Pregabalin Zentiva 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalin Zentiva 25 mg hard capsules EFG

Pregabalin Zentiva 50 mg hard capsules EFG

Pregabalin Zentiva 75 mg hard capsules EFG

Pregabalin Zentiva 100 mg hard capsules EFG

Pregabalin Zentiva 150 mg hard capsules EFG

Pregabalin Zentiva 200 mg hard capsules EFG

Pregabalin Zentiva 225 mg hard capsules EFG

Pregabalin Zentiva 300 mg hard capsules EFG

pregabalin

Read all of this 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, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Pregabalin Zentiva is and what it is used for
2. What you need to know before you take 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 Pregabalin Zentiva is and what it is used for

Pregabalin Zentiva belongs to a group of medicines used to treat 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 conditions can cause peripheral neuropathic pain, such as diabetes or shingles. The sensation of pain may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, muscle spasms, 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 when your current treatment does not adequately control your condition. You should take Pregabalin Zentiva in addition to your current treatment. Pregabalin Zentiva must not be used as monotherapy; it should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder

Pregabalin Zentiva is used to treat 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 fatigability, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the stress and worries of everyday life.

2. What you need to know before taking Pregabaline Zentiva

Do not take Pregabaline Zentiva

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Pregabaline 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 widespread skin rash. If you experience any of these symptoms, you must seek immediate medical attention.
• Serious skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis associated with pregabalin treatment. Stop taking pregabalin and seek immediate medical help if you notice any symptoms related to these serious skin reactions described in section 4.
• Pregabalin has been associated with dizziness and drowsiness, which may 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, inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.
• Certain adverse effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medications for treatment, for example, for pain or spasticity (tight or rigid muscles), which have similar adverse effects to 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 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 kidney failure have been reported in some patients treated with pregabalin. If during treatment with Pregabaline Zentiva you notice a decrease in your ability to urinate, inform your doctor, as discontinuing the treatment may improve this condition.
• Some patients taking antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or have exhibited such behavior, 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 suffer from 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 medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on pregabalin.
• 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 also had other illnesses. Inform your doctor if you have a history of serious illness, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have disorders of the nervous system, respiratory disorders, kidney failure, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience difficulty breathing or shallow breathing.

Dependence

Some people may become dependent on pregabalin (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop taking pregabalin (see section 3, “How to take Pregabaline Zentiva” and “If you stop taking Pregabaline Zentiva”). If you are concerned about possibly becoming dependent on pregabalin, it is important to 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 the 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 your use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better again once you take it.

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

Children and adolescents

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

Taking Pregabaline Zentiva with other medicines

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

Pregabaline 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 and may lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, 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.

Pregabaline Zentiva can be taken with oral contraceptives.

Taking Pregabaline Zentiva with food, drinks, and alcohol

Pregabaline Zentiva capsules can be taken with or without food.

It is advised not to drink alcohol during treatment with Pregabaline Zentiva.

Pregnancy and breastfeeding

You should not take Pregabaline Zentiva during pregnancy or while breastfeeding unless your doctor has specifically instructed 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 reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 babies had such congenital malformations. This contrasts with 4 out of every 100 babies born to women not treated with pregabalin in the study. Malformations reported include facial clefts, eyes, the nervous system (including the brain), kidneys, and genitals.

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and reduced 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 tasks.

Pregabaline Zentiva contains lactose monohydrate

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

3. How to take Pregabalina Zentiva

Follow exactly the dosing instructions given to you by your doctor. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalina 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, adjusted according to your condition, will generally range between 150 mg and 600 mg daily.

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

If you feel that the effect of Pregabalina 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 Pregabalina Zentiva as usual, 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 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 department immediately. Take the Pregabalina Zentiva hard capsule pack with you. Taking more Pregabalina Zentiva than prescribed may cause drowsiness, confusion, agitation, or restlessness. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalina Zentiva

It is important to take Pregabalina Zentiva capsules regularly at the same time each day. If you miss a dose, take it as soon as you remember, unless it is nearly 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 a missed dose.

If you stop taking Pregabalina Zentiva

Do not stop taking Pregabalina Zentiva suddenly. If you wish to discontinue Pregabalina Zentiva, speak with your doctor first. He or she will advise you on how to do so. If you are going to stop treatment, it should be done gradually over a minimum of one week.

After stopping Pregabalina Zentiva treatment, whether short- or long-term, you should be aware that you may experience certain adverse effects known as withdrawal symptoms. These include sleep disturbances, headache, nausea, feelings of anxiety, 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 of time. If you experience withdrawal symptoms, you should contact your doctor.

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.
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Attention disturbance, clumsiness of movement, 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, diarrhoea, nausea, bloated abdomen.
• Difficulty in erection.
• Swelling of the body including limbs.
• Feeling of drunkenness, disturbances in gait.
• Weight gain.
• Muscle cramp, 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 levels, high blood sugar levels.
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, problems in sexual relations including inability to reach climax, delayed ejaculation.
• Changes in vision, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor during movement, 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 rhythm disturbances, 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, burning, 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.
• Feeling of cold in hands and feet.

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

• Altered sense of smell, flickering vision, altered depth perception, visual glare, vision loss.
• Dilated pupils, squint.
• Cold sweat, throat tightness, tongue swelling.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slow or reduced body movement.
• 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.
• Interruption of menstrual periods.
• Kidney failure, reduced urine output, urine retention.
• Decreased white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a serious skin reaction characterised by non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms such as tremor, bradykinesia (reduced ability to move), and muscle rigidity.

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

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

Frequency not known: cannot be estimated from the available data

• Becoming dependent on pregabalin (“drug dependence”).

After stopping short- or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects, known as withdrawal effects (see “If you stop taking Pregabalina Zentiva”).

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 medicines to treat, for example, pain or spasticity (tight or stiff muscles), which have adverse effects similar to those of pregabalin, so that 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, talk to your doctor or pharmacist, even if they are possible adverse effects not listed 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 expiry date stated on the blister and carton after the letters “CAD/EXP”. The expiry date refers to 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 you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Pregabalin 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 monohydrate lactose, pregelatinized corn starch, talc, black iron oxide (E172), titanium dioxide (E171), gelatin, black ink (containing Shellac lacquer, black iron oxide (E172), propylene glycol, strong ammonium hydroxide solution, potassium hydroxide).

The 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg capsules also contain red iron oxide (E172) and yellow iron oxide (E172).

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

Pregabaline 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.

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

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

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

Pregabaline Zentiva 225 mg is available in pack sizes of 14, 56, 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 responsible

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

Date of the most recent revision 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.