Losartan and hydrochlorothiazide Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan and hydrochlorothiazide DOC 50 mg/12.5 mg film-coated tablets, 100 mg/25 mg film-coated tablets

Generic Medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losartan and hydrochlorothiazide DOC is and what it is used for

Losartan and hydrochlorothiazide DOC is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Angiotensin II is a substance produced by the body that binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, allowing blood vessels to relax, thereby lowering blood pressure. Hydrochlorothiazide works by increasing the amount of water and salts excreted by the kidneys. This also helps reduce blood pressure.
Losartan and hydrochlorothiazide DOC 50 mg/12.5 mg:
Losartan and hydrochlorothiazide DOC is used to treat high blood pressure. Losartan and hydrochlorothiazide DOC is an appropriate alternative for people who would otherwise be treated with losartan and hydrochlorothiazide as separate tablets.
Losartan and hydrochlorothiazide DOC 100 mg/25 mg:
Losartan and hydrochlorothiazide DOC is used to treat high blood pressure in patients who have not responded adequately to treatment with Losartan and hydrochlorothiazide DOC 50 mg/12.5 mg.

2. What you need to know before taking Losartan and hydrochlorothiazide DOC

Do not take Losartan and hydrochlorothiazide DOC:

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other sulfonamide-derived drugs (for example, other thiazides, certain antibacterial agents such as cotrimoxazole; consult your doctor if in doubt)
• if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected with treatment
• if you suffer from gout
• if you are more than three months pregnant (Losartan and hydrochlorothiazide DOC should also be avoided during early pregnancy – see section Pregnancy)
• if you have severe liver dysfunction
• if you have severe kidney dysfunction or if your kidneys do not produce urine
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Inform your doctor if you think you are (or think you might become) pregnant. Losartan and hydrochlorothiazide DOC is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).
It is important that you inform your doctor before taking Losartan and hydrochlorothiazide DOC:

• if you have previously experienced swelling of the face, lips, throat, or tongue
• if you are taking diuretics ("water tablets")
• if you are on a low-salt diet
• if you have or have had severe vomiting and/or diarrhoea
• if you suffer from heart failure
• if liver function is impaired (see section 2 “Do not take Losartan and hydrochlorothiazide DOC”)
• if you have narrowing of the renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone kidney transplantation
• if you have narrowing of arteries (atherosclerosis), angina pectoris (chest pain due to heart problems)
• if you suffer from "aortic or mitral valve stenosis" (narrowing of heart valves) or "hypertrophic cardiomyopathy" (a condition causing thickening of the heart muscle)
• if you have diabetes
• if you have had gout
• if you have or have had allergic conditions, asthma, or a disease causing joint pain, skin rash, and fever (systemic lupus erythematosus)
• if you have high levels of calcium or potassium, or if you are on a low-potassium diet
• if you need to receive an anaesthetic (even from a dentist) or before surgery, or if you are due to undergo tests to assess parathyroid function, inform your doctor or healthcare provider that you are taking Losartan and hydrochlorothiazide DOC
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased aldosterone hormone secretion from the adrenal gland due to an abnormality of this gland)
• if you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium) at regular intervals.
See also the section “Do not take Losartan and hydrochlorothiazide DOC”.
Children and adolescents
Losartan and hydrochlorothiazide DOC must not be used in children and adolescents.
Other medicines and Losartan and hydrochlorothiazide DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretic agents such as hydrochlorothiazide contained in Losartan and hydrochlorothiazide DOC may interact with other medicines.
Medicines containing lithium must not be taken with Losartan and hydrochlorothiazide DOC unless under strict medical supervision.
Special precautions (e.g., blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics ("water tablets"), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).
It is also important that your doctor knows if you are taking other medicines to lower blood pressure, steroids, cancer treatment medicines, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sedatives, opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines in the same class, oral antidiabetic agents, or insulin.
Inform your doctor that you are taking Losartan and hydrochlorothiazide DOC if you are scheduled for a radiographic procedure involving iodinated contrast agents.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
if you are taking an ACE inhibitor or aliskiren (see also sections “Do not take Losartan and hydrochlorothiazide DOC” and “Warnings and precautions”).
Losartan and hydrochlorothiazide DOC with food and drink
You are advised not to drink alcohol while taking these tablets: alcohol may enhance the effect of Losartan and hydrochlorothiazide DOC and vice versa.
Consuming excessive amounts of dietary salt may reduce the effectiveness of Losartan and hydrochlorothiazide DOC.
Losartan and hydrochlorothiazide DOC may be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan and hydrochlorothiazide DOC before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
Losartan and hydrochlorothiazide DOC is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan and hydrochlorothiazide DOC is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed.
Use in elderly patients
Losartan and hydrochlorothiazide DOC has similar efficacy and is equally well tolerated in most younger and elderly patients. Most elderly patients require the same dosage as younger patients.
Driving and using machines
When starting treatment with this medicine, do not perform tasks requiring particular attention (e.g., driving a vehicle or operating dangerous machinery) until you know how you react to the medicine.
Losartan and hydrochlorothiazide DOC contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.
For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Losartan and hydrochlorothiazide DOC

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking Losartan and hydrochlorothiazide DOC for the entire duration prescribed by your doctor in order to maintain regular control of your blood pressure.

Use in adults
Losartan and hydrochlorothiazide DOC 50 mg/12.5 mg
High blood pressure
The recommended dose is one tablet once daily. If necessary, your doctor may increase the dose up to a maximum of two tablets once daily.

Losartan and hydrochlorothiazide DOC 100 mg/25 mg
High blood pressure
The recommended dose is one tablet once daily.

If you take more Losartan and hydrochlorothiazide DOC than you should
If you (or someone else) swallow many tablets at once, or if you think a child has ingested any tablets, contact the nearest emergency department, your doctor, or a poison control centre immediately. Overdose may cause low blood pressure, palpitations, slow pulse rate, changes in blood composition, and dehydration.

If you forget to take Losartan and hydrochlorothiazide DOC
Do not take a double dose to make up for the missed tablet. Take the next dose at your usual time.

If you have any questions about the use of this medicine, 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 any of the following symptoms, stop taking Losartan and hydrochlorothiazide DOC and contact your doctor immediately or go to the nearest hospital emergency department:

• Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing)

This is a serious, but rare side effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. Urgent medical treatment or hospitalization may be required.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal sinus disorders
• Diarrhoea, abdominal pain, nausea, indigestion
• Muscle pain or cramps, leg pain, back pain
• Insomnia, headache, dizziness
• Weakness, fatigue, chest pain
• Increased potassium levels in the blood (which may cause heart rhythm abnormalities), reduced haemoglobin levels

Uncommon (may affect up to 1 in 100 people):

• Anaemia, red or brownish spots on the skin (sometimes mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising, reduced number of white blood cells, blood clotting problems, reduced platelet count
• Loss of appetite, increased uric acid levels or clinical signs of gout, increased blood sugar levels, abnormal blood electrolyte levels
• Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, nightmares, sleep disturbances, drowsiness, memory loss
• Tingling or similar sensations, pain in extremities, tremor, migraine, fainting
• Blurred vision, burning or irritation in the eye, conjunctivitis, worsening of vision, yellow vision
• Ringing, buzzing, noise or clicking in the ears, vertigo
• Low blood pressure, which may be associated with changes in posture (dizziness or weakness when standing up), angina (chest pain), irregular heartbeat, stroke (TIA, "mini-stroke"), heart attack, palpitations
• Inflammation of blood vessels, often associated with skin rash or bruising
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion
• Constipation, persistent constipation, bloating, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache
• Jaundice (yellowing of eyes and skin), inflammation of the pancreas
• Hives, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, hot flushes, sweating, hair loss
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
• Frequent need to urinate, including at night, kidney function abnormalities, including kidney inflammation, urinary tract infection, presence of sugar in urine
• Decreased sexual desire, impotence
• Facial swelling, localized swelling (oedema), fever

Rare (may affect up to 1 in 1,000 people):

• Hepatitis (inflammation of the liver), abnormalities in liver function tests

Not known (frequency cannot be estimated from the available data):

• Influenza-like symptoms
• Unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis)
• Low sodium levels in the blood (hyponatraemia)
• General feeling of being unwell (malaise)

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan and hydrochlorothiazide DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Losartan and Hydrochlorothiazide DOC contains
The active substances are losartan potassium and hydrochlorothiazide.
Losartan and Hydrochlorothiazide DOC 50 mg/12.5 mg: each tablet contains 50 mg of losartan
potassium and 12.5 mg of hydrochlorothiazide.
Losartan and Hydrochlorothiazide DOC 100 mg/25 mg: each tablet contains 100 mg of losartan
potassium and 25 mg of hydrochlorothiazide.
The other components are:
Tablet core: microcrystalline cellulose (E460a), monohydrate lactose, pregelatinized corn starch, magnesium stearate (E572).
Tablet coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Losartan and Hydrochlorothiazide DOC and package contents
Film-coated, round, yellow tablets.
The tablets are available in blisters of 14, 28, 30, 56 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici s.r.l.
Via Turati, 40
20121 – Milan
Italy

Manufacturer
Laboratorios Liconsa
Avenida Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorised in the European Economic Area countries under the
following names:
Denmark: Licolos plus
Germany: Losartan/Hydrochlorothiazide Liconsa
France: Losartan/Hydrochlorothiazide Liconsa
Spain: Losartan/Hidroclorotiazida Liconsa
Italy: Losartan e idroclorotiazide DOC
United Kingdom: Losartan potassium/Hydrochlorothiazide
Sweden: Losartan/Hydrochlorothiazide Medical Valley
Iceland: Losartan/Hydrochlorothiazide Medical Valley
Netherlands: Kaliumlosartan/hydrochlorothiazide Liconsa
Portugal: Losartan + Hidroclorotiazida Basi
Slovenia: Losartan Potassium hydrochlorothiazide Liconsa