PREGABALIN ACCORD 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Pregabalin Accord 25 mg hard capsules EFG

Pregabalin Accord 50 mg hard capsules EFG

Pregabalin Accord 75 mg hard capsules EFG

Pregabalin Accord 100 mg hard capsules EFG

Pregabalin Accord 150 mg hard capsules EFG

Pregabalin Accord 200 mg hard capsules EFG

Pregabalin Accord 300 mg hard capsules EFG

pregabalin

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.

• 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

1. What is Pregabalin Accord and what is it used for
2. What you need to know before you take Pregabalin Accord
3. How to take Pregabalin Accord
4. Possible side effects
5. Storage of Pregabalin Accord
6. Contents of the pack and other information

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

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

Peripheral and central neuropathic pain

This medicine is used to treat long-term 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, 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

This medicine is used to treat certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Accord for you to treat epilepsy when your current treatment does not control the disease. You should take Pregabalin Accord in addition to your current treatment. Pregabalin Accord should not be taken alone, but should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder

This medicine 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 tired (fatigue) easily, having difficulty concentrating or having a blank mind, irritability, muscle tension, or sleep disturbances. This is different from everyday stress and strain.

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

Do not take Pregabalin Accord

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 Accord.

• Some patients treated with this medicine 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.

• This medicine has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should be cautious until you are familiar with the effects that the medicine can have.

• This medicine 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 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, for 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 treated with this medicine. Most of them were elderly patients with cardiovascular diseases. 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 treated with this medicine. If you notice a decrease in your ability to urinate during treatment with this medicine, you should inform your doctor, as stopping treatment may improve this situation.

• Some patients taking antiepileptics such as Pregabalin Accord have had thoughts of harming themselves or committing 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 Accord is taken with other medications that can cause constipation (such as some types of pain medications), it is possible that gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis) may appear. 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 medications, or illegal drugs; this may mean that you have a higher risk of becoming dependent on Pregabalin Accord.

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

• There have been reports of reduced brain function (encephalopathy) in some patients who were taking this medicine and 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, renal 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.

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.

Dependence

Some people may become dependent on Pregabalin Accord (need to continue taking the medicine). They may have withdrawal effects when they stop using Pregabalin Accord (see section 3, "How to take Pregabalin Accord" and "If you stop taking Pregabalin Accord"). If you are concerned that you may become dependent on Pregabalin Accord, it is important that you consult your doctor.

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

• You need to take the medicine for longer than recommended by your doctor.
• You feel that you need to take more of 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, so pregabalin should not be used in this age group.

Using Pregabalin Accord with other medicines

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

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

Oxycodone - (used as a pain reliever)

Lorazepam - (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Pregabalin Accord with food, drinks, and alcohol

The capsules of this medicine can be taken with or without food.

It is advised not to drink alcohol during treatment with this medicine.

Pregnancy and breastfeeding

Do not take this medicine during pregnancy or breastfeeding, unless your doctor has told you to. Pregabalin during pregnancy or breastfeeding, unless your doctor has told you to. 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 in 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 (clefts), 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

This medicine 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.

Pregabalin Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is essentially "sodium-free".

3. How to take Pregabalin Accord

Take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

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

This medicine 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 this medicine two or three times a day. In the case of twice a day, take this medicine once in the morning and once in the evening, approximately at the same time every day. In the case of three times a day, take this medicine in the morning, at noon, and in the evening, approximately at the same time every day.

If you think that the effect of this medicine 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 this medicine normally, unless 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 this medicine until your doctor tells you to stop.

If you take more Pregabalin Accord than you should

Call your doctor or go to the nearest emergency room immediately. Take the pack or bottle of capsules with you. As a result of taking more of this medicine than you should, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

If you forget to take Pregabalin Accord

It is important that you take your medication 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 forgotten doses.

If you stop taking Pregabalin Accord

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

Once you have finished taking Pregabalin Accord for a long or short time, you should know that you may experience certain side effects, called withdrawal effects. These include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been taking this medicine for a longer period. If you experience withdrawal effects, you should see 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.

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, speech difficulties, 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.
• Body swelling 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 levels.
• 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.
• Breathing difficulties, 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, 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, not raised, 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 rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).

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 Accord ("drug dependence").

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

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 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 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. Conservation of Pregabalina Accord

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 or bottle.

The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

The HDPE bottle should be used within 30 days (for 30 units) and 100 days (for 200 units) after opening it for the first time.

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

6. Package Contents and Additional Information

Composition of Pregabalina Accord

The active ingredient is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg of pregabalin.

The other ingredients are: pregelatinized starch, talc (E553b), gelatin, titanium dioxide (E171), sodium lauryl sulfate, black ink (containing Shellac lacquer, propylene glycol, black iron oxide (E172), and potassium hydroxide).

The 75 mg, 100 mg, 200 mg, and 300 mg capsules also contain red iron oxide (E172).

The hard capsules Pregabalina Accord 25/50/75/100/150/200/300mg are available in blister packs (PVC/aluminum) containing 14, 21, 56, 60, 84, 90, 100, or 112 hard capsules. Additionally, Pregabalina Accord 75 mg hard capsules are also available in PVC/Aluminum blister packs containing 70 hard capsules.

The hard capsules Pregabalina Accord 25/50/75/100/150/200/300mg are available in 100 x 1 hard capsule blister packs of PVC/aluminum.

The hard capsules Pregabalina Accord 25/50/75/100/150/200/300mg are also available in HDPE bottles containing 30 or 200 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Wessling Hungary Kft

Anonymus u. 6, Budapest 1045 Hungary

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of the Last Revision of this Leaflet

Other Sources of Information

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