25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 225 mg, 300 mg hard capsules
pregabalin

What Pregabalin Orion is and what it is used for

Pregabalin Orion 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

Pregabalin Orion is used to treating 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

Pregabalin Orion is used to treating some form of epilepsy ( partial epilepsy with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Orion to you to treat your epilepsy as your current treatment does not keep the disease under control. You should take Pregabalin Orion as a supplement to your current treatment. Pregabalin Orion is not for use alone but should always be taken in combination with other antiepileptic medicines.

Generalized anxiety disorder

Pregabalin Orion 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.

Pregabalin contained in Pregabalin Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Pregabalin Orion

Do not use Pregabalin Orion

  • 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 Orion.

  • Some patients treated with pregabalin have reported symptoms suggestive of 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.
  • Pregabalin 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.
  • Pregabalin 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 medications.
  • 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 drugs 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 pregabalin, 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 pregabalin. If you experience any decrease in urine output during treatment with Pregabalin Orion, 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 Orion have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
  • When Pregabalin Orion 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 medicines than prescribed.
  • There have been reports of seizures when taking pregabalin or shortly after stopping pregabalin. Contact your doctor immediately if you experience seizures.
  • There have been reports of cerebral palsy ( encephalopathy ) in some patients taking pregabalin 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 or respiratory system, impaired kidney function, or if you are older than 65 years, your doctor may prescribe another dose. Contact your doctor if you have difficulty breathing or shallow breathing.

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 Orion

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

Pregabalin Orion and some other medicines may interact ( interaction ). When taken with certain other medicines that have sedative effects (including opioids ), Pregabalin Orion 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 Orion is used with medicines containing:

  • oxycodone (used as a painkiller)
  • lorazepam (used to treat anxiety)
  • alcohol.

Pregabalin Orion can be taken at the same time as oral contraceptives ( birth control pills ).

Pregabalin Orion with food, drink, and alcohol

Pregabalin Orion capsules can be taken with or without food.

Patients are advised not to drink alcohol while taking Pregabalin Orion.

Pregnancy and breastfeeding

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 Orion should not be used during pregnancy or breastfeeding unless you have been told otherwise by your doctor. Effective contraception must be used by women of childbearing potential.

Driving and using machines

Pregabalin Orion may cause dizziness, drowsiness, and impaired concentration. 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.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Excipients

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

How to take Pregabalin Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide which dose is right for you.

Pregabalin Orion 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.
  • Dose one, which is adapted for you and your disease, is usually between 150 mg and 600 mg per day.
  • Your doctor will tell you to take Pregabalin Orion either twice a day or 3 times a day. When dosing twice daily, Pregabalin Orion should be taken once in the morning and once in the evening, at approximately the same time each day. When dosing three times a day, Pregabalin Orion 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 Pregabalin Orion is too strong or too weak, talk to your doctor or pharmacist.

If you are older (over 65 years) you should use Pregabalin Orion 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.

Continue to take Pregabalin Orion until your doctor tells you to stop.

If you use more Pregabalin Orion than you should 

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Bring your pack or jar of Pregabalin Orion capsules to the hospital.

You may feel sleepy, confused, anxious, or restless as a result of taking too much Pregabalin Orion. Seizures have also been reported.

If you forget to use Pregabalin Orion

It is important to take Pregabalin Orion capsules 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 using Pregabalin Orion

Do not stop taking Pregabalin Orion unless your doctor tells you to. If your treatment is to be stopped, it should be done gradually for at least a week.

You should know that after abrupt discontinuation of long-term and short-term treatment with Pregabalin Orion, you may experience certain withdrawal symptoms/side effects. These include sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. If you have been taking Pregabalin Orion 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 elation, confusion, disorientation, decreased sexual desire, irritability
  • impaired 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, violent anxiety, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, indifference, aggression, increased 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
  • heart rhythm disorders, 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 test results of blood and liver samples (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 are, 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 ), which corresponds to disturbances in the heart rhythm
  • muscle injuries
  • breast secretion, abnormal breast growth, breast growth in men
  • interrupted menstruation
  • renal failure decreased urine output, difficulty urinating
  • decreased white blood cell count
  • inappropriate behavior
  • allergic reactions (which may include difficulty breathing, inflammation of the eye ( keratitis ), and a severe skin reaction characterized by itching, blisters, scaly skin, and pain)
  • 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 you experience swelling of the face or tongue or if your skin becomes red and starts to get blisters or scales, contact 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 drugs 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 Orion

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage instructions.

Do not use this medicine after the expiry date which is stated on the blister, carton, or jar. The expiration date is the last day of the specified month.

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, 225 mg or 300 mg of pregabalin.
  • Other ingredients are:

Capsule contents: corn starch, talc.

Capsule shell: titanium dioxide (E171), gelatin, water, sodium lauryl sulfate. The 75 mg, 100 mg, 225 mg, and 300 mg capsules also contain red iron oxide (E172).

Printing ink: shellac (E904), black iron oxide (E172)

What the medicine looks like and the contents of the pack

25 mg: white, oblong hard capsules, length 11 mm, marked with “Z” on the upper part and “10” on the lower part with black brook.

50 mg: white, oblong hard capsules, length 14 mm, marked with “Z” on the upper part and “11” on the lower part with black brook.

75 mg: orange / white, oblong hard capsules, length 14 mm, marked with ‘Z’ on the upper part and ’12 ‘on the lower part with black ink.

100 mg: orange, oblong hard capsules, length 16 mm, marked with “Z” on the top and “13” on the bottom with black ink.

150 mg: white, oblong hard capsules, 18 mm long, marked with “Z” on the top and “14” on the bottom with black ink.

225 mg: light orange/white, oblong hard capsules, length 19 mm, marked with “Z” on the top and “16” on the bottom with black ink.

300 mg: orange/white, oblong hard capsules, length 21 mm, marked with “Z” on the upper part and “17” on the lower part with black ink.

Pregabalin Orion capsules are available in PVC / aluminum blisters of 14, 56, 84, 98, and 200 capsules or HDPE cans of 56 and 100 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

Muhammad Nadeem

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