Orphengesic Forte Tablets

Orphenadrine: Acts centrally at the brain stem level, possibly by inhibiting polysynaptic reflexes, and has anticholinergic properties. It does not directly relax tense muscles. Aspirin: Irreversibly inhibits cyclooxygenase (COX-1 and COX-2) enzymes, leading to decreased prostaglandin synthesis, resulting in anti-inflammatory, analgesic, and antipyretic effects. It also inhibits platelet aggregation. Caffeine: A CNS stimulant that acts as a non-selective adenosine receptor antagonist (A1, A2A, A2B, A3). It enhances the analgesic effects of Aspirin.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Confusion
Hallucinations (seeing or hearing things that are not there)
Ringing in the ears
Abnormal or rapid heartbeat
Difficulty urinating
Changes in vision
Severe dizziness or fainting
Fever

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can affect not only the skin but also other organs and can be life-threatening. Seek medical help immediately if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach or vomiting
Dry mouth
Headache
Constipation
* Feeling nervous or excitable

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
Certain health conditions, such as:
+ Enlarged prostate gland
+ Glaucoma
+ Bowel blockage
+ Myasthenia gravis
+ Ulcer disease
+ Difficulty urinating
+ Swallowing problems
If you have trouble swallowing, as this may affect the administration of the medication.
If you have chickenpox, the flu, or flu-like symptoms, as the risk of Reye's syndrome, a severe condition, may be increased.
If you are pregnant, planning to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

Special Considerations for Children:

If the patient is under 12 years old, do not administer this medication. It is not approved for use in children under 12 years of age.

Interactions with Other Medications and Health Conditions:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Share information about your health problems to ensure it is safe to take this medication with your other treatments.
* Do not start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. If you are taking this medication long-term, your doctor will likely recommend regular blood tests and other laboratory evaluations to monitor your condition.

As this medication may increase your risk of bleeding, it is crucial to be cautious and avoid injuries. To minimize this risk, use a soft-bristled toothbrush and an electric razor for shaving.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that can cause drowsiness, consult with your doctor. Additionally, limit your intake of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate, as combining these with this medication may lead to nervousness, shakiness, and a rapid heartbeat.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk with Aspirin
• Methotrexate (high dose) - increased methotrexate toxicity with Aspirin
• Ketorolac - increased GI toxicity with Aspirin
• Other NSAIDs - increased GI toxicity and bleeding risk with Aspirin
• Alcohol (chronic heavy use) - increased GI bleeding risk with Aspirin, enhanced CNS depression with Orphenadrine

• SSRIs/SNRIs - increased bleeding risk with Aspirin
• Corticosteroids - increased GI ulceration/bleeding risk with Aspirin
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic effect, increased nephrotoxicity with Aspirin
• ACE inhibitors/ARBs - reduced antihypertensive effect, increased renal impairment risk with Aspirin
• Valproic acid - increased valproic acid levels with Aspirin
• Oral hypoglycemics (sulfonylureas) - enhanced hypoglycemic effect with Aspirin
• CNS depressants (e.g., opioids, benzodiazepines, alcohol) - enhanced sedation/CNS depression with Orphenadrine
• Anticholinergics (e.g., tricyclic antidepressants, antihistamines) - additive anticholinergic effects with Orphenadrine
• Fluoroquinolones - increased CNS stimulation/seizure risk with Caffeine
• Cimetidine, Fluconazole, Fluvoxamine - increased caffeine levels

• Lithium - increased lithium levels with Aspirin
• Phenytoin - increased phenytoin levels with Aspirin
• Probenecid/Sulfinpyrazone - reduced uricosuric effect with Aspirin
• Beta-blockers - reduced antihypertensive effect with Aspirin
• Oral contraceptives - increased caffeine levels
• Theophylline - increased theophylline levels with Caffeine

• Antacids - may reduce Aspirin absorption
• Iron supplements - may reduce iron absorption (Aspirin)

• Signs of GI bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
• Signs of CNS depression (excessive drowsiness, confusion, impaired coordination)
• Signs of anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
• Signs of liver dysfunction (yellowing eyes/skin, dark urine, persistent nausea/vomiting)
• Signs of kidney problems (decreased urination, swelling in ankles/feet)
• Ringing in ears (tinnitus) or hearing loss (salicylism)

Contraindicated in the third trimester due to the Aspirin component, which can cause premature closure of the fetal ductus arteriosus, fetal renal dysfunction, and increased maternal/fetal bleeding. Use in earlier trimesters should be avoided unless clearly necessary and benefits outweigh risks, due to potential for congenital malformations (Aspirin) and limited data for Orphenadrine.

Not recommended during breastfeeding. Aspirin and Caffeine are excreted into breast milk. Aspirin can cause adverse effects in the infant (e.g., bleeding, metabolic acidosis) and is generally discouraged. Orphenadrine's excretion into breast milk is unknown, but its anticholinergic effects could theoretically affect the infant.

Contraindicated in children and adolescents due to the Aspirin component and the risk of Reye's Syndrome, especially during viral infections. Safety and efficacy have not been established in pediatric patients.

Use with extreme caution in elderly patients. They are more susceptible to the anticholinergic side effects of Orphenadrine (e.g., confusion, urinary retention, constipation, dry mouth, blurred vision) and the CNS depressant effects. They are also at increased risk for Aspirin-induced GI bleeding, renal impairment, and cardiovascular adverse events. Start with lower doses and monitor closely.

• This combination product is typically used for short-term management of acute musculoskeletal pain.
• Due to the Aspirin component, it carries the same risks as Aspirin, including GI bleeding and Reye's Syndrome.
• Patients should be advised about the potential for drowsiness and anticholinergic effects (dry mouth, blurred vision, urinary retention) from Orphenadrine.
• The caffeine component is intended to counteract some of the sedative effects of Orphenadrine and enhance Aspirin's analgesic effect, but can still cause nervousness or insomnia in sensitive individuals.
• Always inquire about other medications, including OTCs and herbal supplements, to avoid drug interactions, especially with anticoagulants or other NSAIDs.

• Single-agent muscle relaxants (e.g., Cyclobenzaprine, Tizanidine, Methocarbamol)
• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac)
• Acetaminophen
• Topical analgesics
• Physical therapy, heat/cold therapy, rest

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.