Leaflet: information for the user

Pregabalina Tarbis Farma 300 mg hard capsules EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Pregabalina Tarbis Farma is and what it is used for

2. What you need to know before you start taking Pregabalina Tarbis Farma

3. How to take Pregabalina Tarbis Farma

4. Possible side effects

5. Storage of Pregabalina Tarbis Farma

6. Contents of the pack and additional information

Pregabalina Tarbis Farmabelongs to a group of medications used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:pregabalina is used for the treatment of chronic pain caused by nerve damage.There are various diseases that can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, numbness, tingling, and pins and needles sensation.The peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can affect physical and social activity and overall quality of life.

Epilepsy:pregabalinais used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults.Your doctor will prescribe pregabalinato treat epilepsy when your current treatment does not control the disease.You must take pregabalina in addition to your current treatment.Pregabalina should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:pregabalinais used in the treatment of generalized anxiety disorder (GAD).The symptoms of GAD are excessive and prolonged anxiety and worry that are difficult to control.GAD can also produce restlessness or feeling of excitement or nervousness, feeling easily fatigued (tired), difficulty concentrating, feeling mentally blank, irritability, muscle tension, or sleep disturbances.This is different from everyday stress and tension.

Do not take Pregabalina

If you are allergic to pregabalin or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina.

• Some patients treated with Pregabalina have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a widespread skin rash. If you experience any of these symptoms, you should seek immediate medical attention.

• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

• Pregabalina has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects of the medication.

• Pregabalina may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should inform your doctor immediately.

• Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medications.

• Severe heart failure has been reported in some patients treated with Pregabalina. Most of them were elderly patients with cardiovascular diseases.Before using this medication, you should inform your doctor if you have a history of heart disease.

• Severe kidney failure has been reported in some patients treated with Pregabalina. If during treatment with Pregabalina you notice a decrease in your ability to urinate, you should inform your doctor as the interruption of treatment may improve this situation.

• Some patients treated with antiepileptic medications such as Pregabalina have had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you experience these thoughts or show such behavior, you should contact your doctor as soon as possible.

• When Pregabalina is taken with other medications that can cause constipation (such as certain types of pain medications), it may be possible to experience gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis). Inform your doctor if you experience constipation, especially if you are prone to this problem.

• Before taking this medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may mean that you have a higher risk of becoming dependent on Pregabalina.

• Severe seizures have been reported during treatment with Pregabalina or shortly after stopping treatment with Pregabalina. If you experience seizures, you should contact your doctor immediately.

• Severe brain dysfunction (encephalopathy) has been reported in some patients taking Pregabalina and having other serious diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• Severe breathing difficulties have been reported. If you have nervous system disorders, respiratory disorders, kidney failure, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on Pregabalina Tarbis Farma (need to continue taking the medication). They may experience withdrawal symptoms when they stop using Pregabalina Tarbis Farma (see section 3, "How to take Pregabalina Tarbis Farma" and "If you stop taking Pregabalina Tarbis Farma"). If you have doubts about the possibility of becoming dependent on Pregabalina Tarbis Farma, you should consult your doctor.

If you notice any of the following signs while taking Pregabalina Tarbis Farma, it could be a sign that you have become dependent:

• You need to take the medication for a longer time than recommended by your doctor
• You feel the need to take more of the recommended dose
• You are using the medication for reasons other than those prescribed
• You have made repeated failed attempts to stop or control the use of the medication
• When you stop taking the medication, you feel unwell and feel better once you start taking the medication again

If you notice any of these symptoms, you should talk to your doctor to analyze the best course of treatment for you, including when it is appropriate to discontinue it and how to do it safely.

Children and adolescents

The safety and efficacy of Pregabalina have not been established in children and adolescents (under 18 years) and therefore Pregabalina should not be used in this age group.

Use of Pregabalina Tarbis Farma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregabalina Tarbis Farma and certain medications may influence each other (interactions). When Pregabalina is taken with certain medications that have sedative effects (including opioids), these effects may be potentiated, and may cause respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Pregabalina is taken with other medications that contain:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

Pregabalina can be taken with oral contraceptives.

Taking Pregabalina Tarbis Farma with food, drinks, and alcohol

Pregabalina capsules can be taken with or without food.

It is recommended not to take alcohol during treatment with Pregabalina.

Pregnancy and breastfeeding

You should not take Pregabalina during pregnancy or breastfeeding, unless your doctor has told you to. The use of pregabalin during the first 3 months of pregnancy may cause birth defects in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 babies out of 100 had such congenital defects. This compares with 4 babies out of 100 born to women who were not treated with pregabalin in the study. Abnormalities in the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

A reliable contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pregabalina may cause dizziness, somnolence, and decreased concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you.

Pregabalina Tarbis Farmais exclusively for oral use.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules indicated by your doctor.
• The dose, adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.
• Your doctor will tell you to take Pregabalina Tarbis Farmatwo or three times a day. In the case of twice a day, take Pregabalina Tarbis Farmaonce in the morning and once at night, approximately at the same hour every day. In the case of three times a day, take Pregabalina Tarbis Farmain the morning, at noon, and at night, approximately at the same hour every day.

If you estimate that the action of Pregabalina Tarbis Farmais too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take Pregabalina Tarbis Farmanormally, except if you have kidney problems.

Your doctor may prescribe another dosing regimen or different doses if you have kidney problems.

Swallow the entire capsule with water.

Continue taking Pregabalina Tarbis Farmauntil your doctor tells you to stop.

If you take more Pregabalina Tarbis Farma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, go to the nearest hospital emergency department with the packaging, or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

As a result of having taken more Pregabalina Tarbis Farma than you should, you may feel drowsy, confused, agitated, or restless. Also, seizures have been reported.

If you forgot to take Pregabalina Tarbis Farma

It is essential to take the Pregabalina Tarbis Farmacapsules regularly at the same hour every day. If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. In that case, continue with the next dose normally. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Pregabalina Tarbis Farma

Do not stop taking Pregabalina Tarbis Farmaunless your doctor tells you to. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once the treatment with Pregabalina Tarbis Farmais completed, whether short-term or long-term, you should know that you may experience certain adverse effects. These include sleep problems, headaches, nausea, anxiety symptoms, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may appear more frequently or with greater severity if you have been taking Pregabalina Tarbis Farmafor a longer period.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 euphoria, confusion, disorientation, changes in sexual appetite, irritability
• Alteration of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, feeling of numbness, tingling, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen
• Difficulty with erection
• Swelling of the body including extremities
• Feeling of intoxication, alterations in gait
• Weight gain
• Muscle cramps, joint pain, back pain, pain in extremities
• Sore throat

Uncommon: may affect up to 1 in 100 people:

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, sexual dysfunction including inability to achieve orgasm, delayed ejaculation
• Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort
• Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation
• Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Flushing, hot flashes
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, burning sensation, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Breast pain
• Difficulty or pain urinating, inability to hold urine
• Weakness, thirst, chest oppression
• Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, snoring
• Menstrual cramps
• Feeling of cold in hands and feet

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

• Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat oppression, swollen tongue
• Pancreatitis
• Difficulty swallowing
• Slowed or reduced body movement
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual interruption
• Renal insufficiency, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Severe allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat, red patches, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe 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's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

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

Frequency not known:cannot be estimated from available data.

• Becoming dependent on Pregabalina Tarbis Farma ('drug dependence').

After stopping short-term or long-term treatment with Pregabalina Tarbis Farma, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Pregabalina Tarbis Farma").

If you experience swelling in the face or tongue, or if your skin becomes red and blisters or peels, you should seek immediate medical attention.

Certain side effects may be more common, such as drowsiness, because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, which have similar side effects to pregabalin and the severity of these side effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

• Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or in the bottle after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, it must be used within 3 months.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pregabalina Tarbis Farma

The active ingredient is pregabalina. Each hard capsule contains 25 mg of pregabalina.

The other components are: mannitol, cornstarch, talc, gelatin, titanium dioxide (E171), shellac, iron oxide black (E172), propylene glycol, and potassium hydroxide.

Appearance of Pregabalina Tarbis Farma and contents of the packaging

Hard gelatin capsules containing a white to off-white powder.

The hard capsules are white, approximately 14.4 mm x 5.3 mm, with "138" marked on the capsule cap and "J" on the body.

This medication is available in PVC-Aluminum or Aluminum/Aluminum blister packs of 7, 14, 21, 28, 50, 56, 84, 98, 100, 100x1, 112, 168, 200, and 500 capsules.

It is also available in HDPE bottles of 60, 200, and 500 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

This medication is authorized in the member states of the European Economic Area with the following names:

NLPregabaline Amarox 25 mg capsule hard

DEPregabalin Amarox 25 mg hartkapseln

ESPregabalina Tarbis Farma 25 mg hard capsules EFG

Last review date of this leaflet:May 2024

Further detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/