Neo-Lotan Plus

Italy
Brand name Neo-Lotan Plus
Form tablets, film-coated
Active substance / Dosage
LOSARTAN POTASSICO
HYDROCHLOROTHIAZIDE
Prescription type Prescription only
ATC code
C09DA01
Registration number 032993
Manufacturer NEOPHARMED GENTILI S.P.A.

Table of Contents

Package leaflet: Information for the patient

Neo-Lotan Plus 50 mg + 12.5 mg film-coated tablets, 100 mg + 25 mg film-coated tablets

losartan potassium and hydrochlorothiazide
Read this entire 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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What NEO-LOTAN PLUS is and what it is used for

Neo-Lotan Plus 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 the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure.
Hydrochlorothiazide works by increasing the renal excretion of a greater amount of water and salt. This mechanism also helps reduce blood pressure.
Neo-Lotan Plus is indicated for the treatment of essential hypertension (high blood pressure).

2. What you should know before taking NEO-LOTAN PLUS

Do not take Neo-Lotan Plus:

  • 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 medicines (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; consult your doctor if in doubt);
  • if you have severe liver dysfunction;
  • if you have low potassium levels, low sodium levels, or high calcium levels in the blood that cannot be corrected by treatment;
  • if you suffer from gout;
  • if you are more than 3 months pregnant. It is also advisable to avoid taking Neo-Lotan Plus during early pregnancy (see section “Pregnancy and breastfeeding”);
  • if you have severe kidney dysfunction or your kidneys are not producing 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, pharmacist, or nurse before taking Neo-Lotan Plus.
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Neo-Lotan Plus 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 child if used during this period (see section “Pregnancy and breastfeeding”).
It is important that you inform your doctor before taking Neo-Lotan Plus if:

  • you have a history of angioedema, which presents as swelling of the face, lips, throat, and/or tongue;

  • you are taking diuretics (medicines that increase the amount of water excreted by the kidneys);

  • you are on a low-salt diet;

  • you have had or are experiencing severe vomiting and/or diarrhoea;

  • you suffer from heart failure;

  • your liver function is impaired (see section 2 “Do not take Neo-Lotan Plus”);

  • you have narrowing of the renal arteries (renal artery stenosis), have only one functioning kidney, or have recently undergone a kidney transplant;

  • you have arterial narrowing (atherosclerosis), chest pain due to reduced heart function (angina pectoris);

  • you suffer from mitral or aortic valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle);

  • you have diabetes;

  • you have had gout;

  • you have had or currently have an allergic condition, asthma, or a disease causing joint pain, skin redness, and fever (systemic lupus erythematosus);

  • you have high calcium levels or low potassium levels in the blood, or if you are on a low-potassium diet;

  • you need to take an anaesthetic (even from a dentist) or before undergoing surgery, or if you need to have tests to monitor parathyroid function; in such cases, inform your doctor or healthcare professional that you are taking Neo-Lotan Plus tablets;

  • you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone from the adrenal gland due to an abnormality);

  • you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Neo-Lotan Plus. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or a sulfonamide, you may be at higher risk of developing this condition;

  • you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Neo-Lotan Plus;

  • you are taking any of the following medicines used to treat high blood pressure:

  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;

  • aliskiren.

  • you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Neo-Lotan Plus, consult a doctor immediately.

Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood. See also the section “Do not take Neo-Lotan Plus”.
Contact your doctor if, after taking Neo-Lotan Plus, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Neo-Lotan Plus on your own.

Children and adolescents
There is no experience regarding the use of Neo-Lotan Plus in children. Therefore, Neo-Lotan Plus must not be administered to children.

Elderly patients
Neo-Lotan Plus has the same efficacy and is equally well tolerated in most younger and older patients. Most elderly patients require the same dosage as younger patients.

Other medicines and Neo-Lotan Plus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics, such as hydrochlorothiazide contained in Neo-Lotan Plus, may interact with other medicines.
Lithium-containing preparations must not be taken with Neo-Lotan Plus without close medical supervision.
Special precautionary measures (e.g. blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics (medicines that increase water excretion via the kidneys), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral antidiabetics or insulin).

It is also important that you inform your doctor if you are taking:

  • other medicines to lower blood pressure;
  • steroids;
  • cancer treatment medicines;
  • painkillers;
  • antifungal medicines;
  • medicines for arthritis;
  • cholesterol-lowering resins such as cholestyramine;
  • muscle relaxants;
  • sleeping pills;
  • opioids such as morphine;
  • pressor amines such as adrenaline or similar medicines;
  • oral antidiabetic medicines or insulin.

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 Neo-Lotan Plus” and “Warnings and precautions”).
Inform your doctor that you are taking Neo-Lotan Plus if you are scheduled for a radiographic procedure involving iodinated contrast agents.

Neo-Lotan Plus with food, drinks, and alcohol
It is recommended not to drink alcoholic beverages while taking Neo-Lotan Plus: alcohol may enhance the effect of Neo-Lotan Plus and vice versa.
A diet particularly high in salt may counteract the effect of Neo-Lotan Plus.
Neo-Lotan Plus may be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Neo-Lotan Plus before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine instead of Neo-Lotan Plus.
Neo-Lotan Plus 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 child if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Neo-Lotan Plus is not recommended for women who are breastfeeding; your doctor may choose an alternative treatment if you wish to breastfeed.

Driving and using machines
When starting treatment with this medicine, do not perform activities requiring special attention (e.g. driving a vehicle or operating dangerous machinery) until you know how you tolerate the medicine.

Neo-Lotan Plus contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take NEO-LOTAN PLUS

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Neo-Lotan Plus based on your condition and any other medications you may be taking. It is important to continue taking Neo-Lotan Plus for the entire duration prescribed by your doctor in order to maintain consistent blood pressure control.

Treatment of high blood pressure
The recommended dose is 1 tablet of Neo-Lotan Plus 50 mg + 12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 tablets of Neo-Lotan Plus 50 mg + 12.5 mg once daily or changed to 1 tablet daily of Neo-Lotan Plus 100 mg + 25 mg (higher strength).
The maximum daily dose is 2 tablets of Neo-Lotan Plus 50 mg + 12.5 mg per day or 1 tablet per day of Neo-Lotan Plus 100 mg + 25 mg.

Administration
The tablets should be swallowed whole with a glass of water.

If you take more Neo-Lotan Plus than you should
In case of overdose, contact your doctor immediately so that prompt medical treatment can be provided. Overdose may cause low blood pressure, palpitations, slow pulse rate, changes in blood electrolytes, and dehydration.

If you forget to take Neo-Lotan Plus
Take Neo-Lotan Plus once daily as prescribed. However, if you forget to take a tablet, do not take a double dose to make up for the missed dose. Skip the missed tablet and take the next tablet at the usual time on the following day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following symptoms, stop taking Neo-Lotan Plus and contact your doctor
immediately, or go to the nearest hospital emergency department:

  • severe allergic reaction, presenting as 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, which may affect more than 1 in 10,000 patients but less than 1 in 1,000. Immediate medical intervention 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 (cephalalgia), dizziness;
  • weakness, fatigue, chest pain;
  • increased blood potassium levels (which may cause heart rhythm abnormalities), decreased haemoglobin levels;
  • impaired kidney function including renal failure;
  • low blood sugar levels (hypoglycaemia).

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

  • anaemia, red or brownish spots on the skin (sometimes particularly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, reduced number of white blood cells, coagulation problems, reduced platelet count;
  • loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels;
  • anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, insomnia, memory loss;
  • sensation of pins and needles or similar sensations, extremity pain, tremor, migraine, fainting;
  • blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, yellow vision of objects;
  • sensation of hearing a sound, ringing, buzzing or clicking noises in the ears, vertigo;
  • low blood pressure, which may be associated with changes in posture (feeling of lightheadedness or weakness when standing up), chest pain (angina pectoris), abnormal heartbeat, cerebrovascular accident (TIA, "mini-stroke"), heart attack, sensation of rapid heartbeat (palpitations);
  • inflammation of blood vessels, often associated with skin rash and bruising;
  • sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleed, runny nose, congestion;
  • constipation, persistent constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
  • jaundice (yellowing of eyes and skin), inflammation of the pancreas;
  • urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, 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 (liver inflammation), changes in liver function tests;
  • intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Very rare (may affect up to 1 in 10,000 people):

  • acute respiratory distress (symptoms include severe shortness of breath, fever, weakness and confusion).

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

  • flu-like symptoms;
  • unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis);
  • low sodium levels in the blood (hyponatraemia);
  • general feeling of malaise;
  • altered taste (dysgeusia);
  • sudden-onset difficulty seeing at a distance (acute myopia), decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
  • skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEO-LOTAN PLUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Blister
Do not store above 30°C.
Keep in the original packaging to protect the medicine from light and moisture.
Bottle
Do not store above 25°C.
Keep in the original container to protect the medicine from light.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Neo-Lotan Plus contains

  • The active substances are losartan potassium and hydrochlorothiazide. Each Neo-Lotan Plus 50 mg + 12.5 mg tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Each Neo-Lotan Plus 100 mg + 25 mg tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
  • The other components are: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171), quinoline yellow lake on hydrated alumina (E104), and carnauba wax (E903).

Neo-Lotan Plus 50 mg + 12.5 mg tablets contain 4.24 mg (0.108 mEq) of potassium.
Neo-Lotan Plus 100 mg + 25 mg tablets contain 8.48 mg (0.216 mEq) of potassium.

Description of the appearance of Neo-Lotan Plus and package contents
Neo-Lotan Plus 50 mg + 12.5 mg is supplied as yellow, oval, film-coated tablets, with "717" printed on one side and the other side smooth or with a breakline.
The score line is not intended to divide the tablet into equal parts.
Neo-Lotan Plus 100 mg + 25 mg is supplied as light yellow, oval, film-coated tablets, with "747" printed on one side and the other side smooth.

Neo-Lotan Plus is available in the following pack sizes:
Neo-Lotan Plus 50 mg + 12.5 mg: PVC/PE/PVDC blisters with aluminum foil lid, in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 or 280 tablets, and unit-dose packs containing 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 tablets.
Neo-Lotan Plus 100 mg + 25 mg: PVC/PE/PVDC blisters with aluminum foil lid, in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets, and unit-dose packs containing 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via S.G. Cottolengo, 15 – 20143 Milano
Manufacturer
VAMFARMA S.r.l.
Via Kennedy, 5 – 26033 Comazzo (Lodi)
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de' Stampi 20089 Rozzano (Milano)