Cozaar Comp 50 mg / 12.5 mg, Cozaar Comp 100 mg / 12.5 mg, Cozaar Comp Forte 100 mg / 25 mg film-coated tablets 
losartan potassium / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Cozaar Comp / Cozaar Comp Forte is and what it is used for 
2. What you need to know before taking Cozaar Comp / Cozaar Comp Forte tablets 
3. How to take Cozaar Comp / Cozaar Comp Forte tablets 
4. Possible side effects 
5. How to store Cozaar Comp / Cozaar Comp Forte 
6. Contents of the packaging and other information 

1. What Cozaar Comp / Cozaar Comp Forte is and what it is used for

Cozaar Comp / Cozaar Comp Forte 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 the 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.

Cozaar Comp / Cozaar Comp Forte is used to treat essential hypertension (high blood pressure ).

What you need to know before you take Cozaar Comp / Cozaar Comp Forte tablets

Do not take Cozaar Comp / Cozaar Comp Forte tablets

  • 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 (ie 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 that cannot be corrected by treatment
  • if you have gout
  • during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Cozaar Comp / Cozaar Comp Forte, see 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, pharmacist, or nurse before taking Cozaar Comp / Cozaar Comp Forte.

If you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and the retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Cozaar Comp / Cozaar Comp Forte. This can lead to permanent visual impairment if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing this.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Cozaar Comp / Cozaar Comp Forte 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 Cozaar Comp or Cozaar Comp Forte:

  • if you have previously experienced swelling of the face, lips, throat, and/or tongue,
  • if you are being treated with diuretics ( diuretics ),
  • if you eat a low-salt diet,
  • you have or have been ill with vomiting and/or diarrhea,
  • if you have heart failure,
  • if you have impaired liver function (see section 2; Do not take Cozaar Comp / Cozaar Comp Forte ),
  • if you have a narrowing of the blood vessels leading to your kidneys (renal artery stenosis) or have only a functioning kidney, or if you have recently had a kidney transplant,
  • if you have narrowing of your arteries (arteriosclerosis), 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 gout,
  • if you 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 are on a potassium-sparing diet,
  • if you are going to undergo anesthesia (even at the dentist) or before a surgical procedure, or if you are going to have a test for your parathyroid function. You should then tell your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets.
  • if you suffer from primary hyperaldosteronism (a syndrome in which your adrenal glands produce too much of the hormone et alaldosterone, 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.

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 Cozaar Comp / Cozaar Comp Forte tablets”.

  • if you are taking other medicines that may increase the concentration of potassium in your blood (see section 2 “Other medicines and Cozaar Comp / Cozaar Comp Forte”).
  • 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 Cozaar Comp / Cozaar Comp Forte.

Children and young people

Lack of experience with Cozaar Comp / Cozaar Comp Forte in children. Cozaar Comp / Cozaar Comp Forte should therefore not be given to children.

Other medicines and Cozaar Comp / Cozaar Comp Forte

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, or other medicines that may increase the concentration of potassium in your blood (eg medicines containing trimethoprim), as their use with Cozaar Comp / Cozaar Comp Forte are not recommended.

Diuretic drugs such as hydrochlorothiazide in Cozaar Comp / Cozaar Comp Forte may interact with other drugs. Medicines containing lithium should not be taken with Cozaar Comp / Cozaar Comp Forte without the close supervision of your doctor. Special precautions (eg blood tests) are suitable if you are taking 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,
  • anticancer drugs,
  • painkillers,
  • medicines for fungal infections,
  • drugs for arthritis,
  • resins against elevated cholesterol such as cholestyramine,
  • muscle relaxants,
  • sleeping pills,
  • opioid drugs such as morphine,
  • pressor amines 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 Cozaar Comp / Cozaar Comp Forte tablets” and “Warnings and precautions”).

Also, tell your doctor that you are taking Cozaar Comp / Cozaar Comp Forte if you are going to have an X-ray examination with an iodinated contrast medium.

Cozaar Comp / Cozaar Comp Forte with food and drink

Alcohol should be avoided while taking these tablets. Alcohol and Cozaar Comp / Cozaar Comp Forte can enhance each other’s effects.

An excess of salt in the diet can counteract the effect of Cozaar Comp / Cozaar Comp Forte.

Cozaar Comp / Cozaar Comp Forte can be taken with or without food.

Pregnancy and breastfeeding

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 Cozaar Comp / Cozaar Comp Forte before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Cozaar Comp / Cozaar Comp Forte 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 breast-feeding or planning to start breast-feeding. Cozaar Comp / Cozaar Comp Forte is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby.

Use in the elderly

Cozaar Comp / Cozaar Comp Forte has an equivalent effect and is tolerated just as well in the elderly as in young people. Most elderly patients need the same dose as younger patients.

Driving and using machines

When starting treatment with this medicine, you should not perform actions that may require sharp attention (such as 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 increased 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.

Cozaar Comp / Cozaar Comp Forte 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.

3. How to take Cozaar Comp / Cozaar Comp Forte tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the appropriate dose of Cozaar Comp / Cozaar Comp Forte, depending on your medical condition and whether you are taking other medicines. It is important that you continue to take Cozaar Comp / Cozaar Comp Forte as prescribed by your doctor to maintain even control of your blood pressure.

High blood pressure

The usual maintenance dose for most patients is one Cozaar Comp 50 mg / 12.5 mg tablet once a day to monitor blood pressure over a 24-hour period. Dose one can be increased to two tablets once daily of losartan/hydrochlorothiazide 50 mg / 12.5 mg film-coated tablets or changed to a tablet of losartan/hydrochlorothiazide 100 mg / 25 mg film-coated tablets (a stronger strength) once daily. The maximum daily dose is two losartan/hydrochlorothiazide 50 mg / 12.5 mg film-coated tablets or one losartan/hydrochlorothiazide 100 mg / 25 mg film-coated tablet once daily.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Cozaar Comp / Cozaar Comp Forte then you should

In case of overdose, contact your doctor immediately so that care can be given immediately. Symptoms of overdose include a drop in blood pressure, palpitations, a slow pulse, changes in blood composition, and dehydration.

If you forget to take Cozaar Comp / Cozaar Comp Forte

Try to take Cozaar Comp / Cozaar Comp Forte as prescribed. Do not take a double dose to make up for a forgotten dose, but take the next dose as usual.

4. Possible 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 Cozaar Comp / Cozaar Comp Forte and to talk to your doctor immediately or seek medical attention:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing and breathing).

This is a serious but rare side effect, occurring in more than 1 in 10,000 and less than 1 in 1,000 patients. You may need emergency medical care or hospitalization.

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 rhythms), decreased hemoglobin levels,
  • changes in renal function, including renal failure,
  • too low blood sugar (hypoglycemia).

Uncommon (may affect up to 1 in 100 people):

  • anemia, red or brown skin spots (in some cases especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and stomach pain), bruising, decreased white blood cell count, coagulation problems, decreased platelet count,
  • loss of appetite, increased levels of uric acid or gout, increased blood sugar levels, electrolyte disturbances,
  • anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, altered dream patterns, 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, thunder 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, 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, inflammation of the salivary gland, toothache,
  • jaundice (yellowing of the whites of the eyes and skin), inflammation of the pancreas,
  • hives, itching, inflammation of the skin, rash, redness of the skin, photosensitivity, dry skin, flushing (heat sensation, redness of the skin), sweating, hair loss,
  • pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
  • frequent urination including at night, renal impairment including renal inflammation, 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.

No known frequency (cannot be calculated from the available data):

  • 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 ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Cozaar Comp / Cozaar Comp Forte

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. date. The expiration date is the last day of the specified month.

Blister: Do not store above 30 ° C. Store in the original package. Sensitive to light. Moisture sensitive.

Plastic jar: Do not store above 25 ° C. Store in the original package. Sensitive to light. Close the jar tightly. Moisture sensitive.

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.

6. Contents of the packaging and other information

Content declaration

The active substances are losartan potassium and hydrochlorothiazide.

Cozaar Comp 50 mg / 12.5 mg contains the active substances 50 mg losartan potassium and 12.5 mg hydrochlorothiazide .

Cozaar Comp 100 mg / 12.5 mg contains the active substances 100 mg losartan potassium and 12.5 mg hydrochlorothiazide .

Cozaar Comp Forte 100 mg / 25 mg contains the active substances 100 mg losartan potassium and 25 mg hydrochlorothiazide .

Cozaar Comp 50 mg / 12.5 mg, Cozaar Comp 100 mg / 12.5 mg and Cozaar Comp Forte 100 mg / 25 mg contain the following excipients: microcrystalline cellulose (E460), lactose monohydrate , pregelatinised starch , magnesium stearate (E572), hydroxypropylcellulose ( E463) and hypromellose (E464).

Cozaar Comp 50 mg / 12.5 mg contains 4.24 mg (0.108 mEq) of potassium . Cozaar Comp 100 mg / 12.5 mg and Cozaar Comp Forte 100 mg / 25 mg contain 8.48 mg (0.216 mEq) of potassium .

Cozaar Comp 50 mg / 12.5 mg and Cozaar Comp Forte 100 mg / 25 mg also contain titanium dioxide (E171), quinoline yellow (E104) and carnauba wax (E903).

Cozaar Comp 100 mg / 12.5 mg also contains titanium dioxide (E171) and carnauba wax (E903).

What the medicine looks like and the contents of the pack

Cozaar Comp 50 mg / 12.5 mg is supplied as yellow, oval film-coated tablets marked 717 on one side and smooth or scored on the other. The notch is not intended for splitting the tablet.

Cozaar Comp 100 mg / 12.5 mg is supplied as white, oval film-coated tablets marked 745 on one side and smooth on the other.

Cozaar Comp Forte 100 mg / 25 mg is supplied as light yellow, oval film-coated tablets marked 747 on one side and smooth on the other.

Cozaar Comp / Cozaar Comp Forte is available in the following packages:

Cozaar Comp 50 mg / 12.5 mg: PVC / PE / PVDC blister packs with aluminum closure in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 or 280 tablets tablets and single-dose packs for hospital use containing 28, 56 or 98 tablets. HDPE jar containing 100 tablets.

Cozaar Comp 100 mg / 12.5 mg: PVC / PE / PVDC blister packs with aluminum closure in cartons containing 14, 15, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. HDPE jar containing 100 tablets.

Cozaar Comp Forte 100 mg / 25 mg: PVC / PE / PVDC blister packs with aluminum closure in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and single-dose packs for hospital use containing 28, 56 or 98 tablets. HDPE jar containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme BV

PO Box 581

2003 PC Haarlem

Netherlands

Manufacturer

Merck Sharp & Dohme BV

PO Box 581

2003 PC Haarlem

Netherlands

or

Merck Sharp & Dohme Ltd

Shotton Lane

NE23 3JU Cramlington

Northumberland

UK

or

Schering-Plow Labo NV

Industrial Park 30

Heist-op-den-Berg, 2220

Belgium

Information provided by:

Box 45192

104 30 Stockholm

Tel: 077-570 04 88

Muhammad Nadeem

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