Pregabalin reddy

Package leaflet: 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
Pregabalinum
Please read all of this leaflet carefully before 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Pregabalin Reddy belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain, and generalized anxiety disorders in adults.
Peripheral and central neuropathic pain: Pregabalin Reddy is used to treat long-lasting pain caused by nerve damage. Various diseases such as diabetes or shingles may cause peripheral neuropathic pain. Pain sensations may be described as burning, shooting, stabbing, tingling, electric shocks, sharp pain, cramps, aching, pins and needles, or numbness. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, which can affect the patient's physical and social functioning and overall quality of life.
Epilepsy: Pregabalin Reddy is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Pregabalin Reddy if previous treatment has not fully controlled the disease. Pregabalin Reddy should always be used as an add-on therapy to your current treatment. Pregabalin Reddy must not be used as monotherapy, but always in combination with other antiepileptic medicines.
Generalized anxiety disorder: Pregabalin Reddy is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD include prolonged, excessive anxiety and worry that are difficult to control. GAD may also cause motor restlessness, nervousness or feeling keyed up, easy fatigability, difficulty concentrating or a feeling of "mind going blank", irritability, increased muscle tension, or sleep disturbances. These symptoms are different from the everyday stresses and strains of normal life.

2. Important information before using Pregabalin Reddy

When not to use 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 treatment with Pregabalin Reddy, discuss this with your doctor or
pharmacist.

• Some patients taking Pregabalin Reddy have experienced symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, or throat, as well as widespread skin rash. If any of these symptoms occur, contact your doctor immediately.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. If the patient develops any symptoms of serious skin reactions listed in section 4, treatment with pregabalin must be discontinued and immediate medical help sought.
• Treatment with Pregabalin Reddy may cause dizziness and drowsiness: this may lead to an increased risk of accidental injury (falls), especially in elderly patients. Therefore, caution should be exercised until the patient becomes familiar with the possible effects of the medicine.
• Treatment with Pregabalin Reddy may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If any changes in vision occur, inform your doctor immediately.
• In diabetic patients who gain weight during pregabalin treatment, adjustment of antidiabetic therapy may be necessary.
• Some adverse effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g. painkillers or muscle relaxants, which have similar adverse effects to Pregabalin Reddy, and the severity of these effects may be greater when such medicines are taken concomitantly.
• Cases of heart failure have been reported in some patients taking Pregabalin Reddy; these were mainly elderly patients with cardiovascular disorders. Before taking this medicine, inform your doctor if you have ever had heart disease.
• Cases of kidney failure have been reported in some patients taking Pregabalin Reddy. If the patient notices a decrease in the frequency of urination while taking Pregabalin Reddy, inform the doctor, as discontinuation of the medicine may lead to resolution of this symptom.
• A small number of patients taking antiepileptic medicines such as Pregabalin Reddy have had thoughts of self-harm or suicide, or exhibited suicidal behaviour. If the patient ever experiences such thoughts or behaviour, contact the doctor immediately.
• If Pregabalin Reddy is used concomitantly with other medicines that may cause constipation (such as certain painkillers), gastrointestinal problems (e.g. constipation, bowel obstruction, or intestinal paralysis) may occur. Inform the doctor if the patient experiences constipation, especially if there is a predisposition to it.
• Before starting treatment with this medicine, inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Pregabalin Reddy.
• Seizures have been reported during treatment with Pregabalin Reddy or shortly after discontinuation. If seizures occur, contact the doctor immediately.
• Cases of worsening brain function (encephalopathy) have been reported in some patients with other underlying diseases who were treated with Pregabalin Reddy. Inform the doctor about all previous serious illnesses, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If the patient has neurological disorders, breathing problems, kidney dysfunction, or is aged 65 years or older, the doctor may recommend an alternative dosing regimen. If the patient develops breathing difficulties or shallow breathing, contact the doctor.

Dependence
Some individuals may become dependent on Pregabalin Reddy (a need to continue taking the medicine). Withdrawal symptoms may occur after stopping Pregabalin Reddy (see section 3 “How to use Pregabalin Reddy” and “Stopping Pregabalin Reddy”). If the patient is concerned about possibly becoming dependent on Pregabalin Reddy, they should definitely discuss this with their doctor.
If the patient notices any of the following symptoms while taking Pregabalin Reddy, this may indicate dependence:

• Needing to take the medicine for longer than prescribed by the doctor
• Feeling the need to take a higher dose than recommended
• Taking the medicine for reasons other than those for which it was prescribed
• Repeated unsuccessful attempts to stop or control taking the medicine
• Feeling unwell after stopping the medicine and feeling better after restarting it

If the patient notices any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when and how to stop taking the medicine safely.

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

Pregabalin Reddy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregabalin Reddy and certain medicines may interact with each other. When taken together with other central nervous system depressants (including opioids), Pregabalin Reddy may enhance these effects and cause respiratory depression, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if Pregabalin Reddy is taken together with medicines containing:

• oxycodone – (a painkiller)
• lorazepam – (a medicine used for anxiety)
• alcohol

Pregabalin Reddy may be used together with oral contraceptives.

Taking Pregabalin Reddy with food, drink, and alcohol
Pregabalin Reddy capsules may be taken with or without food.
Alcohol should not be consumed while taking Pregabalin Reddy.

Pregnancy and breastfeeding
Pregabalin Reddy should not be used during pregnancy or breastfeeding unless otherwise decided by the doctor. Taking pregabalin during the first three months of pregnancy may cause congenital malformations in the unborn child requiring treatment. In a Scandinavian country study, analysis of data from women who took pregabalin during the first three months of pregnancy showed congenital malformations in 6 out of every 100 live births, compared to 4 out of every 100 live births in women not treated with pregabalin. Reported congenital malformations involved the face (cleft lip/palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing potential should use an effective method of contraception. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
Pregabalin Reddy may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until the effect of this medicine on the ability to perform such activities has been determined.

Pregabalin Reddy contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Pregabalin Reddy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. it is considered "sodium-free".

3. How to take Pregabalin Reddy

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist. Do not take more medicine than prescribed.
The dose will be determined by the doctor according to what is most appropriate for the individual patient.
Pregabalin Reddy is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy or generalized anxiety disorders:

• Take the number of capsules prescribed by your doctor.
• The recommended dose will range from 150 mg to 600 mg per day.
• Your doctor will inform you whether Pregabalin Reddy should be taken twice or three times a day. If taken twice daily, Pregabalin Reddy should be taken in the morning and evening at the same time each day. If taken three times daily, Pregabalin Reddy should be taken in the morning, at midday, and in the evening at the same time each day.

If you feel that Pregabalin Reddy is too strong or not strong enough, inform your doctor or pharmacist.
Patients over 65 years of age should take Pregabalin Reddy according to the recommended regimen unless they have kidney disease.
In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose.
The capsule should be swallowed whole with water.
Continue taking Pregabalin Reddy for as long as your doctor recommends. Do not stop treatment without medical advice.
Taking more Pregabalin Reddy than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department. Take the medicine package or bottle with you. After taking more than the prescribed dose of Pregabalin Reddy, you may feel drowsy, confused, agitated or restless. Seizures and loss of consciousness (coma) have also been reported.
If you miss a dose of Pregabalin Reddy
It is important to take Pregabalin Reddy regularly at the same times each day. If you miss a dose, take it as soon as possible unless it is almost time for your next dose. In that case, continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Pregabalin Reddy
Do not stop taking Pregabalin Reddy suddenly. If you wish to discontinue treatment with Pregabalin Reddy, speak to your doctor first. Your doctor will advise you how to do this. If treatment needs to be stopped, it should be done gradually over at least one week. Be aware that after short- or long-term treatment with Pregabalin Reddy, certain unwanted effects known as withdrawal symptoms may occur. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness.
These symptoms may be more frequent or more severe if you have taken Pregabalin Reddy for a long time. If withdrawal symptoms occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common – may occur in more than 1 in 10 people:

• Dizziness, somnolence, headache

Common – may occur in not more than 1 in 10 people:

• Increased appetite
• Euphoria, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory impairment, memory loss, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling
• Blurred vision, double vision
• Dizziness, balance disorders, fall
• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension
• Erectile dysfunction
• Swelling of the body, including limbs
• Feeling of alcohol intoxication, abnormal gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat

Uncommon – may occur in not more than 1 in 100 people:

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in perception of self, psychomotor agitation, depression, excitement, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased libido, sexual problems, including inability to achieve orgasm, delayed ejaculation
• Visual disturbances, unusual eye movements, visual impairment including tunnel vision, perception of flashes of light, jerky movements, reduced reflexes, increased activity, dizziness in standing position, skin hypersensitivity, loss of taste, burning sensation, intention tremor, disturbances of consciousness, loss of consciousness, fainting, syncope, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, impaired eye movement, tearing, eye irritation
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden reddening of the face, hot flushes
• Breathing difficulties, dry nose, stuffy nose sensation
• Increased salivation, heartburn, tingling sensation 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 urge to urinate, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function (increased creatine kinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration)
• Hypersensitivity, facial swelling, itching, urticaria, catarrh, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

Rare – may occur in not more than 1 in 1,000 people:

• Altered sense of smell, sensation of image oscillation, altered depth perception, vivid vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, tightness in throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or limited movements
• Difficulties with writing function
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG corresponding to heart rhythm disturbances
• Muscle damage
• Nipple discharge, breast enlargement, gynaecomastia in men
• Absence of menstruation
• Renal failure, reduced urine volume, urine retention
• Decreased white blood cell count
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and serious skin reactions characterised by red, flat, disc-shaped or circular lesions on the trunk, often with blisters in the centre, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. Such serious 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 resembling Parkinson's disease such as tremor, bradykinesia (reduced ability to move) and rigidity (muscle stiffness)

Very rare – may occur in not more than 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’)

It should be noted that after discontinuation of short- or long-term treatment with Pregabalin Reddy, certain adverse reactions, known as withdrawal symptoms, may occur (see section “Discontinuing treatment with Pregabalin Reddy”).

If swelling of the face or tongue, or skin redness occurs, along with blisters or skin peeling, medical help should be sought immediately.

Some adverse reactions, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g. painkillers or muscle relaxants, which have similar adverse effects to Pregabalin Reddy, and the severity of these effects may be greater when such medicines are taken concomitantly.

After the medicine was placed on the market, the following adverse reactions have also been reported: breathing difficulties, shallow breathing.

Reporting of adverse reactions

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pregabalin Reddy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package or
bottle after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. Following this advice will help
protect the environment.

6. Contents of the pack and other information

What Pregabalin Reddy contains

• The active substance 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: monohydrate lactose, corn starch, talc
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate
Ink: shellac, black iron oxide (E 172), potassium hydroxide.

Pregabalin Reddy 75 mg, 100 mg, 200 mg, 225 mg, 300 mg, hard capsules
Capsule contents: monohydrate lactose, corn starch, talc
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, iron oxide red (E 172)
Ink: shellac, black iron oxide (E 172), potassium hydroxide.

Pregabalin Reddy, hard capsules, 25 mg:
PVC/PVDC/Aluminium foil blister containing 56 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 50 mg:
PVC/PVDC/Aluminium foil blister containing 56 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 75 mg:
PVC/PVDC/Aluminium foil blister containing 56 or 84 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 100 mg:
PVC/PVDC/Aluminium foil blister containing 84 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 150 mg:
PVC/PVDC/Aluminium foil blister containing 56 or 84 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 200 mg:
PVC/PVDC/Aluminium foil blister containing 84 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 225 mg:
PVC/PVDC/Aluminium foil blister containing 56 capsules in a cardboard box.
Pregabalin Reddy, hard capsules, 300 mg:
PVC/PVDC/Aluminium foil blister containing 56 capsules in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised for marketing in 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 Hartkapseln
Austria Pregabalin Reddy 25, 50, 75, 100, 150, 200, 225, 300 mg Hartkapseln
Czech Republic Pregabalin Reddy
Netherlands Pregabaline Reddy 25, 50, 75, 100, 150, 200, 225, 300 mg harde capsules
Poland Pregabalin Reddy
Slovakia Pregabalin Reddy 25, 50, 75, 100, 150, 200, 225, 300 mg tvrdé kapsuly