Pregabalin medreg

Package leaflet: Information for the patient

Pregabalin Medreg, 75 mg, hard capsules
Pregabalin Medreg, 150 mg, hard capsules
Pregabalinum
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

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

Pregabalin Medreg belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: Pregabalin Medreg is used to treat long-term pain caused by nerve damage. Various conditions, such as diabetes or shingles, can cause peripheral neuropathic pain. The pain may be described as a sensation of heat, burning, throbbing, shooting, stabbing, sharp pain, cramps, aching, tingling, or numbness. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, which may affect the patient's physical and social functioning and overall quality of life.

Epilepsy: Pregabalin Medreg is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Pregabalin Medreg if previous treatment has not fully controlled the condition. Pregabalin Medreg should always be used as an add-on therapy to current treatment. Pregabalin Medreg must not be used as monotherapy (as the sole antiepileptic medicine), but always in combination with other antiepileptic drugs.

Generalized anxiety disorder: Pregabalin Medreg is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD include persistent, excessive anxiety and worry that are difficult to control. GAD may also cause motor restlessness, nervousness or a feeling of being keyed up, easy fatigability, difficulty concentrating or a feeling of "mind going blank", irritability, increased muscle tension, or sleep disturbances. These symptoms are distinct from the stress and tension associated with everyday life.

2. Important information before using Pregabalin Medreg

When not to use Pregabalin Medreg

• 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 Medreg, discuss this with your doctor or
pharmacist.

• Some patients taking Pregabalin Medreg have experienced symptoms suggesting an allergic reaction. These symptoms include: swelling of the face, lips, tongue and throat, as well as widespread skin rash. If any of these symptoms occur, contact your doctor immediately.

• Use of Pregabalin Medreg has been associated with dizziness and drowsiness, which may lead to an increased risk of accidental injuries (falls) in elderly patients. Therefore, caution should be exercised until the patient's response to the medicine is known.

• Treatment with Pregabalin Medreg may cause blurred vision, loss of vision or other visual disturbances, most of which are transient. If any changes in vision occur, inform your doctor immediately.

• In diabetic patients who gain weight during treatment with pregabalin, 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, and these effects may be intensified when such medicines are taken concomitantly.

• Cases of heart failure have been reported in some patients taking Pregabalin Medreg; these were mainly elderly patients with cardiovascular disorders. Before taking this medicine, the patient should inform the doctor if they have ever had heart disease.

• Cases of renal failure have been reported in some patients taking Pregabalin Medreg. If the patient notices a decrease in frequency of urination while taking Pregabalin Medreg, inform the doctor, as discontinuation of the medicine may lead to resolution of this symptom.

• Some patients taking antiepileptic medicines, such as Pregabalin Medreg, have had thoughts of self-harm or suicide. If such thoughts or behaviours occur, contact your doctor immediately.

• If Pregabalin Medreg is taken 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 your doctor if the patient experiences constipation, especially if they are prone 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 Medreg.

• Seizures have been reported during treatment with Pregabalin Medreg or shortly after discontinuation of Pregabalin Medreg. If seizures occur, contact your doctor immediately.

• Cases of worsening brain function (encephalopathy) have been reported in some patients with coexisting medical conditions who were taking Pregabalin Medreg. Inform your doctor about all serious medical conditions the patient has had, including liver or kidney disease.

• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney dysfunction or is over 65 years of age, the doctor may recommend an alternative dosing regimen. If the patient develops breathing difficulties or shallow breathing, contact the doctor.

• Severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis, has been reported with pregabalin. If the patient develops any of the symptoms of serious skin reactions listed in section 4, treatment with pregabalin should be discontinued and immediate medical help sought.

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

• Need 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 use of the medicine.
• Feeling unwell after stopping the medicine and feeling better after restarting it. If the patient notices any of these symptoms, they should discuss them with their doctor to determine 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 Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
Pregabalin Medreg and certain other medicines may interact with each other.
When taken concomitantly with other medicines that have a depressant effect on the central nervous system (including opioids), Pregabalin Medreg may intensify these effects and cause respiratory depression, coma and death. The severity of dizziness, drowsiness and reduced concentration may increase if Pregabalin Medreg is taken together with medicines containing:

• oxycodone (used as a painkiller)
• lorazepam (used for anxiety)
• alcohol

Pregabalin Medreg may be taken together with oral contraceptives.

Taking Pregabalin Medreg with food, drink and alcohol
Pregabalin Medreg capsules may be taken with or without food.
Alcohol should not be consumed during treatment with Pregabalin Medreg.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregabalin Medreg 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 study from Scandinavian countries, 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 with 4 out of every 100 live births in women who were 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.

Driving and using machines
Pregabalin Medreg 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 Medreg contains lactose
Patients with known intolerance to certain sugars should consult their doctor before taking this medicine.

3. How to take Pregabalin Medreg

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist. Do not take a higher dose than prescribed.
Your doctor will determine the dose that is most suitable for you.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

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

If you feel that Pregabalin Medreg is too strong or not strong enough, you should inform your
doctor or pharmacist.
Elderly patients (over 65 years of age) should take Pregabalin Medreg according to the recommended
schedule unless they have kidney disease.
For patients with impaired kidney function, your doctor may decide on a different dosing schedule
and/or adjust the dose of the medicine.
Pregabalin Medreg is intended for oral use only.
Swallow the capsule whole with water.
Continue taking Pregabalin Medreg as long as your doctor has not advised you to stop.
Taking more Pregabalin Medreg 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 Medreg, you may feel drowsy, confused, agitated, or restless. Seizures and loss of
consciousness (coma) have also been reported.
Missing a dose of Pregabalin Medreg
It is important to take Pregabalin Medreg regularly at the same time 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 Medreg
Do not suddenly stop taking Pregabalin Medreg. If you wish to discontinue treatment with
Pregabalin Medreg, you should first discuss this with your doctor. Your doctor will advise you
on 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 Medreg, certain
adverse effects may occur, known as withdrawal symptoms. These symptoms include sleep
disturbances, headache, nausea, feelings of 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 severe if you have been taking Pregabalin Medreg
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very common (may affect more than 1 in 10 patients):

• dizziness, drowsiness, headache

Common (may affect up to 1 in 10 patients):

• increased appetite
• elevated mood, confusion, disorientation, decreased sexual interest, 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
• difficulty achieving erection
• swelling of the body, including limbs
• feeling of alcohol intoxication, unusual gait
• weight gain
• muscle cramps, joint pain, back pain, limb pain
• sore throat

Uncommon (may affect up to 1 in 100 patients):

• loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• changes in self-perception, psychomotor agitation, depression, restlessness, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased sexual interest, sexual problems including inability to achieve orgasm, delayed ejaculation
• vision changes, unusual eye movements, visual disturbances including tunnel vision, perception of flashes, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin hypersensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• dry eyes, eye swelling, eye pain, weakness of eye movements, 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 facial skin, sudden hot flushes
• difficulty breathing, dryness in the nose, sensation of nasal congestion
• increased salivation, heartburn, 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 pain during urination, urinary incontinence
• weakness, thirst, chest tightness
• changes in blood test results and liver function (increased creatine phosphokinase, 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 affect up to 1 in 1,000 patients):

• altered sense of smell, sensation of swaying vision, altered depth perception, vivid vision, vision loss
• dilated pupils, strabismus
• cold sweats, throat tightness, tongue swelling
• pancreatitis
• difficulty swallowing
• slowed or limited body movements
• difficulty writing properly
• ascites
• fluid in the lungs
• seizures
• ECG changes indicating heart rhythm disturbances
• muscle damage
• nipple discharge, gynecomastia, breast enlargement in males
• absence of menstruation
• kidney failure, reduced urine volume, urinary retention
• decreased white blood cell count
• inappropriate behaviour, suicidal behaviour, suicidal thoughts
• allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and a serious skin reaction characterised by red, flat, disc-shaped or circular spots on the trunk, often with blisters in their centre, peeling of the skin, oral, throat, nose, genital and ocular ulcers. 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 movement ability) and rigidity (muscle stiffness)

Very rare (may affect up to 1 in 10,000 patients):

• liver failure
• hepatitis

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

• dependence on Pregabalin Medreg (‘drug dependence’)

It should be noted that certain side effects, known as withdrawal symptoms, may occur after discontinuation of short- or long-term treatment with Pregabalin Medreg (see section “Discontinuing treatment with Pregabalin Medreg”).
If swelling of the face or tongue occurs, or if skin redness appears accompanied by blisters or peeling, medical advice must be sought immediately.
Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines for conditions such as pain or spasticity, which have similar side effects to pregabalin, and the severity of these effects may be increased when such medicines are taken concomitantly.
After the medicine was placed on the market, the following side effects have been reported: breathing difficulties, shallow breathing.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Pregabalin Medreg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Pregabalin Medreg contains

• The active substance is pregabalin. Each hard capsule contains 75 mg or 150 mg of pregabalin.
• The other ingredients are: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E 171), indigo carmine (E 132, for 75 mg only), and erythrosine (E 127, for 75 mg only).

What Pregabalin Medreg looks like and contents of the pack
Pregabalin Medreg, 75 mg:
Hard gelatin capsules, size no. 4, with a white body and burgundy cap,
containing white or almost white powder.
Pregabalin Medreg, 150 mg:
Hard gelatin capsules, size no. 2, with a white body and white cap,
containing white or almost white powder.
The capsules are supplied in PVC/PVDC/Aluminum foil blisters, packed in a cardboard box.
Pack sizes: 14, 28, 30, 56, 60, 84, 90, 98, 100 or 112 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer:
Laboratorios Liconsa S.A.
Avda. Miralcampo, 7, Pol. Ind. Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Pregabalin Medreg
Poland: Pregabalin Medreg
Slovakia: Pregabalin Medreg 75 mg
Pregabalin Medreg 150 mg