Patient leaflet - GABAPENTIN TEVA 50 MG / ML ORAL SOLUTION
1. What Gabapentin Teva is and what it is used for
2. What you need to know before you take Gabapentin Teva
3. How to take Gabapentin Teva
4. Possible side effects
5. How to store Gabapentin Teva
6. Contents of the pack and other information
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What Gabapentin Teva is and what it is used for
Gabapentin Teva belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).
The active substance in Gabapentin Teva is gabapentin.
Gabapentin Teva is used to treat
- Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). Your doctor will prescribe Gabapentin Teva for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin Teva in addition to your current treatment unless told otherwise. Gabapentin Teva can also be used on its own to treat adults and children over 12 years of age.
- Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms), such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.
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What you need to know before you take Gabapentin Teva
Do not take Gabapentin Teva:
- if you are allergic 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 Teva if you:
- suffer from kidney problems your doctor may prescribe a different dosing schedule
- are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness
- develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas)
- have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen.
Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.
A small number of people being treated with antiepileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Important information about potentially serious reactions A small number of people taking gabapentin get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know the symptoms to look out for while you are taking Gabapentin Teva.
Read the description of these symptoms in section 4 of this leaflet under ‘Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious’
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.
Children
Gabapentin Teva is not recommended for use in children below 6 years of age.
Other medicines and Gabapentin Teva
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 been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
Medicines containing opioids such as morphine
If you are taking any medicines containing opioids (such as morphine), please tell your doctor or pharmacist as opioids may increase the effect of Gabapentin Teva. In addition, combination of Gabapentin Teva with opioids may cause symptoms like sleepiness and/or decrease in breathing.
Antacids for indigestion
If Gabapentin Teva and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Teva from the stomach may be reduced. It is therefore recommended that Gabapentin Teva is taken at the earliest two hours after taking an antacid.
Gabapentin Teva
- is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.
- may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking.
Pregnancy, breast-feeding and fertility
- If you are pregnant or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby
- If you are planning to become pregnant you should discuss your treatment with your doctor as early as possible before you become pregnant
- You should not stop your treatment without discussing this with your doctor.
Pregnancy
Gabapentin Teva should not be taken during pregnancy, unless you are told otherwise by your doctor.
Effective contraception must be used by women of child-bearing potential.
There have been very few studies specifically looking at the use of gabapentin in pregnant women. More research is needed to better understand about the safety of use of gabapentin during pregnancy and whether it is associated with an increased risk of harm to the unborn child.
Some medicines used to treat epilepsy have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy.
Breast-feeding
Gabapentin, the active substance of Gabapentin Teva, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Teva.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Teva may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Gabapentin Teva contains propylene glycol, methyl and ethyl parahydroxybenzoates, potassium and sodium
This medicine contains 35 mg propylene glycol in each ml. If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. Gabapentin Teva contains methyl and ethyl parahydroxybenzoates. These may cause an allergic reaction which may happen some time after starting the medicine. This medicine contains 3.89 mg potassium per ml. If you have kidney problems or are on a low potassium diet, you need to take this into consideration.
This medicine contains 0.93 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.047% of the recommended maximum daily dietary intake of sodium for an adult.
^3 How to take Gabapentin
Teva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is appropriate for you.
Measuring your dose using the oral syringe provided
Your pack contains a plastic oral syringe to measure the right amount of liquid prescribed for you. The numbers up the side show how many millilitres (ml) of liquid you have inside the syringe.
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1. Open the bottle: press the cap and turn it anticlockwise (figure 1). After opening, an adaptor remains fitted into the bottle neck.
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2. Take the syringe and put it in the adaptor opening (figure 2).
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3. Turn the bottle upside down keeping the syringe still in place (figure 3).
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4. Fill the syringe with a small amount of solution by pulling the plunger down (figure 4). Then push the plunger upward in order to remove any possible bubbles (figure 5). Finally, pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 6).
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5. Turn the bottle the right way up and remove the syringe from the adaptor (figure 7).
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6. Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine.
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7. Close the bottle with the plastic screw cap.
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8. Wash the syringe with water and
For epilepsy:
Adults and adolescents over 12 years old
The recommended starting dose is between 300 mg and 900 mg a day (6 to 18 ml).
This will be increased gradually by your doctor.
The maximum dose is 3,600 mg a day (72 ml).
Take the medicine in three separate doses: once in the morning, once in the afternoon and once in the evening.
Children aged 6 years old and above The doctor will decide the dose, depending on your child’s weight. The treatment is started with a low starting dose which is gradually increased over a period of about three days.
The recommended dose is 25 to 35 mg for each kilogram of body weight a day.
It is usually given in three separate doses: once in the morning, once in the afternoon and once in the evening.
For peripheral neuropathic pain:
Adults
The recommended starting dose is between 300 mg and 900 mg a day (6 to 18 ml).
This will be increased gradually by your doctor.
The maximum dose is 3,600 mg a day (72 ml).
Take the medicine in three separate doses: once in the morning, once in the afternoon and once in the evening.
If you have kidney problems or are receiving haemodialysis
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.
If you are an elderly patient (over 65 years of age)
You should take the normal dose of Gabapentin Teva unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
If you have the impression that the effect of Gabapentin Teva is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration Gabapentin Teva is for oral use.
Gabapentin Teva can be taken with or without food.
Continue taking Gabapentin Teva until your doctor tells you to stop.
If you take more Gabapentin Teva than you should
Higher than recommended doses may result in an increase in side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to the nearest hospital emergency unit immediately if you take more Gabapentin Teva than your doctor prescribed. Take the medicine pack with you.
If you forget to take Gabapentin Teva
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 Teva Do not stop taking Gabapentin Teva unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you stop taking Gabapentin Teva suddenly or before your doctor tells you, there is an increased risk of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
- severe skin reactions that require immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction)
- persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)
- anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
- Gabapentin Teva may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin Teva. Call your doctor right away if you have any of the following symptoms: skin rash hives fever
- swollen glands that do not go away
- swelling of your lip and tongue.
- yellowing of your skin or of the whites of the eyes
- unusual bruising or bleeding
- severe fatigue or weakness
- unexpected muscle pain
- frequent infections.
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin Teva.
If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common (may affect more than 1 in 10 people)
- viral infection
- feeling drowsy, dizziness, lack of coordination
- feeling tired, fever.
Common (may affect up to 1 in 10 people)
- pneumonia, respiratory infections, urinary tract infection, inflammation of the ear or other infections
- low white blood cell counts
- anorexia, increased appetite
- anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking
- convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes
- blurred vision, double vision
- vertigo
- high blood pressure, flushing or dilation of blood vessels
- difficulty breathing, bronchitis, sore throat, cough, dry nose
- vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
- facial swelling, bruises, rash, itch, acne
- joint pain, muscle pain, back pain, twitching
- difficulties with erection (impotence)
- swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms
- decrease in white blood cells, increase in weight
- accidental injury, fracture, abrasion.
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Uncommon (may affect up to 1 in 100 people)
- agitation (a state of chronic restlessness and unintentional and purposeless motions)
- allergic reaction such as hives
- decreased movement
- racing heartbeat
- swelling that may involve the face, trunk and limbs
- abnormal blood test results suggesting problems with the liver
- mental impairment
- fall
- increase in blood glucose levels (most often observed in patients with diabetes)
- difficulty swallowing.
Rare (may affect up to 1 in 1,000 people)
- loss of consciousness
- decrease in blood glucose levels (most often observed in patients with diabetes)
- trouble breathing, shallow breaths (respiratory depression).
Not known (frequency cannot be estimated from the available data)
- decreased platelets (blood clotting cells)
- hallucinations
- problems with abnormal movements such as writhing, jerking movements and stiffness
- ringing in the ears
- a group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occurring together
- yellowing of the skin and eyes (jaundice), inflammation of the liver
- acute kidney failure, incontinence
- increased breast tissue, breast enlargement
- adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
- breakdown of muscle fibers (rhabdomyolysis)
- change in blood test results (creatine phosphokinase increased)
- problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
- low blood sodium level.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
% How to store Gabapentin Teva
Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original package in order to protect from light. Do not refrigerate or freeze.
Do not use after 3 months of first opening the bottle.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
rg Contents of the pack and other information
What Gabapentin Teva contains
- The active substance is gabapentin. Each 1 ml contains 50 mg gabapentin.
- The other ingredients are: propylene glycol (E1520), acesulfame potassium (E950), saccharin sodium (E954), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), carmellose sodium (E466), anis flavour (containing natural flavouring substances, ethyl alcohol and water) and purified water.
What Gabapentin Teva looks like and contents of the pack
Gabapentin Teva is a clear, colourless to a pale yellow oral solution. It comes in a brown glass bottle containing 150 ml of solution.In the pack there is also a 10 ml oral syringe, with markings at every 0.5 ml from 0 to 10 ml.
The pack contains either one bottle or three bottles of Gabapentin Teva.
Not all pack sizes may be marketed.
Marketing Authorisation Holder TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer
Balkanpharma – Troyan AD, 1 Krayrechna Str., Troyan, 5600, Bulgaria
This leaflet was last revised in 09/2021.
PL 00289/2154
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TEVA UK LIMITED
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