Pregabalin Tarbis Farma 300 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pregabalin Tarbis Farma 300 mg hard capsules EFG

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

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

Contents of the leaflet

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

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

Pregabalin Tarbis Farma belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: Pregabalin is used to treat chronic pain caused by nerve damage. Various medical conditions can cause peripheral neuropathic pain, such as diabetes or herpes. The sensation of pain may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, continuous pain, tingling, numbness, or prickling sensations. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

Epilepsy: Pregabalin is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin when your current treatment does not adequately control your condition. You should take pregabalin in addition to your current treatment. Pregabalin must not be used as monotherapy, but always in combination with other antiepileptic treatments.

Generalized anxiety disorder (GAD): Pregabalin is used to treat generalized anxiety disorder (GAD). Symptoms of GAD include excessive and prolonged anxiety and worry that are difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigability (tiredness), difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stress and strains of normal life.

2. What you need to know before taking Pregabalin Tarbis Farma

Do not take Pregabalin

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 starting Pregabalin.

• Some patients treated with Pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread rash. If you experience any of these symptoms, you must seek medical help immediately.

• Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin. Stop taking pregabalin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

• Pregabalin 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 become familiar with the effects this medicine may have on you.

• Pregabalin may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, you must inform your doctor immediately.

• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.

• Cases of heart failure have been reported in some patients treated with Pregabalin. Most of these patients were elderly with pre-existing cardiovascular disease. Before using this medicine, you must inform your doctor if you have a history of heart disease.

• Cases of renal failure have been reported in some patients treated with Pregabalin. If during treatment with Pregabalin you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.

• Some patients taking antiepileptic medicines such as Pregabalin have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or behaviors, contact your doctor as soon as possible.

• When Pregabalin is taken together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or 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 ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on Pregabalin.

• Cases of seizures during treatment with Pregabalin or shortly after discontinuation have been reported. If you experience seizures, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have been reported in some patients taking Pregabalin who also had other medical conditions. Inform your doctor if you have a history of serious illness, including liver or kidney disease.

• Cases of difficulty breathing have been reported. If you have disorders of the nervous system, respiratory disorders, renal impairment, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience breathing difficulties or shallow breathing.

Dependence

Some people may become dependent on Pregabalin Tarbis Farma (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop taking Pregabalin Tarbis Farma (see section 3, “How to take Pregabalin Tarbis Farma” and “If you stop taking Pregabalin Tarbis Farma”). If you have concerns about the possibility of becoming dependent on Pregabalin Tarbis Farma, it is important to consult your doctor.

If you notice any of the following signs while taking Pregabalin Tarbis Farma, it could indicate dependence:

• You need to take the medicine for longer than recommended by your doctor
• You feel the need to take higher doses than prescribed
• You are using the medicine for reasons other than those prescribed
• You have made repeated unsuccessful attempts to stop or control your use of the medicine
• You feel unwell when you stop taking the medicine and feel better once you resume taking it

If you notice any of these symptoms, talk to your doctor to discuss the best treatment approach for you, including when it is appropriate to discontinue the medicine and how to do so safely.

Children and adolescents

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

Taking Pregabalin Tarbis Farma with other medicines

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

Pregabalin Tarbis Farma and certain medicines may affect each other (interactions). When Pregabalin is used together with certain medicines that have sedative effects (including opioids), these effects may be enhanced, potentially leading to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if Pregabalin is taken together with other medicines containing:

Oxycodone – (used as an analgesic)
Lorazepam – (used to treat anxiety)
Alcohol

Pregabalin can be taken with oral contraceptives.

Taking Pregabalin Tarbis Farma with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to consume alcohol during treatment with Pregabalin.

Pregnancy and breastfeeding

You should not take Pregabalin during pregnancy or breastfeeding unless your doctor has specifically instructed you to do so. 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 reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 babies had such congenital malformations. This compares with 4 out of every 100 babies born to women not treated with pregabalin in the study. Abnormalities reported include facial clefts, eyes, the nervous system (including the brain), kidneys, and genitals.

Women of childbearing potential should use an effective method of contraception. If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform such tasks.

3. How to take Pregabalin Tarbis Farma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you.

Pregabalin Tarbis Farma is for oral use only.

Neuropathic pain (peripheral and central), epilepsy, or generalized anxiety disorder:

• Take the number of capsules your doctor has prescribed.
• The dose, which has been adjusted for your condition, is generally between 150 mg and 600 mg daily.
• Your doctor will instruct you to take Pregabalin Tarbis Farma two or three times a day. If twice daily, take Pregabalin Tarbis Farma once in the morning and once at night, approximately at the same time each day. If three times daily, take Pregabalin Tarbis Farma in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of Pregabalin Tarbis Farma is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Pregabalin Tarbis Farma as normal, unless you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking Pregabalin Tarbis Farma until your doctor tells you to stop.

If you take more Pregabalin Tarbis Farma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department taking the container with you, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

As a result of taking more Pregabalin Tarbis Farma than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported.

If you forget to take Pregabalin Tarbis Farma

It is important to take Pregabalin Tarbis Farma capsules regularly at the same time each day. 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, continue with your next dose as normal. Do not take a double dose to make up for a missed dose.

If you stop taking Pregabalin Tarbis Farma

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

After stopping short-term or long-term treatment with Pregabalin Tarbis Farma, you should be aware that you may experience certain adverse effects. These include sleep disturbances, headache, nausea, feeling of anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or be more severe if you have been taking Pregabalin Tarbis Farma for a longer period of time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Dizziness, somnolence, headache

Common: may affect up to 1 in 10 people:

• Increased appetite
• Feeling of euphoria, confusion, disorientation, changes in sexual desire, irritability
• Attention disturbance, clumsiness of movement, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Erectile dysfunction
• Swelling of the body including the limbs
• Feeling of drunkenness, disturbances in gait
• Weight gain
• Muscle cramp, 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, high blood sugar

• Altered self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, sexual problems including inability to reach climax, delayed ejaculation

• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, movement tremor, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise

• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation

• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure

• Flushing, hot flushes

• Breathing difficulty, dry nose, nasal congestion

• Increased saliva production, burning sensations, 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 when urinating, inability to control urine

• Weakness, thirst, chest tightness

• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, low blood potassium)

• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring

• Painful menstrual periods

• Feeling of cold in hands and feet

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

• Altered sense of smell, flickering vision, depth perception disturbance, visual brightness, vision loss

• Dilated pupils, strabismus

• Cold sweat, throat tightness, tongue swelling

• Pancreatitis

• Difficulty swallowing

• Slow or reduced body mobility

• Difficulty writing properly

• Increased fluid in the abdominal area

• Fluid in the lungs

• Seizures

• Changes in electrocardiogram (ECG) corresponding to heart rhythm disturbances

• Muscle damage

• Milk secretion, abnormal breast growth, breast enlargement in men

• Interruption of menstrual periods

• Kidney failure, reduced urine output, urinary retention

• Decreased white blood cell count

• Inappropriate behavior, suicidal behavior, suicidal thoughts

• Allergic reactions which may include breathing difficulty, eye inflammation (keratitis), and a severe skin reaction characterized by flat red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These severe skin rashes 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 muscle rigidity.

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

• Liver failure
• Hepatitis (liver inflammation).

Frequency not known: cannot be estimated from available data.

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

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

If you experience swelling of the face or tongue, or if your skin becomes red, blistered, or peeling, you should seek immediate medical attention.

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

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

• Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Tarbis Farma

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

Do not use this medicine after the expiry date stated on the packaging or on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Once the bottle has been opened, the medicine should be used within 3 months.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pregabaline Tarbis Farma

The active substance is pregabalin. Each hard capsule contains 25 mg of pregabalin.

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

Appearance of Pregabaline Tarbis Farma and pack contents

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" printed on the capsule cap and "J" on the body.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

The Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

NL Pregabaline Amarox 25 mg capsule hard

DE Pregabalin Amarox 25 mg hartkapseln

ES Pregabalina Tarbis Farma 25 mg cápsulas duras EFG

Date of the most recent revision of this leaflet: May 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/