Gabapentin Almus: detailed information

Package Leaflet: Information for the User

Gabapentin Almus 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Generic medicine
Please read this 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gabapentin Almus is and what it is used for
What you need to know before taking Gabapentin Almus
How to take Gabapentin Almus
Possible side effects
How to store Gabapentin Almus
Contents of the pack and other information

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

Gabapentin Almus belongs to a group of medicines used to treat 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 (epileptic seizures initially limited to certain areas of the brain, whether or not they spread to other parts of the brain). The doctor treating you or your child aged 6 years or older will prescribe Gabapentin Almus as an add-on treatment for epilepsy when the current treatment does not fully control the condition. You, or your child aged 6 years or older, must take Gabapentin Almus in addition to the ongoing treatment unless otherwise instructed. Gabapentin Almus may 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 (which occurs mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations may be described as warmth, burning, pulsing, shooting pains, stabbing pains, sharp pains, cramp-like pains, discomfort, 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 to 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 you a different dosage
if you are undergoing haemodialysis (to remove waste due to kidney failure), inform your doctor if you develop pain and/or muscle 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 nervous system/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses
if you have myasthenia gravis (a disease causing muscle weakness), as this medicine could worsen its symptoms
before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; this may mean you have a higher risk of developing dependence on Gabapentin Almus.

Dependence
Some people may become dependent on Gabapentin Almus (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using Gabapentin Almus or reduce the dose (see section 3, “How to take Gabapentin Almus” and “If you stop taking Gabapentin Almus”). If you are concerned about becoming dependent on Gabapentin Almus, it is important to speak with your doctor.
If, while taking Gabapentin Almus, you notice any of the following signs, this could mean you have become dependent:

you feel the need to take the medicine for longer than recommended by your doctor
you feel the need to take a higher dose than recommended
you use the medicine for reasons other than those prescribed
you have repeatedly tried to stop or control use of the medicine but failed
you feel unwell after stopping the medicine and feel better when you start taking it again.
If you notice any of these situations, talk to your doctor to discuss the best treatment for you, including when and how to stop taking it safely. A small number of patients treated with antiepileptic medicines such as gabapentin have developed suicidal thoughts or self-harming behaviour. If at any time you have such thoughts, contact your doctor immediately.

Important information about potentially serious reactions
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with gabapentin. If you notice the onset of signs and symptoms related to the serious skin reactions described in section 4, stop treatment with gabapentin and contact your doctor immediately.
Please read the description of serious symptoms in section 4 of this leaflet under “You must contact your doctor immediately if you notice any of the following symptoms after taking this medicine, as they may be serious”.
Muscle weakness, tenderness or pain, especially if accompanied by feeling unwell and fever, may be caused by muscle injury which can be life-threatening and may lead to kidney problems. Discoloration of urine and abnormalities in blood tests (particularly increased creatine phosphokinase) may also occur. If any of these signs or symptoms occur, 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, inform your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety or other neurological or psychiatric conditions.
Medicines containing opioids such as morphine
If you are taking medicines containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin Almus. In addition, the combination of Gabapentin Almus with opioids may cause drowsiness, sedation, reduced breathing or death.
Antacids for indigestion
If Gabapentin Almus and antacids containing aluminium 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 sooner than two hours after taking an antacid.
Gabapentin Almus:

is not expected to interact with other antiepileptic medicines or with oral contraceptives.
may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about the medicines you are taking.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or think you may be pregnant, you must inform your doctor immediately and discuss the possible risks that the medicine you are taking may pose to the unborn child.
Do not stop treatment without discussing it with your doctor.
If you are planning a pregnancy, you should discuss your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Gabapentin Almus may be used during the first trimester of pregnancy if your doctor considers it necessary.
If you are planning a pregnancy, are pregnant or think you may be pregnant, contact your doctor immediately.
If you are pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen your condition. Worsening of epilepsy could endanger both you and your unborn child.
In a study examining data from women in Nordic countries who took gabapentin during the first three months of pregnancy, no increased risk of birth defects or problems in brain function development (neurodevelopmental disorders) was observed. However, children born to women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm delivery.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken together with opioid analgesics (medicines for the treatment of severe pain).
Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy while being treated with Gabapentin Almus. Do not suddenly stop taking this medicine, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your baby.

Breastfeeding
Gabapentin, the active substance in Gabapentin Almus, passes into breast milk. Since the effect on the infant is unknown, breastfeeding is not recommended during treatment with Gabapentin Almus.

Fertility
Animal studies have shown no effect on fertility.

Driving and using machines
Gabapentin Almus may cause dizziness, drowsiness and fatigue. Do not drive, operate heavy machinery or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform such tasks.

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

3. How to take Gabapentin Almus

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 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, divided into 3 separate doses—once in the morning, once in the afternoon, and once in the evening.

Children aged 6 years and older:
The dose for the child will be determined by the doctor based on the child's body weight. Treatment is started with a low initial dose, which is gradually increased over approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg/kg per day, administered in 3 divided doses—typically once in the morning, once in the afternoon, and once in the evening.

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

Peripheral neuropathic pain, the recommended dose is:
Adults:
Take the number of capsules as instructed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 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, divided into 3 separate doses—once in the morning, once in the afternoon, and once in the evening.

If you have kidney problems or are on haemodialysis
If you have kidney problems or are undergoing haemodialysis, your doctor may prescribe a different dosing schedule and/or a different dose.

If you are an elderly patient (aged over 65 years)
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 schedule and/or a different dose.

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

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

If you take more Gabapentin Almus than you should
Taking more than the recommended dose may lead to an increase in side effects, including loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, and diarrhoea.
Contact your doctor immediately or go to the nearest emergency department if you take more Gabapentin Almus than prescribed. Bring with you any unused capsules, the packaging, and the leaflet so that hospital staff can quickly identify the 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 almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Gabapentin Almus
Do not stop treatment with Gabapentin Almus suddenly or reduce the dose without medical advice. If you wish to stop treatment or reduce the dose, speak to your doctor first, who will advise you on how to do so safely. Stopping treatment or reducing the dose should be done gradually over a period of at least 1 week.
After stopping short- or long-term treatment with Gabapentin Almus or after reducing the dose, you should be aware that you may experience certain side effects known as withdrawal symptoms. These may include epileptic seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling abnormal, dizziness, and general malaise. These symptoms usually occur within 48 hours of stopping or reducing the dose of Gabapentin Almus. If you experience withdrawal symptoms, contact your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using Gabapentin Almus and contact your doctor immediately if you notice any of the
following symptoms:

Reddish, flat patches on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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).

Contact your doctor immediately if you experience any of the following symptoms after taking this
medicine, as they may be serious:

Persistent stomach pain, nausea and vomiting, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
Breathing problems which, if severe, may require emergency and intensive care to allow normal breathing to continue.
Gabapentin Almus may cause a serious or life-threatening allergic reaction affecting the skin or any other part of the body such as the liver or blood. When experiencing this type of reaction, you may or may not develop a skin rash. This may lead to hospitalization or discontinuation of treatment with Gabapentin Almus.

Call your doctor immediately if you experience any of the following symptoms:

Skin rashes and redness and/or hair loss
Hives
Fever
Swollen lymph glands that do not go away
Swelling of the lips, face and tongue
Yellowing of the skin or whites of the eyes
Unusual bleeding or bruising
Severe tiredness or weakness
Sudden muscle pain
Frequent infections

These symptoms may be early signs of a serious reaction. Your doctor should examine you to
determine whether you should continue taking Gabapentin Almus.

If you are on haemodialysis, inform your doctor if you develop pain and/or muscle weakness.

Other side effects include:
Very common (may affect more than 1 in 10 people):

Viral infections
Drowsiness, dizziness, lack of coordination
Feeling tired, fever

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

Pneumonia, respiratory infections, urinary tract infections, ear inflammation or other infections
Low white blood cell count
Anorexia, increased appetite
Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
Seizures, jerky movements, difficulty speaking, memory loss, tremors, sleep disturbances, headache, skin sensitivity, reduced sensation (numbness), coordination problems, eye movement abnormalities, increased, decreased or absent reflexes
Blurred vision, double vision
Dizziness
High blood pressure, facial flushing or blood vessel dilation
Breathing difficulties, bronchitis, sore throat, cough, dry nose
Vomiting, nausea, dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence
Facial swelling, bruising, rash, itching, acne
Joint pain, muscle pain, back pain, muscle cramps
Erectile problems (impotence)
Swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
Reduced white blood cell count, weight gain
Accidental injuries, fractures, abrasions

In addition, in clinical studies conducted in children, aggressive behaviour and convulsive movements were commonly reported.
Uncommon (may affect up to 1 in 100 people):

Agitation (a state of chronic restlessness and unintentional, purposeless movements)
Allergic reaction such as hives
Reduced movement
Increased heart rate
Difficulty swallowing
Swelling affecting the face, trunk and limbs
Abnormal blood test results suggesting liver problems
Mental impairment
Falls
Increased blood glucose levels (observed more frequently in patients with diabetes)

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

Decreased blood glucose levels (observed more frequently in patients with diabetes)
Loss of consciousness
Breathing difficulties, shortness of breath (respiratory depression)

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

Dependence on Gabapentin Almus (drug dependence)
Worsening of myasthenia gravis (a disease causing muscle weakness)

After stopping short- or long-term treatment with Gabapentin Almus or after reducing the dose, you should be aware that you may experience some side effects known as withdrawal effects (see “If you stop taking Gabapentin Almus”).
The following side effects have been reported after marketing:

Reduced platelet count (blood cells responsible for clotting)
Suicidal thoughts, hallucinations
Movement disorders such as convulsive restlessness, jerky movements and rigidity
Ringing in the ears
Yellowing of the skin and eyes (jaundice), liver inflammation
Acute kidney failure, incontinence
Increased breast tissue, breast enlargement
Adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
Damage to muscle fibres (rhabdomyolysis)
Abnormal blood tests (elevated creatine phosphokinase)
Sexual dysfunction including inability to reach orgasm, delayed ejaculation
Low sodium levels in the blood
Anaphylaxis (severe, potentially fatal allergic reaction including breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring emergency treatment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://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 stated on the packaging after "Expiry:". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gabapentin Almus contains
Gabapentin Almus 100 mg hard capsules

The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin.
The other components are: maize starch, lactose monohydrate, talc, gelatin, titanium dioxide (E171).

Gabapentin Almus 300 mg hard capsules

The active substance is gabapentin. Each hard capsule contains 300 mg of gabapentin.
The other components are: maize starch, lactose monohydrate, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Gabapentin Almus 400 mg hard capsules

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

Description of the appearance of Gabapentin Almus and pack sizes
Box of 50 hard capsules of 100 mg in blister packs
Box of 50 hard capsules of 300 mg in blister packs
Box of 30 hard capsules of 400 mg in blister packs

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

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