Losarstad Comp 50 mg / 12.5 mg and 100 mg / 12.5 mg and 100 mg / 25 mg film-coated tablets
losartan potassium / hydrochlorothiazide
what Is Losarstad Comp And What Losarstad Comp Used For
Losarstad Comp is a combination of an angiotensin II receptor antagonist ( losartan ) and a diuretic ( hydrochlorothiazide ). Angiotensin II is a body-specific substance that binds to receptors in blood vessels and causes them to constrict. This causes blood pressure to rise. Losartan prevents the binding of angiotensin II to these receptors, which causes the blood vessels to dilate and the blood pressure to drop. Hydrochlorothiazide helps the kidneys get rid of more water and salt, which also lowers blood pressure.
Losarstad Comp is used to treat essential hypertension (high blood pressure).
Losartan/hydrochlorothiazide contained in Losarstad Comp may also be authorized for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What You Need To Know Before Using Losarstad Comp
Do Not Take Losarstad Comp
- 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 sulfonamide derivatives (eg other thiazides , certain antibacterial drugs such as the combination trimethoprim and sulfamethoxazole, ask your doctor if you are unsure)
- If you have severe hepatic impairment
- If you have low potassium or sodium levels or high calcium levels in your blood that cannot be corrected by treatment
- If you have gout
- During the last 6 months of pregnancy. (Even earlier during pregnancy, it is good to avoid Losarstad Comp, see the section on Pregnancy)
- 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 Losarstad Comp. If you think you may be pregnant or become pregnant during treatment, consult your doctor. Losarstad Comp is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see Pregnancy).
Tell your doctor before starting treatment with Losarstad Comp:
- If you have previously experienced swelling of the face, lips, throat or tongue ( angioedema )
- If you are using diuretics ( diuretics )
- If you follow a low-salt diet
- If you have or have been ill with severe vomiting and / or diarrhea
- If you have heart failure
- If you have impaired liver function (see section 2. Do not take Losarstad Comp)
- If you have a narrowing of the blood vessels leading to your kidneys (renal artery stenosis) or just have a functioning kidney, or if you have recently had a kidney transplant
- If you have narrowing of your arteries (arterosclerosis), angina pectoris (chest pain due to impaired heart function)
- If you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that enlarges the heart muscle)
- If you have diabetes
- If you have had gout
- If you have or have had an allergic condition, asthma or a condition that causes joint pain, rash and fever ( SLE , systemic lupus erythematosus)
- If you have high calcium or low potassium levels or if you follow a low potassium diet
- If you are going to undergo anesthesia (even at the dentist) or before a surgical procedure, or are going to undergo a test for your parathyroid function. You should then tell your doctor or medical staff that you are taking losartan and hydrochlorothiazide tablets
- If you suffer from primary hyperaldosteronism (a syndrome in which your adrenal glands produce too much of the hormone et aldosterone , caused by a disorder of the adrenal gland)
- If you are taking any of the following medicines used to treat high blood pressure:
- An ACE inhibitor (eg enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- 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 Losarstad Comp.
- If you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Losarstad Comp. 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.
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 take Losarstad Comp”.
Children And Young People
There is no experience in the treatment of Losarstad Comp in children. Losarstad Comp should therefore not be given to children.
Use in elderly patients
Losarstad Comp has an equivalent effect and is tolerated just as well in older as in younger adult patients. Most elderly patients need the same dose as younger patients.
Other Medicines And Losarstad Comp
- Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Diuretic drugs such as hydrochlorothiazide in Losarstad Comp may interact with other drugs.
- Medicines containing lithium should not be taken with Losarstad Comp without close supervision by your doctor.
- Special precautions (eg blood tests) may be needed if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics ( diuretics ), certain laxatives, medicines to treat gout, medicines to control your heart rhythm, or to treat diabetes. (for oral use or insulin ).
- It is also important for your doctor to know if you are taking:
- Other antihypertensive drugs
- Steroid is
- Anti-cancer drugs
- Painkiller
- Medicines for fungal infections
- Drugs for arthritis
- Resins against elevated cholesterol such as cholestyramine
- Muscle relaxants
- Sleeping pills
- Opioid drugs such as morphine
- Pressoramines such as adrenaline or other drugs within the same drug group
- Oral diabetes drugs or insulin
- 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 take Losarstad Comp” and “Warnings and precautions”).
- Also, tell your doctor that you are taking Losarstad Comp before a planned examination with an iodinated contrast medium.
Losarstad Comp With Food, Drinks And Alcohol
- Alcohol should be avoided while you are taking these tablets. Alcohol and Losarstad Comp can enhance each other’s effects.
- An excess of salt in the diet can counteract the effect of Losarstad Comp.
- Losarstad Comp can be taken with or without food.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you think you may be pregnant or may become pregnant during treatment, consult your doctor. Usually, your doctor suggests that you stop taking Losarstad Comp before pregnancy or as soon as you know you are pregnant and recommend another medicine instead of Losarstad Comp. Losarstad Comp should not be used during 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. Losarstad Comp is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby.
Driving And Using Machines
When starting treatment with this medicine, you should not perform actions that may require sharpened attention (eg driving a motor vehicle or performing dangerous work) until you know how well you tolerate your medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Losarstad Comp 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 Losarstad Comp
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the appropriate dose of Losarstad Comp, depending on your medical condition and whether you are taking other medicines. You must continue to take Losarstad Comp according to your doctor’s prescription to maintain even control of your blood pressure.
- High blood pressure
- The usual dose for most patients with high blood pressure is 1 tablet Losarstad Comp 50 mg / 12.5 mg once daily to control blood pressure over 24 hours. Dose one can be increased to 2 tablets once daily by Losarstad Comp 50 mg / 12.5 mg or changed to 1 tablet of Losarstad Comp 100 mg / 25 mg (a stronger strength) daily. The maximum daily dose is 2 tablets Losarstad Comp 50 mg / 12.5 mg or 1 tablet Losarstad Comp 100 mg / 25 mg once daily.
- You should swallow the tablets or tablet halves whole, without chewing, together with a glass of water. You can take the tablets with or without food.
- Losarstad Comp film-coated tablets are available in 3 strengths: Losarstad Comp 50 mg / 12.5 mg, 100 mg / 12.5 mg and 100 mg / 25 mg.
If You Forget To Take Losarstad Comp
Try to take Losarstad Comp as prescribed. But if you miss a dose, do not take an extra dose, but take the next dose as usual.
If You Stop Taking Losarstad Comp
Never discontinue treatment on your initiative unless you suspect that you have a serious side effect. In all cases, you should contact your doctor immediately. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Losarstad Comp side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking Losarstad Comp and contact a doctor immediately or see your nearest hospital:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat which may cause difficulty swallowing and breathing).
This is a serious but rare side effect, which may affect up to 1 in 1,000 people. You may need emergency medical care or hospitalization.
- Muscle pain
- Sore muscles
- Muscle weakness
- Muscle cramps
- In rare cases, these muscle problems can become severe and include muscle breakdown that results in kidney damage.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):
- Cough
- Upper respiratory tract infection
- Nasal congestion
- Sinusitis
- Sinus problems
- Diarrhea
- Abdominal pain
- Nausea
- Indigestion
- Muscle aches or cramps
- Leg pain
- Back pain
- Insomnia
- Headache
- Dizziness
- Weakness
- Fatigue
- Chest pain
- Increased potassium levels (which may cause abnormal heart rhythm)
- Decreased hemoglobin and hematocrit levels
- Changes in renal function
- Including renal failure
- Too low blood sugar ( hypoglycaemia )
Uncommon (may affect up to 1 in 100 people) :
- Anemia
- Red or brown skin spots (in some cases especially on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain)
- Bruising
- Decreased number of white blood cells
- Coagulation problems
- Decreased number of platelets
- Loss of appetite
- Increased levels of uric acid and urea in the blood, or gout
- Increased blood sugar levels
- Electrolyte disturbances
- Anxiety
- Nervousness
- Panic disorder (recurrent panic attacks)
- Confusion
- Depression
- Altered dream pattern
- Sleep disorders
- Drowsiness
- Impaired memory
- Numbness and tingling or similar sensations, pain in the extremities , tremors, migraines , fainting
- Blurred vision
- Burning sensation in the eye
- Conjunctivitis
- Decreased visual acuity
- Yellowing
- Ringing, buzzing, throbbing or clicking in the ears
- Dizziness
- Low blood pressure , which may be associated with posture (feeling dizzy or weak when standing up), angina (chest pain)
- Irregular heartbeat
- Cerebrovascular event ( TIA , “mini-stroke”)
- Heart attack
- Palpitations
- Inflammation of blood vessels, which is often associated with skin rashes or bruising
- Sore throat / throat infection
- Laryngitis
- Shortness of breath
- Bronchitis
- Pneumonia
- Water in the lungs (causing difficulty breathing)
- Nosebleeds
- Runny nose
- Nasal congestion
- Constipation
- Difficult-to-treat constipation
- Flatulence
- Stomach irritation
- Stomach spasms
- Vomiting
- Dry mouth
- Salivary gland inflammation
- Toothache
- Jaundice (yellow whites of the eyes and skin)
- Pancreatitis
- Hives
- Itching
- Inflammation of the skin
- Rash
- Redness
- Photosensitivity
- Dry skin
- Flushing
- Sweating
- Hair loss
- Severe skin reactions with blistering and flaking of the upper layer of skin
- pain in arms, shoulders, hips, knees or other joints
- Joint swelling
- Stiffness, muscle weakness
- Joint inflammation
- Chronic pain throughout the body ( fibromyalgia )
- Frequent urination even at night
- Renal impairment including inflammation of the kidneys
- Urinary tract infection
- Sugar in the urine
- Decreased sexual desire
- Impotence
- Facial swelling
- Local swelling ( edema )
- Fever
Rare (may affect up to 1 in 1,000 people) :
- Hepatitis ( inflammation of the liver), abnormal liver function tests
- Severe allergic (anaphylactic) reactions.
Has been reported (occurs in the unknown number of users):
- Muscle breakdown
- Flu-like symptoms
- Unexplained muscle pain with dark (tea-colored) urine ( rhabdomyolysis )
- Low levels of sodium in the blood ( hyponatremia )
- General malaise
- Taste change ( dysgeusia )
- Skin and lip cancer (Non- melanoma skin cancer)
- Impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma )
How To Store Losarstad Comp
- 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.
- One Losarstad Comp 50 mg / 12.5 mg film-coated tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
- One Losarstad Comp 100 mg / 12.5 mg film-coated tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
- One Losarstad Comp 100 mg / 25 mg film-coated tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
- The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, colloidal anhydrous silica, magnesium stearate
- The other ingredients in the film coating are hypromellose, macrogol 400, and titanium dioxide (E171).
What The Medicine Looks Like And Contents Of The Pack
- Losarstad Comp 50 mg / 12.5 mg film-coated tablets are white, round tablets.
- Losarstad Comp is packed in a plastic/aluminum blister.
- Pack sizes of 7, 7×1 (single blister), 14, 14×1 (single blister), 28, 28×1 (single blister), 30, 30×1 (single blister), 56, 56×1 (single blister), 60, 60×1 (single blister), 90, 90×1 (single blister) , 98, 98×1 (single-dose blisters), 112, 112×1 (single-dose blisters), 120, 120×1 (single-dose blisters), 126, 126×1 (single-dose blisters, 154, 154×1 (single-dose blisters), 196 and 196×1 (single-dose blisters) film-coated tablets.
- Losarstad Comp 100 mg / 12.5 mg film-coated tablets are white, oval, and biconvex.
- Losarstad Comp is packed in a plastic/aluminum blister.
- Pack sizes of 28, 28×1 (single blister), 30, 30×1 (single blister), 56, 56×1 (single blister), 98, 98×1 (single blister), 100, 100×1 (single blister), 126, 126×1 (single blister), 154, 154×1 (single blister) , 182, 182×1 (single-dose blisters), 196 and 196×1 (single-dose blisters) film-coated tablets.
- Losarstad Comp 100 mg / 25 mg film-coated tablets are white, oblong, scored tablets. The tablet can be divided into two equal doses.
- Losarstad Comp is packed in a plastic/aluminum blister.
- Pack sizes of 10, 10×1 (single dose blisters), 28, 28×1 (single dose blisters), 30, 30×1 (single dose blisters), 56, 56×1 (single dose blisters), 60, 60×1 (single dose blisters), 98, 98×1 (single dose blisters), 112, 112×1 (single dose blisters) , 120 and 120×1 (single-dose blisters) film-coated tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co.
Tipperary
Ireland
Sanico nv
Industrial Zone 4, Veedijk 59
2300 Turnhout
Belgium
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmar