Pregabalin Combix 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalina Combix 25 mg hard capsules EFG

Read all of this 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, and you should not give it 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 adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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 side 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 diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The sensation of pain may be described as warmth, burning, throbbing, shooting, stabbing, sharp, constant pain, tingling, numbness, and prickling 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 in 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

Consult your doctor or pharmacist before starting to take 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 immediate medical attention.

1. 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 help 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.

• 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 (tight or rigid muscles), which have similar side effects to pregabalin, thereby 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 diseases. 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 pregabalin you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.

• Some patients receiving antiepileptic medicines such as pregabalin have experienced thoughts of self-harm or suicide, 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 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 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 discontinuation 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 had other underlying illnesses. 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 effects 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 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 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.

Pregabalina Combix and certain medicines may affect each other (interactions). When Pregabalina Combix 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, drowsiness, and reduced concentration may increase if Pregabalina Combix 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

Pregabalina Combix capsules can be taken with or without food.

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

Pregnancy and breastfeeding

You should not take Pregabalina Combix during pregnancy or while 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 requiring 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 may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these tasks.

Pregabalina Combix contains sodium

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

3. How to take Pregabaline Combix

Follow exactly the instructions for administration 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 for your condition, will generally be 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 different doses 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 package 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.

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 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, continue with your next dose as normal. 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 tell you how to do it. If you are going to stop treatment, this should be done gradually over a minimum of one week.

After stopping 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 problems, headache, nausea, feeling anxious, 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, 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.

Very common: may affect more than 1 in 10 people

• Dizziness, somnolence, headache.

Common: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of euphoria, confusion, disorientation, decreased sex drive, irritability.
• Attention disturbance, 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.
• Erectile dysfunction.
• Body swelling 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.
• Altered perception of self, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sex drive, sexual problems including inability to reach orgasm, 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, movement-related 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.
• Breathing difficulty, nasal dryness, 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, low blood potassium).
• Hypersensitivity, facial swelling, itching, urticaria, 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, oscillating vision, altered depth perception, visual glare, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• 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 failure, reduced urine output, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions which may include breathing difficulties, 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, and ulcers in the mouth, 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, 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 (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, seek immediate medical attention.

Certain adverse effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (tight or rigid muscles), which have similar adverse effects to Pregabalina, 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, 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 Pregabalin Combix

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pregabalina Combix

• The active substance is pregabalin. Each hard capsule contains 25 mg of pregabalin.
• The other components are: pregelatinized corn starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, purified water, black printing ink (containing Shellac lacquer (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 pack

Pregabalina Combix 25 mg is presented as hard capsules of size number 4, with opaque white cap and body, marked with "865" printed in black ink on the cap, containing a white or almost white powder.

Pregabalina Combix 25 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 review of this leaflet: January 2024

Detailed and up-to-date 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/