if any of these side
effect worsens.

Is INSOMIN FORTE TABLET safe to use in children?

INSOMIN FORTE TABLET is generally not recommended for use in children and
adolescents (aged below 18 years). However, consult your doctor before taking
it.

Is INSOMIN FORTE TABLET safe?

INSOMIN FORTE TABLET is safe at doses prescribed by the doctor. Do not alter the
dosage of INSOMIN FORTE TABLET without consulting your doctor.