Damlovan 5 mg/160 mg/10 mg Film-Coated Tablets

You have been prescribed DAMLOVAN because:

DAMLOVAN tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure. Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. Valsartan belongs to a group of substances called “angiotensin - II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered. DAMLOVAN is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled with a single blood pressure lowering medicines either amlodipine or valsartan.

Do not take DAMLOVAN:

• If you have a history of allergies related to taking this type of medicine.
• If you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors).
• If you have recurrent episodes of severe swelling without a known cause.
• If your doctor has diagnosed that you are suffering from a narrowing of valves in your heart (called aortic or mitral stenosis), or abnormally increased thickness of your heart muscle with narrowing (called obstructive hypertrophic cardiomyopathy).
• If you have received a kidney transplant or if you had been diagnosed to suffer from a narrowing of your kidney artery or if you are suffering from severe kidney problems.
• If you are taking other medicine or substances, which increase the potassium levels in your blood (such as certain types of diuretics, potassium supplements, etc.)
• If you are taking medicines that contain lithium (a medicine used to treat some type of depression).
• If you have porphyria.
• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• If you have severe liver impairment.
• If you have severe low blood pressure (hypotension).
• If you have cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
• If you suffer from heart failure after a heart attack.
• If you are pregnant or breastfeeding.

If any of these apply to you, tell your doctor without taking DAMLOVAN.

Warnings and precautions

Take special care with DAMLOVAN:

• If you are suffering from several episodes of vomiting or diarrhoea.
• If you suffer from liver or severe kidney problems.
• If you have a condition affecting the renal glands called “primary hyperaldosteronism”.
• If you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors). If you get these symptoms, stop taking DAMLOVAN and contact your doctor straight away. You should never take DAMLOVAN again.
• If you have had heart failure or have experienced a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function.
• Contact your doctor to re-evaluate your treatment if you are treated with ACE Inhibitors/Angiotensin receptor blockers together with a fluoroquinolone antibiotic. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Children and adolescents

The use of DAMLOVAN in children and adolescents is not recommended (aged below 18 years old).

Do not share medicines prescribed for you with any other person. Always take DAMLOVAN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

• The usual dose of DAMLOVAN is one tablet per day.
• It is preferable to take your medicine at the same time each day.
• Swallow the tablets with a glass of water.
• You can take DAMLOVAN with or without food.
• Do not take DAMLOVAN with grapefruit or grapefruit juice.
• Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
• Do not exceed the prescribed dose.

DAMLOVAN and older people (age 65 years or over): Your doctor should exercise caution when increasing your dose.

If you take more DAMLOVAN than you should

If you have accidentally taken too many tablets of DAMLOVAN, consult your doctor immediately. If doctor is not available, contact the nearest hospital or poison centre. Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24 - 48 hours after intake.

If you forget to take DAMLOVAN

It is advisable to take your medicine at the same time each day, preferably in the morning. If you forget to take DAMLOVAN, take it as soon as you remember and then take your next dose at its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for the forgotten tablet.

If you stop taking DAMLOVAN

Stopping your treatment with DAMLOVAN may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.

DAMLOVAN can have side effects. Not all side effects reported for DAMLOVAN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DAMLOVAN, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following symptoms occur, stop taking DAMLOVAN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DAMLOVAN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sudden wheeziness, chest pain, shortness of breath or difficulty in breathing
• severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens - Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions
• inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell
• heart attack, abnormal heartbeat
• upper airway swelling.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent: Flu-like symptoms; nasal congestion;
• Sore throat and discomfort when swallowing;
• Low potassium levels in the body;
• Headache;
• Asthenia (weakness);
• Dizziness;
• Stomach pain;
• Feeling sick (nausea);
• Tiredness;
• Facial swelling;
• Redness and warm feeling of the face and/or the neck;
• Swelling in the body caused by excess fluid. It often affects the lower body, such as the legs, feet, and ankle but it can occur anywhere.

Less Frequent: Anorexia, loss of appetite; High Calcium levels in the body; High uric acid levels in the body; High lipid levels in the body; Low levels of sodium in the blood; Anxiety (feeling anxious); Abnormal coordination; Paraesthesia (Tingling or prickling sensation); Somnolence (sleepiness, feeling of drowsiness); Vision disturbance and impairment; Tinnitus (ringing in the ears);

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store at or below 25 °C (room temperature). Do not remove blisters from the original carton until required for use. Keep HDPE containers tightly closed. Keep all medicines out of the reach and sight of children.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).