Gabapentin Teva Pharma: detailed information

Package Leaflet: Information for the User

Gabapentin Teva Pharma 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Generic Medicine
Please read all of this leaflet carefully before you take 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 they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gabapentin Teva Pharma is and what it is used for

Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain. The active substance in
Gabapentin Teva Pharma is gabapentin.
Gabapentin Teva Pharma 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). Your doctor will prescribe Gabapentin Teva Pharma as an add-on treatment for epilepsy if your current treatment is not fully controlling your condition. You must take Gabapentin Teva Pharma in addition to your ongoing treatment, unless otherwise directed by your doctor. Gabapentin Teva Pharma may also be used as monotherapy to treat adults and children over 12 years of age.
Peripheral neuropathic pain (treatment of long-lasting pain caused by nerve damage). A wide range of diseases can cause peripheral neuropathic pain (occurring primarily in the legs and/or arms), such as diabetes or Herpes zoster. Painful sensations may be described in various ways, such as heat, burning, pulsation, stabbing, shooting pain, piercing pain, cramping, dull pain, burning pain, numbness, tingling, etc.

2. What you need to know before taking Gabapentin Teva Pharma

Do not take Gabapentin Teva Pharma

if you are allergic to gabapentin or to any of the excipients of this medicine (listed in section 6). Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentin Teva Pharma

if you have kidney problems. In this case, your doctor may prescribe a different dose
if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or muscle weakness
if you experience symptoms such as persistent stomach pain, feeling unwell or malaise, contact your doctor immediately, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
if you have neurological/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses.

Cases of abuse and dependence on gabapentin have been reported in post-marketing experience. Inform your doctor if you have a history of substance abuse or dependence.
A small number of patients treated with antiepileptic medicines such as Gabapentin Teva Pharma have experienced suicidal thoughts or self-harming thoughts. If you experience such thoughts at any time, contact your doctor immediately.
Important information about potentially serious reactions
A small number of patients treated with Gabapentin Teva Pharma have shown allergic reactions or potentially serious skin reactions, which, if not treated, may progress to more serious problems. You should be aware of these symptoms so that you can recognize them while taking Gabapentin Teva Pharma.
Read the description of these symptoms in section 4 of this leaflet under “Contact your doctor immediately if any of the following symptoms occur after taking this medicine, as they could be serious.”
Weakness, tenderness or muscle pain, especially if you also feel unwell and have fever, may be caused by muscle injury which can be life-threatening and may lead to kidney problems. You may also notice discolouration of urine and abnormalities in blood tests (particularly an increase in creatine phosphokinase). If you experience any of these signs or symptoms, contact your doctor immediately.
Other medicines and Gabapentin Teva Pharma
Inform 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 (e.g. morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin Teva Pharma.
Moreover, the combination of Gabapentin Teva Pharma with opioids may cause symptoms such as drowsiness and/or reduced breathing.
If Gabapentin Teva Pharma and antacids containing aluminium and magnesium are taken simultaneously, the absorption of Gabapentin Teva Pharma from the stomach may be reduced.
It is therefore recommended to take Gabapentin Teva Pharma at least two hours after taking an antacid.
Gabapentin Teva Pharma

is not expected to interact with other antiepileptic drugs or with oral contraceptives.
may interfere with certain laboratory tests; therefore, if you are due to have a urine test, inform your doctor or hospital that you are taking Gabapentin Teva Pharma.

Gabapentin Teva Pharma with food and drink
Gabapentin Teva Pharma can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Gabapentin Teva Pharma should not be taken during pregnancy unless otherwise prescribed by your doctor.
Women of childbearing potential must use effective contraceptive methods.
Specific studies on the use of gabapentin during pregnancy have not been conducted, but with other medicines used to treat epilepsy, an increased risk of developmental problems in the unborn child has been observed, particularly when multiple antiepileptic drugs are taken together. Therefore, whenever possible, during pregnancy you should try to take only one antiepileptic medicine 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 Teva Pharma. 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 baby.
Breast-feeding
Gabapentin, the active ingredient in Gabapentin Teva Pharma, passes into human breast milk. Since its effects on the infant are unknown, breast-feeding is not recommended during treatment with Gabapentin Teva Pharma.
Fertility
Animal studies have not shown any effect on fertility.
Driving and using machines
Gabapentin Teva Pharma may cause dizziness, drowsiness and fatigue. Therefore, you should not drive, operate complex machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform such tasks.
Gabapentin Teva Pharma contains lactose
and capsules contain lactose (a type of sugar). If you know you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Gabapentin Teva Pharma

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose for you. For dosages higher than those achievable with these formulations, other formulations with different strengths are available.

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. Your doctor will instruct you to take this dose in three separate administrations, i.e. once in the morning, once in the afternoon, and once in the evening.

Children from 6 years of age:
The dose to be administered to the child will be determined by the doctor, as it is calculated based on the child's body weight. Treatment starts with a low initial dose, which is then gradually increased over approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg/kg/day. This dose is usually divided into three separate administrations, taking the capsule(s) every day generally once in the morning, once in the afternoon, and once in the evening.

The use of Gabapentin Teva Pharma 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.
Subsequently, the dose may be increased, as directed 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, i.e. 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 (over 65 years of age), you should take the normal dose, 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 the effect of Gabapentin Teva Pharma is too strong or too weak, inform your doctor or pharmacist as soon as possible.

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

If you take more Gabapentin Teva Pharma than you should
If you or someone else has accidentally taken more capsules than prescribed, or if you suspect a child has swallowed some, contact your doctor immediately or go to the nearest hospital emergency department. Since Gabapentin Teva Pharma may cause drowsiness, it is advisable to ask someone else to take you to the doctor or nearest hospital, or to call an ambulance. Symptoms of overdose include dizziness, double vision, difficulty speaking, loss of consciousness, drowsiness, and mild diarrhoea.
Take any unused capsules with the container and label to show the hospital doctors exactly which medicine has been taken.

If you forget to take Gabapentin Teva Pharma
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 forgotten dose.

If you stop taking Gabapentin Teva Pharma
Do not stop taking Gabapentin Teva Pharma unless advised by your doctor. Discontinuation of treatment should be done gradually over a minimum period of at least one week. If you stop taking Gabapentin Teva Pharma suddenly or before your doctor has instructed you to do so, there is a risk of increased epileptic seizures.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience any of the following symptoms after taking this
medicine, as they could be serious:

Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of the lips, throat and tongue, and hypotension, requiring emergency treatment)
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, feeling unwell or malaise, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
Gabapentin Teva Pharma may cause a severe 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 Teva Pharma. Call your doctor immediately if you experience any of the following symptoms:
skin rash
hives
fever
swollen lymph nodes that do not go away
swelling of the lips and tongue
yellowing of the skin or whites of the eyes
unusual bleeding or bruising
severe fatigue or weakness
sudden muscle pain
frequent infections
breathing problems, which, if severe, may require emergency and intensive care to maintain normal breathing.

These symptoms may be early signs of a serious allergic reaction. A doctor should examine you to determine whether you can continue taking Gabapentin Teva Pharma.

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

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

Viral infection
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
Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
Seizures, jerky movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, reduced sensation (numbness), coordination problems, abnormal eye movements, exaggerated, diminished or absent reflexes
Blurred vision, double vision
Dizziness
High blood pressure, hot flushes or dilation of blood vessels
Shortness of breath, bronchitis, sore throat, cough, dry nose
Vomiting (feeling unwell), nausea (feeling sick), dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence
Facial swelling, bruising, skin rash, itching, acne
Joint pain, muscle pain, back pain, muscle spasms
Erectile dysfunction (impotence)
Swelling of arms and legs, difficulty walking, weakness, pain, malaise, flu-like symptoms
Decreased 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)

Allergic reactions such as hives
Reduced movement
Rapid heartbeat
Swelling that may affect the face, trunk and limbs
Abnormal blood test results suggesting liver problems
Mental impairment
Falls
Increased blood glucose levels (more commonly observed in patients with diabetes)

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

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

Following marketing, the following side effects have been reported:
Uncommon (may affect up to 1 in 100 people)

Agitation (a state of chronic restlessness and involuntary, purposeless movements)

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

Decreased platelet count (blood cells involved in clotting)
Hallucinations
Abnormal movements such as twisting, jerky movements and stiffness
Ringing in the ears
A group of side effects including swollen lymph nodes (small isolated lumps under the skin), fever, skin rash and liver inflammation, which may occur together
Yellowing of the skin and eyes (jaundice), liver inflammation
Acute kidney failure, incontinence
Increased breast tissue, breast enlargement
Adverse events following abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, feeling unwell, pain, sweating), chest pain
Muscle fibre damage (rhabdomyolysis)
Abnormalities in blood tests (increased creatine phosphokinase)
Sexual dysfunction including inability to reach orgasm, delayed ejaculation
Low sodium levels in the blood

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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gabapentin Teva Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after the abbreviation EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gabapentin Teva Pharma contains

The active substance is gabapentin. Each capsule contains 100 mg/300 mg/400 mg of gabapentin.
The excipients are:
Capsule contents: Anhydrous lactose, maize starch, talc
Capsule shell: Gelatin
Additionally, in Gabapentin Teva Pharma 100 mg hard capsules:
Titanium dioxide (E171)
Additionally, in Gabapentin Teva Pharma 300 mg hard capsules:
Titanium dioxide (E171)
Yellow iron oxide (E172)
Additionally, in Gabapentin Teva Pharma 400 mg hard capsules:
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)
Printing ink:
Shellac
Propylene glycol
Ammonia solution
Potassium hydroxide
Black iron oxide

Description of the appearance of Gabapentin Teva Pharma and pack sizes

Gabapentin 100 mg hard capsules:
Capsules are white, printed with “100” on one side and “G” on the other.

Gabapentin 300 mg hard capsules:
Capsules are yellow, printed with “300” on one side and “G” on the other.

Gabapentin 400 mg hard capsules:
Capsules are orange, printed with “400” on one side and “G” on the other.

Pack sizes:
10, 20, 30, 50, 90, 100, 200 (2x100), 250 hard capsules
Hospital pack: 500 (5x100), 1000 (10x100) hard capsules
Unit dose: 20x1, 60x1, 100x1 hard capsule

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands

Manufacturers responsible for batch release
Merckle GmbH, Ludwig-Merckle-Strasse 3 - 89143 Blaubeuren, Germany
Teva UK Limited Company, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
TEVA Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland

This medicinal product is authorized in the European Economic Area countries under the following names:

Denmark: Gabaratio 100 mg capsules
Germany: Gabapentin AbZ 100 mg Hartkapseln
Italy: Gabapentin Teva Pharma 100 mg capsule rigide
Portugal: Gabapentina ratiopharm 100 mg cápsulas
United Kingdom: Gabapentin ratiopharm 100 mg Capsules

Denmark: Gabaratio 300 mg capsules
Germany: Gabapentin AbZ 300 mg Hartkapseln
Italy: Gabapentin Teva Pharma 300 mg capsule rigide
Portugal: Gabapentina ratiopharm 300 mg cápsulas
United Kingdom: Gabapentin ratiopharm 300 mg Capsules

Denmark: Gabaratio 400 mg capsules
Germany: Gabapentin AbZ 400 mg Hartkapseln
Italy: Gabapentin Teva Pharma 400 mg capsule rigide
Portugal: Gabapentina ratiopharm 400 mg cápsulas
United Kingdom: Gabapentin ratiopharm 400 mg Capsules