25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg hard capsules 
pregabalin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to 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.

In this leaflet you will find information about: 
1. What Brieka is and what it is used for 
2. What you need to know before taking Brieka 
3. How to take Brieka 
4. Possible side effects 
5. How to store Brieka 
6. Contents of the packaging and other information 

1. What Brieka is and what it is used for

Brieka belongs to a group of medicines that are used i.a. to treat epilepsy , neuropathic pain and generalized anxiety disorder in adults.

Peripheral and central neuropathic pain: Brieka is used to treat long-term pain caused by a nerve injury. A number of 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 disturbances, fatigue (fatigue), and can have an impact on physical and social functioning as well as the overall quality of life.

Epilepsy: Brieka is used to treat a certain form of epilepsy ( partial epilepsy with or without secondary generalization) in adults. Your doctor will prescribe Brieka to you to treat your epilepsy as your current treatment does not keep the disease under control. You should take Brieka as an adjunct to your current treatment. Brieka is not intended to be used alone, but should always be taken in combination with other medicines to treat epilepsy .

Generalized Anxiety Disorder: Brieka 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.

Pregabalin found in Brieka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before taking Brieka

Do not take Brieka

  • 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 Brieka.

  • Some patients treated with Brieka have reported symptoms suggestive of 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.
  • Brieka 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.
  • Brieka 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 injuries 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 Brieka; 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 Brieka. If you experience any decrease in urine output during treatment with Brieka, tell your doctor as this may stop if you stop taking the medicine.
  • A small number of people who are treated with antiepileptic drugs such as Brieka has also had thoughts of harming herself or committing suicide. If you ever get these thoughts, contact your doctor immediately.
  • When Brieka is taken with other medicines that can cause constipation (such as certain types of painkillers), 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 Brieka or shortly after stopping taking Brieka. Contact your doctor immediately if you experience seizures.
  • There have been reports of cerebral palsy ( encephalopathy ) in some patients taking Brieka when they have other conditions. Tell your doctor if you have any serious medical conditions, including liver or kidney disease.

Children and young people

Safety and efficacy 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 Brieka

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

Brieka and certain other medicines may interact ( interaction ). When taken with certain other medicines that have sedative effects (including opioids ), Brieka may aggravate these effects, which may lead to impaired breathing, coma and death. The degree of dizziness, drowsiness and impaired concentration may increase if Brieka is used with medicines containing:

Oxycodone – (used as a painkiller)

Lorazepam – (used to treat anxiety)

Alcohol

Brieka can be taken at the same time as oral contraceptives ( birth control pills ).

Brieka with food, drink and alcohol

Brieka capsules can be taken with or without food.

Patients are advised not to drink alcohol while using Brieka.

Pregnancy and breastfeeding

Brieka should not be used during pregnancy or breast-feeding unless you have been told otherwise by your doctor. Effective contraception must be used by women of childbearing 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.

Driving and using machines

Brieka can cause dizziness, drowsiness and impaired concentration. You should not drive, operate advanced machinery or engage in any other risky activity until you know how this medicine affects your ability to perform these activities.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Brieka

Always take this medicine 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.

Brieka 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.
  • 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 Brieka either twice a day or three times a day. At dosage twice a day should Brieka taken once in the morning and once in the evening, at about the same time each day. When dosed three times a day, Brieka 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 Brieka is too strong or too weak, talk to your doctor or pharmacist.

If you are older (over 65 years) you should use Brieka 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 Brieka until your doctor tells you to stop.

If you forget to take Brieka

It is important to take the Brieka 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 this case, continue with the next dose as usual . Do not take a double dose to make up for a forgotten dose .

If you stop taking Brieka

Do not stop taking Brieka 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 Brieka, you may experience certain withdrawal symptoms / side effects. These include sleep problems, headaches, nausea, feeling anxious, diarrhea, flu-like symptoms , seizures, nervousness, depression, pain, sweating and dizziness. If you have been taking Brieka 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

If you experience swelling of the face or tongue or if your skin becomes red and starts to get blisters or scales, you should contact a doctor immediately.

Very common (may affect more than 1 user in 10):

  • Dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people):

  • Increased appetite.
  • Feeling of excitement, confusion, disorientation, decreased sexual desire, irritability.
  • Decreased attention, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, stinging 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, mood swings, 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, insensitivity.
  • Dry eyes, eye swelling, eye pain, tired eyes, increased tear flow, eye irritation.
  • Heart rhythm disturbances, 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 test results of blood and liver 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 er, squinting.
  • Cold sweat, feeling of tightness in the throat, swelling of the tongue.
  • Inflammation of the pancreas.
  • Difficulty swallowing.
  • Slow or decreased body movements.
  • 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).

Very rare (may affect up to 1 in 10,000 people):

  • Liver failure
  • Hepatitis ( inflammation of the liver)

Some side effects may be more common, such as drowsiness, as patients with spinal cord injuries 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.

If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Brieka

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, blister or jar after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

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.

6. Contents of the packaging 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: mannitol, combined starch (pregelatinised starch and maize starch ), talc, gelatin, titanium dioxide (E171) and black ink (containing shellac, black iron oxide (E172), potassium hydroxide). 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

25 mg capsules White hard capsules (14.5 mm), marked with “PGB 25” on the base.
50 mg capsules White hard capsules (16 mm), marked with “PGB 50” on the base. The lower part of the capsule is marked with a black stripe.
75 mg capsules White and orange hard capsules (14.5 mm), marked with “PGB 75” on the base.
100 mg capsules Orange hard capsules (16 mm), marked with “PGB 100” on the base.
150 mg capsules White hard capsules (18 mm), marked with “PGB 150” on the base.
200 mg capsules Bright orange hard capsules (19.5 mm), marked with “PGB 200” on the base.
225 mg capsules White and light orange hard capsules (19.5 mm), marked with “PGB 225” on the base.
300 mg capsules White and orange hard capsules (21.5 mm), marked with “PGB 300” on the base.

Brieka 25 mg, 50 mg, 75 mg, 100 mg, 200 mg and 225 mg are available in eight pack sizes made of PVC with aluminum foil backing: 14, 21, 30, 56, 60, 84, 90 and 100 capsules.

Brieka 150 mg is available in five pack sizes made of PVC with an aluminum foil backing: 14, 30, 56, 60 and 100 capsules.

Brieka 300 mg is available in four pack sizes made of PVC with an aluminum foil backing: 14, 56, 60 and 100 capsules.

Brieka is also available in plastic jars containing 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

Muhammad Nadeem

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