SPIKALON DV ER 500 Tablet 6's

Introduction About SPIKALON DV ER 500 TABLET

SPIKALON DV ER 500 TABLET is used as monotherapy and adjunctive therapy to
manage patients with complex partial seizures that occur either in isolation or
in association with other types of seizure and m
bipolar disorder. It is indicated for prophylaxis of migraine headache. It
contains Divalproex which belongs to the group of medicines called
Anticonvulsants.

Before the management with this medicine, your physician may want you to take
relevant tests to understand your existing condition. Avoid consum
alcohol SPIKALON DV ER 500 TABLET, as it may make you feel drowsy. It is not
recommended for use in patients with liver disease or significant liver
dysfunction or urea cycle disorders. Before taking SPIKALON DV ER 500 TABLET,
inform your physician if you have kidney problems, systemic lupus erythematosus
and porphyria. It should be used with caution by pregnant and breastfeeding
women.

The most common side effects are nausea, vomiting, dizziness, double vision,
weight gain, problems with walking or coordination, headache, weakness, stomach
pain, diarrhoea, hair loss, sleepiness, tremors, blurry vision, increased
appetite, loss of appetite. Contact your physician if any of the side effects
worsen or if you have self-harming thoughts.

Uses Of SPIKALON DV ER 500 TABLET

It is used:

• As monotherapy and adjunctive therapy in the manage patients with complex partial seizures that occur either in isolation or in association with other types of seizure
• As prophylaxis of migraine headache
• As monotherapy or adjunctive therapy in the treatment of patients with complex partial seizure and m

How SPIKALON DV ER 500 TABLET Works

SPIKALON DV ER 500 TABLET helps to control abnormal electrical activity in the
brain (by binding to sodium channels), thus reducing the chances of having fits
or seizures.

How to use SPIKALON DV ER 500 TABLET

• Take SPIKALON DV ER 500 TABLET as advised by your physician
• For Tablet: Swallow the medicine with a glass of water. Do not crush or chew the medicine
• For Sprinkle Capsule: It can beswallowed whole or may be administered by carefully opening the Capsule and sprinkling the entire contents on a small amount of soft food. It should be swallowed immediately and not chewed
• Your physician will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Side Effects Of SPIKALON DV ER 500 TABLET

Common side effects of SPIKALON DV ER 500 TABLET:

• nausea
• vomiting
• dizziness
• double vision
• weight gain
• problems with walking or coordination
• headache
• weakness
• stomach pain
• diarrhoea
• hair loss
• sleepiness
• tremor
• blurry vision
• increased or loss of appetite

Stop taking SPIKALON DV ER 500 TABLET and contact your physician immediately if
you experience any of the following side effects:

• bleeding problems (Ex. red or purple spots on the skin, bruising, pain and swelling in the joints due to bleeding or bleeding from the mouth or nose)
• high ammonia levels in the blood (signs include feeling tired, vomiting and changes in mental status)
• low body temperature (hypothermia)
• symptoms include fever, skin rash, hives, sores in the mouth, blistering and peeling of the skin, swelling of the lymph nodes, swelling of the eyes, face, lips, tongue, or throat, trouble swallowing or breathing
• loss of appetite, pain on the right side of the stomach (abdomen), dark urine, swelling of the face or yellowing of the skin or the whites of the eyes
• inflammation of the pancreas (signs include stomach pain, pain in the back, nausea or vomiting that does not go away)
• self-harming thoughts

Warning & Precautions

!### Pregnancy

Use with CautionSPIKALON DV ER 500 TABLET should be used with caution in pregnant women as it
can cause developmental defects and decreased IQ level of the baby.

!### Breastfeeding

Consult your doctorSPIKALON DV ER 500 TABLET should be used with caution in breastfeeding women
only if recommended by your doctor, as it passes through the breast milk.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines after taking SPIKALON DV ER 500 TABLET if
you experience dizziness, drowsiness, balance or coordination problems, eye
problems like double or blurred vision, low blood levels of sodium causing
muscle weakness, or decreased consciousness.

!### Alcohol

Consult your doctorAvoid consum
make you feel sleepy or drowsy.

!### Allergy

ContraindicatedDo not take SPIKALON DV ER 500 TABLET if you are allergic to Divalproex or any
of the other ingredients of this medicine.

!### Use In Pediatrics

Consult your doctorYour doctor will prescribe the right dose depends on your child’s age, body
weight and disease condition.

!### Use In Geriatrics

Use with CautionSPIKALON DV ER 500 TABLET should be used with caution in elderly patients (aged
above 65 years) with kidney impairment.

Others

Do not take SPIKALON DV ER 500 TABLET, if you have:

• POLG and its associated disorder, especially in children less than 2 years of age
• urea cycle disorders

Before taking SPIKALON DV ER 500 TABLET, inform your physician if you have:

• systemic lupus erythematosus
• porphyria
• bleeding or other disorders of the blood
• pancreatitis
• hyperammonemia and hyperammonemic encephalopathy
• DRESS syndrome

Interactions

A. Drug-Drug interactions:

Before taking SPIKALON DV ER 500 TABLET, inform your physician if you are taking
any of the following medicine:

• Anticonvulsants (Ex. phenobarbital, phenytoin, carbamazepine, lamotrigine, valproic acid, felbamate and topiramate)
• Oral contrace
• Anti-m
• Non-steroidal anti-inflammatory agents (Ex. indomethacin, ibuprofen, acetaminophen)
• Immunosuppressants (Ex. ciclosporin, tacrolimus)
• Antibiotics (Ex. rifampicin, meropenem)
• Antacids (Ex. aluminium hydroxide, magnesium carbonate)
• H2 blockers (Ex. cimetidine and r
• Anticoagulants (Ex. warfarin, aspirin)
• Anti-retroviral (Ex. zidovudine)

Overdosage:

If you or anyone else accidentally takes too much of SPIKALON DV ER 500 TABLET,
consult your physician immediately or visit the nearby hospital. Symptoms of
overdose is drowsiness.

Synopsis

Drug	:	Divalproex
Pharmacological Category	:	Antiepile
Therapeutic Indication	:	M
Dosage Forms	:	Tablet, Capsule, Oral Solution, Solution

More Information

FAQs About SPIKALON DV ER 500 TABLET

Q: Can taking SPIKALON DV ER 500 TABLET lead to self-harming thoughts ?

A: Self harming thoughts are seen in a small number of patients being managed
with SPIKALON DV ER 500 TABLET. If you have such thoughts at any time,
immediately contact your physician or go to the nearby hospital.

Q: Can I continue taking my contrace

A: No. It can stop hormonal contrace
of contrace
taking the medicine. Inform your physician immediately if you have irregular
vaginal bleeding or spotting. If you have any doubts about this, discuss it with
your physician.

Q: Can I crush SPIKALON DV ER 500 TABLET if I cannot swallow it whole?

A: No. Swallow SPIKALON DV ER 500 TABLET with a glass of water. If you cannot
swallow it whole, do not crush or chew it. Consult your, physician, for other
forms of the medicine that you can take.

Q: What if I forget to take a dose of SPIKALON DV ER 500 TABLET?

A: If you forget to take a dose of SPIKALON DV ER 500 TABLET, take it as soon as
you remember. However, omit the missed dose if it is almost time for the next
dose. Do not take twice to make up for a forgotten dose.

Q: Can I stop taking SPIKALON DV ER 500 TABLET?

A: Do not stop taking SPIKALON DV ER 500 TABLET without consulting your
physician, as it can lead to a sudden increase in fits. If you have any more
doubts about using the medicine, ask your physician.

Q: Can SPIKALON DV ER 500 TABLET be used in pregnancy?

A: SPIKALON DV ER 500 TABLET should be used with caution in pregnant women as it
can cause developmental defects and decreased IQ level of the baby.