Cozaar-comp Tablets

How do I take it?

• The dose of this medicine that is prescribed depends on how well your blood pressure is controlled. Follow the instructions given by your doctor or pharmacist. These will be printed on the dispensing label your pharmacist has put on the packet of medicine.
• Cozaar-comp tablets are usually taken once a day. They can be taken either with or without food. The tablets should be swallowed with a drink of water.
• As diuretics cause your kidneys to produce more urine, this medicine might make you need to go to the toilet more often. For this reason most people find it best to take the medicine in the morning rather than later in the day, as this will reduce the likelihood of you needing to get up in the night to visit the toilet. However, you can take the medicine at another time of day if this suits you better. Seek further advice from your doctor or pharmacist.
• If you forget to take a dose take it as soon as you remember. However if you forget a dose for the whole day, just leave out the missed dose and take your next dose as usual the following day. Do not take a double dose to make up for a missed dose.
• You will usually need to keep taking this medicine long-term to help control your blood pressure. Don't stop taking this medicine unless your doctor tells you to.

Use with caution in

• Elderly people.
• People with mild to moderately decreased liver function.
• People with decreased kidney function.
• People who have had a kidney transplant.
• People with narrowing of one or both of the arteries that supply blood to the kidneys (renal artery stenosis).
• Severe heart failure.
• People with narrowing of the main artery that leaves the heart to supply blood to the body (aortic stenosis).
• Heart valve disease (mitral valve stenosis).
• Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
• People with low fluid volume or salt levels in the body, eg due to diuretic therapy, low-sodium diet, diarrhoea or vomiting.
• People with a condition called systemic lupus erythematosus, in which there is long-term inflammation of skin and some internal organs.
• People with a history of gout.
• Diabetes.
• People who have previously experienced an allergic reaction to a medicine that involved swelling of the lips, face, throat or tongue (angioedema).

Not to be used in

• Children and adolescents under 18 years of age.
• People who are allergic to medicines from the sulphonamide group, eg the antibiotic sulfamethoxazole.
• People with severely decreased liver function.
• People with failure of the normal flow of bile from the liver to the intestines (cholestasis).
• People with a rare form of liver disease involving the bile ducts (biliary cirrhosis).
• People with severely decreased kidney function and people who are having haemodialysis for kidney failure.
• People whose kidneys are not producing urine (anuria).
• People with low blood levels of sodium or potassium or high blood levels of calcium that don't respond to treatment.
• People with high levels of uric acid in their blood that are causing symptoms such as gout attacks or kidney stones.
• Untreated Addison's disease (disease in which there is inadequate production of natural steroid hormones by the adrenal glands).
• Pregnancy.
• Breastfeeding.

Cozaar comp tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine may be harmful to a developing baby. It is not recommended for use during the first trimester of pregnancy and should not be used during the second and third trimesters. If you think you could be pregnant or want to plan a pregnancy while taking this medicine you should get medical advice from your doctor straight away.
• It is not known if losartan passes into breast milk, however hydrochlorothiazide does pass into breast milk. It may also decrease the production of breast milk. This medicine should therefore not be used during breastfeeding. Mothers will need to either stop breastfeeding while taking this medicine, or not take this medicine. This will depend on how important the medicine is for treating the mother's blood pressure. It is important to seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Disturbances of the gut, such as nausea, vomiting, diarrhoea, abdominal pain.
• Feeling weak or tired.
• Chest pain.
• Dizziness, including dizziness when moving from sitting to standing.
• Headache.
• Decreased kidney function.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Spinning sensation (vertigo).
• Ringing in the ears (tinnitus).
• Pain in the muscles and joints.
• Sleepiness.
• Awareness of your heartbeat (palpitations).
• Irregular heartbeats (arrhythmias).
• Increased need to pass urine.
• Decreased sex drive or erectile dysfunction (impotence).
• Shortness of breath.
• Cough.
• Skin rashes or itching.
• Loss of appetite.
• Raised blood sugar level.
• Low level of sodium in the blood (hyponatraemia).
• Inflammation of the pancreas (pancreatitis).
• Low red blood cell count (anaemia), white blood cell count (leucopenia) or platelet count (thrombocytopenia).
• Depression or anxiety.
• Migraine.
• Fainting.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• High blood potassium level (hyperkalaemia).
• Inflammation of the liver (hepatitis).
• Allergic reactions such as severe swelling of lips, face or tongue (angioedema).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

If this medicine is used in combination with other medicines that lower blood pressure, either to treat high blood pressure (antihypertensives), or as a side effect, the combination might lower your blood pressure too much. This could make you feel dizzy or faint, particularly when moving from a lying or sitting position to sitting or standing. If this happens to you, you should sit or lie down until the symptoms pass. This is more likely to happen when you first start taking this medicine, particularly if you have been taking a high dose of a diuretic. Tell your doctor if any dizziness persists, as your medicine doses may need adjusting. Other medicines that decrease blood pressure include the following:

• ACE inhibitors, eg enalapril
• aldesleukin
• alpha-blockers such as prazosin
• alprostadil
• other angiotensin II receptor antagonists such as valsartan
• antipsychotics such as chlorpromazine
• benzodiazepines, eg temazepam, diazepam
• baclofen
• beta-blockers such as propranolol
• calcium-channel blockers such as verapamil, nifedipine
• clonidine
• diazoxide
• diuretics, eg furosemide, bendroflumethiazide
• dopamine agonists, eg bromocriptine, apomorphine
• hydralazine
• levodopa
• MAOI antidepressants, eg phenelzine
• methyldopa
• minoxidil
• moxonidine
• moxisylyte
• nicorandil
• nitrates, eg glyceryl trinitrate
• sildenafil
• tizanidine.

Both losartan and hydrochlorothiazide may increase the blood level of the medicine lithium, and this medicine is therefore not recommended for people taking lithium. If it is necessary to take lithium with this medicine, your doctor should carefully monitor your blood level of lithium. You should let your doctor know if you experience any signs that your lithium level is increasing, for example, loss of appetite, diarrhoea, vomiting, blurred vision, muscle weakness, lack of co-ordination, drowsiness, tremor, unsteadiness, muscle twitching, ringing in the ears or confusion.

References:

http://patient.info/medicine/losartan-an-angiotensin-receptor-blocker-cozaar

https://www.drugs.com/uk/cozaar-comp-50-mg-12-5-mg-film-coated-tablets-leaflet.html

http://www.netdoctor.co.uk/medicines/heart-and-blood/a6478/cozaar-comp-losartan-and-hydrochlorothiazide/

http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con2033488.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Cozaar_Comp_30/WC500008584.pdf