Pramep 20 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pramep 20 mg/ml oral solution EFG

pregabalin

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pramep is and what it is used for
2. What you need to know before taking Pramep
3. How to take Pramep
4. Possible side effects
5. How to store Pramep
6. Contents of the pack and other information

1. What Pramep is and what it is used for

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

Peripheral and central neuropathic pain: Pramep is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as warmth, burning, throbbing, shooting, stabbing, sharp, continuous pain, tingling, numbness, or pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may 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 when your current treatment does not adequately control your condition. You should take Pramep as an add-on to your current treatment. Pramep must not be used as monotherapy; it should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pramep is used to treat generalized anxiety disorder (GAD). Symptoms of GAD include excessive and prolonged anxiety and worry that are difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stresses and strains of life.

2. What you need to know before taking Pramep

Do not take Pramep

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pramep.

• Some patients treated with pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek medical attention immediately.

• Pregabalin has been associated with dizziness and drowsiness, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have.

• Pregabalin may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any changes in your vision, you must inform your doctor immediately.

• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.

• Certain adverse effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medications for conditions such as pain or spasticity (tight or stiff muscles), which have adverse effects similar to those of pregabalin, thereby increasing the intensity of these effects when taken together.

• Cases of heart failure have been reported in some patients treated with pregabalin. Most of these patients were elderly with cardiovascular diseases. Before using this medicine, you must inform your doctor if you have a history of heart disease.

• Cases of renal failure have been reported in some patients treated with pregabalin. If during treatment with Pramep you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.

• Some patients taking antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or have exhibited such behavior, contact your doctor as soon as possible.

• When pregabalin is taken together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal paralysis) may occur. Inform your doctor if you suffer from 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 medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on pregabalin.

• Cases of seizures during treatment with pregabalin or shortly after discontinuation of pregabalin have been reported. If you experience seizures, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who had other underlying diseases. Inform your doctor if you have a history of serious illness, including liver or kidney disease.

• Cases of difficulty breathing have been reported. If you have disorders of the nervous system, respiratory disorders, renal failure, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience breathing difficulties or shallow breathing.

• Serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Dependence

Some people may become dependent on Pramep (a need to keep taking the medicine). They may experience withdrawal effects when they stop using Pramep (see section 3, “How to take Pramep” and “If you stop taking Pramep”). If you are concerned about possibly becoming dependent on Pramep, it is important 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 longer than recommended by your doctor.
• You feel you need to take a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better again once you take it again.

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

Children and adolescents

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

Taking Pramep with other medicines

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

Pregabalin and certain medicines may interact with each other. When pregabalin is used together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced, potentially leading to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if pregabalin is taken together with other medicines containing:

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 or without food.

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

Pregnancy and breastfeeding

You should not take pregabalin during pregnancy or while breastfeeding unless specifically instructed by your doctor. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations. This compares with 4 out of 100 babies born to women not treated with pregabalin in the study. Malformations reported include facial clefts, eyes, nervous system (including the brain), kidneys, and genitals.

An effective method of contraception should be used in women of childbearing age. If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pramep may cause symptoms such as dizziness, drowsiness, and reduced concentration. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, you should not drive, operate machinery, or perform other potentially hazardous activities until you know whether this medicine affects your ability to carry out such activities.

Pramep contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

May cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Pramep contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per ml; therefore, it is essentially “sodium-free”.

3. How to take Pramep

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Do not take a higher dose 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 exactly as directed by your doctor.
• The dose, adjusted according to your condition, will generally range between 150 mg (7.5 ml) and 600 mg (30 ml) daily.
• Your doctor will instruct you to take Pramep either twice or three times a day. If twice daily, take Pramep once in the morning and once in the evening, approximately at the same time each day. If three times daily, take Pramep in the morning, at midday, and in the evening, approximately at the same time each day.

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

If you are an elderly patient (over 65 years of age), you should take Pramep as usual, unless you have kidney problems.

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

Continue taking Pramep until your doctor tells you to stop.

Administration:

Instructions for use

Pramep is for oral use only.

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

2. Only the first time you use it: an oral syringe and a bottle adapter are provided. This adapter must be placed on the neck of the bottle to facilitate withdrawal of the solution using the syringe. If the adapter is not already on the bottle, remove the adapter and the 5 ml syringe from the transparent bag. Place the bottle on a firm surface and attach the adapter to the neck of the bottle with the flat side facing you, pressing it down firmly (Figure 2).

3. Push the plunger of the syringe fully towards the end of the syringe barrel (towards its tip) to expel excess air. Insert the syringe into the bottle adapter with a slight twisting motion (Figure 3).

4. Invert the bottle (with the syringe attached) and draw the liquid into the syringe by pulling the plunger down until slightly past the graduation mark corresponding to the amount in millilitres (ml) prescribed by your doctor (Figure 4). Remove air bubbles from the syringe by pushing the plunger upward until the liquid reaches the correct graduation mark.

5. Return the bottle to its upright 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 your mouth by pushing the plunger fully towards the end of the syringe barrel (Figure 7).

Note: 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 two withdrawals from the bottle to achieve the full dose. Using the syringe, first withdraw 5 ml, empty the contents directly into the mouth, then withdraw another 2.5 ml with the syringe, and empty the remaining contents into the mouth.]

1. Rinse the syringe by drawing water into it using the plunger and expelling it by pressing the plunger towards the tip, at least three times (Figure 8).

2. Replace the cap on the bottle (leaving the adapter in place on the neck of the bottle) (Figure 9).

Figure 1 Figure 2 Figure 3

Figure 4 Figure 5 Figure 6

Figure 7 Figure 8 Figure 9

Table 1. Volume to withdraw 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 department immediately. Take the pack or bottle of Pramep oral solution 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pramep

It is important that you take the Pramep oral solution regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, continue with your next dose as normal. Do not take a double dose to make up for a missed dose.

If you stop taking Pramep

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

After stopping long-term or short-term treatment with Pramep, you should be aware that you may experience certain adverse effects known as withdrawal effects. These include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, restlessness, depression, thoughts of harming yourself or of suicide, pain, sweating, and dizziness.

These symptoms may occur more frequently or severely if you have been taking Pramep for a longer period of time. If you experience withdrawal effects, you should contact your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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.
• Feeling of euphoria, confusion, disorientation, decreased sex drive, irritability.
• Attention disturbance, clumsiness of movement, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, bloated abdomen.
• Difficulty in erection.
• Swelling of the body including limbs.
• Feeling of drunkenness, disturbances 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 levels, high blood sugar levels.
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sex drive, sexual problems including inability to reach climax, delayed ejaculation.
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, 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 flushes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, burning sensations, 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 when urinating, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, low blood potassium).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual periods.
• Feeling of coldness in hands and feet.

Rare: may affect up to 1 in 1,000 people

• Altered sense of smell, fluctuating vision, depth perception disturbance, visual glare, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing properly.
• Increased fluid 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, breast enlargement in men.
• Interruption of menstrual periods.
• Kidney failure, reduced urine output, urine retention.
• Decreased white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterised by flat, non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms such as tremor, bradykinesia (reduced ability to move), and muscle rigidity.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency not known: cannot be estimated from available data

• Becoming dependent on pregabalin (“drug dependence”).

After stopping short- or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects, known as withdrawal effects (see “If you stop taking Pramep”).

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

Certain adverse effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity (tight or rigid muscles), which have adverse effects similar to those of Pramep, so the intensity of these effects may increase when taken together.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramep

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the pack or bottle. The expiry date refers to the last day of the month indicated.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramep

• The active substance is pregabalin. Each ml contains 20 mg of pregabalin.
• The other components are: methylparaben (E218), propylparaben (E216), anhydrous sodium dihydrogen phosphate, disodium monohydrogen phosphate, sucralose, strawberry flavour 10131/P, purified water.

Appearance of the product and contents of the container

Pramep 20 mg/ml oral solution EFG is a clear, colourless solution supplied in a white HDPE bottle containing 473 ml of oral solution, packaged in a cardboard box. The pack also contains an oral syringe with graduations at 1.25 ml and a total capacity of 5 ml, and a bottle adapter.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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 most recent revision of this leaflet: December 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.