Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg film-coated tablets

• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Losartan potassium/Hydrochlorothiazide Tablets is and what it is used for
2. What you need to know before you take Losartan potassium/Hydrochlorothiazide Tablets
3. How to take Losartan potassium/Hydrochlorothiazide Tablets
4. Possible side effects
5. How to store Losartan potassium/Hydrochlorothiazide Tablets
6. Contents of the pack and other information

The name of your medicine is “Losartan potassium/ Hydrochlorothiazide 50 mg/12.5 mg, 100 mg/12.5 mg & 100 mg/25 mg film-coated tablets” (referred to as ‘Losartan potassium/Hydrochlorothiazide Tablets’ or as ‘Losartan potassium/Hydrochlorothiazide’ throughout this leaflet).

• if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
• 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 have severely impaired liver function
• if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment,
• if you are suffering from gout
• if you are more than 3 months pregnant. It is also better to avoid Losartan/Hydrochlorothiazide in early pregnancy (see also pregnancy section)
• if you have severely impaired kidney function or your kidneys are not producing any urine.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Talk to your doctor or pharmacist before taking Losartan potassium /Hydrochlorothiazide.

If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Losartan potassium /Hydrochlorothiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

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).

It is important to tell your doctor before taking Losartan potassium /Hydrochlorothiazide:

• if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Losartan potassium/Hydrochlorothiazide, seek medical attention immediately.
• 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 Losartan potassium /Hydrochlorothiazide”)
• 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 erythematosus).
• 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 aldoesterone by the adrenal gland, caused by an abnormality within the gland).
• if you are taking any of the following medicines used to treat high blood pressure.
  • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
  • aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Losartan potassium/Hydrochlorothiazide”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and ‘Losartan potassium/Hydrochlorothiazide”).
• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan potassium /Hydrochlorothiazide.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Losartan . Your doctor will decide on further treatment. Do not stop taking Losartan on your own.

There is no experience with the use of Losartan potassium/ Hydrochlorothiazide in children. Therefore, Losartan potassium/Hydrochlorothiazide should not be given to children.

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

Tell your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g., trimethoprim-containing medicines), as the combination with Losartan potassium/Hydrochlorothiazide is not advisable.

Diuretic agents such as the hydrochlorothiazide contained in Losartan potassium/Hydrochlorothiazide may interact with other medicines.

Preparations containing lithium should not be taken with Losartan potassium/Hydrochlorothiazide without close supervision by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate if you take 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 colestyramine
• 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

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan potassium /Hydrochlorothiazide” and “Warnings and precautions”)

Please also inform your doctor when it is planned to apply iodine contrast media about taking Losartan potassium/ Hydrochlorothiazide.

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan potassium/Hydrochlorothiazide tablets may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Losartan potassium/Hydrochlorothiazide tablets.

Losartan potassium/Hydrochlorothiazide tablets may be taken with or without food.

Grapefruit juice should be avoided while taking Losartan potassium/Hydrochlorothiazide tablets.

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.

Losartan potassium/Hydrochlorothiazide 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.

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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The recommended dose of Losartan potassium/ Hydrochlorothiazide for most patients with high blood pressure is 1 tablet of Losartan potassium/ Hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of Losartan potassium / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan potassium / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan potassium / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets The dosage strength of Losartan potassium/ Hydrochlorothiazide 100 mg/12.5 mg is available for those patients titrated to 100 mg of Losartan who required additional blood pressure control.

Method of Administration

The Losartan/Hydrochlorothiazide tablets should be swallowed with a glass of water.

In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. Over dosage can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

Try to take Losartan potassium/Hydrochlorothiazide daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine

The active substances are losartan potassium and hydrochlorothiazide.

Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.

Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.

Losartan potassium/Hydrochlorothiazide 100 mg/25 mg tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.

The other ingredients are cellulose microcrystalline, lactose monohydrate, starch pregelatinised, silica colloidal anhydrous, magnesium stearate.

Tablet coat: Hydroxypropyl cellulose (E463), hypromellose 6cp (E464), titanium dioxide (E171), quinoline yellow aluminium lake (E104) [only in 50 mg/12.5 mg & 100 mg/ 25 mg].

Film coated tablets

Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg Yellow coloured, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side.

Losartan potassium/Hydrochlorothiazide 100 mg/12.5 mg White, Oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘F’ on one side and ‘74’ on the other side.

Losartan potassium/Hydrochlorothiazide 100 mg/25 mg Yellow coloured, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side.

Losartan potassium/Hydrochlorothiazide is available in packs of white opaque PVC/PE/PVDC – Aluminium foil blisters and HDPE bottle packs.

Pack sizes:

Blister pack: 14, 28, 30, 50, 56, 60, 90, 98, 100, 280 and 500 film-coated tablets

Bottle pack: 14, 30 and 500 film-coated tablets

Not all pack sizes may be marketed.

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