Introduction

Leaflet: information for the user

Pregabalina cinfa 50 mg hard capsules EFG

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Pregabalina cinfa 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 may 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 this medication to treat epilepsy when your current treatment does not control the disease. You must take pregabalina in addition to your current treatment. This medication 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). Symptoms of GAD 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, feeling of being mentally blank, irritability, muscle tension, or sleep disturbances. This is different from the stress and tensions of everyday life.

2. What you need to know before starting Pregabalin cinfa

Do not take Pregabalina cinfa

If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

Some patients treated with this medicine 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 immediately see your doctor.
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 be cautious until you become familiar with the effects the medicine can have.
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 immediately inform your doctor.
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 similar adverse effects to pregabalin, so the intensity of these effects may increase when taken together.
There have been reports of heart failure in some patients treated with this medicine. Most of them were elderly patients with cardiovascular diseases.Before using this medicine, you should inform your doctor if you have a history of heart disease.
There have been reports of kidney failure in some patients treated with this medicine. If during treatment with this medicine you notice a decrease in your ability to urinate, you should inform your doctor as the interruption of treatment may improve this situation.
Some patients treated with antiepileptic drugs 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 medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, 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 experience seizures, contact your doctor immediately.
There have been reports of encephalopathy (brain dysfunction) in some patients taking pregabalin and who had 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 breathing difficulties. If you have neurological 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 continue taking the medicine). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabalina cinfa" and "If you interrupt treatment with Pregabalina cinfa"). 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 medicine for a longer time than recommended by your doctor.
You feel the need to take a higher dose than recommended.
You are using the medicine for reasons other than those prescribed.
You have made repeated and 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 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

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

Other medicines and Pregabalina cinfa with other medicines

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

Pregabalin and certain medicines mayinteract with each otherbetween them (interactions). When this medicine is used with certain medicinesthat have a sedative effect (including opioids),those effects may be potentiatedand may lead torespiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

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

This medicine can be taken with oral contraceptives.

Taking Pregabalina cinfa with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is recommended not to take alcohol during treatment with this medicine.

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 babies out of 100 had such congenital anomalies. This contrasts with 4 babies out of 100 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 medicine.

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 medicine affects your ability to perform these activities.

Pregabalina cinfa contains lactose

If your doctor has told you that you have a lactose intolerance, consult with him before taking this medicine.

3. How to take Pregabalin cinfa

Follow exactly the administration instructions of this medication 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.

This medication is exclusively for oral use.

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

Take the number of capsules 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 instruct you to take pregabalin two or three times a day. In the case of twice a day, take pregabalin once in the morning and once at night, approximately at the same time every day. In the case of three times a day, take pregabalin in the morning, at noon, and at night, approximately at the same time every day.

If you estimate that the action of this medication is too strong or too weak, inform 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 doses if you have kidney problems.

Swallow the entire capsule with water.

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

If you take more Pregabalina cinfa than you should

Call your doctor or go to the nearest emergency service immediately. Bring the packaging 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.

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 cinfa

It is essential to take the pregabalin capsules regularly at the same time 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 cinfa

Do not stop taking this medication suddenly. If you want to stop taking pregabalin, 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 pregabalin 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 this medication 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.

4. Possible Adverse Effects

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, speech difficulty, numbness, tingling, 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.
Swelling of the body including extremities.
Sensation of intoxication, gait disturbances.
Weight gain.
Muscle cramps, joint pain, back pain, limb pain.
Throat pain.

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.
Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation.
Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
Flushes, 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.
Dysphagia.
Reduced mobility of the body.
Difficulty writing correctly.
Abdominal fluid accumulation.
Pulmonary edema.
Seizures.
Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations.
Muscle damage.
Milk secretion, abnormal breast growth, increased breast size in men.
Menstrual interruption.
Renal insufficiency, reduced urine output, urinary retention.
Leukopenia.
Inappropriate behavior, suicidal behavior, suicidal thoughts.
Allergic reactions that may include difficulty breathing, conjunctivitis, and a severe skin reaction characterized by flat, red patches, often with central blisters, skin desquamation, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions 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):

Hepatic insufficiency.
Hepatitis (liver inflammation).

Frequency not known: cannot be estimated from available data

Becoming dependent on pregabalin ("drug dependence").

Once a short- or long-term treatment with pregabalin has been completed, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Pregabalin cinfa").

If you experience swelling in the face or tongue, or if your skin becomes red and blisters or peels, 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 side effects similar to those of 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 reactions

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/.

5. Pregabalin Cinfa Storage

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

Do not use this medication after the expiration date shown on the packaging or in the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Contents of the packaging and additional information

Pregabalina cinfa Composition

The active ingredient is pregabalina.

Each hard capsule contains 50 mg of pregabalina.

The other components are:

Capsule content:monohydrate lactose, cornstarch and talc.

Capsule coating:gelatin and titanium dioxide (E-171).

Product appearance and packaging contents

Hard gelatin capsules with a white body and a white cap with the logo “50 mg” and a white cap with the logo “A002”.

Pregabalina cinfa 50 mg is presented in PVC-PVDC/Aluminum blister packaging containing 56 hard capsules.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/85279/P_85279.html

QR code to:https://cima.aemps.es/cima/dochtml/p/85279/P_85279.html