TREPIXAL 300 mg HARD CAPSULES

Introduction

Leaflet:information for the patient

Trepixal 75 mg hard capsules EFG

Trepixal 150 mg hard capsules EFG

Trepixal 300 mg hard capsules EFG

pregabalin

Read all of this leaflet carefullybefore you start taking thismedicine,because it contains important informationfor you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Trepixal and what is it used for

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

Peripheral and central neuropathic pain:Trepixal is used to treat long-standing pain caused by damage to the nerves. There are several diseases that can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain can be described as heat, burning, throbbing, shooting, stabbing, sharp, spasms, continuous, tingling, numbness, and a sensation of pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can have an effect on physical and social activity and overall quality of life.

Epilepsy:Trepixal 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 you to treat epilepsy when your current treatment is not controlling your condition. You should take this medicine in addition to your current treatment. Pregabalin should not be taken on its own but should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Trepixal is used to treat generalized anxiety disorder (GAD). The symptoms of GAD are prolonged and excessive worry and anxiety that are difficult to control. GAD can also cause restlessness or feeling on edge or nervous or irritable, being easily fatigued (feeling tired), having difficulty concentrating or having your mind go blank, irritability, muscle tension or sleep disturbance. This is different from the stress and tension of everyday life.

2. What you need to know before you take Trepixal

Do not take Trepixal

• 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.

• Some patients taking this medicine have reported symptoms that may be signs of an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, you should contact 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 the symptoms related to these severe skin reactions described in section 4.

• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injury (falls) in older people. Therefore, you should be cautious until you are used to the effects the medicine can have.

• Pregabalin may cause blurred vision, loss of vision, or other changes in your sight, many of which are temporary. If you experience any changes in your vision, you should immediately inform your doctor.

• Diabetic patients who gain weight while taking pregabalin may need an adjustment in their blood sugar control medicines.

• Certain side 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 (stiff or rigid muscles), with side effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.

• There have been reports of heart failure in some patients taking this medicine. Most were elderly patients 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 taking this medicine. If, while taking pregabalin, you notice a decrease in your ability to urinate, you should inform your doctor, as stopping treatment may improve this situation.

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

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

• Before taking this medicine, tell 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.

• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with this medicine. If you have a seizure, contact your doctor immediately.

• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin who had other conditions. Tell your doctor if you have a history of any serious disease, including liver or kidney disease.

• There have been reports of difficulty breathing. If you have nervous system disorders, respiratory disorders, kidney 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 keep taking the medicine). They may have withdrawal effects when they stop taking pregabalin (see section 3, “How to take Trepixal” and “If you stop taking Trepixal”). If you are concerned that you may become dependent on pregabalin, it is important that you talk to your doctor.

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

• You need to take the medicine for longer than your doctor recommended.
• You feel that 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 the use of the medicine.
• 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.

Children and adolescents

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

Other medicines and Trepixal

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

Pregabalin and certain medicines may affect each other (interact). When pregabalin is taken with certain medicines that have a sedating effect (including opioids), these effects may be increased, and may lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, 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 can be taken with oral contraceptives.

Taking Trepixalwith food,drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol while taking pregabalin.

Pregnancy and breastfeeding

Do 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 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 babies out of 100 had such congenital malformations. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. There have been reports of malformations of the face (clefts), eyes, nervous system (including the brain), kidneys, and genitals.

An effective contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, 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 may cause dizziness, drowsiness, and decreased 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 activities.

Trepixal contains orange yellow S (E110)

May cause allergic reactions.

Trepixal contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule; i.e., it is essentially “sodium-free”.

3. How to take Trepixal

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than your doctor has recommended.

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

Trepixal is for oral use only.

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

• Take the number of capsules that your doctor has told you to take.
• 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 tell you to take this medicine either twice or three times a day. For twice a day, take pregabalin once in the morning and once in the evening, approximately at the same time every day. For 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 that the effect of pregabalin is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years old), 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 Trepixal than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken. Bring the pack or bottle of Trepixal capsules with you. As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

If you forget to take Trepixal

It is important that you take your 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 time for your next dose. In that case, continue with your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Trepixal

Do not stop taking pregabalin suddenly. If you want to stop taking this medicine, 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 one week.

Once you have finished a short or long treatment course with pregabalin, you should be aware that you may experience certain side effects, called withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should contact 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.

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 appetite, irritability.
• Attention alteration, movement clumsiness, memory impairment, memory loss, tremors, speech difficulty, 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.
• Body swelling including extremities.
• Feeling of drunkenness, gait disturbances.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in extremities.
• 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, anxiety attacks, apathy, aggression, elevated mood, mental impairment, 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, 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, teary eyes, eye irritation.
• Heart rhythm alterations, increased heart rate, low blood pressure, high blood pressure, heart rhythm changes, heart failure.
• Flushing, hot flashes.
• Breathing difficulty, 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, nosebleed, cough, snoring.

• Painful menstrual periods.
• Cold sensation in hands and feet.

Rare (may 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 alterations.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual period interruption.
• Kidney failure, reduced urine output, urine retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 tremors, bradykinesia (decreased ability to move), and muscle stiffness.

Very Rare (may affect up to 1 in 10,000 people):

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known (cannot be estimated from the available data):

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

Once you have finished a short or long-term treatment with pregabalin, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop taking Trepixal").

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

Certain adverse effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medications 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Trepixal

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 and blister 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 SIGRE point of the pharmacy. In case of doubt, 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

Trepixal Composition

• The active ingredient is pregabalin. Each hard capsule contains 75, 150, or 300 mg of pregabalin.
• The other components (excipients) are:

Capsule content:pregelatinized starch and talc

Capsule shell:gelatin, titanium dioxide (E171), sodium lauryl sulfate, and orange yellow S (E110).

The Trepixal 75 mg capsules also contain erythrosine (E127).

The Trepixal 150 mg capsules also contain quinoline yellow (E104).

The Trepixal 300 mg capsules also contain brilliant blue FCF (E133).

Printing ink:shellac, iron oxide black (E172), propylene glycol (E1520), potassium hydroxide, and concentrated ammonia solution.

Product Appearance and Package Contents

Trepixal 75 mg hard capsules EFG

Hard capsules of size 4 (14.4 mm x 5.3 mm, approximately), with an orange opaque cap and a white opaque body, with the mark "867" printed in black ink on the cap, containing a white or off-white powder.

Trepixal 150 mg hard capsules EFG

Hard capsules of size 2 (17.8 mm x 6.3 mm, approximately), with an ivory opaque cap and a white opaque body, with the mark "869" printed in black ink on the cap, containing a white or off-white powder.

Trepixal 300 mg hard capsules EFG

Hard capsules of size 0 (21.4 mm x 7.7 mm, approximately), with an orange opaque cap and a white opaque body, with the mark "872" printed in black ink on the cap, containing a white or off-white powder.

Packaging available in PVC/PVDC-aluminum blisters containing 56 hard capsules.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón

Madrid - Spain

Manufacturer

Zydus FranceZAC Les Hautes PaturesParc d'activités des Peupliers25 Rue des Peupliers92000 NanterreFrance

or

Centre Specialites Pharmaceutiques

Z.A.C. des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of Last Revision of this Prospectus: January 2025

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/)