Pregabalin Stada 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalin Stada 25 mg hard capsules EFG

Pregabalin Stada 50 mg hard capsules EFG

Pregabalin Stada 75 mg hard capsules EFG

Pregabalin Stada 100 mg hard capsules EFG

Pregabalin Stada 150 mg hard capsules EFG

Pregabalin Stada 200 mg hard capsules EFG

Pregabalin Stada 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; you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only; do not pass it on 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Pregabalin Stada

3. How to take Pregabalin Stada

4. Possible side effects

5. How to store Pregabalin Stada

6. Contents of the pack and other information

1. What Pregabalina Stada is and what it is used for

Pregabalina Stada belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: pregabaline 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, throbbing, shooting, stabbing, sharp, cramping, continuous pain, tingling, numbness, or pins and needles. 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: pregabaline is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabaline if your current treatment does not adequately control your condition. You should take pregabaline in addition to your current treatment. Pregabaline must not be used as monotherapy; it should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder: pregabaline 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 everyday stress and worries of normal life.

2. What you need to know before taking Pregabalina Stada

Do not take Pregabalina Stada

• 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 taking pregabalin.

• Some patients treated with pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of widespread skin rash. If you experience any of these symptoms, you must seek medical attention 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 of the symptoms related to these serious skin reactions described in section 4.

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

• Pregabalin may cause blurred vision, loss of vision, or other changes in eyesight, many of which are transient. If you experience any changes in your vision, 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 drowsiness, may be more frequent in patients with spinal cord injury, as they may be taking other medications for conditions such as pain or spasticity, which have similar side effects to pregabalin, potentially 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 kidney failure have been reported in some patients treated with pregabalin. If during treatment with pregabalin you notice a decrease in your ability to urinate, inform your doctor, as discontinuing the 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 exhibited 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 medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this condition.

• 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.

• Seizures have been reported during treatment with pregabalin or shortly after stopping treatment. 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 difficulty breathing or shallow breathing.

Dependence

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

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

• You need to take the medicine for longer than recommended by your doctor.
• You feel the 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 once you take it again.

If you notice any of these signs, talk to 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 of pregabalin have not been established in children and adolescents (under 18 years of age), so pregabalin should not be used in this age group.

Other medicines and Pregabalina Stada

Inform 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 sedative effects (including opioids), pregabalin may enhance these effects, 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 a painkiller)
• Lorazepam – (used to treat anxiety)
• Alcohol

Pregabalin may be taken with oral contraceptives.

Taking Pregabalina Stada with food, drinks, and alcohol

Pregabalin capsules may be taken with or without food.

Alcohol consumption is not recommended during treatment with pregabalin.

Pregnancy and breastfeeding

You should not take pregabalin during pregnancy or 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. Malformations reported include those of the face (cleft lip/palate), eyes, nervous system (including the brain), kidneys, and genitals.

An effective method of contraception should be used in women of childbearing age. 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 hazardous activities until you know whether this medicine affects your ability to perform these tasks.

Pregabalina Stada 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 Pregabalina Stada

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

Dosage

Your doctor will determine the appropriate dose for you.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules your doctor has indicated.
• The dose, adjusted for 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 the effect of pregabalin is too strong or too weak, inform your doctor or pharmacist.

Elderly patients

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

Patients with kidney problems

Your doctor may prescribe a different dosing schedule and/or different doses if you have kidney problems.

Method of administration

Pregabalina is for oral use only.

Swallow the capsule whole with water.

Duration of treatment

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabalina Stada than you should

Call your doctor or go to the nearest emergency room immediately. Take the pregabalin pack with you. As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalina Stada

It is important that you take pregabalin 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 almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you stop taking Pregabalina Stada

Do not stop taking pregabalin suddenly. If you wish to stop taking pregabalin, speak to your doctor first. Your doctor will advise you on how to do this. If you are going to stop treatment, it should be done gradually over a period of at least one week.

After short- or long-term treatment with pregabalin has ended, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, restlessness, depression, thoughts of harming yourself or of suicide, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have been taking pregabalin for a longer period of time. If you experience withdrawal effects, you should 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.

If you experience swelling of the face or tongue, or if your skin becomes red and develops blisters or peeling, you must seek immediate medical attention.

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, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Difficulty in achieving erection
• Swelling of the body including limbs
• Feeling of drunkenness, disturbances in gait
• Weight gain
• Muscle cramps, 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, sexual problems 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 with 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, changes in heart rhythm, 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, hives, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Feeling of coldness 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, squint
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis (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 behavior, suicidal behavior, suicidal thoughts
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These severe 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 similar to Parkinson’s disease such as tremor, bradykinesia (reduced 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)

Frequency not known (cannot be estimated from available data):

• Becoming dependent on pregabalin (“drug dependence”)

After stopping short- 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 Stada”).

Some adverse 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, which have similar adverse effects to pregabalin, so the intensity of these effects may increase when taken together.

The following adverse reaction has been reported during 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Stada

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 pack and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to 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. Package contents and other information

Composition of Pregabalin Stada

The active substance is pregabalin.

Pregabalin Stada 25 mg: each hard capsule contains 25 mg of pregabalin.

Pregabalin Stada 50 mg: each hard capsule contains 50 mg of pregabalin.

Pregabalin Stada 75 mg: each hard capsule contains 75 mg of pregabalin.

Pregabalin Stada 100 mg: each hard capsule contains 100 mg of pregabalin.

Pregabalin Stada 150 mg: each hard capsule contains 150 mg of pregabalin.

Pregabalin Stada 200 mg: each hard capsule contains 200 mg of pregabalin.

Pregabalin Stada 300 mg: each hard capsule contains 300 mg of pregabalin.

The other components are:

Pregabalin Stada 25 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin and titanium dioxide (E-171).

Pregabalin Stada 50 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171), shellac glaze, black iron oxide (E172) and propylene glycol.

Pregabalin Stada 75 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171) and red iron oxide (E172).

Pregabalin Stada 100 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171) and red iron oxide (E172).

Pregabalin Stada 150 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin and titanium dioxide (E-171).

Pregabalin Stada 200 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171) and red iron oxide (E172).

Pregabalin Stada 300 mg: monohydrate lactose, pregelatinized starch (from corn), talc, gelatin, titanium dioxide (E-171) and red iron oxide (E172).

Appearance of the product and contents of the pack

Pregabalin Stada 25 mg: hard capsules are white (approximately 14 mm in length).

Pregabalin Stada 50 mg: hard capsules are white (approximately 16 mm in length). The body has a black circular band.

Pregabalin Stada 75 mg: hard capsules are white and orange (approximately 14 mm in length).

Pregabalin Stada 100 mg: hard capsules are orange (approximately 16 mm in length).

Pregabalin Stada 150 mg: hard capsules are white (approximately 18 mm in length).

Pregabalin Stada 200 mg: hard capsules are light orange (approximately 19 mm in length).

Pregabalin Stada 300 mg: hard capsules are white and orange (approximately 22 mm in length).

Pregabalin Stada is available in the following pack sizes:

Pregabalin Stada 25 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 70, 84, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 84 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Pregabalin Stada 50 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 84, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Pregabalin Stada 75 mg:

PVC blisters with an aluminum foil: 14, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Pregabalin Stada 100 mg:

PVC blisters with an aluminum foil: 14, 21, 30, 56, 60, 84, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Pregabalin Stada 150 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Pregabalin Stada 200 mg:

PVC blisters with an aluminum foil: 14, 21, 30, 56, 60, 84, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Pregabalin Stada 300 mg:

PVC blisters with an aluminum foil: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.

Unit dose PVC blisters with an aluminum foil: 14 x 1, 21 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 70 x 1, 100 x 1, 200 x 1 and 210 x 1 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Lamp San Prospero S.p.a.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of the latest revision of this leaflet: March 2024

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/