PREGABALIN Zentiva 300 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 vision, many of which are transient. If you experience any changes in your vision, you should inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may need a change in their diabetes treatment.
• Certain side effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medicines for treatment, for example, pain or spasticity (stiff or rigid muscles), with similar side effects 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 were elderly with cardiovascular conditions. Before using this medicine, you should inform your doctor if you have a history of heart disease.
• There have been reports of renal failure in some patients taking pregabalin. If during treatment with Pregabalin Zentiva you notice a decrease in your ability to urinate, you should inform your doctor as discontinuation of treatment may improve this condition.
• A small number of people taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor as soon as possible.
• When pregabalin is taken with other medicines that can cause constipation (such as some types of pain medicines), 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, you should inform 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 discontinuing 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. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

Children and adolescents

The safety and efficacy in children and adolescents (below 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

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

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

Pregnancy and breastfeeding

You should not take Pregabalin Zentiva during pregnancy or breastfeeding, unless your doctor has told you to do so. An effective contraceptive method 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.

If you are unsure, consult your doctor or pharmacist.

Your doctor will determine the dose that is right for you.

Pregabalin Zentiva is for oral use only.

Neuropathic pain peripheral and central, 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 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 old), you should take Pregabalin Zentiva as normal, unless you have kidney problems.

Your doctor may prescribe a different dosage 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

Contact your doctor or the nearest 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.

After stopping treatment with Pregabalin Zentiva, either after a short or a long period of time, 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 of time.

If you have any further questions on 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, somnolence, headache.

Common: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of euphoria, confusion, disorientation, decreased sexual interest, irritability.
• Attention disturbances, clumsiness, memory disturbances, amnesia, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Vertigo, balance disturbances, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal distension.
• Difficulty achieving an erection.
• Swelling of the body, including the limbs.
• Feeling drunk, 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 perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual interest, sexual dysfunction including inability to achieve orgasm, delayed ejaculation.
• Changes in vision, unusual 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, tremors 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.
• Difficulty breathing, 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 sweats, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced movement of the body.
• 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, breast enlargement in men.
• Menstrual irregularities.
• Kidney failure, decreased urine production, 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 a 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 for treatment, for example, pain or spasticity (stiff or rigid muscles), with similar side effects 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 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.

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 shown.

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 protect the environment.

6. Contents of the pack and further 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, 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 aluminium-aluminium (OPA/alu/PVC/alu) blisters 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/aluminium 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.