Pregabalin Reddi

Leaflet accompanying the packaging: information for the user

Pregabalin Reddy, 25 mg, hard capsules

Pregabalin Reddy, 50 mg, hard capsules

Pregabalin Reddy, 75 mg, hard capsules

Pregabalin Reddy, 100 mg, hard capsules

Pregabalin Reddy, 150 mg, hard capsules

Pregabalin Reddy, 200 mg, hard capsules

Pregabalin Reddy, 225 mg, hard capsules

Pregabalin Reddy, 300 mg, hard capsules

Pregabalin

Read the leaflet carefully before taking the medicine, as it contains important information for you.

Important information for patients.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pregabalin Reddy and what is it used for
• 2. Important information before taking Pregabalin Reddy
• 3. How to take Pregabalin Reddy
• 4. Possible side effects
• 5. How to store Pregabalin Reddy
• 6. Contents of the packaging and other information

1. What is Pregabalin Reddy and what is it used for

Pregabalin Reddy belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Neuropathic pain of peripheral and central origin: Pregabalin Reddy is used to treat long-lasting pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain. Painful sensations can be described as a feeling of heat, burning, pulsating, shooting, stabbing, sharp pain, cramps, aching, tingling, or numbness. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances, fatigue, which can affect the patient's physical and social functioning and overall quality of life.
Epilepsy: Pregabalin Reddy is used to treat certain types of epilepsy (partial seizures, which are or are not secondarily generalized) in adults. The doctor may prescribe Pregabalin Reddy if the current treatment does not fully control the course of the disease. Pregabalin Reddy should always be used as an add-on therapy to the currently used treatment. Pregabalin Reddy should not be used as monotherapy, but always in combination with other antiepileptic drugs.
Generalized anxiety disorder:Pregabalin Reddy is used to treat generalized anxiety disorder (GAD). GAD symptoms include prolonged, excessive anxiety and worry that are difficult to control. GAD can also cause restlessness, nervousness, or feeling on edge, easy fatigability, difficulty concentrating or feeling of "emptiness in the head", irritability, increased muscle tension, or sleep disturbances. Symptoms are different from the stresses and tensions of everyday life.

2. Important information before taking Pregabalin Reddy

When not to take Pregabalin Reddy

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

Warnings and precautions

Before starting to take Pregabalin Reddy, you should discuss it with your doctor or pharmacist.

• In some patients taking Pregabalin Reddy, symptoms suggesting an allergic reaction have occurred. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread rash. If any of these symptoms occur, you should contact your doctor immediately.
• Pregabalin has been associated with reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the symptoms of serious skin reactions mentioned in section 4, you should stop taking pregabalin and seek medical attention immediately.
• Taking Pregabalin Reddy has been associated with dizziness and drowsiness: this may lead to more frequent accidental injuries (falls) in the elderly. Therefore, you should be cautious until you know how the medicine affects you.
• Taking Pregabalin Reddy may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If you experience any changes in vision, you should tell your doctor immediately.
• In patients with diabetes who gain weight during pregabalin treatment, it may be necessary to adjust their antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to Pregabalin Reddy, and the severity of these effects may be greater when such medicines are taken at the same time.
• There have been reports of heart failure in some patients taking Pregabalin Reddy; these were mainly elderly patients with cardiovascular disorders. You should tell your doctor about any history of heart disease before taking this medicine.
• There have been reports of kidney failure in some patients taking Pregabalin Reddy. If you experience a decrease in urine output while taking Pregabalin Reddy, you should tell your doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking antiepileptic drugs, such as Pregabalin Reddy, have had thoughts of self-harm or suicide, or have exhibited suicidal behavior. If you have ever had such thoughts or behaviors, you should contact your doctor immediately.

Dependence
Some people may become dependent on Pregabalin Reddy (need to continue taking the medicine). After stopping Pregabalin Reddy, withdrawal symptoms may occur (see section 3 "How to take Pregabalin Reddy" and "Stopping Pregabalin Reddy"). If you are concerned that you may become dependent on Pregabalin Reddy, you should discuss this with your doctor.
If you experience any of the following symptoms while taking Pregabalin Reddy, it may indicate dependence:

• Need to take the medicine for a longer period than prescribed by the doctor
• Feeling the need to take a higher dose than prescribed
• Taking the medicine for reasons other than prescribed
• Repeatedly trying to stop or control the use of the medicine, but failing to do so
• Feeling unwell after stopping the medicine and feeling better after taking it again If you experience any of these symptoms, you should discuss them with your doctor to determine the best course of treatment, including when to stop taking the medicine and how to do it safely.

Children and adolescents

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

Pregabalin Reddy and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking, or have recently taken, and about any medicines you plan to take.
Pregabalin Reddy and some medicines may interact with each other (interactions). When taken with other medicines with a sedating effect (e.g., opioids), Pregabalin Reddy may enhance these effects and cause respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Pregabalin Reddy is taken with medicines containing:

• oxycodone - (pain reliever)
• lorazepam - (medicine used for anxiety)
• alcohol

Pregabalin Reddy can be taken with oral contraceptives.

Taking Pregabalin Reddy with food, drink, and alcohol

Pregabalin Reddy capsules can be taken with or without food.
You should not drink alcohol while taking Pregabalin Reddy.

Pregnancy and breastfeeding

Pregabalin Reddy should not be taken during pregnancy or breastfeeding, unless your doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn child that require treatment. A Scandinavian study analyzing data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of every 100 born children, while in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 born children. The reported birth defects involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing age should use effective contraception. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pregabalin Reddy may cause dizziness, drowsiness, and decreased concentration. You should not drive a car, operate complex machines, or perform potentially hazardous activities until you know how the medicine affects you.

Pregabalin Reddy contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Pregabalin Reddy contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means that the medicine is considered "sodium-free".

3. How to take Pregabalin Reddy

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist. Do not take more of the medicine than prescribed.
Your doctor will determine the dose of the medicine that is right for you.
Pregabalin Reddy is for oral use only.

Neuropathic pain of peripheral and central origin, epilepsy, or generalized anxiety disorder:

• You should take the number of capsules prescribed by your doctor.
• The recommended dose for you will be between 150 mg and 600 mg per day.
• Your doctor will tell you whether to take Pregabalin Reddy twice or three times a day. If you take it twice a day, you should take it in the morning and evening at the same time every day. If you take it three times a day, you should take it in the morning, at noon, and in the evening at the same time every day.

If you feel that Pregabalin Reddy is too strong or too weak, you should tell your doctor or pharmacist.
Patients over 65 years of age should take Pregabalin Reddy according to the presented schedule, unless they have kidney problems.
In patients with impaired renal function, the doctor may decide on a different dosing schedule and/or change the dose of the medicine.
The capsule should be swallowed whole and washed down with water.
Pregabalin Reddy should be taken for as long as your doctor prescribes, and the treatment can only be stopped on the doctor's advice.

Taking a higher dose of Pregabalin Reddy than prescribed

You should tell your doctor or go to the nearest hospital emergency department immediately. You should take the packaging or bottle of Pregabalin Reddy with you. After taking a higher dose of Pregabalin Reddy than prescribed, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

Missing a dose of Pregabalin Reddy

It is important to take Pregabalin Reddy regularly at the same times every day. If you miss a dose, you should take it as soon as possible, unless it is almost time for the next dose. In this case, you should continue treatment according to the prescribed schedule. Do not take a double dose to make up for the missed dose.

Stopping Pregabalin Reddy

You should not stop taking Pregabalin Reddy suddenly. If you want to stop taking Pregabalin Reddy, you should first talk to your doctor. Your doctor will tell you how to do it. If the treatment needs to be stopped, it should be done gradually over at least one week. You should be aware that after stopping short-term or long-term treatment with Pregabalin Reddy, certain side effects may occur, known as withdrawal symptoms. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or severe if you have taken Pregabalin Reddy for a longer period. If you experience withdrawal symptoms, you should contact your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pregabalin Reddy can cause side effects, although not everybody gets 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
• Mood swings, confusion, disorientation, decreased sexual interest, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling of strangeness
• Blurred vision, double vision
• Dizziness, balance disturbances, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• Difficulty achieving an erection
• Body swelling, including limb swelling
• Feeling of intoxication, ataxia
• Weight gain
• Muscle spasms, 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, high blood sugar
• Changes in self-perception, restlessness, depression, agitation, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, mental disorders, difficulty thinking, increased sexual interest, sexual problems, including difficulty achieving orgasm, delayed ejaculation
• Changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, jerky movements, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, burning sensation, tremors when moving, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, decreased eye movements, tearing, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden flushing of the face, sudden hot flashes
• Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
• Increased salivation, heartburn, feeling of numbness around the mouth
• Sweating, rash, chills, fever
• Muscle tremors, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
• Chest pain
• Difficulty urinating or painful urination, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

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

• Changed sense of smell, feeling of swaying, changed sense of depth, bright vision, loss of vision,
• Dilated pupils, strabismus
• Cold sweats, tightness in the throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or restricted movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG corresponding to heart rhythm disturbances
• Muscle damage
• Nipple discharge, breast enlargement, gynecomastia in men
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions, which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions, characterized by red, flat, plate-like, or circular patches on the torso, often with blisters in their center, peeling of the skin, ulcers in the mouth, throat, nose, and genitals, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and whites of the eyes)
• Parkinsonism, i.e., symptoms similar to Parkinson's disease, such as tremors, slowed movement (decreased ability to move), and stiffness (muscle stiffness)

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

• Liver failure
• Hepatitis

Frequency not known: frequency cannot be estimated from the available data

• Dependence on Pregabalin Reddy ("drug dependence")

You should be aware that after stopping short-term or long-term treatment with Pregabalin Reddy, certain side effects may occur, known as withdrawal symptoms (see section "Stopping Pregabalin Reddy").

In case of swelling of the face or tongue, or redness of the skin and appearance of blisters or peeling of the skin, you should seek medical attention immediately.

Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to Pregabalin Reddy, and the severity of these effects may be greater when such medicines are taken at the same time.
After the medicine was placed on the market, the following side effects were also reported: breathing difficulties, shallow breathing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pregabalin Reddy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pregabalin Reddy contains

• The active substance of the medicine is pregabalin.

Pregabalin Reddy, 25 mg, hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Reddy, 50 mg, hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Reddy, 75 mg, hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Reddy, 100 mg, hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Reddy, 150 mg, hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Reddy, 200 mg, hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Reddy, 225 mg, hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Reddy, 300 mg, hard capsules
Each hard capsule contains 300 mg of pregabalin.

• Other ingredients are:

Pregabalin Reddy, 25 mg, 50 mg, 150 mg, hard capsules
Capsule contents: lactose monohydrate, cornstarch, talc
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate
Ink: shellac, iron oxide black (E 172), potassium hydroxide.
Pregabalin Reddy, 75 mg, 100 mg, 200 mg, 225 mg, 300 mg, hard capsules
Capsule contents: lactose monohydrate, cornstarch, talc
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, iron oxide red (E 172)
Ink: shellac, iron oxide black (E 172), potassium hydroxide.
Pregabalin Reddy, hard capsules, 25 mg:
PVC/PVDC/Aluminum blister pack containing 56 capsules in a carton.
Pregabalin Reddy, hard capsules, 50 mg:
PVC/PVDC/Aluminum blister pack containing 56 capsules in a carton.
Pregabalin Reddy, hard capsules, 75 mg:
PVC/PVDC/Aluminum blister pack containing 56 or 84 capsules in a carton.
Pregabalin Reddy, hard capsules, 100 mg:
PVC/PVDC/Aluminum blister pack containing 84 capsules in a carton.
Pregabalin Reddy, hard capsules, 150 mg:
PVC/PVDC/Aluminum blister pack containing 56 or 84 capsules in a carton.

Pregabalin Reddy, hard capsules, 200 mg:
PVC/PVDC/Aluminum blister pack containing 84 capsules in a carton.
Pregabalin Reddy, hard capsules, 225 mg:
PVC/PVDC/Aluminum blister pack containing 56 capsules in a carton.
Pregabalin Reddy, hard capsules, 300 mg:
PVC/PVDC/Aluminum blister pack containing 56 capsules in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0
Manufacturer/Importer:
Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

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

Germany
Pregabalin beta 25, 50, 75, 100, 150, 200, 225, 300 mg hard capsules
Austria
Pregabalin Reddy 25, 50, 75, 100, 150, 200, 225, 300 mg hard capsules
Czech Republic
Pregabalin Reddy
Netherlands
Pregabaline Reddy 25, 50, 75, 100, 150, 200, 225, 300 mg hard capsules
Poland
Pregabalin Reddy
Slovakia
Pregabalin Reddy 25, 50, 75, 100, 150, 200, 225, 300 mg hard capsules

Date of last revision of the leaflet: 07/2024