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What Pregabalin Accord and what it is used
Pregabalin Accord belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalized anxiety disorder (GAD) in adults.
This drug is used to treat some forms of epilepsy (partial onset seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Accord, to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Accord in addition to your current treatment. Pregabalin Accord is not intended for private use and should always be used in combination with other antiepileptic treatment.
Generalised Anxiety Disorder:
This medicine is used to treat generalized anxiety disorder (GAD). Symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling agitated or restless, easily weary, having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep problems. This is different from the stress and strains of everyday life.
2. 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 Precautions
Consult your doctor or pharmacist before taking Pregabalin Accord.
Some patients who take this medicine have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue and throat, as well as extensive skin rash. If you experience any of these reactions, you should immediately contact your doctor;
The use of this drug is associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you get used to any effect the medicine;
This medicine may cause blurred vision or loss of vision or other changes in eyesight, many of which are temporary. You should immediately contact your doctor if you experience changes in your vision;
Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines;
Certain side effects, such as drowsiness may be more frequent, because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may increase when co-administered;
There are reports of heart failure in some patients taking this medicine; these patients were mostly elderly with cardiovascular damage. Before taking this medication, 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 decreased urination while taking this medicine, you should tell your doctor as stopping the medicine may improve this situation;
A small number of people being treated with antiepileptic drugs such as Pregabalin Accord, have had thoughts of harming or killing themselves. If you have these thoughts, immediately contact your doctor;
Pregabalin Accord when taken with other drugs that can cause constipation (such as some types of pain relievers), there may occur some gastrointestinal problems (eg. Constipation, blockage or paralysis of the bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem;
Before taking this medicine you should tell your doctor if you suffer from alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed;
Cases of convulsions while taking this medicine or shortly after discontinuation of this medication. If you get convulsion, tell your doctor immediately;
Cases of impairment of brain function (encephalopathy) in some patients taking this medication and suffering from other diseases. Tell your doctor if you have a history of any serious diseases, including liver or kidney disease.
Children and adolescents
Safety and efficacy in children and adolescents (under 18 years) 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 certain other medicines can affect each other (interaction). When taken with certain other medicines Pregabalin Accord may intensify the side effects seen with these medicines, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Accord is taken with medicines containing:
Oxycodone - (used as a tool against pain);
Lorazepam - (used for the treatment of anxiety);
This medicine may be taken with oral contraceptives.
Pregabalin Accord with food, drink and alcohol
This medicine may be taken with or without food.
It is recommended not to drink alcohol while taking this medicine.
Pregnancy and lactation
This drug should not be taken during pregnancy or breastfeeding, unless your doctor tells you otherwise. Women of childbearing potential should use effective contraception. If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine may cause dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
3. How to take Pregabalin Accord
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
Your doctor will determine what dose is appropriate for you.
This medicine is for oral use only.
Epilepsy or generalized anxiety disorder:
Take the number of capsules as instructed by your doctor.
The dose for you and your condition, will generally be between 150 mg and 600 mg each day.
Your doctor will tell you to take this medicine or twice or three times daily. The twice a day take this medicine every day, morning and evening at about the same time. In a three day take this medicine every day, morning, afternoon and evening at about 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 an elderly patient (over 65 years) should not take this medicine normally except if you have kidney problems.
Your doctor may prescribe a different dosing schedule and / or dose if you have kidney problems.
Swallow the capsules whole with water.
Continue taking this medicine unless your doctor tells you to stop.
If you take more than the amount of Pregabalin Accord
Immediately call your doctor or the nearest hospital emergency room. Take your box or bottle of this medicine with you. You may feel sleepy, confused, agitated or restless as a result of taking more than the required dose of this medicine.
If you forget to take Pregabalin Accord
It is important to 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 this case, just carry on with the next dose as usual. Do not take a double dose to make up the missed dose.
If you stop taking Pregabalin Accord
Do not stop taking this medicine unless your doctor has told you to do this. Discontinuation of treatment should be done gradually for at least one week
You should know that after stopping long and short-term pregabalin Accord may experience certain side effects. These include sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness. These symptoms may occur more frequently or severely if you have been taking this medication for a longer period of time.
If you have any further questions on 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):
Dizziness, drowsiness, headache.
Common (may affect up to 1 in 10 people):
High mood, confusion, disorientation, decreased sexual interest, irritability;
Disturbance in attention, clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation;
Blurred vision, double vision;
Dizziness, problems with balance, fall;
Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloating;
Swelling of the body, including the extremities;
Inebriation, impaired gait;
Accumulation of body weight;
Muscle cramps, joint pain, back pain, pain in extremity;
Uncommon (may affect up to 1 in 100 people):
Loss of appetite, weight loss, low blood sugar, high blood sugar;
Changing the perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental disorder, difficulty thinking, increased sexual interest, problems with sexual function, including the inability to reach orgasm, delayed ejaculation;
Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, convulsive movements, depressed reflexes, increased activity, dizziness on standing, increased skin sensitivity, loss of taste, burning, shaking motion, depressed level of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise;
Dry eyes, eye swelling, eye pain, weak eyes, watery, eye irritation;
Abnormal heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure;
Flushing, hot flush;
Difficulty breathing, dry nose, nasal
Changes in the results of blood and liver tests (increased creatinine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased potassium levels in the blood);
Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, coughing, snoring;
Cold hands and feet.
Rare (may affect up to 1 in 1,000 people):
Altered sense of smell, unstable vision, altered depth perception, visual brightness, loss of vision;
Dilated pupils, strabismus;
Cold sweat, throat tightness, swelling of the tongue;
Inflammation of the pancreas;
Delayed or limited movement of the body;
Difficulty in writing;
Increased amount of fluid in the abdomen;
Fluid in the lungs;
Changes in recording the electrical activity of the heart (ECG), corresponding to heart rhythm disturbances;
Breast discharge, abnormal breast enlargement, breast enlargement in men;
Disruption of the menstrual cycle;
Renal failure, decreased amount of urine, urinary retention;
A decrease in white blood cells;
Allergic reactions (which may include shortness of breath, inflammation of the eye (keratitis), and serious skin reaction, characterized by rash, blisters, skin peeling and pain).
If you have swelling of the face or tongue or if your skin is red and begin to appear blistering or peeling, you should seek immediate medical advice.
Certain side effects, such as drowsiness may be more frequent, because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may increase when co-administered.
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can do your bit for getting more information on the safety of this medicine.
5. How to store Pregabalin Accord
Keep out of 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.
HDPE bottle should be used within 30 days (30 capsules) and 100 days (for 200 capsules) after first opening.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Pregabalin Accord
The active substance is pregabalin. Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg pregabalin.
The other ingredients are pregelatinised starch, talc (E553b), gelatin, titanium dioxide (E171), sodium lauryl sulfate, black ink (which contains shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide).
Capsules of 75 mg, 100 mg, 200 mg, 225 mg and 300 mg also contain red ferric oxide (E172).
25 mg capsules - opaque white / White opaque size "4" hard gelatin capsules with the inscription 'PG' on the cap and "25" on the body. Each capsule has an approximate length of 14,4 mm.
50 mg capsules - White opaque / opaque white, size "3" hard gelatin capsules with the inscription 'PG' on the cap and "50" on the body. Each capsule has an approximate length of 15,8 mm.
75 mg capsules - opaque Red / White opaque size "4" hard gelatin capsules with the inscription 'PG' on the cap and "75" on the body. Each capsule has an approximate length of 14,4 mm.
100 mg capsules - opaque Red / Red opaque size "3" hard gelatin capsules with the inscription 'PG' on the cap and "100" on the body. Each capsule has an approximate length of 15,8 mm.
150 mg capsules - White opaque / opaque white, size "2" hard gelatin capsules with the inscription 'PG' on the cap and "150" on the body. Each capsule has an approximate length of 17,8 mm.
200 mg capsules - Orange opaque / opaque orange size '1' hard gelatin capsules with the inscription 'PG' on the cap and "200" on the body. Each capsule has an approximate length of 19,3 mm.
225 mg capsules - Orange opaque / opaque white, size '1' hard gelatin capsules with the inscription 'PG' on the cap and "225" on the body. Each capsule has an approximate length of 19,3 mm.
300 mg capsules - opaque Red / White opaque size "0" hard
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