PREGABALIN TAD 50 mg HARD CAPSULES

2. What you need to know before taking Pregabalin TAD

DonottakePregabalinTAD

• if you are allergic to pregabalin or any of the other components of this medicine (listed in section 6).

Warningsandprecautions

Consult your doctor or pharmacist before starting to take Pregabalin TAD.

• Some patients treated with pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a diffuse rash. If you experience any of these symptoms, you should see your doctor immediately.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you notice any of these symptoms related to these severe 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 be cautious until you become familiar with the effects that the medicine can have.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any changes in your vision, you should inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may need a change in their diabetes medications.
• Certain side effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medications for treatment, for example, for pain or spasticity (stiff or rigid muscles), with similar side effects to those of pregabalin, so the intensity of these effects may increase when taken together.
• Cases of heart failure have been reported in some patients treated with this medicine. Most of them were elderly patients with cardiovascular diseases. Beforeusingthismedicine,youmusttellyourdoctorifyouhaveahistoryofheartdisease.
• Cases of renal failure have been reported in some patients treated with this medicine. If you notice a decrease in your ability to urinate during treatment with pregabalin, you should inform your doctor, as stopping treatment may improve this situation.
• Some patients treated with antiepileptics, such as pregabalin, have had thoughts of self-harm or have shown suicidal behavior. If at any time you experience these thoughts or have shown such behavior, contact your doctor as soon as possible.
• When pregabalin is taken with other medications that can cause constipation (such as some types of pain medications), gastrointestinal problems (e.g., constipation and intestinal blockage or 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 medications, or illegal drugs, as this may mean you have a higher risk of becoming dependent on pregabalin.
• Cases of seizures have been reported during treatment with pregabalin or shortly after stopping treatment with this medicine. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients who were taking pregabalin and had other diseases. Tell your doctor if you have a history of any serious illness, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have nervous system disorders, respiratory disorders, renal failure, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medicine). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabalin TAD" and "If you stop taking Pregabalin TAD"). If you are concerned that you may become dependent on pregabalin, 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 a longer period than recommended by your doctor.
• You feel that you need to take a higher dose than prescribed.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated attempts to stop or control the use of the medicine without success.
• When you stop taking the medicine, you feel unwell and feel better once you take the medicine 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 it safely.

Childrenandadolescents

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

Othermedicines and Pregabalin TAD

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

Pregabalin and certain medicines can affect each other (interactions). When Pregabalin TAD is taken with certain sedative medicines (including opioids), these effects may be enhanced, and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

• Oxycodone - (used as a pain reliever)
• Lorazepam - (used to treat anxiety)
• Alcohol

Pregabalin TAD can be taken with oral contraceptives.

Taking Pregabalin TAD with food, drinks, and alcohol

Pregabalin TAD capsules can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital anomalies in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital anomalies. This compares to 4 out of 100 babies born to women not treated with pregabalin in the study. Congenital anomalies of the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

An effective contraceptive method 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 TAD may cause symptoms such as dizziness, somnolence, and decreased concentration. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

3. How to take Pregabalin TAD

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the dose that is right for you.

Pregabalin is for oral use only.

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

• Take the number of capsules that your doctor has indicated.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.
• Your doctor will indicate that you take pregabalin two or three times a day. In the case of twice a day, take pregabalin once in the morning and once in the evening, approximately at the same time every day. In the case of three times a day, take pregabalin in the morning, at noon, and in the evening, approximately at the same time every day.

If you think the effect of pregabalin is too strong or too weak, tell your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take pregabalin normally, except if you have kidney problems. Your doctor may prescribe a different dosing regimen or different doses 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 TAD than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the package or bottle of pregabalin capsules with you.

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

If you forget to take Pregabalin TAD

It is important that you take the pregabalin capsules regularly at the same time every day. If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. In that case, continue with the next dose as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabalin TAD

Do not stop taking pregabalin suddenly. If you want to stop taking pregabalin, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, it should be done gradually over a minimum of 1 week.

Once you have finished treatment with pregabalin for a short or long period, you should know that you may experience certain side effects, called withdrawal effects. These effects include sleep problems, headache, nausea, feeling of anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness.

These symptoms may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should see your doctor.

If you have any other 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 all people suffer from them.

Ifyouexperienceswellinginthefaceorinthetongue,orifyourskinbecomesredanddevelopsblistersorpeeling,youshouldseekmedicalattentionimmediately.

Very Common: can affect more than 1 in 10 people

• Dizziness, drowsiness, headache

Common: can affect up to 1 in 10 people

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Alteration of attention, clumsiness, 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 with erection
• Swelling of the body including the limbs
• Feeling of intoxication, gait disturbances
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain
• Sore throat

Uncommon: can affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation
• Changes in vision, unusual eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness when standing up, sensitive skin, loss of taste, burning sensation, tremor when moving, 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 flashes
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, heartburn, 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 hold urine
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood)
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Feeling of cold in hands and feet

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

• Altered sense of smell, oscillating vision, altered depth perception, visual glare, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced body mobility
• Difficulty writing correctly
• Increased fluid in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual interruption
• Kidney problems, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts

• Allergic reactions that can include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Jaundice (yellow color of the skin and eyes)
• Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle rigidity

Very Rare: can affect up to 1 in 10,000 people

• Liver failure
• Hepatitis (liver inflammation)

Frequency Not Known: frequency cannot be estimated from available data

• Becoming dependent on pregabalin ("drug dependence")

Once you have finished treatment with pregabalin for short and long term, you should know that you may experience certain adverse effects, called withdrawal effects (see section "If you stop treatment with Pregabalin TAD")

Certain adverse effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity (stiff or rigid muscles), with adverse effects similar to those of pregabalin, so 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pregabalin TAD

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pregabalin TAD

• The active ingredient is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, or 300 mg of pregabalin.
• The other components are pregelatinized cornstarch and talc (E553b) in the capsule content.
• The other components of the 25 mg hard capsules are titanium dioxide (E171), gelatin, and black printing ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) on the capsule shell.
• The other components of the 50 mg and 75 mg hard capsules are titanium dioxide (E171), gelatin, yellow iron oxide (E172), and black printing ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) on the capsule shell.
• The other components of the 100 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), and white printing ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) on the capsule shell.
• The other components of the 150 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), and black printing ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) on the capsule shell.
• The other components of the 200 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), and black printing ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) on the capsule shell.
• The other components of the 300 mg hard capsules are titanium dioxide (E171), gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), and white printing ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) on the capsule shell.

Appearance of the Product and Package Contents

Hard capsule.

Pregabalin TAD 25 mg are hard capsules with a white body and a white capsule cap. The capsule cap is printed with the black mark P25. The capsule content is a white or almost white powder. The capsule length is 13.8 - 14.8 mm.

Pregabalin TAD 50 mg are hard capsules with a white body and a bright yellow capsule cap. The capsule cap is printed with the black mark P50. The capsule content is a white or almost white powder. The capsule length is 15.3 - 16.2 mm.

Pregabalin TAD 75 mg are hard capsules with a yellow-brown body and a yellow-brown capsule cap. The capsule cap is printed with the black mark P75. The capsule content is a white or almost white powder. The capsule length is 13.8 - 14.8 mm.

Pregabalin TAD 100 mg are hard capsules with a reddish-brown body and a reddish-brown capsule cap. The capsule cap is printed with the white mark P100. The capsule content is a white or almost white powder. The capsule length is 15.3 - 16.2 mm.

Pregabalin TAD 150 mg are hard capsules with a white body and a yellow-brown capsule cap. The capsule cap is printed with the black mark P150. The capsule content is a white or almost white powder. The capsule length is 17.2 - 18.3 mm.

Pregabalin TAD 200 mg are hard capsules with a brown body and a brown capsule cap. The capsule cap is printed with the black mark P200. The capsule content is a white or almost white powder. The capsule length is 18.7 - 19.8 mm.

Pregabalin TAD 300 mg are hard capsules with a white body and a dark brown capsule cap. The capsule cap is printed with the white mark P300. The capsule content is a white or almost white powder. The capsule length is 20.0 - 22.1 mm.

Pregabalin TAD is presented in blisters containing 14, 56, or 84 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of Last Revision of this Prospectus:March 2024

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