Leaflet: information for the user

Pregabalina pensa pharma 300 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. Contents of the pack and additional information

Pregabalina belongs to a group of medications used for the treatment of epilepsy, neuropathic painand generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalina is used for the treatment of chronic pain caused by nerve damage. There are various diseases that 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 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 medications.

Generalized anxiety disorder:Pregabalina is used in the treatment of generalized anxiety disorder (GAD). The symptoms of GAD are 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 stress and tension.

Do not take Pregabalina Pensa Pharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina Pensa Pharma.

• 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 must see your doctor immediately.
• 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 must inform your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medications.
• Certain side 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 side effects to pregabalin, so the intensity of these side effects may increase when taken together.
• Cases of heart failure have been reported in some patients treated with this medication. Most of them were elderly patients with cardiovascular diseases.Before using this medication, you must inform your doctor if you have a history of heart disease.
• Cases of renal insufficiency have been reported in some patients treated with this medication. If during treatment with pregabalin you notice a decrease in your ability to urinate, you must inform your doctor as the interruption of treatment may improve this situation.
• A small number of people taking antiepileptic medications such as pregabalin have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.
• When pregabalin is taken with other medications that may 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, you must inform your doctor if you have a history of alcoholism or abuse or dependence on any substance. Do not take a higher dose than the one prescribed.
• Cases of seizures have been reported during treatment with pregabalin or shortly after stopping treatment with this medication. If you experience seizures, contact your doctor immediately.
• Cases of encephalopathy (brain dysfunction) have been reported 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.
• Cases of breathing difficulty have been reported. 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.
• Severe skin eruptions, 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.

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.

Taking Pregabalina Pensa Pharma with other medications

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

Pregabalin and certain medications may influence each other (interactions). When pregabalin is used with certain medications, the observed adverse reactions may be potentiated, including respiratory insufficiency and coma. 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

This medication can be taken with oral contraceptives.

Taking Pregabalina Pensa Pharma with food, drinks, and alcohol

Pregabalin capsules can be taken with and without food.

It is recommended not to take alcohol during treatment with pregabalin.

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy, unless your doctor has indicated so. You should use an effective contraceptive method 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.

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the suitable dose for you.

Pregabalina 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 instruct you to take pregabalina 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 pregabalina normally, except if you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking pregabalina until your doctor tells you to stop.

If you take more Pregabalina Pensa Pharma than you should

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.

As a result of having taken more pregabalina than you should, you may feel drowsy, confused, agitated, or restless.Seizures have also been reported.

If you forgot to take Pregabalina Pensa Pharma

It is essential to take the pregabalina capsules 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 Pensa Pharma

Do not stop taking pregabalina unless your doctor tells you to. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once the treatment with pregabalina is completed, whether short-term or long-term, you should know that you may experience certain adverse effects. These include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may appear more frequently or with greater severity if you have been taking pregabalina for a longer period.

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

Like all medicines, this medicine may 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 sexual desire, irritability
• Attention disturbance, clumsiness, memory deterioration, memory loss, tremors, difficulty speaking, numbness, tingling, sedation, drowsiness, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen
• Difficulty achieving 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, anxiety, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual desire
• 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 knowledge, 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, heart rhythm changes, 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
• Painful menstrual periods
• 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 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 cycle interruption
• Renal insufficiency, reduced urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior
• Allergic reactions (which 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).
• 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
• Hepatitis (liver inflammation)

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

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

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.

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet.

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

By reporting side 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 or in the bottle.The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of PregabalinaPensa Pharma

The active ingredient is pregabalina. Each hard capsule contains 300 mg of pregabalina.

The other components are mannitol (E-421), talc, and pregelatinized cornstarch. The capsule contains: gelatin,dióxide of titanium (E-171), yellow iron oxide (E-172), red iron oxide (E-172)and printing ink composed of: shellac lacquer, black iron oxide (E-172),propylene glycol, concentrated solution of ammonium andpotassium hydroxide.

Appearance of the product and contents of the packaging

Pregabalina Pensa Pharma 300 mg are hard, opaque gelatin capsules of pink and cream color and have "300" engraved.

Pre-cut, single-dose blisters of PVC/Aluminum, containing56 capsules.

Blister packs of PVC/Aluminum, containing56 capsules.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

Pliva Croatia, Ltd.

Prilaz baruna Filipovica 25

10.000 Zagreb

Croatia

Or

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

Last review date of this leaflet:February 2022

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/