Pregabalin Accord

Package leaflet: Information for the user

Pregabalin Accord 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules, 300 mg hard capsules

pregabalin
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Pregabalin Accord is and what it is 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 chronic pain caused by damage to the nervous system. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, throbbing, shooting pain, stabbing pain, sharp pain, cramping pain, discomfort, tingling, numbness, or prickling. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, and can impact physical and social activities and overall quality of life.
Epilepsy
This medicine is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Accord to help manage your epilepsy when your current treatment is not adequately controlling your condition. You will need to take Pregabalin Accord in addition to your existing therapy. Pregabalin Accord is not used as monotherapy but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder
This medicine is used to treat Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder may also cause restlessness or a feeling of being tense or on edge, easy fatigability (fatigue), difficulty in concentrating or memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from everyday stress and tension.

2. What you need to know before taking Pregabalin Accord

Do not take Pregabalin Accord
if you are allergic to pregabalin or to any of the excipients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Pregabalin Accord.

• In some patients treated with this medicine, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• This medicine 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 this medicine may have on you.
• This medicine may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbances, contact your doctor immediately.
• In some diabetic patients who gain weight during treatment with pregabalin, adjustment of diabetes medications may be necessary.
• Some side effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have side effects similar to those of pregabalin, and the severity of these effects may increase when these medicines are taken together.
• There have been reports of heart failure in some patients treated with this medicine; most of these patients were elderly with cardiovascular disease. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
• There have been reports of kidney failure in some patients treated with this medicine. If during treatment with this medicine you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of the medicine.
• Some patients treated with antiepileptic medicines such as Pregabalin Accord have experienced thoughts of self-harm or suicide or have exhibited suicidal behaviour. If at any time you have thoughts of this nature, contact your doctor immediately.
• When Pregabalin Accord is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g. constipation, bowel obstruction or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this condition.
• Before taking this medicine, inform your doctor if you have a history of abuse or dependence on alcohol, prescription medicines, or illegal substances, as this may increase the risk of dependence on Pregabalin Accord.
• Cases of seizures have been reported when taking this medicine or shortly after discontinuation. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking this medicine when they have other underlying conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have neurological disorders, respiratory conditions, impaired kidney function, or are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform your doctor if you experience breathing difficulties or shallow breathing.

Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop using pregabalin and contact your doctor immediately if you develop any symptoms related to these serious skin reactions, as described in section 4.

Dependence
Some people may become dependent on Pregabalin Accord (i.e., feel the need to continue taking the medicine). They may experience withdrawal symptoms 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 about the possibility of developing dependence on Pregabalin Accord, talk to your doctor.
If you notice any of the following signs while taking Pregabalin Accord, you may have developed dependence on the medicine:

• You feel the need to take the medicine longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons different from those for which it was prescribed
• You have made repeated unsuccessful attempts to stop or control use of the medicine
• When you stop taking the medicine, you feel unwell and feel better when you start taking it again

If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including when and how to safely discontinue the medicine.

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

Other medicines and Pregabalin Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Accord and other medicines can interact with each other. When Pregabalin Accord is taken together with other medicines that have sedative effects (including opioids), Pregabalin Accord may enhance these effects and could cause respiratory failure.
The intensity of dizziness, somnolence, and reduced concentration may increase if Pregabalin Accord is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol

This medicine may be taken together with oral contraceptives.

Pregabalin Accord with food, drinks and alcohol
This medicine may be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Accord.

Pregnancy and breastfeeding
This medicine should not be taken during pregnancy or breastfeeding unless your doctor has advised otherwise. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the newborn requiring medical treatment. In a study examining data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations, compared with 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (oro-facial clefts), eye, nervous system (including the brain), kidney, and genital abnormalities have been reported.
Women of childbearing age must use an effective method of contraception. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and use of machines
This medicine may cause dizziness, somnolence, and reduced concentration. You should not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine affects your ability to perform these tasks.

Pregabalin Accord contains sodium
This medicine contains less than 1 mmol of sodium per hard capsule, meaning it is essentially sodium-free.

3. How to take Pregabalin Accord

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed. Your doctor will determine the appropriate dose for you.
This medicine is for oral use only.

Neuropathic pain (peripheral and central), epilepsy, or Generalized Anxiety Disorder:

• Take the number of capsules prescribed by your doctor.
• The appropriate dose for you and your condition generally ranges between 150 mg and 600 mg per day.
• Your doctor will instruct you to take this medicine two or three times daily. If you take the medicine twice a day, take Pregabalin Accord once in the morning and once in the evening, approximately at the same time each day. If you take the medicine three times a day, take Pregabalin Accord once in the morning, once in the afternoon, and once in the evening, always at approximately the same time.

If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
If you are elderly (over 65 years of age), you should normally take this medicine as directed unless you have kidney problems.
Your doctor may prescribe you a different dosing schedule and/or dose adjustment if you have kidney problems.
Swallow the capsule whole with water.
Continue taking this medicine until your doctor tells you to stop treatment.

If you take more Pregabalin Accord than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the medicine’s packaging with you. You may feel drowsy, confused, agitated, and restless because you have taken more medicine than prescribed. Seizures and loss of consciousness (coma) have also been reported.

It is important to take the capsules of this medicine regularly every day at the same time. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next one as scheduled. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Accord
Do not stop treatment with this medicine abruptly. If you wish to discontinue the medicine, speak to your doctor first. Your doctor will advise you on how to do this. Discontinuation of treatment should be done gradually over a period of at least one week.

You should know that after stopping long-term or short-term treatment with Pregabalin Accord, certain unwanted side effects, known as withdrawal effects, may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, thoughts of harming yourself or of suicide, pain, sweating, and dizziness.
These effects may occur more frequently or severely if you have taken this medicine for a longer period of time. If you experience withdrawal effects, contact your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very common: may occur in more than 1 out of 10 people:

• Dizziness, drowsiness, headache.

Common: may occur in up to 1 out of 10 people:

• Increased appetite.
• Feeling of excitement, confusion, disorientation, decreased sexual interest, irritability.
• Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling unwell.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, and abdominal bloating.
• Difficulty in erection.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, abnormal gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may occur in up to 1 out of 100 people:

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in ideation, increased sexual interest, including inability to achieve orgasm, delayed ejaculation.
• Visual disturbances, eye movement abnormalities, visual disturbances including tubular vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, movement-related tremor, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling of malaise.
• Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disturbances (flushing), hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever. Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or painful urination, incontinence.
• Weakness, thirst, chest tightness. Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium levels).
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

Rare: may occur in up to 1 out of 1,000 people:

• Altered sense of smell, sensation of visual field oscillation, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disorders.
• Muscle damage.
• Breast secretions, abnormal breast growth, breast enlargement in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterized by flat, non-elevated reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, i.e. symptoms resembling Parkinson's disease such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness).

Very rare: may occur in up to 1 out of 10,000 people:

• Liver failure.
• Hepatitis (inflammation of the liver).

Not known: frequency cannot be estimated from the available data

• Becoming dependent on Pregabalin Accord ("drug dependence").

After stopping short-term or long-term treatment with pregabalin, you should be aware that you may experience certain side effects known as withdrawal effects (see "If you stop taking Pregabalin Accord").
If you experience swelling of the face or tongue, or if your skin becomes red and blisters start to form or skin peeling occurs, you must contact your doctor immediately.
Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to Pregabalin, and the severity of these effects may increase when these medicines are taken together.
The following adverse reaction has been reported during the post-marketing phase of the medicine: breathing difficulties, shallow breathing.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening, the HDPE bottle should be used within 30 days (bottle of 30) and 100 days (bottle of 200).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pregabalin Accord contains
The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
200 mg, 225 mg or 300 mg of pregabalin.
The excipients are: pregelatinized starch, talc (E553b), gelatin, titanium dioxide (E171), sodium
lauryl sulfate, black ink (containing shellac, propylene glycol, black iron oxide (E172)) and
potassium hydroxide.
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).

Pregabalin Accord hard capsules of 25/50/75/100/150/200/225/300 mg are available in blisters (PVC/aluminum) containing 14, 21, 56, 60, 84, 90, 100 or 112 hard capsules. Additionally, Pregabalin Accord 75 mg hard capsules are also available in PVC/aluminum blisters containing 70 hard capsules.
Pregabalin Accord 25/50/75/100/150/200/225/300 mg hard capsules are available in 100 x 1 hard capsules in unit dose divisible blisters made of PVC/aluminum.
Pregabalin Accord 25/50/75/100/150/200/225/300 mg hard capsules are available in HDPE bottles containing 30 or 200 hard capsules.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
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,
The 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
Further information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.