Pregabalin Zentiva

Do not take it if

From the package leaflet in EMA’s product information, p. 60.

How to take it

These directions are for this exact strength and form. Another one is different.

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.
• Your doctor will determine what dose is appropriate for you.
• Pregabalin Zentiva is for oral use only.
• Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
• Your doctor will tell you to take Pregabalin Zentiva either twice or three times a day. For twice a day take Pregabalin Zentiva once in the morning and once in the evening, at about the same time each day.
• For three times a day take Pregabalin Zentiva once in the morning, once in the afternoon and once in the evening, at about the same time each day.
• If you have the impression that the effect of Pregabalin Zentiva is too strong or too weak, talk to your doctor or pharmacist.
• If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva normally except if you have problems with your kidneys.
• Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
• Swallow the capsule whole with water.
• Continue taking Pregabalin Zentiva until your doctor tells you to stop.
• If you take more Pregabalin Zentiva than you should Call your doctor or go to the nearest hospital emergency unit immediately. Take your box of Pregabalin Zentiva hard capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Zentiva than you should. Fits and unconsciousness (coma) have also been reported.
• If you forget to take Pregabalin Zentiva It is important to take your Pregabalin Zentiva hard capsules regularly at the same time each day.
• If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
• In that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose.
• If you stop taking Pregabalin Zentiva Do not suddenly stop taking Pregabalin Zentiva. If you want to stop taking Pregabalin Zentiva, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week.
• After stopping a short or long term treatment with Pregabalin Zentiva, you need to know that you may experience certain side effects, so called withdrawal effects. These effects include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness. These effects may occur more commonly or severely if you have been taking Pregabalin Zentiva for a longer period of time. If you experience withdrawal effects, you should contact your doctor.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 62–63.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 60–61.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 61–62.

Other medicines

From the package leaflet in EMA’s product information, p. 61.

Driving and using machines

• Pregabalin may produce dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
• Pregabalin Zentiva contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

From the package leaflet in EMA’s product information, p. 62.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, you should seek immediate medical advice.
• Very common: may affect more than 1 in 10 people
• Dizziness, drowsiness, headache.
• Common: may affect up to 1 in 10 people
• Increased appetite.
• Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
• Blurred vision, double vision.
• Vertigo, problems with balance, fall.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
• Difficulties with erection.
• Swelling of the body including extremities.
• Feeling drunk, abnormal style of walking.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in limb.
• Sore throat.
• Uncommon: may affect up to 1 in 100 people
• Loss of appetite, weight loss, low blood sugar, high blood sugar.
• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
• Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
• Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart beat, heart failure.
• Flushing, hot flushes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, heartburn, numb around mouth.
• Sweating, rash, chills, fever.
• Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty with or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased, neutropaenia, increase in blood creatinine, decrease in blood potassium).
• Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
• Painful menstrual periods.
• Coldness of hands and feet.
• Rare: may affect up to 1 in 1 000 people
• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
• Dilated pupils, cross eyes.
• Cold sweat, tightness of the throat, swollen tongue.
• Inflammation of the pancreas.
• Difficulty in swallowing.
• Slow or reduced movement of the body.
• Difficulty with writing properly.
• Increased fluid in the abdomen.
• Fluid in the lungs.
• Convulsions.
• Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast growth in males.
• Interrupted menstrual periods.
• Kidney failure, reduced urine volume, urinary retention.
• Decrease in white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include difficulty breathing, inflammation of the eyes (keratitis)
• and serious skin reactions characterized by reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens- Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, that is symptoms resembling Parkinson’s disease; such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).
• Very rare: may affect up to 1 in 10 000 people
• Liver failure.
• Hepatitis (inflammation of the liver).
• Not known: frequency cannot be estimated from the available data
• Becoming dependent on Pregabalin Zentiva (‘drug dependence’).
• After stopping a short or long-term treatment with Pregabalin Zentiva, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Pregabalin Zentiva”).
• Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to pregabalin and the severity of these effects may be increased when taken together.
• The following adverse reaction has been reported in the post-marketing experience: Trouble breathing, shallow breaths.
• Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 63–65.

How to store it

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
• The expiry date refers to the last day of that month.
• Do not store above 25 °C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 65.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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