Package Insert: Information for the User

Aciryl 300 mg Hard Capsules EFG
pregabalina

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 to you alone, and you should not give it to others even if they 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.

Pregabalin belongs 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: pregabalin is used for the treatment of chronic pain caused by nerve damage. Various diseases 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 pins and needles. Peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

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

Generalized anxiety disorder:pregabalin is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD include 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 Aciryl

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take pregabalin.

·Symptoms pointing to an allergic reaction have been reported by some patients treated with pregabalin. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these symptoms, you should seek immediate medical attention.

· Severe skin reactions, 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.

·Pregabalin has 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 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 inform your doctor immediately.

·Patients with diabetes who gain weight while taking pregabalin may need to adjust 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, e.g., pain or spasticity (tense or rigid muscles), with similar adverse effects to pregabalin, so 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 must 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 notice 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 drugs such as pregabalin have 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.

·When pregabalin is 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 medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; it 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 brain dysfunction (encephalopathy) have been reported in some patients who were taking pregabalin and had other underlying diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

· Cases of breathing 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.

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 Aciryl” and “If you stop taking Aciryl”). 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 period than recommended by your doctor.
• You feel the need to take more of the recommended dose.
• 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) and therefore pregabalin should not be used in this age group.

Other medications and Aciryl

Inform your doctororpharmacistif you are taking,have takenrecently or may need to take any other medication.

Pregabalin and certain medications may exert a mutual influence on each other (interactions). When pregabalin is used with certain medicationsthat 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 medications that contain:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medication can be taken with oral contraceptives.

Taking Aciryl with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancyor lactation, unless your doctor has indicated otherwise. 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. The anomalies included facial clefts, eyes, nervous system (including the brain), kidneys, and genitals.

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 doctororpharmacist before using thismedication.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.

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 more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin is exclusively for oral use.

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 tell you to take pregabalin two or three times a day. In the case of twice a day, take pregabalin 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.

If you are an elderly patient (over 65 years old), you should take pregabalin normally, except if 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 morePregabalin 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 takePregabalin

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 as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withPregabalin

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 a short- or long-term treatment with pregabalin is completed, you should know that you may experience certain adverse effects called withdrawal effects. These effects include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been taking pregabalin 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 medicines, this medicine may cause side effects, although not everyone will experience them.

The very common side effects that may affect more than 1 in 10 people are:

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5. Conservation of Aciryl

6. Contents of the packaging and additional information