Synalgos-DC

Dihydrocodeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

This medicine is not for use in children younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are on a schedule, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of dihydrocodeine can be fatal, especially in a child or another person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or insomnia, tremors, fast heart rate, pinpoint pupils, ringing in your ears, fainting, weak pulse, seizure (convulsions), blue lips, shallow breathing, or no breathing.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take with a full glass of water.
• If you have been taking Synalgos-DC for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
• If you have been taking Synalgos-DC on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.

What do I do if I miss a dose?

• If you take Synalgos-DC on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

Each Synalgos-DC capsule contains 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.

The inactive ingredients present are alginic acid, cellulose, D&C Red 28, FD&C Blue 1, gelatin, iron oxides, stearic acid, and titanium dioxide.

Synalgos-DC should be given with caution to certain patients, such as the elderly or debilitated.

Information for Patients

Advise patients that some people have a genetic variation that results in dihydrocodeine changing into dihydromorphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid dihydrocodeine metabolizer or not. These higher-than-normal levels of dihydromorphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. Synalgos- DC is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving Synalgos-DC for other reasons to monitor for signs of respiratory depression.

Advise patients that nursing mothers taking dihydrocodeine can have higher dihydromorphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of dihydromorphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Advise nursing mothers to watch for signs of dihydromorphine toxicity in their infants which includes increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby’s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Drug Interactions

The CNS-depressant effects of Synalgos-DC may be additive with that of other CNS depressants. See “WARNINGS.”

Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents.

Geriatric Use

Clinical studies of Synalgos-DC did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.

In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Synalgos®-DC Capsules are blue and gray, marked “CP” and “419”, supplied in:

Bottles of 100 capsules; NDC 49708-419-88

Store at room temperature, approx. 25°C (77°F). Keep tightly closed.

Dispense in tight container.

Manufactured by:                                                                                                        C.S. No.:8002T02

Mikart, Inc.                                                                                                                  Rev. 02/13

Atlanta, Georgia 30318                                                                                              Code 990B00

Distributed by:

Caraco Pharmaceutical Laboratories, Ltd.

1150 Elijah McCoy Drive

Detroit, MI 48202

www.caraco.com

NDC 49708-419-88

100 Capsules

Synalgos®-DC

(Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, USP)

Each capsules contains: 356.4 mg aspirin, 30 mg caffeine, and 16 mg drocode (dihydrocodeine) bitartrate (Warning-may be habit-forming).

SEALED FOR YOUR PROTECTION

Rx Only

Caraco Pharma, Inc.

Applies to aspirin / caffeine / dihydrocodeine: oral capsule

General

The most frequently expected adverse reactions based on the individual components include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus and skin reactions.[Ref]

Gastrointestinal

Dihydrocodeine:
Frequency not reported: Nausea, vomiting, constipation, abdominal pain, diarrhea, dry mouth, indigestion, spasm of biliary tract

Caffeine:
Frequency not reported: Diarrhea, nausea, stomach pain, vomiting[Ref]

Hypersensitivity

Dihydrocodeine:
Frequency not reported: Anaphylactoid reactions, hypersensitivity reactions[Ref]

Respiratory

Dihydrocodeine:
Frequency not reported: Respiratory depression, cough suppression[Ref]

Psychiatric

Dihydrocodeine:
Frequency not reported: Confusion, physical and psychological dependence, hallucinations vivid dreams

Caffeine:
Frequency not reported: Anxiety, anxiety neurosis, excitement, insomnia, irritability, restlessness, tenseness[Ref]

Dermatologic

Dihydrocodeine:
Frequency not reported: Sweating, pruritus, skin reactions

Caffeine:
Frequency not reported: Urticaria[Ref]

Cardiovascular

Dihydrocodeine:
Frequency not reported: Orthostatic hypotension

Caffeine:
Frequency not reported: Extrasystoles, palpitations, tachycardia[Ref]

Endocrine

Opioids:
Frequency not reported: Adrenal insufficiency, androgen deficiency[Ref]

Chronic opioid use may influence the hypothalamic-pituitary-gonadal axis and lead to androgen deficiency; however, the causal role of opioids is unknown due to the lack of studies into the many medical, physical, lifestyle, and psychological stressors that influence gonadal hormone levels.[Ref]

Genitourinary

Dihydrocodeine:
Frequency not reported: Urinary retention[Ref]

Metabolic

Dihydrocodeine:
Frequency not reported: Anorexia[Ref]

Nervous system

Dihydrocodeine:
Rare (less than 0.1%): Narcosis
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, headache

Caffeine:
Frequency not reported: Headaches, lightheadedness, tremor

Opioids:
Frequency not reported: Serotonin syndrome[Ref]

Ocular

Dihydrocodeine:
Frequency not reported: Miosis

Caffeine:
Frequency not reported: Scintillating scotoma[Ref]

Other

Dihydrocodeine:
Frequency not reported: Fatigue

Caffeine:
Frequency not reported: Tinnitus[Ref]

Renal

Dihydrocodeine:
Rare (less than 0.1%): Acute renal failure
Frequency not reported: Granulomatous interstitial nephritis

Caffeine:
Frequency not reported: Diuresis[Ref]

Some side effects of Synalgos-DC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.