Description

Sudafed is a medicinal product for use in the treatment of swelling and congestion of the nasal mucosa, nasal obstruction, and paranasal sinuses. It is indicated for the symptomatic treatment of runny nose and nasal congestion.

Composition of Sudafed 60 mg

The active substance is: pseudoephedrine ( Pseudoephedrini hydrochloridum ).

1 film-coated tablet contains 60 mg of pseudoephedrine hydrochloride.

Excipients: lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal silica, magnesium stearate; Opadry OY-S-9473 coating composition: red iron oxide, hypromellose, talc, macrogol 400.

Sudafed 60 mg dosage

Always use this medicine exactly as described in this leaflet or as advised by your doctor or pharmacist.

• A drug for oral use.

Adolescents over 12 years of age and adults: 1 tablet, usually 3-4 times daily. In adolescents, use should be limited to 4 days.

Elderly: The dosing regimen remains unchanged and is the same as for adults. Liver and kidney function should be taken into account.

Hepatic and renal impairment: caution should be exercised when dosing this drug in people with the disorders mentioned above.

Sudafed 60 mg film-coated tablets

Sudafed contains pseudoephedrine hydrochloride, which reduces congestion in the upper respiratory tract, particularly the nasal mucosa and paranasal sinuses. This reduces secretions and swelling and clears nasal congestion. Pseudoephedrine affects blood vessels, causing vasoconstriction.

Indications

Symptomatic treatment of rhinitis and paranasal sinusitis (runny nose, blocked nose) in the course of:

• colds,
• flu,
• allergic rhinitis.

Contraindications

When not to use Sudafed:

• if you are allergic to the active substance - pseudoephedrine or any of the other ingredients of this medicine,
• if you have severe coronary heart disease or severe hypertension,
• if you are taking or have taken MAO inhibitors (drugs used to treat depression) in the last 14 days,
• if you are taking furazolidone.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (affects 1 to 10 people in 100):

• nervousness, insomnia,
• dizziness,
• nausea,
• dry mouth.

Very rare side effects (affecting less than 1 in 10,000 people):

• heart rhythm disturbances, increased heart rate, palpitations,
• rash, pustular lesions, itching, which may be accompanied by erythema, fever,
• increase in blood pressure,
• headache, increased psychomotor activity, drowsiness,
• euphoria, anxiety,
• vomiting,
• painful urination, urinary retention.

Warnings and precautions

• Discuss the use of this medicine with your doctor if you have: hypertension, heart disease, diabetes, hyperthyroidism, increased intraocular pressure, prostatic hyperplasia, impaired liver and/or kidney function.
• If symptoms worsen or do not improve after 3 days of using the medicine, consult your doctor.
• Avoid combining pseudoephedrine with alcohol.
• The medicine contains lactose - discuss the use of the medicine with your doctor if you have an intolerance to some sugars.
• The medicine should be stored at a temperature below 30 ^o C, protected from moisture.
• Keep the medicine out of the sight and reach of children.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Sudafed may interact with:

• MAO inhibitors, furazolidone (see "Contraindications"),
• tricyclic antidepressants,
• drugs that reduce congestion of the mucous membrane,
• appetite suppressants,
• psychotropic drugs with effects similar to amphetamines,
• drugs that lower blood pressure, such as methyldopa,
• drugs blocking alpha- and beta-adrenergic receptors.

Taking the medicine with food and drink

Sudafed should not be combined with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medicine.

Use of the drug in children and adolescents

Do not use in children under 12 years of age.