Pregabalin Combix 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalina Combix 300 mg hard capsules EFG

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could 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 Pregabalina Combix is and what it is used for
2. What you need to know before taking Pregabalina Combix
3. How to take Pregabalina Combix
4. Possible adverse effects
5. How to store Pregabalina Combix
6. Contents of the pack and other information

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

Pregabalina Combix 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 conditions can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as warmth, burning, throbbing, shooting, stabbing, sharp pain, continuous pain, tingling, numbness, and 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 activity and overall quality of life.

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

Generalized anxiety disorder: Pregabalina Combix is used in the treatment of 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 stresses and strains of life.

2. What you need to know before taking Pregabalina Combix

Do not take Pregabalina Combix

• 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 Pregabalina Combix.

• 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 medical attention immediately.

• 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 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 may 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 on 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 because patients with spinal cord injury may be taking other medications for conditions such as pain or spasticity (tight or rigid muscles), which have similar side effects to pregabalin, so the intensity of these effects may increase 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 pregabalin. If during treatment with Pregabalina Combix you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of 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 behaviors, 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 and intestinal blockage or 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; this may mean you have a higher risk of becoming dependent on pregabalin.

• Cases of seizures during treatment with pregabalin or shortly after discontinuing pregabalin 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, renal 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 Combix” and “If you stop taking Pregabalina Combix”). 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 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 again once you take the medicine.

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

Other medicines and Pregabalina Combix

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 a sedative effect (including opioids), these effects may be enhanced, potentially leading 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

Pregabalina Combix can be taken with oral contraceptives.

Taking Pregabalina Combix with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol during treatment with Pregabalina Combix.

Pregnancy and breastfeeding

Do not take Pregabalina Combix 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 must 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, somnolence, 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 activities.

Pregabalina Combix contains sodium

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

Pregabalina Combix contains Orange Yellow S.

It may cause allergic-type reactions.

3. How to take Pregabaline Combix

Follow exactly the instructions for use of this medicine given by your doctor. 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.

Pregabaline Combix is for oral use only.

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

• Take the number of capsules indicated 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 this medicine 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 this medicine until your doctor tells you to stop.

If you take more Pregabaline Combix than you should

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

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

If you forget to take Pregabaline Combix

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

If you stop taking Pregabaline Combix

Do not stop taking pregabalin suddenly. If you wish to stop taking pregabalin, speak to your doctor first. He or she will advise you on how to do so. If you are going to stop treatment, this should be done gradually over a minimum of one week.

After ending a short- or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These effects 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 pregabalin for a longer period of time. If you experience withdrawal effects, 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, 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 erection.
• Swelling of the body including the 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, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sex drive, problems in sexual relationships 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, 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.
• 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 sensations, 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, disturbance in depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing properly.
• Increased fluid in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in the 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, 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 similar to 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 (liver inflammation).

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 Combix").

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

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), which have adverse effects similar to those of pregabalin, so that 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Pregabaline Combix

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. Any unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Pregabalina Combix

• The active substance is pregabalin. Each hard capsule contains 300 mg of pregabalin.
• The other components are: pregelatinized corn starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, purified water, brilliant blue FCF (E133), sunset yellow FCF (E110), black printing ink (containing shellac glaze (E904), dehydrated alcohol (E1510), isopropyl alcohol, butyl alcohol, black iron oxide (E172), propylene glycol (E1520), potassium hydroxide (E525), ammonium hydroxide (E527), and purified water).

Appearance of the product and contents of the container

Pregabalina Combix 300 mg is presented as hard capsules of size 0, with an opaque orange cap and an opaque white body, marked with "872" printed in black ink on the cap, containing a white or almost white powder.

Pregabalina Combix 300 mg is available in PVC/PVDC-Aluminum blisters in packs of 56 capsules.

Marketing Authorization Holder and Manufacturer

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent revision of this leaflet: January 2024

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