GABAPENTIN 100 mg Hard Capsule

Зміст інструкції

1. Gabapentin Almus 300 mg hard capsules, 400 mg hard capsules
   1. What is Gabapentin Almus and what it is used for
   2. What you need to know before taking Gabapentin Almus
   3. How to take Gabapentin Almus
   4. Possible side effects
   5. How to store Gabapentin Almus
   6. Contents of the pack and other information

Gabapentin Almus 100 mg hard capsules

Gabapentin Almus 300 mg hard capsules, 400 mg hard capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Gabapentin Almus is and what it is used for
• 2. What you need to know before you take Gabapentin Almus
• 3. How to take Gabapentin Almus
• 4. Possible side effects
• 5. How to store Gabapentin Almus
• 6. Contents of the pack and other information

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

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

• Various forms of epilepsy (seizures initially limited to certain areas of the brain, whether the seizures spread to other parts of the brain or not). Your doctor will prescribe Gabapentin Almus as an adjunct to epilepsy treatment when the treatment you are already following does not fully control your condition. You should take Gabapentin Almus in addition to the treatment you are already undergoing unless you receive other instructions. Gabapentin Almus can also be used alone for the treatment of adults and children over 12 years of age.
• Peripheral neuropathic pain (long-lasting pain caused by nerve damage). A variety of different diseases can cause peripheral neuropathic pain (occurs mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramping pains, suffering, tingling, numbness, prickling pains, etc.

2. What you need to know before taking Gabapentin Almus

Do not take Gabapentin Almus

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Almus:

• if you have kidney problems, your doctor may prescribe a different dosage
• if you are undergoing hemodialysis (to remove waste products due to kidney failure), tell your doctor if you develop muscle pain and/or weakness
• if you develop signs such as persistent stomach pain, nausea and vomiting, contact your doctor immediately as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• if you suffer from neurological/respiratory system diseases or are over 65 years of age, your doctor may prescribe different doses
• before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs or illegal substances, as this may indicate that you are at greater risk of developing a dependence on Gabapentin Almus.

Dependence
Some people may develop a dependence on Gabapentin Almus (a need to continue taking the
medicine). They may experience withdrawal effects when they stop using Gabapentin Almus
(see section 3, “How to take Gabapentin Almus” and “If you stop taking Gabapentin
Almus”). If you are concerned about the possibility of developing a dependence on Gabapentin Almus, talk to
your doctor.
If you notice any of the following signs while taking Gabapentin Almus, you may have
developed a dependence on the medicine.

• You feel the need to take the medicine for longer than prescribed by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine you do not feel well and feel better when you take it again. If you notice any of these signs, talk to your doctor to discuss the best treatment plan for you, including when it is appropriate to stop taking it and how to do so safely. Important information about potentially serious reactionsA small number of patients treated with antiepileptic drugs such as gabapentin have developed thoughts of suicide or self-harm. If at any time you have thoughts of this kind, contact your doctor immediately. Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin treatment. Stop using gabapentin and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section
• 4.

immediately your doctor if you experience any of the following symptoms after taking this medicine, as

they may be serious”
Muscle weakness, soreness or pain, and especially if at the same time you do not feel well and have
fever, may be caused by a muscle injury that can be life-threatening and can lead to
kidney problems. You may also experience discoloration of the urine and abnormalities in blood tests (in
particular increased creatine phosphokinase). If you experience any of these signs or symptoms, please
contact your doctor immediately.

Other medicines and Gabapentin Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently
taken medicines for convulsions, sleep disorders, depression, anxiety or other neurological or
psychiatric problems.
Medicines containing opioids such as morphine
If you are taking medicines that contain opioids (such as morphine), tell your doctor or pharmacist
because opioids can increase the effect of Gabapentin Almus. In addition, the combination of
Gabapentin Almus with opioids can cause symptoms such as drowsiness and/or decreased
breathing.
Antacids for indigestion
If Gabapentin Almus and antacids containing aluminum and magnesium are taken together,
the absorption of Gabapentin Almus from the stomach may be reduced. It is therefore recommended to take
Gabapentin Almus no earlier than two hours after taking the antacid.
Gabapentin Almus:

• It is not expected to interact with other antiepileptic medicines or with the contraceptive pill.
• May interfere with some laboratory tests; if you need a urine test, tell your doctor or hospital what you are taking.

Gabapentin Almus with food
Gabapentin Almus can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Gabapentin Almus should not be taken during pregnancy unless your doctor has told you to do so.
Women of childbearing potential should use effective contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but
an increased risk for the development of the baby has been reported for other medicines used to treat
epileptic seizures, particularly when taking more than
one medicine for epileptic seizures. Therefore, if possible, during pregnancy you should try to
take only one medicine for epilepsy and only on medical advice.
If used during pregnancy, gabapentin can cause withdrawal symptoms in newborns. The risk may
be increased when gabapentin is taken together with opioid analgesics (pain relievers).
Contact your doctor immediately if you are pregnant, think you may be pregnant or are
planning a pregnancy while taking Gabapentin Almus. Do not suddenly stop
taking this medicine as this can cause the sudden onset of seizures which
can have serious consequences for you and the baby.

Breastfeeding
Gabapentin, the active ingredient of Gabapentin Almus, passes into breast milk. As the
effect on the baby is unknown, it is recommended not to breastfeed while taking Gabapentin Almus.

Fertility
Studies in animals have not shown any effect on fertility.

Driving and using machines
Gabapentin Almus can cause dizziness, drowsiness and fatigue. Do not drive vehicles, use
complex machinery or engage in other potentially dangerous activities until you understand whether
this medicine may impair your ability to perform these activities.

Gabapentin Almus contains lactose
The hard capsules of Gabapentin Almus contain lactose (a type of sugar). If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Gabapentin Almus

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist. Do not take more medicine than prescribed.
The doctor will establish the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually the doctor will gradually increase the dose
for you. The initial dose will generally be between 300 mg and 900 mg per day.
Subsequently, the dose may be increased, as directed by your doctor, up to a maximum of 3600
mg per day and your doctor will tell you to take this dose in 3 separate administrations, namely once
in the morning, once in the afternoon and once in the evening.
Children aged 6 years and over:
The dose to be administered to the child will be established by the doctor because it is calculated based on the weight of the
child. Treatment is started with a low initial dose which is gradually increased
over about 3 days. The usual dose for controlling epilepsy is 25-35 mg/kg per day.
It is usually administered in 3 separate doses, taking the capsule every day generally once
in the morning, once in the afternoon and once in the evening.
Gabapentin Almus is not recommended for children under the age of 6 years.

Peripheral neuropathic pain, the recommended dose is:
Adults:
Take the number of capsules following your doctor's instructions. Usually the doctor will gradually increase the dose
for you. The initial dose will generally be between 300 mg and 900 mg per day.
Subsequently, the dose may be increased as directed by your doctor up to a maximum of
3600 mg per day and your doctor will tell you to take the medicine in 3 separate doses, namely once in the
morning, once in the afternoon and once in the evening.

If you have kidney problems or are undergoing hemodialysis
If you have kidney problems or are undergoing hemodialysis, your doctor may prescribe a different dosing regimen for
the medicine and/or a different dose.

If you are an elderly patient (over 65 years of age)you should take the normal dose of Gabapentin
Almus, unless you have kidney problems. If you have kidney problems, your doctor may prescribe a different
dosing regimen for the medicine and/or a different dose.
If you feel that the effect of Gabapentin Almus is too strong or too weak, tell your doctor or
pharmacist as soon as possible.

Method of administration
Gabapentin Almus is taken orally. Always swallow the capsules whole with plenty of
water.
Continue treatment with Gabapentin Almus until your doctor tells you to stop.

If you take more Gabapentin Almus than you should
A dose higher than recommended may lead to an increase in side effects including
loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness and diarrhea. Contact
your doctor immediately or go to the nearest emergency room if you take more Gabapentin Almus than
prescribed by your doctor. Bring with you the capsules you have not taken together with the package and the leaflet
so that the hospital can easily understand how much medicine you have taken.

If you forget to take Gabapentin Almus
If you forget to take a dose, take it as soon as you remember, unless it is time to take
the next dose. Do not take a double dose to make up for a missed dose.

If you stop treatment with Gabapentin Almus
Do not suddenly stop treatment with Gabapentin Almus. If you wish to stop
treatment with Gabapentin Almus, talk to your doctor, who will explain how to do it. If treatment
is stopped, it must be done gradually over at least 1 week. After stopping a short- or long-term treatment with Gabapentin Almus, you should know that you may experience
some side effects, called withdrawal effects. These effects may include seizures,
anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache,
depression, feeling of abnormality, dizziness and general malaise. These effects usually
occur within 48 hours of stopping Gabapentin Almus. If you experience withdrawal effects, you should
contact your doctor.
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 everyone gets them.
manifest.

Stop using Gabapentin Almus and contact your doctor immediately if you notice any of the
following symptoms:

• circular or target-shaped, reddish, non-raised patches on the trunk, often with central blisters, skin
  peeling, mouth, throat, nose, genital and eye ulcers. 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).

You should contact your doctor immediately if you notice any of the following symptoms after taking this medicine
because they may be serious:

• severe skin reactions requiring immediate attention, swelling of the lips and face, skin
  rash and redness, and/or hair loss (these may be symptoms of a severe allergic reaction)
• persistent stomach pain, nausea and vomiting because these may be symptoms of acute
  pancreatitis (inflammation of the pancreas)
• Gabapentin Almus can cause a severe or life-threatening allergic reaction, which may
  affect the skin or any other part of the body such as the liver or blood. When affected by
  this type of reaction, you may or may not have skin rashes. This may lead to hospitalization
  or discontinuation of treatment with Gabapentin Almus
• breathing problems that, if severe, may require emergency and intensive care to
  allow you to continue breathing normally. Call your doctor immediately if you experience any of the following symptoms:
• skin rashes
• hives
• fever
• swollen lymph glands that do not go away
• swelling of the lips and tongue
• yellowing of the skin or the whites of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• sudden muscle pain
• frequent infections

These symptoms may be the first signs of a serious reaction. Your doctor needs to see you to decide if
you should continue taking Gabapentin Almus.

• If you are on hemodialysis, tell your doctor if you experience pain and/or muscle weakness.

Other side effects include:

Very common
(may affect more than 1 in 10 people):

• Viral infections
• Feeling sleepy, dizziness, lack of coordination
• Feeling tired, fever

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

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation or other infections
• Low white blood cell count
• Loss of appetite, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Convulsions, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation (numbness), difficulty coordinating, abnormal eye movements, increased, decreased or absent reflexes.
• Blurred vision, double vision
• Dizziness
• High blood pressure, facial flushing or dilated blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, skin rash, itching, acne
• Joint pain, muscle pain, back pain, muscle contractions
• Erectile dysfunction (impotence)
• Swelling of the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

In addition, aggressive behavior and convulsive movements have been commonly reported in clinical studies
conducted in children.

Uncommon
(may affect up to 1 in 100 people):

• Agitation (state of chronic restlessness and unintentional and aimless movements)
• Allergic reaction such as hives
• Reduced movement
• Increased heart rate
• Swelling that may affect the face, trunk and limbs
• Altered blood test values suggesting liver problems
• Mental impairment
• Falls
• Increased blood glucose levels (observed more often in patients with diabetes)
• Difficulty swallowing

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

• Loss of consciousness
• Decreased blood glucose levels (observed more often in patients with diabetes)
• Difficulty breathing, shortness of breath (respiratory depression)

Not known
(frequency cannot be estimated from available data):

• Becoming dependent on Gabapentin Almus (“drug dependence”)

After stopping short- or long-term treatment with Gabapentin Almus, you should know that
you may experience some side effects called withdrawal effects (see “If you stop taking Gabapentin
Almus”).

The following side effects have been reported after marketing authorization:

• Decreased platelets (cells that coagulate blood)
• Hallucinations
• Problems with abnormal movements such as convulsive agitations, jerky movements and rigidity
• Tinnitus
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events that occur after sudden discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
• Muscle fiber injury (rhabdomyolysis)
• Abnormalities in blood tests (increased creatine phosphokinase)
• Sexual dysfunction including inability to reach orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe allergic reaction potentially fatal including difficulty breathing, swelling of lips, throat and tongue and low blood pressure requiring emergency treatment)
• Thoughts of suicide

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.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Gabapentin Almus

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 pack after “Expiry:”. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30°C.
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. Contents of the pack and other information

What Gabapentin Almus contains
Gabapentin Almus 100 mg hard capsules

• The active ingredient is gabapentin. Each hard capsule contains 100 mg of gabapentin.
• The other ingredients are: corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E171). Gabapentin Almus 300 mg hard capsules
• The active ingredient is gabapentin. Each hard capsule contains 300 mg of gabapentin.
• The other ingredients are: corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Gabapentin Almus 400 mg hard capsules

• The active ingredient is gabapentin. Each hard capsule contains 400 mg of gabapentin.
• The other ingredients are: corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E171), red iron oxide and yellow iron oxide (E172).

Description of the appearance of Gabapentin Almus and contents of the pack
Pack of 50 hard capsules of 100 mg in blisters
Pack of 50 hard capsules of 300 mg in blisters
Pack of 30 hard capsules of 400 mg in blisters

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genova

Manufacturer
Holsten Pharma GmbH
Hahnstrasse 31-35
60528 Frankfurt am Main
Germany