What is Pregabalin Zentiva ks and what is it used for?
Pregabalin Zentiva ks 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 (shingles) or nervous 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 administered as an adjunctive therapy to that existing in patients with partial seizures (seizures that begin in a specific area of the brain) that cannot be controlled with the ongoing therapy;
- generalized anxiety disorder (chronic anxiety or nervousness in everyday life)
Pregabalin Zentiva ks contains the active substance pregabalin. It is a "generic medicine". This means that Pregabalin Zentiva ks contains the same active substance and acts in the same way as a 'reference medicine' already authorized in the European Union (EU) called Lyrica. For more information on generic medicines, see the questions and answers by clicking here.
How is Pregabalin Zentiva ks used?
Pregabalin Zentiva ks 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 a day. Doses can be increased up to twice the dosage until the most effective dose is reached. The maximum dose is 600 mg a day. For patients with kidney problems, the doctor may prescribe lower doses. Treatment with Pregabalin Zentiva ks should be discontinued by gradually reducing the dose over at least a week.
How does Pregabalin Zentiva ks work?
The active ingredient of 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 neighboring cells. The precise mode of action of pregabalin is not entirely known, but pregabalin is believed to affect the way calcium penetrates 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 ks shown during the studies?
With the reference medicine Lyrica, studies have already been carried out on the benefits and risks of the active substance for approved uses, which therefore should not be repeated for Pregabalin Zentiva ks.
As with any medicine, the company has made studies on the quality of Pregabalin Zentiva ks. Furthermore, he carried out a study which showed that Pregabalin Zentiva ks is "bioequivalent" to the reference medicine. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body, so it is expected to have the same effect
Because Pregabalin Zentiva ks is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as the reference medicine's.
What are the risks associated with Pregabalin Zentiva ks?
Because Pregabalin Zentiva ks is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as the reference medicine's.
Why has Pregabalin Zentiva ks been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva ks has been shown to have comparable quality 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 to approve the use of Pregabalin Zentiva ks in the EU.
What measures are being taken to ensure the safe and effective use of Pregabalin Zentiva ks?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Zentiva have been included in the summary of product characteristics and the package leaflet.
More information on Pregabalin Zentiva ks
For the full EPAR of Pregabalin Zentiva ks consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Pregabalin Zentiva ks, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
