“You can’t beat a healthy heart.”
High Blood Pressure Medication
SCHEDULING STATUS S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ZARTAN CO 50/12,5 film-coated tablets
ZARTAN CO 100/25 film-coated tablets
Please read this patient information leaflet carefully before using ZARTAN CO 50/12,5 or 100/25
- Keep this information. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- ZARTAN CO has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
WHAT ZARTAN CO CONTAINS
Each ZARTAN CO 50/12,5 film-coated tablet contains 50 mg losartan potassium and 12,5 mg hydrochlorothiazide.
Each ZARTAN CO 100/25 film-coated tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
Microcrystalline cellulose, pregelatinised maize starch, lactose monohydrate, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide, yellow iron oxide and purified water.
WHAT ZARTAN CO IS USED FOR
ZARTAN CO is used in the treatment of a condition called hypertension or high blood pressure.
BEFORE YOU TAKE ZARTAN CO
Do not use ZARTAN CO:
- If you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other components of ZARTAN CO (see “WHAT ZARTAN CO CONTAINS”).
- If you have a history of angioedema (severe swelling of the skin tissue under the surface layer of the skin) with medicines of the angiotensin-converting enzyme inhibitor or angiotensin receptor blocker group, you must never again be given these medicines.
- If you are unable to pass or produce urine.
- If you are allergic to other sulphonamides (sulfa medicines)
- If you have a severe kidney disorder.
- If you have a severe liver disorder.
- If you have a family history of, or have, a condition where severe swelling of the skin tissue under the surface layer occurs.
- If you are taking medicines used to increase urine production which causes an increase of potassium levels in your blood (such as spironolactone, triamterene or amiloride).
- If you have a condition called porphyria.
- If you have Addison’s disease, characterised by low blood pressure, weight loss, weakness and bronze-like spots on the skin.
- If you are receiving therapy with lithium (medicine to treat depression).
- If you are pregnant or breastfeeding.
Do not use in children as safety has not been established.
Take special care with ZARTAN CO:
- If you have a fluid or electrolyte imbalance due to excessive fluid loss, vomiting or diarrhoea.
- If you are taking medicine to treat high blood sugar (diabetes).
- If you have a lung disorder or asthma.
- If you have gout (a painful condition where uric acid builds up in the joints).
- If you have a condition called lupus (systemic lupus erythematosus).
- If you have a liver or kidney disorder.
- If you suffer from high cholesterol.
Take special care after taking the first dose of ZARTAN CO as you may feel dizzy or light-headed.
Please use adequate contraception to prevent pregnancy while using ZARTAN CO.
If you become pregnant while taking ZARTAN CO please consult your doctor immediately to change your medication.
Pregnancy and breastfeeding:
Do not use ZARTAN CO if you are pregnant, planning to become pregnant or breastfeeding. Please consult your doctor.
Driving and using machines:
ZARTAN CO may cause dizziness. Please take care before driving or using machinery until you know how ZARTAN CO affects you.
Important information about other ingredients of ZARTAN CO:
ZARTAN CO contains lactose (milk sugar). If you were born with an intolerance for lactose or other sugars (such as galactose or glucose), you should not take this medicine before consulting your doctor.
Using other medicines with ZARTAN CO:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ZARTAN CO with these medicines may cause undesirable interactions.
Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. Please consult your doctor, pharmacist or other healthcare professional for advice.
The following medications, may also interact with ZARTAN CO:
- Other medicine to reduce blood pressure
- Non-steroidal anti-inflammatory medicines (such as ibuprofen, indomethacin or aspirin), as these may reduce the blood pressure lowering effect of ZARTAN CO.
- Painkillers may increase the blood pressure lowering effect of ZARTAN CO.
- Certain other diuretics (water tablets)
- Fluconazole (medicine to treat fungal infections)
- Alcohol or barbiturates (medicines such as phenobarbitone)
- Anti-diabetic medicines and insulin
- Cholestyramine and colestipol (medicine to reduce cholesterol)
- Lithium (medicine for certain types of depression)
HOW TO TAKE ZARTAN CO
Take ZARTAN CO every day at the same time, exactly as your doctor has instructed.
It is important to continue taking ZARTAN CO for as long as your doctor prescribes it in order to control your blood pressure.
The recommended dose is one ZARTAN CO 50/12,5 tablet per day to control blood pressure over the 24-hour period. It can be taken with or without food
The dose can be increased by your doctor.
In the event of an overdosage
In the event of an overdosage, contact your doctor or pharmacist immediately. If neither is available, contact the nearest hospital or poison centre as soon as possible.
If you forget to use your ZARTAN CO
Take the missed dose as soon as possible. However, if it is almost time for you next dose, continue to take the next tablet at the usual time. Do not take a double dose.
POSSIBLE SIDE EFFECTS
ZARTAN CO may have side effects.
Not all side effects reported for ZARTAN CO are included in this leaflet.
Should your general health worsen while taking this medicine, please consult your doctor for advice.
Check with your doctor immediately if you should experience any of the following side-effects:
- Symptoms of fluid and electrolyte imbalance such as dry mouth, increased thirst or unusual tiredness.
- Inflammation of the pancreas
- Dizziness, sleep disturbances, restlessness, weakness
- Hypotension (low blood pressure)
- Oedema (swelling)
- Cough, sinus problems, throat and lung infections or chest pain
- Abdominal pain, taste disturbances
- Anaphylactic reactions (severe allergy with symptoms such as large hive-like swelling on the face, eyelids or lips).
- Lower back pain
- Blood disorders such as leucopenia (low number of white blood cells)
- Difficulty to urinate
- Anorexia, hyperuricaemia (excess of uric acid in the blood)
- Muscle spasms
- Yellow eyes and skin
Other side-effects may include:
- Leg pain
- Stomach pain
- Taste disturbances
- Skin rashes, hives, sensitivity to the sun or sun beds
STORAGE AND DISPOSAL OF ZARTAN CO
- Store at or below 25 °C.
- Protect from light and moisture.
- Do not remove from the outer carton until required for use.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
- Please return expired medicine or partially used vials to your pharmacist for safe disposal.
PRESENTATION OF ZARTAN CO
ZARTAN CO 50/12,5 is packed into silver aluminium/ clear transparent PVC/PE/PVDC blisters.
ZARTAN CO 100/25 is packed into silver aluminium/ clear transparent PVC/PE/PVDC blisters.
IDENTIFICATION OF ZARTAN CO
ZARTAN CO 50/12,5: Round, yellow film-coated tablets with a diameter of 7,5 mm.
ZARTAN CO 100/25: Round, yellow film-coated tablets with a diameter of 10,5 mm.
ZARTAN CO 50/12,5: RSA S3 42/7.1.3/1068 NAM NS2 12/7.1.3/0070
ZARTAN CO 100/25: RSA S3 42/7.1.3/1069 NAM NS2 12/7.1.3/0071
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Cape Town, South Africa
DATE OF PUBLICATION
05 August 2011