PREGABALIN ACCORD 225 mg HARD CAPSULES

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

Consult your doctor or pharmacist before taking Pregabalin Accord.

• Some patients taking this medicine 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.

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

• 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 dose adjustment of their diabetic treatments.

• Certain side effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medicines for treatment, for example, pain or spasticity (stiff or rigid muscles), with similar side effects to 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 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 kidney failure in some patients taking this medicine. If you notice a decrease in your ability to urinate while taking 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 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 medicines that may cause constipation (such as some types of painkillers), it is possible that gastrointestinal problems (e.g., constipation and bowel obstruction 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; this may mean 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 taking this medicine 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 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.

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 keep taking the medicine). They may have withdrawal effects when they stop taking 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 (interact). When Pregabalin Accord is used with certain medicines that have a sedating effect (including opioids), these effects may be enhanced, 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 painkiller)

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 during the first 3 months of pregnancy, 6 babies out of 100 had such congenital malformations. This compares with 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

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

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

Your doctor will determine the appropriate dose for you.

This medicine is for oral use only.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules as instructed by your doctor.
• 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 twice 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

Contact your doctor or go to the nearest emergency department 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 medicine 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.

After stopping treatment with 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 occur more frequently or severely if you have been taking this medicine 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.

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.
• 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 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 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, tearful 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, urticaria, 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 rashes 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 Accord ("drug dependence").

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

If you experience swelling in your 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 is not listed in this prospectus. You can also report them directly through the national reporting system included in Annex V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage 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 on the 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, 225 mg, 300 mg of pregabalin.

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

The 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg capsules also contain red iron oxide (E172).

Pregabalina Accord 25/50/75/100/150/200/225/300mg hard capsules are available in PVC/aluminum blisters 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 blisters containing 70 hard capsules.

Pregabalina Accord 25/50/75/100/150/200/225/300mg hard capsules are available in 100 x 1 hard capsule in perforated monodose PVC/aluminum blisters.

Pregabalina Accord 25/50/75/100/150/200/225/300mg hard capsules 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

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht, Netherlands

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009, Greece

Date of Last Revision of this Prospectus

Other Sources of Information

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