PREGABALIN STADA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Pregabalin Stada 25 mg Hard Capsules EFG

Pregabalin Stada 50 mg Hard Capsules EFG

Pregabalin Stada 75 mg Hard Capsules EFG

Pregabalin Stada 100 mg Hard Capsules EFG

Pregabalin Stada 150 mg Hard Capsules EFG

Pregabalin Stada 200 mg Hard Capsules EFG

Pregabalin Stada 300 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Pregabalin Stada and what is it used for
2. What you need to know before you take Pregabalin Stada
3. How to take Pregabalin Stada
4. Possible side effects
5. Storage of Pregabalin Stada

1. Contents of the pack and further information

1. What is Pregabalin Stada and what is it used for

Pregabalin Stada belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalin is used to treat long-standing pain caused by damage to the nerves. There are several diseases that can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain can be described as hot, burning, throbbing, shooting, stabbing, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can have an impact on physical and social activity and overall quality of life.

Epilepsy:Pregabalin is used in the treatment of a certain form of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin for you to treat epilepsy when your current treatment is not controlling your condition. You should take pregabalin in addition to your current treatment. Pregabalin should not be taken alone but should always be used in combination with other anti-epileptic treatments.

Generalized anxiety disorder:Pregabalin is used to treat generalized anxiety disorder (GAD). The symptoms of GAD are prolonged and excessive worry and anxiety that are difficult to control. GAD can also cause restlessness or feeling on edge or irritability, being easily fatigued, having difficulty concentrating or feeling like your mind goes blank, muscle tension or sleep disturbance. This is different from the stress and tension of everyday life.

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

Do not take Pregabalin Stada

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking pregabalin.

• Some patients taking pregabalin have reported symptoms that may be signs of 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 reactionsdescribed in section 4.

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

• 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 immediately inform your doctor.

• Those diabetic patientswho gain weight while taking pregabalin may need an adjustment in their diabetes treatment.

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

• There have been reports of heart failure in some patients treated with pregabalin. Most were elderly patients with cardiovascular conditions. Before taking 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 treated with pregabalin. If you notice a decrease in your ability to urinateduring treatment with pregabalin, you should inform your doctor as stopping treatment may improve this condition.

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

• When pregabalin is taken with other medicines that may cause constipation (such as some types of pain medicines), it is possible that 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, tell 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.

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

• There have been reports of reduction in brain function (encephalopathy) in some patients taking pregabalin who had other conditions. Tell 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 difficulties or shallow breathing.

Dependence

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

If you notice any of the following signs while taking pregabalin, 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) have not been established, and therefore, pregabalin should not be used in this age group.

Other medicines and Pregabalin Stada

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

Pregabalin and certain other medicines may affect each other (interactions). When pregabalin is taken with certain medicines that have a sedating effect (including opioids), pregabalin may increase these effects, and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

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

Pregabalin can be taken with oral contraceptives.

Taking Pregabalin Stada with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol while taking pregabalin.

Pregnancy and breastfeeding

Do not take pregabalin 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 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin may cause dizziness, somnolence, and decreased concentration. Do 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.

Pregabalin Stada contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Pregabalin Stada

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take more medicine than prescribed.

Dose

Your doctor will determine the appropriate dose for you.

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 either twice or three times a day. For twice-daily dosing, take pregabalin once in the morning and once in the evening, approximately at the same time every day. For three-times-daily dosing, 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, talk to your doctor or pharmacist.

Elderly patients

If you are an elderly patient (over 65 years of age), you should take pregabalin normally, except if you have kidney problems.

Patients with kidney problems

Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems.

Method of administration

Pregabalin is for oral use only.

Swallow the capsule whole with water.

Duration of treatment

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabalin Stada than you should

Contact your doctor or go to the nearest emergency department immediately. Take the pregabalin pack with you. As a result of taking more pregabalin 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 Stada

It is important that you take your 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 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 Stada

Do not stop taking pregabalin suddenly. If you want to stop taking pregabalin, 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.

Once you have finished taking pregabalin, either after a short or long treatment period, you should be aware that you may experience certain side effects, called withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should contact your doctor.

If you have any further questions on 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.

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.

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
• Vertigo, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Difficulty getting an erection
• Swelling of the body including limbs
• Feeling of drunkenness, 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, 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 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 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, 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
• 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, 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 chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may 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 rigidity (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 available data):

• Becoming dependent on pregabalin ("drug dependence").

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

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, with similar adverse effects to those of pregabalin, 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 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 prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pregabalin Stada

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

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Pregabalin Stada

The active ingredient is pregabalin.

Pregabalin Stada 25 mg: each hard capsule contains 25 mg of pregabalin.

Pregabalin Stada 50 mg: each hard capsule contains 50 mg of pregabalin.

Pregabalin Stada 75 mg: each hard capsule contains 75 mg of pregabalin.

Pregabalin Stada 100 mg: each hard capsule contains 100 mg of pregabalin.

Pregabalin Stada 150 mg: each hard capsule contains 150 mg of pregabalin.

Pregabalin Stada 200 mg: each hard capsule contains 200 mg of pregabalin.

Pregabalin Stada 300 mg: each hard capsule contains 300 mg of pregabalin.

The other components are:

Pregabalin Stada 25 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, and titanium dioxide (E-171).

Pregabalin Stada 50 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171), shellac lacquer, iron oxide black (E172), and propylene glycol.

Pregabalin Stada 75 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171), and iron oxide red (E172).

Pregabalin Stada 100 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171), and iron oxide red (E172).

Pregabalin Stada 150 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, and titanium dioxide (E-171).

Pregabalin Stada 200 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171), and iron oxide red (E172).

Pregabalin Stada 300 mg: lactose monohydrate, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171), and iron oxide red (E172).

Appearance of the product and package contents

Pregabalin Stada 25 mg: the hard capsules are white (approximately 14 mm).

Pregabalin Stada 50 mg: the hard capsules are white (approximately 16 mm). The body has a black circular band.

Pregabalin Stada 75 mg: the hard capsules are white and orange (approximately 14 mm).

Pregabalin Stada 100 mg: the hard capsules are orange (approximately 16 mm).

Pregabalin Stada 150 mg: the hard capsules are white (approximately 18 mm).

Pregabalin Stada 200 mg: the hard capsules are light orange (approximately 19 mm).

Pregabalin Stada 300 mg: the hard capsules are white and orange (approximately 22 mm).

Pregabalin Stada is available in the following package sizes:

Pregabalin Stada 25 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 70, 84, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 84 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Pregabalin Stada 50 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 84, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Pregabalin Stada 75 mg:

PVC blisters with an aluminum foil: 14, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Pregabalin Stada 100 mg:

PVC blisters with an aluminum foil: 14, 21, 30, 56, 60, 84, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Pregabalin Stada 150 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Pregabalin Stada 200 mg:

PVC blisters with an aluminum foil: 14, 21, 30, 56, 60, 84, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Pregabalin Stada 300 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Unit-dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 100 x 1, 200 x 1, and 210 x 1 capsules.

Some package sizes may only be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

Spain

info@stada.es

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Lamp San Prospero S.p.a.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of last revision of this prospectus:March 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/