Normolepsy — Pregabalin 75 mg / 150 mg Hard Gelatin Capsules — EIPICO — Gabapentinoid
1- Disclaimer
This medical information is intended primarily for healthcare professionals and for general educational reference. It does not replace the current locally approved prescribing information, professional clinical judgment, individual patient assessment, or advice from a qualified physician or pharmacist. Treatment decisions, dose selection, dose adjustment, and discontinuation should be individualized according to the patient's indication, renal function, concomitant medicines, clinical response, and safety profile.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
Drug indications, warnings, dosage recommendations, regulatory status, and approved product presentations may differ between countries and may change over time. The current Egyptian Drug Authority-approved product information, the package labeling supplied with the medicine, and applicable local regulations should take precedence.
2- Summary
Normolepsy is an oral pregabalin-containing medicinal product manufactured by Egyptian International Pharmaceutical Industries Company (EIPICO). Egyptian product information identifies pregabalin strengths of 75 mg and 150 mg, and Egyptian pharmaceutical databases list these presentations as hard gelatin capsules. The supplied product information indicates use in adults for peripheral and central neuropathic pain, as adjunctive therapy for partial-onset seizures with or without secondary generalisation, and for Generalised Anxiety Disorder (GAD).
Pregabalin binds to the α2δ auxiliary subunit of voltage-gated calcium channels in the central nervous system. It has analgesic activity in neuropathic pain, antiseizure activity, and anxiolytic effects. It is eliminated predominantly unchanged by the kidneys, so renal function is a major determinant of dosing. Important safety concerns include dizziness and somnolence, falls, angioedema, severe cutaneous reactions, respiratory depression, suicidal ideation or behaviour, peripheral oedema, dependence, misuse/addiction potential, and withdrawal symptoms after dose reduction or discontinuation.
Pregabalin should not normally be stopped abruptly. Contemporary product information recommends gradual individualized withdrawal, with slower tapering particularly after high-dose or long-term treatment.
3- Brand Name
Normolepsy
4- Category
- Gabapentinoid
- Neuropathic pain treatment / analgesic
- Antiepileptic (antiseizure) medicine
- Anxiolytic where Generalised Anxiety Disorder is an approved indication
- Current ATC classification for pregabalin: N02BF02.
Pregabalin is structurally related to gamma-aminobutyric acid (GABA), but its clinically relevant pharmacological activity is not produced by direct stimulation of GABA receptors.
5- Active Ingredient
Pregabalin
Each Normolepsy capsule contains:
- Pregabalin 75 mg, or
- Pregabalin 150 mg
The product information also lists microcrystalline cellulose, maize starch, and purified talc as excipients.
6- Pharmaceutical Form & Strength
Hard gelatin capsules for oral administration.
Egyptian product listings identify:
- Normolepsy 75 mg hard gelatin capsules
- Normolepsy 150 mg hard gelatin capsules
EIPICO's public product information specifically lists Normolepsy 75 mg as a 20-capsule presentation, while the Egyptian Export Council for Medical Industries database identifies both 75 mg and 150 mg products as hard gelatin capsules manufactured by EIPICO.
The actual marketed pack and current Egyptian labeling should be checked because pack configurations can change.
7- Manufacturer & Marketing Authorization Holder
Manufacturer / Product Company:
Egyptian International Pharmaceutical Industries Company (EIPICO)
Address:
EIPICO, Tenth of Ramadan City, 1st Industrial Zone B1, Egypt.
Egyptian pharmaceutical product databases associate Normolepsy with EIPICO. The exact current legal wording of the Marketing Authorization Holder/registrant should follow the current Egyptian Drug Authority-approved package and prescribing information.
8- Mechanism of Action
Pregabalin binds with high affinity to the α2δ auxiliary subunit of voltage-gated calcium channels in central nervous system tissues.
This interaction modulates calcium-channel function and reduces calcium-dependent release of excitatory or pronociceptive neurotransmitters from hyperexcitable neurons. This contributes to its antinociceptive and antiseizure effects.
Although pregabalin is structurally related to GABA, it does not act as a conventional GABA agonist and does not directly bind to GABA-A or GABA-B receptors.
The complete mechanism responsible for its clinical effects has not been fully elucidated.
9- Spectrum of Activity
An antimicrobial “spectrum of activity” is not applicable to pregabalin, because pregabalin is not an antibacterial, antiviral, antifungal, or antiparasitic medicine.
Its pharmacological activity includes:
- Modulation of neuropathic pain transmission.
- Reduction of neuronal hyperexcitability associated with seizures.
- Anxiolytic activity in Generalised Anxiety Disorder where this indication is approved.
It has no clinically relevant antimicrobial spectrum.
10- Pharmacokinetics
Absorption
Pregabalin is rapidly absorbed after oral administration. In the fasting state, peak plasma concentrations are generally reached within approximately 1 hour.
Oral bioavailability is high, estimated at ≥90%, and is essentially independent of dose.
Steady state is usually achieved within 24–48 hours after repeated administration.
Food reduces the rate, but not the clinically important extent, of absorption. Administration with food decreases Cmax by approximately 25–30% and delays Tmax to about 2.5 hours, without a clinically significant reduction in overall exposure.
Distribution
The apparent volume of distribution is approximately 0.56 L/kg.
Pregabalin is not significantly bound to plasma proteins.
Metabolism
Pregabalin undergoes negligible metabolism in humans. Approximately 98% of recovered urinary radioactivity following radiolabelled pregabalin is unchanged pregabalin.
It therefore has a relatively low potential for conventional hepatic metabolic drug interactions.
Elimination
Pregabalin is eliminated mainly by renal excretion as unchanged drug.
Mean elimination half-life is approximately 6.3 hours.
Pregabalin clearance is directly proportional to creatinine clearance; therefore, dose adjustment is necessary in renal impairment.
Haemodialysis
Pregabalin is effectively removed by haemodialysis. Approximately 50% of plasma pregabalin can be removed during a 4-hour haemodialysis session; an additional post-dialysis dose may therefore be required.
Hepatic impairment
Because pregabalin undergoes little metabolism and is mainly excreted unchanged in urine, hepatic impairment is not expected to substantially alter plasma concentrations, and routine dose adjustment solely for hepatic impairment is generally unnecessary.
11- Indications
According to the Normolepsy product information and corresponding European pregabalin indications, the principal adult indications are:
Neuropathic pain
Treatment of peripheral and central neuropathic pain in adults.
Epilepsy
Adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.
Pregabalin should not automatically be regarded as a replacement for concomitant antiepileptic medicines or as monotherapy unless specifically determined by the treating specialist.
Generalised Anxiety Disorder
Treatment of Generalised Anxiety Disorder (GAD) in adults.
These three indications are stated in the Normolepsy information supplied and correspond to current European reference indications.
Approved indications differ between jurisdictions; indications approved for pregabalin products in another country should not automatically be extrapolated to Normolepsy in Egypt.
12- Administration
General dose range
The usual adult pregabalin dose range for these indications is:
150–600 mg/day, administered in two or three divided doses, subject to indication, response, tolerability, renal function, and prescribing information.
Before starting pregabalin, the patient should be counselled about the risks of dependence, addiction, and withdrawal, and a strategy for eventually ending treatment should be agreed where clinically appropriate. Treatment should be given for the shortest possible duration; when pregabalin is used for epilepsy, treatment should continue for as long as the prescriber considers necessary.
Neuropathic pain
Treatment may begin at 150 mg/day in two or three divided doses.
Depending on response and tolerability:
- Increase to 300 mg/day after 3–7 days if required.
- If necessary, increase to a maximum of 600 mg/day after a further interval of approximately 7 days.
Epilepsy
Treatment may begin at 150 mg/day, divided into two or three doses.
Depending on response and tolerability:
- Increase to 300 mg/day after approximately 1 week.
- Increase, if necessary, to a maximum of 600 mg/day after an additional week.
Generalised Anxiety Disorder
The usual dose range is 150–600 mg/day in two or three divided doses.
A typical titration is:
- 150 mg/day initially.
- 300 mg/day after approximately 1 week if necessary.
- 450 mg/day after a further week if necessary.
- Maximum 600 mg/day after another week if clinically required.
The need for continuing treatment should be reassessed regularly.
Renal impairment
Pregabalin dosage must be reduced according to creatinine clearance.
| Creatinine clearance (mL/min) | Starting total daily dose | Maximum total daily dose | Regimen |
|---|---|---|---|
| ≥60 | 150 mg/day | 600 mg/day | BID or TID |
| ≥30 to <60 | 75 mg/day | 300 mg/day | BID or TID |
| ≥15 to <30 | 25–50 mg/day | 150 mg/day | Once daily or BID |
| <15 | 25 mg/day | 75 mg/day | Once daily |
Following a 4-hour haemodialysis treatment, a single supplementary dose of approximately 25–100 mg, depending on the patient's maintenance dose, may be required.
Because Normolepsy is identified in 75 mg and 150 mg strengths, patients requiring 25 mg or 50 mg doses may require another suitable pregabalin strength or formulation rather than attempting to estimate a fraction of a capsule.
Hepatic impairment
No dose adjustment is normally required solely because of hepatic impairment.
Elderly patients
Dose reduction may be necessary because renal function frequently declines with age.
Administration with food
Pregabalin may be taken with or without food.
Discontinuation
Pregabalin should not be stopped abruptly.
Withdrawal should be gradual and individualized according to the patient's dose, duration of treatment, clinical condition, and withdrawal symptoms. Current prescribing information gives, as examples, a minimum of approximately 1 week for 150–300 mg/day and approximately 3 weeks for 600 mg/day, independent of indication. Tapering from a high dose may take longer than several weeks and, in some patients, months.
If clinically significant withdrawal symptoms occur during dose reduction, the tapering schedule should be reassessed and may need to be paused or slowed. The tapering schedule should be determined by the prescriber.
13- Method of Preparation
No preparation or reconstitution is required.
Normolepsy is a ready-to-use oral hard gelatin capsule.
The prescribed capsule should be swallowed orally with water. Pregabalin can be taken with or without food.
Patients who cannot swallow the capsule should consult their physician or pharmacist about an appropriate alternative pregabalin strength or pharmaceutical form rather than modifying the capsule without professional advice.
14- Contraindications
The principal contraindication is:
Hypersensitivity to pregabalin or to any component/excipient of the medicinal product.
15- Warnings & Precautions
Severe respiratory depression
Severe respiratory depression has been reported with pregabalin, including cases in patients not receiving opioids.
Risk is greater in patients with:
- Compromised respiratory function.
- Respiratory or neurological disease.
- Renal impairment.
- Concomitant CNS depressants, particularly opioids.
- Advanced age.
Dose adjustment and closer observation may be required.
Concomitant opioids and other CNS depressants
Pregabalin can enhance CNS depression associated with opioids and other sedating medicines. Respiratory failure, coma, and deaths have been reported in patients receiving pregabalin together with opioids and/or other CNS depressants.
Dependence, misuse, abuse, and addiction
Pregabalin can cause physical dependence, including at therapeutic doses.
Misuse, abuse, addiction, dose escalation, tolerance, and drug-seeking behaviour have been reported. Risk may be greater in patients with a current or previous substance-use disorder or certain mental-health conditions.
The need for continued therapy should therefore be reassessed periodically.
Withdrawal syndrome
Withdrawal symptoms may occur after dose reduction or discontinuation, especially abrupt discontinuation.
Reported symptoms include:
- Insomnia
- Headache
- Nausea
- Anxiety
- Diarrhoea
- Flu-like symptoms
- Nervousness
- Depression
- Suicidal ideation
- Pain
- Convulsions
- Hyperhidrosis
- Dizziness
The incidence and severity of withdrawal symptoms may be dose-related.
Angioedema and hypersensitivity
Pregabalin should be discontinued promptly if angioedema develops, particularly facial, perioral, tongue, or upper-airway swelling.
Urgent medical treatment may be necessary if breathing or swallowing is affected.
Severe cutaneous adverse reactions
Rare but potentially life-threatening severe cutaneous adverse reactions, including:
- Stevens-Johnson syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
have been reported.
Pregabalin should be stopped and urgent medical evaluation obtained if symptoms suggesting a severe skin reaction occur.
Dizziness, somnolence, and falls
Dizziness and somnolence are among the most frequent adverse effects.
They may impair balance, cognition, driving ability, or operation of machinery and may increase the risk of falls, particularly in older adults.
Suicidal ideation and behaviour
Suicidal thoughts and behaviour have been reported with antiepileptic medicines, including pregabalin.
Patients and caregivers should seek medical advice promptly if suicidal thoughts, unusual mood changes, or concerning behavioural changes develop.
Congestive heart failure
Post-marketing cases of congestive heart failure have been reported, particularly in older patients with cardiovascular disease receiving pregabalin for neuropathic indications.
Use with caution in susceptible patients.
Peripheral oedema and weight gain
Pregabalin may cause peripheral oedema and weight gain.
Diabetic patients who gain weight may require reassessment of their antidiabetic treatment.
Visual effects
Blurred vision, diplopia, visual-field abnormalities, reduced visual acuity, and other visual disturbances have been reported.
Persistent or significant visual symptoms require medical evaluation.
Renal failure
Cases of renal failure have been reported; some have improved after pregabalin was discontinued.
Renal function should be considered during treatment, particularly in patients at risk.
Reduced gastrointestinal motility
Constipation, intestinal obstruction, and paralytic ileus have been reported particularly when pregabalin is combined with medicines that reduce gastrointestinal motility, such as opioids.
Preventive measures against constipation may be appropriate in susceptible patients.
Convulsions during treatment or withdrawal
Convulsions, including severe seizures, can occur during pregabalin therapy or shortly after discontinuation.
Abrupt withdrawal should therefore be avoided.
Encephalopathy
Cases of encephalopathy have been reported, mainly in patients with underlying conditions that predispose them to encephalopathy.
16- Drug Interactions
Pregabalin has a relatively low potential for pharmacokinetic drug interactions because it is:
- Excreted predominantly unchanged in urine.
- Minimally metabolized.
- Not significantly bound to plasma proteins.
- Not a clinically important inhibitor of drug-metabolizing enzymes.
CNS depressants
Pregabalin may enhance the CNS-depressant effects of:
- Opioids
- Benzodiazepines and similar sedatives
- Alcohol
- Other centrally acting sedating medicines
Combinations may increase somnolence, impaired coordination, sedation, respiratory depression, coma, and potentially death.
Opioids
Particular caution is required with opioids because of additive CNS and respiratory depression. Pregabalin may also aggravate opioid-associated constipation and impaired gastrointestinal motility.
Lorazepam and alcohol
Pregabalin may potentiate the effects of lorazepam and ethanol.
Alcohol should therefore generally be avoided or minimized according to medical advice during therapy.
Oxycodone
Pregabalin can add to cognitive and gross-motor impairment associated with oxycodone.
Antiepileptic medicines
Clinical pharmacokinetic studies have not demonstrated clinically relevant pharmacokinetic interactions with drugs including:
- Phenytoin
- Carbamazepine
- Valproate
- Lamotrigine
- Gabapentin
Other medicines
Population pharmacokinetic analyses have not shown clinically significant effects on pregabalin clearance from oral antidiabetic medicines, insulin, diuretics, phenobarbital, tiagabine, or topiramate.
Oral contraceptives
Co-administration with norethisterone and/or ethinylestradiol does not appear to alter the steady-state pharmacokinetics of either medicine.
17- Side Effects
The most frequently reported adverse reactions are dizziness and somnolence. Many adverse reactions are mild to moderate, although serious reactions can occur.
Very common
- Dizziness
- Somnolence
- Headache
Common
Reported common reactions include:
- Nasopharyngitis
- Increased appetite
- Euphoric mood
- Confusion
- Irritability
- Disorientation
- Insomnia
- Reduced libido
- Ataxia
- Abnormal coordination
- Tremor
- Dysarthria
- Amnesia or memory impairment
- Disturbance in attention
- Paraesthesia
- Hypoaesthesia
- Sedation
- Balance disorder
- Lethargy
- Blurred vision
- Diplopia
- Vertigo
- Vomiting
- Nausea
- Constipation
- Diarrhoea
- Flatulence
- Abdominal distension
- Dry mouth
- Muscle cramps
- Arthralgia
- Back pain
- Limb pain
- Cervical spasm
- Erectile dysfunction
- Peripheral oedema
- Oedema
- Abnormal gait
- Falls
- Feeling drunk
- Feeling abnormal
- Fatigue
- Weight gain.
Uncommon
Clinically important uncommon reactions include, among others:
- Neutropenia
- Hypersensitivity
- Anorexia
- Hypoglycaemia
- Hallucination
- Panic attack
- Restlessness
- Agitation
- Depression or depressed mood
- Elevated mood
- Aggression
- Mood swings
- Depersonalisation
- Syncope
- Loss of consciousness
- Cognitive disorder or mental impairment
- Dyspnoea
- Congestive heart failure
- Urticaria
- Pruritus
- Sexual dysfunction
- Generalised oedema or face oedema
Rare
Clinically important rare reactions include, among others:
- Angioedema
- Allergic reaction
- Suicidal behaviour or suicidal ideation
- Convulsions
- Parkinsonism
- QT prolongation
- Pulmonary oedema
- Pancreatitis
- Jaundice
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Rhabdomyolysis
- Renal failure
- Oliguria
- Urinary retention
- Gynaecomastia
Very rare
- Hepatic failure
- Hepatitis
Frequency not known
Important reactions for which a reliable frequency cannot be estimated from the available data include:
- Respiratory depression
- Drug dependence
Any severe allergic reaction, breathing difficulty, extensive rash/blistering, loss of consciousness, suicidal thoughts, severe sedation, or suspected overdose requires urgent medical assessment.
18- Use in Special Populations
Renal impairment
This is the most important pharmacokinetic factor affecting pregabalin dosage.
Dose reduction is required according to creatinine clearance, and supplemental dosing may be required after haemodialysis.
Hepatic impairment
Routine dosage adjustment is not normally required solely for hepatic impairment because pregabalin undergoes negligible hepatic metabolism.
Elderly patients
Older patients may have reduced renal clearance and may therefore need lower doses.
They are also more susceptible to:
- Dizziness
- Somnolence
- Falls
- Cognitive impairment
- Respiratory depression, especially with CNS depressants.
Paediatric population
The safety and efficacy of pregabalin in children below 12 years of age and in adolescents 12–17 years of age have not been established for the referenced product information. Available data exist, but no recommendation on posology can be made. Use in paediatric patients should therefore follow the current locally approved product information and specialist medical advice.
Pregnancy
A large Nordic observational study involving more than 2,700 first-trimester pregabalin-exposed pregnancies found major congenital malformations in approximately 5.9% of exposed pregnancies compared with 4.1% in the unexposed comparison population. The adjusted prevalence ratio versus the unexposed population was 1.14 (95% CI 0.96–1.35); comparisons with lamotrigine or duloxetine suggested modestly higher relative risks, although estimates for individual malformations were imprecise.
Pregabalin should therefore not be used during pregnancy unless clearly necessary, when the expected maternal benefit outweighs potential fetal risk.
Women of childbearing potential should use effective contraception during treatment.
Pregabalin should not be stopped suddenly in a pregnant patient—particularly when being used for epilepsy—without medical supervision because abrupt withdrawal may worsen seizures or cause withdrawal symptoms.
Exposure during pregnancy may also be associated with neonatal withdrawal syndrome.
Breast-feeding
Pregabalin is excreted into human breast milk.
The effect on the breast-fed infant is not fully known. A clinical decision should therefore be made whether to discontinue breast-feeding or discontinue pregabalin, taking into account the benefit of breast-feeding to the infant and the benefit of therapy to the mother.
Fertility
There are no adequate clinical data showing an adverse effect on female human fertility.
In healthy male subjects receiving pregabalin 600 mg/day for three months, no adverse effect on sperm motility was demonstrated. Animal studies have shown reproductive effects whose relevance to humans remains uncertain.
19- Storage Conditions
Store Normolepsy exactly according to the storage conditions stated on the current Egyptian package and approved patient information leaflet. Product-specific storage requirements take precedence over the storage specifications of other pregabalin brands.
Product-specific storage temperature: Follow the temperature/storage limit stated on the current Egyptian package and approved patient information leaflet. A temperature limit specified for another pregabalin product should not be applied to Normolepsy unless it matches the current local labeling.
Keep the medicine out of the sight and reach of children, and do not use it after the expiry date stated on the package.
20- Additional Sections
Effects on driving and operating machinery
Pregabalin can cause dizziness, somnolence, impaired concentration, blurred vision, and other CNS effects.
Patients should not drive, operate complex machinery, or undertake hazardous activities until they know how pregabalin affects them.
Overdose
Reported manifestations of pregabalin overdose include:
- Somnolence
- Confusional state
- Agitation
- Restlessness
- Seizures
Coma has been reported rarely.
Management consists primarily of supportive care. Haemodialysis may be considered when clinically appropriate, particularly because pregabalin is substantially removed by dialysis.
Suspected significant overdose requires urgent medical assessment.
Missed dose
If a dose is forgotten, it should generally be taken when remembered unless it is almost time for the next scheduled dose.
A double dose should not be taken to compensate for a missed dose.
Clinical monitoring
Depending on the patient and indication, clinically relevant monitoring may include:
- Renal function.
- Degree of dizziness or somnolence.
- Respiratory status in high-risk patients.
- Peripheral oedema and body weight.
- Mood, suicidal thoughts, or behavioural changes.
- Signs of misuse, dependence, tolerance, or withdrawal.
- Severe skin reactions or hypersensitivity.
- Visual symptoms.
- Treatment effectiveness and continued clinical need.
21- Frequently Asked Questions (FAQ)
What is Normolepsy used for?
It contains pregabalin and is used in adults for peripheral and central neuropathic pain, as adjunctive treatment for partial-onset seizures, and for Generalised Anxiety Disorder where these indications are approved.
Is Normolepsy an ordinary painkiller?
No. Pregabalin is mainly useful for neuropathic pain caused by abnormal nerve signalling. It is not a conventional NSAID or simple analgesic and is not appropriate for every type of pain.
Can Normolepsy be taken with food?
Yes. Pregabalin can be taken with or without food. Food slows the rate of absorption somewhat but does not meaningfully reduce the total amount absorbed.
Can pregabalin be stopped suddenly?
Usually not. Abrupt discontinuation can produce withdrawal symptoms and may trigger seizures. Treatment should normally be tapered according to an individualized medical plan.
Can dependence occur even at the prescribed dose?
Yes. Physical dependence can occur at therapeutic doses. Addiction, misuse, or abuse can also occur, although these concepts are not identical. Risk assessment and periodic treatment review are important.
Is pregabalin safe with opioids or sedatives?
The combination requires considerable caution. Pregabalin can add to sedation and respiratory depression produced by opioids and other CNS depressants, and serious or fatal respiratory events have been reported.
Can alcohol be consumed while taking Normolepsy?
Pregabalin may intensify the CNS effects of alcohol, including dizziness, sedation, and impaired coordination. Avoiding alcohol is generally prudent unless the treating clinician advises otherwise.
Does kidney disease affect the dose?
Yes. Pregabalin is eliminated predominantly through the kidneys. Lower doses are required as renal function decreases.
Does liver disease require dose adjustment?
Usually not solely because of liver impairment, because pregabalin is minimally metabolized; however, the complete clinical situation should still be assessed.
Can Normolepsy be used during pregnancy?
Pregabalin should generally be avoided during pregnancy unless treatment is clearly necessary and the expected benefit outweighs potential fetal risk. Women who could become pregnant should discuss effective contraception and pregnancy planning with their clinician.
Can it be used while breast-feeding?
Pregabalin passes into human milk. A clinician should determine whether breast-feeding or pregabalin treatment should be discontinued after considering the benefits and risks.
What should a patient do if severe sleepiness or breathing difficulty occurs?
Severe somnolence, slow or difficult breathing, loss of consciousness, or unusual unresponsiveness requires urgent medical evaluation, particularly if opioids, sedatives, or alcohol are also involved.
Does pregabalin affect driving?
It can. Dizziness, somnolence, visual disturbance, and impaired concentration may occur. Driving and hazardous activities should be avoided until the patient's individual response is known.
22- References
- Normolepsy product information — composition, adult indications, dosing information, renal adjustment, warnings, interactions, pregnancy information, adverse reactions, and pharmacokinetic information.
- Egyptian International Pharmaceutical Industries Company (EIPICO) — public product listing and company information. Normolepsy 75 mg is listed as pregabalin 75 mg capsules, 20 capsules.
- Export Council for Medical Industries (ECMI), Egyptian Pharmaceutical Database — Normolepsy 75 mg and 150 mg listed as pregabalin hard gelatin capsules manufactured by EIPICO.
- Lyrica 75 mg Hard Capsules — Summary of Product Characteristics (SmPC), electronic Medicines Compendium (emc), Viatris — dosing, renal adjustment, discontinuation guidance, contraindications, warnings, dependence/withdrawal information, interactions, pregnancy/lactation, adverse reactions, overdose, mechanism, and pharmacokinetics.
- European Medicines Agency (EMA), Lyrica EPAR — pregabalin indications, use, mechanism, and regulatory product information.
- UK Medicines and Healthcare products Regulatory Agency (MHRA): Pregabalin — findings of safety study on risks during pregnancy.
- UK Medicines and Healthcare products Regulatory Agency (MHRA): Pregabalin (Lyrica) — reports of severe respiratory depression.
- Pregabalin pharmacological information — α2δ voltage-gated calcium-channel binding and distinction from direct GABA-receptor activity.
Scientific status: The information above is based on the cited product information and regulatory sources. Current Egyptian Drug Authority-approved Normolepsy labeling remains the controlling source for product-specific regulatory information, approved presentations, storage requirements, and local prescribing conditions.