25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg hard capsules
pregabalin
What Lyrica is and what it is used for
Lyrica belongs to a group of drugs that are used i.a. to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Peripheral and central neuropathic pain: Lyrica is used to treat long-term pain caused by a nerve injury. Several diseases can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain can be described as hot, burning, throbbing, radiating, stabbing, cutting, cramping, aching, stinging, numbness, and ant crawling. Peripheral and central neuropathic pain can also be associated with mood swings, sleep disorders, fatigue (fatigue), and can have an impact on physical and social functioning as well as the overall quality of life.
Epilepsy: Lyrica is used to treat a certain form of epilepsy ( partial epilepsy with or without secondary generalization) in adults. Your doctor will prescribe Lyrica to you to treat your epilepsy as your current treatment does not keep the disease under control. You should take Lyrica as an adjunct to your current treatment. Lyrica is not intended to be used alone, but should always be taken in combination with other medicines to treat epilepsy.
Generalized Anxiety Disorder: Lyrica is used to treat generalized anxiety disorder. The symptoms of generalized anxiety disorder are prolonged excessive anxiety and worry that are difficult to control. Generalized anxiety disorder can also cause restlessness or a feeling of being bloated or tense, that you easily get tired, have concentration problems or episodes of absence, feel irritable, get muscle tension or sleep disturbance. This differs from stress and strain in everyday life.
What you need to know before using Lyrica
Do not take Lyrica
- if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Lyrica.
- Some patients who have been treated with Lyrica have reported symptoms that indicate allergic reactions. These symptoms include swelling of the face, lips, tongue and throat as well as diffuse rash. If you experience any of these reactions, contact your doctor immediately.
- Lyrica has been associated with dizziness and drowsiness, which could increase the incidence of falls in elderly patients. You should therefore be careful until you are used to the effects that the medicine may have.
- Lyrica can cause blurred vision, visual impairment or other form of visual impairment. Many of these side effects are transient. You should contact a doctor immediately if you experience any change in your vision.
- Some diabetic patients who gain weight during the use of pregabalin may need a change in their diabetes medication.
- Some side effects may be more common, such as drowsiness, as patients with spinal cord injury may take other medicines to treat, for example, pain or spasticity. These medicines have similar side effects to pregabalin and the severity of these side effects may increase when taken together.
- There have been reports of heart failure in some patients taking Lyrica, these patients have mostly been elderly with cardiovascular disease. Before taking this medicine, tell your doctor if you have any heart disease.
- There have been reports of renal failure in some patients taking Lyrica. If you experience any decrease in urine output during treatment with LYRICA, tell your doctor as this may stop if you stop taking the medicine.
- A small number of people who are treated with anti- epileptic drugs such as Lyrica has also had thoughts of harming herself or committing suicide. If you ever get these thoughts, contact your doctor immediately.
- When Lyrica is taken with other medicines that can cause constipation (such as certain types of pain medicines), it is possible that problems with the gastrointestinal tract may occur (eg constipation, blocked or sluggish bowel). Tell your doctor if you get constipation, especially if you are prone to this problem.
- Before taking this medicine, you should tell your doctor if you have alcoholism, drug abuse or addiction in your background. Do not take more medicine than prescribed.
- There have been reports of seizures when taking Lyrica or shortly after stopping Lyrica. Contact your doctor immediately if you experience seizures.
- There have been reports of cerebral palsy ( encephalopathy ) in some patients taking Lyrica when they have other conditions. Tell your doctor if you have any serious medical conditions, including liver or kidney disease.
- There have been reports of difficulty breathing. If you have a disease of the nervous or respiratory system, impaired kidney function or if you are older than 65 years, your doctor may prescribe a different dosing regimen. Contact your doctor if you have difficulty breathing or shallow breathing.
Children and young people
The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established and therefore pregabalin should not be used in this age group.
Other medicines and Lyrica
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Lyrica and some other medicines may interact ( interaction ). When taken with certain other medicines that have sedative effects (including opioids ), Lyrica may aggravate these effects, which may lead to impaired breathing, coma, and death. The degree of dizziness, drowsiness, and impaired concentration will be more pronounced if Lyrica is used in combination with medicines containing:
Oxycodone – (used as a painkiller)
Lorazepam – (used to treat anxiety)
Alcohol
Lyrica can be taken at the same time as oral contraceptives ( birth control pills ).
Lyrica with food, drink and alcohol
Lyrica capsules can be taken with or without food.
Patients are advised not to drink alcohol while using Lyrica.
Pregnancy, breastfeeding and fertility
Lyrica should not be used during pregnancy or breastfeeding unless you have been told otherwise by your doctor. If pregabalin is used during the first three months of pregnancy, it may cause fetal malformations that require medical attention. In a study that reviewed data from women in Nordic countries who used pregabalin during the first three months of pregnancy, 6 children out of 100 had such malformations. This compares with 4 children out of 100 in the women in the study who were not treated with pregabalin. Malformations of the face ( cleft lip and palate ), eyes, nervous system (including the brain), kidneys, and genitals have been reported.
Effective contraception must be used by women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Lyrica can cause dizziness, drowsiness, and impaired concentration. You should not drive, operate advanced machinery or engage in any other potentially hazardous activity until you know how this medicine affects your ability to perform these activities.
Lyrica contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lyrica contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, ie it is essentially ‘sodium-free’.
How to use Lyrica
Always take Lyrica exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide which dose is right for you.
Lyrica is for oral use only.
Peripheral and central neuropathic pain, epilepsy , or generalized anxiety disorder:
- Take as many capsules as your doctor has told you to.
- The dose one, which is tailored for you and your illness, is usually between 150 mg and 600 mg per day.
- Your doctor will tell you to take Lyrica either twice a day or 3 times a day. When dosed twice daily, Lyrica should be taken once in the morning and once in the evening, at approximately the same time each day. When dosing three times a day, Lyrica should be taken once in the morning, once in the afternoon and once in the evening at approximately the same time each day.
If you have the impression that the effect of Lyrica is too strong or too weak, talk to your doctor or pharmacist.
If you are older (over 65 years) you should use Lyrica as normal, but not if you have impaired kidney function.
Your doctor may prescribe another dose if you have impaired kidney function.
Swallow the capsule whole with water.
Keep taking Lyrica until your doctor tells you to stop.
If you use more Lyrica than you should
Contact a doctor immediately or go to the nearest emergency room. Bring your box of Lyrica capsules. You may feel sleepy, confused, anxious, or restless as a result of taking too much Lyrica. Seizures have also been reported.
If you forget to use Lyrica
It is important to take Lyrica capsules regularly and 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, continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using Lyrica
Do not stop taking Lyrica unless your doctor tells you to. If your treatment is to be stopped, it should be done gradually over at least 1 week.
You should know that after abrupt discontinuation of long- and short-term treatment with Lyrica, you may experience certain withdrawal symptoms/side effects. These include sleep problems, headaches, nausea, feelings of anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. If you have been taking Lyrica for a long time, these symptoms may occur more often and be more pronounced.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 user in 10
Dizziness, drowsiness, headache
Common: may affect up to 1 in 10 users
- Increased appetite
- Feeling of excitement, confusion, disorientation, decreased sexual desire, irritability
- Decreased attention, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, fatigue, drowsiness, insomnia, fatigue, feeling abnormal
- Blurred vision, double vision
- Fraud, balance difficulties, falls
- Dry mouth , constipation, vomiting, flatulence, diarrhea, nausea, bloating
- Difficulty getting an erection
- Swelling in the body including arms and legs
- Feeling intoxicated, gait disturbance
- Weight gain
- Muscle cramps, joint pain, back pain, pain in arms and legs
- Sore throat
Uncommon: may affect up to 1 in 100 people
- Decreased appetite, weight loss, low blood sugar, high blood sugar
- Altered self-perception, restlessness, depression, intense anxiety, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, indifference, aggression, high mood, mental deterioration, difficulty thinking, increased sexual desire, problems with sexual function including inability to achieve sexual climax, delayed ejaculation
- Vision changes, unusual eye movements, vision changes including tunnel vision, flashes of light, jerky movements, impaired reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremor when moving, loss of consciousness, loss of consciousness, fainting, increased sensitivity to sound, numbness
- Dry eyes, eye swelling, eye pain, tired eyes, increased tear flow, eye irritation
- Disorders of heart rhythm, increased heart rate, low blood pressure , high blood pressure , altered heartbeat, heart failure
- Redness , hot flashes
- Difficulty breathing, nasal congestion, nasal congestion
- Increased saliva production, heartburn, numbness around the mouth
- Sweating, rash, chills, fever
- Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
- Sore breasts
- Difficulty urinating or painful urination, incontinence
- Weakness, thirst, feeling of tightness in the chest
- Changes in blood test results and blood tests (increased blood creatinine phosphokinase, increased alanine aminotransferase , increased aspartate aminotransferase , decreased platelet count , neutropenia , increased blood creatinine, decreased blood potassium)
- Hypersensitivity, swelling of the face, itching , hives, runny nose, nosebleeds, cough, snoring
- Painful menstruation
- Cold hands and feet
Rare: may affect up to 1 in 1,000 people
- Abnormal sense of smell, fluctuations in vision, altered depth of field, altered light experience, visual impairment
- Dilated pupils are, squinted
- Cold sweats, tightness in the throat, swelling of the tongue
- Inflammation of the pancreas
- Difficulty swallowing
- Slow or decreased mobility in the body
- Difficulty writing properly
- Increased fluid in the abdomen
- Fluid in the lungs
- Seizures
- Changes in the measured electrical changes in the heart ( ECG ), which corresponds to disturbances in the heart rhythm
- Muscle injuries
- Breast secretion, abnormal breast growth, breast growth in men
- Interrupted menstruation
- Kidney failure , decreased urine output, difficulty urinating
- Decreased white blood cell count
- Inappropriate behavior
- Allergic reactions (which may include difficulty breathing, inflammation of the eye ( keratitis ), and a severe skin reaction characterized by itching , blisters, scaly skin and pain
- Jaundice (yellowed skin and yellowed eyes)
- Parkinsonism , ie symptoms similar to Parkinson’s disease; such as tremor, bradykinesia (reduced mobility) and rigidity (muscle stiffness)
Very rare: may affect up to 1 in 10,000 people
- Liver failure
- Hepatitis ( inflammation of the liver)
If you experience swelling of the face or tongue or if your skin becomes red and starts to get blisters or scales, contact a doctor immediately.
Some side effects may be more common, such as drowsiness, as patients with spinal cord injury may take other medicines to treat, for example, pain or spasticity. These medicines have similar side effects to pregabalin and the severity of these side effects may increase when taken together.
The following side effects have been reported after the market introduction: difficulty breathing, shallow breathing.
How to store Lyrica
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or can after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
The other ingredients are lactose monohydrate, maize starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, anhydrous colloidal silica, black ink (containing shellac, black iron oxide (E172), propylene glycol, potassium hydroxide), and water.
The 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg capsules also contain red iron oxide (E172).
What the medicine looks like and contents of the pack
| What the medicine looks like and the contents of the pack | |
|---|---|
| 25 mg capsules | White hard capsules marked with “Pfizer” on the top and “PGN 25” on the bottom. |
| 50 mg capsules | White hard capsules marked with “Pfizer” on the top and “PGN 50” on the bottom. The lower part of the capsule is marked with a black stripe. |
| 75 mg capsules | White and orange hard capsules marked with “Pfizer” on the top and “PGN 75” on the bottom. |
| 100 mg capsules | Orange hard capsules are marked with “Pfizer” on the top and “PGN 100” on the bottom. |
| 150 mg capsules | White hard capsules marked with “Pfizer” on the top and “PGN 150” on the bottom. |
| 200 mg capsules | Light orange hard capsules marked with “Pfizer” on the top and “PGN 200” on the bottom. |
| 225 mg capsules | White and light orange hard capsules marked with “Pfizer” on the top and “PGN 225” on the bottom |
| 300 mg capsules | White and orange hard capsules marked with “Pfizer” on the top and “PGN 300” on the bottom. |
Lyrica is available in eight pack sizes made of PVC with aluminum foil backing: a pack of 14 capsules containing 1 blister card, a pack of 21 capsules containing 1 blister card, a pack of 56 capsules containing 4 blister cards, a pack of 70 capsules containing 5 blister cards, a pack of 84 capsules containing 4 blister cards, a pack of 100 capsules containing 10 blister cards, a pack of 112 capsules containing 8 blister cards and a pack of 100 x 1 capsule in perforated single-dose blisters. In addition, Lyrica is available in cans made from HDPE which contain 200 capsules for strengths 25 mg, 75 mg, 150 mg, and 300 mg.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Upjohn EESV, 142 Rivium Westlaan, 2909 LD Capelle aan den IJssel, The Netherlands.
Manufacturer:
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany.
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000 |
| BulgariaPfizer Luxembourg SARE, Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11 |
| Czech RepublicPfizer spol s roTel: + 420-283-004-111 | HungaryPfizer Kft.Tel. + 36 1 488 37 00 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | MaltaVivian Corporation Ltd.Tel: +356 21344610 |
| GermanyPfizer OFG Germany GmbHTel: +49 (0) 800 5500634 | The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NorwayPfizer ASTel: +47 67 52 61 00 |
| GreeceUPJOHN HELLAS ΕΠΕ.:Ηλ .: +30 2100 100 002 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainViatris Pharmaceuticals, SLTel: +34 900 102 712 | PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00 |
| FranceViatris HealthTel: +33 (0) 1 58 07 34 40 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer România SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: + 1800 633 363 (toll free)Tel: +44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: +386 (0) 1 52 11 400 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: + 421–2–3355 5500 |
| ItalyViatris Pharma SrlTel: +39 02 612 46921 | Finland / FinlandPfizer OyPuh./Tel: +358 (0) 9 43 00 40 |
| .ΠροςGPA Pharmaceuticals Ltd:Ηλ: +357 22863100 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: +371 670 35 775 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |