Leaflet: information for the user

Pregabalina Mylan 25 mg hard capsules,

Pregabalina Mylan 50 mg hard capsules,

Pregabalina Mylan 75 mg hard capsules,

Pregabalina Mylan 100 mg hard capsules,

Pregabalina Mylan 150 mg hard capsules,

Pregabalina Mylan 200 mg hard capsules,

Pregabalina Mylan 225 mg hard capsules,

Pregabalina Mylan 300 mg hard capsules

pregabalina

Read this leaflet carefully before you start to take 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 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.

Pregabalina Mylan contains the active ingredient pregabalin, which belongs to a group of medicines used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: Pregabalina Mylan is used for the treatment of chronic pain caused by nerve damage. Various diseases 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, tingling, numbness, and pins and needles sensation. 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:Pregabalina Mylan is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalina Mylan to treat epilepsy when your current treatment does not control the disease. You must take Pregabalina Mylan in addition to your current treatment. Pregabalina Mylan should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalina Mylan is 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 Mylan

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina Mylan.

• Some patients treated with Pregabalina Mylan 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 must go to your doctor immediately.

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

• Pregabalina Mylan 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 must inform your doctor immediately.

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

• Certain adverse effects, such as somnolence, may be more frequent since patients with spinal cord injury may be taking other medications for treatment, for example, pain or spasticity, with adverse effects similar to those of Pregabalin in such a way that the intensity of these effects may increase when taken together.

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

• Cases of renal insufficiency have been reported in some patients treated with Pregabalina Mylan. If during treatment with Pregabalina Mylan you note a decrease in your ability to urinate, you must inform your doctor as the interruption of treatment may improve the situation.

• A small number of people taking antiepileptic medications such as Pregabalina Mylan have had thoughts of self-harm or suicide. If at any time you experience these thoughts, contact your doctor as soon as possible.

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

• Before taking this medication, you must inform your doctor if you have a history of alcoholism or abuse or dependence on any drug. Do not take a dose greater than that prescribed.

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

• Cases of reduced brain function (encephalopathy) have been reported in some patients taking Pregabalina Mylan and who had 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 have not been established in children and adolescents (under 18 years) so pregabalin should not be used in this age group.

Use of Pregabalina Mylan with other medications

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

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

• Oxycodone – (used as an analgesic)

• Lorazepam – (used to treat anxiety)

• Alcohol

Pregabalina Mylan can be taken with oral contraceptives.

Taking Pregabalina Mylan with food, drinks, and alcohol

Pregabalina Mylan capsules can be taken with and without food.

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

Pregnancy and breastfeeding

You should not take Pregabalina Mylan during pregnancy or lactation, 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.

Driving and operating machinery

Pregabalina Mylan 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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you.

Pregabalina Mylan is exclusively for oral use.

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

• Take the number of capsules as indicated by your doctor.

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

If you estimate that the action of Pregabalina Mylan 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 Mylan normally, except if you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking Pregabalina Mylan until your doctor tells you to stop.

If you take more Pregabalina Mylan than you should

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

If you forget to take Pregabalina Mylan

It is essential to take the Pregabalina Mylan 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 treatment with Pregabalina Mylan

Do not stop taking Pregabalina Mylan 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 you have completed long-term and short-term treatment with Pregabalina Mylan, 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 Mylan 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 can 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.
• Euphoria, confusion, disorientation, decreased libido, irritability.
• Alteration of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation 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.
• Sensation 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, increased libido, 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.
• 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, 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.
• Painful menstrual periods.
• Sensation 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, tongue swelling.
• Pancreatitis inflammation.

• Difficulty swallowing.

• Reduced mobility or movement of the body.
• Difficulty writing correctly.
• Fluid accumulation in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in electrocardiogram (ECG) corresponding to changes in heart rhythm.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual cycle interruption.
• Renal insufficiency, reduced urine output, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior.
• Allergic reactions (which may include difficulty breathing, eye inflammation, and a severe skin reaction characterized by rash, blisters, skin peeling, and pain).
• Icterus (yellow skin and eyes).

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

• Liver insufficiency.
• Hepatitis (liver inflammation).

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

Certain side effects, such as drowsiness, may be more frequent as patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, with similar side effects to Pregabalin, so the intensity of these side effects may increase when taken together.

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 thenational notification system included in theAppendix VBy reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Blister pack:Store in the original packaging to protect it from moisture.

Bottle:Keep the bottle tightly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Pregabalina Mylan

The active ingredient is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.

The other components are: hydroxypropylcellulose, cornstarch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, black ink (containing Shellac lacquer, iron oxide black (E172), macrogol, potassium hydroxide, and concentrated ammonia solution), yellow iron oxide (E172), and erythrosine (E127).

Appearance of Pregabalina Mylan and contents of the pack

Hard capsule.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S

117 Allée des Parcs

69800 Saint-Priest

France

Manufacturer

Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary

McDermott Laboratories Limited under the commercial name of Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Netherlands

Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder.

Last update of this leaflet

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.