Pregabalin Zentiva k.s.

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 (caused by damage to the nervous system), including peripheral neuropathic pain, such as pain experienced by patients with shingles (St. Anthony's fire) or nerve disorders caused by diabetes and central neuropathic pain, such as for example the pain experienced by patients who have suffered a spinal cord injury;
• epilepsy, in which the medicine is given as an add-on to existing therapy in patients with partial seizures (seizures starting in a specific "area of ​​the brain) that cannot be controlled with current therapy;
• generalized anxiety disorder (chronic anxiety or nervousness about issues related to everyday life).

Pregabalin Zentiva k.s. contains the active substance pregabalin. It is a 'generic medicine'. This means that Pregabalin Zentiva k.s. it contains the same active substance and works in the same way as a 'reference medicine' already authorized in the European Union (EU) called Lyrica. For more information on generic medicines, please see the questions and answers by clicking here.

How is Pregabalin Zentiva k.s. used? ?

Pregabalin Zentiva k.s. it 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 more than twice as much until the most effective dose is reached. The maximum dose is 600 mg per day. For patients with kidney problems, the doctor may prescribe lower dosages. Discontinuation of treatment with Pregabalin Zentiva k.s. it must be done by reducing the dose gradually, over a period of at least one week.

How does Pregabalin Zentiva k.s. ?

The active substance in Pregabalin Zentiva ks, pregabalin, is similar in structure to the body's 'neurotransmitter', gamma-aminobutyric acid (GABA), but has very different biological effects. Neurotransmitters are substances used by nerve cells to communicate with cells The precise modes of action of pregabalin are not fully known, but pregabalin is thought to affect the way 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.

What benefit has Pregabalin Zentiva k.s. shown during your studies?

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

As with any medicine, the company made available studies on the quality of Pregabalin Zentiva k.s .. In addition, it carried out a study which showed that Pregabalin Zentiva k.s. is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body, so they are expected to have the same effect

Since 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.

What are the risks associated with Pregabalin Zentiva k.s. ?

Since 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 has Pregabalin Zentiva k.s. been 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 qualities and to be bioequivalent to Lyrica. Therefore, the CHMP considered that, as in the case of Lyrica, the benefits outweigh the identified risks and 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.?

The recommendations and precautions that healthcare professionals and patients must observe in order for Pregabalin Zentiva k.s. is used safely and effectively have been reported in the summary of product characteristics and package leaflet.

Other information about Pregabalin Zentiva k.s.

For the complete version of the EPAR of Pregabalin Zentiva k.s. consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Pregabalin Zentiva k.s. therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. The full version of the EPAR of the reference medicine can also be found on the Agency's website.

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