Pregabalin Sun 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Pregabalin SUN 300 mg hard capsules EFG

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 give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What is Pregabalin SUN and what is it used for?

Pregabalin SUN 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: Pregabalin SUN 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, continuous pain, tingling, numbness, and prickling 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: Pregabalin SUN is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin when your current treatment does not adequately control your condition. You should take Pregabalin SUN as an add-on to your current treatment. Pregabalin SUN must not be used as monotherapy, but always in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pregabalin SUN 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 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 stress and worries of normal life.

2. What you need to know before taking Pregabaline SUN

Do not take Pregabaline SUN

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 Pregabaline SUN

• Some patients treated with pregabalin have reported symptoms suggesting an allergic reaction. 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 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.
• 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 of this medicine.
• 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.
• Some 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 treatment, for example, for pain or spasticity (tight or rigid muscles), which have 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 pregabalin. 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 problems (renal failure) have been reported in some patients treated with this medicine. If during treatment with pregabalin 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 shown suicidal behavior. If at any time you experience such thoughts or have shown 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 medicines), 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 a history of alcoholism or abuse of medicines or illegal drugs, as this may indicate 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 medicine. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who also had other medical conditions. 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 pregabalin (a need to continue taking this medicine). They may experience withdrawal symptoms when they stop taking pregabalin (see section 3 “How to take Pregabaline SUN” and “If you stop taking Pregabaline SUN”).

If you are concerned about possibly becoming dependent on pregabalin, it is important to consult your doctor.

If you notice any of the following symptoms while taking Pregabaline SUN, this could be a sign that you have become dependent:

• You need to take this medicine for longer than prescribed by your doctor
• You feel you need to take more than the recommended dose
• You use this medicine for reasons other than those prescribed
• You have made repeated unsuccessful attempts to stop or control use of this medicine
• You feel unwell when you stop taking this medicine, and feel better when you take it again

If you notice any of these symptoms, talk to your doctor to discuss the best treatment for you, including when it may be appropriate to stop taking this medicine and how to do so safely.

Children and adolescents

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

Taking Pregabaline SUN 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 medicines containing:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

Pregabaline SUN can be taken with oral contraceptives.

Taking Pregabaline SUN with food, drinks, and alcohol

Pregabaline SUN capsules can be taken with or without food.

It is advised not to drink alcohol during treatment with pregabalin.

Pregnancy, breastfeeding, and fertility

You should not take pregabalin 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 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 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.

An effective method of contraception should be used in women of childbearing age. 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

Pregabalin may cause dizziness, drowsiness, and reduced 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 tasks.

Pregabaline SUN contains sodium and mannitol

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., essentially “sodium-free”.

Mannitol may have a mild laxative effect.

3. How to take Pregabaline SUN

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Do not take more than the prescribed dose.

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 indicated by your doctor.
• The dose, adjusted according to your condition, is generally between 150 mg and 600 mg daily.
• Your doctor will instruct you to take pregabalin two or three times a day. If twice daily, take pregabalin once in the morning and once at night, approximately at the same time each day. If three times daily, take pregabalin 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 pregabalin as usual, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen and/or dose 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 Pregabalin SUN than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

As a result of taking more pregabalin than prescribed, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin SUN

It is important to take pregabalin capsules regularly at the same time each day. If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Pregabalin SUN

Do not stop taking pregabalin suddenly. If you wish to discontinue pregabalin, discuss this with your doctor first. Your doctor will advise you on how to do so. If treatment is to be stopped, it should be done gradually over a minimum of one week.

After stopping long-term or short-term treatment with pregabalin, you should be aware that you may experience certain adverse effects known as withdrawal symptoms. These symptoms include sleep disturbances, headache, nausea, feelings of anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, thoughts of self-harm or 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 experience withdrawal symptoms, 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 everybody will experience them.

Serious adverse effects:

If you experience any of the following adverse effects, stop treatment with Pregabalin SUN and contact your doctor or go to the nearest hospital, as you may require urgent medical attention.

• Hypersensitivity (uncommon, may affect up to 1 in 100 people) and allergic reactions (which may include facial swelling, swelling of the tongue, difficulty breathing, itching) (rare, may affect up to 1 in 1,000 people).

• Severe skin reaction characterised by flat 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). (rare, may affect up to 1 in 1,000 people).

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

• Inflammation of the pancreas (including symptoms such as severe stomach pain, often with nausea and vomiting) (rare, may affect up to 1 in 1,000 people).

Other adverse effects:

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 sexual desire, irritability
• Attention disturbance, lack of coordination, memory impairment, memory loss, tremor, 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
• Erectile dysfunction
• Swelling of the body including limbs
• Feeling of drunkenness, gait disturbances
• Weight gain
• Throat irritation
• Muscle cramp, joint pain, back pain, limb pain, neck muscle spasm
• Throat irritation

Uncommon (may affect up to 1 in 100 people)

• Loss of appetite, weight loss, low blood sugar, high blood sugar levels
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual desire, sexual relationship problems including inability to reach climax, delayed ejaculation
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spastic movements – abnormal and uncontrollable limb movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, 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, heart failure
• Flushing, hot flushes
• Difficulty breathing, dry nose, nasal congestion
• Cough, facial swelling, urticaria, itching, runny nose, nosebleeds, snoring
• Increased saliva production, burning sensations, numbness around the mouth
• Sweating, rash, chills, fever
• Cold sensation in hands and feet
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Difficulty or pain when urinating, inability to control urine
• Weakness, thirst, chest tightness
• Breast pain
• Painful menstrual periods
• Generalised swelling
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, reduced platelet count, decreased blood potassium, increased blood creatinine, neutropenia)

Rare (may affect up to 1 in 1,000 people)

• Changes in heartbeat
• Altered sense of smell, oscillating vision, altered depth perception, visual brightness, vision loss
• Dilated pupils, strabismus
• Eye inflammation (keratitis)
• Cold sweat, throat tightness, tongue swelling
• Difficulty swallowing
• Slow or reduced body movement
• Difficulty writing correctly
• Fluid in the lungs
• Seizures
• Changes in electrocardiogram (ECG) corresponding to heart rhythm disturbances
• Increased fluid in the abdominal area
• Muscle damage
• Milk secretion, abnormal breast growth, breast enlargement in men
• Interruption of menstrual period
• Kidney problems, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts
• Jaundice (yellowing of the skin and eyes)
• Parkinsonism, symptoms resembling Parkinson’s disease 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).

Not known: frequency cannot be estimated from available data

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

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

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 stiff 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 during 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 side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin SUN

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Bottle: after opening, the capsules should be used within 30 days.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pregabaline SUN

The active substance is pregabalin. Each hard capsule contains 300 mg of pregabalin.

The other components are:

Contents of the capsule:

Mannitol, talc

Capsule composition:

Gelatin, titanium dioxide (E171), sodium lauryl sulfate, purified water, red iron oxide (E172)

Printing ink:

Shellac lacquer, propylene glycol, black iron oxide (E172), potassium hydroxide

Nature of the product and contents of the container

Pregabaline SUN 300 mg hard capsules:

Size “0” hard gelatin capsules with an opaque red cap and an opaque white body, marked with “rbx” in black ink on the cap and “PG300” on the body, containing white or almost white powder. The length of the capsule is approximately 21.0 – 21.8 mm.

OPA/Al/PVC/Al blister:

Pack sizes: 14, 21, 56, 84, 98, 100 or 112 hard capsules

PVC/Aluminum blister:

Pack sizes: 14, 21, 28, 56, 84, 98, 100 or 112 hard capsules

HDPE bottle with child-resistant closure:

Pack sizes: 14, 21, 30, 56, 84, 98, 100 or 112 hard capsules

HDPE bottle with screw cap:

Pack size: 500 hard capsules

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer:

Terapia, S.A.

124, Fabricii Street

400 632 – Cluj Napoca

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 - Barcelona

Spain

+34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

France: PREGABALINE CRISTERS PHARMA 300 mg, gélule

Germany: PREGABALIN BASICS 300 mg Hartkapseln

The Netherlands: Pregabaline SUN 300 mg, harde capsules

Poland: Tabagine

Romania: Pregabalina Terapia 300 mg capsule

United Kingdom (Northern Ireland): Pregabalin Sun 300 mg Capsules, Hard

Date of the most recent review of this leaflet: January 2024

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