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LYRICA 75 mg hard capsules

Patient information sheet for LYRICA 75 mg hard capsules

1.What LYRICA 75 mg hard capsule is and what it is used for

1.1 What are the properties of the medicinal product?

LYRICA 75 mg hard capsules contain the active substance pregabalin, a drug from the group of so-called gamma-aminobutyric acid analogues.

Pregabalin is used in adults to treat neuropathic pain, epilepsy, and generalized anxiety disorder.

For peripheral and central neuropathic pain: Pregabalin is used to treat long-lasting pain caused by damage to the nerves. Peripheral neuropathic pain can be caused by many different conditions, such as diabetes or shingles. The pain felt can be described as hot, burning, throbbing, shooting, stabbing, sharp, cramp-like, sore muscles, tingling, numbing or pinprick-like. Peripheral and central neuropathic pain can also be associated with mood swings, insomnia or fatigue and affect physical and social functions as well as quality of life.

For epilepsy: Pregabalin is used to treat a certain form of epilepsy in adulthood (partial seizures with or without secondary generalization). Your doctor will prescribe LYRICA 75 mg hard capsules to support your treatment for epilepsy if the current treatment for your condition is inadequate. You must take LYRICA 75 mg hard capsules in addition to your current treatment. Pregabalin is not intended to be taken alone, but should always be used in combination with other anti-epileptic treatments.

For generalized anxiety disorder: Pregabalin is used to treat generalized anxiety disorder. The symptoms of generalized anxiety disorder are long-term, difficult-to-treat anxiety and anxiety. Generalized anxiety disorders can also cause restlessness, states of tension and overstimulation, easy exhaustion (tiredness), difficulty concentrating and emptiness, irritability, muscle tension or sleep disorders. These symptoms are different from everyday stress and the stresses associated with it.

Pregabalin requires a prescription and should only be used on the advice of a doctor.

1.2. What strengths and dosage forms are there?

Pregabalin is usually available as

- capsules / hard capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg pregabalin,

- Solution containing 20 mg of pregabalin in 1 ml.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3 Prehabalin is used

- for the treatment of peripheral and central neuropathic pain,

- as additional therapy in a certain form of epilepsy in adulthood: partial seizures with or without secondary generalization,

- for generalized anxiety disorders.

2. What you need to know before you take LYRICA 75 mg hard capsule

2.1 Do not take LYRICA 75 mg hard capsules

- if you are allergic (hypersensitive) to pregabalin or any of the other ingredients of LYRICA 75 mg hard capsules.

2.2 Take special care when taking LYRICA 75 mg hard capsules

- Some patients taking LYRICA 75 mg hard capsules have reported symptoms suggestive of an allergic reaction. These complaints were, for example, swelling of the face, lips, tongue or throat or extensive reddening of the skin. If these symptoms occur, you must contact your doctor immediately.

- LYRICA 75 mg hard capsules have been associated with drowsiness and sleepiness, which could lead to more frequent accidental injuries in the elderly. This is why you need to be careful until you are used to all of the effects the medicine may have.

- LYRICA 75 mg hard capsule can cause blurred vision, loss of vision and other visual disturbances, many of which are temporary. If you notice any changes in your eyesight, you must inform your doctor immediately.

- Some diabetic patients who gain weight while taking pregabalin may need to adjust their diabetes medicines accordingly.

- Patients with spinal cord injuries may be more likely to experience certain side effects, such as drowsiness, as patients with spinal cord injuries may be taking other medicines that have side effects similar to pregabalin to treat, for example, pain or cramps (spasticity). The severity of these effects may be increased if taken together.

- There have been reports of heart failure (heart failure) in some patients taking LYRICA 75 mg hard capsules, mainly elderly patients with cardiovascular disease. Tell your doctor before taking this medicine if you have or have had heart disease.

- Renal failure has been reported in some patients while taking LYRICA 75 mg hard capsules. If you notice a decrease in the amount of urine you have in your urine while taking LYRICA 75 mg hard capsules, you should talk to your doctor about this, as this can be corrected by stopping the medicine.

- A small number of people being treated with anti-epileptic medicines such as LYRICA 75 mg hard capsules have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

- If LYRICA 75 mg hard capsule is taken with medicines that can cause constipation (such as some types of pain relievers), gastrointestinal problems (such as constipation, blocked or paralyzed digestion) may occur. Talk to your doctor if you experience constipation, especially if you are prone to the problem.

- Before taking this medicine, you should talk to your doctor if you are or have been addicted to alcohol or drugs. Tell your doctor if you think you may need more medicine than prescribed.

- There have been reports of seizures while taking LYRICA 75 mg hard capsules or shortly after they stop taking them. If you have a seizure, contact your doctor immediately.

- There have been reports of decreased brain function (encephalopathy) in some patients taking LYRICA 75 mg capsules and having other conditions. Talk to your doctor if you have or have previously had serious medical conditions, including liver or kidney disease.

Note on other ingredients: Oral medicines can contain different types of sugar. Therefore, please only take this after consulting your doctor if you know that you suffer from an intolerance to certain sugars. Oral solutions may contain the preservatives methyl 4-hydroxybenzoate (Ph.Eur.) (E218) and propyl 4-hydroxybenzoate (Ph.Eur.) (E216), which can cause hypersensitivity reactions, including late reactions. Solutions can also contain a small amount of alcohol.

2.2.a) Children

The safety and efficacy in children and adolescents under 18 years of age have not been studied. Therefore pregabalin should not be used in this age group.

2.2.b) Elderly patients

A dose adjustment is usually not necessary. However, if the kidney function is reduced, it may be necessary to reduce the pregabalin dose.

2.2.c) Pregnancy

LYRICA 75 mg hard capsules must not be taken during pregnancy unless your doctor has specifically recommended it. Women who can become pregnant must use effective contraception. If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

2.2.d) Breastfeeding

As it is not known whether LYRICA 75 mg hard capsules are excreted in breast milk, breast-feeding is not recommended during treatment with LYRICA 75 mg hard capsules. If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.

2.2.e) Ability to drive and use machines

LYRICA 75 mg hard capsules can cause drowsiness, drowsiness and lack of concentration. You should not drive, operate complicated machines, or engage in other potentially dangerous activities until you know if this medicine will affect you.

2.3 Which interactions with other medicinal products have to be considered?

Tell your doctor or pharmacist if you are taking, have recently used, or may use any other medicines.

LYRICA 75 mg hard capsules and certain other medicines can affect each other (interactions).

When taken with certain other medicines, LYRICA 75 mg hard capsules can increase the side effects of these medicines, up to and including difficulty breathing (respiratory failure) and coma.

Drowsiness, sleepiness and inability to concentrate may become worse if LYRICA 75 mg hard capsules are taken with medicines that:

- oxycodone (a pain reliever),

- Lorazepam (a sedative) or

- alcohol

contain.

LYRICA 75 mg hard capsules can be used together with the "birth control pills" (oral contraceptives).

2.4 What should I think of when taking LYRICA 75 mg hard capsules with food, luxury foods and beverages?

LYRICA 75 mg hard capsules can be taken with or without food. It is recommended that you do not drink alcohol while taking LYRICA 75 mg hard capsules.

3. How to take LYRICA 75 mg hard capsule

Always take LYRICA 75 mg hard capsule exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

Capsules / hard capsules are for oral use. Swallow the hard capsule whole with water.

Oral solution contains a graduated oral syringe. Using the oral syringe, take your dose and empty it directly into your mouth.

If taken twice, take LYRICA 75 mg hard capsules once in the morning and once in the evening, at about the same time each day. If you take a 3-time dose, take LYRICA 75 mg hard capsules 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 LYRICA 75 mg hard capsules is too strong or too weak, talk to your doctor or pharmacist.

Keep taking LYRICA 75 mg hard capsule until your doctor tells you to stop.

When discontinuing pregabalin, it is recommended that the dose be gradually reduced over a period of at least 1 week, regardless of the indication.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Adults and elderly patients

The dose, which has been adjusted for you and your condition, will usually be between 150 mg and 600 mg of pregabalin per day. Your doctor will tell you whether you should take LYRICA 75 mg hard capsules two or three times a day.

3.2.a.1.Neuropathic pain

Treatment can be started with a daily dose of 150 mg pregabalin given in 2 or 3 divided doses. Depending on the response and individual tolerance, the dose can be increased to 300 mg daily after 3 to 7 days. If necessary, the dose can be increased after a further 7 days to a maximum dose of 600 mg daily.

3.2.a.2.Epilepsy

Treatment can be started with a daily dose of 150 mg pregabalin given in 2 or 3 divided doses. Depending on the response and individual tolerance, the dose can be increased to 300 mg daily after 1 week. The maximum dose of 600 mg daily can be reached after another week.

3.2.a.3.Generalized anxiety disorders

The dose is between 150 and 600 mg of pregabalin per day given in 2 or 3 divided doses. The need for therapy should be checked regularly.

3.2.b) If you have kidney problems

Your doctor may prescribe a different rhythm and / or dosage for you.

3.3 If you take more LYRICA 75 mg hard capsule than you should

Contact your doctor immediately or go to the emergency room at the nearest hospital. Take your medicine with you. You may feel sleepy, confused, aroused, or restless.

3.4 If you forget to take LYRICA 75 mg hard capsules

It is important that you take your LYRICA 75 mg hard capsules, hard 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 the next dose. In this case, continue with the next normal dose. Do not take a double dose to make up for a forgotten dose.

3.5 Effects if treatment with LYRICA 75 mg hard capsules is stopped

Do not stop taking LYRICA 75 mg hard capsules unless your doctor tells you to. When your treatment is stopped, it must be done gradually over at least 1 week. It is important to know that you may experience certain side effects after stopping long and short term treatment with pregabalin. These include sleeping problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and drowsiness. It is not clear at this point whether these symptoms become more common or severe if you have been taking pregabalin for a long time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, LYRICA 75 mg hard capsules can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

4.1.a) Very common

Drowsiness, drowsiness, headache.

4.1.b) Often

Increased appetite, euphoria, confusion, disorientation, change in sex drive, irritability, decreasing alertness, clumsiness, memory impairment, tremors, speech difficulties, abnormal sensations such as tingling, calming, lethargy, insomnia, tiredness, headache, blurred vision, double vision, dizziness, dizziness , Constipation, vomiting, flatulence, erectile dysfunction, swelling of the body including extremities, feeling drunk, abnormal gait, weight gain, muscle cramps, joint pain, back pain, pain in extremities, sore throat.

4.1.c) Occasionally


4.1.d) Rarely

Abnormal sense of smell, changes in heart rate, nasal congestion, changes in vision including tunnel vision, rocking vision, altered depth perception, flashes of light, optical brightness, dilated pupils, squint, eye irritation, fever, cold sweat, tightness in the throat, inflammation of the pancreas, difficulty swallowing, slow or decreased body movement, difficulty writing, hives, increased fluid in the abdomen, muscle damage, neck pain, chest pain, breast discharge, abnormal breast enlargement, breast enlargement in men, interrupted menstrual periods, high blood sugar, weight loss, high mood, kidney failure, decreased urine output , EKG changes, inappropriate behavior, allergic reactions.

If you notice swelling of your face or tongue, or if your skin turns red and starts to blister or peel, seek medical advice immediately.

Certain side effects such as drowsiness may be more common in patients with spinal cord injuries, as patients with spinal cord injuries may be taking other medicines that have side effects similar to pregabalin to treat, for example, pain or cramps (spasticity). The severity of these effects may be increased if taken together.

4.2 What measures should be taken if side effects occur?

Let your doctor know if you experience any side effects.He will decide on possible measures.

If you notice swelling of your face or tongue, or if your skin turns red and starts to blister or peel, seek medical advice immediately.

If you have a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can have serious consequences under certain circumstances. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.

5. How to store LYRICA 75 mg hard capsules

Store LYRICA 75 mg hard capsules at normal room temperature and keep the medicine in the original package, away from light and moisture.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; November 2014 (3)