Patient leaflet - Pregabalin Krka 75 mg hard capsules

1. What Pregabalin Krka is and what it is used for

This medicine has been prescribed for you to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD). It contains pregabalin which belongs to a class of medicines called gabapentinoids.

Peripheral and central neuropathic pain: Pregabalin Krka is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life. Epilepsy: Pregabalin Krka is used to treat a certain form of epilepsy (partial seizures with or without secondary

generalisation) in adults. Your doctor will prescribe Pregabalin Krka for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Krka in addition to your current treatment. Pregabalin Krka is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin Krka is used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This is different to the stresses and strains of everyday life.

This medicine has been prescribed to you and should not be given to anyone else.

Gabapentinoids can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.

2. What you need to know before you take Pregabalin Krka

Do not take Pregabalin Krka:

if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Pregabalin Krka.
- Some patients taking pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. Should you experience any of these reactions, you should contact your physician immediately.
- Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
- Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have.
- Pregabalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any 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 may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to pregabalin and the severity of these effects may be increased when taken together.
- There have been reports of heart failure in some patients when taking pregabalin; these patients were mostly elderly with cardiovascular conditions. Before taking this medicine, you should tell your doctor if you have a history of heart disease.
  - There have been reports of kidney failure in some patients when taking pregabalin. If while taking Pregabalin Krka you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
  - Some patients being treated with anti-epileptics such as Pregabalin Krka have had thoughts of harming or killing themselves or shown suicidal behaviour. If at any time you have these thoughts or shown such behaviour, immediately contact your doctor.
  - When Pregabalin Krka is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible, that gastrointestinal problems may occur (e.g., constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem.
  - There have been reports of convulsions when taking pregabalin or shortly after stopping pregabalin. If you experience a convulsion, contact your doctor immediately.
  - There have been reports of reduction in brain function (encephalopathy) in some patients taking pregabalin when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
  - There have been reports of breathing difficulties. If you have nervous system disorders, respiratory disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths.
  - If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
  - If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
    - If you feel you need to take more of Pregabalin Krka to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your doctor who will discuss your treatment and may change your dose or switch you to an alternative medication.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Gabapentinoids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentinoids, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. Children and adolescents

The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, Pregabalin Krka 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 influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Krka may potentiate these effects, and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Krka is taken together with medicinal products containing:

Oxycodone (used as a pain-killer)
Lorazepam (used for treating anxiety)
Alcohol

Pregabalin Krka may be taken with oral contraceptives. Pregabalin Krka with food, drink and alcohol

Pregabalin Krka capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Krka. Pregnancy and breast-feeding and fertility

Pregabalin Krka should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. Pregabalin use during the first 3 months of pregnancy may cause birth defects in the unborn child that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies in every 100 had such birth defects. This compares to 4 babies in every 100 born to women not treated with pregabalin in the study. Abnormalities of the face (orofacial clefts), the eyes, the 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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin Krka 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 medicine affects your ability to perform these activities.

3. How to take Pregabalin Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed. Your doctor will determine what dose is appropriate for you. Pregabalin Krka is for oral use only.

Your doctor should have discussed with you how long the course of treatment will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:

Take the number of capsules as instructed by your doctor.
The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Your doctor will tell you to take Pregabalin Krka either twice or three times a day. For twice a day take Pregabalin Krka once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Krka once in the morning, once in the afternoon and once in the evening, at about 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.

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If you are an elderly patient (over 65 years of age), you should take Pregabalin Krka normally except if you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys. Swallow the capsule whole with water.

Continue taking Pregabalin Krka until your doctor tells you to stop.

If you take more Pregabalin Krka than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box of Pregabalin Krka capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Krka than you should. Fits and unconsciousness (coma) have also been reported. If you forget to take Pregabalin Krka

It is important to take your Pregabalin Krka capsules 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 that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you stop taking Pregabalin Krka

Do not suddenly stop taking Pregabalin Krka. If you want to stop taking Pregabalin Krka, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

After stopping a short or long-term treatment with Pregabalin Krka, you may experience certain side effects, so called withdrawal effects. These effects include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

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.

If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.

Very common (may affect more than 1 in 10 people)

Dizziness, drowsiness, headache

Common (may affect up to 1 in 10 people)

Increased appetite.
Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Blurred vision, double vision.
Vertigo, problems with balance, fall.
Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen.
Difficulties with erection.
Swelling of the body including extremities.
Feeling drunk, abnormal style of walking.
Weight gain.
Muscle cramp, joint pain, back pain, pain in limb.
Sore throat.

Uncommon (may affect up to 1 in 100 people)

Loss of appetite, weight loss, low blood sugar, high blood sugar.
- Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
- Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
- Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
- Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
- Flushing, hot flushes.
- Difficulty breathing, dry nose, nasal congestion.
- Increased saliva production, heartburn, numb around mouth.
- Sweating, rash, chills, fever.
- Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
- Breast pain.
- Difficulty with or painful urination, incontinence.
- Weakness, thirst, chest tightness.
- Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased, neutropaenia, increase in blood creatinine, decrease in blood potassium).
- Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
  - Painful menstrual periods.
  - Coldness of hands and feet.

Rare (may affect up to 1 in 1,000 people)

Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
Dilated pupils, cross eyes.
Cold sweat, tightness of the throat, swollen tongue.
Inflammation of the pancreas.
Difficulty in swallowing.
Slow or reduced movement of the body.
Difficulty with writing properly.
Increased fluid in the abdomen.
Fluid in the lungs.
Convulsions.
Changes in the recording of electrical changes (ECG) in the heart, which correspond to heart rhythm disturbances.
Muscle damage.
Breast discharge, abnormal breast growth, breast growth in males.
Interrupted menstrual periods.
Kidney failure, reduced urine volume, urinary retention.
Decrease in white blood cell count.
Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
Allergic reactions which may include difficulty breathing, inflammation of the eyes (keratitis) and serious skin reactions characterized by reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Jaundice (yellowing of the skin and eyes).
Parkinsonism, that is symptoms resembling Parkinson’s disease; such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).
Very rare (may affect up to 1 in 10,000 people)
- Liver failure.
- Hepatitis (inflammation of the liver).

Not known: frequency cannot be estimated from the available data

Dependence or addiction (see section “How do I know if I am tolerant or addicted?”).

Drug Withdrawal

When you stop taking Pregabalin Krka, you may experience drug withdrawal symptoms, which include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness. How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Pregabalin Krka, it could be a sign that you have become addicted.

You may feel the need to keep taking the medication for longer than your doctor recommended
You feel you need to use more than the recommended dose
You are using the medicine for reasons other than prescribed
When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your doctor.

Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to pregabalin and the severity of these effects may be increased when taken together. The following adverse reaction has been reported in the post-marketing experience:

Trouble breathing, shallow breaths (respiratory depression).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pregabalin Krka 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 pregabalin.
The other ingredients are pregelatinised maize starch, talc (E553b) in capsule contents.
The other ingredients of 25 mg hard capsules are titanium dioxide (E171), gelatin, black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in capsule shell.
- The other ingredients of 50 mg and 75 mg hard capsules are titanium dioxide (E171), gelatin, yellow iron oxide (E172), black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in capsule shell.
- The other ingredients of 100 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), white printing ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in capsule shell.
- The other ingredients of 150 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in capsule shell.
- The other ingredients of 200 mg and 225 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in capsule shell.
- The other ingredients of 300 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), white printing ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in capsule shell. What Pregabalin Krka looks like and contents of the pack
- 25 mg hard capsules: The body of the capsule is white colour, the cap of the capsule is white colour. Capsule cap is imprinted with black mark P25. The content of the capsule is white to off white powder.
- 50 mg hard capsules: The body of the capsule is white colour, the cap of the capsule is pale yellow colour. Capsule cap is imprinted with black mark P50. The content of the capsule is white to off white powder.
- 75 mg hard capsules: The body of the capsule is brownish yellow colour, the cap of the capsule is brownish yellow colour. Capsule cap is imprinted with black mark P75. The content of the capsule is white to off white powder.
  - 100 mg hard capsules: The body of the capsule is reddish brown colour, the cap of the capsule is reddish brown colour. Capsule cap is imprinted with white mark P100. The content of the capsule is white to off white powder.
  - 150 mg hard capsules: The body of the capsule is white colour, the cap of the capsule is yellowish brown colour. Capsule cap is imprinted with black mark P150. The content of the capsule is white to off white powder.
  - 200 mg hard capsules: The body of the capsule is brown colour, the cap of the capsule is brown colour. Capsule cap is imprinted with black mark P200. The content of the capsule is white to off white powder.
  - 225 mg hard capsules: The body of the capsule is white colour, the cap of the capsule is brown colour. Capsule cap is imprinted with black mark P225. The content of the capsule is white to off white powder.
  - 300 mg hard capsules: The body of the capsule is white colour, the cap of the capsule is dark brown colour. Capsule cap is imprinted with white mark P300. The content of the capsule is white to off white powder.

Pregabalin Krka is available in boxes of 14, 21, 56, 70, 84, 100 or 112 (2 x 56) hard capsules in blister packs. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d. d., Novo mesto, Šmarješka cesta 6,

8501 Novo mesto, Slovenia

This leaflet was last revised in 11/2025.