ACIRYL 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Aciryl 300 mg hard capsules EFGpregabalin

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 further questions, ask your doctor or pharmacist.- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack1. What Aciryl is and what it is used for 2. What you need to know before you take Aciryl 3. How to take Aciryl 4. Possible side effects 5. How to store Aciryl 6. Contents of the pack and other information

1. What Aciryl is and what it is used for

Pregabalin belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: pregabalin is used to treat long-lasting pain caused by damage to the nerves. There are many diseases that can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain may be described as hot, burning, throbbing, shooting, stabbing, sharp, crampy, aching, tingling, numbness, and pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can have an impact on physical and social activity and overall quality of life.

Epilepsy:pregabalin is used to treat certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin for you to treat epilepsy when your current treatment is not controlling your condition. You should take pregabalin in addition to your current treatment. Pregabalin should not be taken alone but should always be used in combination with other anti-epileptic treatments.

Generalized anxiety disorder:pregabalin is used to treat generalized anxiety disorder (GAD). The symptoms of GAD are prolonged and excessive worry and anxiety that are difficult to control. GAD can also cause restlessness or feeling on edge or irritability, being easily fatigued, having difficulty concentrating or feeling like your mind goes blank, muscle tension or sleep disturbances. This is different from the worries and concerns of everyday life.

2. What you need to know before you take Aciryl

Do not take Aciryl

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

Warnings and precautions

Talk to your doctor or pharmacist before taking pregabalin.

• Some patients taking pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
• Pregabalin has been associated with dizziness and somnolence, which may increase the occurrence of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are used to the effects the medicine has.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any changes in your vision, you should immediately inform your doctor.
• Diabetic patients who gain weight while taking pregabalin may need an adjustment in their antidiabetic medications.
• Certain adverse effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medications for treatment, e.g., for pain or spasticity (stiff or rigid muscles), with similar adverse effects to those of pregabalin, so the intensity of these effects may increase when taken together.
• Heart failure has been reported in some patients taking this medicine. Most were elderly patients with cardiovascular conditions. Before using this medicine, you should tell your doctor if you have a history of heart disease.
• Kidney failure has been reported in some patients taking this medicine. If, while taking pregabalin, you notice a decrease in your ability to urinate, you should inform your doctor as stopping treatment may improve this situation.
• Some patients taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or suicide or have shown signs of suicide. If at any time you have these thoughts or have shown such behavior, contact your doctor as soon as possible.
• When pregabalin is taken with other medicines that may cause constipation (such as some types of pain medicines), gastrointestinal problems (e.g., constipation and intestinal blockage or 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.
• Seizures have been reported in patients taking pregabalin or shortly after stopping pregabalin. If you have a seizure, contact your doctor immediately.
• Reduced brain function (encephalopathy) has been reported in some patients taking pregabalin who had other conditions. Tell your doctor if you have a history of any serious disease, including liver or kidney disease.
• Breathing difficulties have been reported in patients taking pregabalin. If you have nervous system disorders, respiratory disorders, kidney failure, or are over 65 years old, 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 pregabalin (need to keep taking the medicine). They may have withdrawal effects when they stop taking pregabalin (see section 3, “How to take Aciryl” and “If you stop taking Aciryl”). If you are concerned that you may become dependent on pregabalin, it is important that you talk to 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 medicine for longer than your doctor recommended.
• You feel that you 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 the use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better once you take the medicine again.

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

Children and adolescents

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

Other medicines and Aciryl

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

Pregabalin and certain medicines may influence each other (interactions). When pregabalin is used with certain medicines that have a sedating effect (including opioids), these effects may be enhanced, 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:

Oxicodona – (used as a pain reliever)

Lorazepam – (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Aciryl with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol while taking pregabalin.

Pregnancy, breastfeeding, and fertility

Do not take pregabalin during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause birth defects in the baby 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 babies out of 100 had such birth defects. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. Birth defects have been reported, including facial defects (cleft lip or palate), eye, central nervous system (including brain), kidney, and genital defects.

An effective contraceptive method should be used in women of childbearing potential. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines

Pregabalin may cause dizziness, somnolence, and decreased concentration. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

3. How to take Aciryl

Take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin is for oral use only.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules that your doctor has told you to take.• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.• Your doctor will tell you to take pregabalin either twice or three times a day. For twice a day, take pregabalin once in the morning and once in the evening, approximately at the same time every day. For three times a day, take pregabalin in the morning, at noon, and in the evening, approximately at the same time every day.

If you think that the effect of pregabalin is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take pregabalin as normal, unless you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Aciryl than you should

In case of overdose or accidental intake, contact your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures and unconsciousness (coma) have also been reported.If you forget to take Aciryl

It is important that you take your 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 your next dose. In that case, continue with your next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Aciryl

Do not stop taking pregabalin suddenly. If you want to stop taking pregabalin, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once you have finished a short or long-term treatment with pregabalin, you should know that you may experience certain side effects called withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of harming yourself or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should contact your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The very common adverse effects that may affect more than 1 person in 10 are:

• Dizziness, drowsiness, headache

The common adverse effects that may affect more than 1 person in 100 are:

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Alteration of attention, clumsiness, 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 with erection
• Swelling of the body including limbs
• Feeling of drunkenness, gait disturbances
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain
• Sore throat

The uncommon adverse effects that may affect more than 1 person in 1,000 are:

• 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, anxiety crises, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation.
• Changes in vision, unusual eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness when standing up, sensitive skin, loss of taste, burning sensation, tremor when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, swollen eyes, eye pain, tired eyes, teary 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, heartburn, numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle spasms, swollen joints, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain when urinating, inability to hold urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual periods.
• Cold sensation in hands and feet.

The rare adverse effects that may affect less than 1 person in 1,000 are:

• Altered sense of smell, oscillating vision, altered depth perception, visual glare, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced body mobility
• Difficulty writing correctly
• Increased fluid in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual period interruption
• Kidney failure, reduced urine output, urine 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 reddish patches, or circular or coin-shaped patches on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

The very rare adverse effects that may affect up to 1 in 10,000 people are:

• Liver failure.
• Hepatitis (liver inflammation).

The adverse effects of unknown frequency that cannot be estimated from the available data are:

• Becoming dependent on pregabalin ("drug dependence").

Once you have finished a short or long-term treatment with pregabalin, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop treatment with Aciryl").

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

Certain adverse 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 (stiff or rigid muscles), with 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, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aciryl

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

Do not use this medicine after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAciryl

The active ingredient is pregabalin. Each hard capsule contains 75 mg of pregabalin.

The other components (excipients) are: mannitol (E-421), pregelatinized corn starch, talc, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and gelatin. The components of the printing ink are: shellac lacquer, black iron oxide (E-172), propylene glycol, strong ammonia solution, and potassium hydroxide.

Appearance of the Product and Package Contents

Aciryl 75 mg are hard gelatin capsules, opaque, ivory and pink in color, and bear the imprint "75". PVC/Aluminum blisters in cardboard boxes containing 56 hard capsules.

Precut unit-dose PVC/Aluminum blisters in cardboard boxes containing 56 hard capsules.

Only certain package sizes may be marketed.

Marketing Authorization Holder and ManufacturerMarketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

ManufacturerPliva Croatia, Ltd.

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

or

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren - Weiler

Germany

Date of the Last Revision of this Prospectus: December 2023

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