Ecubalin

Patient Information Leaflet: Information for the Patient

Ecubalin 25 mg Hard Capsules, 75 mg Hard Capsules, 150 mg Hard Capsules, 300 mg Hard Capsules

pregabalin
Generic Medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ecubalin is and what it is used for

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

2. What you should know before taking Ecubalin

Do not take Ecubalin:
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 Ecubalin.

• In some patients treated with pregabalin, 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.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop using pregabalin and contact your doctor immediately if you develop any of the symptoms related to these serious skin reactions described in section 4.
• Ecubalin 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.
• Ecubalin 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 Ecubalin, 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 medicines to treat, for example, pain or spasticity, which have side effects similar to those of Ecubalin, and the severity of these effects may increase when these medicines are taken together.
• Cases of heart failure have been reported in some patients treated with pregabalin; 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.
• Cases of renal failure have been reported in some patients treated with pregabalin. If during treatment with Ecubalin you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of the medicine.
• Some patients treated with antiepileptic medicines such as Ecubalin have experienced suicidal thoughts and self-harming thoughts (hurting oneself), or have shown suicidal behavior. If at any time you have such thoughts or exhibit such behavior, contact your doctor immediately.
• When Ecubalin is used together with other medicines that may cause constipation (such as certain pain medications), gastrointestinal problems (e.g., constipation, intestinal obstruction, or intestinal paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, inform your doctor if you have a history of alcohol, prescription medicine, or illegal substance abuse or dependence, as this may indicate that you are at higher risk of becoming dependent on Ecubalin.
• Seizures have been reported when taking pregabalin or shortly after discontinuation. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred during treatment with pregabalin in some patients who had other medical conditions. Inform your doctor if you have a history of serious medical conditions, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have nervous system disorders, respiratory disorders, impaired renal function, or if you are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform your doctor if you experience breathing difficulties or shallow breathing.

Dependence
Some people may become dependent on Ecubalin (i.e., feel the need to continue taking the medicine). They may experience withdrawal symptoms when they stop using Ecubalin (see section 3, “How to take Ecubalin” and “If you stop taking Ecubalin”). If you are concerned about the possibility of developing dependence on Ecubalin, talk to your doctor.
If you notice any of the following signs while taking Ecubalin, you may have developed dependence on the medicine:

• You feel the need to take the medicine for longer than recommended by your doctor;
• You feel the need to take a higher dose than recommended;
• You are using the medicine for reasons different from those for which it was prescribed;
• You have made repeated unsuccessful attempts to stop or control the use of the medicine;
• When you stop taking the medicine, you do not feel well and feel better when you start taking it again.
  If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including when and how to safely discontinue the medicine.

Children and adolescents
The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established, and therefore Ecubalin must not be used in this age group.

Other medicines and Ecubalin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ecubalin and other medicines can interact with each other. When Ecubalin is taken together with other medicines that have sedative effects (including opioids), Ecubalin may enhance these effects and may cause respiratory failure, coma, and death. The intensity of dizziness, somnolence, and reduced concentration may increase if Ecubalin is taken together with medicines containing:

• Oxycodone (used as an analgesic)
• Lorazepam (used for the treatment of anxiety)
• Alcohol.

Ecubalin can be taken in combination with oral contraceptives.

Ecubalin with food, drinks, alcohol
Ecubalin capsules can be taken with or without food.
It is advisable not to drink alcohol during treatment with Ecubalin.

Pregnancy, breastfeeding, and fertility
Ecubalin must not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise. The use of pregabalin during the first three months of pregnancy may cause congenital malformations in the newborn requiring medical treatment. In a study examining data from women in Nordic countries who took pregabalin during the first three months of pregnancy, 6 out of 100 babies had such congenital malformations, compared to 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (oro-facial clefts), eye, nervous system (including the brain), kidney, and genital abnormalities have been reported.
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
Ecubalin may cause dizziness, somnolence, and reduced concentration. Do not drive vehicles, operate complex machinery, or engage in potentially hazardous activities until you are certain that this medicine does not impair your ability to perform such tasks.

Ecubalin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., it is essentially ‘sodium-free’.

3. How to take Ecubalin

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.
Ecubalin is for oral use only.

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

• Take the number of capsules as prescribed by your doctor.
• The appropriate dose for you and your medical condition is generally between 150 mg and 600 mg per day.
• Your doctor will instruct you to take Ecubalin two or three times a day. If you take the medicine twice daily, take Ecubalin 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 Ecubalin 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 Ecubalin is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (age over 65 years), you should normally take Ecubalin as directed, unless you have kidney problems. Your doctor may prescribe a different dosing schedule and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Ecubalin until your doctor tells you to stop treatment.

If you take more Ecubalin than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the Ecubalin packaging with you. You may feel drowsy, confused, agitated, and restless because you have taken more Ecubalin than you should have. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Ecubalin
It is important to take Ecubalin 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 dose as scheduled. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ecubalin
Do not stop treatment with Ecubalin suddenly. If you wish to discontinue taking Ecubalin, speak to your doctor first. Your doctor will advise you on how to do this. If treatment is to be stopped, discontinuation must be gradual over a period of at least 1 week.
You should know that after stopping long-term or short-term treatment with Ecubalin, you may experience certain unwanted effects, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, suicidal thoughts or self-harm, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have taken Ecubalin for a longer period of time. If you experience withdrawal effects, contact your doctor.

If you have any questions about the use of 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.

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, loss of libido, irritability;
• Attention disturbances, 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, abdominal bloating;
• Erectile dysfunction;
• 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, abnormal dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty thinking, increased sexual interest, sexual problems including inability to achieve orgasm, delayed ejaculation;
• Vision changes, eye movement abnormalities, visual disturbances including tunnel 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 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;
• 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 urinating or painful urination, incontinence;
• Weakness, thirst, chest tightness;
• Changes in blood test results and liver function tests (increased serum creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium levels);
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring;
• Painful menstruation;
• Cold hands and feet.

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

• Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss;
• Dilated pupils, strabismus;
• Cold sweats, throat tightness, tongue swelling;
• Pancreatitis (inflammation of the pancreas);
• Difficulty swallowing;
• Slowed or reduced body movement;
• Difficulty writing properly;
• Fluid accumulation in the abdomen;
• Fluid in the lungs;
• Seizures;
• Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disturbances;
• Muscle damage;
• Breast discharge, abnormal breast growth, breast development in men;
• Interruption of menstrual cycles;
• Kidney failure, reduced urine volume, urinary retention;
• Decreased white blood cell count;
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts;
• Allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterised by flat, non-elevated red patches on the trunk, target-shaped or circular lesions, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Jaundice (yellowing of the skin and eyes);
• Parkinsonism, Parkinson-like symptoms such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness).

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

• Liver failure;
• Hepatitis (liver inflammation).

Not known: frequency cannot be estimated from the available data

• Becoming dependent on Ecubalin (“drug dependence”).

After stopping short- or long-term treatment with Ecubalin, you should be aware that you might experience certain side effects known as withdrawal effects (see “If you stop taking Ecubalin”).

If you experience swelling of the face or tongue, or skin redness with the onset of blisters and skin peeling, seek immediate medical attention.

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 similar side effects to Ecubalin, and the severity of these side effects may increase when these medicines are taken together.

The following adverse reaction has been reported during the post-marketing phase of the medicine: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ecubalin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine 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 Ecubalin contains
The active substance is pregabalin. Each hard capsule contains 25 mg, 75 mg, 150 mg or 300 mg of pregabalin.

• The other components contained inside the capsule are pregelatinized maize starch, talc (E553b).
• The other components of the 25 mg hard capsules are titanium dioxide (E171), gelatin (E441), black ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) in the capsule shell.
• The other components of the 75 mg hard capsules are titanium dioxide (E171), gelatin (E441), iron oxide yellow (E172), black ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) in the capsule shell.
• The other components of the 150 mg hard capsules are titanium dioxide (E171), gelatin (E441), iron oxide red (E172), iron oxide yellow (E172), black ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) in the capsule shell.
• The other components of the 300 mg hard capsules are titanium dioxide (E171), gelatin (E441), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), white ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule shell.

Description of the appearance of Ecubalin and contents of the pack
Hard capsules.
25 mg hard capsules: the body of the capsule is white, the cap is white. The cap is marked with the black code P25. The contents of the capsule are powder ranging from white to off-white. Capsule length: 13.8–14.8 mm.
75 mg hard capsules: the body of the capsule is yellowish-brown, the cap is yellowish-brown. The cap is marked with the black code P75. The contents of the capsule are powder ranging from white to off-white. Capsule length: 13.8–14.8 mm.
150 mg hard capsules: the body of the capsule is white, the cap is yellowish-brown. The cap is marked with the black code P150. The contents of the capsule are powder ranging from white to off-white. Capsule length: 17.2–18.3 mm.
300 mg hard capsules: the body of the capsule is white, the cap is dark brown. The cap is marked with the white code P300. The contents of the capsule are powder ranging from white to off-white. Capsule length: 20.0–22.1 mm.
Ecubalin is available in packs of 14 (only for 25 mg, 75 mg, 150 mg) or 56 (only for 75 mg, 150 mg, 300 mg) hard capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder:
Ecupharma S.r.l., via Mazzini 20, 20123 Milano (Italy).

Manufacturers:
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
IT: Ecubalin