Leaflet: information for the user

Pregabalina Tarbis300 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 is Pregabalina Tarbis and what is it used for

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

3. How to take Pregabalina Tarbis

4. Possible side effects

5. Storage of Pregabalina Tarbis

6. Contents of the pack and additional information

Pregabalina belongs to a group of medications used for the treatment of epilepsy and generalized anxiety disorder (GAD) in adults.

Epilepsy:Pregabalina is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe this medication to 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 rather always used in combination with other antiepileptic treatments.

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

Do not take Pregabalina Tarbis

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

Warnings and precautions

• Some patients treated with pregabalin 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.
• 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 of the medication.
• Pregabalin 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 adjust their diabetes medications.
• Cases of heart failure have been reported in some patients treated with this medication. 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.
• Cases of kidney problems (insufficiency) have been reported in some patients treated with this medication. If during treatment with pregabalin you notice a decrease in your ability to urinate, you should inform your doctor as the discontinuation of treatment may improve this situation.
• A small number of people taking antiepileptic medications such as pregabalin have had thoughts of self-harm or suicide. If at any time you experience these thoughts, contact your doctor as soon as possible.
• When pregabalin 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, you should inform your doctor if you have a history of alcoholism or abuse or dependence on any substance. Do not take a higher dose than the one prescribed.
• Cases of seizures have been reported during treatment with pregabalin or shortly after discontinuing treatment with this medication. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin and having other diseases. Inform your doctor if you have a history of any serious disease, 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) and therefore pregabalin should not be used in this age group.

Taking Pregabalina Tarbis with other medications

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

Pregabalin and certain medications may influence each other (interactions). When pregabalin is used with certain medications, the observed adverse reactions may be potentiated, including respiratory insufficiency and coma. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medications that contain:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medication can be taken with oral contraceptives.

Taking Pregabalina Tarbis with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy, unless your doctor has indicated otherwise. You should use an effective contraceptive method in women of childbearing age.If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It is not recommended to breastfeed while taking this medication, as it is unknown whether pregabalin can be found in breast milk. If you are breastfeeding, consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Pregabalin 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 as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you.

Pregabalina is exclusively for oral use.

Epilepsy or generalized anxiety disorder:

• Take the number of capsules as 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 instruct you to take Pregabalina two or three times a day. In the case of twice a day, take Pregabalina once in the morning and once at night, approximately at the same hour every day. In the case of three times a day, take Pregabalina in the morning, at noon, and at night, approximately at the same hour every day.

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

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

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

Swallow the capsule whole with water.

Continue taking Pregabalina until your doctor tells you to stop.

If you take more Pregabalina Tarbis than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pregabalina Tarbis

It is essential to take the Pregabalina capsules 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

Do not stop taking Pregabalina unless 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 is completed, whether short-term or long-term, you should know that you may experience certain adverse effects. These include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may appear more frequently or severely if you have been taking Pregabalina for 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.

The very common side effects that may affect more than 1 in 10 people are:

• Dizziness, drowsiness, headache

The common side effects that may affect more than 1 in 100 people are:

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual desire, irritability
• Alteration of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of numbness, tingling, sedation, drowsiness, 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
• Sensation of intoxication, alterations in gait
• Weight gain
• Muscle cramps, joint pain, back pain, pain in extremities
• Sore throat

The uncommon side effects that may affect more than 1 in 1,000 people are:

• Loss of appetite, weight loss, low blood sugar, high blood sugar inblood
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety crisis, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual desire,sexual problems including inability to reach climax, delayed ejaculation
• Changes in vision, unusual eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, sensation of burning, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort
• Eye dryness, eye swelling, 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, 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 (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
• Painful menstrual periods
• Sensation of cold in hands and feet

The rare side effects that may affect less than 1 in 1,000 people are:

• Altered sense of smell, oscillating vision, alteration of depth perception, visual brightness, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat constriction, tongue swelling
• Pancreatitis inflammation
• Difficulty swallowing
• Reduced mobility or slowness of the body
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in the electrocardiogram (ECG) corresponding to alterations in heart rhythm
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual cycle interruption
• Renal problems, reduced urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by rash, blisters, skin peeling, and pain)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side 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.The expiration date is the last day of the month indicated.

No special storage conditions are required

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

Composition of Pregabalina Tarbis

The active ingredient is pregabalina. Each hard capsule contains 300 mg of pregabalina.

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

Appearance of the product and contents of the packaging

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 packaging of 56 capsules and 100 capsules (clinical packaging) containing strips formed by PVC and an aluminum foil. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès (Barcelona)

(Spain)

Last review date of this leaflet: December 2016

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