Pregabalin Zentiva

Patient Information Leaflet: Information for the User

Pregabalin Zentiva 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules, 300 mg hard capsules

pregabalin
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 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 yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Pregabalin Zentiva belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain
Pregabalin Zentiva is used to treat chronic pain caused by damage to the nervous system. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsing, throbbing, shooting, stabbing, sharp, or cramping pain, discomfort, tingling, numbness, or prickling. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, and can impact physical and social activities and overall quality of life.
Epilepsy
Pregabalin Zentiva is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Zentiva to help manage your epilepsy when your current treatment is not adequately controlling your seizures. You will need to take Pregabalin Zentiva in addition to your existing treatment. Pregabalin Zentiva is not used alone but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder
Pregabalin Zentiva is used to treat Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder may also cause restlessness or a feeling of being tense or on edge, easy fatigability (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from the everyday stress and pressures of normal life.

2. What you need to know before taking Pregabalin Zentiva

Do not take Pregabalin Zentiva

• if you are allergic to pregabalin or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Pregabalin Zentiva.

• In some patients treated with pregabalin, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• Serious skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop using pregabalin and contact your doctor immediately if you develop any symptoms related to these severe skin reactions described in section 4.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have on you.
• Pregabalin may cause blurred vision, loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbance, contact your doctor immediately.
• In diabetic patients who gain weight during treatment with pregabalin, adjustment of diabetes medications may be necessary.
• Some side effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to pregabalin, and the severity of these effects may increase when these medicines are taken together.
• Cases of heart failure have been reported in some patients treated with pregabalin; most of these patients were elderly with cardiovascular disease. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
• Cases of renal failure have been reported in some patients treated with pregabalin. If you notice a decrease in urine output during treatment with pregabalin, inform your doctor, as discontinuing the use of this medicine may improve this condition.
• Some patients taking antiepileptic medicines such as pregabalin have experienced suicidal thoughts and self-harm (hurting oneself) or exhibited suicidal behavior. If at any time you have such thoughts or exhibit suicidal behavior, contact your doctor immediately.
• When pregabalin is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, bowel obstruction, or paralytic ileus) may occur. Inform your doctor if you experience constipation, especially if you are prone to this condition.
• Before taking this medicine, inform your doctor if you have a history of alcohol, prescription medicine, or illegal substance abuse or dependence, as this may indicate that you are at higher risk of becoming dependent on Pregabalin Zentiva. Seizures have been reported when taking pregabalin or shortly after stopping it. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking pregabalin when other medical conditions are present. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Breathing difficulties have been reported. If you suffer from nervous system disorders, respiratory disorders, renal failure, or if you are over 65 years of age, your doctor may prescribe a different dosing regimen. Contact your doctor if you have difficulty breathing or if you breathe shallowly.

Dependence
Some people may become dependent on Pregabalin Zentiva (i.e., feel the need to continue taking the medicine). They may experience withdrawal symptoms when they stop using Pregabalin Zentiva (see section 3, “How to take Pregabalin Zentiva” and “If you stop taking Pregabalin Zentiva”). If you are concerned about the possibility of developing dependence on Pregabalin Zentiva, talk to your doctor.
If you notice any of the following signs while taking Pregabalin Zentiva, you may have developed dependence on the medicine:

• You feel the need to take the medicine longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons different from those for which it was prescribed
• You have made repeated unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine, you feel unwell and feel better when you start taking it again

If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including when and how to safely discontinue the medicine.

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

Other medicines and Pregabalin Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Zentiva and other medicines can affect each other (interaction). When pregabalin is taken together with other medicines that have sedative effects (including opioids), it may enhance these effects and could lead to respiratory failure, coma, and death. The intensity of dizziness, somnolence, and reduced concentration may increase if pregabalin is taken together with other medicines containing:

• Oxycodone – (used as an analgesic).
• Lorazepam – (used for the treatment of anxiety).
• Alcohol. Pregabalin Zentiva can be taken with oral contraceptives.

Pregabalin Zentiva with food and drink
Pregabalin Zentiva hard capsules can be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Zentiva.

Pregnancy and breastfeeding
Pregabalin Zentiva must not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise.
Taking pregabalin during the first three months of pregnancy may cause congenital malformations in the newborn requiring medical treatment. In a study examining data from women in Nordic countries who took pregabalin during the first three months of pregnancy, 6 out of 100 babies had such congenital malformations, compared to 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (oro-facial clefts), eye, nervous system (including the brain), kidney, and genital abnormalities have been reported.
Women of childbearing potential must use an effective method of contraception. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Pregabalin may cause dizziness, somnolence, and reduced concentration. You should not drive, operate heavy machinery, or engage in potentially dangerous activities until you know how this medicine affects your ability to perform these tasks.

Pregabalin Zentiva contains lactose monohydrate
If your doctor has told you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Pregabalin Zentiva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.
Pregabalin Zentiva is for oral use only.

Peripheral and central neuropathic pain, epilepsy or Generalized Anxiety Disorder
Take the number of hard capsules prescribed by your doctor.
The appropriate dose for you and your condition generally ranges between 150 mg and 600 mg per day.
Your doctor will instruct you to take Pregabalin Zentiva two or three times a day. If you take the medicine twice daily, take Pregabalin Zentiva once in the morning and once in the evening, always approximately at the same time. If you take the medicine three times daily, take Pregabalin Zentiva once in the morning, once in the afternoon, and once in the evening, always approximately at the same time.

If you feel that the effect of Pregabalin Zentiva is too strong or too weak, discuss this with your doctor or pharmacist.

If you are elderly (over 65 years of age), you should normally take Pregabalin Zentiva as directed, unless you have kidney problems.
Your doctor may prescribe you a different dosing schedule and/or a different dose if you have kidney problems.

Swallow the capsule whole with water.

Continue taking Pregabalin Zentiva until your doctor tells you to stop treatment.

If you take more Pregabalin Zentiva than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the pack of Pregabalin Zentiva capsules with you. You may feel drowsy, confused, agitated, and restless because you have taken more Pregabalin Zentiva than you should have. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Zentiva
It is important to take Pregabalin Zentiva hard capsules regularly every day at the same time.
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and take the next one at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Zentiva
Do not stop treatment with Pregabalin Zentiva abruptly.
If you wish to discontinue taking Pregabalin Zentiva, speak to your doctor first. Your doctor will advise you on how to do this.
If treatment is to be stopped, discontinuation should be gradual over a period of at least 1 week.

You should know that after stopping long-term or short-term treatment with Pregabalin Zentiva, certain undesirable effects may occur, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, depression, suicidal thoughts or self-harming thoughts, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have taken Pregabalin Zentiva for a longer period of time. If you experience withdrawal effects, contact your doctor.

If you have any questions about how to use 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.
If you experience swelling of the face or tongue, or if your skin becomes red and blisters start to form, or if skin peeling occurs, you must contact your doctor immediately.

Very common: may occur in more than 1 out of 10 people

• Dizziness, drowsiness, headache.

Common: may occur in up to 1 out of 10 people

• Increased appetite.
• Feeling of excitement, confusion, disorientation, decreased interest in sex, irritability.
• Attention disorders, clumsiness, impaired memory, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Dizziness, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, and abdominal swelling.
• Difficulty in erection.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, abnormal gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may occur in up to 1 out of 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased interest in sex, sexual problems including inability to reach orgasm, delayed ejaculation.
• Visual disturbances, abnormal eye movements, visual alterations including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
• Dry eyes, eye swelling, eye pain, eye weakness, tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disturbances (flushing), hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels, decreased potassium levels).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

Rare: may occur in up to 1 out of 1,000 people

• Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatic inflammation.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) changes corresponding to heart rhythm disorders.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast enlargement in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe reaction characterized by flat, non-elevated reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and 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 up to 1 out of 10,000 people

• Liver failure.
• Hepatitis (inflammation of the liver).

Not known: frequency cannot be estimated from the available data

• Becoming dependent on Pregabalin Zentiva (“drug dependence”).

After stopping short-term or long-term treatment with Pregabalin Zentiva, you should be aware that you may experience certain side effects, known as withdrawal effects (see “If you stop taking Pregabalin Zentiva”).
Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to Pregabalin, and the severity of these effects may increase when these medicines are taken together.
The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or bottle after "Exp". The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pregabalin Zentiva contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.

The other ingredients are: lactose monohydrate, pregelatinized corn starch, talc, black iron oxide (E 172), titanium dioxide (E 171), gelatin, black ink (containing shellac, black iron oxide (E 172), propylene glycol, strong ammonia solution, potassium hydroxide).
Capsules with strengths of 75 mg, 100 mg, 200 mg, 225 mg and 300 mg also contain red iron oxide (E 172), yellow iron oxide (E 172).

Pregabalin Zentiva 25 mg hard capsules are packaged in aluminium/aluminium blisters (OPA/
aluminium/PVC/ALU) or PVC/PVDC/ALU as primary packaging.
Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg hard capsules are
packaged in PVC/aluminium blisters as primary packaging.
Pregabalin Zentiva 25 mg and 50 mg hard capsules are available in packs of 14, 21, 56, 84, 98 and
100 hard capsules.
Pregabalin Zentiva 75 mg, 150 mg and 300 mg hard capsules are available in packs of 14,
56, 98, 100 and 112 hard capsules.
Pregabalin Zentiva 100 mg and 200 mg hard capsules are available in packs of 21, 84, 98 or 100
hard capsules.
Pregabalin Zentiva 225 mg hard capsules are available in packs of 14, 56, 98 and 100 hard
capsules.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic
or
S.C. Zentiva, S.A.
B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266
Romania

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +359 244 17 136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2034 1796
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +45 787 68 400
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva Spain S.L.U. Zentiva Polska Sp. z o.o.
Tel: +34 671 365 828 Tel: + 48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360
[email protected] [email protected]

Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021.304.7597
[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 5025 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39 800081631 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +30 211 198 7510 Tel: +46 840 838 822
[email protected] [email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.