MYCA-P 75 Capsules (Pregabalin 75mg and Methylcobalamin 750mcg Capsules)

This medication is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia.

What is pregabalin?

Pregabalin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Pregabalin is used to treat pain caused by fibromyalgia, or nerve pain in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.

Pregabalin is also used with other medications to treat partial onset seizures in adults and children who are at least 4 years old.

Pregabalin may also be used for purposes not listed in this medication guide.

Important Information

Pregabalin can cause a severe allergic reaction. Stop taking pregabalin and seek emergency medical help if you have hives or blisters on your skin, trouble breathing, or swelling in your face, mouth, or throat.

Some people have thoughts about suicide while taking pregabalin. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

If you have diabetes or heart problems, call your doctor if you have weight gain or swelling in your hands or feet while taking pregabalin.

Do not stop using pregabalin suddenly, even if you feel fine. Stopping suddenly may cause withdrawal symptoms.

Before taking this medicine

You should not use pregabalin if you are allergic to it.

Tell your doctor if you have ever had:

• a mood disorder, depression, or suicidal thoughts;
• heart problems (especially congestive heart failure);
• a bleeding disorder;
• low levels of platelets in your blood;
• kidney disease (or if you are on dialysis);
• diabetes (unless you are taking pregabalin to treat diabetic neuropathy);
• drug or alcohol addiction; or
• a severe allergic reaction (angioedema).

Some people have thoughts about suicide while taking pregabalin. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pregabalin on the baby.

This medication can decrease sperm count and may affect fertility in men (your ability to have children). In animal studies, pregabalin also caused birth defects in the offspring of males treated with this medicine. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

You should not breast-feed while using pregabalin.

Do not give this medicine to a child without medical advice. Pregabalin is not approved for seizures in anyone younger than 4 years old.

How should I take pregabalin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not stop using pregabalin suddenly, even if you feel fine, or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose for at least 1 week before stopping completely.

Call your doctor if your symptoms do not improve, or if they get worse.

In case of emergency, wear or carry medical identification to let others know you take seizure medication.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pregabalin?

Avoid drinking alcohol. It may increase certain side effects of pregabalin.

Avoid driving or hazardous activity until you know how pregabalin will affect you. Your reactions could be impaired.

Pregabalin side effects

Pregabalin can cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• vision problems;
• skin sores (if you have diabetes);
• easy bruising, unusual bleeding;
• swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or
• unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, or dark colored urine).

If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.

Common side effects may include:

• dizziness, drowsiness;
• swelling in your hands and feet;
• trouble concentrating;
• increased appetite;
• weight gain;
• dry mouth; or
• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect pregabalin?

Using pregabalin with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• oral diabetes medicine–pioglitazone, rosiglitazone; or
• an ACE inhibitor–benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

This list is not complete. Other drugs may affect pregabalin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.