Pregabalin Tarbis 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pregabalin Tarbis 300 mg hard capsules EFG

Read all of 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, 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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 this medicine to treat epilepsy when your current treatment does not adequately control the condition. You should take pregabalin as an add-on to your current treatment. Pregabalin must not be used as monotherapy, but always in combination with other antiepileptic treatments.

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

2. What you need to know before starting to take Pregabalin Tarbis

Do not take Pregabalin Tarbis

• If you are allergic to pregabalin or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

• 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 the appearance of widespread skin rash. If you experience any of these symptoms, you must seek immediate medical attention.
• 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.
• 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 this medicine. Most of these patients were elderly with cardiovascular diseases. Before using this medicine, you must inform your doctor if you have a history of heart disease.
• Cases of kidney problems (renal failure) have been reported in some patients treated with this medicine. If during treatment with pregabalin you notice a decrease in your ability to urinate, you should inform your doctor, as discontinuation of treatment may improve this condition.
• A small number of people taking antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, 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 intestinal paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, you must inform your doctor if you have a history of alcoholism or drug abuse or dependence. Do not take a higher dose than the one prescribed to you.
• Cases of seizures during treatment with pregabalin or shortly after discontinuation of treatment 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 underlying diseases. Inform your doctor if you have a history of any serious illness, including liver or kidney disease.

Children and adolescents

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

Taking Pregabalin Tarbis with other medicines

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

Pregabalin and certain medicines may interact with each other. When pregabalin is used together with certain medicines, adverse reactions may be intensified, including respiratory failure and coma. The degree of dizziness, somnolence, 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

This medicine can be taken with oral contraceptives.

Taking Pregabalin Tarbis with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advisable not to consume alcohol during treatment with pregabalin.

Pregnancy, breastfeeding, and fertility

You must not take pregabalin during pregnancy unless your doctor has specifically instructed you to do so. An effective method of contraception should be used in women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding is not recommended while taking this medicine, as it is unknown whether pregabalin passes into breast milk. If you are breastfeeding, consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

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

3. How to take Pregabalin Tarbis

Follow exactly the instructions for using 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 is for oral use only.

Epilepsy or generalized anxiety disorder:

• Take the number of capsules prescribed by your doctor.
• 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 twice or three times a day. If twice daily, take pregabalin once in the morning and once at night, approximately at the same time each day. If three times daily, take pregabalin in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of pregabalin 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 as usual, unless you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabalin Tarbis than you should

Call your doctor or go to the nearest emergency department immediately. Take the pack or bottle of Pregabalin Tarbis capsules with you. As a result of taking more Pregabalin Tarbis than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pregabalin Tarbis

It is important to take pregabalin 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, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Pregabalin Tarbis

Do not stop taking pregabalin 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 both short- and long-term treatment with pregabalin has ended, you should be aware that you may experience certain adverse effects. These include sleep problems, headache, nausea, feeling of anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have been taking pregabalin 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 will experience them.

Very common adverse effects (which may affect more than 1 in 10 people) are:

• Dizziness, drowsiness, headache

Common adverse effects (which may affect more than 1 in 100 people) are:

• Increased appetite
• Euphoria, confusion, disorientation, decreased sexual desire, irritability
• Attention disturbance, motor clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Vertigo, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Erectile dysfunction
• Swelling of the body including limbs
• Drunken feeling, gait disturbances
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain
• Sore throat

Uncommon adverse effects (which may affect more than 1 in 1,000 people) are:

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, diminished reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor with movement, 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
• Difficulty breathing, nasal dryness, 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, decreased blood potassium)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Cold sensation in hands and feet

Rare adverse effects (which may affect less than 1 in 1,000 people) are:

• Altered sense of smell, oscillating vision, depth perception disturbance, visual glare, vision loss
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced body movement
• 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 problems, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behavior
• Allergic reactions (which may include difficulty breathing, eye swelling (keratitis), and a severe skin reaction characterized by rash, blisters, skin peeling, and pain)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Tarbis

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Pregabalina Tarbis

The active substance is pregabalin. Each hard capsule contains 300 mg of pregabalin.

The other components are: anhydrous dicalcium phosphate (powder), anhydrous dicalcium phosphate (granulate), sodium croscarmellose, talc. The capsule shell contains: gelatin, water, titanium dioxide (E-171), yellow iron oxide (E172), red iron oxide (E172), and printing ink composed of: shellac glaze, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonium hydroxide solution, black iron oxide, potassium hydroxide, and purified water.

Appearance of the product and contents of the container

Pregabalina Tarbis 300 mg are hard gelatin capsules, pale pink and pale yellow in color, marked with “PGB” on the cap and “300” on the body. Pregabalina is available in packs of 56 capsules and in a 100-capsule pack (hospital pack), which contains strips made of PVC and an aluminum foil laminate. Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.
Gran Vía Carlos III, 94
08028 - Barcelona (Spain)

Manufacturer

Ferrer Internacional, S.A.
Joan Buscallà, 1-9
08173 - Sant Cugat del Vallès (Barcelona)
(Spain)

Date of the most recent review of this leaflet: December 2016

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