ACLATON 25 mg Hard Capsules

Зміст інструкції

1. 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

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

ACLATON 225 mg hard capsules
ACLATON 300 mg hard capsules
Pregabalin
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:
What Aclaton is and what it is used for
What you need to know before you take 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 ingredient pregabalin and belongs to a group of medicines used for
treating epilepsy and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain: Aclaton is used to treat chronic pain
caused by damage to the nervous system. Several diseases can cause peripheral neuropathic pain,
such as diabetes or shingles.
Pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramps, suffering, tingling, numbness, pricking sensations. 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: Aclaton is used to treat certain types of epilepsy in adults (partial seizures with or without
secondary generalisation). Your doctor will prescribe Aclaton to help you treat your epilepsy when the
treatment you are already receiving is not controlling your condition. You will need to take
Aclaton in addition to the treatment you are already receiving. Aclaton is not used alone, but
must always be used with other antiepileptic treatments.

Generalised Anxiety Disorder: Aclaton 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 being on edge or keyed up, easy
fatigability (tiredness), difficulty concentrating or memory problems, irritability, muscle tension
or sleep disturbances. These conditions are different from the stress and strains of everyday life.

What you need to know before you take Aclaton
Do not take Aclaton

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

Warnings and precautions
In some patients treated with pregabalin, 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

immediatelyyour doctor.
Pregabalin has been associated with dizziness and drowsiness which may increase the risk of accidental
injuries (falls) in the elderly. Therefore, you should be careful until you know how the medicine affects
you.
Pregabalin can cause blurred or loss of vision or other visual disturbances, many of which are
transient. If you experience any visual disturbance you should contact

immediatelyyour doctor (see section 4).
In some patients with diabetes who gain weight during treatment with pregabalin, it may
be necessary to adjust your current diabetes therapy.
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.
There have been reports of heart failure in some patients treated with pregabalin;
these patients were mostly elderly with cardiovascular disease. If you have a history
of cardiovascular disease before starting treatment with this medicine you
should inform your doctor (see section 4).
There have been reports of kidney failure in some patients treated with pregabalin.
If you notice a reduction in urine production during treatment with Aclaton,
you should inform your doctor, as stopping the use of this medicine may
improve this condition.
A small number of patients taking antiepileptic medicines like pregabalin have
experienced thoughts of self-harm or suicide. At any time if you have thoughts of
this kind, contact immediatelyyour doctor.
If Aclaton is taken with other medicines that can cause constipation (such as some types of
pain medicines) you may experience gastrointestinal problems (e.g. constipation, blocked or
paralysed bowel). 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 or drug
abuse or dependence. Do not take a dose of medicine higher than the one prescribed.
Cases of reduced brain function (encephalopathy) have been reported in some patients
taking pregabalin 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 in children and adolescents (under 18 years of age) have not been established
and therefore Aclaton should not be used in this age group.

Other medicines and Aclaton
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Aclaton and other medicines can influence each other (interaction). When Aclaton is
taken together with other medicines it can enhance the side effects observed with 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 a painkiller)
• Lorazepam - (used for the treatment of anxiety)
• Alcohol

Aclaton can be taken at the same time as oral contraceptives.

Aclaton with food, drinks and alcohol
The Aclaton capsules can be taken with or without food.
It is recommended NOT to drink alcohol during treatment with Aclaton.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Aclaton should NOT be taken during pregnancy unless your doctor tells you otherwise. Women of
childbearing potential should use effective contraception.

Driving and using machines
Aclaton can cause dizziness, drowsiness and reduced concentration. Do NOT drive,
operate complex machinery or engage in potentially dangerous activities until you have
determined whether this medicine affects your ability to perform these activities.

How to take Aclaton
Always take this medicine exactly as your doctor has told you. If you are unsure, ask 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 Generalised Anxiety Disorder:
Take the number of capsules prescribed by your doctor.
The appropriate dose for you and your condition generally ranges from 150 mg to 600 mg per day.
Your doctor will tell you to take Aclaton two or three times a day. If you take the medicine twice
a day, take Aclaton once in the morning and once in the evening, at about the same time.
If you take the medicine three times a day, take Aclaton once in the
morning, once in the afternoon and once in the evening, at about the same time.
If you think that the effect of Aclaton is too strong or too weak, talk to your doctor or
pharmacist.
If you are elderly (over 65 years of age), you should take Aclaton as normal unless you have
kidney problems.
Your doctor may prescribe a different dosing regimen and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue to take Aclaton until your doctor tells you to stop the treatment.

If you take more Aclaton than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring the
pack of ACLATONcapsules with you. You may feel sleepy, confused, agitated and restless, as
you have taken more Aclaton than you should. Seizures have also been reported.

If you forget to take Aclaton
It is important to take the Aclaton 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 time to take your next dose.
In this case, 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 has told you to. If
treatment is stopped, it should be done gradually over at least 1
week.
You should know that some side effects may occur after stopping long- or short-term treatment with Aclaton. 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 of time.
If you have any questions about using this medicine, ask 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 that may affect more than 1 in 10 people:
Dizziness
Drowsiness
Headache

Common side effects that may affect up to 1 in 10 people:
Increased appetite
Feeling of excitement, confusion, disorientation, decreased sexual drive, irritability
Difficulty with attention, clumsiness, impaired memory, memory loss, tremor,
difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia,
tiredness (fatigue), feeling strange
Blurred vision, double vision
Vertigo, balance disorders, falls
Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, abdominal bloating
Difficulty with erection
Swelling of the body, including hands and feet
Feeling drunk, abnormal gait
Weight gain
Muscle cramps, joint pain, back pain, pain in the limbs
Sore throat

Uncommon side effects that 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, elevated mood,
mental impairment, difficulty thinking, increased sexual desire, sexual problems, including inability to achieve orgasm, delayed ejaculation
Vision disturbances, abnormalities in eye movement, visual changes 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,
reduced consciousness, loss of consciousness, fainting, increased sensitivity to noises,
feeling unwell
Dry eyes, eye swelling, eye pain, eye weakness, tearing, eye irritation
Heart rhythm disturbances, increased heartbeat, low blood pressure, high blood pressure, changes in heartbeat, heart failure
Flushing, hot flashes
Difficulty breathing, nasal dryness, 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 urinating or with pain, 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 in the blood,
decreased potassium in the blood)
Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough,
snoring
Painful menstruation
Cold hands and feet

Rare side effects that can affect up to 1 in 1,000 people:
Altered sense of smell, visual disturbances, altered depth perception, visual brightness,
loss of vision
Dilated pupils, strabismus
Cold sweats, feeling of constriction in the throat, tongue swelling
Pancreatitis
Difficulty swallowing
Slowed or reduced body movement
Difficulty writing appropriately
Increased fluid in the abdomen
Fluid in the lungs
Convulsions
Changes in electrocardiogram (ECG) corresponding to heart rhythm disturbances
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 allergic reaction characterized by rash, blisters, skin peeling
and pain)

In case of facial or tongue swelling 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 medications 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 medications 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 through 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 which is stated on the blister, carton or bottle. The
expiry date refers to the last day of that month.
Bottles can be used for 3 months after first opening.
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.

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 other ingredients are: mannitol, pregelatinized maize starch, talc, titanium dioxide (E171), gelatin
and black ink (contains shellac, propylene glycol, strong ammonia solution, iron oxide
black (E172) and potassium hydroxide).
The 25, 50, 75, 150, 225 and 300 mg capsules also contain iron oxide yellow (E172), and the
75, 100, 200, 225 and 300 mg capsules also contain iron oxide red (E172)

Description of ACLATON and contents of the pack
ACLATON 25 mg are opaque ivory-colored hard gelatin capsules marked with the inscription 25
printed in black on the body of the capsule.
ACLATON 50 mg are opaque ivory-colored hard gelatin capsules marked with a black radial band
on the cap of the capsule and the inscription 50 printed in black and a black radial band on the body
of the capsule.
ACLATON 75 mg are opaque gelatin hard capsules with a pink cap and an ivory body
marked with the inscription 75 printed in black.
ACLATON 100 mg are opaque pink-colored hard gelatin capsules marked with the inscription 100
printed on the body of the capsule.
ACLATON 150 mg are opaque ivory-colored hard gelatin capsules marked with the inscription 150
printed in black on the body of the capsule.
ACLATON 200 mg are opaque flesh-colored hard gelatin capsules marked with the inscription 200
printed in black on the body of the capsule.
ACLATON 225 mg are opaque gelatin hard capsules with a flesh-colored cap and an ivory body
marked with the inscription 225 printed in black.
ACLATON 300 mg are opaque gelatin hard capsules with a pink cap and an ivory body
marked with the inscription 300 printed 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.
In addition, ACLATON 75 mg, 150 mg, 225 mg and 300 mg capsules are available in HDPE bottles with
a PP closure containing 200 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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
10000
Croatia
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
89143
Germany