Pregabalin Zentiva 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabaline Zentiva 25 mg hard capsules EFG

Pregabaline Zentiva 50 mg hard capsules EFG

Pregabaline Zentiva 75 mg hard capsules EFG

Pregabaline Zentiva 100 mg hard capsules EFG

Pregabaline Zentiva 150 mg hard capsules EFG

Pregabaline Zentiva 200 mg hard capsules EFG

Pregabaline Zentiva 225 mg hard capsules EFG

Pregabaline Zentiva 300 mg hard capsules EFG

pregabalin

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pregabalin Zentiva is and what it is used for
2. What you need to know before taking Pregabalin Zentiva
3. How to take Pregabalin Zentiva
4. Possible side effects
5. How to store Pregabalin Zentiva
6. Contents of the pack and other information

1. What is Pregabalin Zentiva and what is it used for

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

Peripheral and central neuropathic pain

Pregabalin Zentiva is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The sensation of pain may be described as warmth, burning, throbbing, shooting, stabbing, sharp pain, continuous pain, tingling, numbness, and prickling sensations. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

Epilepsy

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

Generalized anxiety disorder

Pregabalin Zentiva is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD include excessive and prolonged anxiety and worry that are difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigue, difficulty concentrating or the mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stress and worries of normal life.

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

Do not take Pregabalin Zentiva

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

Warnings and precautions

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

• Some patients treated with pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek medical advice immediately.
• Pregabalin has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects of the medicine.
• Pregabalin may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, you must inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.
• Certain adverse effects, such as somnolence, may be more frequent in patients with spinal cord injury, as they may be taking other medications for conditions such as pain or spasticity (tight or stiff muscles), which have adverse effects similar to those of pregabalin; thus, the intensity of these effects may increase when taken concomitantly.
• Cases of heart failure have been reported in some patients treated with pregabalin. Most of these patients were elderly with cardiovascular disease. Before using this medicine, you must 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 during treatment with Pregabalin Zentiva you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.
• A small number of people taking antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide. If at any time you experience such thoughts, contact your doctor as soon as possible.
• When pregabalin is taken together with other medicines that may cause constipation (such as certain types of pain medicines), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal paralysis) may occur. Inform your doctor if you develop 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 of drug abuse, dependence, or addiction. Do not take a higher dose than the one prescribed to you.
• Seizures have been reported during treatment with pregabalin or shortly after discontinuation of pregabalin treatment. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who also had other medical conditions. Inform your doctor if you have a history of any serious illness, including liver or kidney disease.

Children and adolescents

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

Taking Pregabalin Zentiva with other medicines

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

Pregabalin Zentiva and certain medicines may interact with each other. When pregabalin is used together with certain medicines that have sedative effects (including opioids), these effects may be enhanced, potentially leading to respiratory depression, coma, and death. The degree of dizziness, somnolence, and reduced concentration may increase if pregabalin is taken together with other medicines containing:

• oxycodone (used as an analgesic)
• 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 may be taken with or without food.

It is recommended not to drink alcohol during treatment with Pregabalin Zentiva.

Pregnancy and breastfeeding

You must not take Pregabalin Zentiva during pregnancy or breastfeeding unless your doctor has instructed you to do so. An effective method of contraception must be used in women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalin may cause dizziness, somnolence, and reduced concentration. You must not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform such tasks.

Pregabalin Zentiva contains lactose monohydrate

If your doctor has advised you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pregabaline Zentiva

Follow exactly the instructions given by your doctor for taking this medicine.

If in doubt, please consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you.

Pregabaline Zentiva is for oral use only.

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

Take the number of hard capsules your doctor has indicated.

The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg daily.

Your doctor will instruct you to take Pregabaline Zentiva twice or three times a day. If twice daily, take Pregabaline Zentiva once in the morning and once at night, approximately at the same time each day. If three times daily, take Pregabaline Zentiva in the morning, at midday, and at night, approximately at the same time every day.

If you feel that the effect of Pregabaline Zentiva is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Pregabaline Zentiva as normal, 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 Pregabaline Zentiva until your doctor tells you to stop.

If you take more Pregabaline Zentiva than you should

Contact your doctor or go to the nearest emergency department immediately. Take the Pregabaline Zentiva hard capsules pack with you. As a result of taking more Pregabaline Zentiva than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported.

If you forget to take Pregabaline Zentiva

It is important to take Pregabaline 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 normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabaline Zentiva

Do not stop taking Pregabaline 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.

After stopping long-term or short-term treatment with Pregabaline Zentiva, you should be aware that you may experience certain adverse effects. These include sleep problems, headache, nausea, feeling anxious, diarrhoea, 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 of time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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.
• Feelings of euphoria, confusion, disorientation, decreased sexual drive, irritability.
• Attention disturbances, clumsiness, 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.
• Erectile dysfunction.
• Swelling of the body including limbs.
• Feeling of drunkenness, 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.
• Altered self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation.
• Visual disturbances, unusual eye movements, vision changes including tunnel vision, light flashes, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, movement tremor, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise.
• Dry eyes, eye swelling, 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 flushes.
• Breathing difficulty, nasal dryness, nasal congestion.
• Increased saliva production, burning sensations, 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 urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium).
• 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, fluctuating vision, depth perception disturbances, visual glare, vision loss.

• Dilated pupils, strabismus.

• Cold sweat, throat tightness, tongue swelling.

• Pancreatitis.

• Difficulty swallowing.

• Slow or reduced body movement.

• Difficulty writing properly.

• 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, breast enlargement in men.

• Interruption of menstrual periods.

• Kidney failure, reduced urine output, urine retention.

• Decreased white blood cell count.

• Inappropriate behavior.

• Allergic reactions (which may include breathing difficulties, eye swelling (keratitis), and a severe skin reaction characterized by rash, blisters, skin peeling, and pain).

• Jaundice (yellowing of the skin and eyes).

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

• Liver failure.
• Hepatitis (liver inflammation).

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 store above 30°C.

Do not use this medicine after the expiry date stated on the blister pack and carton after the letters “CAD/EXP”. The expiry date refers to 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 you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pregabaline 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 components are lactose monohydrate, pregelatinized corn starch, talc, titanium dioxide (E171), gelatin, shellac glaze, black iron oxide (E172).

The 50 mg capsules also contain propylene glycol, strong ammonium 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 red iron oxide (E172) and yellow iron oxide (E172).

Pregabalin Zentiva 25 mg hard capsules are packaged in alu-alu blisters (OPA/alu/PVC/alu) as the 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 the 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 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, code 032266

Romania

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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