2. BEFORE YOU TAKE COZAAR COMP
Do not take Cozaar Comp
- 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 more than 3 months pregnant. (It is also better to avoid Cozaar Comp in early pregnancy - see Pregnancy)
- 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 Cozaar Comp
You must tell your doctor if you think you are (or might become) pregnant. Cozaar Comp is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
It is important to tell your doctor before taking Cozaar Comp:
- 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 diarrhoea
- if you have heart failure
- if your liver function is impaired (see section 2 “Do not take Cozaar Comp”)
- 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 on a low potassium diet
- if you need to have an anaesthetic (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 aldosterone by the adrenal gland, caused by an abnormality within the gland).
Taking other medicines
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 Cozaar Comp may interact with other medicines.
Preparations containing lithium should not be taken with Cozaar Comp 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 for 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
- resins used for high cholesterol, such as cholestyramine
- medicines which relax your muscles
- sleeping tablets
- opioid medicines such as morphine
- ‘pressor amines’ such as adrenaline or other drugs from the same group
- oral agents for diabetes or insulins.
Please also inform your doctor if you are taking Cozaar Comp and you will be undergoing a radiographic procedure and will be given iodine contrast media.
Taking Cozaar Comp with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Cozaar Comp tablets.
Cozaar Comp tablets may be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Cozaar Comp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cozaar Comp. Cozaar Comp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Cozaar Comp is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Use in children and adolescents
There is no experience with the use of Cozaar Comp in children. Therefore, Cozaar Comp should not be given to children.
Use in elderly patients
Cozaar Comp 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 Cozaar Comp
Cozaar 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 medicinal product.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them.
If you experience the following, stop taking Cozaar Comp 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 hospitalisation.
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
- Diarrhoea, 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 haemoglobin levels
- Changes in kidney function including kidney failure
- Too low sugar in the blood (hypoglycaemia)
Uncommon (affecting less than one person in 100 but more than one person in 1,000):
- Anaemia, red or brownish spots on the skin (sometimes especially 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, reduced number of platelets
- 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, vertigo
- 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, obstipation, 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 tract infection, sugar in the urine
- Decreased sexual appetite, impotence
- Swelling of the face, localised swelling (oedema), fever
Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients):
- Hepatitis (inflammation of the liver), abnormal liver function tests
Not known
- Flu-like symptoms
- Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis)
- Low levels of sodium in the blood (hyponatraemia)
- Generally feeling unwell (malaise)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
6. FURTHER INFORMATION
What Cozaar Comp contains
The active substances are losartan potassium and hydrochlorothiazide.
Cozaar Comp 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.
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 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp 100 mg/12.5 mg also contains: titanium dioxide (E171) and carnauba wax (E903).
What Cozaar Comp looks like and 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 plain or scored on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Cozaar Comp 100 mg/12.5 mg is supplied as white, oval film-coated tablets marked 745 on one side and plain on the other.
Cozaar Comp 100 mg/25 mg is supplied as light yellow, oval film-coated tablets marked 747 on one side and plain on the other.
Cozaar Comp is supplied in the following pack sizes:
Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.
Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets. HDPE bottles of 100 tablets.
Cozaar Comp 100 mg/25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in the UK and Malta is
Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UK
Manufacturers:
50mg/12.5mg strength:
Merck Manufacturing Division
Shotton Lane
Cramlington
Northumberland
NE23 3JU
UK
100mg/12.5mg and 100mg/25mg strengths:
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN
Haarlem
Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria COSAAR Plus – Filmtabletten, FORTZAAR-Filmtabletten
Belgium COZAAR PLUS FORTE 100 mg/25 mg, COZAAR PLUS 50mg/12.5mg, LOORTAN PLUS FORTE 100mg/25mg, LOORTAN PLUS 50mg/12.5mg
Cyprus FORTZAAR, HYZAAR
Denmark COZAAR Comp, COZAAR Comp Forte, FORTZAAR, COZAAR Comp 100mg / 12.5mg
Estonia HYZAAR, FORTZAAR
Finland COZAAR Comp Forte, COZAAR Comp
France FORTZAAR 100 mg/25mg film-coated tablets, HYZAAR 100mg/25mg film-coated tablets, FORTZAAR 50mg/12.5 mg film-coated tablets, HYZAAR 50 mg/12.5 mg film-coated tablets, FORTZAAR 100 mg/12.5 mg film-coated tablets
Germany LORZAAR PLUS 50/12.5 mg Filmtabletten, FORTZAAR 100/25 mg Filmtabletten, LORZAAR PLUS forte 100/12.5 mg Filmtabletten
Greece HYZAAR, HYZAAR Extra Forte, HYZAAR Forte
Hungary HYZAAR 50/12.5 mg, HYZAAR Forte 100/25 mg, HYZAAR 100/12.5 mg
Ireland COZAAR Comp 50mg/12.5mg film-coated tablets, COZAAR Comp 100mg/25mg film-coated tablets, COZAAR Comp 100mg/12.5mg film-coated tablets
Italy HIZAAR 50 mg + 12.5 mg compresse rivestite con film, HIZAAR 100 mg + 25 mg compresse rivestite con film, FORZAAR 100 mg + 25 mg compresse rivestite con film, NEO-LOTAN PLUS 50 mg + 12.5 mg compresse rivestite con film, NEO-LOTAN PLUS 100 mg + 25 mg compresse rivestite con film, LOSAZID 50 mg + 12.5 mg compresse rivestite con film, LOSAZID 100 mg + 25 mg compresse rivestite con film
Lithuania HYZAAR 50 mg/12.5 mg plėvele dengtos tabletės, FORTZAAR 100 mg/25 mg plėvele dengtos tabletės, FORTZAAR 100 mg/12.5 mg plėvele dengtos tabletės
Luxembourg COZAAR PLUS FORTE 100 MG/25 MG, COZAAR PLUS 50 MG/12.5 MG, LOORTAN PLUS 50 mg/12.5 mg, LOORTAN PLUS FORTE 100 mg/25 mg
Malta COZAAR Comp 100/12.5 mg pilloli miksija b’rita, COZAAR Comp 100/25 mg pilloli miksija b’rita, COZAAR Comp 50/12.5 mg pilloli miksija b’rita
Netherlands COZAAR Plus 100/12.5, FORTZAAR 100/25, HYZAAR 50/12.5
Poland HYZAAR, HYZAAR FORTE
Portugal COZAAR Plus, FORTZAAR, SIAARA, LORTAAN PLUS, Losartan + Hidrochlorotiazide Fross
Romania HYZAAR 50 mg/12.5 mg comprimate filmate, FORTZAAR 100/ 25 mg comprimate filmate
Slovenia HYZAAR, FORTZAAR
Spain COZAAR Plus, FORTZAAR
Sweden COZAAR Comp 50mg/12.5mg filmdragerade tabletter, COZAAR Comp 100mg/12.5mg filmdragerade tabletter, COZAAR Comp Forte 100mg/25mg filmdragerade tabletter,
United Kingdom COZAAR-COMP 50/12.5mg FILM COATED TABLETS, COZAAR-COMP 100/25mg FILM COATED TABLETS, COZAAR-COMP 100/12.5 mg Film-coated tablets
Iceland COZAAR-COMP 50/12.5mg, COZAAR COMP FORTE, COZAAR-COMP 100/12.5mg
Norway COZAAR Comp, COZAAR Comp Forte
© Merck Sharp & Dohme Limited 2012. All rights reserved.
