PREGABALIN ALTER

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PREGABALIN ALTER 25 mg hard capsules, 75 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules

Pregabalin
Generic medicine
Read this entire 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT PREGABALIN ALTER IS AND WHAT IT IS USED FOR

PREGABALIN ALTER 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 ALTER is used to
treat chronic pain caused by damage to the nervous system. Various
conditions can cause peripheral neuropathic pain, such as diabetes or herpes zoster (a
viral infection causing inflammation and blistering rash along the path of the affected nerve).
Pain sensations may be described as heat, burning, pulsing, electric shock-like pains, stabbing pains, sharp pains, cramping pains, discomfort, tingling, numbness, or prickling.
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 ALTER is used to treat certain types of epilepsy
in adults (partial seizures with or without secondary generalization). Your doctor will prescribe
PREGABALIN ALTER to help manage your epilepsy when your current treatment does not adequately control your symptoms. You must take
PREGABALIN ALTER in addition to your existing therapy. PREGABALIN
ALTER is not used as monotherapy, but must always be used in combination with other
antiepileptic treatments.
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Generalized Anxiety Disorder: PREGABALIN ALTER is used for the
treatment of 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 tension or being on edge, easy fatigability (tiredness), difficulty concentrating or memory lapses, irritability,
muscle tension, or sleep disturbances. These conditions are different from everyday stress and pressures.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PREGABALIN ALTER

Do not take PREGABALIN ALTER

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

Warnings and precautions

• In some patients treated with PREGABALIN ALTER, symptoms suggestive of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin reactions. If any of these reactions occur, contact your doctor immediately.

• PREGABALIN ALTER 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 on you.

• PREGABALIN ALTER may cause blurred vision, loss of vision, or other visual disturbances, many of which are transient. If you experience any visual changes, contact your doctor immediately.

• In diabetic patients who gain weight during treatment with pregabalin, adjustments to diabetes medications may be necessary.

• Some side effects, such as somnolence, may be more pronounced in patients with spinal cord injury, as they may be taking other medications to treat, for example, pain or spasticity, which have similar side effects to pregabalin; 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 ALTER; most of these patients were elderly and had pre-existing cardiovascular diseases. If you have a history of cardiovascular disease before starting treatment with this medicine, inform your doctor.

• Cases of renal failure have been reported in some patients treated with PREGABALIN ALTER. If you notice a decrease in urine output during treatment with PREGABALIN ALTER, inform your doctor, as discontinuing the medicine may improve this condition.

• A small number of patients treated with antiepileptic medicines such as PREGABALIN ALTER have experienced suicidal thoughts and self-harming behaviors (harming oneself). If you have thoughts of this kind at any time, contact your doctor immediately.

• When PREGABALIN ALTER is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems may occur (e.g., constipation, intestinal obstruction, or paralytic ileus). 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 or medicine dependence. Inform your doctor if you feel the need to take a higher dose than prescribed.

• Seizures have been reported when taking PREGABALIN ALTER or immediately after stopping it. If seizures occur, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have occurred in some patients taking PREGABALIN ALTER when other medical conditions are present. Inform 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 ALTER
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
PREGABALIN ALTER and other medicines may affect each other (interaction). When PREGABALIN ALTER is taken together with other medicines, it may enhance the side effects observed with these medicines, including respiratory depression and coma. The intensity of dizziness, somnolence, and reduced concentration may increase if PREGABALIN ALTER is taken together with medicines containing:
Oxycodone (used as an analgesic),
Lorazepam (used to treat anxiety),
Alcohol.
PREGABALIN ALTER can be taken together with oral contraceptives.

Taking PREGABALIN ALTER with food, drinks, and alcohol
PREGABALIN ALTER capsules can be taken with or without food.
It is advisable not to drink alcohol during treatment with PREGABALIN ALTER.

Pregnancy and breastfeeding
PREGABALIN ALTER must not be taken during pregnancy or breastfeeding, unless your doctor has advised otherwise. Women of childbearing potential must use an effective method of contraception. Contact your doctor immediately if you become pregnant, if you are breastfeeding, if you think you may be pregnant, or if you are planning a pregnancy while being treated with PREGABALIN ALTER.
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Driving and using machines
PREGABALIN ALTER may cause dizziness, somnolence, and reduced concentration. Do not drive, operate complex machinery, or engage in potentially hazardous activities until you are certain that this medicine does not impair your ability to perform these tasks.

3. HOW TO TAKE PREGABALIN ALTER
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you. PREGABALIN ALTER 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 ranges between 150 mg and 600 mg per day. Your doctor will instruct you to take PREGABALIN ALTER two or three times daily. If you take the medicine twice a day, take PREGABALIN ALTER once in the morning and once in the evening, approximately at the same time each day. If you take the medicine three times a day, take PREGABALIN ALTER once in the morning, once in the afternoon, and once in the evening, approximately at the same time each day. If you feel that the effect of PREGABALIN ALTER is too strong or too weak, discuss it with your doctor or pharmacist. If you are an elderly patient (over 65 years of age), you should normally take PREGABALIN ALTER unless you have kidney problems. Your doctor may prescribe a different dosage and/or dose adjustment if you have kidney impairment. Swallow the capsule whole with water. Continue taking PREGABALIN ALTER until your doctor tells you to stop treatment.

If you take more PREGABALIN ALTER than you should
Contact your doctor immediately or go immediately to the nearest hospital emergency department. Bring the package of PREGABALIN ALTER capsules with you. You may feel drowsy, confused, agitated, and restless because you have taken more PREGABALIN ALTER than prescribed.

If you forget to take PREGABALIN ALTER
It is important to take PREGABALIN ALTER 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, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking PREGABALIN ALTER
Do not stop treatment with PREGABALIN ALTER unless your doctor tells you to. If treatment is to be discontinued, it should be gradually tapered over a period of at least 1 week.
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You should know that after stopping treatment, both in the short and long term, some adverse effects may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have taken pregabalin for a longer period.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not
everyone experiences them.
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, loss of libido, irritability
• Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange
• Blurred vision, double vision
• Vertigo, balance disorders, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Erectile dysfunction
• 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, altered dreams, panic attacks, apathy, aggressiveness, elevated mood, mental retardation, difficulty in ideation, increased sexual interest, sexual problems including inability to achieve orgasm, delayed ejaculation

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• Changes in vision, unusual eye movements, visual disturbances including tunnel vision, flashes of light, convulsive movements, reduced reflexes, increased activity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremors, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
• Dry eyes, eye swelling, eye pain, eye weakness, watery eyes, irritated eyes
• 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
• Painful or difficult 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 blood creatinine, decreased blood potassium) Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
  • Menstrual pain
  • Coldness of hands and feet Rare (may occur in up to 1 out of 1,000 people):
• Altered sense of smell, fluctuation in visual field, altered depth perception, visual brightness, decreased vision
• Dilated pupils, strabismus
• Cold sweats, throat tightness, swollen tongue
• Pancreatitis
• Difficulty swallowing
• Slowed or reduced body movement
• Difficulty writing properly
• Fluid accumulation in the abdomen
• Fluid in the lungs
• Seizures
• Changes in the heart's electrocardiogram (ECG) corresponding to alterations in heart rhythm

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• Muscle damage
• Breast milk secretion, abnormal breast growth, breast enlargement in men
• Disrupted menstrual cycles
• Kidney failure, reduced urine volume, urinary retention
• Reduced white blood cell count
• Inappropriate behaviors
• Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and severe skin reactions characterized by rashes, blisters, skin peeling, and pain)

If you experience swelling of the face or tongue, or if your skin turns red and blisters
start to form, or if skin peeling occurs, contact your doctor immediately.
Some adverse reactions, 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 adverse effects to pregabalin, and the severity of these effects may increase when these medicines are taken together.
If any of the adverse reactions worsen, or if you notice any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this
leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PREGABALIN ALTER

Keep PREGABALIN ALTER out of the sight and reach of children.
Do not use PREGABALIN ALTER after the expiry date stated on the carton. The expiry date refers to the last day of that month.
This medicinal product requires no special storage conditions.
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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. PACK CONTENT AND OTHER INFORMATION

The active substance is pregabalin. Each hard capsule contains 25 mg, 75 mg, 150 mg, or
300 mg of pregabalin.
The other components are:
pregelatinized starch, mannitol, talc, gelatin, titanium dioxide (E171), black ink
(containing shellac, iron oxide black (E172), propylene glycol (E1520), ammonium hydroxide (E527)).
Capsules of 75 mg and 300 mg also contain iron oxide red (E172).
Description of the appearance of PREGABALIN ALTER and pack contents
Pregabalin Alter 25 mg hard capsules:
Capsules with white cap and white body marked with the number "25".
Pregabalin Alter 75 mg hard capsules:
Capsules with orange cap and white body marked with the number "75".
Pregabalin Alter 150 mg hard capsules:
Capsules with white cap and white body marked with the number "150".
Pregabalin Alter 300 mg hard capsules:
Capsules with orange cap and white body marked with the number "300".
PREGABALIN ALTER is available in PVC/aluminum blisters containing 14 or 56
hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratori Alter, Via Egadi 7 - 20144 Milano, Italy
Manufacturer:
Pharmathen S.A.
6 Dervenakion
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15351 Pallini Attiki
Greece
or
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block n°5
Rodopi 69300
Greece
This medicinal product is authorised in the European Economic Area Member States under the following names:
France: Prégabaline Alter
Italy: Pregabalin Alter
Spain: Pregabalina Alter
This leaflet was last approved on
10/11