PREGABALIN GENMED 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Pregabalin GENMED 200 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 pack1. What is Pregabalin GENMEDand what is it used for 2. What you need to know before you take Pregabalin GENMED3. How to take Pregabalin GENMED4. Possible side effects 5. Storage of Pregabalin GENMED6. Contents of the pack and other information

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

Pregabalin 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 herpes. The sensation of pain can be described as heat, burning, throbbing, 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 effect on physical and social activity and overall quality of life.

Epilepsy:pregabalin is used in the treatment of certain types 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 the condition. You should take pregabalin in addition to your current treatment. Pregabalin must not be taken alone, but should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder:pregabalin is used to treat generalized anxiety disorder (GAD). The symptoms of GAD are excessive and prolonged worry and anxiety that are difficult to control. GAD can also cause restlessness or a feeling of being "on edge" or nervous, feeling easily fatigued (tired), having difficulty concentrating or an empty mind, irritability, muscle tension, or sleep disturbance. This is different from everyday stress and strain.

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

Do not take Pregabalin GENMED

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 GENMED:

• Some patients taking pregabalin 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 diffuse rash. If you experience any of these symptoms, you should see your doctor immediately.
• Pregabalin has been associated with dizziness and somnolence, which could 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 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 change in their diabetes medication.
• Certain adverse 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 (stiff or rigid muscles), with similar adverse 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 this medicine. Most of them were elderly patients with cardiovascular disease. Before using this medicine, you must tell your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients taking this medicine. If during treatment with pregabalin you notice a decrease in your ability to urinate, you should inform your doctor, as stopping treatment may improve this situation.
• A small number of people taking antiepileptics, such as pregabalin, 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 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 suffer from constipation, especially if you are prone to this problem.
• Before taking this medicine, you must tell your doctor if you have a history of alcoholism or abuse or dependence on any drug. Do not take a higher dose than prescribed.
• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with this medicine. If you have seizures, contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin who had other diseases. Tell your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of breathing difficulties. 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.
• There have been reports of serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with pregabalin treatment. Stop taking pregabalin and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children and adolescents

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

Using Pregabalin GENMED with other medicines

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

Pregabalin and certain medicines may influence each other (interactions). When pregabalin is used with certain medicines, the adverse reactions seen with them may be increased, including respiratory failure and coma. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

Oxicodone - (used as a pain reliever)

Lorazepam - (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Pregabalin GENMED with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol during treatment with pregabalin.

Pregnancy and breastfeeding

Do not take pregabalin 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 using 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.

Warnings about excipients

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

3. How to take Pregabalin GENMED

Take this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist again.

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

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

If you are an elderly patient (over 65 years old), you should take pregabalin as normal, unless you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabalin GENMED than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported.

If you forget to take Pregabalin GENMED

It is important that you take the pregabalin capsules regularly at the same time every 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 forgotten doses.

If you stop taking Pregabalin GENMED

Do not stop taking pregabalin unless your doctor tells you to do so. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once you have finished treatment with pregabalin, either in the short or long term, you should be aware that you may experience certain side effects. These include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have been taking pregabalin for a longer period.

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) are:

• Dizziness, drowsiness, headache

Common (may affect up to 1 in 10 people) are:

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Changes in attention, clumsiness, impaired memory, memory loss, tremors, difficulty speaking, tingling, 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 the limbs
• Feeling of intoxication, changes in gait
• Weight gain
• Muscle cramps, joint pain, back pain, pain in the limbs
• Sore throat

Uncommon (may affect up to 1 in 100 people) are:

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, 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 up, sensitive skin, loss of taste, burning sensation, tremors 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.
• Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Flushing, hot flushes.
• Breathing difficulties, 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, coughing, snoring.
• Painful menstrual periods.
• Feeling of cold in hands and feet.

Rare (may affect up to 1 in 1,000 people) are:

• Altered sense of smell, wavering vision, altered depth perception, visual glare, loss of vision
• Dilated pupils, crossed eyes
• Cold sweats, 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 disorders
• Muscle damage
• Milk secretion, abnormal breast growth, breast enlargement in men
• Disruption of menstrual periods
• Kidney failure, decreased urine production, urinary retention
• Decreased white blood cell count
• Inappropriate behavior

Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis), and a serious skin reaction characterized by red patches that are not raised, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, genital ulcers, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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 adverse 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 (stiff or rigid muscles), with similar adverse effects to those of pregabalin, so the intensity of these effects may increase when taken together.

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es .

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin

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 after the abbreviation CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pregabalin GENMED

The active ingredient is pregabalin. Each hard capsule contains 200 mg of pregabalin.

The other ingredients (excipients) are: Capsule content: corn starch, lactose monohydrate, and talc (E-553b). Capsule components: gelatin, titanium dioxide (E-171), red iron oxide (E-172), and yellow iron oxide (E-172). Components of the black printing ink: shellac lacquer, black iron oxide (E-172), propylene glycol, and potassium hydroxide.

Appearance of the Product and Package Contents

Pregabalin GENMED200 mg are hard capsules of orange-pink color, marked with "200" on the body of the capsule and BS15 on the cap.

PVC/Aluminum blisters in cardboard boxes containing 14, 21, 84, or 100 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and ManufacturerMarketing Authorization Holder

GENMED Pharma GmbH

Schlüterstraße 18,

10625 Berlin

Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH,

Goerzallee 305 b, 14167 Berlin,

Germany

Date of Last Revision of this Leaflet:May 2022

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