25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg hard capsules
pregabalin
What Pregabalin Accord is and what it is used for
Pregabalin Accord belongs to a group of medicines that are used i.a. to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Peripheral and central neuropathic pain
This medicine is used to treat long-term pain caused by a nerve injury. Several diseases can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain can be described as hot, burning, throbbing, radiating, stabbing, cutting, cramping, aching, stinging, numbness, and ant crawling. Peripheral and central neuropathic pain can also be associated with mood swings, sleep disorders, and fatigue (fatigue), and can have an impact on physical and social functioning as well as the overall quality of life.
Epilepsy
This medicine is used to treat a particular form of epilepsy ( partial epilepsy with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Accord to you to treat your epilepsy as your current treatment does not keep the disease under control. You should take Pregabalin Accord in addition to your current treatment. Pregabalin Accord is not for use alone but should always be taken in combination with other antiepileptic medicines.
Generalized anxiety disorder
This medicine is used to treat generalized anxiety disorder. The symptoms of generalized anxiety disorder are prolonged excessive anxiety and worry that are difficult to control. Generalized anxiety disorder can also cause restlessness or a feeling of being bloated or tense, that you easily get tired, have concentration problems or episodes of absence, feel irritable, get muscle tension or sleep disturbance. This differs from stress and strain in everyday life.
What you need to know before taking 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 cautions
Talk to your doctor or pharmacist before taking Pregabalin Accord.
- Some patients who have been treated with this medicine have reported symptoms that indicate allergic reactions. These symptoms include swelling of the face, lips, tongue, and throat as well as a diffuse rash. If you experience any of these reactions, contact your doctor immediately.
- This medicine has been associated with dizziness and drowsiness, which could increase the incidence of falls in elderly patients. You should therefore be careful until you are used to the effects that the medicine may have.
- This medicine may cause blurred vision, visual impairment, or another form of visual impairment. Many of these side effects are transient. You should contact a doctor immediately if you experience any change in your vision.
- Some diabetic patients who gain weight during the use of pregabalin may need a change in their diabetes medication.
- Some side effects may be more common, such as drowsiness, as patients with spinal cord injury may take other medicines to treat, for example, pain or spasticity. These medicines have similar side effects to pregabalin and the severity of these side effects may increase when taken together.
- There have been reports of heart failure in some patients taking this drug, these patients have mostly been elderly with cardiovascular disease. Before taking this medicine, tell your doctor if you have any heart disease.
- There have been reports of renal failure in some patients taking this medicine. If you experience decreased urine output during treatment with this medicine, tell your doctor as this may stop if you stop taking the medicine.
- A small number of people who are treated with anti-epileptic drugs such as Pregabalin Accord have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
- When Pregabalin Accord is taken with other medicines that can cause constipation (such as certain types of painkillers), problems with the gastrointestinal tract may occur (eg constipation, blocked or sluggish bowel). Tell your doctor if you get constipation, especially if you are prone to this problem.
- Before taking this medicine, you should tell your doctor if you have alcoholism, drug abuse, or addiction in your background. Do not take more medicine than prescribed.
- There have been reports of seizures when taking this medicine or shortly after stopping taking medicine. Contact your doctor immediately if you experience seizures.
- There have been reports of cerebral palsy ( encephalopathy ) in some patients who have taken this medicine when they have other conditions. Tell your doctor if you have any serious medical conditions, including liver or kidney disease.
- There have been reports of difficulty breathing. If you have a disease of the nervous system or respiratory system, impaired kidney function, or if you are older than 65 years, your doctor may prescribe a different dosing regimen. Contact your doctor if you have difficulty breathing or shallow breathing.
Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin therapy. Stop taking pregabalin and see a doctor immediately if you get any of the symptoms of the severe skin reactions described in section 4.
Children and young people
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
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Accord and some other medicines may interact ( interaction ). When taken with certain other medicines that have a sedative effect (including opioids ), Pregabalin Accord may potentiate these effects, which may lead to impaired breathing, coma, and death. The degree of dizziness, drowsiness, and impaired concentration will be more pronounced if Pregabalin Accord is used with medicines containing:
Oxycodone – (used as a painkiller)
Lorazepam – (used to treat anxiety)
Alcohol
This medicine can be taken at the same time as oral contraceptives ( birth control pills ).
Pregabalin Accord with food, drink, and alcohol
This medicine can be taken with or without food.
Patients are advised not to drink alcohol while using this medicine.
Pregnancy and breastfeeding
This medicine should not be used during pregnancy or breastfeeding unless you have been told otherwise by your doctor. If pregabalin is used during the first three months of pregnancy, it may cause fetal malformations that require medical attention. In a study that reviewed data from women in Nordic countries who used pregabalin during the first three months of pregnancy, 6 children out of 100 had such malformations. This compares with 4 children out of 100 the women in the study who were not treated with pregabalin. Malformations of the face (cleft lip and palate ), eyes, nervous system (including the brain), kidneys, and genitals have been reported.
Effective contraception must be used by women of childbearing potential. 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.
Pregabalin Accord contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, ie it is essentially ‘sodium-free’.
Driving and using machines
This medicine may cause dizziness, drowsiness, and decreased ability to concentrate. You should not drive, operate advanced machinery or engage in any other potentially hazardous activity until you know how this medicine affects your ability to perform these activities.
How to take Pregabalin Accord
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide which dose is right for you.
This medicine is for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder :
- Take as many capsules as your doctor has told you to.
- The dose, which is tailored for you and your illness, is usually between 150 mg and 600 mg per day.
- Your doctor will tell you to take this medicine either twice a day or 3 times a day. When dosed twice a day, this medicine should be taken once in the morning and once in the evening, at about the same time each day. When dosed three times a day, this medicine should be taken once in the morning, once in the afternoon, and once in the evening at approximately the same time each day.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
If you are older (over 65 years) you should use this medicine as normal, but not if you have impaired kidney function.
Your doctor may prescribe another dose if you have impaired kidney function.
Swallow the capsule whole with water.
Keep taking this medicine until your doctor tells you to stop.
If you take more Pregabalin Accord than you should
Contact a doctor immediately or go to the nearest emergency room. Take the carton or bottle of this medicine with you. You may feel sleepy, confused, anxious, or restless as a result of taking too much of this medicine. Seizures have also been reported.
If you forget to take Pregabalin Accord
It is important that you take your medicine regularly and 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 the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Pregabalin Accord
Do not stop taking this medicine unless your doctor tells you to. If your treatment is to be stopped, it should be done gradually over at least 1 week.
You should know that after abrupt discontinuation of long-term and short-term treatment with Pregabalin Accord, you may experience certain withdrawal symptoms/side effects. These include sleep problems, headaches, nausea, feelings of anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. If you have been taking this medicine for a long time, these symptoms may occur more often and be more pronounced.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 user in 10):
- Dizziness, drowsiness, headache
Common (may affect up to 1 in 10 people):
- Increased appetite
- The feeling of excitement, confusion, disorientation, decreased sexual desire, irritability
- Decreased attention, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, fatigue, drowsiness, insomnia, fatigue, feeling abnormal
- Blurred vision, double vision
- Fraud, balance difficulties, falls
- Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloating
- Difficulty getting an erection
- Swelling in the body including arms and legs
- Feeling intoxicated, gait disturbance
- Weight gain
- Muscle cramps, joint pain, back pain, pain in arms and legs
- Sore throat.
Uncommon (may affect up to 1 in 100 people):
- Decreased appetite, weight loss, low blood sugar, high blood sugar
- Altered self-perception, restlessness, depression, intense anxiety, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, indifference, aggression, high mood, mental deterioration, difficulty thinking, increased sexual desire, problems with sexual function including the inability to achieve sexual climax, delayed ejaculation
- Vision changes, unusual eye movements, vision changes including tunnel vision, flashes of light, jerky movements, impaired reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremor when moving, loss of consciousness, loss of consciousness, fainting, increased sensitivity to sound, numbness
- Dry eyes, eye swelling, eye pain, tired eyes, increased tear flow, eye irritation
- Disorders of heart rhythm, increased heart rate, low blood pressure , high blood pressure, altered heartbeat, heart failure
- Redness, hot flashes
- Difficulty breathing, nasal congestion, nasal congestion
- Increased saliva production, heartburn, numbness around the mouth
- Sweating, rash, chills, fever
- Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
- Sore breasts
- Difficulty urinating or painful urination, incontinence
- Weakness, thirst, feeling of tightness in the chest
- Changes in blood test results and blood tests (increased blood creatinine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium)
- Hypersensitivity, swelling of the face, itching, hives, runny nose, nosebleeds, cough, snoring
- Painful menstruation
- Cold hands and feet
Rare (may affect up to 1 in 1,000 people):
- Abnormal sense of smell, fluctuations in vision, altered depth of field, altered light experience, visual impairment
- Dilated pupils er, squinted
- Cold sweats, tightness in the throat, swelling of the tongue
- Inflammation of the pancreas
- Difficulty swallowing
- Slow or decreased mobility in the body
- Difficulty writing properly
- Increased fluid in the abdomen
- Fluid in the lungs
- Seizures
- Changes in the measured electrical changes in the heart ( ECG ) correspond to disturbances in the heart rhythm
- Muscle injuries
- Breast secretion, abnormal breast growth, breast growth in men
- Interrupted menstruation
- Kidney failure decreased urine output, difficulty urinating
- Decreased white blood cell count
- Inappropriate behavior
- Allergic reactions that may include difficulty breathing, eye inflammation ( keratitis ), and a severe skin reaction characterized by reddish, flat, annular, or round spots on the torso, often with blisters in the middle, scaly skin, sores in the mouth, throat, nose, genitals and the eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome, toxic epidermal necrolysis )
- Jaundice (yellowed skin and yellowed eyes)
- Parkinsonism, ie symptoms similar to Parkinson’s disease; such as tremors, bradykinesia (reduced mobility), and rigidity (muscle stiffness)
Very rare (may affect up to 1 in 10,000 people):
- Liver failure
- Hepatitis ( inflammation of the liver)
If your face or tongue swells or if your skin turns red with blistering or scaling, see a doctor immediately.
Some side effects may be more common, such as drowsiness, as patients with spinal cord injury may take other medicines to treat, for example, pain or spasticity. These medicines have similar side effects to pregabalin and the severity of these side effects may increase when taken together.
The following side effects have been reported after the market introduction: difficulty breathing, and shallow breathing.
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 which is stated on the carton or can after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
The capsules in the HDPE bottle should be used within 30 days (for 30) and 100 days (for 200) after the first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg pregabalin.
The other ingredients are pregelatinized starch, talc (E553b), gelatin, titanium dioxide (E171), sodium lauryl sulfate, and black ink (containing shellac, propylene glycol, iron oxide black (E172), and potassium hydroxide).
The 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg capsules also contain iron oxide red (E172).
What the medicine looks like and the contents of the pack
| 25 mg capsules | White opaque/white opaque hard gelatin capsules of size “4” embossed with “PG” on the upper part and “25” on the lower part. Each capsule is approximately 14.4 mm long. |
| 50 mg capsules | White opaque/white opaque hard gelatin capsules of size “3” embossed with “PG” on the upper part and “50” on the lower part. Each capsule is approximately 15.8 mm long. |
| 75 mg capsules | Red opaque/white opaque hard gelatin capsules of size “4” embossed with “PG” on the upper part and “75” on the lower part. Each capsule is approximately 14.4 mm long. |
| 100 mg capsules | Red opaque/red opaque hard gelatin capsules of size “3” embossed with “PG” on the upper part and “100” on the lower part. Each capsule is approximately 15.8 mm long. |
| 150 mg capsules | White opaque/white opaque hard gelatin capsules of size “2” embossed with “PG” on the upper part and “150” on the lower part. Each capsule is approximately 17.8 mm long. |
| 200 mg capsules | Orange opaque/orange opaque hard gelatin capsules of size “1” embossed with “PG” on the upper part and “200” on the lower part. Each capsule is approximately 19.3 mm long. |
| 225 mg capsules | Orange opaque/white opaque hard gelatin capsules of size “1” embossed with “PG” on the upper part and “225” on the lower part. Each capsule is approximately 19.3 mm long |
| 300 mg capsules | Red opaque/white opaque hard gelatin capsules of size “0” embossed with “PG” on the upper part and “300” on the lower part. Each capsule is approximately 21.4 mm long. |
Pregabalin Accord 25/50/75/100/150/200/225/300 mg hard capsules are available in PVC / aluminum blisters in pack sizes of 14, 21, 56, 60, 84, 90, 100, or 112 hard capsules. In addition, Pregabalin Accord 75 mg hard capsules are also available in PVC / aluminum blisters in pack sizes of 70 hard capsules.
Pregabalin Accord 25/50/75/100/150/200/225/300 mg hard capsules are available as 100 x 1 hard capsule in PVC / aluminum perforated unit dose blisters.
Pregabalin Accord 25/50/75/100/150/200/225/300 mg hard capsules are supplied in HDPE bottles containing 30 or 200 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland