Pregastar M OD 150mg Tablet 10'S

Introduction About PREGASTAR M OD 150MG TABLET

PREGASTAR M OD 150MG TABLET is used for the management of neuropathic pain. It
is a combination of Pregabalin and Methylcobalamin which belongs to the group of
medicines called Anticonvulsants and Vitamin-B complex respectively. It consists
of Methylcobalamin and Pregabalin where Methylcobalamin acts by rejuvenating the
damaged neurons by improving the production of myelin and pregabalin acts by
interfering with various pain signals travelling through the damaged nerves and
the brain, thus leading to a significant pain relief in various neuropathic pain
states.

Do not stop taking PREGASTAR M OD 150MG TABLET without consulting your doctor as
it could precipitate withdrawal symptoms such as headache, insomnia, nausea,
pain, diarrhea, flu syndrome, anxiety, nervousness, depression, convulsion,
excessive sweating, dizziness and physical dependence. PREGASTAR M OD 150MG
TABLET has high potential to cause addiction and therefore caution should be
exercised among patients who already has a history of substance abuse.

PREGASTAR M OD 150MG TABLET is not recommended for use in pregnant or
breastfeeding women unless advised by the doctor and in male patients who plan
to father a child. The most common side effects are dizziness, sleepiness,
headache, dry mouth, mood changes, fluid retention and weight gain. Consult your
doctor if any of the side effects worsen.

Uses Of PREGASTAR M OD 150MG TABLET

• Used to manage neuropathic pain

How PREGASTAR M OD 150MG TABLET Works

PREGASTAR M OD 150MG TABLET effectively alleviates the symptoms of various types
of neuropathic pain, where Methylcobalamin acts by rejuvenating the damaged
neurons by improving the production of myelin and Pregabalin acts by interfering
with various pain signals travelling through the damaged nerves and the brain,
thus leading to a significant pain relief in various neuropathic pain states.

How to use PREGASTAR M OD 150MG TABLET

• Take PREGASTAR M OD 150MG TABLET as advised by your physician
• Swallow PREGASTAR M OD 150MG TABLET with a glass of water. Do not crush or chew the medicine
• Your doctor will decide the correct dose and duration depending upon your age, body weight and disease condition

Side Effects Of PREGASTAR M OD 150MG TABLET

Common side effects of PREGASTAR M OD 150MG TABLET:

• dizziness
• sleepiness
• headache
• common cold
• nausea, vomiting
• increased appetite
• constipation, diarrhea, flatulence, abdominal distension
• dry mouth
• feeling excited or pleasurable)
• impaired balance or coordination
• tremor (shaking)
• tingling and numbness in extremities)
• tiredness
• blurred vision
• spinning sensation
• muscle cramps
• pain in limbs, joints or back
• cervical spasm (a sudden, involuntary contraction of a muscle in the neck)
• joint swelling, muscle or neck pain

Stop taking PREGASTAR M OD 150MG TABLET and contact your doctor immediately if
you experience any of the following side effects:

• severe allergic reactions (skin rash, itching, swelling of the face, lips, throat, neck and difficulty in breathing)
• symptoms of elevated creatine kinase (unexplained muscle pain, tenderness or weakness, accomp

Warning & Precautions

!### Pregnancy

Consult your doctorThere is no proper information on the use of PREGASTAR M OD 150MG TABLET during
pregnancy and therefore should be used only if the benefit to the mother clearly
outweighs the potential risk to the fetus.

!### Breastfeeding

Monitoring requiredPREGASTAR M OD 150MG TABLET is not recommended for use in breastfeeding women
unless it is considered clearly necessary.

!### Driving and Using Machines

Use with CautionDo not drive or operate any heavy tools or machines if you experience dizziness
or sleepiness after taking this medicine.

!### Alcohol

Consult your doctorAvoid consum
cause impairment of motor skills and sedating effects of alcohol.

!### Kidney

Use with CautionPREGASTAR M OD 150MG TABLET should be taken with caution in patients with
impaired kidney function.

!### Liver

Use with CautionPREGASTAR M OD 150MG TABLET should be taken with caution in patients with liver
disease.

!### Allergy

ContraindicatedDo not take PREGASTAR M OD 150MG TABLET if you are allergic to Pregabalin,
Methylcobalamin or any other ingredients of this medicine.

!### Heart Disease

Use with CautionPREGASTAR M OD 150MG TABLET should be taken with caution in patients with heart
disease such as congestive heart failure.

!### Use In Pediatrics

ContraindicatedPREGASTAR M OD 150MG TABLET is not recommended for use in children and
adolescents (aged below 18 years) due to lack of safety data.

!### Use In Geriatrics

Use with CautionPREGASTAR M OD 150MG TABLET should be used with caution in elderly patients
(aged 65 years and above), especially in patients with decreased renal function.
Proper dose adjustments and careful monitoring of kidney function are required
in such patients.

Others

PREGASTAR M OD 150MG TABLET is not recommended for use if you:

• have Leber’s disease
• have problems in glucose metabolism

Before taking this medicine, inform your physician if you:

• have history of misuse or substance abuse
• have folate deficiency
• have diabetes
• have epilepsy
• have or at risk of encephalopathy

Interactions

A. Drug-Drug interactions:

Before taking the medicine, inform your doctor if you are taking any of the
following medicines:

• Anti-diabetics (Ex. metformin, pioglitazone, rosiglitazone)
• Anti-spasticity agents (Ex. dantrolene, baclofen)
• Opioid analgesics (Ex. morphine, pethidine)
• CNS depressants (Ex. lorazepam)
• Oral contrace
• Antibiotics (Ex. Chloramphenicol)
• Vitamins (Ex. folic acid, Vitamin C)
• Anti-lipidemic agents (Ex. cholestyramine or colestipol)
• Anti-gout agents (Ex. Colchicine)
• Antituberculosis agent (Ex. Para-amino salicylic acid)
• Electrolyte supplement (Ex. Potassium chloride)

Overdosage:

If you or anyone else accidentally takes too much of PREGASTAR M OD 150MG
TABLET, contact your doctor immediately or go to a hospital straight away.
Overdosage symptoms such as sleepiness, confusion, agitation, restlessness or
seizures.

Synopsis

Drug	:	Pregabalin, Methylcobalamin
Pharmacological Category	:	Anticonvulsants, Vitamin B complex
Therapeutic Indication	:	Neuropathic pain
Dosage Forms	:	Tablet, Capsule, Soft gels, Syrup

More Information

Disease Descri

Neuropathic pain is now defined by the International Association for the Study
of Pain (IASP) as ‘pain caused by a lesion or disease of the somatosensory
nervous system’. It is the result of disease or damage anywhere along the
neuraxis of the peripheral or central (spinal and supraspinal) nervous system.

FAQs About PREGASTAR M OD 150MG TABLET

Q: Can PREGASTAR M OD 150MG TABLET affect fertility?

A: Fertility studies in men have shown that there were no effects on sperm
motility. However, PREGASTAR M OD 150MG TABLET can be associated with an
increased risk of male-mediated teratogenicity (abnormalities in fetus). Men
being managed with this medicine who plan to father a child should be informed
about the potential risk of male-mediated teratogenicity. There are not enough
clinical data on the effects of this medicine on female fertility.

Q: Can PREGASTAR M OD 150MG TABLET cause weight gain?

A: Yes. It may cause weight gain in some individuals mainly due to the formation
of peripheral edema (fluid retention). Inform your doctor if you have diabetes
prior to management with [as a precaution.

Q: Can PREGASTAR M OD 150MG TABLET decrease libido?

A: Yes, PREGASTAR M OD 150MG TABLET may cause decrease in sex drive (libido) in
some individuals, although not everybody gets them.

Q: Is PREGASTAR M OD 150MG TABLET addictive?

A: Yes, PREGASTAR M OD 150MG TABLET has high potential to create substance abuse
or dependence and therefore caution should be exercised among patients who
already has a history of substance abuse.

Q: Can I stop taking PREGASTAR M OD 150MG TABLET once my pain is relieved?

A: No. Do not stop taking PREGASTAR M OD 150MG TABLET without consulting your
doctor as it could precipitate withdrawal symptoms such as headache, lack of
sleep, nausea, pain, diarrhea, flu syndrome, anxiety, nervousness, depression,
convulsion, hyperhidrosis and dizziness and dependence. If your condition
improves, contact your doctor so that he might reduce the dose appropriately
before discontinuation of the therapy with the medicine.

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Useful Diagnostic Tests

• Complete Blood Count (CBC) with ESR
• Liver Funtion Basic
• Kidney Function Test with Electrolytes (KFT / RFT)
• Advance Diabetes Care
• HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin