Gabapentin Rivopharm – Gabapentin uses, dose and side effects


600 mg and 800 mg film-coated tablets

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

Gabapentin Rivopharm belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-term pain caused by nerve damage).

The active substance in Gabapentin Rivopharm is gabapentin.

Gabapentin Rivopharm is used to treat:

  • various forms of epilepsy (seizures that are initially limited to certain parts of the brain, with or without spreading to other parts of the brain). Your doctor may prescribe Gabapentin Rivopharm to treat your epilepsy if your current epilepsy treatment does not have sufficient effect. You should take Gabapentin Rivopharm as a supplement to your current treatment, unless your doctor tells you otherwise. Gabapentin Rivopharm can also be used as the only medicine for adults and children from 12 years.
  • peripheral neuropathic pain (prolonged pain caused by nerve damage). A variety of diseases can cause peripheral neuropathic pain (mainly in the legs and / or arms), such as diabetes or shingles . The pain can be described as a hot, burning, throbbing, flashing, stinging, sharp, cramping, aching, stinging, paralyzing sensation or as ant crawls.

Gabapentin contained in Gabapentin Rivopharm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Gabapentin Rivopharm

Do not take Gabapentin Rivopharm

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Gabapentin Rivopharm.

  • if you have kidney problems. Your doctor may then prescribe a different dosing schedule.
  • if you are on hemodialysis (treatment method for renal impairment where waste products are removed), tell your doctor if you experience muscle pain and / or muscle weakness.
  • if you get symptoms such as persistent stomach pain, nausea and vomiting, you should contact a doctor immediately, as this may be a symptom of acute pancreatitis ( inflammation of the pancreas)
  • If you have diseases of the nervous system, respiratory diseases or if you are older than 65 years, your doctor may prescribe you a different dosage .

Cases of abuse and dependence have been reported for gabapentin since its introduction. Talk to your doctor if you have a history of substance abuse or addiction.

A small number of people being treated with antiepileptic drugs such as gabapentin have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.

Important information about potentially serious reactions

A few patients taking Gabapentin Rivopharm have an allergic reaction or potentially serious skin reaction, which can develop into more serious problems if left untreated. You need to know the symptoms that you need to be aware of when taking Gabapentin Rivopharm.

Read the description of these symptoms in section 4 of this leaflet under “Contact your doctor immediately if you get any of the following symptoms”.

Muscle weakness, soreness, or pain, especially if you also feel unwell or have a high fever. This can be due to an abnormal muscle breakdown that can be life-threatening and lead to kidney problems. You may also have discolored urine and altered blood test results (especially elevated blood creatine phosphokinase). If you experience any of these symptoms, contact your doctor immediately.

Other medicines and Gabapentin Rivopharm

Tell your doctor or pharmacist if you 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 seizures, sleep disorders, depression, anxiety, or any other neurological or mental problems.

Drugs that contain opioids such as morphine

If you are taking any medicines that contain opioids (such as morphine), tell your doctor or pharmacist, as opioids may increase the effect of Gabapentin Rivopharm. Also, a combination of gabapentin and Rivopharm opioids causes symptoms such as fatigue and/or breathing difficulties.

Antacids for stomach problems

If Gabapentin Rivopharm is taken with an antacid containing aluminum and magnesium, the absorption of Gabapentin Rivopharm from the stomach may decrease. Gabapentin Rivopharm should therefore be taken no earlier than two hours after taking antacids.

Gabapentin Rivopharm

  • is not expected to affect or be affected by other antiepileptic drugs or birth control pills .
  • may interfere with certain laboratory tests. If you need to take a urine sample, tell your doctor or hospital staff what you are taking.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


Gabapentin Rivopharm should not be taken during pregnancy unless your doctor tells you otherwise. An effective contraceptive must be used by women of childbearing potential.

No studies have been performed to specifically investigate the use of gabapentin in pregnant women, but the use of other epilepsy medicines has been reported to increase the risk of birth defects, especially when more than one such medicine is taken at the same time. As far as possible, you should try not to take more than one epilepsy medication during pregnancy, and only in consultation with a doctor.

Contact your doctor immediately if you become pregnant, if you think you may be pregnant or if you are planning to become pregnant while taking Gabapentin Rivopharm.

Do not abruptly stop taking this medicine. This can lead to a breakthrough spasm and have serious consequences for you and your child.


Gabapentin, the active substance in Gabapentin Rivopharm, passes into breast milk. As the effect on the baby is unknown, you should not breastfeed while being treated with Gabapentin Rivopharm.


No effect on fertility has been observed in animal studies.

Driving and using machines

Gabapentin Rivopharm may cause dizziness, drowsiness, and fatigue. You should not drive, use advanced machines or engage in any other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Gabapentin Rivopharm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide which dose is right for you.

The recommended dose of epilepsy is:

Adults and adolescents
Take the number of tablets prescribed by your doctor. Your doctor may increase the dose gradually. The usual starting dose is between 300 mg and 900 mg daily. Then, according to your doctor’s instructions, the dose can be increased up to a maximum of 3,600 mg daily, divided into 3 separate doses, ie. once in the morning, once in the afternoon, and once in the evening.

Children from 6 years The
the doctor decides which dose to give to your child, as it is calculated taking into account the child’s weight. The treatment begins with a low starting dose, which is then gradually increased over about 3 days. The usual dose for epilepsy treatment is 25-35 mg per kg body weight per day. The tablets are usually taken in 3 separate doses every day, once in the morning, once in the afternoon, and once in the evening.

Gabapentin Rivopharm is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain recommended dose is:


Take the number of capsules or tablets that your doctor has prescribed. Your doctor may increase the dose one by one. The usual starting dose is between 300 mg and 900 mg daily. Then, according to your doctor’s instructions, the dose can be increased up to a maximum of 3,600 mg daily, divided into 3 separate doses, ie. once in the morning, once in the afternoon, and once in the evening.

For lower doses, which cannot be used with these strengths, other strengths and dosage forms are available.

If you have kidney problems or go for hemodialysis

Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems or are on hemodialysis.

If you are older (over 65 years), you should take the normal dose of Gabapentin Rivopharm, unless you have kidney problems. Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems.

If you have the impression that the dose is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration Gabapentin Rivopharm should be swallowed. Always swallow the tablets whole along with plenty of water. Gabapentin Rivopharm can be taken with or without food. Continue to take Gabapentin Rivopharm until your doctor tells you to stop.

If you take more Gabapentin Rivopharm than you should

Higher than recommended doses can lead to increased side effects including unconsciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the tablets you have not taken with you, together with the packaging and label, so that the staff can easily see which medicine you have taken.

If you forget to take Gabapentin Rivopharm

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gabapentin Rivopharm

Do not stop taking Gabapentin Rivopharm unless your doctor tells you to. If treatment is stopped, this should be done gradually for at least 1 week. If you stop taking Gabapentin Rivopharm suddenly or before your doctor tells you to do so, there is an increased risk of seizures.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

  • anaphylactic reaction (severe allergic reaction that can be life-threatening, with symptoms such as difficulty breathing, swelling of the lips, throat and tongue and low blood pressure that requires emergency treatment).
  • severe skin reactions requiring immediate action, swollen lips and face, skin rash and redness and / or hair loss (this may be a sign of a severe allergic reaction )
  • persistent abdominal pain, nausea and vomiting as this may be a symptom of acute pancreatitis (inflammation of the pancreas)
  • Gabapentin Rivopharm can cause a serious or life-threatening allergic reaction that can affect your skin or other parts of your body e.g. the liver or blood cells . When you get such a reaction, you may get a rash, but it is not certain that you will get it. You may need to be hospitalized or stop taking Gabapentin Rivopharm.

Contact your doctor immediately if you get any of the following symptoms:

  • rash
  • hives
  • fever
  • swelling of glands that do not disappear
  • swelling of the lips or tongue
  • yellow skin or whites of the eyes
  • unusual bruising or bleeding
  • severe fatigue or weakness
  • unexpected muscle pain
  • recurrent infection er
  • breathing problems, where in severe cases you may need emergency and intensive care to continue breathing normally.

These symptoms may be the first signs of a severe reaction. A doctor should examine you to decide if you should continue to take Gabapentin Rivopharm.

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

Other side effects include:

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

  • virus infection
  • drowsiness, dizziness, uncoordinated muscle movements
  • feeling tired, fever.

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

  • pneumonia , respiratory infections, urinary tract infection, ear infection or other infection s
  • decreased white blood cell count
  • anorexia , increased appetite
  • aggression towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking clearly
  • convulsions, jerky movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensation (loss of sensation), coordination difficulties, abnormal eye movements, increased / decreased or absence of reflexes
  • blurred vision, double vision
  • dizziness
  • high blood pressure , redness / dilation of blood vessels
  • difficulty breathing, tracheitis , sore throat, cough, runny nose
  • vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth and throat, gas
  • facial swelling, bruising, rash, itching , acne
  • joint pain, muscle aches, back pain, twitching
  • erectile dysfunction ( impotence )
  • swollen legs and arms, difficulty walking, weakness, aches, malaise, flu-like symptoms
  • decreased white blood cell count , weight gain
  • accidents, fractures , abrasions.

In addition, aggressive behavior and jerky movements have been reported as common side effects in clinical trials in children.

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

  • agitation (a state of constant restlessness and involuntary, meaningless movements)
  • allergic reactions such as hives
  • reduced movements
  • palpitation
  • swelling that may include face, torso and limbs
  • abnormal blood test results indicating liver problems
  • psychological disorder
  • fall accidents
  • increased blood sugar levels (most commonly seen in patients with diabetes ).
  • Difficulty swallowing

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

  • loss of consciousness
  • decreased blood sugar level (most commonly seen in patients with diabetes )
  • difficulty breathing, shallow breathing ( respiratory depression ).

Following the introduction of the drug on the market, the following side effects have been reported:

  • decreased platelet count (cells important for coagulation )
  • hallucinations
  • problems with abnormal movements, such as swaying or jerky movements and stiffness
  • earrings
  • a group of side effects that may include swollen lymph nodes (isolated, small, raised bumps under the skin), fever, rash and hepatitis occur simultaneously with yellowing of the skin and eyes (jaundice), inflammation of the liver
  • acute renal failure , incontinence
  • increase in breast tissue, breast enlargement
  • side effects after abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, nausea, aches, sweating), chest pain
  • degradation of muscle fibers ( rhabdomyolysis )
  • change in blood test results (elevated blood creatine phosphokinase)
  • sexual problems including inability to orgasm, late ejaculation.
  • low sodium level in the blood.
    Reporting of side effects arIf you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase the safety of medicines.The Medical Products AgencyBox 26751 03

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gabapentin Rivopharm

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25 ° C.
Jar: Close the jar tightly. Store in the original package.
Blister: Store in the original package. Store the blister card in the outer carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is gabapentin. A film-coated tablet contains either 600 mg or 800 mg of gabapentin.
  • The other ingredients are:
    Core: povidone, microcrystalline cellulose, crospovidone, talc, hydrated vegetable (cottonseed) oil Type I
    Coating: hypromellose, titanium dioxide (E171) and macrogol 400

What the medicine looks like and contents of the pack

Gabapentin Rivopharm tablets are available in two different strengths:

Gabapentin Rivopharm 600 mg film-coated tablets:

white to off-white, oval, with beveled edges, film-coated tablets, marked “7173” on one side and “93” on the other side.

Gabapentin Rivopharm 800 mg film-coated tablets:

white to off-white, oval, with bevelled edges, film-coated tablets, marked “7174” on one side and “93” on the other side.

The tablets are available in cans of 28, 50, 90, 100, 200 or 500 tablets or in blister packs of 10, 20, 28, 50, 84, 90, 100 or 200 (2 x 100) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Rivopharm Ltd.

17 Corrig Road

Sandyford, Dublin 18,



Rivopharm UK Ltd, Eastbourne, United Kingdom

Pharmachemie BV, Haarlem, The Netherlands

Rivopharm Pharmaceutical Works Private Limited Company, Debrecen, Hungary

Rivopharm Operations Poland Sp.zoo, Krakow, Poland

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