Pregabalin TAD 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pregabalin TAD 25 mg hard capsules EFG

Pregabalin TAD 50 mg hard capsules EFG

Pregabalin TAD 75 mg hard capsules EFG

Pregabalin TAD 100 mg hard capsules EFG

Pregabalin TAD 150 mg hard capsules EFG

Pregabalin TAD 200 mg hard capsules EFG

Pregabalin TAD 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.

Contents of the leaflet:

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

1. What is Pregabalin TAD and what is it used for?

Pregabalin belongs to a group of medicines used to treat 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 medical conditions can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as warmth, burning, throbbing, shooting, stabbing, sharp, continuous pain, tingling, numbness, or pins-and-needles sensations. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activities 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 TAD when your current treatment does not adequately control your condition. You should take pregabalin as an add-on to your current treatment. Pregabalin must not be used as monotherapy, but should always be used in combination with other antiepileptic treatments.

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

2. What you need to know before starting to take Pregabalin TAD

Do not take Pregabalin TAD

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Pregabalin TAD.

• 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 development of widespread skin rash. If you experience any of these symptoms, you must seek immediate medical attention.
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek immediate medical help 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 may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with how this medicine affects you.
• 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 conditions such as pain or spasticity (stiff or rigid muscles), which have adverse effects similar to those of pregabalin, potentially increasing the intensity of these effects when taken together.
• Cases of heart failure have been reported in some patients treated with this medicine. 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 you notice a decrease in your ability to urinate during treatment with pregabalin, inform your doctor, as discontinuation of the treatment may improve the condition.
• Some patients treated with antiepileptic medicines such as pregabalin have had thoughts of harming themselves 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 medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal paralysis) may occur. Inform your doctor if you experience 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, 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 discontinuation of treatment. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who had other underlying diseases. Inform your doctor if you have a history of serious illness, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have disorders of the nervous system, respiratory disorders, renal impairment, or are over 65 years of age, 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 (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop taking pregabalin (see section 3, “How to take Pregabalin TAD” and “If you stop taking Pregabalin TAD”). 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 be a sign that you have become dependent:

• You need to take the medicine for longer than recommended by your doctor.
• You feel the need to take higher doses than recommended.
• You are using the medicine for reasons different from 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 management 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 Pregabalin TAD

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 TAD is taken together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, 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

Pregabalin TAD can be taken with oral contraceptives.

Taking Pregabalin TAD with food, drink, 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 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 facial clefts, eyes, nervous system (including the brain), kidneys, and genitals.

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 TAD may cause symptoms such as dizziness, somnolence, and reduced concentration. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Pregabalin TAD

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.

Pregabalin is for oral use only.

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

• Take the number of capsules your doctor has indicated.
• The dose, adjusted for you and 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 pregabalin 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 TAD than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. Take the pack 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 loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin TAD

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 next scheduled dose. Do not take a double dose to make up for a missed dose.

If you stop taking Pregabalin TAD

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 discontinue treatment, it should be done gradually over a minimum of 1 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, feelings 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 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 turns red and develops blisters or peeling, you must seek immediate medical help.

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 sexual desire, irritability
• Attention disturbance, lack of coordination, 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, diarrhoea, nausea, bloated abdomen
• Erectile dysfunction
• 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
• Altered perception of self, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, light flashes, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, movement tremor, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise
• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Heart rhythm disturbances, 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 creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, low 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, flickering vision, altered depth perception, visual glare, vision loss

• Dilated pupils, squint

• 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 heart rhythm disturbances

• Muscle damage

• Milk secretion, abnormal breast growth, breast enlargement in men

• Interruption of menstrual periods

• Kidney problems, reduced urine output, urine retention

• Decreased white blood cell count

• Inappropriate behaviour, suicidal behaviour, suicidal thoughts

• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterised by flat, non-elevated 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, Parkinson's disease-like symptoms 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: frequency cannot be estimated from the 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 section “If you stop taking Pregabalin TAD”).

Some 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 type of 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 TAD

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

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.

This medicine does not require any special storage conditions.

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 pack and other information

Composition of Pregabalin TAD

• The active substance 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 in the capsule contents are pregelatinized corn starch and talc (E553b).
• The other components of the 25 mg hard capsules are titanium dioxide (E171), gelatin and black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in 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), black iron oxide (E172), propylene glycol (E1520)) in 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)) in 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), black iron oxide (E172), propylene glycol (E1520)) in 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), black iron oxide (E172), propylene glycol (E1520)) in 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)) in the capsule shell.

Nature and contents of the container

Hard capsule.

Pregabalin TAD 25 mg are hard capsules with a white body and a white cap. The cap bears a black printed mark "P25". The capsule contents are white or almost white powder. Capsule length is 13.8 – 14.8 mm.

Pregabalin TAD 50 mg are hard capsules with a white body and a bright yellow cap. The cap bears a black printed mark "P50". The capsule contents are white or almost white powder. Capsule length is 15.3 – 16.2 mm.

Pregabalin TAD 75 mg are hard capsules with a brownish-yellow body and a brownish-yellow cap. The cap bears a black printed mark "P75". The capsule contents are white or almost white powder. Capsule length is 13.8 – 14.8 mm.

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

Pregabalin TAD 150 mg are hard capsules with a white body and a brownish-yellow cap. The cap bears a black printed mark "P150". The capsule contents are white or almost white powder. Capsule length is 17.2 – 18.3 mm.

Pregabalin TAD 200 mg are hard capsules with a brown body and a brown cap. The cap bears a black printed mark "P200". The capsule contents are white or almost white powder. Capsule length is 18.7 – 19.8 mm.

Pregabalin TAD 300 mg are hard capsules with a white body and a dark brown cap. The cap bears a white printed mark "P300". The capsule contents are white or almost white powder. Capsule length is 20.0 – 22.1 mm.

Pregabalin TAD is available in blister packs containing 14, 56 or 84 hard capsules.

Only certain 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: March 2024

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