PREGABALIN 25 mg Kapsułki Twarde

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1. PREGABALIN EG STADA ITALIA 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules
   1. What PREGABALIN EG STADA ITALIA is and what it is used for
   2. What you need to know before taking PREGABALIN EG STADA ITALIA
2. PREGABALIN EG STADA ITALIA has experienced suicidal thoughts or self-harm
3. PREGABALIN EG STADA ITALIA should not be taken during pregnancy or
4. PREGABALIN EG STADA ITALIA may cause dizziness, drowsiness and reduced
   1. How to take PREGABALIN EG STADA ITALIA
   2. Possible side effects
   3. How to store PREGABALIN EG STADA ITALIA
   4. Contents of the pack and other information

PREGABALIN EG STADA ITALIA 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules

Generic medicine

Read 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. 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 EG STADA ITALIA is and what it is used for
• 2. What you need to know before you take PREGABALIN EG STADA ITALIA
• 3. How to take PREGABALIN EG STADA ITALIA
• 4. Possible side effects
• 5. How to store PREGABALIN EG STADA ITALIA
• 6. Contents of the pack and other information

1. What PREGABALIN EG STADA ITALIA is and what it is used for

PREGABALIN EG STADA ITALIA 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 EG STADA ITALIA is
used to treat chronic pain caused by damage to the nervous system. Several
diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. The
pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramping pains, suffering, tingling,
numbness, pricking pains. 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 EG STADA ITALIA is used to treat certain forms of
epilepsy in adults (partial seizures with or without secondary generalization). Your
doctor will prescribe PREGABALIN EG STADA ITALIA to help you treat
your epilepsy when the treatment you are already receiving does not control the condition. You should take
PREGABALIN EG STADA ITALIA in addition to the treatment you are already undergoing.
PREGABALIN EG STADA ITALIA is not used alone, but must always be
used in combination with other antiepileptic treatments.
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Generalised Anxiety Disorder:PREGABALIN EG STADA ITALIA 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 the stress and strains of everyday
life.

2. What you need to know before taking PREGABALIN EG STADA ITALIA

DO NOT take PREGABALIN EG STADA ITALIA

• 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 EG STADA ITALIA.

• In some patients treated with PREGABALIN EG STADA ITALIA, 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 EG STADA ITALIA 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 are familiar with the effects the medicine may have.
• PREGABALIN EG STADA ITALIA 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, it may be necessary to adjust 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 EG STADA ITALIA; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease beforestarting treatment with this medicine, you should inform your doctor.
• There have been reports of kidney failure in some patients treated with PREGABALIN EG STADA ITALIA. If you notice a decrease in urination during treatment with PREGABALIN EG STADA ITALIA, you should inform your doctor because stopping the use of this medicine may improve this condition.

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• A small number of patients treated with antiepileptic medicines such as

PREGABALIN EG STADA ITALIA has experienced suicidal thoughts or self-harm

(to harm oneself). If these thoughts occur at any time, contact your doctor immediately.

• When PREGABALIN EG STADA ITALIA is used together with other medicines that can cause constipation (such as some types of pain medications), gastrointestinal problems (e.g. constipation, blocked or paralyzed bowel) may occur. Inform 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 dependence, or any abuse or dependence on medicines. Do not take a dose of medicine higher than the one prescribed.
• Cases of seizures have been reported when taking PREGABALIN EG STADA ITALIA or immediately after its discontinuation. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients treated with PREGABALIN EG STADA ITALIA and with other conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.

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 EG STADA ITALIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
PREGABALIN EG STADA ITALIA and other medicines can influence each other (interaction). When PREGABALIN EG STADA ITALIA is taken together with other medicines it may potentiate the undesirable effects observed with these medicines, including respiratory failure and coma. The intensity of dizziness, drowsiness and reduced concentration may increase if PREGABALIN EG STADA ITALIA is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol
PREGABALIN EG STADA ITALIA can be taken simultaneously with oral contraceptives.

Use of PREGABALIN EG STADA ITALIA with food, beverages and alcohol
PREGABALIN EG STADA ITALIA capsules can be taken independently of food.
It is advisable not to drink alcohol during treatment with PREGABALIN EG STADA ITALIA.
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Pregnancy and breastfeeding

PREGABALIN EG STADA ITALIA should not be taken during pregnancy or

breastfeeding, unless your doctor has given you different instructions.
Women of childbearing potential must use an effective method of contraception. If you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery

PREGABALIN EG STADA ITALIA may cause dizziness, drowsiness and reduced

concentration. Do 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.

PREGABALIN EG STADA ITALIA contains lactose.
If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PREGABALIN EG STADA ITALIA

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

Dosage
The doctor will establish the appropriate dose for you.

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

• Take the number of capsules prescribed by your doctor.
• The appropriate dose for you and your condition generally varies between 150 mg and 600 mg per day.
• Your doctor will tell you to take PREGABALIN EG STADA ITALIA two or three times a day. If you take PREGABALIN EG STADA ITALIA twice a day, take it once in the morning and once in the evening, always at approximately the same time. If you take PREGABALIN EG STADA ITALIA three times a day, take it 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 EG STADA ITALIA is too strong or
too weak, consult your doctor or pharmacist.

Elderly patients
If you are elderly (over 65 years of age), you should take PREGABALIN EG STADA ITALIA
normally unless you have kidney problems.

Patients with kidney problems
Your doctor may prescribe a different dosage regimen and/or a different dose if you have kidney
problems.
PREGABALIN EG STADA ITALIA is for oral use only.
Swallow the capsule whole with water.
Continue to take PREGABALIN EG STADA ITALIA until your doctor tells you
to stop the treatment.
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If you take more PREGABALIN EG STADA ITALIA than you should
Contact your doctor immediately or go immediately to the nearest Emergency Room.
Bring with you the package of PREGABALIN EG STADA ITALIA capsules. You may feel
sleepy, confused, agitated and restless, as you have taken more PREGABALIN EG STADA
ITALIA than you should. Seizures have also been reported.

If you forget to take PREGABALIN EG STADA ITALIA
It is important to take PREGABALIN EG STADA ITALIA capsules regularly every
day at the same time. If you forget to take a dose, take it as soon as you remember, unless
it is already time to take the next dose. In this case, take the next dose as scheduled. Do not
take a double dose to make up for the missed dose.

If you stop taking PREGABALIN EG STADA ITALIA
Do not stop taking PREGABALIN EG STADA ITALIA unless your doctor has
told you to. If the treatment is stopped, the discontinuation must be carried out
gradually over at least 1 week.
You should know that some undesirable effects may occur after discontinuation of
PREGABALIN EG STADA ITALIA treatment, both long-term and short-term. 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 EG STADA ITALIA 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, 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;
• Disturbances in 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 problems, falls;
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea and abdominal bloating;
• Difficulty in achieving an erection; Page | 5
• Swelling of the body, including hands and feet;
• Feeling of drunkenness, abnormalities in gait;
• 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, altered dreams, panic attacks, apathy, aggressiveness, 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, alterations in vision 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, reduced level of consciousness, loss of consciousness, fainting, increased sensitivity to noises, feeling unwell;
• Dry eyes, swollen eyes, eye pain, eye weakness, watery eyes, eye irritation;
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure;
• Flushing, hot flushes;
• Difficulty breathing, nasal dryness, nasal congestion;
• Increased saliva production, heartburn, loss of sensation around the mouth;
• Sweating, rash, chills, fever;
• Muscle contractions, swollen joints, 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, urticaria, runny nose, nosebleeds, cough, snoring;
• Painful menstrual cycles;
• Cold hands and feet.

Rare (may affect up to 1 in 1000 people):

• Changes in smell, sensation of visual field oscillation, 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;

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• Difficulty writing appropriately;
• Increased fluid in the abdomen;
• Fluid in the lungs;
• Convulsions;
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders;
• Muscle damage;
• Nipple discharge, abnormal breast growth, breast growth in men;
• Interrupted menstrual cycles;
• Kidney failure, reduced urine volume, urinary retention;
• Decreased 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 (may affect up to 1 in 10,000 people):

• liver impairment;
• hepatitis (inflammation of the liver).

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.

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
http://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 EG STADA ITALIA

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 packaging or on the
blister after the wording 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. Contents of the pack and other information

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What PREGABALIN EG STADA ITALIA contains

• The active ingredient is: pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg or 300 mg of pregabalin.
• The other ingredients are: lactose monohydrate, pre-gelatinized starch (of corn), talc, gelatin, titanium dioxide (E171). The 75, 100 and 300 mg capsules also contain red iron oxide (E172). Only in the 50 mg capsules: shellac, black iron oxide (E172), propylene glycol.

Description of the appearance of PREGABALIN EG STADA ITALIA and contents of the pack
25 mg Capsules Hard capsules of white color (approximately 14 mm).
50 mg Capsules
Hard capsules of white color (approximately 16 mm). The capsule has a black circular line imprinted
on the body.
75 mg Capsules Hard capsules of white and orange color (approximately 14 mm).
100 mg Capsules Hard capsules of orange color (approximately 16 mm).
150 mg Capsules Hard capsules of white color (approximately 18 mm).
300 mg Capsules Hard capsules of white and orange color (approximately 22 mm).
PREGABALIN EG STADA ITALIA 25 mg is available in PVC blisters with aluminum support,
containing: 14, 21, 28, 30, 56, 60, 70, 84, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 50 mg is available in PVC blisters with aluminum support,
containing: 14, 21, 28, 30, 56, 60, 84, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 75 mg is available in PVC blisters with aluminum support,
containing: 14, 14 (sample), 28, 30, 56, 60, 70, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 100 mg is available in PVC blisters with
aluminum support, containing: 14, 21, 30, 56, 60, 84, 100, 200 and 210 capsules
PREGABALIN EG STADA ITALIA 150 mg is available in PVC blisters with
aluminum support, containing: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 300 mg is available in two PVC blisters with
aluminum support, containing: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18 Bad Vilbel 61118 - Germany
Centrafarm Services B.V., Nieuwe Donk 9, Etten-Leur 4879 AC – Netherlands
Clonmel Healthcare Ltd., Waterford Road Clonmel, Co. Tipperary - Ireland
STADA Arzneimittel GmbH., Muthgasse 36/2 1190 Vienna - Austria

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
BE Pregabaline Eurogenerics 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg,
300 mg hard capsules
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CZ Pregabalin STADA Arzneimittel AG
DE Pregabalin AL 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
Hartkapseln
ES Pregabalina Stada 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
cápsulas duras EFG
FR Pregabaline EG LABO 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg
gélules
HU Pregabalin STADA Arzneimittel 75 mg, 150 mg kemény kapszula
IE Pregabalin Clonmel 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
hard capsules
IT PREGABALIN EG STADA ITALIA
LU Pregabaline Eurogenerics 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg,
300 mg gélules
NL Pregabaline CF 25 mg, 75 mg, 150 mg, 300 mg harde capsules
PL Pregabalin Stada
PT Pregabalina Stada
SE Pregabalin Aliud Pharma 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg,
300 mg hårda kapslar
SI Pregabalin STADA Arzneimittel 25 mg, 75 mg, 150 mg, 300 mg trde kapsule
SK Pregabalin Stada Arzneimittel 75 mg, 150 mg, 300 mg
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