Patient Information Leaflet: Product Information

Pramep 20 mg/ml Oral Solution EFG

pregabalina

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 Pramep and what it is used for

2. What you need to know before you start taking Pramep

3. How to take Pramep

4. Possible side effects

5. Storage of Pramep

6. Contents of the pack and additional information

Pramepbelongs to a group of medications used for the treatment of epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pramepis 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 can affect physical and social activity and overall quality of life.

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

Generalized anxiety disorder:Pramepis 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 mind going blank, irritability, muscle tension, or sleep disturbances. This is different from everyday stress and life tensions.

Do not take Pramep

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 takePramep.

• Some patients treated withpregabalinhave 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 medical attention immediately.

• Pregabalinhas 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 of the medicine.

• Pregabalinmay 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.

• Diabetic patients who gain weight while taking pregabalin may need to change their diabetes medication.

• Certain adverse effects, such as somnolence, may be more frequent because 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 withpregabalin. Most of them were elderly patients with cardiovascular disease.Before using this medicine, you should inform your doctor if you have a history of heart disease.

• There have been reports of renal insufficiency in some patients treated withpregabalin. If during treatment with Pramep 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 taking antiepileptic medications such aspregabalinhave 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.

• Whenpregabalinis taken with other medications that may 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 medicine, 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.

• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with pregabalin. 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, kidney 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.

• There have been reports of severe skin eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, 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 Pramep (need to continue taking the medicine). They may experience withdrawal effects when they stop using Pramep (see section 3, “How to take Pramep” and “If you interrupt treatment with Pramep”). If you are concerned that you may become dependent on Pramep, it is essential to consult your doctor.

If you notice any of the following signs while taking Pramep, 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 experience discomfort 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.

Use of Pramep 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 may influence each other (interactions). When pregabalin is taken with certain medicines 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 medicines that contain:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

Pramep can be taken with oral contraceptives.

Taking Pramep with food, drinks, and alcohol

Pramep can be taken with and without food.

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

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 fertile women. 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

Pramep may cause symptoms such as dizziness, somnolence, and decreased concentration. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other potentially hazardous activities until it is known whether this medicine affects your ability to perform these activities.

Pramep contains parahydroxybenzoic acid methyl ester (E-218) and parahydroxybenzoic acid propyl ester (E-216)

It may cause allergic reactions (possibly delayed) because it containsparahydroxybenzoic acid methyl ester (E-218) and parahydroxybenzoic acid propyl ester (E-216).

Pramep contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per ml; 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 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 solution as instructed by your doctor.
• The dose, adjusted for you and your condition, will generally be between 150 mg (7.5 ml) and 600 mg (30 ml) per day.
• Your doctor will tell you to take Pramep two or three times a day. In the case of two times a day, take Pramep once in the morning and once at night, approximately at the same hour every day. In the case of three times a day, take Pramep in the morning, at noon, and at night, approximately at the same hour every day.

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

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

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

Continue taking Pramep until your doctor tells you to stop.

Administration:

Instructions for use

Pramep is exclusively for oral use.

1.Open the bottle: press down the cap and turn it clockwise (Figure 1).

2.Only the first time you use it:along with the oral syringe, a bottle adapter is provided. This adapter should be placed on the neck of the bottle, making it easier to extract the solution with the syringe. If the adapter is not on the bottle, remove the adapter and the 5 ml syringe from the transparent bag. Place the bottle on a stable surface, and proceed to place the adapter on the neck of the bottle with the flat side facing you and pressing it down (Figure 2).

3.Press the plunger of the syringe towards the end of the syringe barrel (towards the tip) to eliminate excess air. Insert the syringe into the bottle adapter with a slight rotational movement (Figure 3).

4.Invert the bottle (with the syringe in place) and load the syringe with the liquid by pulling the plunger of the syringe downwards until just past the graduation mark corresponding to the prescribed amount in milliliters (ml) (Figure 4). Remove air bubbles from the syringe by pulling the plunger upwards to the correct graduation mark.

5.Put the bottle back in its normal position, without removing the syringe from the bottle adapter (Figure 5).

6.Remove the syringe from the bottle adapter (Figure 6).

7.Empty the contents of the syringe directly into the mouth by pressing the plunger towards the end of the syringe barrel (Figure 7).

Note:The steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).

[For example, a dose of 150 mg (7.5 ml) will require removing two volumes from the bottle to reach the complete dose. Using the syringe, remove first 5 ml, empty the contents directly into the mouth, and then take the syringe again for 2.5 ml, emptying the remaining contents into the mouth.]

8.Wash the syringe by taking water with the help of the plunger and expelling it from the syringe by pressing the plunger towards the tip, at least three times (Figure 8).

9.Put the cap back on the bottle (leaving the adapter on the neck of the bottle) (Figure 9).

Figure 1Figure 2Figure 3

Figure 4Figure 5Figure 6

Figure 7Figure 8Figure 9

Table 1. Volume to extract with the syringe to obtain the prescribed dose of Pramep

If you take more Pramep than you should

Call your doctor or go to the nearest emergency service immediately. Bring the packaging or bottle of the oral solution of Pramep with you. As a result of taking more Pramep 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 forget to take Pramep

It is essential to take the oral solution of Pramep 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 as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Pramep

Do not stop taking Pramep 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 Pramep is completed, both short-term and 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 Pramep for a longer period of time.If you experience withdrawal effects, you should see 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 sexual desire, 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 sexual desire, 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.
• 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, incontinence.
• 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.
• Menstrual cramps.
• 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 constriction, 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 alterations.
• 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.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat, red patches, often with central blisters, skin peeling, mouth ulcers, throat, nasal, 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 you have completed 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 treatment with Pramep").

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 Pramep, 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.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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 not listed 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 reactions, 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.

Pramep 20 mg/ml oral solution EFG should be used within the 60 days following the first opening of the bottle.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pramep

• The active principle is pregabalina. Each ml contains 20 mg of pregabalina.
• The other components are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), anhydrous sodium dihydrogen phosphate, monohydrogen phosphate disodium, sucralose, strawberry flavor 10131/P, purified water.

Appearance of the product and contents of the packaging

Pramep 20 mg/ml oral solution EFG is a transparent and colorless solution presented in a white HDPE bottle containing 473 ml of oral solution in a cardboard container. The packaging also contains an oral syringe with graduations of 1.25 ml and a total capacity of 5 ml and a bottle adapter.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Vianex S.A. Plant A

12 Km National Road Athens Lamia

144 51 Metamorfossi

Greece

or

One Pharma S.A.

60th km N. N. R. Athinon-Lamias,

32 009 Sximatari Voiotias

Greece

Date of the last review of this leaflet:December 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/.