MacGabalin Plus

Composition :
Each capsule contains :
Pregabalin : 75 mg
Methylcobalamin : 1 mg
Excipients : Q.S.

Pharmaceutical Form : Capsules

Read all of this leaflet carefully before you start taking Mac Gabalin Plus.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your health care provider.
– This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
– If any of the side effects becomes serious, or if you notice any side effects not listed
in this leaflet, please tell your health care provider.

In this leaflet:
1. What Mac Gabalin Plus is and what it is used for
2. What you need to know Before you take Mac Gabalin Plus
3. How to take Mac Gabalin Plus
4. Possible side effects
5. How to store Mac Gabalin Plus
6. Further information

1. What Mac Gabalin Plus is and what it is used for
Mac Gabalin Plus is combination of Pregabalin with Methylcobalamin. this medicine is used for the treatment of Nerve Damage Pain, Seizures, Anxiety Disorder in Adults, Anemia, Nerve Damage, Numbness and Tingling and other conditions.
Pregabalin Methyl cobalamin Tablet contains Methylcobalamin, and Pregabalin as active ingredients. Pregabalin Methyl cobalamin Tablet works by modifying the release of certain substances released by the nerves in the brain; works in recovery process of damaged nerve cells.
Mac Gabalin Plus is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: Nerve Damage Pain, Seizures, Anxiety Disorder in Adults, Anemia Nerve Damage, Numbness and Tingling, Pain in Neurological Disorders.

2. What you need to know Before you take Mac Gabalin Plus

  • Drug Warnings

    Mac Gabalin Plus may increase the risk of heart failure in patients with heart diseases. It may cause dizziness
    and somnolence (sleepiness). So, it might increase the risk of accidental injury in elderly patients. Mac
    Gabalin Plus may also cause temporary vision problems. However, if this condition is persistent, consult your
    doctor immediately. Patients with diabetes who gain weight with Mac Gabalin Plus may need a change in diabetic
    medicines. If you notice decreased urination while taking Mac Gabalin Plus, inform your doctor as Mac Gabalin
    Plus may cause kidney failure in some cases. It may increase suicidal tendencies, though it is rare. You may
    experience convulsions after discontinuing Mac Gabalin Plus. In such cases, inform your doctor immediately.

  • Drug Interactions

    Drug-Drug Interaction: Mac Gabalin Plus may interact with a pain killer (oxycodone), opioids, antianxiety drugs (lorazepam), antacid (omeprazole), antibiotic (neomycin), and anti-gout medication (colchicine).
    Drug-Food Interaction: Avoid alcohol consumption while using Mac Gabalin Plus.
    Drug-Disease Interaction: Mac Gabalin Plus should be used with caution in patients with liver diseases, kidney diseases, heart problems, alcoholism, drug abuse, and suicidal tendencies.

  • PREGNANCY

    Mac Gabalin Plus is a category C medicine. It is not recommended for use in pregnant women unless the doctor thinks the benefits outweigh the risks.
    Driving and Using Machine Mac Gabalin Plus may cause dizziness and drowsiness. So, avoid driving or operating heavy machinery while using Mac Gabalin Plus

3. How to take Mac Gabalin Plus
Mac Gabalin Plus is given orally with or without food.
The dose range for pregabalin is 150 to 300 mg per day given in two or three divided doses. The dosage range for methyl cobalamin for clinical effectiveness is 0.5-6 mg/day, and no significant therapeutic advantage is observed beyond this range. However, the most commonly used dose was 0.5 – 1.5 mg/day administered orally. Mac Gabalin Plus treatment can be started at a dose of two capsules b.i.d.
Based on individual patient response and tolerability, the dosage may be increased to 4 capsules in two divided doses after an interval of 3 to 7 days. If you take more Mac Gabalin Plus than you should If you take more than the recommended dose of Mac Gabalin Plus per day, then you should tell your doctor or go to your nearest hospital emergency
department. Take the remaining capsules with you. This is so that the doctor knows what you have taken.
If you forget to take Mac Gabalin Plus
If you forget to take Mac Gabalin Plus, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you miss more than 4 consecutive doses of Mac Gabalin Plus (1 day), contact your doctor.

4. Possible side effects

  • Pregabalin

    The most common side effects events seen with pregabalin treatment are dizziness, somnolence, headache, ataxia, asthenia, dry mouth, constipation, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention).
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.
    Controlled Studies with Neuropathic Pain Associated with Diabetic

  • Peripheral Neuropathy

    Undesirable Effects Leading to Discontinuation
    In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin and 4% of patients treated with placebo discontinued prematurely due to undesirable effects. In the pregabalin treatment group, the most common reasons for discontinuation due to undesirable effects were dizziness (3%) and somnolence (2%). In comparison,
    < 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients. Most Common Undesirable Effects Table 2 lists all undesirable effects, regardless of causality, occurring in ≥1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had undesirable effects with a maximum intensity of "mild" or "moderate”. Table 2: Treatment-emergent adverse reaction incidence in controlled trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (Events in at least 1% of all pregabalin -treated patients and at least numerically more in all pregabalin than in the placebo group)

* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia Controlled Studies in Postherpetic Neuralgia Undesirable
Effects Leading to Discontinuation
In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to undesirable effects. In the pregabalin treatment group, the most common reasons for discontinuation due to undesirable effects were dizziness (4%) and somnolence
(3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the pregabalin group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).
Most Common Undesirable Effects
Table 3 lists all undesirable effects, regardless of causality, occurring in ≥ 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. In addition, an event is included, even if the
incidence in the all pregabalin group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had undesirable effects with a maximum intensity of “mild” or “moderate”. Overall, 12.4% of all
pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment- related adverse event.
Table 3: Treatment-emergent adverse reaction incidence in controlled trials in Neuropathic Pain Associated with Postherpetic Neuralgia (Events in at least 1% of all pregabalin -treated patients and at least numerically more in all pregabalin than in the placebo group)

* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia Controlled Studies with Fibromyalgia Undesirable Effects Leading to Discontinuation
In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150–600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to undesirable effects. In the pregabalin treatment group, the most common reasons for discontinuation due to undesirable effects were dizziness (6%) and somnolence (3%). In comparison, 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these undesirable effects led to withdrawal in approximately 1% of patients. Most Common Undesirable Effects Table 4 lists all undesirable effects, regardless of causality, occurring in ≥2% of patients with fibromyalgia in the ‘all pregabalin’ treatment group for which the incidence was greater than in the placebo treatment group. A
majority of pregabalin-treated patients in clinical studies experienced undesirable effects with a maximum intensity of “mild” or “moderate” . Table 4:Treatment-emergent adverse reaction incidence in controlled trials in Fibromyalgia (Events in at least 2% of all pregabalin -treated patients and occurring more
frequently in the all pregabalin-group than in the placebo treatment group).

Methyl cobalamin:
Methyl cobalamin has no known toxicity at the dosage for clinical effects and it appears to be well tolerated, with a safety and tolerability profile similar to that of the placebo.
Mild transient diarrhoea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methyl cobalamin.

5. How to store Mac Gabalin Plus

  • This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.

  • Do not use Mac Gabalin Plus after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

  • 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 protect the environment

6. Further information
What Mac Gabalin Plus Mac Gabalin Plus contains Pregabalin and Methylcobalamin