Premax 20 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Premax 20 mg/ml oral solution EFG

Pregabalin

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

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Premax is and what it is used for

This medicine 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: this medicine 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 heat, burning, throbbing, shooting, stabbing, sharp pain, spasms, continuous pain, tingling, numbness, and pins-and-needles sensations. 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: this medicine is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe this medicine when your current treatment does not adequately control your condition. You should take this medicine in addition to your current treatment. This medicine must not be used as monotherapy, but should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder (GAD): this medicine 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, being easily fatigued (tired), difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stress and worries of normal life.

2. What you need to know before taking Premax

Do not take Premax:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

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

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

• This medicine 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 on you.

• This medicine may cause blurred vision, vision loss, or other changes in eyesight, many of which are temporary. 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 common because patients with spinal cord injury may be taking other medications for conditions such as pain or spasticity (stiff or rigid muscles), which have similar adverse effects to pregabalin, thereby increasing the intensity of these effects when taken together.

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

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

• Some patients receiving antiepileptic medicines such as this one 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 this medicine 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 Premax.

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

• Cases of reduced brain function (encephalopathy) have been reported in some patients taking this medicine who also had other illnesses. 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, kidney 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.

Dependence

Some people may become dependent on Premax (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using Premax (see section 3, “How to take Premax” and “If you stop taking Premax”). If you are concerned about becoming dependent on Premax, it is important to consult your doctor.

If you notice any of the following signs while taking Premax, it could indicate dependence:

• You need to take the medicine for longer than recommended by your doctor.
• You feel the need to take more than the recommended dose.
• 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.

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

Taking Premax 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 affect each other (interactions). When this medicine 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 this medicine is taken together with other medicines containing:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Premax with food, drinks, and alcohol

This medicine can be taken with or without food.

You are advised not to drink alcohol during treatment with this medicine.

Pregnancy and breastfeeding

You should not take this medicine during pregnancy or breastfeeding unless your doctor has instructed you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus requiring 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 every 100 babies had such congenital malformations. This compares with 4 out of every 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.

Women of childbearing age should use an effective method of contraception. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these tasks.

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

This medicine contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and sodium

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

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

3. How to take Premax

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 more medicine than prescribed.

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, is generally between 150 mg (7.5 ml) and 600 mg (30 ml) daily.
• Your doctor will instruct you to take this medicine twice or three times a day. If twice daily, take it once in the morning and once at night, approximately at the same time each day. If three times daily, take it in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of this medicine 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 this medicine as usual, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

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

Administration:

Instructions for use

This medicine 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 is provided along with a bottle adapter. 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 to the end of the barrel (towards its tip) to remove 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 it slightly exceeds 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 up to the correct graduation mark.

5. Return the bottle to the 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 pressing the plunger to 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 your mouth, then withdraw another 2.5 ml and again empty the remaining contents into your 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).

Table 1. Volume to withdraw with the syringe to obtain the prescribed dose of this medicine

If you take more Premax than you should

Call your doctor or go to the nearest emergency department immediately. Take the pack or bottle of this oral solution with you. If you take more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures 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, stating the name of the medicine and the amount ingested.

If you forget to take Premax

It is important that you take this 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, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Premax

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

After stopping treatment with this medicine, whether short-term or long-term, you should be aware that you may experience certain adverse effects. These include sleep problems, headache, nausea, feeling anxious, diarrhoea, 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 this medicine for a longer period of time.

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 experiences them.

Very common: may affect more than 1 in 10 people

• Dizziness, somnolence, 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, diarrhea, nausea, bloated abdomen.

• Difficulty in erection.

• Swelling of the body including limbs.

• Feeling of drunkenness, disturbances in gait.

• Weight gain.

• Muscle cramp, 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 relationship problems including inability to reach climax, delayed ejaculation.
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, light flashes, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor when moving, 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, 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, inability to control urine.
• 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.
• Cold sensation in hands and feet.

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

• Altered sense of smell, flickering vision, disturbance in depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• 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 behavior, suicidal behaviors, suicidal thoughts.
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genitals and eyes. These severe 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 (inflammation of the liver).

Frequency not known: cannot be estimated from available data

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

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

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

Certain adverse effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (stiff or rigid muscles), which have adverse effects similar to those of Pregabalin, so the intensity of these 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 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 through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Premax

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

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

This medicine does not require any special storage conditions.

This medicine should be used within 60 days after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Premax

The active substance is pregabalin. Each ml contains 20 mg of pregabalin.

The other components are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate anhydrous, disodium monohydrogen phosphate, sucralose, strawberry flavour 10131/P, purified water.

Appearance of Premax and contents of the container

Premax 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 package also includes an oral syringe with graduations of 1.25 ml and a total capacity of 5 ml, and a bottle adapter.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Neuraxpharm Spain, S.L.U
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain

Manufacturer

One Pharma S.A.
60th km National Road Athens-Lamia,
32 009 Schimatari, Viotia
Greece

VIANEX PLANT-A
12 Km National Road Athens-Lamia,
144 51 Metamorfossi
Greece

Date of the most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.