PREGABALIN DOC GENERICI

Patient Information Leaflet

PREGABALIN DOC Generics 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 300 mg hard capsules

Generic medicine
Please read 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 you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What PREGABALIN DOC Generici is and what it is used for

PREGABALIN DOC Generici 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 DOC Generici 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, pulsations, shooting pains, stabbing pains, sharp pains, cramps, discomfort, tingling, numbness, or pricking pains. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue (tiredness), and can impact physical and social activities and overall quality of life.
Epilepsy: PREGABALIN DOC Generici is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor has prescribed PREGABALIN DOC Generici to help manage your epilepsy when your current treatment is not adequately controlling your condition. You must take PREGABALIN DOC Generici in addition to your existing treatment. PREGABALIN DOC Generici is not used as monotherapy but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: PREGABALIN DOC Generici 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 everyday stress and life pressures.

2. What you need to know before taking PREGABALIN DOC Generici

Do not take PREGABALIN DOC Generici

• 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 DOC Generici.

• Severe 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 of the symptoms related to these serious skin reactions described in section 4.
• In some patients treated with PREGABALIN DOC Generici, 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 any of these reactions occur, contact your doctor immediately.
• PREGABALIN DOC Generici 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 are familiar with the effects this medicine may have.
• PREGABALIN DOC Generici may cause blurred vision or 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 pregabalin treatment, adjustments to 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 side effects similar to those of 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 DOC Generici; most of these patients were elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with this medicine, you must inform your doctor.
• Cases of renal failure have been reported in some patients treated with PREGABALIN DOC Generici.

If during treatment with PREGABALIN DOC Generici you notice a decrease in urination,
inform your doctor, as this condition may improve upon discontinuation of the medicine.

• Some patients treated with antiepileptic medicines such as PREGABALIN DOC Generici have experienced suicidal thoughts or self-harming thoughts (hurting oneself) or exhibited suicidal behaviour. If at any time you have such thoughts or behaviours, contact your doctor immediately.
• When PREGABALIN DOC Generici is used concomitantly with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g. constipation, intestinal obstruction or paralysis) 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 DOC Generici.
• Seizures have been reported when taking PREGABALIN DOC Generici or shortly after discontinuing it. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking PREGABALIN DOC Generici when they have other medical conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of breathing difficulties have occurred. If you have neurological disorders, respiratory diseases, renal impairment, or are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform your doctor if you experience breathing difficulties or shallow breathing.

Dependence
Some people may become dependent on PREGABALIN DOC Generici (i.e., feel the need to continue taking the medicine). They may experience withdrawal symptoms when they stop using PREGABALIN DOC Generici (see section 3, “How to take PREGABALIN DOC Generici” and “If you stop taking PREGABALIN DOC Generici”). If you are concerned about the possibility of developing dependence on PREGABALIN DOC Generici, talk to your doctor.
If you notice any of the following signs while taking PREGABALIN DOC Generici, 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 your 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, and therefore pregabalin should not be used in this age group.

Other medicines and PREGABALIN DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
PREGABALIN DOC Generici and other medicines may interact with each other. When PREGABALIN DOC Generici is taken together with other medicines that have sedative effects (including opioids), PREGABALIN DOC Generici may enhance these effects and could cause respiratory failure, coma, and death. The intensity of dizziness, somnolence, and reduced concentration may increase if PREGABALIN DOC Generici is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol
PREGABALIN DOC Generici may be taken concomitantly with oral contraceptives.

PREGABALIN DOC Generici with food, drinks and alcohol
PREGABALIN DOC Generici capsules may be taken with or without food.
It is advisable not to drink alcohol during treatment with PREGABALIN DOC Generici.

Pregnancy and breastfeeding
PREGABALIN DOC Generici should not be taken during pregnancy or breastfeeding unless your doctor has advised otherwise.
Use of pregabalin during the first 3 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 3 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 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
PREGABALIN DOC Generici may cause dizziness, somnolence, and reduced concentration. Do not drive, operate complex machinery, or engage in potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.

PREGABALIN DOC Generici contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take PREGABALIN DOC Generici

Take this medicine exactly as directed 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 dose appropriate for you.
PREGABALIN DOC Generici is for oral use.

Neuropathic pain (peripheral and central), Epilepsy or Generalized Anxiety Disorder:

• Take the number of capsules prescribed by your doctor.
• The appropriate dose for you and your condition generally ranges between 150 mg and 600 mg daily.
• Your doctor will instruct you to take PREGABALIN DOC Generici two or three times a day. If you take the medicine twice daily, take one dose in the morning and one in the evening, approximately at the same time each day. If you take the medicine three times daily, take one dose in the morning, one in the afternoon, and one in the evening, approximately at the same time each day.

If you feel that the effect of PREGABALIN DOC Generici is too strong or too weak, inform your doctor or pharmacist.
If you are elderly (over 65 years of age), you should normally take PREGABALIN DOC Generici unless you have kidney problems.
Your doctor may prescribe you a different dosage and/or dose adjustment if you have kidney problems.
Swallow the capsule whole with water.
Continue taking PREGABALIN DOC Generici until your doctor tells you to stop treatment.

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

If you forget to take PREGABALIN DOC Generici
It is important to take PREGABALIN DOC Generici 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 that case, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten capsule.

If you stop taking PREGABALIN DOC Generici
Do not stop taking PREGABALIN DOC Generici suddenly. If you wish to discontinue treatment with PREGABALIN DOC Generici, discuss this with your doctor first. Your doctor will advise you on how to do this properly.
If treatment is to be stopped, discontinuation should be carried out gradually over a period of at least 1 week.
You should know that after stopping long-term or short-term treatment with PREGABALIN DOC Generici, certain undesirable effects may occur, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness.
These effects may occur more frequently or be more severe if you have taken PREGABALIN DOC Generici for a longer period of time. If you experience withdrawal effects, contact your doctor.
If you have any 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 everyone experiences 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.
• Feeling of excitement, confusion, disorientation, decreased interest in sex, irritability.
• Attention disorders, clumsiness, memory impairment, 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.
• Erectile dysfunction.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, gait abnormalities.
• 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 levels, high blood sugar levels.
• Altered perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered 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, eye movement abnormalities, 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, loss of consciousness, fainting, increased sensitivity to noise, feeling of malaise.
• Dry eyes, eye swelling, eye pain, eye weakness, eye 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, nasal dryness, nasal congestion.
• Increased saliva production, heartburn, loss of sensitivity 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 (increase in serum creatine phosphokinase, increase in alanine aminotransferase, increase in aspartate aminotransferase, decrease in platelet count, neutropenia, increased creatinine in blood, decreased potassium levels).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

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

• Changes in smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Accumulation of fluid in the abdomen.
• Presence of fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) changes indicating heart rhythm disturbances.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast enlargement in men.
• Interrupted menstrual cycles.
• 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 severe skin reaction characterized by flat, non-elevated red patches on the trunk, target-shaped or circular rashes, often with central blisters, skin exfoliation, 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, symptoms resembling Parkinson's disease such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness).

Very rare: may occur in no more than 1 in 10,000 people:

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

Not known: frequency cannot be estimated from the available data

• Becoming dependent on PREGABALIN DOC Generici (“drug dependence”).

After stopping short-term or long-term treatment with PREGABALIN DOC Generici, you should be aware that you might experience some side effects, known as withdrawal effects (see “If you stop taking PREGABALIN DOC Generici”).

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, contact your doctor immediately.

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 during the post-marketing phase of the medicine: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PREGABALIN DOC Generici

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use any pack that is damaged or shows signs of tampering.
Do not dispose of medicines 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 DOC Generici contains
The active substance is pregabalin.
PREGABALIN DOC Generici 25 mg hard capsules: each hard capsule contains 25 mg of pregabalin
PREGABALIN DOC Generici 50 mg hard capsules: each hard capsule contains 50 mg of pregabalin
PREGABALIN DOC Generici 75 mg hard capsules: each hard capsule contains 75 mg of pregabalin
PREGABALIN DOC Generici 100 mg hard capsules: each hard capsule contains 100 mg of pregabalin
PREGABALIN DOC Generici 150 mg hard capsules: each hard capsule contains 150 mg of pregabalin
PREGABALIN DOC Generici 200 mg hard capsules: each hard capsule contains 200 mg of pregabalin
PREGABALIN DOC Generici 300 mg hard capsules: each hard capsule contains 300 mg of pregabalin

The other ingredients are: monohydrate lactose, pregelatinized starch, talc, gelatin, titanium dioxide (E171), black iron oxide (E172) (25 mg, 50 mg, 75 mg, 150 mg and 300 mg capsules), red iron oxide (E172) (75 mg, 100 mg, 200 mg and 300 mg capsules), yellow iron oxide (E172) (75 mg, 100 mg, 200 mg and 300 mg capsules), and black ink (containing shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide).

Description of the appearance of PREGABALIN DOC Generici and package contents

PREGABALIN DOC Generici is available in various PVC packages with an aluminium-coated side:
PREGABALIN DOC Generici 25 mg hard capsules: package containing 14 capsules in 1 blister
PREGABALIN DOC Generici 50 mg hard capsules: package containing 21 capsules in 1 blister
PREGABALIN DOC Generici 75 mg hard capsules: package containing 14 capsules in 1 blister and a package containing 56 capsules in 4 blisters
PREGABALIN DOC Generici 100 mg hard capsules: package containing 21 capsules in 1 blister
PREGABALIN DOC Generici 150 mg hard capsules: package containing 14 capsules in 1 blister and a package containing 56 capsules in 4 blisters
PREGABALIN DOC Generici 200 mg hard capsules: package containing 21 capsules in 1 blister
PREGABALIN DOC Generici 300 mg hard capsules: package containing 56 capsules in 4 blisters

Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Medis International a.s., Karlovo náměstí 319/3, Prague 2, 1200, Czech Republic.
Vamfarma S.r.l., Via Kennedy 5, 26833 Comazzo (Lodi), Italy.
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