LOSARTAN/HYDROCHLOROTHIAZIDE FARMALIDER 50/12.5 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Losartan/Hydrochlorothiazide Farmalider 100 mg/25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine:

• 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.

Contents of the pack and other information

1. What is Losartan/Hydrochlorothiazide Farmalider and what is it used for
2. Before you take Losartan/Hydrochlorothiazide Farmalider
3. How to take Losartan/Hydrochlorothiazide Farmalider
4. Possible side effects
5. Storing Losartan/Hydrochlorothiazide Farmalider

Additional information

1. What is LOSARTAN/HYDROCHLOROTHIAZIDE APOTEX and what is it used for

Losartan/Hydrochlorothiazide Farmalider is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Losartan/Hydrochlorothiazide Farmalider is indicated for the treatment of essential hypertension (high blood pressure).

2. BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE APOTEX

Do not take Losartan/Hydrochlorothiazide Farmalider

• if you are allergic (hypersensitive) to losartan, to hydrochlorothiazide or to any of the other ingredients of this medicine.
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you are not sure)
• if you are more than 3 months pregnant. (It is also better to avoid Losartan/Hydrochlorothiazide Farmalider during the first months of pregnancy – see section Pregnancy).
• if you have severe hepatic impairment
• if you have severe renal impairment or your kidneys are not producing urine
• if you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment
• if you have gout.
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Losartan/Hydrochlorothiazide Farmalider. In the absence of treatment, this can lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of suffering from it.

Be especially careful with Losartan/Hydrochlorothiazide Farmalider

Tell your doctor if you are pregnant (or think you might be). Losartan/Hydrochlorothiazide Farmalider is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide Farmalider:

• if you have previously suffered from swelling of the face, lips, tongue or throat
• if you are taking diuretics (medicines that make you urinate)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if you have narrow arteries that supply the kidneys (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma or a condition that causes joint pain, skin rash and fever (systemic lupus erythematosus)
• if you have high levels of calcium or low levels of potassium or if you are on a low-potassium diet
• if you need to have anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland).

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
• aliskiren

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the headings “Do not take Losartan/Hydrochlorothiazide Farmalider” and “Be especially careful with Losartan/Hydrochlorothiazide Farmalider”.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Losartan/Hydrochlorothiazide Farmalider.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Farmalider may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Farmalider without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes that contain potassium, or potassium-sparing medicines, diuretics (water pills), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral or insulin), or other blood pressure-lowering medicines. It is also important that your doctor knows if you are taking steroids, anticancer medicines, painkillers, antifungal medicines, or arthritis medicines, cholesterol-lowering resins such as colestyramine, muscle relaxants, sleeping pills; opioid medicines like morphine, "pressor amines" like adrenaline or other medicines in the same group; (oral diabetes medicines or insulins).

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Losartan/Hydrochlorothiazide Farmalider” and “Be especially careful with Losartan/Hydrochlorothiazide Farmalider”).

Please, when taking Losartan/Hydrochlorothiazide Farmalider, inform your doctor when you are scheduled to have a contrast medium with iodine.

Taking Losartan/Hydrochlorothiazide Farmalider with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Farmalider tablets may increase each other's effects.

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Farmalider tablets.

Losartan/Hydrochlorothiazide Farmalider can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Farmalider before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Farmalider. Losartan/Hydrochlorothiazide Farmalider is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan/Hydrochlorothiazide Farmalider is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide Farmalider works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When you start treatment with this medicine, you should not perform tasks that require special attention (e.g. driving a car or using hazardous machinery) until you know how your medicine affects you.

Important information about some of the ingredients of Losartan/Hydrochlorothiazide Farmalider

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, ask your doctor before taking this medicine.

Use in athletes

This medicine contains Hydrochlorothiazide which may produce a positive result in doping tests.

3. HOW TO TAKE LOSARTAN/HYDROCHLOROTHIAZIDE APOTEX

Follow exactly the administration instructions of Losartan/Hydrochlorothiazide Farmalider given by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Farmalider, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide Farmalider as long as your doctor prescribes it to maintain constant control of your blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg of losartan/12.5 mg of hydrochlorothiazide per day or 1 tablet of 100 mg of losartan/25 mg of hydrochlorothiazide per day.

If you take more Losartan/Hydrochlorothiazide Farmalider than you should

In case of overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: 915 620 420, indicating the medicine and the amount taken.

Overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartan/Hydrochlorothiazide Farmalider

Try to take Losartan/Hydrochlorothiazide Farmalider as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your usual schedule.

4. Possible side effects

Like all medicines, Losartan/Hydrochlorothiazide Farmalider can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Farmalider tablets and inform your doctor immediately or go to the emergency department of the nearest hospital:

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

This is a serious but rare side effect, affecting more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Common (affecting less than 1 in 10 but more than 1 in 100):

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorders,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• High levels of potassium (which can cause an abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (affecting less than 1 in 100 but more than 1 in 1,000):

• Anemia, red or brown spots on the skin, (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), bruising, reduced white blood cell count, coagulation disorders and bruising,
• Loss of appetite, high levels of uric acid or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic attacks (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises or clicking in the ears,
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach cramps, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), pancreatitis,
• Hives, itching, skin inflammation, 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, weakness,
• Frequent urination even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine,
• Decreased sexual desire, impotence,
• Swelling of the face, fever.

Rare (affecting more than 1 in 10,000 but less than 1 in 1,000):

• Hepatitis (inflammation of the liver), abnormal liver function tests.

Frequency not known (cannot be estimated from the available data):

• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to high pressure in the eye [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

If you think any of the side effects you are experiencing is serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing LOSARTAN/HYDROCHLOROTHIAZIDE FARMALIDER

Keep out of the reach and sight of children.

Do not use Losartan/Hydrochlorothiazide Farmalider after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not store above 30 ºC.

Store Losartan/Hydrochlorothiazide Farmalider in its original packaging.

Keep the blister in the outer packaging. Do not open the blister until you are ready to take the tablet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Losartan/HydrochlorothiazideFarmalider

The active ingredients are losartan potassium and hydrochlorothiazide. Each tablet contains, as active ingredients, 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.

Losartan/Hydrochlorothiazide Farmalider contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized corn starch, and magnesium stearate.

Losartan/Hydrochlorothiazide Farmalider 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.

Losartan/Hydrochlorothiazide Farmalider also contains Opadry Y-1-7000 White (hypromellose, titanium dioxide (E-171), and polyethylene glycol 400).

Appearance of the product and packaging content

Losartan/Hydrochlorothiazide Farmalider 100 mg/25 mg are film-coated tablets, white in color, oblong, and scored on one side. The tablet can be divided into two equal halves.

Losartan/Hydrochlorothiazide Farmalider is supplied in the following package sizes:

Opaque white PVC/Aluminum blister pack, in packages of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Farmalider S.A.

C/ La Granja, 1

28108 Alcobendas

Madrid, Spain

Manufacturer:

Atlantic Pharma Produçoes de Especialidades Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2

Abrunheira, 2710-089 Sintra

Portugal

This leaflet was approved inJune 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/