PREGABALIN TARBIS 25 mg HARD CAPSULES

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

Do not take Pregabalin Tarbis

• If you are allergic to pregabalin or any of the other ingredients of this medicine (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 diffuse rash. If you experience any of these symptoms, you should see your doctor immediately.
• Pregabalin has been associated with dizziness and somnolence, which could increase the risk of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are familiar with the effects that the medicine may have.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any changes in your vision, you should inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may need a change in their diabetes medications.
• There have been reports of heart failure in some patients treated with this medicine. Most of them were elderly patients with cardiovascular disease. Before using this medicine, you should tell your doctor if you have a history of heart disease.
• There have been reports of kidney problems (insufficiency) in some patients treated with this medicine. If you notice a decrease in your ability to urinate during treatment with pregabalin, you should inform your doctor, as stopping treatment may improve this situation.
• A small number of people being treated with antiepileptics such as pregabalin have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, you should contact your doctor as soon as possible.
• When pregabalin is taken with other medicines that can cause constipation (such as some types of painkillers), it is possible that gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis) may appear. Inform your doctor if you suffer from constipation, especially if you are prone to this problem.
• Before taking this medicine, you should tell your doctor if you have a history of alcoholism or abuse or dependence on any drug. Do not take a higher dose than prescribed.
• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with this medicine. If you have seizures, you should contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients who were taking pregabalin and who had other diseases. You should tell 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 in children and adolescents (under 18 years of age) have not been established, so pregabalin should not be used in this age group.

Taking Pregabalin Tarbis with other medicines

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

Pregabalin and certain medicines can affect each other (interact). When pregabalin is used with certain medicines, the adverse reactions seen with them may be increased, including respiratory failure and coma. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

Oxycodone - (used as a painkiller)

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 advised not to drink alcohol during treatment with pregabalin.

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy, unless your doctor has told you to. An effective contraceptive method should be used in women of childbearing age. 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 not known whether pregabalin can be found in breast milk. If you are breastfeeding, consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Pregabalin can cause dizziness, somnolence, and decreased 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 these activities.

3. How to take Pregabalin Tarbis

Take this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the dose that is right for you.

Pregabalin is for oral use only.

Epilepsy or generalized anxiety disorder:

• Take the number of capsules that your doctor has told you to.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.
• Your doctor will tell you to take pregabalin twice or three times a day. In the case of twice a day, take pregabalin once in the morning and once in the evening, approximately at the same time every day. In the case of three times a day, take pregabalin in the morning, at noon, and in the evening, approximately at the same time every day.

If you think that the effect of pregabalin is too strong or too weak, tell your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take pregabalin normally, 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

Contact your doctor or go to the nearest emergency room 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pregabalin Tarbis

It is important that you take the 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 time for your next dose. In that case, continue with your next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabalin Tarbis

Do not stop taking pregabalin unless your doctor tells you to. If you are going to stop treatment, it should be done gradually over a minimum of one week.

Once you have finished treatment with pregabalin, either after a short or long period, you should be aware that you may experience certain side effects. These include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may appear more frequently or severely if you have been taking pregabalin for a longer period.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Dizziness, drowsiness, headache

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

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Attention disturbance, movement disturbance, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Vertigo, balance disorder, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal distension
• Difficulty with erection
• Swelling of the body, including the limbs
• Feeling drunk, gait disturbance
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain
• Sore throat

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
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual appetite, sexual function problems including inability to reach climax, 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 up, sensitive skin, loss of taste, burning sensation, tremor when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise
• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Abnormal heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Flushing, hot flushes
• Breathing difficulties, dry nose, nasal congestion
• Increased saliva production, heartburn, 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 urination
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood)
• Hypersensitivity, swelling of the face, itching, hives, runny nose, nosebleeds, coughing, snoring
• Painful menstrual periods
• Cold sensation in hands and feet

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

• Altered sense of smell, wavering vision, altered depth perception, visual glare, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced body movement
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances
• Muscle damage
• Milk secretion, abnormal breast growth, breast enlargement in men
• Menstrual disruption
• Kidney problems, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior
• Allergic reactions (which can include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by rash, blisters, peeling, and pain)

If you experience swelling of the face or tongue, or if your skin turns red and develops blisters or peels, you should seek medical attention immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es.

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

5. Storage of Pregabalin Tarbis

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

Do not use this medicine after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Pregabalin Tarbis

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

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

Appearance of the product and pack contents

Pregabalin Tarbis 25 mg are hard gelatin capsules, pale yellow in color, marked with “PGB” on the cap and “25” on the body. Pregabalin is available in packs of 56 capsules and 100 capsules (clinical pack) which contain strips formed by PVC and an aluminum foil. Not all pack sizes may be marketed.

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 last revision 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.