Leaflet: information for the user

Pregabalina Sandoz 25mg hard EFG capsules

Pregabalina Sandoz 50mg hard EFG capsules

Pregabalina Sandoz 75mg hard EFG capsules

Pregabalina Sandoz 100mg hard EFG capsules

Pregabalina Sandoz 150mg hard EFG capsules

Pregabalina Sandoz 200mg hard EFG capsules

Pregabalina Sandoz 225mg hard EFG capsules

Pregabalina Sandoz 300mg hard EFG capsules

pregabalina

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 section4.

1.What is Pregabalina Sandoz and what it is used for

2.What you need to know before starting to take Pregabalina Sandoz

3.How to take Pregabalina Sandoz

4.Possible side effects

5.Storage of Pregabalina Sandoz

6.Contents of the pack and additional information

Pregabalina Sandoz belongs to a group of medications used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

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

Generalized anxiety disorder:Pregabalina Sandoz 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 Sandoz

• if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section6).

Warnings and precautions

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

• Some patients treated with Pregabalina Sandoz have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these symptoms, you should seek immediate medical attention.

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

• Pregabalina Sandoz 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 medicine.

• Pregabalina Sandoz 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 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 (tense or rigid muscles), with similar adverse effects to pregabalin, so the intensity of these effects may increase when taken together.

• There have been reports of heart failure in some patients treated with Pregabalina Sandoz. Most of them were elderly patients with cardiovascular diseases.Before using this medicine, you should inform your doctor if you have a history of heart disease.

• There have been reports of renal insufficiency in some patients treated with Pregabalina Sandoz. If during treatment with Pregabalina Sandoz you notice a decrease in your ability to urinate, you should inform your doctor as the interruption of treatment may improve this situation.

• Some patients treated with antiepileptic drugs such as Pregabalina Sandoz have had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you experience these thoughts or have shown such behavior, you should contact your doctor as soon as possible.

• When Pregabalina Sandoz 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 medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may mean that you have a higher risk of becoming dependent on Pregabalina Sandoz.

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

• There have been reports of encephalopathy (brain dysfunction) in some patients taking Pregabalina Sandoz and who had other underlying diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• There have been reports of respiratory difficulty. If you have neurological disorders, respiratory disorders, kidney insufficiency, 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 Pregabalina Sandoz (need to continue taking the medicine). They may experience withdrawal effects when they stop using Pregabalina Sandoz (see section 3, "How to take Pregabalina Sandoz" and "If you interrupt treatment with Pregabalina Sandoz"). If you are concerned that you may become dependent on Pregabalina Sandoz, it is essential to consult your doctor.

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

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

• You feel the need to take a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated and 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 analyze the best plan of care for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

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

Other medicines and Pregabalina Sandoz

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

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

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

Pregabalina Sandoz can be taken with oral contraceptives.

Taking Pregabalina Sandoz with food, drinks, and alcohol

Pregabalina Sandoz capsules can be taken with or without food.

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

Pregnancy and breastfeeding

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

A reliable contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Pregabalina 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 if this medicine 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.Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalina Sandoz 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 150mg and 600mg per day.

Your doctor will tell you to take Pregabalina Sandoz two or three times a day. In the case of twice a day, take Pregabalina Sandoz 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 Sandoz in the morning, at noon, and at night, approximately at the same hour every day.

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

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

If you take more Pregabalina Sandoz than you should

Call your doctor or go to the nearest emergency service immediately. Bring the packaging or bottle of Pregabalina Sandoz capsules with you. As a result of taking more Pregabalina 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 Pregabalina Sandoz

It is essential to take Pregabalina Sandoz 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 as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pregabalina Sandoz

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

Once treatment with Pregabalina Sandoz is completed, either in the short or long term, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness,thoughts of self-harm or suicide,depression, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been taking Pregabalina Sandoz for a longer period.If you experience withdrawal effects, consult your doctor.

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
• Attention disturbance, clumsiness, memory deterioration, memory loss, tremors, difficulty speaking, 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, gait disturbances
• Weight gain
• Muscle cramps, 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, high blood sugar
• Change in self-perception, anxiety, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased libido, sexual dysfunction, delayed ejaculation
• Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremors on movement, decreased consciousness, loss of knowledge, fainting, increased sensitivity to sounds, general discomfort
• Eye dryness, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, heart rhythm changes, heart failure
• Flushing, hot flashes
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, burning sensation, 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
• Menstrual cramps
• 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 constriction, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Reduced mobility of the body
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Fluid in the lungs
• Convulsions
• Changes in electrocardiogram (ECG) corresponding to heart rhythm disturbances
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual interruption
• Renal insufficiency, reduced urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Severe skin reactions that may include difficulty breathing, eye inflammation (keratitis) and a severe skin rash characterized by flat, red patches, often with central blisters, skin peeling, mouth ulcers, throat, nasal, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Icterus (yellowing of the skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver insufficiency.
• Heptatitis (inflammation of the liver).

Frequency not known: cannot be estimated from available data

• Becoming dependent on Pregabalina Sandoz (“drug dependence”).

After completing a short or long-term treatment with Pregabalina Sandoz, you should know that you may experience certain side effects, called withdrawal effects (see “If you stop taking Pregabalina Sandoz”).

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

Certain side 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 (tense or rigid muscles), with similar side effects to Pregabalina, so the intensity of these side 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 side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse 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 blister pack, on the container, or on the 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 the first opening.

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

Composition of Pregabalin Sandoz

• The active ingredient is pregabalin. Each hard capsule contains 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg or 300mg of pregabalin.
• The other components are pregelatinized maize starch, maize starch, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172) (all dose presentations except 150mg), red iron oxide (E172) (all dose presentations except 50mg and 150mg), and black iron oxide (E172) (only 25mg and 300mg).

Appearance of the product and contents of the pack

Pregabalin Sandoz is available in the following presentations:

PVC/PVDC//Aluminium blisters packed in a box.

Unit dose PVC/PVDC//Aluminium blisters packed in a box.

High-density polyethylene container with a polypropylene screw cap packed in a box.

25mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 28, 56, 70, 84, 100 or 120hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 56x 1, 84x 1 or 100x 1hard capsules.

High-density polyethylene containers containing 200hard capsules.

50mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 21, 28, 56, 84 or 100hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 84x 1hard capsules.

High-density polyethylene containers containing 200hard capsules.

75mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 21, 28, 56, 70, 84, 100 or 120hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 14x 1, 56x 1, 84x 1, 100x 1 or 210x 1 (3 x 70)hard capsules.

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

100mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 21, 28, 56, 84 or 100hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 84x 1 or 100x 1hard capsules.

150mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 21, 28, 56, 70, 84, 100 or 120hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 56x 1, 84x 1, 100x 1 or 210x 1 (3 x 70)hard capsules.

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

200mg capsules:

PVC/PVDC//Aluminium blisters containing 21, 28, 84 or 100hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 84x 1 or 100x 1hard capsules.

225mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 56, 70, 84, 100 or 120hard capsules.

300mg capsules:

PVC/PVDC//Aluminium blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100, 100 (2 x 50) or 120 (2 x 60)hard capsules.

Unit dose PVC/PVDC//Aluminium blisters containing 56x 1, 84x 1 (2 x 42), 100x 1, 100x 1 (2 x 50) or 210x 1 (3 x 70)hard capsules.

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

Only some pack sizes may be marketed.

Marketing Authorisation 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

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:June 2023

For more information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.