PREGABALIN VIATRIS 300 mg HARD CAPSULES

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

Do not take Pregabalin Mylan

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Pregabalin Mylan.

• Some patients taking Pregabalin Mylan have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.

• Pregabalin Mylan has been associated with dizziness and somnolence, which may increase the risk of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are used to the effects of the medicine.

• Pregabalin Mylan 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 dose adjustment of their diabetic medications.

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

• There have been reports of heart failure in some patients taking Pregabalin Mylan. Most of these patients were elderly with cardiovascular conditions. Before using this medicine, you should tell your doctor if you have a history of heart disease.

• There have been reports of renal failure in some patients taking Pregabalin Mylan. If you notice a decrease in your ability to urinate during treatment with Pregabalin Mylan, you should inform your doctor, as stopping treatment may improve the situation.

• A small number of people taking antiepileptics, such as Pregabalin Mylan, have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

• When Pregabalin Mylan is taken with other medications that can cause constipation (such as some types of pain medications), 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 medicine, you should tell your doctor if you have a history of alcoholism or drug abuse or dependence. Do not take a higher dose than prescribed.

• There have been reports of seizures during treatment with Pregabalin Mylan or shortly after stopping treatment with Pregabalin Mylan. If you experience seizures, contact your doctor immediately.

• There have been reports of reduced brain function (encephalopathy) in some patients taking Pregabalin Mylan who had other illnesses. You should tell your doctor if you have a history of any serious illness, including liver or kidney disease.

Children and adolescents

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

Using Pregabalin Mylan with other medicines

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

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

• Oxycodone - (used as a pain reliever)
• Lorazepam - (used to treat anxiety)
• Alcohol

Pregabalin Mylan can be taken with oral contraceptives.

Taking Pregabalin Mylan with food, drinks, and alcohol

Pregabalin Mylan capsules can be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Mylan.

Pregnancy and breastfeeding

Do not take Pregabalin Mylan during pregnancy or breastfeeding, unless your doctor has told you to do so. 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 taking this medicine.

Driving and using machines

Pregabalin 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 whether this medicine affects your ability to perform these activities.

3. How to take Pregabalin Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

Pregabalin Mylan is for oral use only.

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

• Take the number of capsules that your doctor has told you to take.

• 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 Mylan either twice or three times a day. If twice a day, take Pregabalin Mylan once in the morning and once in the evening, approximately at the same time every day. If three times a day, take Pregabalin Mylan in the morning, at noon, and in the evening, approximately at the same time every day.

If you think that the effect of Pregabalin Mylan is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take Pregabalin Mylan normally, except if 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 Mylan until your doctor tells you to stop.

If you take more Pregabalin Mylan than you should

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

If you forget to take Pregabalin Mylan

It is important that you take your Pregabalin Mylan 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 this case, continue with your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Mylan

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

After stopping treatment with Pregabalin Mylan, either after a short or a long period of time, you may experience certain side effects. These include sleep disturbances, headache, nausea, 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 Mylan for a longer period of time.

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: 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, decreased sexual appetite, irritability.
• Disturbance in attention, clumsiness, impaired memory, memory loss, tremors, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance disorder, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal distension.
• Difficulty with erection.
• Swelling of the body, including the limbs.
• Feeling of intoxication, gait disturbances.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in the limbs.
• 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, unusual dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual appetite, sexual dysfunction 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 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, swollen eyes, 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.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, heartburn, numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle spasms, swollen joints, 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, 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, wavering vision, altered depth perception, visual glare, loss of vision.

• Dilated pupils, strabismus.
• Cold sweat, throat tightness, swollen tongue.
• Pancreatitis.

• Difficulty swallowing.

• Slow or reduced body movement.

• Difficulty writing correctly.

• Increased fluid 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, increased breast size in men.

• Disruption of menstrual periods.

• Kidney failure, decreased 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, peeling of the skin, and pain).

• Jaundice (yellowing of the skin and eyes).

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

• Liver failure.
• Hepatitis (inflammation of the liver).

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.

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

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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Mylan

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 and blister after EXP. The expiry date refers to the last day of the month shown.

Blister:Store in the original package to protect from moisture.

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

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

6. Container contents and additional information

Pregabalin Mylan composition

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 ingredients 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), iron oxide yellow (E172) and erythrosine (E127).

Appearance of Pregabalin Mylan and container contents

Hard capsule.

Only some pack sizes may be marketed.

Marketing authorization 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 trade 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

For more information on this medicinal product, please contact the local representative of the marketing authorization holder.

Date of last revision of this leaflet

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.