Pregabalin Focus 20 mg/ml oral solution

• Keep this leaflet. You may need to read it again.
• If you have 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.

The name of your medicine is Pregabalin Focus 20 mg/ml oral solution. It will be referred to as “Pregabalin oral solution” for ease of use hereafter.

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

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

Talk to your doctor, pharmacist or nurse before taking Pregabalin oral solution.

• Some patients taking Pregabalin oral solution have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. Should you experience any of these reactions, you should contact your physician immediately;
• Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Pregabalin oral solution has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have;
• Pregabalin oral solution may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision;
• Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines;
• Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increased when taken together;
• There have been reports of heart failure in some patients when taking Pregabalin oral solution; these patients were mostly elderly with cardiovascular conditions. Before taking this medicine you should tell your doctor if you have a history of heart disease;
• There have been reports of kidney failure in some patients when taking Pregabalin oral solution. If while taking Pregabalin oral solution you notice decreased urination, you should tell your doctor as stopping the medicine may improve this;
• Some patients being treated with anti-epileptics such as Pregabalin oral solution have had thoughts of harming or killing themselves or shown suicidal behaviour. If at any time you have these thoughts, immediately contact your doctor;
• When Pregabalin oral solution is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem;
• There have been reports of convulsions when taking Pregabalin oral solution or shortly after stopping Pregabalin oral solution. If you experience a convulsion, contact your doctor immediately;
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin oral solution when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
• There have been reports of breathing difficulties. If you have nervous system disorders, respiratory disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths.

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 Pregabalin oral solution 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

Gabapentinoids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentinoids may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregabalin oral solution and certain other medicines may influence each other (interaction). When taken with certain other medicines, which have sedative effects (including opioids), Pregabalin oral solution may potentiate the side effects seen with these medicines, including respiratory failure,coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin oral solution is taken together with medicines containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin oral solution may be taken with oral contraceptives.

Pregabalin oral solution may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin oral solution

Pregabalin oral solution should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. Pregabalin use during the -first 3 months of pregnancy may cause birth defects in the unborn child that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin in the -first 3 months of pregnancy, 6 babies in every 100 had such birth defects. This compares to 4 babies in every 100 born to women not treated with pregabalin in the study. Abnormalities of the face (orofacial clefts), the eyes, the nervous system (including the brain), kidneys and genitals have been reported. Effective contraception must be used by women of child-bearing potential. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregabalin oral solution may produce dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Pregabalin oral solution oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

• Take the solution as instructed by your doctor;
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg (7.5 ml) and 600 mg (30 ml) each day;
• Your doctor will tell you to take Pregabalin oral solution either twice or three times a day. For twice a day take Pregabalin oral solution once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin oral solution once in the morning, once in the afternoon and once in the evening, at about the same time each day.

If you have the impression that the effect of Pregabalin oral solution is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Pregabalin oral solution normally except if you have problems with your kidneys.

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

Your prescriber should have discussed with you how long the course of Pregabalin Oral solution will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. 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.

Administration:

Pregabalin oral solution is for oral use only.

Instructions for use

1. Open the bottle: Press downward on the cap and turn it counter-clockwise (Figure 1).
2. First time use only: A Press-In Bottle Adapter (PIBA) is provided with the oral syringe. This is the device that gets inserted into the neck of the bottle to make it easier to withdraw the solution using the oral syringe. With the bottle on a flat surface, insert the PIBA into the bottle neck while keeping the PIBA’s flat surface facing up and pressing on it (Figure 2).
3. Push the syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove excess air. Attach the syringe to the PIBA with a slight twisting motion (Figure 3).
4. Invert the bottle (with the syringe attached) and fill the syringe with the liquid by pulling the syringe plunger down to just beyond the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4). Remove air bubbles from the syringe by pushing the plunger up to the appropriate graduation mark.
5. Return the bottle to an upright position with the syringe still in the PIBA/bottle (Figure 5).
6. Remove the syringe from the bottle/PIBA (Figure 6).
7. Empty the contents of the syringe directly into mouth by pushing the syringe plunger to the bottom of the syringe barrel (Figure 7).

Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).

[For example, a 150 mg (7.5 ml) dose will require two withdrawals from the bottle to achieve the entire dose. Using the oral syringe, first withdraw 5 ml and empty contents of syringe directly into the mouth, then refill the oral syringe with 2.5 ml and empty the remaining contents into the mouth.]

8. Rinse the syringe by drawing water into the syringe and pushing the syringe plunger to the bottom of the syringe barrel, at least three times (Figure 8).
9. Replace the cap on the bottle (leaving the PIBA in place in the bottle neck) (Figure 9).

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin oral solution with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin oral solution than you should. Fits and unconsciousness (coma) have also been reported.

It is important to take your Pregabalin oral solution regularly at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. In that case, just carry on with the next dose as normal. 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 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.

If you get any side effects, talk to your doctor or 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 website: 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 pregabalin. Each ml contains 20 mg of pregabalin.

The other ingredients are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate dihydrate, disodium phosphate, anhydrous (E339), sucralose (E955), strawberry flavour, sodium hydroxide 1N (for pH adjustment), purified water.

Pregabalin oral solution is a clear colourless solution with characteristic strawberry odour in white HDPE bottles containing 250 ml of oral solution, in a cardboard carton. The carton contains two HDPE bottles of 250 ml nominal capacity with HDPE - lined tamper evident and child-resistant screw caps. The carton also contains a 5 ml, CE marked oral syringe with intermediate graduations of 0.25 ml and two press-in bottle adaptors (PIBA).

Marketing Authorisation Holder:

Manufacturer: