Pregabalin Eg Stada Italia: detailed information

Package leaflet: Information for the user

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
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What PREGABALIN EG STADA ITALIA is and what it is used for
What you need to know before taking PREGABALIN EG STADA ITALIA
How to take PREGABALIN EG STADA ITALIA
Possible side effects
How to store PREGABALIN EG STADA ITALIA
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 Generalized 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. Various
diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster.
Pain sensations may be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramps, discomfort, tingling,
numbness, or prickling. Peripheral and central neuropathic pain may also be
associated with mood changes, sleep disturbances, and fatigue, and can have an
impact on physical and social activities and overall quality of life.
Epilepsy: PREGABALIN EG STADA ITALIA is used to treat certain types of
epilepsy in adults (partial seizures with or without secondary generalization). Your
doctor will prescribe PREGABALIN EG STADA ITALIA to help manage your
epilepsy when your current treatment does not adequately control your seizures. You will need to take PREGABALIN EG STADA ITALIA in addition to your
existing treatment.
PREGABALIN EG STADA ITALIA is not used as monotherapy, but must always be
used in combination with other antiepileptic treatments.
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Generalized anxiety disorder: PREGABALIN EG STADA ITALIA is used for the
treatment of Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety
Disorder are characterized by excessive and prolonged anxiety and worry that are
difficult to control. Generalized Anxiety Disorder may also cause restlessness or a
feeling of being on edge, easy fatigability (tiredness), difficulty concentrating or
mental blanks, irritability, muscle tension, or sleep disturbances. These conditions are distinct from the everyday stress and tensions of normal 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 indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as widespread skin rash. If any of these reactions occur, contact your doctor immediately.
PREGABALIN EG STADA ITALIA has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have on you.
PREGABALIN EG STADA ITALIA may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbance, contact your doctor immediately.
In some diabetic patients who gain weight during treatment with pregabalin, it may be necessary to adjust their diabetes medications.
Some adverse effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to 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 and had cardiovascular diseases. If you have a history of cardiovascular disease, inform your doctor before starting treatment with this medicine.
There have been reports of renal failure in some patients treated with PREGABALIN EG STADA ITALIA. If during treatment with PREGABALIN EG STADA ITALIA you notice a decrease in urination, inform your doctor, as discontinuing the use of this medicine may improve this condition.

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A small number of patients taking antiepileptic medicines such as PREGABALIN EG STADA ITALIA have experienced suicidal thoughts or self-harming thoughts (hurting oneself). If you experience such thoughts at any time, contact your doctor immediately.
When PREGABALIN EG STADA ITALIA is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal obstruction or paralysis) may occur. Inform your doctor if you have constipation, especially if you are prone to this condition.
Before taking this medicine, inform your doctor if you have a history of alcohol dependence or of any drug abuse or dependence. Do not take a higher dose than prescribed.
Cases of seizures have been reported when taking PREGABALIN EG STADA ITALIA or shortly after stopping it. If seizures occur, contact your doctor immediately.
Cases of reduced brain function (encephalopathy) have occurred in some patients treated with PREGABALIN EG STADA ITALIA who also had other medical 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
PREGABALIN EG STADA ITALIA and other medicines may interact with each other. When PREGABALIN EG STADA ITALIA is taken together with other medicines, it may enhance the adverse effects observed with these medicines, including respiratory failure and coma. The intensity of dizziness, somnolence, and reduced concentration may increase if PREGABALIN EG STADA ITALIA is taken together with medicines containing:

Oxycodone – (used as an analgesic)
Lorazepam – (used to treat anxiety)
Alcohol

PREGABALIN EG STADA ITALIA may be taken concurrently with oral contraceptives.

Use of PREGABALIN EG STADA ITALIA with food, beverages and alcohol
PREGABALIN EG STADA ITALIA capsules can be taken regardless of meals.
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 must not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise.
Women of childbearing potential must use an effective method of contraception. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
PREGABALIN EG STADA ITALIA may cause dizziness, somnolence, and reduced concentration. You must not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine impairs your ability to perform such tasks.

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

3. How to take PREGABALIN EG STADA ITALIA

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
Dosage
Your doctor will determine the dose suitable for you.
Peripheral and central neuropathic pain, Epilepsy or Generalized Anxiety Disorder:

Take the number of capsules prescribed by your doctor.
The dose suitable for you and your condition generally ranges between 150 mg and 600 mg per day.
Your doctor will instruct you to take PREGABALIN EG STADA ITALIA two or three times a day. If you take PREGABALIN EG STADA ITALIA twice daily, take it once in the morning and once in the evening, approximately at the same time each day. 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 approximately at 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 normally take PREGABALIN EG STADA ITALIA
unless you have kidney problems.
Patients with renal problems
Your doctor may prescribe you a different dosing 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 taking PREGABALIN EG STADA ITALIA until your doctor tells you
to stop 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 Department.
Bring the pack of PREGABALIN EG STADA ITALIA capsules with you. You may feel
drowsy, confused, agitated, and restless because you have taken more PREGABALIN EG STADA
ITALIA than prescribed. 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 almost time for your next dose. In that case, skip the missed dose and take the next one as scheduled. Do not take a double dose to make up for a forgotten dose.
If you stop taking PREGABALIN EG STADA ITALIA
Do not stop taking PREGABALIN EG STADA ITALIA unless your doctor tells you to. If treatment is to be stopped, discontinuation should be gradual over at least 1 week.
You should know that after stopping treatment with PREGABALIN EG STADA ITALIA,
some adverse effects may occur in both the short and long term. These include
sleep disturbances, headache, nausea, anxiety, diarrhoea, 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 how to use this medicine, consult 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 your skin turns red and blisters start to
form, or if you experience skin peeling, you must 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 interest in sex, irritability;
Attention disturbances, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange;
Blurred vision, double vision;
Dizziness, balance problems, falls;
Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, and abdominal bloating;
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Swelling of the body, including hands and feet;
Feeling of drunkenness, abnormal gait;
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 levels, high blood sugar levels;
Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased interest in sex, sexual problems including inability to reach orgasm, delayed ejaculation;
Visual disturbances, eye movement abnormalities, visual changes including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, movement tremor, reduced level of consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell;
Dry eyes, eye swelling, eye pain, eye weakness, watery eyes, eye irritation;
Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure;
Flushing, hot flushes;
Breathing difficulties, 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 painful urination, incontinence;
Weakness, thirst, chest tightness;
Changes in blood test results and liver function tests (increase in blood creatine phosphokinase, increase in alanine aminotransferase, increase in aspartate aminotransferase, decrease in platelet count, neutropenia, increase in creatinine, decrease in potassium);
Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring;
Painful menstrual cycles;
Cold hands and feet.

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

Changes in smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss;
Dilated pupils, strabismus;
Cold sweats, throat tightness, tongue swelling;
Inflammation of the pancreas;
Difficulty swallowing;
Slowed or reduced body movement;

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Difficulty writing properly;
Fluid accumulation in the abdomen;
Fluid in the lungs;
Seizures;
Changes in the electrocardiogram (ECG) indicating heart rhythm disturbances;
Muscle damage;
Breast discharge, abnormal breast growth, breast enlargement in men;
Interrupted menstrual cycles;
Kidney failure, reduced urine volume, urinary retention;
Decreased white blood cell count;
Inappropriate behaviour;
Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterised 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 taking 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the packaging or on the
blister after the words 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 medicines via wastewater 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

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What PREGABALIN EG STADA ITALIA contains

The active substance is: pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg or 300 mg of pregabalin.
The other components are: monohydrate lactose, pregelatinized starch (from maize), talc, gelatin, titanium dioxide (E171). Capsules of 75 mg, 100 mg and 300 mg also contain red iron oxide (E172). Only in 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, white in colour (approx. 14 mm).
Hard white capsules (approx. 16 mm). The capsule has a
50 mg capsules
black circular line marked on the body.
75 mg capsules Hard capsules, white and orange in colour (approx. 14 mm).
100 mg capsules Hard capsules, orange in colour (approx. 16 mm).
150 mg capsules Hard capsules, white in colour (approx. 18 mm).
300 mg capsules Hard capsules, white and orange in colour (approx. 22 mm).
PREGABALIN EG STADA ITALIA 25 mg is available in PVC/aluminum foil blisters containing: 14, 21, 28, 30, 56, 60, 70, 84, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 50 mg is available in PVC/aluminum foil blisters containing: 14, 21, 28, 30, 56, 60, 84, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 75 mg is available in PVC/aluminum foil blisters containing: 14, 14 (sample pack), 28, 30, 56, 60, 70, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 100 mg is available in PVC/aluminum foil blisters containing: 14, 21, 30, 56, 60, 84, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 150 mg is available in PVC/aluminum foil blisters containing: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.
PREGABALIN EG STADA ITALIA 300 mg is available in two types of PVC/aluminum foil blisters containing: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel - 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 Wien - Austria

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