1.         WHAT CYPLOSART PLUS IS AND WHAT IS USED FOR

Cyplosart Plus is a combination of an angiotensin II receptor antagonist (Losartan) and a diuretic (hydrochlorothiazide).

Cyplosart Plus is indicated for the treatment of essential hypertension (high blood pressure).

 

2.         BEFORE YOU TAKE CYPLOSART PLUS

Do not take Cyplosart Plus

• If you are allergic (hypersensitive) to Losartan, hydrochlorothiazide or to any of the other ingredients in this medicine.
• If you are allergic (hypersensitive) to other sulfonamide – derived substances (e.g. other thiazides, some antibacterial drugs such as co – trimoxazole, ask your doctor if you are not sure).
• If you are, think you may be or are planning to become pregnant (see also ‘’Pregnancy and breast – feeding’’).
• If you are breast – feeding.
• If you have severely impaired liver function.
• If you have severely impaired kidney function or your kidneys are not producing any urine.
• If you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment.
• If you are suffering from gout.

 

Take special care with Cyplosart Plus

• If you have previously suffered from swelling of the face, lips, throat or tongue.
• If you take diuretics (water pills).
• If you are on a salt – restricted diet.
• If you have or have had severe vomiting and/or diarrhea.
• If you have heart failure.
• If you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant.
• If you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function).
• If you have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle).
• If you are diabetic.
• If you have had gout.
• If you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus).
• If you have high calcium or low potassium levels or you are in a low potassium diet.
• If you need to have an anesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking Losartan potassium and Hydrochlorothiazide tablets.
• If you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland).

Taking other medicine:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Diuretic agents such as the hydrochlorothiazide contained in Cyplosart Plus may interact with other medicines.

Preparations containing lithium should not be taken with Cyplosart Plus without close supervision by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or diabetes (oral agents or insulins).

It is also important for your doctor to know if you are taking

• other medicines to reduce your blood pressure,
• steroids,
• medicines to treat cancer,
• pain killers,
• drugs for treatment of fungal infections,
• arthritis medicines,
• resin used for high cholesterol, such as colestryramine,
• medicines which relax your muscles,
• sleeping tablets,
• opioid medicines such as morphine,
• ‘pressor amines’ such as adrenaline or other drugs from the same group.

Please also inform your doctor you are taking Cyplosart Plus if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Taking Cyplosart Plus with food and drink

You are advised not to drink alcohol while taking these tablets: alcohol and Cyplosart Plus tablets may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Cyplosart Plus tablets.

Cyplosart Plus tablets may be taken with or without food.

Pregnancy and breast – feeding

You should not take Cyplosart Plus in the first 12 weeks of pregnancy, and you must not take them at all after the 13^th week as their use during pregnancy may possibly be harmful to the baby.

If you become pregnant while on Cyplosart Plus, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

You must not take Cyplosart Plus if you are breast – feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

There is no experience with the use of Cyplosart Plus in children. Therefore, Cyplosart Plus should not be given to children.

Use in elderly patients

Cyplosart Plus works equally well in and is equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients.

Driving and using machines

When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.

Important information about some of the ingredients of Cyplosart Plus

Cyplosart Plus contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

 

3. HOW TO TAKE CYPLOSART PLUS

Always take Cyplosart Plus exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Cyplosart Plus depending on your condition and whether you are taking other medicines. It is important to continue taking Cyplosart Plus for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High Blood Pressure

The usual dose of Cyplosart Plus for most patients with high blood pressure is 1 tablet of Cyplosart Plus 50mg/12.5mg per day to control blood pressure over the 24- hour period. This can be increased to 2 tablets once daily of Losartan/Hydrochlorothiazide 50mg/12.5mg Film – Coated Tablets or changed to 1 tablet daily of Losartan/Hydrochlorothiazide 100mg/25mg Film – Coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan/Hydrochlorothiazide 50mg/12.5mg Film – Coated Tablets or 1 tablet daily of Losartan/Hydrochlorothiazide 100mg/25mg Film – Coated Tablets

If you take more Cyplosart Plus than you should

In case of overdose, contact your doctor immediately so that medical attention may be given promptly. Overdosage can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition and dehydration.

If you forget to take Cyplosart Plus

Try to take Cyplosart Plus daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your unusual schedule.

If you stop taking Cyplosart Plus:

The treatment must only be changed or stopped in consultation with your doctor.

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cyplosart Plus tablets can cause side effects, although not everybody gets them.

If you experience the following, stop taking Cyplosart Plus tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 out of 10.000 patients but fewer than 1 out of 1.000 patients. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Common (affecting less than one person in 10 but more than one person in 100)

• Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder ,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, tiredness, chest pain,
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (affecting less than one person in 100 but more than one person in 1.000):

• Anemia, red or brownish spots on the skin (sometimes specially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems and bruising,
• Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorder (recurring panic attacks), confusion depression, abnormal dreams, sleep disorders, sleepiness, memory impairment,
• Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting,
• Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow,
• Ringing, buzzing, roaring or clicking in the ears,
• Low blood pressure, which may be associated with changes in posture (feeling light – headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular  accident (TIA, “mini – stroke”), heart attack, palpitations,
• Inflammation of blood vessels, which is often associated with a skin rash or bruising,
• Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Swelling of the face, fever.

Rare (more than 1 out of 10.000 and less than 1 out of 1.000 patients)

• Hepatitis (inflammation of the liver) abnormal liver function tests

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

 

5.         HOW TO STORE CYPLOSART PLUS

Keep out of the reach and sight of children

Expiry date:

Do not use Cyplosart Plus after the expiry date stated on the inner and outer packaging.

Storage Conditions:

Store below 30°C protected from light and moisture.

 

6.         FURTHER INFORMATION

What Cyplosart Plus contains:

• The active substances are Losartan potassium and Hydrochlorothiazide
• The other ingredients are Microcrystalline Cellulose, Lactose, Pregelatinised Starch, Sodium Starch Glycolate, Magnesium Stearate, Hydroxypropylcellulose, Hypromellose, Titanium Dioxide.

How Cyplosart Plus Tablets look like:

• Cyplosart Plus 50/12.5: White, oblong, tablets with break-line on both sides.
• Cyplosart Plus 100/25:  White, oblong, tablets with break -line on both sides.

Pack sizes:

Cyplosart Plus 50/12.5, Cyplosart Plus 100/25 Tablets: These products are available in boxes of 10, 20, 30, 60 and 90 tablets packed in 1, 2, 3, 6 or 9 blisters each containing 10 tablets or in boxes of 7, 14, 28, 56, 98 or 112 tablets packed in 1, 2, 4, 8, 14 or 16 blisters each containing 7 tablets.

Not all pack sizes may be marketed.

For any other information regarding this pharmaceutical product, contact the Marketing License Holder.

Marketing Authorisation Holder:

Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.