Gabapentin Glenmark 50 mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• This medicine contains Gabapentin, which can cause dependence, tolerance and addiction. You can get withdrawal symptoms if you stop taking it or reduce the dose suddenly. If this medicine is being used for the treatment of epilepsy you must continue to take this medicine as instructed by your doctor.

1. What Gabapentin Oral Solution is and what it is used for
2. What you need to know before you take Gabapentin Oral Solution
3. How to take Gabapentin Oral Solution
4. Possible side effects
5. How to store Gabapentin Oral Solution
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before taking Gabapentin:

• if you suffer from kidney problems your doctor may prescribe a different dosing schedule
• if you are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness
• if you 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)
• if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen
• if you have a history of abuse or dependence.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Gabapentin Oral Solution.

Some people may become dependent on Gabapentin Oral Solution (a need to keep taking the medicine).

They may have withdrawal effects when they stop using Gabapentin Oral Solution or reduce the dose (see section 3, “How to take Gabapentin Oral Solution” and “If you stop taking Gabapentin Oral Solution”). If you have concerns that you may become dependent on Gabapentin Oral Solution, it is important that you consult your doctor.

If you notice any of the following signs whilst taking Gabapentin Oral Solution, it could be a sign that you have become dependent.

• You feel you need to take the medicine for longer than advised by your prescriber
• You feel you need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.

• A small number of people taking epilepsy medicines like Gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, talk to your doctor straight away.
  Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using gabapentin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Read the description of serious 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 creatinine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.

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 recently taken any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.

Gabapentin is not expected to interact with other antiepileptic drugs or the oral contraceptive pill. Gabapentin may interfere with some laboratory tests. If you require a urine test, tell your doctor or the hospital staff that you are taking Gabapentin.

Tell your doctor or pharmacist if you are taking medicines containing opioids (such as morphine) as opioids may increase the effect of Gabapentin. In addition, combination of Gabapentin with opioids may cause sleepiness, sedation, decrease in breathing, or death.

If Gabapentin and antacids containing aluminium and magnesium are taken at the same time, the absorption of Gabapentin from the stomach may be reduced. It is therefore recommended that Gabapentin is taken at the earliest two hours after taking an antacid.

Gabapentin can be taken with or without food.

• 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.
• You should not stop your treatment without discussing this with your doctor.
• If you are planning to become pregnant you should discuss your treatment with your doctor or pharmacist as early as possible before you become pregnant.
• If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Contact your doctor immediately if you become pregnant or think you might be pregnant while taking Gabapentin.

Gabapentin Oral Solution can be used during the first trimester of pregnancy if needed.

If you plan to become pregnant or if you are pregnant or think you may be pregnant, talk to your doctor straight away.

If you have become pregnant and you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your illness. Worsening of your epilepsy may put you and your unborn child at risk.

In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with the development of brain function (neurodevelopment disorders). However, babies of women who took gabapentin during pregnancy had an increased risk of low birth weight and preterm birth.

If used during pregnancy, gabapentin may lead to withdrawal symptoms in newborn infants. This risk might be increased when gabapentin is taken together with opioid analgesics (drugs for treatment of severe pain).

Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.

Breast-feeding

Gabapentin is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin.

Fertility

There is no effect on fertility in animal studies.

Gabapentin may cause dizziness, drowsiness and tiredness. You should not drive, operate machinery or take part in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

• Methyl parahydroxybenzoate (E218) and Ethyl parahydroxybenzoate (E214). These may cause allergic reactions (possibly delayed).
• Potassium – 2.37 mg per 1ml dose. This should be taken into consideration for patients with reduced kidney function or patients on controlled potassium diets.
• Sodium – This medicine contains less than 1 mmol sodium (23 mg) per dose (300 mg gabapentin), that is to say essentially ‘sodium-free’.
• Propylene glycol (43 mg in a 1 ml dose) – if you are pregnant, breast-feeding or 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. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
• Benzyl alcohol – 0.04 mg per 1 ml dose. Benzyl alcohol may cause allergic reactions. Ask your doctor of pharmacist for advice if you have a liver or kidney disease, if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called ‘metabolic acidosis’).

Do not suddenly stop taking this medicine or reduce your dose. If you want to stop taking this medicine or reduce your dose, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as:

trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.

Your doctor will determine what dose is appropriate for you. This will depend on how well your body responds to this medicine.

Gabapentin is for oral use and should be taken with plenty of water.

It is usually given in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.

Continue taking Gabapentin until your doctor tells you to stop.

Epilepsy:

Adults and adolescents

The starting dose will generally be between 300 mg and 900 mg each day (6 to 18 ml). Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day (72 ml)

Children aged 6 years old and above

The dose to be given to your child will be decided by your doctor as it is calculated against your child’s weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 25 – 35 mg per kg per day. Gabapentin is not recommended for use in children under 6 years old.

Peripheral neuropathic pain:

Adults

The starting dose will generally be between 300 mg and 900 mg each day (6 to 18 ml).

Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600 mg each day (72 ml).

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 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 think that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

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.

1. Open the bottle: press the cap and turn it anticlockwise (figure 1).
2. Insert the syringe adaptor into the bottle neck (figure 2).
3. Take the syringe and put it in the adaptor opening (figure 2).
4. Turn the bottle upside down (figure 3).
5. Fill the syringe with a small amount of solution by pulling the piston down (figure 4A).
6. Push the piston upward in order to remove any possible bubbles (figure 4B).
7. Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 4C).
8. Turn the bottle the right way up.
9. Remove the syringe from the adaptor. Put the end of the syringe into your mouth and push the piston slowly back in to take the medicine.
10. Wash the syringe with water and let it dry before you use it again.
11. Close the bottle with the plastic screw cap.

• Call your doctor or go to the nearest hospital emergency unit immediately if you take more Gabapentin than you should. Take the medicine pack with you.
• Higher than recommended doses may result in an increase in side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea.

• If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

• Do not suddenly stop taking Gabapentin Oral Solution. If you want to stop taking Gabapentin Oral Solution, discuss this with your doctor first. They will tell you how to do this.
• If your treatment needs to be stopped, it should be done gradually over a minimum of a week.
• After stopping a short or long-term treatment with Gabapentin Oral Solution, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects can include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping Gabapentin Oral Solution. If you experience withdrawal effects, you should contact your doctor.

• Decreased platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness.
• Ringing in the ears
• 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 fibres (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.
• Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat and tongue and hypotension requiring emergency treatment).
• Becoming dependent on Gabapentin Oral Solution (‘drug dependence’)

Not known (cannot be estimated from the available data)

• Worsening of myasthenia gravis (a disease causing muscle weakness)

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Gabapentin Oral Solution, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

After stopping a short or long-term treatment with Gabapentin Oral Solution or after reducing your dose, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Gabapentin Oral Solution).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.

• The active substance is gabapentin. Each 1 ml contains 50 mg gabapentin.
• The other ingredients are acesulfame potassium (E950), saccharin sodium (E954), propylene glycol (E1520), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), carmellose sodium (E466), tutti frutti flavour (containing benzyl alcohol) and purified water.

Gabapentin is a clear, colourless oral solution. It comes in an amber coloured glass bottle as well as in an amber coloured polyethylene terephthalate bottle holding 150 ml of solution.

In the pack there is also a 10 ml oral syringe, with markings at every 1ml and intermediate marks at every 0.5 ml.