Leaflet: information for the user

Pregabalina Zentiva 25mg hard EFG capsules

Pregabalina Zentiva 50mg hard EFG capsules

Pregabalina Zentiva 75mg hard EFG capsules

Pregabalina Zentiva 100mg hard EFG capsules

Pregabalina Zentiva 150mg hard EFG capsules

Pregabalina Zentiva 200mg hard EFG capsules

Pregabalina Zentiva 225mg hard EFG capsules

Pregabalina Zentiva 300mg hard EFG capsules

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, ask 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, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Neuropathic pain peripheral and central

Pregabalina Zentiva is used for the treatment of chronic pain caused by damage to the nerves. There are various diseases that can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation can be described as heat, burning, pulsating pain, lightning pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles sensation. Peripheral and central neuropathic pain may 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 or feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from the stress and tensions of everyday life.

Do not take Pregabalina 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 starting to take Pregabalina Zentiva.

• Some patients treated with pregabalin have reported symptoms that suggest 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 must see your doctor immediately.
• Pregabalin has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should be cautious until you become familiar with 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 alteration in your vision, you must inform your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medication.
• Certain side 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 side effects to pregabalin, so the intensity of these side 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 medicine, you must 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 notice a decrease in your ability to urinate, you must inform your doctor since stopping treatment may improve this situation.
• A small number of people taking antiepileptic drugs such as pregabalin have had thoughts of self-harm or suicide. If at any time you experience these thoughts, 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), 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 medicine, you must inform your doctor if you have a history of alcoholism or abuse or dependence on any drug. Do not take a higher dose than prescribed.
• 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 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.

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 medicines

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

Pregabalina Zentiva and certain medicines may influence each other (interactions). When pregabalin is used with certain medicines that have a sedative effect (including opioids), these effects may be potentiated, leading 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 an analgesic)
• lorazepam (used to treat anxiety)
• alcohol.

Pregabalina Zentiva can be taken with oral contraceptives.

Taking Pregabalina Zentiva with food, drinks, and alcohol

Pregabalina Zentiva capsules 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 told you to. You should use an effective contraceptive method in women of childbearing age. If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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 medicine affects your ability to perform these activities.

Pregabalina Zentiva contains lactose monohydrate

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the suitable dose for you.

Pregabalina Zentiva is exclusively for oral use.

Neuropathic pain periphery and central, epilepsy or generalized anxiety disorder

Take the number of hard capsules that your doctor has indicated.

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 instruct you to take Pregabalina Zentiva two or three times a day. In the case of two times a day, take Pregabalina Zentiva once in the morning and once at night, approximately at the same hour 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 hour 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 have also been reported.

If you forgot to take Pregabalina Zentiva

It is essential to take Pregabalina Zentiva capsules regularly at the same hour 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 unless your doctor tells you to. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once the treatment with Pregabalina Zentiva at short and long term is finished, you should know that you may experience certain adverse effects. These include insomnia, headaches, nausea, anxiety sensation, 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 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 libido, irritability.
• Alteration of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of numbness, tingling, sedation, lethargy, 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, alterations in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in extremities.
• 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 libido, sexual problems 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, sensitive skin, loss of taste, burning sensation, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.
• Eye dryness, eye swelling, eye pain, tired eyes, watery eyes, eye irritation.
• Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Flushes, 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 stiffness, 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.
• Painful menstruation.
• 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 inflammation.
• 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 changes in heart rhythm.
• 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.

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

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

• Liver insufficiency.
• Hepatitis (liver inflammation).

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.

Reporting of side effects

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 thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not store at a temperature above 30°C.

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.

Medicines should not be disposed of through the 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.

Pregabalin Zentiva Composition

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, 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).

Pregabalin Zentiva 25 mg hard capsules are packed in alu-alu blister (OPA/alu/PVC/alu) as primary packaging.

Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg hard capsules are packed in PVC/alu blister 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, 225 mg, and 300 mg are available in pack sizes of 14, 56, 98, and 100 hard capsules.

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

Only some 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 medicinal product, please consult the representative in your country of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:

http://www.ema.europa.eu.