PREGABALIN 25 mg Капсулы Твердые

Содержание инструкции

1. Pregabalin HCS 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules
   1. What is Pregabalin HCS and what it is used for
   2. What you need to know before taking Pregabalin HCS
   3. How to take Pregabalin HCS
   4. Possible side effects
   5. How to store Pregabalin HCS
   6. Package contents and other information

Pregabalin HCS 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules

Pregabalin HCS 200 mg hard capsules
Pregabalin HCS 225 mg hard capsules
Pregabalin HCS 300 mg hard capsules
Pregabalin
Generic medicine

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 they have the same symptoms as you, as it may 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 is Pregabalin HCS and what it is used for
• 2. What you need to know before you take Pregabalin HCS
• 3. How to take Pregabalin HCS
• 4. Possible side effects
• 5. How to store Pregabalin HCS
• 6. Contents of the pack and other information

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

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

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

Generalised Anxiety Disorder:Pregabalin HCS 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 that 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 stress and tensions of everyday life.

2. What you need to know before taking Pregabalin HCS

Do not take Pregabalin HCS
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 HCS.

• In some patients 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 any of these reactions occur, you should contact your doctor immediately.
• Pregabalin has been associated with dizziness and drowsiness which may increase the incidence of accidental injuries (falls) in elderly patients. Therefore, you should be careful until you are familiar with the effects that the medicine may have.
• Pregabalin HCS can cause blurred or loss of vision or other changes in vision, many of which are transient. If you experience any changes in vision, you should contact your doctor immediately.
• In some patients with diabetes who gain weight during treatment with Pregabalin HCS, it may be necessary to adjust the medicines for diabetes.
• 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 HCS 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 reduction in urination during treatment with Pregabalin HCS, you should inform your doctor because stopping the use of this medicine may improve this condition.
• A small number of patients treated with antiepileptic medicines such as Pregabalin HCS have experienced suicidal thoughts and self-harm (hurting yourself). At any time if you have thoughts of this kind, contact your doctor immediately.
• When Pregabalin HCS is used together with other medicines that can cause constipation (such as some medicines for the treatment of pain), gastrointestinal problems (e.g. constipation, blockage or paralysis of the intestine) 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 or drug dependence. Do not take more medicine than prescribed.
• Cases of decreased brain function (encephalopathy) have been reported during treatment with pregabalin, in some patients with other medical conditions. Tell your doctor if you have a history of other serious medical conditions, including liver or kidney disease.

Children and adolescents
Studies have not been conducted to demonstrate the safety and efficacy of pregabalin in children and
adolescents (under 18 years of age) and therefore Pregabalin HCS should not be used in
this age group.

Other medicines and Pregabalin HCS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Pregabalin HCS and other medicines can influence each other
(interaction). When Pregabalin HCS is taken together with other medicines it can enhance the
undesirable effects observed with these medicines, including respiratory failure and coma.
The intensity of dizziness, drowsiness and decreased concentration may increase if
Pregabalin HCS is taken together with other medicines containing:

• Oxycodone (used as a pain reliever)
• Lorazepam (used for the treatment of anxiety)
• Alcohol Pregabalin HCS can be taken in association with oral contraceptives.

Pregabalin HCS with food, beverages, alcohol
Pregabalin HCS capsules can be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin HCS.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregabalin HCS should not be taken during pregnancy or during breastfeeding, unless
your doctor has told you otherwise. Women of childbearing potential should use an
effective method of contraception.

Driving and using machines
Pregabalin HCS can cause dizziness, drowsiness and decreased concentration. You should not
drive, operate complex machinery or engage in potentially dangerous activities until
you have ascertained whether this medicine alters your ability to perform these activities.

3. How to take Pregabalin HCS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will establish the appropriate dose for you.
Pregabalin HCS is for oral use only.

Peripheral and central neuropathic pain, epilepsy or Generalized Anxiety Disorder:

• Take the number of capsules as prescribed by your doctor.
• The dose, which has been recommended for you and for your medical condition, is generally between 150 mg and 600 mg per day.
• Your doctor will tell you to take Pregabalin HCS two or three times a day. If you take the medicine twice a day, take Pregabalin HCS once in the morning and once in the evening, always at the same time. If you take the medicine three times a day, take Pregabalin HCS once in the morning, once in the afternoon and once in the evening, at the same time.

If you feel that the effect of Pregabalin HCS is too strong or too weak, talk to your
doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take Pregabalin HCS normally, unless
you have kidney problems. Your doctor may prescribe you a different dosage and/or a different dose if you
have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin HCS until your doctor tells you to stop treatment.

If you take more Pregabalin HCS than you should
Contact your doctor or go immediately to the nearest hospital. Bring the package of
Pregabalin HCS with you. You may feel sleepy, confused, agitated and restless, as you have taken more
Pregabalin HCS than you should have. Seizures have also been reported.

If you forget to take Pregabalin HCS
It is important to take the Pregabalin HCS 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 HCS
Do not stop treatment with Pregabalin HCS unless your doctor has told you to do so. If the
treatment is stopped, it must be done gradually over at least 1
week.
You should know that after stopping treatment with Pregabalin HCS, both long-term and short-term
side effects may occur. 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 severely if you have taken Pregabalin HCS for
a longer period of time.
If you have any doubts 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 everybody 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, seek medical attention immediately.
Very common side effects (may affect more than 1 in 10 people):

• Dizziness, drowsiness, headache.

Common side effects (may affect up to 1 in 10 people):

• Increased appetite.
• Feeling of excitement, confusion, disorientation, loss of libido, irritability.
• Difficulty with attention, clumsiness, impaired memory, memory loss, tremor, difficulty speaking, sensation of tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal bloating.
• Difficulty with erection.
• Swelling of the body including hands and feet.
• Feeling of intoxication, gait abnormalities.
• Weight gain.
• Muscle cramps, joint pain, back pain, lower back pain.
• Sore throat.

Uncommon side effects (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, altered dreams, panic attacks, apathy, aggression, altered mood, mental fatigue, difficulty thinking, increased sexual drive, sexual problems including inability to reach orgasm, delayed ejaculation
• Changes in vision, abnormalities in eye movement, visual disturbances including tunnel vision, light flashes, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, loss of consciousness, fainting, increased sensitivity to noises, malaise
• Dry eyes, eye swelling, eye pain, ocular discomfort, eye irritation, watery eyes
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, heart rhythm changes, heart failure
• Vasomotor disorders (flushing), hot flashes
• Difficulty breathing, nasal dryness, 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
• Chest 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)
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring
• Painful menstruation
• Feeling of coldness in hands and feet

Rare side effects (may affect up to 1 in 1,000 people):

• Alteration of smell, sensation of oscillating visual field, altered depth perception, light flashes, 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 properly
• Increased fluid in the abdomen
• Fluid in the lungs
• Convulsions
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders
• Muscle damage
• Breast secretions, abnormal breast growth, breast development in men
• Interruption of menstrual cycles
• Renal failure, reduced urine volume, urinary retention
• Reduced white blood cell count
• Inappropriate behavior
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by rash, blisters, skin peeling and pain).
• Jaundice (yellowing of the skin and eyes)

Very rare side effects (may affect up to 1 in 10,000 people):

• Liver failure.
• Hepatitis (inflammation of the liver). Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have side effects similar to those of Pregabalin HCS and the severity of these effects may increase when these medicines are taken at the same time.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pregabalin HCS

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 after “Expiry/EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Pregabalin HCS 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 components contained within the capsule are:
pregelatinized corn starch, talc (E553b).

• The other components of the 25 mg hard capsules are: titanium dioxide (E171), gelatin (E441), black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.
• The other components of the 50 mg and 75 mg hard capsules are: titanium dioxide (E171), gelatin (E441), yellow iron oxide (E172), black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.
• The other components of the 100 mg hard capsules are titanium dioxide (E171), gelatin (E441), red iron oxide (E172), white ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule shell.
• The other components of the 150 mg hard capsules are: titanium dioxide (E171), gelatin (E441), red iron oxide (E172), yellow iron oxide (E172), black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.
• The other components of the 200 mg and 225 mg hard capsules are titanium dioxide (E171), gelatin (E441), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172),

black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520))
in the capsule shell.

• The other components of the 300 mg hard capsules are: titanium dioxide (E171), gelatin (E441), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), white ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule shell.

Description of the appearance of Pregabalin HCS and contents of the pack
Capsules, hard.
25 mg hard capsules: the capsule body is white in colour, the capsule cap is white in colour.
The capsule cap is marked with the black lettering P25. The capsule content is powder of colour from white to off-white. Capsule length: 13.8-14.8 mm.
50 mg hard capsules: the capsule body is white in colour, the capsule cap is light yellow in colour. The capsule cap is marked with the black lettering P50. The capsule content is powder of colour from white to off-white. Capsule length: 15.3-16.2 mm.
75 mg hard capsules: the capsule body is yellowish-brown in colour, the capsule cap is yellowish-brown in colour. The capsule cap is marked with the black lettering P75. The capsule content is powder of colour from white to off-white. Capsule length: 13.8-14.8 mm.
100 mg hard capsules: the capsule body is reddish-brown in colour, the capsule cap is reddish-brown in colour. The capsule cap is marked with the white lettering P100. The capsule content is powder of colour from white to off-white. Capsule length: 15.3-16.2 mm.
150 mg hard capsules: the capsule body is white in colour, the capsule cap is yellowish-brown in colour. The capsule cap is marked with the black lettering P150. The capsule content is powder of colour from white to off-white. Capsule length: 17.2-18.3 mm.
200 mg hard capsules: the capsule body is brown in colour, the capsule cap is brown in colour. The capsule cap is marked with the black lettering P200. The capsule content is powder of colour from white to off-white. Capsule length: 18.7-19.8 mm.
225 mg hard capsules: the capsule body is white in colour, the capsule cap is brown in colour. The capsule cap is marked with the black lettering P225. The capsule content is powder of colour from white to off-white. Capsule length: 18.7-19.8 mm.
300 mg hard capsules: the capsule body is white in colour, the capsule cap is dark brown in colour. The capsule cap is marked with the black lettering P300. The capsule content is powder of colour from white to off-white. Capsule length: 20.0-22.1 mm.
Pregabalin HCS is available in packs of 14, 56 or 84 hard capsules divided into blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straβe 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following names: