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.

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

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

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

• You feel you need to take this 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.

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.

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.

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 Gabapentin or reduce your dose. If you want to stop taking Gabapentin or reduce your dose, discuss this with your doctor first. They will tell you how to do this.
• If your treatment needs to be stopped or your dose is reduced, it should be done gradually over a minimum of a week.
• After stopping a short or long-term treatment with Gabapentin or after reducing your dose, 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 or reducing your dose. If you experience withdrawal effects, you should contact your doctor.

Common side-effects (affects less than 1 in 10 people):

• convulsions/fits
• pneumonia, respiratory infections
• breathing problems, which if severe you may need emergency and intensive care to continue breathing normally.

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

• loss of consciousness.

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

• suicidal thoughts
• Gabapentin may cause a “serious, potentially life-threatening allergic reaction (anaphylaxis) including difficulty breathing, swelling of the lips, throat and tongue, and hypotension requiring emergency treatment”. You may or may not have a rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin.
• persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)
• skin rash, hives, fever, swollen glands that do not go away, swelling of your lip and tongue
• yellowing of your skin or the whites of the eyes
• unusual bruising or bleeding, severe fatigue or weakness
• unexpected muscle pain
• signs of frequent infections such as fever, flu like symptoms and sore throat
• ringing in the ears
• problems with abnormal movements such as writhing, jerking movements and stiffness.
• becoming dependent on Gabapentin (drug dependence).

After stopping a short or long-term treatment with Gabapentin 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”).

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

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

Other side effects include:

Very common side-effects (affects more than 1 in 10 people):

• viral infection
• feeling drowsy, dizziness, lack of coordination
• feeling tired, fever.

Common side-effects (affects less than 1 in 10 people):

• urinary tract infections, 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 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 your 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
• joint pain, muscle pain, back pain, twitching
• facial swelling, bruises, rash, itch, acne
• difficulty with erection (impotence)
• swelling in your legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms
• decrease in your 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 side effects (affects less than 1 in 100 people):

• allergic reactions 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)
• agitation (a state of chronic restlessness and unintentional and purposeless motions
• difficulty swallowing.

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

• decrease in blood glucose levels (most often observed in patients with diabetes)
• loss of consciousness
• trouble breathing, shallow breaths (respiratory depression).

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

• 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 fibers (rhabdomyolysis)
• blood glucose fluctuations in patients with diabetes
• 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
• worsening of myasthenia gravis (a disease causing muscle weakness).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.