PREGABALIN 25 mg Капсулы Твердые

Содержание инструкции

1. Pregabalin Zentiva 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules
   1. What is Pregabalin Zentiva and what is it 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

Pregabalin Zentiva 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules

Pregabalin Zentiva300 mg hard capsules
pregabalin

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 is Pregabalin Zentiva and what is it used for

Pregabalin Zentiva belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain
Pregabalin Zentiva is used to treat chronic pain caused by damage to the nervous system. Various diseases can cause neuropathic pain
peripheral, such as diabetes or herpes zoster. Pain sensations may be described as
heat, burning, throbbing, pulsating pain, stabbing pain, sharp pain, cramping pain,
suffering, tingling, numbness, pricking pain. Peripheral and central neuropathic pain can
also be associated with mood changes, sleep disturbances and fatigue (tiredness) and can have
an impact on physical and social activity and overall quality of life.

Epilepsy
Pregabalin Zentiva is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Zentiva to
help in the treatment of epilepsy when the treatment you are already receiving does not control the situation.
You will need to take Pregabalin Zentiva in addition to the treatment you are already undergoing. Pregabalin Zentiva
is not used alone, but must always be associated with other antiepileptic treatments.

Generalised Anxiety Disorder
Pregabalin Zentiva is used for the treatment of Generalised Anxiety Disorder (GAD). The
symptoms of Generalised Anxiety Disorder are characterised by excessive and prolonged anxiety and worry
which are difficult to control. Generalised Anxiety Disorder can also cause
restlessness or a feeling of tension or being on edge, easy fatigue
(tiredness), difficulty concentrating or memory lapses, irritability, muscle tension or
sleep disturbances. These conditions are different from the stress and tensions of everyday life.

2. What you need to know before you 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
Talk to your doctor or pharmacist before taking Pregabalin Zentiva.

• In some patients being treated with pregabalin, symptoms indicative of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as a widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• Severe skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported in association with treatment with pregabalin. Stop taking pregabalin and contact your doctor immediately if you develop any symptoms related to these serious skin reactions, as described in section 4.
• Pregabalin has been associated with dizziness and drowsiness which may increase the risk of accidental injuries (falls) in the elderly. Therefore, you should be careful until you know how this medicine affects you.
• Pregabalin can cause blurred or loss of vision or other changes in vision, many of which are transient. If you experience any changes in vision, contact your doctor immediately.
• In some patients with diabetes who gain weight during treatment with pregabalin, it may be necessary to adjust your diabetes medications.
• Some undesirable effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have undesirable effects similar to those of Pregabalin and the severity of these effects may increase when these medicines are taken together.
• There have been reports of heart failure in some patients treated with pregabalin; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with thismedicine you must inform your doctor.
• There have been reports of kidney failure in some patients treated with pregabalin. If you notice a decrease in urination during treatment with pregabalin, you should inform your doctor because stopping the use of this medicine this condition may improve.
• Some patients treated with antiepileptic medicines like pregabalin have experienced thoughts of self-harm or suicide (hurting yourself) or have shown suicidal behaviour. At any time if you have thoughts of this kind or show suicidal behaviour, contact your doctor immediately.
• When pregabalin is used together with other medicines that can cause constipation (such as some types of pain medicines) gastrointestinal problems (e.g. constipation, blocked or paralyzed bowel) may occur. Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, tell your doctor if you have a history of alcohol, prescription drug or illegal substance abuse or dependence, as this may indicate that you are at a higher risk of becoming dependent on Pregabalin Zentiva than prescribed. Cases of seizures have been reported when taking pregabalin or shortly after its discontinuation. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking pregabalin when they have other conditions. Tell your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Breathing difficulties have been reported. If you suffer from nervous system disorders, respiratory disorders, kidney failure or if you are over 65 years of age, your doctor may prescribe a different dosage regimen. Contact your doctor if you have difficulty breathing or breathe shallowly.

Dependence
Some people may become dependent on Pregabalin Zentiva (i.e., feel the need to
continue taking the medicine). They may experience withdrawal symptoms when they stop
using Pregabalin Zentiva (see section 3, “How to take Pregabalin Zentiva” and “If you stop
taking Pregabalin Zentiva”). If you are concerned about the possibility of developing a dependence on
Pregabalin Zentiva, talk to your doctor.
If you notice any of the following signs while taking Pregabalin Zentiva, you may have
developed a
dependence on the medicine:

• You feel the need to take the medicine for longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine, you do not feel well and feel better when
• you start taking it again

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

Children and adolescents
The safety and efficacy 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.

Other medicines and Pregabalin Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pregabalin Zentiva and other medicines can influence each other (interaction). When
pregabalin is taken together with other medicines that have sedative effects (including opioids),
it may enhance these effects and may cause respiratory depression, coma and death. The intensity
of dizziness, drowsiness and decreased concentration may increase if pregabalin
is taken together with other medicines containing:

• Oxycodone - (used as a pain reliever).
• Lorazepam - (used to treat anxiety).
• Alcohol. Pregabalin Zentiva can be taken at the same time as oral contraceptives.

Pregabalin Zentiva with food and drink
The hard capsules of Pregabalin Zentiva can be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Zentiva.

Pregnancy and breastfeeding
Pregabalin Zentiva should not be taken during pregnancy or breastfeeding, unless your
doctor has told you otherwise.
Use of pregabalin during the first 3 months of pregnancy may cause birth defects in the
newborn that require medical care. In a study that examined data from women in the Nordic
countries who had taken pregabalin during the first 3 months of pregnancy, 6 children out of 100 had
such birth defects, compared with 4 children out of 100 born to women not treated with
pregabalin in the study. Anomalies of the face (orofacial clefts), eyes, the
nervous system (including the brain), kidneys and genitals have been reported.
Women of childbearing potential should use effective contraception. If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Pregabalin can cause dizziness, drowsiness and decreased concentration. You should not drive,
operate complex machinery or engage in potentially dangerous activities until you
have determined 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 your doctor before taking this
medicine.

3. How to take Pregabalin Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. Do not take more medicine than prescribed.
The doctor will establish the appropriate dose for you.
Pregabalin Zentiva is for oral use only.

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder
Take the number of hard capsules prescribed by your doctor.
The appropriate dose for you and your condition generally varies between 150 mg and 600 mg per day.
The doctor will tell you to take Pregabalin Zentiva two or three times a day. If you take the medicine twice
a day, take Pregabalin Zentiva once in the morning and once in the evening, always at approximately the same
time. If you take the medicine three times a day, take Pregabalin Zentiva once in the morning,
once in the afternoon and once in the evening, always at approximately the same time.
If you feel that the effect of Pregabalin Zentiva is too strong or too weak, talk to your
doctor or pharmacist.
If you are elderly (over 65 years of age), you should take Pregabalin Zentiva as normal unless
you have kidney problems.
The doctor may prescribe a different dosage and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue to take Pregabalin Zentiva until your doctor tells you to stop the
treatment.

If you take more Pregabalin Zentiva than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring with you the
pack of Pregabalin Zentiva capsules. You may feel sleepy, confused, agitated and restless,
because you have taken more Pregabalin Zentiva than you should have. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Zentiva
It is important to take the Pregabalin Zentiva hard capsules regularly every day at the same time.
If you forget to take a dose, take it as soon as you remember if it has not been long before the next
dose is due. In this case, take the next dose as scheduled.
Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabalin Zentiva
Do not suddenly stop treatment with Pregabalin Zentiva.
If you want to stop taking Pregabalin Zentiva, talk to your doctor first. They will
explain how to do it.
If treatment is stopped, it must be done gradually over at least 1 week.
You should know that after stopping long and short-term treatment with Pregabalin Zentiva
some undesirable effects may occur, so-called withdrawal effects. These effects
include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms,
seizures, nervousness, depression, suicidal or self-harm thoughts, pain,
sweating and dizziness. These effects may occur more frequently or severely if you have
taken Pregabalin Zentiva for a longer period of time. If you experience withdrawal effects,
you should contact your doctor.
If you have any 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 everyone gets them.

If you experience swelling of the face or tongue or if the skin becomes red and blisters begin to form or skin peeling occurs, you should contact your doctor immediately. 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 excitement, confusion, disorientation, decreased sexual interest, irritability.
• Difficulty concentrating, clumsiness, impaired memory, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea and abdominal bloating.
• Difficulty with erection.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, gait abnormalities.
• Weight gain.
• Muscle cramps, 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 levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty with ideation, increased sexual interest, sexual problems including inability to reach orgasm, delayed ejaculation.
• Changes in vision, abnormalities in eye movement, visual disturbances including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noises, feeling unwell.
• Dry eyes, eye swelling, eye pain, eye weakness, tearing of the eyes, eye irritation.
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disorders (flushing), hot flashes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain when urinating, incontinence.
• Weakness, thirst, feeling of tightness in the chest.
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine-aminotransferase, increased aspartate-aminotransferase, reduced platelet count, neutropenia, increased creatinine, reduced potassium levels.
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

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

• Alteration of smell, sensation of oscillation of the visual field, altered depth perception, visual brilliance, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, feeling of constriction in the throat, swelling of the tongue.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing appropriately.
• Increased fluid in the abdomen.
• Presence of fluid in the lungs.
• Convulsions.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders.
• Muscle damage.
• Breast secretions, abnormal breast growth, breast growth in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis), and a severe reaction characterized by reddish, non-raised patches on the trunk, shaped like targets or circles, often with central blisters, skin exfoliation, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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, i.e. symptoms similar to Parkinson's disease such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).

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

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

Not known: frequency cannot be estimated based on available data

• Becoming dependent on Pregabalin Zentiva (“drug dependence”).

After stopping short-term or long-term treatment with Pregabalin Zentiva, you should know that you may experience some side effects, so-called discontinuation effects (see “If you stop taking Pregabalin Zentiva”). Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have side effects similar to those of Pregabalin and the severity of these effects may increase when these medicines are taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of side effects
If you get 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 detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack or the bottle after
“Exp”. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pregabalin Zentiva contains

• 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 ingredients are: lactose monohydrate, pregelatinized maize starch, talc, black iron oxide
(E 172), titanium dioxide (E171), gelatin, black ink (containing shellac, black iron oxide
(E172), propylene glycol, strong ammonia solution, potassium hydroxide).
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172),
yellow iron oxide (E172).

Pregabalin Zentiva 25 mg hard capsules are packaged in aluminium/aluminium (OPA /
aluminium / PVC / ALU) or PVC/PVDC/ALU blisters as primary packaging.
Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg hard capsules are
packaged in PVC / alu blisters as primary packaging.
Pregabalin Zentiva 25 mg, 50 mg hard capsules are available in packs of 14, 21, 56, 84, 98 and
100 hard capsules.
Pregabalin Zentiva 75 mg, 150 mg and 300 mg hard capsules are available in packs of 14,
56, 98, 100 and 112 hard capsules.
Pregabalin Zentiva 100 mg, 200 mg hard capsules are available in packs of 21, 84, 98 or 100
hard capsules.
Pregabalin Zentiva 225 mg hard capsules are available in packs of 14, 56, 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 on this medicine, please contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +359 244 17 136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2034 1796
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
More detailed information on this medicine is available on the website of the European Medicines
Agency: https://www.ema.europa.eu .