Losartan Potassium/Hydrochlorothiazide 100 Mg/12.5 Mg Film-Coated Tablets
Sandoz Ltd
Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
Page 1 of 8
02/06/14
PACKAGE LEAFLET: INFORMATION FOR THE USER
Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets
Losartan potassium/Hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Losartan Potassium/Hydrochlorothiazide is and what it is used for
2. What you need to know before you take Losartan Potassium/Hydrochlorothiazide
3. How to take Losartan Potassium/Hydrochlorothiazide
4. Possible side effects
5. How to store Losartan Potassium/Hydrochlorothiazide
6. Contents of the pack and other information
1. WHAT LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
Losartan potassium belongs to a group of medicines called angiotensin-II receptor antagonists. These cause the blood vessels to relax which in turn lowers the blood pressure.
Hydrochlorothiazide belongs to a group of drugs called diuretics (water tablets).
These tablets are used to treat high blood pressure. The combination of losartan and hydrochlorothiazide is a suitable alternative for those people who would otherwise have to be treated with losartan potassium and hydrochlorothiazide given as separate tablets. Losartan Potassium/Hydrochlorothiazide is available for patients who require additional blood pressure control and already are taking either 100 mg of losartan or hydrochlorothiazide monotherapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
Do not take Losartan Potassium/Hydrochlorothiazide if you:
• are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6 and end of section 2)
• are allergic to sulphonamide derived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure)
• are more than 3 months pregnant. (It is also better to avoid Losartan Potassium/Hydrochlorothiazide in early pregnancy - see pregnancy section)have severely impaired liver function
• have severely impaired kidney function or your kidneys are not producing any urine
• have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
• are suffering from gout.
If you think any of the above conditions applies to you, consult your doctor or pharmacists.
Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium/Hydrochlorothiazide 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).
These tablets are not generally recommended in the following cases if you:
• have previously suffered from swelling of the face, lips, throat or tongue
• take diuretics (water pills)
• are on a salt-restricted diet
• have or have had severe vomiting and/or diarrhoea
• have heart failure
• have impaired liver function (see sections 2 “Do not take Losartan Potassium/Hydrochlorothiazide” and “Dosage in special patient groups”)
• have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney,
or you have recently had a kidney transplant
• are on haemodialysis
• have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
• have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle)
• are diabetic
• have had gout
• have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus)
• have high calcium or low potassium levels or you are on a low potassium diet
• need an anaesthetic (even at the dentist) or before surgery, you must tell the doctor or medical staff that you are taking Losartan Potassium and Hydrochlorothiazide tablets
• have primary hyperaldosteronism associated with increased secretion of the hormone aldosteron by the adrenal gland, caused by an abnormality within the gland.
• are going to have tests to check your parathyroid function
Children and adolescents
The safety and efficacy of Losartan Potassium/Hydrochlorothiazide in children and adolescents under the age of 18 years have not been established. Losartan Potassium/Hydrochlorothiazide should not be given to children and adolescents.
Talk to your doctor if you are an athlete taking a doping test, as Losartan
Potassium/Hydrochlorothiazide contain an active ingredient that can cause positive results in a doping test.
Other medicines and Losartan Potassium/Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is essential that you tell the doctor if you use the following medicines:
• lithium (a medicine for treatment of mania or depression)
• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing medicines
• other diuretics (water tablets)
• some laxatives
• medicines for the treatment of gout
• medicines to control heart rhythm
• medicines for diabetes (oral agents or insulins)
• medicines to reduce your blood pressure
• steroids
• medicines to treat cancer
• pain killers
• arthritis medicines
• medicines to treat fungal infections
• resins used for high cholesterol (e.g. colestyramine)
• medicines which relax muscles
• sleeping tablets
• opioid medicines (e. g. morphine)
• medicines called pressor amines (e.g. adrenaline)
• glycyrrhizin (found in liquorice root)
Ask your doctor if you are not sure what these medicines are.
Please also inform your doctor you are taking Losartan Potassium/Hydrochlorothiazide if you will be undergoing a radiographic procedure and will be given iodine contrast media.
Taking Losartan Potassium/Hydrochlorothiazide with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium/Hydrochlorothiazide may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan Potassium/Hydrochlorothiazide.
Losartan Potassium/Hydrochlorothiazide 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 Losartan Potassium/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Potassium/Hydrochlorothiazide. Losartan Potassium/Hydrochlorothiazide is not recommended in 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan Potassium/Hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or bom prematurely.’
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been reported by people taking Losartan Potassium/Hydrochlorothiazide, if you experience this do not drive a car and do not operate machinery.
3. HOW TO TAKE LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
Always take Losartan Potassium/Hydrochlorothiazide exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure. It is important to continue taking Losartan Potassium/Hydrochlorothiazide for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Take the tablet with a glass of water. It may be taken with or without food.
Use in adults
The usual dose is one tablet once daily.
Use in the elderly:
Dosage adjustment is not usually necessary for the elderly.
Use in kidney impairment and haemodialysis:
In case of moderate kidney problems dosage adjustment is not usually necessary. However, do not take Losartan Potassium/Hydrochlorothiazide if your kidney function is severely impaired.
Losartan Potassium/Hydrochlorothiazide is not recommended for patients on haemodialysis.
Use in liver impairment:
Losartan Potassium/Hydrochlorothiazide should be used with caution in patients with history of mild to moderate liver impairment. However, do not take Losartan Potassium/Hydrochlorothiazide if your
liver function is severely impaired (see section 2. “Do not take Losartan Potassium/Hydrochlorothiazide”).
Use in children and teenagers under 18 years of age:
Losartan Potassium/Hydrochlorothiazide should not be given to children and teenagers.
Use in black patients:
Dosage adjustment may be necessary as Losartan Potassium/Hydrochlorothiazide may be less effective in black patients than in non-black patients.
If you take more Losartan Potassium/Hydrochlorothiazide than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department / your doctor immediately / a poison centre. An overdose is likely to cause heart and dehydration problems. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know what tablets were consumed
If you forget to take Losartan Potassium/Hydrochlorothiazide
Do not take a double dose to make up for a forgotten tablet. Take your next dose at the usual time.
If you stop taking Losartan Potassium/Hydrochlorothiazide
Always consult your doctor, if you wish to stop taking this medicine. Even if you feel well, it may be necessary to continue taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following, stop taking Losartan Potassium/Hydrochlorothiazide 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 (affects 1 to 10 users 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
Uncommon (affects 1 to 10 users in 1000):
• 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 and bruising
• loss of appetite, high level of uric acid in the blood or frank gout, high blood sugar level, abnormal level of electrolyte in the blood
• 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, dizziness, 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
• 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, “ministroke”), 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, wind, stomach upsets, stomach spasms, nausea, 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, Lyell syndrome (skin looking as if it were burnt and peeling off), dry skin, flushing, sweating, hair loss
• pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle pain, weakness or cramps
• frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine
• decreased sexual appetite, impotence
• swelling of the face, fever
Rare (affects 1 to 10 users in 10000)
• hepatitis (inflammation of the liver), abnormal liver function tests
Unknown (frequency cannot be estimated from the available data)
• muscle damage in adults (any unusual aches or pains in your muscles which go on for longer than expected)
• disturbed taste (dysgeusia)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 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/ bottle/ blister after EXP. The expiry date refers to the last day of that month.
- OPA/Al/PVC//Al blisters: Do not store above 25° C. Keep in the original packaging.
- White Aclar/PVC//Al blisters: Do not store above 25° C. Keep in the original packaging.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Losartan Potassium/Hydrochlorothiazide contains
-The active substances are losartan potassium and hydrochlorothiazide.
Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets contain 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide
The other ingredients are:
Tablet core: silicified microcrystalline cellulose, croscarmellose sodium, silica, silica colloidal anhydrous, magnesium stearate.
Film-coating: hypromellose, hydroxypropyl cellulose, titanium dioxide (E171).
What Losartan Potassium/Hydrochlorothiazide looks like and contents of the pack Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets are white, round, biconvex, film-coated tablets, embossed with 100 and 12.5 on one side.
Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets are packed in OPA/Al/PVC//Al blisters or Aclar/PVC//Al blister.
Blister: 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 and 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturer
Lek Pharmaceuticals d.d., Verovskova 57 1526 Ljubljana Slovenia or
Lek S.A., ul. Podlipie 16, 95 010 Strykow Poland or
Lek S.A., ul. Domaniewska 50 C, 02-672 Warsaw Poland or
Salutas Pharma GmbH, Otto von Guericke Allee 1, 39179 Barleben, Germany or
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
This leaflet was last revisved in 06/2014
PIL.1199.003d V022: Update SPC & PIL in line with PRMS-FAR JG