Package Insert: Information for the User

Pramep 100 mg Hard Capsules EFG

Pregabalin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

- Keep this package insert, as you may need to refer to it again.

­ If you have any questions, consult your doctor or pharmacist.

­ This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

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

Generalized anxiety disorder:Pramep 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 a feeling of excitement or nervousness, feeling easily fatigued (tired), having difficulty concentrating or feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from the stress and tensions of everyday life.

Do not take Pramep

• 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 pregabalin.

• Some patients treated with this medication have reported symptoms indicating 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.

• 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 immediately inform your doctor.

• Diabetic patients 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 that the intensity of these 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 should 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 note 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 medications such as pregabalin have had thoughts of self-harm or suicide. 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 some 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 mean that you have a higher risk of becoming dependent on pregabalin.

• 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 respiratory 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.

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 Pramep" and "If you stop taking Pramep"). 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

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

Other medications and Pramep

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

Pramep and certain medications may influence each other (interactions). When pregabalin is used with certain medications that have a sedative effect (including opioids), pregabalin may potentiate those effects, 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 a pain medication)

Lorazepam - (used to treat anxiety)

Alcohol

Pregabalin can be taken with oral contraceptives.

Taking Pramep with food, drinks, and alcohol

The pregabalin capsules can be taken with or without food.

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

Pregnancy and breastfeeding

You should not take this medication 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.

Pramep contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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 a dose greater than the one prescribed to you.

Your doctor will determine the appropriate dose for you.

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 pregabalin two or three times a day. In the case of twice a day, take this medication 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 pregabalin is too strong or too weak, inform your doctor or pharmacist.

Patients over 65 years old

If you are a patient over 65 years old, take this medication normally, except if you have kidney problems.

Patients with kidney problems

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

Administration form

Pramep is exclusively for oral use.

Swallow the capsule whole with water.

Treatment duration

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pramep 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 taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forgot to take Pramep

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 Pramep

Do not stop taking pregabalin 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 pregabalin is completed, whether it is short-term or long-term, you should know that you may experience certain adverse effects called withdrawal effects. These include sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These symptoms 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.

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

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
• Alteration of attention, clumsiness of movement, deterioration of memory, memory loss, tremors, difficulty speaking, sensation of 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
• Difficulty achieving erection
• Swelling of the body including extremities
• Sensation of intoxication, alterations 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, 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 on standing, sensitive skin, loss of taste, burning sensation, tremors on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort
• Eye dryness, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Alterations in heart rhythm, 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)
• Allergic reactions, 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, vision loss
• Dilated pupils, strabismus
• Cold sweat, throat constriction, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Reduced mobility or movement of the body
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Pulmonary edema
• Seizures
• Changes in electrocardiogram (ECG) corresponding to alterations in heart rhythm
• 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, suicidal behavior, suicidal thoughts.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat, non-elevated red patches, circular or coin-shaped patches on the chest, often with central blisters, skin peeling, 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):

• Liver insufficiency
• Hepatitis (inflammation of the liver).

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 Pramep").

Certain side effects, such as drowsiness, may be more frequent as 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 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 Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 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 trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pramep

The active ingredient is pregabalin. Each hard capsule contains 100 mg of pregabalin.

The other components are lactose monohydrate, pregelatinized cornstarch, talc, gelatin, titanium dioxide (E-171), iron oxide red (E-172).

Appearance of the product and content of the packaging

Hard orange-colored capsules (approximately 16 mm in size).

Pramep 100 mg is available in a formed packaging size made of PVC with an aluminum foil: 84 and 100 capsules.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Nieuwe Donk 9

NL-4879 AC Etten-Leur

Netherlands

or

Lamp San Prospero S.p.a.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

Last review date of this leaflet:January 2024

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