• 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 Pregabalin Tillomed is and what it is used for
2. What you need to know before you take Pregabalin Tillomed
3. How to take Pregabalin Tillomed
4. Possible side effects
5. How to store Pregabalin Tillomed
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 or pharmacist before taking Pregabalin Tillomed.

• Do not take Pregabalin Tillomed if you 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 Tillomed may cause 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 Tillomed 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.
• If you have diabetes and you gain weight while taking pregabalin, please contact your doctor as you may need an alteration in your diabetic medicines.
• If you have a spinal cord injury and are taking other medicines to treat, for example, pain or spasticity, you may find that certain side effects, such as sleepiness, become more common. This is because these other medicines have similar side effects to Pregabalin Tillomed and the severity of these effects may be increased when taken together.
• Before taking this medicine you should tell your doctor if you have a history of heart disease. There have been reports of heart failure in some patients when taking pregabalin; these patients were mostly elderly with cardiovascular conditions.
• If you notice decreased urination while taking Pregabalin Tillomed you should tell your doctor as stopping the medicine may improve this. There have been reports of kidney failure in some patients when taking pregabalin.
• A small number of people being treated with anti-epileptics such as pregabalin 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 Tillomed 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.
• Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
• If you experience a convulsion, contact your doctor immediately. There have been reports of convulsions when taking pregabalin or shortly after stopping pregabalin.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking pregabalin 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.

Dependence

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

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

• 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.

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

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin may be taken with oral contraceptives

Pregabalin Tillomed capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Tillomed

Pregabalin Tillomed 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 Tillomed 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.

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

It is important to take your Pregabalin Tillomed capsules 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 stop taking Pregabalin Tillomed unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week.

After stopping long or short-term Pregabalin Tillomed treatment, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating and dizziness. These effects may occur more commonly or severely if you have been taking Pregabalin Tillomed for a longer period of time. If you experience withdrawal effects, you should contact your doctor.

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 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 pregabalin.
• 25 mg: Each hard capsule contains 25 mg of pregabalin
  50 mg: Each hard capsule contains 50 mg of pregabalin
  75 mg: Each hard capsule contains 75 mg of pregabalin
  100 mg: Each hard capsule contains 100 mg of pregabalin
  150 mg: Each hard capsule contains 150 mg of pregabalin
  200 mg: Each hard capsule contains 200 mg of pregabalin
  225 mg: Each hard capsule contains 225 mg of pregabalin
  300 mg: Each hard capsule contains 300 mg of pregabalin
• Other ingredients are:
• Capsules content: Mannitol and Talc
• Gelatin Capsule: Gelatin, Titanium dioxide (E171), Purified water
• 75mg, 100mg, 200mg, 225mg and 300mg also contain Iron Oxide Red (E172)
• Printing ink: Black Ink TEK SW 9008 comprising of: Shellac, Propylene Glycol, Black Iron Oxide (E172), Potassium Hydroxide, Strong Ammonia Solution.

Pregabalin Tillomed capsules hard is available in 8 strengths: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.

The 25 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 25” with black ink and white opaque cap available in blister packs of 14, 28, 56, 84, 100 capsules.

The 50 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 50” with black ink and white opaque cap. The body is marked with black coloured ink band and is available in blister packs of 14, 21, 28, 42, 56, 84, 100 capsules.

The 75 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 75” with black ink and orange opaque cap available in blister packs of 14, 56, 70, 100 capsules.

The 100 mg capsules are hard gelatin capsules with an orange opaque body imprinted with “PGBN 100” with black ink and orange opaque cap available in blister packs of 14, 21, 56, 84, 100 capsules.

The 150 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 150” with black ink and white opaque cap. The body is marked with black coloured ink band and is available in blister packs of 14, 56, 84, 100 capsules.

The 200 mg capsules are hard gelatin capsules with a light orange opaque body imprinted with “PGBN 200” with black ink and light orange opaque cap available in blister packs of 14, 21, 56, 84, 100 capsules.

The 225 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 225” with black ink and light orange opaque cap available in blister packs of 56, 84 and 100 capsules.

The 300 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 300” with black ink and orange opaque cap. The body is marked with black coloured ink band and is available in blister packs of 14, 56, 84, 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer¹