PREGABALIN Zentiva 100 mg HARD CAPSULES

2. What you need to know before you take Pregabalin Zentiva

Do not take Pregabalin Zentiva

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

Warnings and precautions

Consult your doctor or pharmacist before taking Pregabalin Zentiva.

• Some patients taking pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. If you experience any of these symptoms, you should contact your doctor immediately.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. Stop taking pregabalin and seek medical attention immediately if you experience 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 occurrence of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are used to the effects of the medicine.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any changes in your vision, you should immediately inform your doctor.
• Diabetic patients who gain weight while taking pregabalina may need a dose adjustment of their antidiabetic medications.
• Certain adverse effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medications for treatment, for example, for pain or spasticity (stiff or rigid muscles), with similar adverse effects to those of 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 conditions. Before using this medicine, you should inform your doctor if you have a history of heart disease.
• Cases of renal failure have been reported in some patients treated with pregabalin. If you experience a decrease in your ability to urinate while taking Pregabalin Zentiva, you should inform your doctor, as stopping treatment may improve this situation.
• Some patients taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or suicidal behavior. If at any time you have these thoughts or have shown such behavior, contact your doctor as soon as possible.
• When pregabalin is taken with other medications that can cause constipation (such as some types of pain medications), 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 medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; this may mean you have a higher risk of becoming dependent on pregabalin.
• Cases of seizures have been reported during treatment with pregabalin or shortly after stopping treatment with pregabalin. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who had other illnesses. Inform your doctor if you have a history of any serious illness, including liver or kidney disease.
• Cases of difficulty breathing have been reported. If you have nervous system disorders, respiratory disorders, kidney failure, 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 keep taking the medicine). They may have withdrawal effects when they stop taking pregabalin (see section 3, “How to take Pregabalin Zentiva” and “If you stop taking Pregabalin Zentiva”). If you are concerned that you may become dependent on pregabalin, it is important that you consult your doctor.

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

• You need to take the medicine for longer than recommended by your doctor.
• You feel that you need to take more than the recommended dose.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better once you take the medicine again.

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

Children and adolescents

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

Using Pregabalin Zentiva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregabalin Zentiva and certain medicines may affect each other (interactions). When pregabalin is used with certain medicines that have a sedating effect (including opioids), these effects may be enhanced, 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 medicines that contain:

• oxycodone (used as a pain reliever)
• lorazepam (used to treat anxiety)
• alcohol.

Pregabalin Zentiva can be taken with oral contraceptives.

Taking Pregabalin Zentiva with food, drinks, and alcohol

Pregabalin Zentiva capsules can be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Zentiva.

Pregnancy and breastfeeding

Do not take Pregabalin Zentiva during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations 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 babies out of 100 had such congenital malformations. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. Congenital malformations reported include facial defects (cleft lip and palate), eyes, nervous system (including brain), kidneys, and genitals.

An effective contraceptive method should be used in women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin may cause dizziness, somnolence, and decreased concentration. Do not drive, operate heavy 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 your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Pregabalin Zentiva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin Zentiva is for oral use only.

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

Take the number of 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 per day.

Your doctor will tell you to take Pregabalin Zentiva twice or three times a day. If twice a day, take Pregabalin Zentiva once in the morning and once in the evening, approximately at the same time every day. If three times a day, take Pregabalin Zentiva in the morning, at noon, and in the evening, approximately at the same time every day.

If you think 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 old), you should take Pregabalin Zentiva normally, unless you have kidney problems.

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

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 emergency room immediately. Take the Pregabalin Zentiva capsule pack with you. As a result of taking more Pregabalin Zentiva than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Zentiva

It is important that you take your Pregabalin Zentiva 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, continue with your next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabalin Zentiva

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

Once you have finished taking Pregabalin Zentiva for a long or short period, you should be aware that you may experience certain side effects, called withdrawal effects. These include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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.
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Attention disturbance, movement disturbance, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen.
• Difficulty with erection.
• Swelling of the body including the limbs.
• Feeling of intoxication, gait disturbances.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in the limbs.
• Sore throat.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation.
• Changes in vision, unusual eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness when standing up, sensitive skin, loss of taste, burning sensation, tremor when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation.
• Heart rate disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rate, heart failure.
• Flushing, hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain when urinating, inability to hold urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual periods.
• Cold sensation in hands and feet.

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

• Altered sense of smell, oscillating vision, depth perception disturbance, visual brightness, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing correctly.
• Increased fluid in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual period interruption.
• Kidney failure, reduced urine output, urine 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 red, non-raised, target-like or circular patches on the trunk, often with central blisters, skin peeling, mouth, 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).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known: cannot be estimated from the available data

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

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

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

Certain adverse 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 (stiff or rigid muscles), with adverse effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Zentiva

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

Do not use this medicine after the expiration date that appears on the blister pack and carton after the letters "EXP". The expiration date is the last day of the month indicated. Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Additional Information

Composition of Pregabalin 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 ingredients are lactose monohydrate, pregelatinized corn starch, talc, iron oxide black (E172), titanium dioxide (E171), gelatin, black ink (containing Shellac, iron oxide black (E172), propylene glycol, strong 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).

Pregabalin Zentiva 25 mg hard capsules are packaged in Alu/Alu blisters (OPA/Alu/PVC/Alu) or PVC/PVDC/Alu as primary packaging.

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

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

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

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

Pregabalin Zentiva 225 mg is available in pack sizes of 14, 56, 98, and 100 hard capsules. Not all pack sizes may 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.