Gabapentin aurovitas

Package leaflet: Information for the user

Gabapentin Aurovitas, 100 mg, hard capsules
Gabapentin Aurovitas, 300 mg, hard capsules
Gabapentin Aurovitas, 400 mg, hard capsules
Gabapentinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Gabapentin Aurovitas is and what it is used for
2. Important information before taking Gabapentin Aurovitas
3. How to take Gabapentin Aurovitas
4. Possible side effects
5. How to store Gabapentin Aurovitas
6. Contents of the pack and other information

1. What Gabapentin Aurovitas is and what it is used for

Gabapentin Aurovitas belongs to a group of medicines used in the treatment of epilepsy and peripheral
neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Gabapentin Aurovitas is gabapentin.
Gabapentin Aurovitas is indicated for the treatment of:

• Various forms of epilepsy (seizures that originate in specific areas of the brain and may or may not spread to the rest of the brain). Gabapentin Aurovitas is prescribed for adults and children aged 6 years and older as an adjunctive therapy in epilepsy when previous treatment has not fully controlled seizures. Gabapentin Aurovitas should be taken as an add-on therapy in the treatment of epilepsy in adults or children aged 6 years and older, unless otherwise directed by a physician. Gabapentin Aurovitas may also be used as monotherapy in adults and children over 12 years of age.
• Peripheral neuropathic pain (long-lasting pain caused by nerve damage). Peripheral pain (occurring mainly in the lower and/or upper limbs) arises from a variety of different diseases such as diabetes or shingles. Patients describe the pain they feel as burning, stinging, pulsating, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important information before using Gabapentin Aurovitas

When not to take Gabapentin Aurovitas

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Gabapentin Aurovitas, discuss this with your doctor or
pharmacist:

• in case of kidney disease, your doctor may recommend a different dosing regimen,
• if undergoing haemodialysis (to remove waste products due to kidney failure), inform your doctor of any muscle pain and/or weakness,
• if symptoms such as persistent abdominal pain, nausea or vomiting occur, contact your doctor immediately, as these may be signs of acute pancreatitis,
• if the patient has neurological or respiratory disorders or is over 65 years of age; your doctor may recommend a different dosage,
• before starting treatment with this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; this may mean that the risk of becoming dependent on Gabapentin Aurovitas is higher.

Dependence
Some people may develop dependence on Gabapentin Aurovitas (a need to keep taking the medicine continuously). After stopping Gabapentin Aurovitas, withdrawal symptoms may occur (see section 3, “How to take Gabapentin Aurovitas” and “Stopping treatment with Gabapentin Aurovitas”). If you are concerned that you may become dependent on Gabapentin Aurovitas, it is important to consult your doctor.
If, while taking Gabapentin Aurovitas, you notice any of the following signs, this may indicate the development of dependence:

• You feel you need to take the medicine longer than prescribed by your doctor
• You feel you need to take a higher dose than prescribed
• You use the medicine for reasons other than those prescribed
• You have made repeated unsuccessful attempts to stop or control use of the medicine
• You feel unwell after stopping the medicine, and feel better after taking it again

If you notice any of the above behaviours, you should speak with your doctor to discuss the best treatment approach for you, including when it would be appropriate to stop taking the medicine and how to do so safely.
A small number of patients taking antiepileptic medicines such as gabapentin have had thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately.
Important information regarding potentially serious reactions
Serious skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred with the use of gabapentin. If any of the symptoms associated with serious skin reactions described in section 4 occur, stop taking gabapentin and contact your doctor immediately.
A description of the symptoms can be found in section 4 of this leaflet under: “Due to possible serious health consequences, contact your doctor immediately if any of the following symptoms occur after taking the medicine.”
Muscle weakness, tenderness or pain, especially when accompanied by general malaise and high fever, may be caused by abnormal breakdown of muscle fibres, which can be life-threatening and lead to kidney problems. Urine may change in colour and blood test results may show changes (markedly increased blood levels of creatine kinase). If such subjective or objective symptoms occur, contact your doctor immediately.

Gabapentin Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, inform your doctor (or pharmacist) about all medicines you have recently or are currently using to treat seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
If you are taking medicines containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may enhance the effects of Gabapentin Aurovitas.
In addition, taking Gabapentin Aurovitas together with opioids may cause drowsiness, sedation, respiratory depression, or death.
Antacids used for indigestion
If Gabapentin Aurovitas is taken at the same time as antacids containing aluminium and magnesium, absorption of Gabapentin Aurovitas from the stomach may be reduced. It is therefore recommended to take Gabapentin Aurovitas at least two hours after taking an antacid.
Gabapentin Aurovitas:

• does not interact with other antiepileptic medicines or with oral contraceptives,
• may affect the results of certain laboratory tests; if undergoing urine testing, inform your doctor or hospital about the medicines you are currently taking.

Gabapentin Aurovitas with food, drink and alcohol
Gabapentin Aurovitas can be taken independently of meals.

Pregnancy, breastfeeding and fertility

• If you are pregnant or think you may be pregnant, contact your doctor immediately to discuss the potential risk to the unborn child associated with taking this medicine.
• Do not stop treatment without discussing it with your doctor.
• If you are planning a pregnancy, discuss your treatment with your doctor or pharmacist as early as possible before becoming pregnant.
• If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before starting this medicine.

Pregnancy
Gabapentin Aurovitas may be used during the first trimester of pregnancy if necessary.
If you are planning to become pregnant, are pregnant or suspect you may be pregnant, contact your doctor immediately.
If you become pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen your condition. Severe seizures may pose a risk to both you and your unborn child.
In a study involving data from women in Scandinavian countries who took gabapentin during the first three months of pregnancy, no increased risk of congenital malformations or problems with brain development (neurodevelopmental disorders) was observed. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and premature delivery.
If you become pregnant, suspect pregnancy or are planning a pregnancy while taking Gabapentin Aurovitas, contact your doctor immediately. Do not suddenly stop taking Gabapentin Aurovitas, as this may lead to withdrawal seizures, which could have serious consequences for both the pregnant woman and her child.
Taking gabapentin during pregnancy may lead to withdrawal symptoms in newborns. This risk may increase if gabapentin is taken together with opioid pain medicines (medicines used to treat severe pain).

Breastfeeding
Gabapentin, the active substance in Gabapentin Aurovitas, passes into human milk. As it is not known what effect it may have on a breastfed child, breastfeeding is not recommended during treatment with Gabapentin Aurovitas.

Fertility
Animal studies have not shown any effect of the medicine on fertility.

Driving and using machines
Gabapentin Aurovitas may cause dizziness, drowsiness and fatigue. Until you know how this medicine affects your ability to drive, operate complex machinery or perform other potentially hazardous activities, you should refrain from such activities.

Gabapentin Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Gabapentin Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the dose.

Epilepsy – recommended dose
Adults and adolescents:
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually.
The most commonly used starting dose is 300 mg to 900 mg per day.
This may then be gradually increased, as directed by your doctor, up to a maximum dose of 3600 mg per day,
divided into 3 separate doses (one in the morning, one in the afternoon, and one in the evening).

Children aged 6 years and older:
The dose to be given to a child is determined by the doctor based on the child's body weight.
Treatment starts with a small initial dose, which is gradually increased over a period of about 3 days.
The usual dose providing control of epilepsy is typically 25 to 35 mg/kg body weight per day.
This dose is usually given in three separate doses, meaning the child takes a capsule (or capsules) daily,
typically once in the morning, once in the afternoon, and once in the evening.

Gabapentin Aurovitas is not recommended for children under 6 years of age.

Peripheral neuropathic pain – recommended dose
Adults:
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually.
The most commonly used starting dose is 300 mg to 900 mg per day.
This may then be gradually increased up to a maximum dose of 3600 mg per day,
divided into 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or undergoing haemodialysis
Your doctor may recommend a different dosing schedule and/or a different dose of Gabapentin Aurovitas
for patients with renal impairment or those undergoing haemodialysis.

Elderly patients (over 65 years of age)
Patients should take the normally recommended dose of Gabapentin Aurovitas unless they have kidney problems.
For patients with kidney problems, the doctor may recommend a different dosing schedule and/or a different dose.

If you feel that the effect of Gabapentin Aurovitas is too strong or too weak,
you should consult your doctor or pharmacist as soon as possible.

Method of administration
Gabapentin Aurovitas is taken orally. The capsules should be swallowed with a large amount of water.
Do not stop taking Gabapentin Aurovitas unless your doctor advises you to do so.

Taking more Gabapentin Aurovitas than recommended
Taking higher than recommended doses may increase the number of adverse effects,
including loss of consciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhoea.
If you take more Gabapentin Aurovitas than prescribed, contact your doctor immediately or go to the nearest hospital emergency department (A&E).
In such a case, you should also bring all remaining capsules, the packaging, and the leaflet with you,
so that hospital staff can immediately identify which medicine has been taken.

Missing a dose of Gabapentin Aurovitas
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for a missed dose.

Stopping Gabapentin Aurovitas
Do not suddenly stop taking Gabapentin Aurovitas. If you wish to stop taking Gabapentin Aurovitas,
you should first discuss this with your doctor. Your doctor will advise you on how to proceed.
The medicine should be discontinued gradually over a period of at least 1 week.
After stopping short-term or long-term treatment with Gabapentin Aurovitas,
be aware that certain adverse effects, known as withdrawal symptoms, may occur.
These symptoms may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremor, headache, depression,
a feeling of abnormality, dizziness, and general malaise.
These symptoms usually occur within 48 hours after stopping Gabapentin Aurovitas.
If withdrawal symptoms occur, contact your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Due to the possible serious health consequences, you should contact your doctor immediately
if any of the following symptoms occur after taking the medicine:

• Red, non-elevated, target-like or round spots on the trunk, often with blisters in the centre, peeling of the skin, ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Due to the possible serious health consequences, you should contact your doctor immediately
if any of the following symptoms occur after taking the medicine:

• Persistent abdominal pain, nausea and vomiting, as these may be symptoms of acute pancreatitis
• Breathing difficulties, which may, especially if severe, require immediate and intensive medical care to restore normal breathing
• The medicine Gabapentin Aurovitas may cause serious or life-threatening allergic reactions affecting the skin or other parts of the body, for example the liver or blood cells. Such a reaction may present with a rash. This type of reaction may require hospitalisation or discontinuation of Gabapentin Aurovitas. You should contact your doctor immediately if any of the following symptoms occur:
  • Skin rash and skin redness, and (or) hair loss
  • Urticaria (hives)
  • Fever
  • Persistent swelling of lymph nodes
  • Swelling of lips, face and tongue
  • Yellowing of the skin or whites of the eyes
  • Unusual bruising or bleeding
  • Severe fatigue or weakness
  • Unexpected muscle pain
  • Frequent infections

These symptoms may be the first sign of a serious reaction. The doctor should examine the patient and
decide whether treatment with Gabapentin Aurovitas should be continued.
If you are undergoing haemodialysis, inform your doctor about any muscle pain and (or) weakness.
Other adverse reactions include:
Very common (may affect more than 1 in 10 people):

• Viral infections
• Drowsiness, dizziness, lack of coordination
• Feeling of fatigue, fever

Common (may affect up to 1 in 10 people):

• Pneumonia, respiratory tract infections, urinary tract infections, ear infection or other infections
• Decrease in white blood cell count
• Loss of appetite, increased appetite
• Hostility towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking disturbances
• Seizures, sudden muscle movements, speech problems, memory loss, tremor, sleep disturbances, headache, increased skin sensitivity, reduced sensation (numbness), coordination disturbances, unusual eye movements, increased, decreased or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dryness in the nose
• Vomiting, nausea, dental problems, gingivitis, diarrhoea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle twitching
• Erectile dysfunction (impotence)
• Swelling of hands and feet, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decrease in white blood cell count, weight gain
• Accidental injuries, bone fractures, skin abrasions

Additionally, in clinical trials in children, aggressive behaviour and sudden bending of limbs were commonly reported.
Uncommon (may affect up to 1 in 100 people):

• Agitation (a state of constant restlessness and unintentional, aimless movements)
• Allergic reactions, e.g. urticaria
• Restricted movement
• Palpitations
• Swelling affecting the face, trunk, limbs
• Abnormal blood test results indicating liver function disorders
• Psychiatric disorders
• Falls
• Increased blood glucose levels (most commonly observed in patients with diabetes)
• Difficulty swallowing

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

• Loss of consciousness
• Low blood glucose levels (most commonly observed in patients with diabetes)

After the introduction of Gabapentin Aurovitas to the market, the following adverse reactions have been observed:
Frequency unknown (frequency cannot be estimated from available data):

• Decrease in platelet count (blood cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Abnormal movements, such as twisting of limbs or sudden bending, muscle stiffness
• Ringing in the ears
• Yellowing of the skin and whites of the eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue overgrowth, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep difficulties, nausea, pain, excessive sweating), chest pain
• Rhabdomyolysis (breakdown of muscle fibres)
• Changes in blood test results (increased creatine phosphokinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylactic reactions (severe, potentially life-threatening allergic reactions involving breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring immediate treatment)
• Development of dependence on Gabapentin Aurovitas ("drug dependence")

After discontinuation of short-term or long-term treatment with Gabapentin Aurovitas, it should be noted that certain adverse reactions may occur, known as withdrawal symptoms (see "Discontinuation of Gabapentin Aurovitas").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gabapentin Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Store below 25 °C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Gabapentin Aurovitas contains

• The active substance is gabapentin. Each hard capsule contains 100 mg gabapentin. Each hard capsule contains 300 mg gabapentin.

Each hard capsule contains 400 mg gabapentin.

• Other components are:
  Capsule contents: corn starch and talc.
  Capsule shell:
  100 mg: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water.
  300 mg: iron oxide yellow (E 172), titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water.
  400 mg: iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water.
  Printing ink: shellac, iron oxide black (E 172), potassium hydroxide.

What Gabapentin Aurovitas looks like and contents of the pack
Hard capsule
Gabapentin Aurovitas 100 mg hard capsules:
White to white, size "3", hard gelatin capsules with "D" printed on the white cap and "02" on the white body in black edible printing ink, containing white or almost white, crystalline powder.
Gabapentin Aurovitas 300 mg hard capsules:
Yellow to yellow, size "1", hard gelatin capsules with "D" printed on the yellow cap and "03" on the yellow body in black edible printing ink, containing white or almost white, crystalline powder.
Gabapentin Aurovitas 400 mg hard capsules:
Orange to orange, size "0", hard gelatin capsules with "D" printed on the orange cap and "04" on the orange body in black edible printing ink, containing white or almost white, crystalline powder.
Gabapentin Aurovitas capsules are available in blister packs made of transparent PVC/PVDC/Aluminium. Pack sizes: 20, 30, 60, 90 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13 D lok. 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Malta: Gabapentin Aurobindo 100 mg/300 mg capsules, hard
Poland: Gabapentin Aurovitas
Portugal: Gabapentina Aurovitas
Spain: Gabapentina Aurovitas 300 mg/400 mg hard capsules EFG