^®روباكين كرونو

Ropakin® Chrono is a central nervous system agent used in the management of a wide range of neurological and psychiatric conditions. By modulating neurotransmitter activity and inhibiting neuronal signal transmission pathways, it reduces neuronal excitability, thereby helping to control epilepsy and stabilize mood.

• Treatment of various forms of epilepsy (partial and generalized seizures)
• Treatment of bipolar disorder
• Prevention of migraine attacks

500 mg Extended-Release Scored Tablets

Each Ropakin® Chrono tablet contains 333 mg sodium valproate and 145 mg valproic acid, equivalent to 500 mg sodium valproate.

Ropakin® Chrono contains extended-release sodium valproate. Following oral administration, the active ingredient is released slowly over an extended period of time. As a result, stable plasma valproate concentrations can be maintained with fewer daily doses, while reducing adverse effects, particularly gastrointestinal side effects.

The scored tablet can be divided into two halves. Splitting the tablet does not alter the drug-release characteristics, and the active ingredients continue to be released in a controlled, extended-release manner.

Take Ropakin® Chrono exactly as prescribed by your physician. If you are uncertain about the correct method of administration, consult your physician or pharmacist.

To achieve optimal therapeutic outcomes, do not alter the dose or duration of treatment without consulting a healthcare professional.

Sodium valproate should not be discontinued abruptly.

Do not chew or crush the tablets.

The use of sodium valproate is not recommended in children younger than 6 years of age.

If you miss a dose, take it as soon as you remember. If it is almost time for the next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses simultaneously or an extra dose to compensate for a missed dose.

In the event of an overdose, immediately contact your physician or seek medical attention.

Before and during treatment, your physician may periodically monitor:

• Complete blood cell count (CBC)
• Bone mineral density
• Coagulation parameters
• Plasma valproate concentrations
• Liver and kidney function tests
• Blood glucose and plasma electrolyte levels (sodium and potassium)
• Urinalysis (including glucose and electrolyte excretion)
• Signs and symptoms of pancreatitis
• Signs of DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms), including rash, redness, and blistering
• Symptoms of polycystic ovary syndrome (PCOS)
• Patient alertness, cognitive status, and motor function

• Hypersensitivity to valproic acid, its derivatives, or any component of the formulation
• Severe hepatic impairment
• Pregnancy (unless no suitable alternative treatment is available) and women of childbearing potential who are not using effective contraception
• Urea cycle disorders
• Metabolic disorders associated with mitochondrial dysfunction
• Primary carnitine deficiency
• Porphyria

• A small number of patients receiving sodium valproate may experience suicidal thoughts or self-harming ideation. Contact your physician immediately if these symptoms occur.
• Seek medical advice immediately if symptoms of liver dysfunction develop, including dark urine, fatigue, loss of appetite, stomach discomfort, pale stools, vomiting, or jaundice.
• Consult your physician if symptoms suggestive of pancreatitis occur, such as abdominal pain, nausea, vomiting, or decreased appetite.
• Report symptoms such as altered consciousness, excessive drowsiness, lethargy, or cognitive impairment to your physician.
• Sodium valproate may increase the risk of bleeding. This effect is more common in elderly patients and at higher doses.
• If signs of a severe hypersensitivity reaction occur, including rash, swelling, blistering, skin peeling, eye redness, or sores of the mouth, throat, nose, or eyes, seek immediate medical attention.
• Elderly patients may be more susceptible to adverse effects such as dehydration and somnolence; therefore, sodium valproate should be used with additional caution in this population.
• Abrupt discontinuation of antiepileptic drugs may increase seizure frequency. To minimize this risk, sodium valproate should be withdrawn gradually.
• Concomitant use of certain medications may lead to serious adverse reactions. Inform your physician about all medications you are taking to prevent potential drug interactions.
• Inform your physician if you have previously undergone bariatric surgery.

• Consult your physician before using sodium valproate during pregnancy or while breastfeeding.
• Use during pregnancy may result in serious congenital and neurodevelopmental abnormalities in the fetus.
• If you are planning to become pregnant, discuss treatment options with your physician.
• Women of childbearing potential must use effective contraception throughout treatment.
• If pregnancy occurs, do not discontinue sodium valproate abruptly; consult your physician immediately.
• Estrogen-containing contraceptives (such as combined oral contraceptives) may reduce plasma valproate concentrations and increase the risk of seizures. Consult your physician regarding the most appropriate contraceptive method.
• Sodium valproate is excreted into breast milk. Consult your physician before breastfeeding.

Like all medicines, Ropakin® Chrono may cause side effects, although not everybody experiences them. Possible adverse reactions include:

• Headache, lethargy, fever
• Nausea, vomiting, abdominal pain, diarrhea, loss of appetite, dyspepsia, constipation
• Tremor, dizziness, diplopia, blurred vision, nystagmus
• Impaired balance, emotional instability, cognitive impairment, memory disturbances
• Flu-like symptoms, respiratory tract infections, runny nose
• Weight gain or weight loss
• Hair loss
• Fatigue, drowsiness, weakness, dizziness
• Sleep disturbances, particularly in elderly patients

Consult your physician or pharmacist before taking sodium valproate concomitantly with other medications or dietary supplements.

Each bottle contains 30 tablets.

• Keep out of the sight and reach of children.
• Store below 30°C, protected from light and moisture.
• The product may be used until the last day of the month indicated as the expiration date on the package.
• Do not use or store expired medicines.
• Keep the medication in its original packaging.

1. Valproate (Valproic Acid): Drug information, UpToDate 2025
2. http://www.medicines.org.uk/emc/product/11806/smpc
3. Valproic Acid: FDA label 2025