Product Description

Drug Name
Sominex

Drug Uses
Sominex tablets contain the active ingredient promethazine, which is a type of medicine called a sedating antihistamine.

Promethazine enters the brain in significant quantities and causes drowsiness. It decreases the time taken to fall asleep and increases the depth of sleep. This makes it helpful for the temporary relief of sleeping difficulties, for example if you have difficulty going to sleep or staying asleep because of disturbances to your normal routine.

One tablet should be taken at bedtime or up to an hour after going to bed if you are having difficulty falling asleep.

How Taken
Adults and Children 12 Years of Age and Over: Take 1 caplet at bedtime if needed, or as directed by a doctor. For best results, take recommended dose. This will provide approximately six to eight hours of restful sleep.

Drug Class and Mechanism
Active Ingredient (each Caplet Contains): Diphenhydramine HCI (50 mg). Inactive Ingredients: Carnauba Wax, Crospovidone, Dibasic Calcium Phosphate, FD&C Blue No. 1 Aluminum Lake, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Silicon Dioxide, Starch, Titanium Dioxide.

Missed Dose

• Children under 16 years of age.
• Reduced awareness, slow reactions or extreme drowsiness due to medicines or illness that reduce activity in the central nervous system (CNS depression).
• Comatose states.
• People who have taken a type of medicine called a monoamine oxidase inhibitor (MAOI) in the past 14 days.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Sominex tablets contain lactose).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Safety Information

Warnings/Precautions
Do not give to children under 12 years of age. If sleeplessness persists continuously for more than two weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination or nursing a baby, seek the advice of a health professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Store at room temperature. Avoid excessive heat (greater than 100 degrees F) or humidity.

Side Effects

Possible Side Effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Drowsiness.
• Dizziness.
• Restlessness.
• Headache.
• Nightmares.
• Tiredness.
• Blurred vision.
• Difficulty passing urine (urinary retention).
• Dry mouth.
• Confusion.
• Rash or itching.
• Loss of appetite.
• Awareness of your heartbeat (palpitations).
• Low blood pressure (hypotension).
• Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
• Blood disorders.
• Increased sensitivity of the skin to sunlight (photosensitivity). If affected you should avoid sun lamps and direct sunlight while you are taking this medicine.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist

More Information
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• If you are pregnant you should not take this medicine without consulting your doctor first. This medicine should only be used during pregnancy if the expected benefit to the mother outweighs any potential risks to the developing baby. It should not be used during the last two weeks of a pregnancy, because if taken during this time it may cause irritability or excitement in the baby after birth. Seek further medical advice from your doctor.
• Small amounts of this medicine may pass into breast milk. This is not expected to be harmful to a nursing infant, but there is a risk that it may cause irritability or excitement in a newborn baby. If you are breastfeeding you should not take this medicine without seeking medical advice from your doctor first.