ACLATON

Package Leaflet: Information for the User

ACLATON 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
Equivalent medicinal product
Please read all of 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 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, please inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
What ACLATON is and what it is used for
What you need to know before taking ACLATON
How to take ACLATON
Possible side effects
How to store ACLATON
Contents of the pack and other information

What ACLATON is and what it is used for
ACLATON contains the active substance pregabalin and belongs to a group of medicines used to treat epilepsy and Generalized Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain: ACLATON 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.
Pain sensations may be described as warmth, burning, throbbing, shooting pain, stabbing pain, sharp pain, discomfort, tingling, numbness, or pricking pain. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue (tiredness), and may impact physical and social activities and overall quality of life.

Epilepsy: ACLATON is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe ACLATON to help manage your epilepsy when your current treatment does not adequately control your seizures. You will need to take ACLATON in addition to your existing treatment. ACLATON is not used alone but must always be taken together with other antiepileptic treatments.

Generalized Anxiety Disorder: ACLATON 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 tension or being on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from everyday stress and tension.

What you need to know before taking ACLATON

Do not take ACLATON

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

Warnings and precautions
Allergic reactions have been reported in some patients treated with pregabalin. 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.
Pregabalin may cause dizziness and drowsiness, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects of this medicine.
Pregabalin may cause blurred vision or loss of vision or other visual disturbances, many of which are transient. If you experience any visual disturbances, contact your doctor immediately (see section 4).
In diabetic patients who gain weight during treatment with pregabalin, it may be necessary to adjust their ongoing diabetes therapy.
Some side effects, such as drowsiness, may be more common in patients with spinal cord injury, as they 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 and had cardiovascular disease. If you have a history of cardiovascular disease, inform your doctor before starting treatment with this medicine (see section 4).
Cases of kidney failure have been reported in some patients treated with pregabalin. If during treatment with ACLATON you notice a reduction in urine output, inform your doctor, as this condition may improve upon discontinuation of this medicine.
A small number of patients treated with antiepileptic medicines such as pregabalin have experienced suicidal thoughts and self-harm. If you experience such thoughts at any time, contact your doctor immediately.
If ACLATON is taken together with other medicines that may cause constipation (such as certain 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 or medicine abuse or dependence. Do not take a higher dose than prescribed.
Seizures have been reported when taking pregabalin or immediately after stopping it. If you experience seizures, contact your doctor immediately.
Cases of reduced brain function (encephalopathy) have occurred in some patients taking pregabalin when they have other medical conditions. 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 in children and adolescents (under 18 years of age) have not been established, and therefore ACLATON must not be used in this age group.

Other medicines and ACLATON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ACLATON and other medicines may interact with each other. When ACLATON is taken together with other medicines, it may enhance the side effects of these medicines, including respiratory failure and coma. The intensity of dizziness, drowsiness, and reduced concentration may increase if ACLATON is taken together with other medicines containing:

• Oxycodone – (used as an analgesic)
• Lorazepam – (used to treat anxiety)
• Alcohol

ACLATON may be taken together with oral contraceptives.

ACLATON with food, drinks and alcohol
ACLATON capsules may be taken with or without food.
You are advised NOT to drink alcohol during treatment with ACLATON.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
ACLATON must not be taken during pregnancy unless your doctor has specifically instructed otherwise. Women of childbearing potential must use an effective method of contraception.

Driving and using machines
ACLATON may cause dizziness, drowsiness, and reduced concentration. You must not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine affects your ability to perform these tasks.

How to take ACLATON
Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
ACLATON 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 ACLATON two or three times a day. If you take the medicine twice daily, take ACLATON once in the morning and once in the evening, approximately at the same time each day. If you take the medicine three times daily, take ACLATON 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 ACLATON is too strong or too weak, discuss this with your doctor or pharmacist.
If you are elderly (over 65 years of age), you should take ACLATON as usual unless you have kidney problems.
Your doctor may prescribe a different dosing regimen and/or dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking ACLATON until your doctor tells you to stop.

If you take more ACLATON than you should
Contact your doctor or go immediately to the nearest hospital. Bring the ACLATON capsule pack with you. You may feel drowsy, confused, agitated, and restless because you have taken more ACLATON than prescribed. Seizures have also been reported.

If you forget to take ACLATON
It is important to take ACLATON capsules regularly every day at the same time. If you forget 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 as scheduled. Do not take a double dose to make up for the missed dose.

If you stop taking ACLATON
Do not stop taking ACLATON unless your doctor tells you to. If treatment is to be discontinued, it should be gradually reduced over a period of at least 1 week.
You should be aware that after stopping long-term or short-term treatment with ACLATON, certain side effects may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have taken ACLATON for a longer period.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common side effects (may affect more than 1 in 10 people):
Dizziness
Drowsiness
Headache

Common side effects (may affect up to 1 in 10 people):
Increased appetite
Feeling of excitement, confusion, disorientation, decreased libido, irritability
Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue (tiredness), feeling strange
Blurred vision, double vision
Vertigo, balance disorders, falls
Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, abdominal distension
Erectile dysfunction
Body swelling, including hands and feet
Feeling of drunkenness, gait abnormalities
Weight gain
Muscle cramps, joint pain, back pain, limb pain
Sore throat

Uncommon side effects (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, aggression, elevated mood, mental impairment, difficulty thinking, increased libido, sexual problems, including inability to achieve orgasm, delayed ejaculation
Visual disturbances, eye movement abnormalities, visual changes including tunnel vision, light flashes, jerky movements, reduced reflexes, increased activity, dizziness in upright position, skin sensitivity, loss of taste, burning sensation, movement tremor, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation
Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, irregular heartbeat, heart failure
Flushing, hot flushes
Breathing difficulties, dry nose, nasal congestion
Increased saliva production, heartburn, loss of sensation around the mouth
Sweating, rash, chills, fever
Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Breast pain
Difficulty or pain when urinating, incontinence
Weakness, thirst, chest tightness
Changes in blood test results and liver function tests (increased serum creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased creatinine, decreased blood potassium)
Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
Painful menstruation
Cold hands and feet

Rare side effects (may affect up to 1 in 1,000 people):
Altered sense of smell, visual disturbances, altered depth perception, visual brightness, vision loss
Dilated pupils, strabismus
Cold sweats, throat tightness, tongue swelling
Pancreatitis
Swallowing difficulties
Slowed or reduced body movement
Difficulty writing properly
Increased abdominal fluid
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
Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe allergic reaction characterized by rash, blisters, skin peeling, and pain)

If you experience swelling of the face or tongue, or if your skin turns red and blisters or skin peeling begins, 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.

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

How to store ACLATON
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, or bottle. The expiry date refers to the last day of that month.
Bottles may be used for 3 months after first opening.
This medicine does not require special storage conditions.
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.

Contents of the pack and other information

What ACLATON 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 excipients are: mannitol, pregelatinized maize starch, talc, titanium dioxide (E171), gelatin, and black ink (containing shellac, propylene glycol, strong ammonia solution, iron oxide black (E172), and potassium hydroxide).
Capsules of 25 mg, 50 mg, 75 mg, 150 mg, 225 mg, and 300 mg also contain iron oxide yellow (E172), and capsules of 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg also contain iron oxide red (E172).

Description of the appearance of ACLATON and contents of the pack
ACLATON 25 mg are opaque ivory hard gelatin capsules marked with the number "25" in black on the body of the capsule.
ACLATON 50 mg are opaque ivory hard gelatin capsules with a black radial band on the cap and the number "50" in black with a black radial band on the body of the capsule.
ACLATON 75 mg are opaque hard gelatin capsules with a pink cap and ivory body marked with the number "75" in black.
ACLATON 100 mg are opaque pink hard gelatin capsules marked with the number "100" on the body of the capsule.
ACLATON 150 mg are opaque ivory hard gelatin capsules marked with the number "150" in black on the body of the capsule.
ACLATON 200 mg are opaque flesh-coloured hard gelatin capsules marked with the number "200" in black on the body of the capsule.
ACLATON 225 mg are opaque hard gelatin capsules with a flesh-coloured cap and ivory body marked with the number "225" in black.
ACLATON 300 mg are opaque hard gelatin capsules with a pink cap and ivory body marked with the number "300" in black.

ACLATON 25 mg capsules are packaged in blisters of 14, 14x1, 21, 21x1, 50x1, 56, 56x1, 60, 84, 84x1, 90, 100, or 100x1 capsules.
ACLATON 50 mg capsules are packaged in blisters of 14, 21, 21x1, 56, 56x1, 60, 84, 84x1, 100, or 100x1 capsules.
ACLATON 75 mg capsules are packaged in blisters of 14, 14x1, 50x1, 56, 56x1, 60, 90, 100, or 100x1 capsules.
ACLATON 100 mg capsules are packaged in blisters of 14, 21, 21x1, 56, 56x1, 84, 84x1, 100, or 100x1 capsules.
ACLATON 150 mg capsules are packaged in blisters of 14, 14x1, 50x1, 56, 56x1, 60, 90, 100, 100x1, 168, 168x1, or 200x1 capsules.
ACLATON 200 mg capsules are packaged in blisters of 14, 21, 21x1, 84, 84x1, 100, or 100x1 capsules.
ACLATON 225 mg capsules are packaged in blisters of 14, 14x1, 56, 56x1, 60, 100, or 100x1 capsules.
ACLATON 300 mg capsules are packaged in blisters of 14, 14x1, 50x1, 56, 56x1, 60, 84, 84x1, 90, 100, 100x1, 168, 168x1, or 200x1 capsules.

Additionally, ACLATON 75 mg, 150 mg, 225 mg, and 300 mg capsules are available in HDPE bottles with PP closure containing 200 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
NEURAXPHARM ITALY S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno
Italy

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
Croatia
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
Germany