PACKAGE LEAFLET: Information for the patient

Gabapentin Hexal A/S 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

gabapentin
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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gabapentin Hexal A/S is and what it is used for

Gabapentin Hexal A/S belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Gabapentin Hexal A/S is gabapentin.
Gabapentin Hexal A/S is used to treat:
Various forms of epilepsy (both seizures initially limited to certain areas of the brain, and seizures that may or may not spread to other parts of the brain). Your doctor, or the doctor treating your child aged 6 years or older, will prescribe Gabapentin Hexal A/S 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 Hexal A/S in addition to the ongoing treatment, unless otherwise instructed. Gabapentin Hexal A/S may also be used alone for the treatment of adults and children aged over 12 years.
Peripheral neuropathic pain: (long-lasting pain caused by nerve damage). A variety of different diseases can cause peripheral neuropathic pain (occurring mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsing, electric shock-like pains, stabbing pains, sharp pains, cramp-like pains, discomfort, tingling, numbness, pricking pains, etc.

2. What you need to know before taking Gabapentin Hexal A/S

Do not take Gabapentin Hexal A/S

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 Hexal A/S

if you have kidney problems, your doctor may prescribe a different dosage
if you are on haemodialysis (to remove waste due to kidney failure), inform your doctor if muscle pain and/or weakness develop
if you develop signs of 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 disorders of the nervous/respiratory system or are over 65 years of age, your doctor may prescribe different doses.

Cases of abuse and dependence have been reported with gabapentin in post-marketing experience. Inform your doctor
if you have a history of abuse or dependence.
A small number of patients taking antiepileptic medicines such as gabapentin have had suicidal thoughts or thoughts of self-harm. If you have such thoughts at any time, contact
your doctor immediately.
Important information about potentially serious reactions
A small number of people taking Gabapentin Hexal A/S have developed an allergic reaction or a potentially serious skin reaction, which, if untreated, may progress to more serious problems. It is important to be aware of these symptoms in order to prevent complications while taking Gabapentin Hexal A/S.
Please read the description of these symptoms in section 4 of this leaflet under the heading 'Contact your doctor immediately if any of the following symptoms occur after taking this medicine as they may be serious'.
Muscle weakness, tenderness or pain, especially if accompanied by feeling unwell or fever, may be caused by abnormal muscle injury which can be life-threatening and may lead to kidney problems. Discoloration of the 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 Hexal A/S
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. 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, because opioids may increase the effect of Gabapentin Hexal A/S.
In addition, the combination of Gabapentin Hexal A/S with opioids may cause symptoms such as drowsiness and/or breathing difficulties.
Antacids for indigestion
If Gabapentin Hexal A/S and antacids containing aluminium and magnesium are taken together, the absorption of Gabapentin Hexal A/S from the stomach may be reduced. Therefore, it is recommended to take Gabapentin Hexal A/S no sooner than two hours after taking the antacid.
Gabapentin Hexal A/S

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 Hexal A/S with food
Gabapentin Hexal A/S can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin Hexal A/S should not be taken during pregnancy unless your doctor has advised otherwise. Women of childbearing potential should use an effective method of contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted. However, with other medicines used to treat epileptic seizures, an increased risk of developmental problems in the unborn child has been reported, particularly when more than one antiepileptic medicine is taken at the same time. Therefore, whenever possible, you should try to take only one antiepileptic medicine during pregnancy and only under medical supervision.
Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning a pregnancy while being treated with Gabapentin Hexal A/S.
Do not stop taking this medicine suddenly, as this may cause sudden onset of epileptic seizures which could have serious consequences for you and your unborn child.
Breast-feeding
Gabapentin, the active substance in Gabapentin Hexal A/S, passes into breast milk. Since the effects of breastfeeding on the infant are unknown, it is recommended not to breast-feed during treatment with Gabapentin Hexal A/S.
Fertility
No effects on fertility were observed in animal studies.
Driving and using machines
Gabapentin Hexal A/S may cause dizziness, drowsiness and fatigue. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform such tasks.
Gabapentin Hexal A/S contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Gabapentin Hexal A/S

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will determine the right 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. Afterwards, the dose may be gradually increased up to a maximum of 3600 mg per day; your doctor will instruct you to take this dose in three separate administrations (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. This dose is usually administered in three separate doses, taking the capsule daily once in the morning, once in the afternoon, and once in the evening.
The use of Gabapentin Hexal A/S is not recommended in 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. Afterwards, the dose may be increased, as advised by your doctor, up to a maximum of 3600 mg per day; your doctor will instruct you to take this dose in three separate administrations (once in the morning, once in the afternoon, and once in the evening).
If you have kidney problems or are undergoing haemodialysis
Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems or are undergoing haemodialysis.
If you are an elderly patient (aged over 65 years), you should take the normal dose of Gabapentin Hexal A/S, unless you have kidney problems. If you have kidney problems, your doctor may prescribe a different dosing schedule and/or dose.
If you think that the effect of Gabapentin Hexal A/S is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Hexal A/S is for oral use. Always swallow the capsules with plenty of water.
Continue treatment with Gabapentin Hexal A/S until your doctor tells you to stop.
If you take more Gabapentin Hexal A/S than you should
Doses higher than those recommended may lead to an increase in side effects, including loss of consciousness, dizziness, double vision, speech disorders, drowsiness, and diarrhoea. Contact your doctor or go immediately to the nearest emergency department if you take more Gabapentin Hexal A/S than prescribed. Take with you any remaining capsules, the packaging, and the leaflet so that hospital staff can easily identify the medicine you have taken.
If you forget to take Gabapentin Hexal A/S
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 a forgotten dose.
If you stop taking Gabapentin Hexal A/S
Do not stop treatment with Gabapentin Hexal A/S unless your doctor tells you to. Stopping treatment should be done gradually over at least 1 week. If you stop treatment with Gabapentin Hexal A/S suddenly or before your doctor has instructed you to do so, your risk of epileptic seizures increases.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if any of the following symptoms occur after taking this medicine, as they
may be serious:

severe skin reactions requiring immediate attention, swelling of the lips and face, skin rashes, redness and/or hair loss (these may be symptoms of a severe allergic reaction)
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 treatment to allow normal breathing to continue
Gabapentin Hexal A/S may cause severe or life-threatening allergic reactions affecting the skin or other parts of the body, such as the liver or blood cells. A rash may or may not occur with this type of reaction. This may lead to hospitalization or discontinuation of treatment with Gabapentin Hexal A/S. Immediately inform your doctor if you experience any of the following symptoms:
rash
hives
fever
swollen glands that do not heal
swelling of the lips 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 early signs of a serious reaction. Your doctor should examine you to determine whether
you should continue taking Gabapentin Hexal A/S.
If you are undergoing haemodialysis, inform your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common side effects (may affect more than 1 in 10 people):

viral infections
drowsiness, dizziness, lack of coordination
feeling tired, fever

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

pneumonia, respiratory infections, urinary tract infections, 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 in thinking
seizures, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation (numbness), coordination difficulties, eye movement abnormalities, increased, decreased or absent reflexes
blurred vision, double vision
dizziness
high blood pressure, facial flushing or dilation of blood vessels
breathing difficulties, bronchitis, sore throat, cough, runny nose
vomiting (feeling unwell), nausea (feeling sick), dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, intestinal gas (flatulence)
facial swelling, bruising, rash, itching, acne
joint pain, muscle pain, back pain, muscle spasms
erection problems (impotence)
swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
reduced white blood cells, weight gain
accidental injuries, fractures, abrasions

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

Agitation (a state of chronic restlessness and purposeless, unintentional movements)
Allergic reactions such as hives
Decreased movement
Rapid heartbeat
Swelling that may affect the trunk, face and limbs
Abnormal blood test results suggesting liver problems
Changes in thinking
Fall
High blood sugar levels (more frequently observed in patients with diabetes)
Difficulty swallowing

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

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

The following side effects have been reported after marketing:
Not known (frequency cannot be estimated from available data):

reduced platelet count (blood cells responsible for clotting)
hallucinations
problems with abnormal movements such as convulsive agitation, jerky movements and stiffness
ringing in the ears
a group of side effects occurring together, including swollen lymph nodes (small isolated lumps under the skin), fever, skin rashes, and liver inflammation
yellowing of the skin and eyes (jaundice), liver inflammation
acute kidney failure, incontinence
increase in breast tissue, breast enlargement
adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
muscle fibre breakdown (rhabdomyolysis)
changes in blood test results (increased creatine phosphokinase)
sexual function problems 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 effects, 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 the website 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 Hexal A/S

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 carton after “Exp.’’.
The expiry date refers to the last day of that month.
Store below 25°C.
Blister packs: Keep in the original packaging to protect the medicine from moisture.
Tablet container: Keep the container tightly closed to protect the medicine from moisture.
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 Hexal A/S contains

The active substance is gabapentin. Gabapentin Hexal A/S: Each hard capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
The other components of the capsules are: capsule contents: pregelatinized maize starch, maize starch, talc, anhydrous colloidal silica. Capsule shell: gelatin, sodium lauryl sulfate, colored with titanium dioxide (E171) and yellow iron oxide (E172) (300 mg and 400 mg capsules) and red iron oxide (E172) (400 mg capsules).

Description of the appearance of Gabapentin Hexal A/S and pack sizes
Hard capsules
Gabapentin Hexal A/S 100 mg hard capsules are hard gelatin capsules with an opaque white body and cap.
Gabapentin Hexal A/S 300 mg hard capsules are hard gelatin capsules with an opaque yellow body and cap.
Gabapentin Hexal A/S 400 mg hard capsules are hard gelatin capsules with an opaque brown body and cap.
Gabapentin Hexal A/S 100 mg hard capsules
PVC/PE/PVDC/Alu blister packs: 20, 30, 50, 90, 100, 200 and 500 hard capsules
Gabapentin Hexal A/S 300 mg hard capsules
PVC/PE/PVDC/Alu blister packs: 20, 30, 50, 90, 100, 200 and 500 hard capsules
HDPE container with child-resistant closure: 50 and 100 hard capsules
Gabapentin Hexal A/S 400 mg hard capsules
PVC/PE/PVDC/Alu blister packs: 20, 30, 50, 90, 100, 200 and 500 hard capsules
HDPE container with child-resistant closure: 100 hard capsules
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Hexal A/S - Edvard Thomsens Vej 14 - 2300 Copenhagen - Denmark
Local representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH – Otto-von-Guericke-Allee 1 – 39179 Barleben (Germany)
LEK SA – Ul. Domaniewska 50 C – 02-672 Warszawa (Poland)
Sandoz GmbH - Biochemiestrasse 10, 6250 Kundl (Austria)
LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana (Slovenia)
LEK Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava (Slovenia)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Gabapentin Hexal 100 mg – HartKapseln
Gabapentin Hexal 300 mg - HartKapseln
Gabapentin Hexal 400 mg - HartKapseln
Germany: Gabapentin Hexal 100 mg Hartkapseln
Gabapentin Hexal 300 mg Hartkapseln
Gabapentin Hexal 400 mg Hartkapseln
Italy: GABAPENTIN HEXAL A/S 100 mg hard capsules
GABAPENTIN HEXAL A/S 300 mg hard capsules
GABAPENTIN HEXAL A/S 400 mg hard capsules
Luxembourg: Gabapentin HEXAL 100 mg Hartkapseln
Gabapentin HEXAL r 300 mg Hartkapseln
Gabapentin HEXAL r 400 mg Hartkapseln
Netherlands: Gabapentine Sandoz capsules 100 mg
Gabapentine Sandoz capsules 300 mg
Gabapentine Sandoz capsules 400 mg
Spain: Gabapentina Bexal 300 mg cápsulas EFG
Gabapentina Bexal 400 mg cápsulas EFG

This leaflet was last updated