Aspirin, caffeine, and dihydrocodeine

Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow. Dihydrocodeine is related to codeine. It is an opioid pain medication. An opioid is sometimes called a narcotic.

Aspirin, caffeine, and dihydrocodeine is a combination medicine used to treat moderate to severe pain.

Aspirin, caffeine, and dihydrocodeine may also be used for purposes not listed in this medication guide.

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.

In the U.S.

• Synalgos-DC

Available Dosage Forms:

• Capsule

Therapeutic Class: Opioid/Salicylate, Aspirin Combination

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Aspirin

Take aspirin, caffeine, and dihydrocodeine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of aspirin, caffeine, and dihydrocodeine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

aspirin, caffeine, and dihydrocodeine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take aspirin, caffeine, and dihydrocodeine with food or a full glass of water to prevent stomach upset.

aspirin, caffeine, and dihydrocodeine is taken only when needed, so there are no special instructions for a missed dose.

Dosing

The dose of aspirin, caffeine, and dihydrocodeine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of aspirin, caffeine, and dihydrocodeine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For moderate to moderately severe pain:
    • Adults—Two capsules every 4 hours as needed.
    • Children 13 years of age and older—Use and dose must be determined by your doctor.
    • Children 12 years of age and younger—Use is not recommended.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Applies to aspirin / caffeine / dihydrocodeine: oral capsule

Along with its needed effects, aspirin / caffeine / dihydrocodeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aspirin / caffeine / dihydrocodeine:

• Lightheadedness

Get emergency help immediately if any of the following symptoms of overdose occur while taking aspirin / caffeine / dihydrocodeine:

• Confusion
• difficult or troubled breathing
• extreme sleepiness
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin

Some side effects of aspirin / caffeine / dihydrocodeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• dizziness
• drowsiness
• itching skin
• nausea
• relaxed and calm
• sleepiness
• vomiting

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 aspirin / caffeine / dihydrocodeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use with caution

Animal reproduction studies have not been conducted. Dihydrocodeine use in pregnant women may lead to neonatal abstinence syndrome. There are no controlled data on this combination product in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is not recommended US FDA pregnancy category: Not assigned Comment: -Aspirin should be avoided after 30 weeks gestation as it may lead to premature closure of the fetal ductus arteriosus. -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.