Gabapentin Rosemont 50mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. 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 it as instructed by your doctor.

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

• you are allergic (hypersensitive) to gabapentin or any of the other ingredients (listed in Section 6). An allergic reaction can include a rash, itching or shortness of breath.

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 myasthenia gravis (a disease causing muscle weakness) because this medicine may make your symptoms worse.
• 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.

Dependence

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Gabapentin to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine.

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

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. 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.

Gabapentin should only be used by the patient for whom it has been prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of Gabapentin may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Suicidal thoughts

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.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Gabapentin.

Serious skin rashes including Steven-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 these symptoms in section 4 of this leaflet under “Stop using Gabapentin and seek medical attention immediately if you notice any of the following symptoms”

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.

Please tell your doctor or pharmacist if you are taking or have recently taken 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. This includes medicines obtained without a prescription, including herbal medicines. This is because Gabapentin can affect the way some other medicines work. Also some other medicines can affect the way Gabapentin works.

In particular tell your doctor or pharmacist if you are taking medicines containing opioids (such as morphine), used for pain. This is because morphine may increase the effect of Gabapentin. In addition, combination of Gabapentin with opioids may cause symptoms like sleepiness, sedation, decrease in breathing, or death.

If Gabapentin and antacids containing aluminium and magnesium are taken at the same time, 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 does not normally affect other medicines for epilepsy or the oral contraceptive pill.

Gabapentin may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking Gabapentin.

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

Gabapentin 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 (medicines 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Gabapentin 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.

• methyl and ethyl parahydroxybenzoates - these may cause an allergic reaction which may happen some time after starting the medicine
• potassium (3.8mg in a 1ml dose) - if you have kidney problems or are on a low potassium diet, you need to take this into account
• sodium (0.72mg in 1ml dose) - (main component of cooking/table salt) this is equivalent to 0.04% of the recommended maximum daily dietary intake of sodium for an adult. If you are on a low sodium diet, you need to take this into account
• propylene glycol (35mg in a 1ml 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.

Gabapentin is for oral use.

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 (mls) 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).Then push the piston upward in order to remove any possible bubbles (figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 4C).
6. Turn the bottle the right way up.
7. 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.
8. Wash the syringe with water and let it dry before you use it again.
9. Close the bottle with the plastic screw cap.

This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes only. There is further information in the SmPC, ask your doctor, pharmacist or nurse for this information.

The minimum volume of water that is required to flush tube sizes 8 Fr and below is 5mL and for tube sizes 10 Fr and above it is 10mL.

1. Ensure the tube is clear before taking the medicine.
2. Flush the tube with the minimum volume of water required.
3. Administer the medicine into the tube with a suitable measuring device.The syringe included in the pack is only for patients who are able to swallow the medicine. HCPs administering this product to patients via a NG or PEG tube must use another suitable device.
4. Flush the tube again with the minimum volume of water.

For use with silicone, PVC and polyurethane NG or PEG tubes only.

For epilepsy:

Adults and young people over 12 years old

• The usual starting dose is between 300mg and 900mg a day (6 to 18ml).
• This will be increased gradually by your doctor.
• The maximum dose is 3,600mg a day (72ml).
• 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 about three days.
• The usual dose is 25 to 35mg 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.

Gabapentin is not recommended for use in children under 6 years old.

For peripheral neuropathic pain:

Adults

• The usual starting dose is between 300mg and 900mg a day (6 to 18ml).
• This will be increased gradually by your doctor.
• The maximum dose is 3,600mg a day (72ml).
• Take the medicine in three separate doses: once in the morning, once in the afternoon and once in the evening.

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.

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

• 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 than you should. Take the medicine pack with you.

• 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 this medicine. If you want to stop taking this medicine, 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 may include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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

Gabapentin is a clear, colourless oral solution. It comes in a brown glass bottle holding 150ml of solution.

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