What is this medicine used for?

REGABALINE EG belongs to a class of medicines used to treat epilepsy, neuropathic pain and Generalized Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain

PREGABALINE STADA is used to treat persistent pain caused by nerve damage. Different pathologies such as diabetes or shingles can cause peripheral neuropathic pain. Painful manifestations may be described as sensations of heat, burning, shooting pain, throbbing, stabbing, shooting pain, cramping, aching, tingling, numbness, pinching and of needle strokes. Peripheral and central neuropathic pain can also be associated with changes in mood, sleep disturbances, fatigue, and can have an impact on physical and social functioning, and on quality of life in general.

Epilepsy

PREGABALIN EG is used to treat a particular type of epilepsy (partial epileptic seizures with or without secondary generalization) in adults. Your doctor will prescribe PREGABALIN STADA to help treat your epilepsy when your current treatment does not completely control your seizures. You must take PREGABALINE EG in combination with your current treatment. PREGABALINE EG should not be used alone, but should always be used in combination with another antiepileptic treatment.

Generalized Anxiety Disorder

PREGABALINE EG is used to treat Generalized Anxiety Disorder (GAD). Symptoms of GAD include prolonged excessive anxiety and worry that is difficult to control. GAD may also cause restlessness or a feeling of excitement or nervousness, feeling easily tired, difficulty concentrating or forgetfulness, irritability, muscle tension or trouble sleeping. This is different from the stresses and strains of everyday life.

What does this medicine contain?

pregabalin

What is its reimbursement rate?

Reimbursement rate: 65 %

How to take it?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if in doubt.

Your doctor will determine the dosage that is appropriate for you.

PREGABALINE EG is intended for oral use only.

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

· take the number of capsules prescribed by your doctor;

· the usual dose, which has been adapted to you and your condition, is between 150 mg and 600 mg per day;

· Your doctor will tell you whether you should take PREGABALINE STADA twice or three times a day.

If taken twice a day, take PREGABALINE EG once in the morning and once in the evening, at approximately the same times each day. If taken three times a day, take PREGABALINE EG once in the morning, once at midday and once in the evening, at approximately the same times each day.

If you have the impression that the effect of PREGABALINE STADA is too strong or too weak, consult your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take PREGABALINE EG normally except in cases of kidney disease.

Your doctor may prescribe a different dosing schedule and/or dose if you have kidney disease.

Swallow the capsule whole with water.

Continue to take PREGABALINE STADA until your doctor tells you to stop.

Use in children and adolescents

Not applicable.

If you take more PREGABALINE EG 300 mg, capsule than you should:

You should immediately contact your doctor or go to the emergency department of the nearest hospital. Take your box of PREGABALINE EG capsules with you. You may feel sleepy, confused, restless or nervous if you take more PREGABALIN STADA than you should.

If you forget to take PREGABALINE EG 300 mg, capsule:

It is important to take your PREGABALINE EG capsules regularly at the same times each day. If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. In this case, simply take the next dose as agreed. Do not take a double dose to make up for a dose you forgot to take.

If you stop taking PREGABALINE EG 300 mg, capsule:

Do not stop your treatment with PREGABALINE EG unless your doctor tells you to. If your treatment is stopped, the cessation must be carried out gradually over a minimum of 1 week.

After stopping long-term or short-term treatment with PREGABALINE STADA, you should be aware that you may experience some side effects.

These effects include trouble sleeping, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating and dizziness. These symptoms may appear more frequently or more severely when Pregabalin STADA is administered for a prolonged period.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are its possible side effects?

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common: likely to affect more than 1 in 10 people:

· dizziness, drowsiness, headache.

Common: may affect up to 1 in 10 people:

· increased appetite;

· feeling of euphoria, confusional state, disorientation, decreased libido, irritability;

· attention problems, clumsiness, memory problems, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensations;

· blurred vision, double vision;

· dizziness, balance problems, falls;

· dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloating;

· erectile dysfunction;

· swelling of the body including the extremities;

· feeling drunk, walking problems;

· 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, high blood sugar;

personality changes, nervousness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elation, altered mental function, difficulty concentrating, increased libido, problems with sexual functioning including inability to achieve orgasm, delayed ejaculation;

· blurred vision, abnormal eye movements, vision disturbances including narrowing of the visual field, flashes of light, jerky movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremor during movements, decreased alertness, loss of consciousness, syncope, increased sensitivity to noise, feeling unwell;

· dry eyes, swollen eyes, eye pain, eye weakness, watery eyes, eye irritation;

· heart rhythm disturbances, increased heart rate, decreased blood pressure, increased blood pressure, changes in heartbeat, heart failure;

· redness of the face, hot flashes;

· difficulty breathing, dry nose, nasal congestion;

· salivary hypersecretion, heartburn, numbness around the mouth;

· sweating, skin rash, chills, fever;

· muscle contractions, joint swelling, muscle rigidity, pain including muscle pain, neck pain;

· pain in the breasts;

· difficult or painful urination, incontinence;

· feeling of weakness, feeling of thirst, tightness in the chest;

– changes in blood and liver test results (increased blood creatinine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased potassium in the blood);

· hypersensitivity, facial swelling, itching, hives, runny nose, nasal bleeding, cough, snoring;

· menstrual pain;

· coldness of the hands and feet;

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

· disturbances in smell, oscillating vision, altered depth perception, visual flashing, loss of vision;

· pupil dilation, strabismus;

· cold sweats, tightness of the throat, swelling of the tongue;

· inflammation of the pancreas;

· difficulty swallowing;

· slow or reduced body movement;

· difficulty writing correctly;

· accumulation of fluid in the abdomen;

· fluid in the lungs;

· seizures;

· changes in the recording of electrical parameters (ECG) of the heart corresponding to heart rhythm disturbances;

· muscle injury;

· breast discharge, abnormal breast growth, increased breast size in men;

· interruption of periods;

· renal failure, decreased urinary volume, urinary retention;

· decrease in the number of white blood cells;

· abnormal behavior;

· allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis), and a serious skin reaction including rash, blisters, peeling skin, and pain).

· Jaundice (yellowing of the skin and eyes)

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

· Hepatic insufficiency

· Hepatitis (inflammation of the liver)

Some side effects may be more common, including drowsiness, because patients with spinal cord injury may receive other medications, such as to treat pain or spasticity, that have similar side effects to spinal cord injury. pregabalin and whose severity may be increased when these treatments are taken at the same time.

Additional side effects in children and adolescents

Not applicable.