Amlodipine + Valsartan Normon Tablets 5 mg + 160 mg

Composition:

Each tablet contains 5 mg amlodipine and 160 mg valsartan as active ingredients.
Other excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, Opadry II white 85F18422 (contains polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc), iron oxide yellow (E172), and iron oxide red (E172).

Indications:

Treatment of arterial hypertension in adults when blood pressure control is not achieved with amlodipine or valsartan alone.

Dosage and Administration:

• Medication must be taken exactly as prescribed by the doctor.

• Usual dose: 1 tablet once daily.

• It is preferable to take the medication at the same time each day.

• Swallow the tablet whole with a glass of water.

• Can be taken with or without food.

• Taking amlodipine-valsartan with grapefruit or grapefruit juice is contraindicated.

• Dose adjustments (increase or decrease) may be needed depending on treatment response.

• Do not exceed the prescribed dose.

• Caution is advised when increasing the dose in elderly patients.

Side Effects:

If any of the following symptoms occur, seek immediate medical attention:

• Allergic reactions (rash, itching, swelling of lips, face, or tongue, difficulty breathing, low blood pressure causing fainting or dizziness).

Other possible side effects include:

• Flu-like symptoms, nasal congestion, sore throat, swallowing discomfort

• Swelling of arms, hands, legs, ankles, or feet

• Fatigue, weakness

• Redness and rash on face or neck

• Dizziness, nausea, abdominal pain

• Dry mouth

• Drowsiness, tingling or numbness in hands and feet

• Palpitations including heart rhythm disturbances

• Dizziness upon standing

• Cough, diarrhea, constipation

• Skin rash, redness

• Joint swelling and pain, back pain

• Irritability, tinnitus (ringing in ears)

• Fainting

• Increased or uncontrolled urination

• Erectile dysfunction

• Feeling of heaviness

• Low blood pressure symptoms (dizziness, fainting)

• Excessive sweating

• Generalized rash and itching

• Muscle spasms

Contraindications:

• Allergy to amlodipine or other calcium channel blockers

• Allergy to valsartan or any other ingredients of the medication

• Liver or biliary problems such as cirrhosis or cholestasis

• Pregnancy beyond 3 months

• Low blood pressure

• Aortic valve stenosis or cardiogenic shock

• Heart failure after myocardial infarction

• Diabetes or kidney dysfunction when treated with blood pressure medication containing aliskiren

Pregnancy and Lactation:

• Contraindicated during pregnancy

• Not recommended during breastfeeding

Driving and Operating Machinery:

• Medication may cause dizziness and affect concentration.

• Avoid driving or operating machinery if unsure how the medication affects you.

Storage:

• Keep out of reach of children.

• No special storage conditions required.

• Do not use if packaging is damaged.