PREGABALIN SANDOZ 200 mg HARD CAPSULES

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

Do not take Pregabalin Sandoz

• 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 Sandoz.

• Some patients taking Pregabalin Sandoz 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.

• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

• Pregabalin Sandoz 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 treatments.

• Certain side effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medicines for treatment, for example, for pain or spasticity (stiff or rigid muscles), 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 Sandoz. 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 kidney failure in some patients taking Pregabalin Sandoz. If you notice a decrease in your ability to urinate while taking Pregabalin Sandoz, you should inform your doctor as stopping treatment may improve this condition.

• Some patients taking antiepileptics, such as Pregabalin Sandoz, have had thoughts of harming themselves or suicidal behavior. If at any time you have these thoughts or have shown such behavior, contact your doctor as soon as possible.

• When Pregabalin Sandoz is taken with other medicines that may cause constipation (such as some types of pain medicines), gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you suffer from constipation, especially if you are prone to this problem.

• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; it may mean you have a higher risk of becoming dependent on Pregabalin Sandoz.

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

• There have been reports of reduction of brain function (encephalopathy) in some patients taking Pregabalin Sandoz who had other conditions. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• There have been reports of difficulty breathing. If you have nervous system disorders, respiratory disorders, kidney failure, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on Pregabalin Sandoz (need to keep taking the medicine). They may have withdrawal effects when they stop taking Pregabalin Sandoz (see section 3, “How to take Pregabalin Sandoz” and “If you stop taking Pregabalin Sandoz”). If you are concerned that you may become dependent on Pregabalin Sandoz, it is important that you talk to your doctor.

If you notice any of the following signs while taking Pregabalin Sandoz, it could be a sign that you have become dependent:

• You need to take the medicine for longer than your doctor recommended.

• You feel that you need to take more than the recommended dose.

• You are using the medicine for reasons other than those prescribed.

• You have made repeated unsuccessful attempts to stop or control the use of the medicine.

• When you stop taking the medicine, you feel unwell and feel better once you take the medicine again.

If you notice any of these signs, talk to your doctor to discuss the best care plan for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

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

Other medicines and Pregabalin Sandoz

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

Pregabalin Sandoz and certain medicines may influence each other (interactions). When Pregabalin Sandoz is taken with certain medicines that have sedative effects (including opioids), these effects may be enhanced, which may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Pregabalin Sandoz is taken with other medicines that contain:

Oxicodona – (used as a pain reliever)

Lorazepam – (used to treat anxiety)

Alcohol

Pregabalin Sandoz can be taken with oral contraceptives.

Taking Pregabalin Sandoz with food, drinks, and alcohol

Pregabalin Sandoz capsules can be taken with or without food.

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

Pregnancy and breastfeeding

You should not take Pregabalin Sandoz during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 babies out of 100 had such congenital malformations. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. There have been reports of malformations of the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genitals.

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, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin Sandoz 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 Sandoz

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

Do not take more medicine than your doctor has recommended.

Pregabalin Sandoz 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 Sandoz either twice or three times a day. For twice-daily dosing, take Pregabalin Sandoz once in the morning and once in the evening, approximately at the same time every day.

For three-times-daily dosing, take Pregabalin Sandoz in the morning, at noon, and in the evening, approximately at the same time every day.

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

If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz 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 Sandoz until your doctor tells you to stop.

If you take more Pregabalin Sandoz than you should

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

If you forget to take Pregabalin Sandoz

It is important that you take your doses of Pregabalin Sandoz 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 a forgotten dose.

If you stop taking Pregabalin Sandoz

Do not stop taking Pregabalin Sandoz suddenly. If you want to stop taking Pregabalin Sandoz, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, it should be done gradually over a minimum of one week.

After stopping treatment with Pregabalin Sandoz, you may experience certain side effects, known as withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, thoughts of self-harm or suicide, depression, pain, sweating, and dizziness. These effects may occur more frequently or be more severe if you have been taking Pregabalin Sandoz for a longer period. If you experience withdrawal effects, you should contact your doctor.

If you have any other 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 all people suffer from 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
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Attention alteration, movement clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Difficulty with erection
• Swelling of the body including the limbs
• Feeling of intoxication, gait disturbances
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain
• Sore throat

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual appetite, sexual relationship 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, reduced reflexes, hyperactivity, dizziness when standing, 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, teary eyes, eye irritation
• Heart rhythm disturbances, 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, 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 hold urine,
• 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, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Cold sensation in hands and feet

Rare: may affect up to 1 in 1,000 people

• Altered sense of smell, oscillating vision, depth perception alteration, visual glare, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced body mobility
• 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
• Menstrual period interruption
• Kidney failure, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by reddish patches, or circular or coin-shaped patches on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known: cannot be estimated from the available data

• Becoming dependent on Pregabalina Sandoz ("drug dependence").

Once you have finished a short or long-term treatment with Pregabalina Sandoz, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop treatment with Pregabalina Sandoz").

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

Certain adverse effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (stiff or rigid muscles), with adverse effects similar to those of Pregabalina, so the intensity of these effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pregabalina Sandoz

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

Do not use this medicine after the expiration date that appears on the blister, packaging, or box after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

High-density polyethylene bottles: use within 6 months after first opening.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pregabalina Sandoz

• 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 pregelatinized corn starch, corn starch, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172) (all dose presentations except 150 mg), red iron oxide (E172) (all dose presentations except 50 mg and 150 mg), black iron oxide (E172) (only 25 mg and 300 mg).

Appearance of the Product and Package Contents

Pregabalina Sandoz is available in the following presentations:

PVC/PVDC//Aluminum blisters packaged in a box.

Unit-dose PVC/PVDC//Aluminum blisters packaged in a box.

High-density polyethylene bottle with a polypropylene screw cap packaged in a box.

25 mg capsules:

Blister packs containing 14, 28, 56, 70, 84, 100, or 120 hard capsules.

Unit-dose blister packs containing 56 x 1, 84 x 1, or 100 x 1 hard capsules.

High-density polyethylene bottles containing 200 hard capsules.

50 mg capsules:

Blister packs containing 14, 21, 28, 56, 84, or 100 hard capsules.

Unit-dose blister packs containing 84 x 1 hard capsules.

High-density polyethylene bottles containing 200 hard capsules.

75 mg capsules:

Blister packs containing 14, 21, 28, 56, 70, 84, 100, or 120 hard capsules.

Unit-dose blister packs containing 14 x 1, 56 x 1, 84 x 1, 100 x 1, or 210 x 1 (3 x 70) hard capsules.

High-density polyethylene bottles containing 100, 200, or 250 hard capsules.

100 mg capsules:

Blister packs containing 14, 21, 28, 56, 84, or 100 hard capsules.

Unit-dose blister packs containing 84 x 1 or 100 x 1 hard capsules.

150 mg capsules:

Blister packs containing 14, 21, 28, 56, 70, 84, 100, or 120 hard capsules.

Unit-dose blister packs containing 56 x 1, 84 x 1, 100 x 1, or 210 x 1 (3 x 70) hard capsules.

High-density polyethylene bottles containing 100, 200, or 250 hard capsules.

200 mg capsules:

Blister packs containing 21, 28, 84, or 100 hard capsules.

Unit-dose blister packs containing 84 x 1 or 100 x 1 hard capsules.

225 mg capsules:

Blister packs containing 14, 56, 70, 84, 100, or 120 hard capsules.

300 mg capsules:

Blister packs containing 14, 21, 28, 56, 70, 84 (2 x 42), 100, 100 (2 x 50), or 120 (2 x 60) hard capsules.

Unit-dose blister packs containing 56 x 1, 84 x 1 (2 x 42), 100 x 1, 100 x 1 (2 x 50), or 210 x 1 (3 x 70) hard capsules.

High-density polyethylene bottles containing 100, 200, or 250 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:June 2023

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