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 later.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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, with or without secondary generalization) 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 strains of everyday life.

2. Important information before taking Pregabalin Reddy

When not to take Pregabalin Reddy

If the patient is 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, the patient should discuss it with their 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, the patient should contact their doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient experiences any of the serious skin reactions listed in section 4, they 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 elderly people. Therefore, caution should be exercised until the effects of the medicine are known.
• Taking Pregabalin Reddy may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If any changes in vision occur, the patient should inform their 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. Before taking this medicine, the patient should inform their doctor about any history of heart disease.
• There have been reports of kidney failure in some patients taking Pregabalin Reddy. If the patient notices a decrease in urine output while taking Pregabalin Reddy, they should inform their 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 shown suicidal behavior. If the patient has ever had such thoughts or behavior, they should contact their 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 the patient is concerned that they may become dependent on Pregabalin Reddy, they should discuss this with their doctor.
If the patient notices 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
• Feeling unwell after stopping the medicine and feeling better after taking it again If the patient notices any of these symptoms, they should discuss them with their 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 Reddy 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 - (painkiller)
• 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.
The patient should not drink alcohol while taking Pregabalin Reddy.

Pregnancy and breastfeeding

Pregabalin Reddy should not be taken during pregnancy or breastfeeding, unless the doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby that require treatment. In a Scandinavian study, analysis of data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of every 100 babies born, whereas in women who did not take pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genitals.
Women of childbearing age should use effective contraception. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Pregabalin Reddy may cause dizziness, drowsiness, and decreased concentration. The patient should not drive a car, operate complex machines, or perform potentially dangerous activities until they know how the medicine affects their ability to perform these activities.

Pregabalin Reddy contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their 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 it is essentially "sodium-free".

3. How to take Pregabalin Reddy

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not take more of the medicine than prescribed.
The doctor will determine the dose of the medicine that is most suitable for the patient.
Pregabalin Reddy is for oral use only.

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

• The patient should take the number of capsules prescribed by their doctor.
• The recommended dose for the patient will be between 150 mg and 600 mg per day.
• The doctor will inform the patient whether to take Pregabalin Reddy twice or three times a day. When taken twice a day, Pregabalin Reddy should be taken in the morning and evening at the same time every day. When taken three times a day, Pregabalin Reddy should be taken in the morning, at noon, and in the evening at the same time every day.

If the patient feels that Pregabalin Reddy is too strong or too weak, they should inform their doctor or pharmacist.
Patients over 65 years of age should take Pregabalin Reddy according to the presented schedule, unless they have kidney disease.
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 the doctor prescribes, and the treatment can only be stopped on the doctor's advice.

Taking a higher dose of Pregabalin Reddy than prescribed

The patient should inform their doctor or go immediately to the nearest hospital emergency department. The patient should take the packaging or bottle of Pregabalin Reddy with them. After taking a higher dose of Pregabalin Reddy than prescribed, the patient 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 a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. In this case, the patient should continue treatment according to the prescribed schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Pregabalin Reddy

The patient should not stop taking Pregabalin Reddy suddenly. If the patient wants to stop taking Pregabalin Reddy, they should first discuss it with their doctor. The doctor will inform them how to do it. If the treatment needs to be stopped, it should be done gradually over at least one week. The patient 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 the patient has taken Pregabalin Reddy for a longer period. If withdrawal symptoms occur, the patient should contact their doctor.
In case of any further doubts about taking this medicine, the patient should consult their 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 impairment, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling unusual
• Blurred vision, double vision
• Dizziness, balance disturbances, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea
• Difficulty achieving an erection
• Swelling of the body, including limbs
• Feeling of intoxication, abnormal gait
• Weight gain
• Muscle cramps, 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, increased skin sensitivity, loss of taste, burning sensation, tremors when moving, impaired 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 twitching, 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, coughing, 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
• Slow or limited movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG corresponding to heart rhythm disturbances
• Muscle damage
• Spontaneous milk flow from the breast, breast enlargement, gynecomastia (breast enlargement 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 the appearance of reddened, flat, plate-like or round patches on the torso, often with blisters in their centers, 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 those of 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")

The patient 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, the patient 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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, phone: +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.
The patient should not take 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. The patient should ask their 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
Phone: +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