50 mg / 12.5 mg and 100 mg / 25 mg film-coated tablet
Losartan potassium / hydrochlorothiazide
What Marozid is and what it is used for
Marozide is a combination of an angiotensin II receptor antagonist ( losartan ) and a diuretic ( hydrochlorothiazide ). Angiotensin -II is a substance that is produced in the body and that binds to receptors in the blood vessels and causes them to contract. This increases blood pressure. Losartan prevents the binding of angiotensin -II to these receptors, which causes the blood vessels to dilate, which in turn leads to lowered blood pressure.
Hydrochlorothiazide works by helping the kidneys get rid of more water and salt, which also lowers blood pressure.
Microzide 50 mg / 12.5 mg is used to treat high blood pressure in patients who have otherwise been treated with losartan potassium and hydrochlorothiazide given as separate medicines.
Marozid 100 mg / 25 mg is used to treat high blood pressure in patients who do not respond satisfactorily to Marozid 50 mg / 12.5 mg.
Losartan potassium/hydrochlorothiazide contained in Marozid may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Marozid
Do not use Marozid
– if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
– if you are allergic to other derivatives of sulfonamides (ie another thiazide, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are unsure)
– if you have low potassium, low sodium, or high calcium levels which can not be corrected by treatment
– pregnant women should not use Marozid during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Marozid – see the section Pregnancy and breastfeeding).
– if you have severe hepatic impairment
– if you have severe renal impairment or if your kidneys do not produce any urine.
– if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
Warnings and cautions
Talk to your doctor or pharmacist before taking Marozid.
You must tell your doctor if you think you are (or might become) pregnant. Marozide should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see section Pregnancy and breastfeeding.
You must talk to your doctor before taking Marozid:
• if you have previously experienced swelling of the face, lips, neck, or tongue
• if you are taking diuretics ( diuretic tablets)
• if you eat a low-salt diet
• if you have or have had severe vomiting and/or diarrhea
• if you have heart failure
• if you have impaired liver function (see section 2 “Do not use Marozid”)
• if you have narrow blood vessels to the kidneys (renal artery stenosis) or if you have only one functioning kidney or if you have recently undergone a kidney transplant
• if you have narrowing of the arteries are (atherosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have “aortic or mitral valve stenosis” (narrowing of the heart valves) or “hypertrophic cardiomyopathy” (a disease that causes thickening of the heart muscle)
• if you have diabetes
• if you have had gout
• if you have or have had allergies, asthma, or a disease that causes joint pain, rash, or fever (systemic lupus erythematosus)
• if you have high calcium or potassium levels or if you are on a low potassium diet
• if you need to be given anesthetics (also at the dentist) or if you are going to have surgery, or if you are going to have your thyroid function checked, you must tell your doctor or healthcare professional that you are taking Marozid.
• if you suffer from primary hyperaldosteronism (a syndrome with increased secretion of the hormone et alaldosterone from the adrenal glands, caused by a disorder of the adrenal glands).
• if you are taking any of the following medicines used to treat high blood pressure:
o an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
o aliskiren
• if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Marozid.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not use Marozid”.
Talk to your doctor, pharmacist, or nurse before taking Marozid
- if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Marozid. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.
Children and young people
Losartan potassium/hydrochlorothiazide should not be given to children and adolescents.
Other medicines and Marozid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Diuretics such as hydrochlorothiazide in Marozid may interact with other medicines.
Medicines containing lithium should not be taken at the same time as Marozid without the close supervision of a doctor.
Some preventative measures (ie blood tests) may be needed if you are taking potassium supplements, salt substitutes containing potassium or potassium-sparing agents, other diuretics ( diuretic tablets), certain laxatives, medicines to treat gout, medicines to control the heart rhythm, or for diabetes (oral medicines or insulin ). It is also important that you tell your doctor if you are taking other antihypertensive drugs, steroids, anticancer medicines, painkillers, antifungal medicines, or arthritis medicines, resins used for high cholesterol such as cholestyramine, medicines that relax your muscles, sleeping pills, opioid medicines such as morphine, pressor amines such as adrenaline or other medicines from the same group, oral diabetes medicines or insulin.
Also, tell your doctor that you are taking Marozid if you will have an X-ray and will be given iodine contrast agents.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not use Marozid” and “Warnings and precautions”).
Marozide with food, drink and alcohol
You should not drink alcohol while taking this medicine: alcohol and Marozid may increase the effect of each other.
Too much salt in the diet can counteract the effects of Marozid.
Marozide can be taken with or without food.
Pregnancy, breastfeeding and fertility
Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Marozid before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Marozide should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Marozid is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby.
Use in elderly patients
Marozide works just as well and is equally well tolerated by most older and younger adult patients. Most elderly patients need the same dose as younger patients.
Driving and using machines
When starting treatment with this medicine, do not perform any tasks that may require special attention (such as driving or using dangerous machines) until you know how to tolerate the medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Marozide contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Marozid
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. It is important to continue taking Marozid for as long as your doctor prescribes it to maintain even control of your blood pressure.
Adults
Marozide 50 mg / 12.5 mg:
Hypertension
The usual dose is one tablet once a day. In some cases, your doctor may increase the dose to one to a maximum of two tablets once a day.
Marozide 100 mg / 25 mg:
High blood pressure
The usual dose is one tablet once a day.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop treatment with Marozid and contact a doctor or emergency department at the nearest hospital immediately.
• Severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat which may cause difficulty swallowing or difficulty breathing)
This is a serious but rare side effect that more than 1 in 10,000 users but less than 1 in 1000 users may get. You may need emergency medication or hospitalization.
The following side effects have been reported:
Common (may affect up to 1 in 10 users)
• cough, infection of the upper airways, nasal congestion, sinusitis, sinus problems
• Diarrhea, abdominal pain, nausea, indigestion
• Muscle pain or cramps, leg pain, back pain
• Insomnia, headache, dizziness
Weakness, fatigue, chest pain
• Increased potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels
Uncommon (may affect up to 1 in 100 people)
• Anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising, reduction in white blood cells, clotting, decreased number of blood platelets
• Loss of appetite, increased amount of uric acid or gout, increased blood sugar, abnormal levels in the blood salt balance
• Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, impaired memory
• Tingling and burning sensation or similar sensations, pain in arms and legs, tremors, migraines, fainting
• Blurred vision, burning or stinging sensation in the eyes, conjunctivitis, impaired vision, seeing things in yellow
• Ringing, roaring, screaming, or clicking sounds in the ears
• Low blood pressure which may be associated with altered body position (feeling of dizziness or weakness when you get up), chest pain, abnormal heart rhythm, cerebrovascular event ( TIA, “mini-stroke”), heart attack, palpitations
• Inflammation of the blood vessels that often arises in connection with a rash or bruising
Sore throat, shortness of breath, inflammation of the trachea, pneumonia, water in the lungs (which causes difficulty breathing), nosebleeds, runny nose, nasal congestion
• Constipation, gas, upset stomach, stomach cramps, vomiting, dry mouth, salivary gland inflammation, toothache
Jaundice (yellowing of the skin and eyes), inflammation of the pancreas
• Hives, itching, dermatitis, rash, redness of the skin, photosensitivity, dry skin, redness, sweating, hair loss
• Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
• Often urinates even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine
• Decreased sexual desire, impotence
• Swelling of the face, local swelling ( edema ), fever
Rare (may affect up to 1 in 1,000 people)
• Hepatitis ( inflammation of the liver), abnormal liver function tests
Has been reported (occurs in an unknown number of users)
• Flu-like symptoms
• Unexplained muscle aches with dark (tea-colored) urine ( rhabdomyolysis )
• Low levels of sodium in the blood ( hyponatremia )
• General feeling of illness
• Skin and lip cancer (Non- melanoma skin cancer)
• Decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the vascular layer (choroidal effusion) or acute narrow-angle glaucoma )
How to store Marozid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substances are losartan potassium and hydrochlorothiazide.
Marozide 50 mg / 12.5 mg: Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide .
Marozide 100 mg / 25 mg: Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide .
– The other ingredients are:
– Tablet core: Microcrystalline cellulose (E460a), lactose monohydrate, pregelatinized starch (maize), and magnesium stearate (E572).
– Film coating: Hydroxypropylcellulose, hypromellose, titanium dioxide (E171), and yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Marozide 50 mg / 12.5 mg:
Marozid 50 mg / 12.5 mg are round, yellow film-coated tablets.
The tablets are available in pack sizes of 7, 28, 50, 56, 50×1 (single dose), 98 and 100 (hospital pack) film-coated tablets.
Marozide 100 mg / 25 mg:
Marozid 100 mg / 25 mg are round, yellow film-coated tablets.
The tablets are available in pack sizes of 7, 28, 30, 50, 56, 90, 98 and 100 (hospital pack) and 280 (hospital pack) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
SE-182 12 Danderyd
Manufacturer
LICONSA LABORATORIES, SA
Of. Miralcampo, No 7, Poigono industrial Miralcampo
19200 Azuqueca de Henares (guadalajara)
Spain
This medicinal product is authorized under the European Economic Area under the names:
50 mg / 12.5 mg
Austria: Losartan potassium Hydrochlorothiazide Liconsa 50 / 12.5 mg Film tablet
Belgium: Co- Losartan Apotex 50 / 12.5 mg compressed pill / Film tablet / film-coated tablet
Denmark: Losartan / Hydrochlorothiazide Medical Valley
Hungary: Prelow Plus 50/12., 5 mg Film Tablet
Ireland: Lotanos Comp 50 mg / 12.5 mg film-coated tablet
Italy: Losartan and Idroclorothiazide Germed 50 / 12.5 mg compressed with film
Luxembourg: Co- Losartan Apotex 50 / 12.5 mg compressed pill
100 mg / 25 mg
Austria: Losartan potassium Hydrochlorothiazide Liconsa 100/25 mg Film tablet
Belgium: Co- Losartan Apotex 100/25 mg compressed pill / Film tablet / film-coated tablet
Denmark: Losartan / Hydrochlorothiazide Medical Valley
Hungary: Prelow Plus 100/25 mg Film Tablet
Ireland: Lotanos Comp 100 mg / 25 mg film-coated tablet
Italy: Losartan and Idroclorothiazide Germed 100/25 mg compressed with film
Luxembourg: Co- Losartan Apotex 100/25 mg compressed pill
Sweden: Marozid 100 mg / 25 mg Film-coated tablet