PREGABALIN 25 mg Kapsułki Twarde

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1. PREGABALIN ALTER 25 mg hard capsules, 75 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules
   1. WHAT IS PREGABALIN ALTER AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREGABALIN ALTER
   3. HOW TO TAKE PREGABALIN ALTER
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PREGABALIN ALTER
   6. PACKAGE CONTENTS AND OTHER INFORMATION

PREGABALIN ALTER 25 mg hard capsules, 75 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules

Pregabalin

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

1. WHAT IS PREGABALIN ALTER AND WHAT IT IS USED FOR

PREGABALIN ALTER 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 ALTER 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 (a
viral infection with inflammation and blistering rash along the path of the
affected nerve). Pain sensations can be described as heat, burning,
pulsations, shooting pains, stabbing pains, acute pains, cramp-like pains,
suffering, tingling, numbness, pricking pains. Peripheral and central
neuropathic pain can also be associated with mood changes, sleep disorders and
fatigue (tiredness) and can have an impact on physical and social activity and on
overall quality of life.

Epilepsy:PREGABALIN ALTER is used to treat certain forms of epilepsy
in adults (partial seizures with or without secondary generalization). The
doctor will prescribe PREGABALIN ALTER to help in the treatment of epilepsy
when the treatment already in progress does not control the situation. You will need to take
PREGABALIN ALTER in addition to the treatment you are already undergoing. PREGABALIN
ALTER is not used alone, but must always be associated with other
antiepileptic treatments.
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Generalised Anxiety Disorder:PREGABALIN ALTER 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
fatigability (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 ALTER

Do not take PREGABALIN ALTER

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

Warnings and precautions.

• In some patients treated with PREGABALIN ALTER, 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 reaction. If any of these reactions occur, you should contact your doctor immediately.
• PREGABALIN ALTER 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 the medicine may have on you.
• PREGABALIN ALTER can cause blurred or loss of vision or other visual disturbances, many of which are transient. If you experience any visual disturbance, you should 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 Alter; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with this medicine, you must inform your doctor.
• There have been reports of kidney failure in some patients treated with PREGABALIN ALTER. If you notice a reduction in urination during treatment with PREGABALIN ALTER, 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 like PREGABALIN ALTER have experienced suicidal thoughts and self-harm (hurting themselves). At any time if you have thoughts of this kind, contact your doctor immediately.
• When Pregabalin Alter is used together with other medicines that can cause constipation (such as some types of pain medications) it is

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possible that 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 or drug dependence. Tell your doctor about the need to take a dose of medicine higher than the prescribed one.
• Cases of seizures have been reported when taking PREGABALIN ALTER or immediately after stopping it. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking PREGABALIN ALTER when they have other conditions. Tell 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 the age of
18 years) have not been established and therefore pregabalin should not be used in
this age group

Other medicines and PREGABALIN ALTER
Tell your doctor or pharmacist if you are taking or have recently taken or
may take other medicines.
PREGABALIN ALTER and other medicines can influence each other
(interaction). When PREGABALIN ALTER is taken together with other medicines
it may enhance the undesirable effects observed with these medicines, including
respiratory failure and coma. The intensity of dizziness, drowsiness and
reduced concentration may increase if PREGABALIN ALTER is
taken together with other medicines containing:
Oxycodone (used as a pain reliever),
Lorazepam (used for the treatment of anxiety),
Alcohol.
PREGABALIN ALTER can be taken at the same time as oral contraceptives.

Taking PREGABALIN ALTER with food, drinks and alcohol
The capsules of PREGABALIN ALTER can be taken with or without food.

It is advisable not to drink alcohol during treatment with PREGABALIN ALTER.
Pregnancy and breastfeeding
PREGABALIN ALTER should not be taken during pregnancy or breastfeeding,
unless your doctor has told you otherwise. Women of childbearing potential
should use an effective method of contraception. Contact your doctor immediately if you become pregnant, if you are breastfeeding or if you think you may be pregnant or if you are planning a pregnancy during treatment with
PREGABALIN ALTER.
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Driving and operating machinery
PREGABALIN ALTER can cause dizziness, drowsiness and reduced
concentration. You should not drive, operate complex machinery or engage in
potentially dangerous activities until you have ascertained whether this medicine
affects your ability to perform these activities.

3. HOW TO TAKE PREGABALIN ALTER

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose for you. PREGABALIN ALTER is for oral use only.

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 ranges from 150 mg to 600 mg per day. Your doctor will tell you to take PREGABALIN ALTER two or three times a day. If you take the medicine twice a day, take PREGABALIN ALTER 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 ALTER 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 ALTER 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 ALTER as normal 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 ALTER until your doctor tells you to stop treatment.

If you take more PREGABALIN ALTER than you should
Contact your doctor immediately or go immediately to the nearest hospital emergency room.
Bring the PREGABALIN ALTER capsule pack with you. You may feel sleepy, confused, agitated and restless, as you have taken
more PREGABALIN ALTER than you should.

If you forget to take PREGABALIN ALTER
It is important to take PREGABALIN ALTER capsules regularly every day
at the same time. If you forget to take a dose, take it as soon as you remember you haven't taken it, unless it is 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 missed doses.

If you stop taking PREGABALIN ALTER
Do not stop treatment with PREGABALIN ALTER unless your doctor has told you to.
If treatment is stopped, it must be done gradually over at least 1 week.
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You should know that some unwanted effects may occur after stopping long-term and short-term treatment. 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 for a longer period of time.
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.
Not all people will experience them.

Very common(may affect more than 1 in 10 people):

• Dizziness
• Sleepiness
• Headache Common (may affect up to 1 in 10 people):
• Increased appetite
• Feeling of excitement, confusion, disorientation, loss of libido, irritability
• Difficulty concentrating, 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, bloated stomach
• Difficulty with erection
• Swelling of the body, including hands and feet
• Feeling of intoxication, abnormalities in 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, elevated mood, mental retardation, difficulty with ideation, increased sexual interest, sexual problems, including inability to reach orgasm, delayed ejaculation,

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• Changes in vision, unusual eye movements, visual disturbances including tunnel vision, flashes of light, convulsive movements, reduced reflexes, increased activity, dizziness when standing up, sensitive skin, loss of taste, burning sensation, tremors, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
• Dry eyes, swollen eyes, eye pain, eye weakness, watery eyes, irritated eyes
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, variations in heart rate, 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, 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 blood creatinine, decreased blood potassium) Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• menstrual pain
• Cold hands and feet Rare (may affect up to 1 in 1,000):
• Alteration of smell, fluctuation of the visual field, altered depth perception, visual brilliance, decreased vision
• Dilated pupils, strabismus,
• Cold sweats, feeling of constriction in the throat, swollen tongue
• Pancreatitis
• Difficulty swallowing
• Slowed or reduced body movement
• Difficulty writing appropriately
• Increased fluid in the abdomen
• Fluid in the lungs
• Convulsions
• Changes in the heart's electrocardiogram (ECG) corresponding to changes in heart rhythm

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• Muscle damage
• Nipple discharge, abnormal breast growth, breast growth in men
• Interrupted menstrual cycles
• Kidney failure, reduced urine volume, urinary retention
• Reduced white blood cell count
• Inappropriate behaviors
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis) and severe skin reactions characterized by rashes, blisters, skin peeling, and pain)

In case of 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.
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 similar side effects to those of pregabalin and the severity of these effects may increase
when these medicines are taken together.
If any of these side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

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/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PREGABALIN ALTER

Keep PREGABALIN ALTER out of the sight and reach of children.
Do not use PREGABALIN ALTER after the expiry date which is reported
on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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Do not dispose of any medicine in 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

The active ingredient is pregabalin. Each hard capsule contains 25 mg, 75 mg, 150 mg, or
300 mg of pregabalin.
The other ingredients are:
pregelatinized starch, mannitol, talc, gelatin, titanium dioxide (E171), black ink
(containing shellac, black iron oxide (E172), propylene glycol
(E1520), ammonium hydroxide (E527)).
The 75 mg and 300 mg capsules also contain red iron oxide (E172).

Description of the appearance of PREGABALIN ALTER and package contents
Pregabalin Alter 25 mg hard capsules:
Capsules with a white cap and a white body marked with the inscription “25”.
Pregabalin Alter 75 mg hard capsules:
Capsules with an orange cap and a white body marked with the inscription “75”.
Pregabalin Alter 150 mg hard capsules:
Capsules with a white cap and a white body marked with the inscription “150”.
Pregabalin Alter 300 mg hard capsules:
Capsules with an orange cap and a white body marked with the inscription “300”.
PREGABALIN ALTER is available in PVC/Aluminum blisters containing 14 or 56
hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratori Alter, Via Egadi 7- 20144 Milan
Manufacturer
Pharmathen S.A.
6 Dervenakion
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15351 Pallini Attiki
Greece
or
PharmathenInternational S.A.
Industrial Park Sapes,
RodopiPrefecture, Block n°5
Rodopi 69300
Greece

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations
France: Prégabaline Alter
Italy: Pregabalin Alter
Spain: Pregabalina Alter

This leaflet was last approved on
10/11