Leaflet: information for the user

Pregabalina Zentiva 25 mg hard capsulesEFG

Pregabalina Zentiva 50 mg hard capsulesEFG

Pregabalina Zentiva 75 mg hard capsules EFG

Pregabalina Zentiva 100 mg hard capsulesEFG

Pregabalina Zentiva 150 mg hard capsules EFG

Pregabalina Zentiva 200 mg hard capsules EFG

Pregabalina Zentiva 225 mg hard capsules EFG

Pregabalina Zentiva 300 mg hard capsules EFG

pregabalina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Pregabalina Zentiva belongs to a group of medications used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain

Pregabalina Zentiva is used for the treatment of chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles sensation. Peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can affect physical and social activity and overall quality of life.

Epilepsy

Pregabalina Zentiva is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalina Zentiva to treat epilepsy when your current treatment does not control the disease. You must take Pregabalina Zentiva in addition to your current treatment. Pregabalina Zentiva should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder

Pregabalina Zentiva is used in the treatment of generalized anxiety disorder (GAD). The symptoms of GAD are excessive and prolonged anxiety and worry that are difficult to control. GAD can also produce restlessness or feeling of excitement or nervousness, feeling easily fatigued (tired), difficulty concentrating, feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from everyday stress and tension.

Do not take Pregabalina Zentiva

• if you are allergic to pregabalin or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina Zentiva.

• Some patients treated with pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a widespread skin rash. If you experience any of these symptoms, you should immediately consult your doctor.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis associated with pregabalin treatment, have been reported. Stop taking pregabalin and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects of the medication.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should immediately inform your doctor.
• Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medications.
• Certain adverse effects, such as somnolence, may be more frequent since patients with spinal cord injury may be taking other medications for treatment, for example, pain or spasticity (tense or rigid muscles), with similar adverse effects to pregabalin, so the intensity of these effects may increase when taken together.
• Cases of heart failure have been reported in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases.Before using this medication, you should inform your doctor if you have a history of heart disease.
• Cases of renal insufficiency have been reported in some patients treated with pregabalin. If during treatment with Pregabalina Zentiva you note a decrease in your ability to urinate, you should inform your doctor as the interruption of treatment may improve this situation.
• Some patients treated with antiepileptic drugs such as pregabalin have had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you experience these thoughts or have shown such behavior, you should contact your doctor as soon as possible.
• When pregabalin is taken with other medications that may cause constipation (such as certain types of pain medications), it is possible that gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illicit drugs; this may indicate that you have a higher risk of becoming dependent on pregabalin.
• Cases of seizures have been reported during treatment with pregabalin or shortly after discontinuing treatment with pregabalin. If you experience seizures, you should immediately contact your doctor.
• Cases of encephalopathy (brain dysfunction) have been reported in some patients taking pregabalin and who had other serious diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• Cases of respiratory difficulty have been reported. If you have neurological disorders, respiratory disorders, renal insufficiency, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medication). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabalina Zentiva" and "If you interrupt treatment with Pregabalina Zentiva"). If you are concerned that you may become dependent on pregabalin, it is essential to consult your doctor.

If you notice any of the following signs while taking pregabalin, it could be a sign that you have become dependent:

If you notice any of these signs, talk to your doctor to analyze the best plan of care for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

The safety and efficacy have not been established in children and adolescents (under 18 years) so pregabalin should not be used in this age group.

Use of Pregabalina Zentiva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregabalina Zentiva and certain medications may influence each other (interactions). When pregabalin is used with certain medications that have a sedative effect (including opioids), these effects may be potentiated, and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medications that contain:

• oxycodone (used as an analgesic)
• lorazepam (used to treat anxiety)
• alcohol.

Pregabalina Zentiva can be taken with oral contraceptives.

Taking Pregabalina Zentiva with food, drinks, and alcohol

The capsules of Pregabalina Zentiva can be taken with and without food.

It is recommended not to take alcohol during treatment with Pregabalina Zentiva.

Pregnancy and breastfeeding

You should not take Pregabalina Zentiva during pregnancy or lactation, unless your doctor has indicated otherwise. The use of pregabalin during the first 3 months of pregnancy may cause congenital anomalies in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital anomalies. This contrasts with 4 out of 100 babies born to women not treated with pregabalin in the study. Congenital anomalies of the face (cleft palate), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

A reliable contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pregabalin may cause dizziness, somnolence, and decreased concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Pregabalina Zentiva contains lactose monohydrate

If your doctor has indicated that you have a intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalina Zentiva is exclusively for oral use.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder

Take the number of hard capsules indicated by your doctor.

The dose, adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.

Your doctor will tell you to take Pregabalina Zentiva two or three times a day. In the case of twice a day, take Pregabalina Zentiva once in the morning and once at night, approximately at the same time every day. In the case of three times a day, take Pregabalina Zentiva in the morning, at noon, and at night, approximately at the same time every day.

If you estimate that the action of Pregabalina Zentiva is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take Pregabalina Zentiva normally, except if you have kidney problems.

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems.

Swallow the entire capsule with water.

Continue taking Pregabalina Zentiva until your doctor tells you to stop.

If you take more Pregabalina Zentiva than you should

Call your doctor or go to the nearest emergency service immediately. Bring the Pregabalina Zentiva hard capsules box with you. As a result of taking more Pregabalina Zentiva than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forgot to take Pregabalina Zentiva

It is essential to take Pregabalina Zentiva capsules regularly at the same time every day. If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. In that case, continue with the next dose normally. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Pregabalina Zentiva

Do not stop taking Pregabalina Zentiva suddenly. If you want to stop taking Pregabalina Zentiva, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once the treatment with Pregabalina Zentiva is completed, either in the short or long term, you should know that you may experience certain adverse effects, called withdrawal effects. These include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may appear more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, see your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

• Dizziness, drowsiness, headache.

Common: may affect up to 1 in 10 people

• Increased appetite.
• Euphoria, confusion, disorientation, decreased sexual desire, irritability.
• Attention disturbance, clumsiness, memory deterioration, memory loss, tremors, difficulty speaking, numbness, tingling, sedation, drowsiness, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.
• Difficulty achieving erection.
• Swelling of the body including extremities.
• Sensation of intoxication, gait disturbances.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar, high blood sugar.
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual desire, sexual dysfunction including inability to achieve orgasm, delayed ejaculation.
• Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.
• Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Flushing, hot flashes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, burning sensation, numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle spasms, joint swelling, muscle rigidity, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain urinating, inability to hold urine.
• Weakness, thirst, chest oppression.
• Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, snoring.
• Dysmenorrhea.
• Sensation of cold in hands and feet.

Rare: may affect up to 1 in 1,000 people

• Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat oppression, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Reduced mobility of the body.
• Difficulty writing correctly.
• Fluid accumulation in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual interruption.
• Renal insufficiency, reduced urine output, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat, red, non-elevated patches, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Icterus (yellow skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle rigidity.

Very rare: may affect up to 1 in 10,000 people

• Liver insufficiency.
• Hepatitis (inflammation of the liver).

Frequency not known: cannot be estimated from available data

• Becoming dependent on pregabalin ("drug dependence").

Once a short- or long-term treatment with pregabalin is completed, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Pregabalin Zentiva").

If you experience swelling in the face or tongue, or if your skin becomes red and develops blisters or peeling, you should seek immediate medical attention.

Certain side effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (tense or rigid muscles), with side effects similar to those of pregabalin, so the intensity of these side effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse reactions

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and carton after the letters “CAD/EXP”. The expiration date is the last day of the month indicated. Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the medications that you no longer need. In this way, you will help protect the environment.

Composition of Pregabalina Zentiva

• The active ingredient is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other components are lactose monohydrate, pregelatinized maize starch, talc, iron oxide black (E172), titanium dioxide (E171), gelatin, black ink (which contains Shellac, iron oxide black (E172), propylene glycol, ammonia solution, potassium hydroxide).

The 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg capsules also contain iron oxide red (E172) and iron oxide yellow (E172).

Pregabalina Zentiva 25 mg hard capsules are packaged in alu-alu blister (OPA/alu/PVC/alu) or PVC/PVDC/alu as primary packaging.

Pregabalina Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg hard capsules are packaged in PVC/alu as primary packaging.

Pregabalina Zentiva 25 mg and 50 mg are available in packaging sizes of 14, 21, 56, 84, 98, and 100 hard capsules.

Pregabalina Zentiva 75 mg, 150 mg, and 300 mg are available in packaging sizes of 14, 56, 84, 98, 100, and 112 hard capsules.

Pregabalina Zentiva 100 mg and 200 mg are available in packaging sizes of 21, 84, 98, and 100 hard capsules.

Pregabalina Zentiva 225 mg is available in packaging sizes of 14, 56, 98, and 100 hard capsules. Some packaging sizes may only be marketed.

Marketing Authorization Holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

or

S.C. Zentiva, S.A

B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266

Romania

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.