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

What Pregabalin Krka is and what it is used for

Pregabalin Krka belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.

Peripheral and central neuropathic pain: Pregabalin Krka 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 may also be associated with mood swings, sleep disturbances, fatigue

(fatigue), and can have an impact on physical and social function as well as the overall quality of life.

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

Generalized Anxiety Disorder: Pregabalin Krka 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 Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Krka

Do not use Pregabalin Krka

  • 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 Krka.

  • 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 Krka 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 Krka 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 Krka 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 decreased urine output during treatment with Pregabalin Krka, tell your doctor as this may stop if you stop taking the medicine.
  • A small number of people treated with antiepileptic drugs, such as pregabalin, have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
  • When Pregabalin Krka 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 a different dosage. 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 Krka

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

Pregabalin Krka and certain other medicines may interact ( interaction ). When taken with certain other medicines that have sedative effects (including opioids ), Pregabalin Krka may aggravate these effects, which may lead to impaired breathing, coma, and death. The degree of dizziness, drowsiness, and decreased ability to concentrate becomes more pronounced if Pregabalin Krka is used with medicines containing:

  • Oxycodone (used as a painkiller)
  • Lorazepam (used to treat anxiety)
  • Alcohol

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

Pregabalin Krka with food, drink, and alcohol

Pregabalin Krka capsules can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

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 Krka 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 Krka 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.

How to use Pregabalin Krka

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 Krka 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 Pregabalin Krka either twice a day or three times a day. When dosing twice a day, Pregabalin Krka 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 Krka 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 Krka is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should use Pregabalin Krka 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 Krka until your doctor tells you to stop. 

If you use more Pregabalin Krka than you should 

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice or go to the nearest emergency room and take the package of Pregabalin Krka with you. You may feel sleepy, confused, anxious, or restless as a result of taking too much Pregabalin Krka. Seizures have also been reported.

If you forget to use Pregabalin Krka

It is important to take the Pregabalin Krka 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 Krka

Do not stop taking Pregabalin Krka 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 Krka, 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 Krka 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.

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.

Very common side effects (may affect more than 1 user in 10):

  • Dizziness, drowsiness, headache

Common side effects ( 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 side effects ( 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 side effects ( 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 ), corresponds 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 (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)

Very rare  side effects ( may affect up to 1 in 10,000 people):

  • Liver failure
  • Hepatitis ( inflammation of the liver)

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 Krka 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 Krka

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 after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

After the first opening of the jar, the contents must be consumed within 4 months.

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 and 300 mg pregabalin respectively.

The other ingredients are pregelatinized starch and talc (E553b) in the capsule contents.

The other ingredients in Pregabalin Krka 25 mg hard capsules are titanium dioxide (E171), gelatin and black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.

The other ingredients in Pregabalin Krka 50 mg and 75 mg hard capsules are titanium dioxide (E171), gelatin, yellow iron oxide (E172), black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.

The other ingredients in Pregabalin Krka 100 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172) and white ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule shell.

The other ingredients in Pregabalin Krka 150 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172) and black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.

The other ingredients in Pregabalin Krka 200 mg and 225 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), and black ink (shellac (E904), black iron oxide (E172) ), propylene glycol (E1520)) in the capsule shell.

The other ingredients in Pregabalin Krka 300 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and white ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E1520). E525), titanium dioxide (E171)) in the capsule shell.

What the medicine looks like and the contents of the pack

Capsule, hard (capsule)

25 mg hard capsules: The capsule body is white, and the capsule cap is white. The capsule cap is marked with black marking P25. The contents of the capsule are white to off-white powder. Capsule length: 13.8 – 14.8 mm.

50 mg hard capsules: The capsule body is white, and the capsule cap is yellow. The capsule cap is marked with black marking P50. The contents of the capsule are white to off-white powder. Capsule length: 15.3 – 16.2 mm.

75 mg hard capsules: The capsule body is brownish yellow, and the capsule cap is brownish yellow. The capsule cap is marked with black marking P75. The contents of the capsule are white to off-white powder. Capsule length: 13.8 – 14.8 mm.

100 mg hard capsules: The capsule body is reddish-brown, and the capsule cap is reddish-brown. The capsule cap is marked with a white marking P100. The contents of the capsule are white to off-white powder. Capsule length: 15.3 – 16.2 mm.

150 mg hard capsules: The capsule body is white, and the capsule cap is amber. The capsule cap is marked with black marking P150. The contents of the capsule are white to off-white powder. Capsule length: 17.2 – 18.3 mm.

200 mg hard capsules: The capsule body is brown, and the capsule cap is brown. The capsule cap is marked with black marking P200. The contents of the capsule are white to off-white powder. Capsule length: 18.7 – 19.8 mm.

225 mg hard capsules: The capsule body is white, and the capsule cap is brown. The capsule cap is marked with black marking P225. The contents of the capsule are white to off-white powder. Capsule length: 18.7 – 19.8 mm.

300 mg hard capsules: The capsule body is white, and the capsule cap is dark brown. The capsule cap is marked with a white marking P300. The contents of the capsule are white to off-white powder. Capsule length: 20.0 – 22.1 mm.

All strengths of Pregabalin Krka are available in packs containing 14, 20, 56, 60, 84, 90, 98, and 100 hard capsules in blister packs, respectively.

The strengths 75 mg and 150 mg of Pregabalin Krka are available in packs containing 100 hard capsules in an HDPE plastic jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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