Gaviria

Italy
Brand name Gaviria
Form capsules, hard gelatin
Active substance / Dosage
PREGABALIN
Prescription type Prescription only – non-repeatable
ATC code
N02BF02
Registration number 045400
Manufacturer GENETIC S.P.A.

Table of Contents

Package Leaflet: Information for the User

GAVIRIA 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 300 mg hard capsules

Pregabalin
Generic Medicine
Read this leaflet carefully before 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 other people, even if they have the same symptoms as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What GAVIRIA is and what it is used for

GAVIRIA belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: GAVIRIA 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, pulsing, throbbing, shooting, stabbing, sharp, cramping, discomfort, tingling, numbness, or prickling. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue (tiredness), and can impact physical and social activities and overall quality of life.
Epilepsy: GAVIRIA is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe GAVIRIA to help manage your epilepsy when your current treatment is not adequately controlling your seizures. You will need to take GAVIRIA in addition to your existing treatment. GAVIRIA is not used alone, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: GAVIRIA is used to treat 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 tense or on edge, easy fatigability (tiredness), difficulty concentrating or mental blanks, irritability, muscle tension, or sleep disturbances. These conditions are different from the everyday stress and tensions of normal life.

2. What you need to know before taking GAVIRIA

Do not take GAVIRIA

  • if you are allergic to the active substance (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 GAVIRIA.

  • In some patients treated with GAVIRIA, 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 you experience any of these reactions, contact your doctor immediately.
  • GAVIRIA 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 are familiar with the effects this medicine may have on you.
  • GAVIRIA may cause blurred vision or vision loss or other visual disturbances, many of which are transient. If you experience any visual disturbances, contact your doctor immediately.
  • In some diabetic patients who gain weight during treatment with pregabalin, adjustment of diabetes medications may be necessary.
  • Some side effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medications 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.
  • There have been reports of heart failure in some patients treated with GAVIRIA; most of these patients were elderly and had cardiovascular diseases. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
  • There have been reports of renal failure in some patients treated with GAVIRIA. If during treatment with GAVIRIA you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of this medicine.
  • A small number of patients treated with antiepileptic medicines such as GAVIRIA have experienced suicidal thoughts and self-harming behaviors (harming oneself). If you experience any such thoughts at any time, contact your doctor immediately.
  • When GAVIRIA 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 experience 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 any history of drug abuse or dependence. Do not take a dose higher than prescribed.
  • Cases of seizures have been reported when taking GAVIRIA or shortly after discontinuation. If seizures occur, contact your doctor immediately.
  • Cases of reduced brain function (encephalopathy) have occurred in some patients taking GAVIRIA when they have 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 GAVIRIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
GAVIRIA and other medicines may affect each other (interaction). When GAVIRIA 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 GAVIRIA is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol
GAVIRIA can be taken together with oral contraceptives.

GAVIRIA with food, drinks, and alcohol
GAVIRIA capsules may be taken with or without food.
It is advisable not to drink alcohol during treatment with GAVIRIA.

Pregnancy and breastfeeding
GAVIRIA should not be taken during pregnancy or breastfeeding unless otherwise directed by your doctor. 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
GAVIRIA may cause dizziness, somnolence, and reduced concentration. You should not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine affects your ability to perform these tasks.

GAVIRIA contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take GAVIRIA

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will determine the dose appropriate for you.
GAVIRIA is for oral use only.
Neuropathic pain (peripheral and central), epilepsy, or Generalized Anxiety Disorder:

  • Take the number of capsules prescribed by your doctor.
  • The dose appropriate for you and your condition generally ranges between 150 mg and 600 mg daily.
  • Your doctor will instruct you to take GAVIRIA two or three times a day. If you take the medicine twice a day, take GAVIRIA once in the morning and once in the evening, always approximately at the same time. If you take the medicine three times a day, take GAVIRIA 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 GAVIRIA is too strong or too weak, talk to your doctor or pharmacist.
If you are elderly (over 65 years of age), you should normally take GAVIRIA unless you have kidney problems.
Your doctor may prescribe you a different dosing schedule and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking GAVIRIA until your doctor tells you to stop treatment.
If you take more GAVIRIA than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring the pack of GAVIRIA capsules with you. You may feel drowsy, confused, agitated, and restless because you have taken more GAVIRIA than you should have.
If you forget to take GAVIRIA
It is important to take GAVIRIA 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 this 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 GAVIRIA
Do not stop treatment with GAVIRIA unless your doctor tells you to. If treatment is to be stopped, it should be discontinued gradually over a period of at least 1 week.
You should know that after stopping treatment with GAVIRIA, some undesirable effects may occur in 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 GAVIRIA 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 everybody gets them.

Very common: may occur in more than 1 in 10 people:

  • Dizziness, drowsiness, headache.

Common: may occur in up to 1 in 10 people:

  • Increased appetite.
  • Feeling of excitement, confusion, disorientation, decreased interest in sex, irritability.
  • Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
  • Blurred vision, double vision.
  • Vertigo, balance disorders, falls.
  • Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea and abdominal swelling.
  • Difficulty in erection.
  • 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 occur in 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 achieve orgasm, delayed ejaculation.
  • Visual disturbances, abnormal eye movements, visual abnormalities including tubular vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling of malaise.
  • Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
  • Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
  • Vasomotor disturbances (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 (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium levels).
  • Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
  • Painful menstrual cycles.
  • Cold hands and feet.

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

  • Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, loss of vision.
  • Dilated pupils, strabismus.
  • Cold sweats, throat tightness, tongue swelling.
  • Pancreatitis.
  • Difficulty swallowing.
  • Slowed or reduced body movement.
  • Difficulty writing properly.
  • Increased fluid in the abdomen.
  • Fluid in the lungs.
  • Seizures.
  • Changes in electrocardiogram (ECG) corresponding to heart rhythm disorders.
  • 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 characterized by rash, blisters, skin peeling and pain).
  • Jaundice (yellowing of the skin and eyes).

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

  • Liver failure.
  • Hepatitis (inflammation of the liver).

If you experience facial or tongue swelling, or if your skin turns red and blisters start to form,
or if skin peeling occurs, contact your doctor immediately.

Some side effects, such as drowsiness, may be more frequent 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.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of side effects

If you get any side effects, 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: 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 GAVIRIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or vial.
The expiry date refers to the last day of the 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

What GAVIRIA contains

  • The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg or 300 mg of pregabalin.
  • The other ingredients are: Capsule contents: lactose monohydrate, pregelatinized maize starch, talc.

Capsule cap for 25 mg, 50 mg, 150 mg and 200 mg capsules
Cap and body of the capsule: Titanium dioxide and gelatin.
Capsule cap for 75 mg and 300 mg capsules
Cap: Titanium dioxide, red iron oxide, yellow iron oxide, gelatin.
Body: Titanium dioxide, gelatin.
Capsule cap for 100 mg capsules
Cap and body of the capsule: Titanium dioxide, red iron oxide, yellow iron oxide, gelatin.
Description of the appearance of GAVIRIA and contents of the pack

Capsules 25 mg, 50 mg, 150 mg and 200 mghard capsules with white cap and white body
Capsules 75 mg and 300 mghard capsules with dark orange cap and white body.
Capsules 100 mghard capsules with dark orange cap and dark orange body.

GAVIRIA capsules are packaged in transparent PVC/PVDC-Al blisters.
GAVIRIA 25 mg is available in packs of 14 hard capsules;
GAVIRIA 50 mg is available in packs of 21 hard capsules;
GAVIRIA 75 mg is available in packs of 14 and 56 hard capsules;
GAVIRIA 100 mg is available in packs of 21 hard capsules;
GAVIRIA 150 mg is available in packs of 14 and 56 hard capsules;
GAVIRIA 200 mg is available in packs of 21 hard capsules;
GAVIRIA 300 mg is available in packs of 56 hard capsules.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Genetic S.p.A. – Via G. Della Monica, 26 – 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 – Fisciano (SA)
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