Prospect: information for the user

Pregabalina Combix 50 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Pregabalina Combix

3. How to take Pregabalina Combix

4. Possible adverse effects

5. Storage of Pregabalina Combix

6. Contents of the package and additional information

Pregabalina Combix belongs to a group of medications used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalina is used for the treatment of chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles sensation. Peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can affect physical and social activity and overall quality of life.

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

Generalized anxiety disorder:Pregabalina is used in the treatment of generalized anxiety disorder (GAD). GAD symptoms include excessive and prolonged anxiety and worry that are difficult to control. GAD can also produce restlessness or feeling of excitement or nervousness, feeling easily fatigued (tired), difficulty concentrating or feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from everyday life stress and tensions.

Do not take Pregabalina Combix

• If you are allergic to pregabalin or any of the other ingredients of this medication (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 that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a widespread skin rash. If you experience any of these symptoms, you should seek immediate medical attention.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you observe any of the 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 exercise caution until you become familiar with the effects of the medication.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should inform your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medications.
• Certain adverse effects, such as somnolence, may be more frequent since patients with spinal cord injury may be taking other medications for treatment, for example, pain or spasticity (tense or rigid muscles), with adverse effects similar to those of pregabalin, so that the intensity of these effects may increase when taken together.
• There have been reports of heart failure in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases.Before using this medication, you should inform your doctor if you have a history of heart disease.
• There have been reports of renal insufficiency in some patients treated with pregabalin. If during pregabalin treatment you note a decrease in your ability to urinate, you should inform your doctor since discontinuing treatment may improve this situation.
• Some patients taking antiepileptic medications such as pregabalin have had thoughts of self-harm or suicide 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 certain types of pain medications), it is possible that 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 medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may indicate that you have a higher risk of becoming dependent on this medication.
• There have been reports of seizures during pregabalin treatment or shortly after discontinuing pregabalin treatment. If you experience seizures, contact your doctor immediately.
• There have been reports of encephalopathy (brain dysfunction) in some patients taking pregabalin and having other serious diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of respiratory difficulty. If you have neurological disorders, respiratory disorders, renal insufficiency, 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 medication). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabalina Combix" and "If you interrupt treatment with Pregabalina Combix"). If you are concerned that you may become dependent on pregabalin, it is essential 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 medication for a longer time than recommended by your doctor.

•You feel the need to take a higher dose than recommended.

•You are using the medication for reasons other than those prescribed.

•You have made repeated and unsuccessful attempts to stop or control the use of the medication.

•When you stop taking the medication, you experience discomfort and feel better once you take the medication again.

•If you notice any of these signs, talk to your doctor to analyze the best plan of care for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

Pregabalin has not been established as safe and effective in children and adolescents (under 18 years) and therefore should not be used in this age group.

Other medications and Pregabalina Combix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication and certain other medications may exert a mutual influence on each other (interactions). When pregabalin is used with certain medications that have a sedative effect (including opioids), these effects may be potentiated, 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 medications that contain:

• Oxycodone - (used as an analgesic)
• Lorazepam - (used to treat anxiety)
• Alcohol

Pregabalin 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 recommended not to take alcohol during pregabalin treatment.

Pregnancy and breastfeeding

You should not take pregabalin during pregnancy or lactation, unless your doctor has told you to. 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 contrasts with 4 out of 100 babies born to women not treated with pregabalin in the study. Congenital anomalies of the face (cleft palate), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

A reliable contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pregabalin may cause dizziness, somnolence, and decreased concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Pregabalina Combix contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per hard capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalina Combix is exclusively for oral use.

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

• Take the number of capsules as indicated by your doctor.
• The dose, 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 medication two or three times a day. In the case of two times a day, take pregabalina once in the morning and once at night, approximately at the same hour every day. In the case of three times a day, take pregabalina in the morning, at noon, and at night, approximately at the same hour every day.

If you estimate that the action of pregabalina is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take this medication normally, except if you have kidney problems.

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems.

Swallow the capsule whole with water.

Continue taking this medication until your doctor tells you to stop.

If you take more Pregabalina Combix than you should

Call your doctor or go to the nearest emergency service immediately. Bring the packaging of this medication with you.As a result of taking more pregabalina 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pregabalina Combix

It is essential to take the capsules of this medication regularly at the same hour 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 normally. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Pregabalina Combix

Do not stop taking pregabalina suddenly. If you want to stop taking pregabalina, talk to your doctor first. He 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.

Once a short- or long-term treatment with pregabalina is completed, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been taking pregabalina for a longer period. If you experience withdrawal effects, consult your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side 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
• Euphoria, confusion, disorientation, decreased libido, irritability
• Attention disturbance, clumsiness, memory deterioration, memory loss, tremors, difficulty speaking, numbness, tingling, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen
• Difficulty with erection
• Swelling of the body including extremities
• Sensation of intoxication, gait disturbances
• 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, 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 libido, sexual dysfunction including inability to achieve orgasm, delayed ejaculation
• Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort
• Eye dryness, 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 flashes
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, burning sensation, 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 urinating, inability to hold urine
• Weakness, thirst, chest oppression
• Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, snoring
• Dysmenorrhea
• Sensation of cold in hands and feet

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

• Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat oppression, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Reduced mobility or movement of the body
• Difficulty writing correctly
• Fluid accumulation 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, increased breast size in men
• Menstrual interruption
• Renal insufficiency, reduced urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Severe skin reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin rash characterized by flat, red patches, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Icterus (yellow skin and eyes)
• Parkinsonism, Parkinson's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver insufficiency
• Heptatitis (inflammation of the liver)

Frequency not known: cannot be estimated from available data

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

After completing a short or long-term treatment with pregabalin, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Pregabalin Combix").

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

Certain side 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 (tense or rigid muscles), with similar side effects to pregabalin, so the intensity of these side 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 side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Pregabalina Combix

The active ingredient is pregabalin. Each hard capsule contains 50 mg of pregabalin.

The other components are: pregelatinized cornstarch, talc, gelatin capsule (composed of: gelatin, titanium dioxide (E171), sodium lauryl sulfate, and yellow iron oxide (E172)) and printing ink (composed of: Shellac lacquer (E904), black iron oxide (E172), propylene glycol (E1520), potassium hydroxide (E525), and ammonium hydroxide (E527)).

Appearance of the product and contents of the packaging

Hard capsules, size 3, with a pale yellow cap and a white opaque body, with the mark "866" printed in black ink on the cap, containing a white or off-white powder.

Pregabalina Combix 50 mg is presented in PVC/PVDC – Aluminum blisters in packs of 56 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet: January 2024

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