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Pregabalin Zentiva k.s.

Active Substance: pregabalin
Common Name: pregabalin
ATC Code: N03AX16
Marketing Authorisation Holder: Zentiva k.s.
Active Substance: pregabalin
Status: Authorised
Authorisation Date: 2017-02-27
Therapeutic Area: Epilepsy Anxiety Disorders Neuralgia
Pharmacotherapeutic Group: Antiepileptics

Therapeutic Indication

Neuropathic pain
Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy
Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised anxiety disorder
Pregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

What is Pregabalin Zentiva k.s. and what is it used for?

Pregabalin Zentiva k.s. is a medicine used to treat adults with the following conditions:

  • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with herpes zoster (shingles) or nerve disorders caused by diabetes, and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
  • epilepsy, where it is used as an ‘add-on’ to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
  • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

Pregabalin Zentiva k.s. contains the active substance pregabalin. It is a ‘generic medicine’. This means that Pregabalin Zentiva k.s. contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Lyrica.

How is Pregabalin Zentiva k.s. used?

Pregabalin Zentiva k.s. is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription. The recommended starting dose is 150 mg per day, divided into two or three doses. After three to seven days, the dose can be increased to 300 mg per day. Doses can be increased up to twice more until the most effective dose is reached. The maximum dose is 600 mg per day. Doctors may choose lower doses in patients with kidney problems. When stopping treatment with Pregabalin Zentiva k.s. the dose should be reduced gradually, over at least a week.

How does Pregabalin Zentiva k.s. work?

The active substance in Pregabalin Zentiva k.s., pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma‑amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells. The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells. This reduces the activity of nerve cells in the brain and spinal cord that are involved in pain, epilepsy and anxiety.

How has Pregabalin Zentiva k.s. been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Zentiva k.s.

As for every medicine, the company provided studies on the quality of Pregabalin Zentiva k.s. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Pregabalin Zentiva k.s.?

Because Pregabalin Zentiva k.s. is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Pregabalin Zentiva k.s. approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva k.s. has been shown to have comparable quality and to be bioequivalent to Lyrica. Therefore, the CHMP’s view was that, as for Lyrica, the benefit outweighs the identified risk. The Committee recommended that Pregabalin Zentiva k.s. be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Pregabalin Zentiva k.s.?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Zentiva k.s. have been included in the summary of product characteristics and the package leaflet.

Other information about Pregabalin Zentiva k.s.

The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Zentiva k.s. on27 February 2017.

For more information about treatment with Pregabalin Zentiva k.s., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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