Pregabalin Kern Pharma 75 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pregabalin Kern Pharma 25 mg hard capsules EFG

Pregabalin Kern Pharma 50 mg hard capsules EFG

Pregabalin Kern Pharma 75 mg hard capsules EFG

Pregabalin Kern Pharma 100 mg hard capsules EFG

Pregabalin Kern Pharma 150 mg hard capsules EFG

Pregabalin Kern Pharma 200 mg hard capsules EFG

Pregabalin Kern Pharma 300 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pregabalin Kern Pharma is and what it is used for
2. What you need to know before taking Pregabalin Kern Pharma
3. How to take Pregabalin Kern Pharma
4. Possible adverse effects
5. How to store Pregabalin Kern Pharma
6. Contents of the pack and other information

1. What is Pregabalin Kern Pharma and what is it used for?

Pregabalin belongs to a group of medicines used for the treatment of epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: pregabalin is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as warmth, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, muscle spasms, continuous pain, tingling, numbness, and prickling sensations. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

Epilepsy: pregabalin is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin for epilepsy when your current treatment does not adequately control the condition. You should take pregabalin as an add-on to your current treatment. Pregabalin should not be used as monotherapy, but always in combination with other antiepileptic treatments.

Generalized anxiety disorder: pregabalin is used to treat generalized anxiety disorder (GAD). Symptoms of GAD include excessive and prolonged anxiety and worry that are difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the stress and strains of everyday life.

2. What you need to know before taking Pregabalina Kern Pharma

Do not take Pregabalina Kern Pharma

If you are allergic to pregabalin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

• Some patients treated with pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek medical advice immediately.

• Serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

• Pregabalin has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have.

• Pregabalin may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, you must inform your doctor immediately.

• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.

• Certain adverse effects, such as somnolence, may be more frequent in patients with spinal cord injury, as they may be taking other medications for treatment (e.g., for pain or spasticity [tight or rigid muscles]) that have similar adverse effects to pregabalin, thereby increasing the intensity of these effects when taken together.

• Cases of heart failure have been reported in some patients treated with pregabalin. Most of these patients were elderly with cardiovascular disease. Before using this medicine, you must inform your doctor if you have a history of heart disease.

• Cases of renal failure have been reported in some patients treated with this medicine. If during treatment with pregabalin you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.

• Some patients taking antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or have shown such behavior, contact your doctor as soon as possible.

• When pregabalin is taken together with other medicines that may cause constipation (such as certain types of pain medicines), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal paralysis) may occur. Inform your doctor if you suffer from constipation, especially if you are prone to this problem.

• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on pregabalin.

• Cases of seizures during treatment with pregabalin or shortly after discontinuation of this medicine have been reported. If you experience seizures, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who also had other medical conditions. Inform your doctor if you have a history of serious illness, including liver or kidney disease.

• Cases of difficulty breathing have been reported. If you have disorders of the nervous system, respiratory disorders, kidney failure, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience breathing difficulties or shallow breathing.

Dependence

Some people may become dependent on pregabalin (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using pregabalin (see section 3, “How to take Pregabalina Kern Pharma” and “If you stop taking Pregabalina Kern Pharma”). If you are concerned about becoming dependent on this medicine, it is important that you consult your doctor.

If you notice any of the following signs while taking pregabalin, it could be a sign that you have become dependent:

• You need to take the medicine for longer than recommended by your doctor.
• You feel you need to take more than the recommended dose.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better again once you take it again.

If you notice any of these signs, speak with your doctor to discuss the best care plan for you, including when it is appropriate to stop treatment and how to do so safely.

Children and adolescents

The safety and efficacy have not been established in children and adolescents (under 18 years of age), so pregabalin should not be used in this age group.

Taking Pregabalina Kern Pharma with other medicines

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

Pregabalin and certain medicines may interact with each other. When pregabalin is used together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced, potentially leading to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if pregabalin is taken together with other medicines containing:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medicine may be taken with oral contraceptives.

Taking Pregabalina Kern Pharma with food, drinks, and alcohol

The capsules may be taken with or without food.

It is recommended not to drink alcohol during treatment with pregabalin.

Pregnancy and breastfeeding

You should not take pregabalin during pregnancy or while breastfeeding, unless your doctor has specifically instructed you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 babies had such congenital malformations. This compares with 4 out of every 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

An effective method of contraception should be used in women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these activities.

Pregabalina Kern Pharma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pregabalin Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

This medicine is for oral use only.

Neuropathic pain (peripheral and central), epilepsy, or generalized anxiety disorder:

• Take the number of capsules prescribed by your doctor.
• The dose, adjusted according to your condition, is generally between 150 mg and 600 mg daily.
• Your doctor will instruct you to take pregabalin two or three times a day. If twice daily, take pregabalin once in the morning and once at night, approximately at the same time each day. If three times daily, take pregabalin in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take pregabalin as usual, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

Swallow the capsule whole with water.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabalin Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Call your doctor or go to the nearest emergency department immediately. Take the package or bottle of pregabalin capsules with you.

As a result of taking more pregabalin than recommended, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Kern Pharma

It is important to take pregabalin capsules regularly at the same time each day. If you forget a dose, take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Kern Pharma

Do not stop taking pregabalin suddenly. If you wish to discontinue pregabalin, speak to your doctor first. Your doctor will advise you on how to do this. Discontinuation should be carried out gradually over a minimum of one week.

After stopping short- or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects, known as withdrawal symptoms. These may include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking this medicine for a longer period of time. If you experience withdrawal symptoms, contact your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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 euphoria, confusion, disorientation, decreased sex drive, irritability
• Attention disturbance, clumsiness of movement, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, bloated abdomen
• Difficulty in erection
• Swelling of the body including limbs
• Feeling of drunkenness, disturbances in gait
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain
• Sore throat

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sex drive, problems in sexual relations including inability to reach climax, delayed ejaculation
• Changes in vision, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise
• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, irregular heartbeat, heart failure
• Flushing, hot flushes
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, burning, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Breast pain
• Difficulty or pain when urinating, inability to control urine
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Feeling of cold in hands and feet

Rare: may affect up to 1 in 1,000 people

• Altered sense of smell, fluctuating vision, altered depth perception, visual glare, vision loss
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Inflammation of the pancreas
• Difficulty swallowing
• Slow or reduced body movement
• Difficulty writing properly
• Increased fluid in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in electrocardiogram (ECG) corresponding to disturbances in heart rhythm
• Muscle damage
• Milk secretion, abnormal breast growth, breast enlargement in men
• Interruption of menstrual periods
• Kidney failure, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions (which may include difficulty breathing, eye swelling (keratitis), and a severe skin reaction characterized by flat, non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes)
• Parkinsonism, symptoms resembling Parkinson's disease such as tremor, bradykinesia (reduced ability to move), and muscle rigidity

Very rare: may affect up to 1 in 10,000 people

• Liver failure
• Hepatitis (inflammation of the liver)

Frequency not known: cannot be estimated from available data

• Becoming dependent on pregabalin ("drug dependence").

After stopping short-term or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects known as withdrawal effects (see "If you stop taking Pregabalina Kern Pharma").

If you experience swelling of the face or tongue, or if your skin becomes red, blistered, or peeling, you should seek immediate medical attention.

Certain adverse effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity (tight or stiff muscles), which have similar adverse effects to pregabalin, so that the intensity of these effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es .

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Kern Pharma

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Pregabaline Kern Pharma

The active substance is pregabalin. Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg or 300 mg of pregabalin.

The other components are monohydrate lactose, corn starch (only in 75 mg, 100 mg, 150 mg, 200 mg, and 300 mg strengths), pregelatinized corn starch (only in 25 mg and 50 mg strengths), talc (E-553b), gelatin, titanium dioxide (E-171), iron oxide red (E-172) (only in 75 mg, 100 mg, 200 mg, and 300 mg strengths), and black printing ink (containing Shellac lacquer (E-904), propylene glycol (E-1520), concentrated ammonium solution, potassium hydroxide (E-525), and black iron oxide (E-172)).

Pregabalin Kern Pharma is available in the following presentations:

Doses of 25 mg, 50 mg, 75 mg, 150 mg and 300 mg:

Standard pack: PVC/Aluminum blisters containing 56 capsules.

Doses of 100 mg and 200 mg:

Standard pack: PVC/Aluminum blisters containing 21 and 84 capsules.

All doses:

Hospital pack: PVC/Aluminum blisters containing 100 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/