PREGABALIN Zentiva 25 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 a rash. If you experience any of these symptoms, you should contact your doctor immediately.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk 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 your sight, many of which are temporary. If you experience any changes in your vision, you should immediately contact your doctor.
• Diabetic patients who gain weight while taking pregabalin may need an adjustment in their blood sugar control medicines.
• Certain side effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity (muscle stiffness or rigidity), with side effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.
• There have been reports of heart failure in some patients taking pregabalin. Most of these patients had pre-existing heart conditions. Before using this medicine, you should tell your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients taking pregabalin. If you notice a decrease in your ability to urinate while taking Pregabalin Zentiva, you should inform your doctor, as stopping treatment may improve this condition.
• A small number of people taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.
• When pregabalin is taken with other medicines that may cause constipation (such as certain types of pain medicines), it is possible that gastrointestinal problems (e.g., constipation and bowel obstruction or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, you should tell your doctor if you have a history of alcoholism or drug abuse or dependence. Do not take a higher dose than prescribed.
• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with pregabalin. If you experience seizures, contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin who had other conditions. You should tell your doctor if you have a history of any serious disease, including liver or kidney disease.

Children and adolescents

The safety and effectiveness of pregabalin in children and adolescents (under 18 years of age) have not been established, and therefore, 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 other medicines may affect each other (interact). When pregabalin is used with certain medicines, such as those with sedative effects (including opioids), these effects may be increased, which 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. An effective method of contraception should be used in women of childbearing age. 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. You should 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, contact them before taking this medicine.

3. How to take Pregabalin Zentiva

Take this medicine exactly as your doctor has told you to.

If you are unsure, consult your doctor or pharmacist.

Your doctor will determine the appropriate dose for you.

Pregabalin Zentiva is for oral use only.

Neuropathic pain peripheral and central, epilepsy, or generalized 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 per 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, approximately at the same time every day. For 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 of age), you should take Pregabalin Zentiva normally, except if you have kidney problems.

Your doctor may prescribe a different dosing schedule and/or dose 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

Contact your doctor or the nearest hospital emergency department immediately. Take the Pregabalin Zentiva pack with you. As a result of taking more Pregabalin Zentiva than you should, you may feel drowsy, confused, agitated, or restless. Seizures 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 this case, continue with your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Zentiva

Do not stop taking Pregabalin Zentiva unless your doctor tells you to. If you are going to stop taking this medicine, it needs to be done gradually over a minimum of one week.

Once you stop taking Pregabalin Zentiva, either after a short or long treatment period, you may experience certain side effects. These include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or be more severe if you have been taking pregabalin for a longer period.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 interest, irritability.
• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremors, difficulty speaking, sensation of tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Vertigo, balance disorder, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal distension.
• Difficulty with erection.
• Swelling of the body, including the limbs.
• Feeling of intoxication, gait disturbance.
• 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, high blood sugar.
• Change in perception of self, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual interest, sexual dysfunction, including inability to reach 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 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.
• Abnormal heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, 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 control urination.
• 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, hives, runny nose, nosebleeds, coughing, snoring.
• Painful menstrual periods.
• Cold sensation in hands and feet.

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

• Altered sense of smell, wavering vision, altered depth perception, visual glare, loss of vision.
• Dilated pupils, squinting.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body movement.
• Difficulty writing correctly.
• Fluid accumulation 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, breast enlargement in men.
• Disruption of menstrual periods.
• Kidney failure, decreased urine output, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior.

• Allergic reactions (which may include difficulty breathing, eye inflammation, and a severe skin reaction characterized by rash, blisters, peeling of the skin, and pain).
• Jaundice (yellowing of the skin and eyes).

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

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

If you experience swelling of the face or tongue, or if your skin turns red and develops blisters or peels, you should seek medical attention immediately.

Certain side effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity (muscle stiffness or rigidity), with side effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalina Zentiva

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the blister and carton after the letters “CAD/EXP”. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Pregabalina Zentiva

The active substance 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 maize starch, talc, titanium dioxide (E171), gelatin, Shellac lacquer, iron oxide black (E172).

The 50 mg capsules also contain propylene glycol, strong ammonia solution, potassium hydroxide.

The 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsules also contain polyethylene glycol.

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 blisters (OPA/Alu/PVC/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 blisters as primary packaging.

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

Pregabalina Zentiva 75 mg, 150 mg, 225 mg, and 300 mg are available in pack sizes of 14, 56, 98, and 100 hard capsules.

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

Not all pack sizes may be marketed.

Marketing authorisation 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 further information about this medicine, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

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