PREGABALIN 25 mg Hard Capsules

Зміст інструкції

1. Pregabalin TecniGen 25 mg hard capsules
2. Pregabalin TecniGen 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules
   1. What is Pregabalin TecniGen and what it is used for
   2. What you need to know before taking Pregabalin TecniGen
   3. How to take Pregabalin TecniGen
   4. Possible side effects
   5. How to store Pregabalin TecniGen
   6. Package Contents and Other Information

Pregabalin TecniGen 25 mg hard capsules

PregabalinTecniGen 50 mg hard capsules

Pregabalin TecniGen 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Pregabalin TecniGen belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain: Pregabalin TecniGen is used to treat chronic pain caused by damage to the nervous system. Various diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations can be described as heat, burning, throbbing, pulsating, stabbing, sharp, cramping, suffering, tingling, numbness, pricking. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances and fatigue (tiredness) and can have an impact on physical and social activity and overall quality of life.

Epilepsy:Pregabalin TecniGen is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin TecniGen to help treat your epilepsy when the treatment you are already receiving does not control the situation. You will need to take Pregabalin TecniGen in addition to the treatment you are already undergoing. Pregabalin TecniGen is not used alone, but must always be associated with other antiepileptic treatments.

Generalised Anxiety Disorder:Pregabalin TecniGen is used to treat Generalised Anxiety Disorder (GAD). The symptoms of Generalised Anxiety Disorder are characterised by excessive and prolonged anxiety and worry that are difficult to control. Generalised Anxiety Disorder can also cause restlessness or a feeling of tension or being on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension or sleep disturbances. These conditions are different from stress and the tensions of everyday life.

2. What you need to know before taking Pregabalin TecniGen

Do not take Pregabalin TecniGen
if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in
section 6).

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

• In some patients treated with Pregabalin TecniGen, symptoms indicative of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as a widespread skin rash. If any of these reactions occur, you should contact your doctor immediately.
• Pregabalin TecniGen has been associated with dizziness and drowsiness which may increase the incidence of accidental injuries (falls) in the elderly. Therefore, you should be careful until you are familiar with the effects the medicine may have.
• Pregabalin TecniGen can cause blurred or loss of vision or other visual disturbances, many of which are transient. If you experience any visual changes, you should contact your doctor immediately.
• In some patients with diabetes who gain weight during treatment with pregabalin, it may be necessary to adjust their diabetes medications.
• Some undesirable effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have undesirable effects similar to those of Pregabalin and the severity of these effects may increase when these medicines are taken together.
• There have been reports of heart failure in some patients treated with Pregabalin TecniGen; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with this medicineyou must inform your doctor.
• There have been reports of kidney failure in some patients treated with Pregabalin TecniGen. If you notice a reduction in urination during treatment with Pregabalin TecniGen, you should inform your doctor because stopping the use of this medicine may improve this condition.
• A small number of patients treated with antiepileptic medicines such as Pregabalin TecniGen have experienced suicidal thoughts and self-harming behavior (hurting yourself). At any time if you have thoughts of this kind, contact your doctor immediately.
• When Pregabalin TecniGen is used together with other medicines that can cause constipation (such as some types of pain medications), gastrointestinal problems (e.g. constipation, blocked or paralyzed bowel) may occur. Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, tell your doctor if you have a history of alcohol dependence or any abuse or dependence on medicines. Do not take a dose of medicine higher than that prescribed.
• Cases of decreased brain function (encephalopathy) have been reported when taking Pregabalin TecniGen or immediately after stopping it. Contact your doctor immediately if seizures occur.
• Cases of decreased brain function (encephalopathy) have been reported in some patients

taking Pregabalin TecniGen when they have other conditions. Tell your doctor if you have a history of
other serious medical conditions, including liver or kidney disease.

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 TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pregabalin TecniGen and other medicines can influence each other (interaction). When
Pregabalin TecniGen is taken together with other medicines it can enhance the undesirable effects that
are observed with these medicines, including respiratory failure and coma. The intensity of dizziness,
drowsiness and reduced concentration may increase if Pregabalin TecniGen
is taken together with other medicines containing:
Oxycodone – (used as a pain reliever) Lorazepam

• (used for the treatment of anxiety) Alcohol

Pregabalin TecniGen can be taken at the same time as oral contraceptives.

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

Pregnancy and breastfeeding
Pregabalin TecniGen should not be taken during pregnancy or breastfeeding, unless
your doctor has told you otherwise. Women of childbearing potential should use
an effective method of contraception. If you are pregnant, suspect or are planning a
pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.

Driving and using machines
Pregabalin TecniGen can cause dizziness, drowsiness and reduced concentration. You should not
drive, operate complex machinery or engage in potentially dangerous activities until you
have ascertained whether this medicine alters your ability to perform these activities.

Pregabalin TecniGen contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact them before taking this
medicine.

3. How to take Pregabalin TecniGen

Take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the appropriate dose for you.
Pregabalin TecniGen is for oral use only.

Peripheral and central neuropathic pain, epilepsy or Generalized Anxiety Disorder:

• Take the number of capsules prescribed by your doctor.
• The appropriate dose for you and your condition generally varies between 150 mg and 600 mg per day.
• Your doctor will tell you to take Pregabalin TecniGen two or three times a day. If you take the medicine twice a day, take Pregabalin TecniGen once in the morning and once in the evening, always at approximately the same time. If you take the medicine three times a day, take Pregabalin TecniGen once in the morning, once in the afternoon and once in the evening, always at approximately the same time.

If you feel that the effect of Pregabalin TecniGen is too strong or too weak, talk to your
doctor or pharmacist.
If you are elderly (over 65 years of age), you should take Pregabalin TecniGen as normal unless
you have kidney problems.
The doctor may prescribe a different dosage and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue to take Pregabalin TecniGen until your doctor tells you to stop the treatment.

If you take more Pregabalin TecniGen than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring with you the
pack of Pregabalin TecniGen capsules. You may feel sleepy, confused, agitated and restless,
because you have taken more Pregabalin TecniGen than you should. Convulsions have also been reported.

If you forget to take Pregabalin TecniGen
It is important to take Pregabalin TecniGen capsules regularly every day at the same time. If
you forget to take a dose, take it as soon as you remember if you have not already
taken it, otherwise take the next dose as scheduled. Do not
take a double dose to make up for forgotten doses.

If you stop taking Pregabalin TecniGen
Do not stop treatment with Pregabalin TecniGen unless your doctor has told you to do so. If the
treatment is stopped, it must be done gradually over at least 1
week.
You should know that after stopping treatment with Pregabalin TecniGen, both short-term and long-term
some undesirable effects may occur. These include sleep disturbances, headache, nausea,
anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness.
These symptoms may occur more frequently or severely if you have taken Pregabalin TecniGen
for a longer period of time.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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
• Feeling of excitement, confusion, disorientation, decreased sexual interest, irritability
• Attention disorders, clumsiness, impaired memory, memory loss, tremor, difficulty speaking, sensation of tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea and abdominal bloating.
• Difficulty with erection.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, abnormalities in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in the limbs.
• 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 self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggressiveness, euphoric mood, mental impairment, difficulty with ideation, increased sexual interest, sexual problems, including inability to reach orgasm, delayed ejaculation
• Changes in vision, abnormalities in eye movement, visual disturbances including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noises, 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 disorders (flushing), hot flashes
• Difficulty breathing, 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 pain when urinating, incontinence
• Weakness, thirst, feeling of tightness in the chest Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased creatinine, decreased potassium.
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring,
• Painful menstrual cycles
• Cold hands and feet

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

• Alteration of smell, sensation of swaying visual field, altered depth perception, visual brilliance, loss of vision
• Dilated pupils, strabismus,
• Cold sweats, feeling of constriction in the throat, swelling of the tongue
• Inflammation of the pancreas
• Difficulty swallowing
• Slowed or reduced body movement
• Difficulty writing properly
• Increased fluid in the abdomen
• Presence of fluid in the lungs.
• Convulsions.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders.
• Muscle damage.
• Breast secretions, abnormal breast growth, breast growth in men
• Interrupted menstrual cycles
• Kidney failure, reduced urine volume, urinary retention,
• Reduced white blood cell count
• Inappropriate behavior
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by rash, blisters, skin peeling and pain
• Jaundice (yellowing of the skin and eyes)

Very rare: may affect up to 1 in 10,000 people:

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

In case of swelling of the face or tongue or if the skin becomes red and blisters begin to form or skin peeling occurs, you should contact your doctor immediately. Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with 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.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Pregabalin TecniGen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the pack after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 TecniGen contains
Pregabalin TecniGen 25 mg
The active ingredient is pregabalin. Each hard capsule contains 25 mg of pregabalin.
The excipients are: lactose monohydrate, corn starch, talc. The 25 mg capsules contain gelatin
and titanium dioxide (E171).

Pregabalin TecniGen 50 mg
The active ingredient is pregabalin. Each hard capsule contains 50 mg of pregabalin.
The excipients are: lactose monohydrate, corn starch, talc. The 50 mg capsules contain gelatin
and titanium dioxide (E171).

Pregabalin TecniGen 75 mg
The active ingredient is pregabalin. Each hard capsule contains 75 mg of pregabalin.
The excipients are: lactose monohydrate, corn starch, talc. The 75 mg capsules contain gelatin
and titanium dioxide (E171) (body and cap), erythrosine, FD&C Red 3
yellow iron oxide (E172), red iron oxide (E172) (cap).

Pregabalin TecniGen 100 mg
The active ingredient is pregabalin. Each hard capsule contains 100 mg of pregabalin.
The excipients are: lactose monohydrate, corn starch, talc. The 100 mg capsules contain
gelatin and titanium dioxide (E171), erythrosine, FD&C Red 3, yellow iron oxide (E172), iron oxide
red (E172) (body and cap).

Pregabalin TecniGen 150 mg
The active ingredient is pregabalin. Each hard capsule contains 150 mg of pregabalin.
The excipients are: lactose monohydrate, corn starch, talc. The 150 mg capsules contain
gelatin and titanium dioxide (E171).

Description of the appearance of Pregabalin TecniGen and package contents
Pregabalin TecniGen 25 mg capsules are hard capsules with a white body and white cap
Pregabalin TecniGen 50 mg capsules are hard capsules with a white body and white cap
Pregabalin TecniGen 75 mg capsules are hard capsules with a white body and red cap
Pregabalin TecniGen 100 mg capsules are hard capsules with a red body and red capPregabalin
TecniGen 150 mg capsules are hard capsules with a white body and white cap
Pregabalin TecniGen 25 mg is available in blisters containing 14 hard capsules
Pregabalin TecniGen 50 mg is available in blisters containing 21 hard capsules
Pregabalin TecniGen 75 mg is available in blisters containing 14 and 56 hard capsules
Pregabalin TecniGen 100 mg is available in blisters containing 21 hard capsules
Pregabalin TecniGen 150 mg is available in blisters containing 14 and 56 hard capsules

Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Manufacturers
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra
Portugal
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora
Portugal