Atolme Plus 40 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atolme Plus 40 mg/12.5 mg film-coated tablets EFG

Atolme Plus 40 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Atolme Plus is and what it is used for

Atolme Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used in the treatment of high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Atolme Plus will only be prescribed if treatment with olmesartan (olmesartan medoxomil) alone has not adequately controlled your blood pressure. The combined administration of both active substances in Atolme Plus contributes to a greater reduction in blood pressure than when each substance is given alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take Atolme Plus to lower it further.

High blood pressure can be controlled with medicines such as Atolme Plus tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Atolme Plus

Do not take Atolme Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Atolme Plus in early pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have moderate or severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).
• Atolme Plus contains soy lecithin. It should not be used if you are allergic to peanuts or soy.

If you think any of these apply to you, or you are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before starting Atolme Plus.

• If you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Atolme Plus.
• If you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Atolme Plus, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Atolme Plus. Your doctor will decide whether to continue treatment. Do not stop taking Atolme Plus monotherapy without medical advice.

Before taking the tablets, tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme (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 electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Atolme Plus”.

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• Vision changes or eye pain. These could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking Atolme Plus. This may lead to permanent vision loss if not treated.

Your doctor may want to see you more frequently and perform some tests if you have any of these problems.

Atolme Plus may increase blood lipid and uric acid levels (which can cause gout – painful joint swelling). Your doctor will likely perform periodic blood tests to monitor for these potential changes. Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely perform periodic blood tests to monitor this possible change. Some signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms. As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking Atolme Plus before the tests are performed.

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Inform your doctor if you are pregnant or think you might be pregnant. Use of Atolme Plus is not recommended during early pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Children and adolescents

Atolme Plus is not recommended for children and adolescents under 18 years of age.

Taking Atolme Plus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines (antihypertensives), as they may enhance the effect of Atolme Plus.

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Atolme Plus” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with Atolme Plus. These include:

• Potassium supplements (as well as salt substitutes containing potassium).

• Medicines that increase urine output (diuretics).

• Heparin (to thin the blood).

• Laxatives.

• Steroids.

• Adrenocorticotropic hormone (ACTH).

• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).

• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).

• Some painkillers such as aspirin or salicylates.

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used with Atolme Plus. If you need to take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Atolme Plus, may increase the risk of kidney failure and reduce the effect of Atolme Plus.

• Sleeping pills, sedatives, and antidepressants, when used with Atolme Plus, may cause a sudden drop in blood pressure upon standing.

• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.

• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.

• Cholestyramine and colestipol, medicines used to lower blood fat levels.

• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of Atolme Plus. Your doctor may advise you to take Atolme Plus at least 4 hours before colesevelam hydrochloride.

• Anticholinergic medicines such as atropine and biperiden.

• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.

• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.

• Oral antidiabetic medicines, such as metformin, or insulin, used to lower blood sugar levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, since Atolme Plus may enhance the blood sugar-raising effect of these medicines.

• Methyldopa, a medicine used to treat high blood pressure.

• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.

• Difemanil, used to treat slow heart rate or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Antibiotics from the tetracycline group or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminum and magnesium hydroxide, which may slightly reduce the effect of Atolme Plus.

• Cisapride, used to increase stomach and intestinal movement.

• Halofantrine, used to treat malaria.

Taking Atolme Plus with food and drinks

Atolme Plus can be taken with or without food.

Be cautious when drinking alcohol while taking Atolme Plus, as some people may feel weak or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of Atolme Plus is somewhat reduced in patients of Black race.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Atolme Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Atolme Plus is not recommended during pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Atolme Plus is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Atolme Plus contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Atolme Plus

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Atolme Plus 40 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Atolme Plus 40 mg/25 mg once daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you continue taking Atolme Plus until your doctor tells you to stop.

If you take more Atolme Plus than you should

If you take more tablets than you should, or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and take the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atolme Plus

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for missed doses.

If you stop taking Atolme Plus

It is important to continue taking Atolme Plus unless your doctor tells you to stop treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Atolme Plus and consult your doctor immediately.
• Atolme Plus may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens, stop taking Atolme Plus, consult your doctor immediately, and remain lying down in a horizontal position.
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Atolme Plus some time ago, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Atolme Plus is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Atolme Plus (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances taken separately.

These are other known adverse effects reported so far with Atolme Plus:

If these effects occur, they are often mild and you do not need to stop treatment.

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

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

Rapid and strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, some changes in blood test results have also been observed, including:

Increased blood fat levels, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute renal failure.

Rarely, some changes in blood test results have also been observed, including:

Increased blood urea nitrogen (BUN), decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Atolme Plus or at a higher frequency:

Olmesartan medoxomilo:

Frequent adverse effects (may affect up to 1 in 10 people):

Bronchitis, cough, nasal congestion and discharge, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently, some changes in blood test results have also been observed, including:

Increased blood fat levels, increased blood urea or uric acid, increased liver or muscle function test levels.

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

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Uncommonly, some changes in blood test results have also been observed, including:

Reduction in the number of a type of blood cells called platelets (thrombocytopenia).

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

Worsening of kidney function, lack of energy.

Rarely, some changes in blood test results have also been observed, including:

Increased blood potassium levels.

Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Hydrochlorothiazide:

Very frequent adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increased blood fat and uric acid levels.

Frequent adverse effects (may affect up to 1 in 10 people):

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Some changes in blood test results have also been observed, including:

Increased creatinine, urea, calcium and blood sugar levels, decreased blood chloride, potassium, magnesium and sodium levels. Increased serum amylase (hyperamylasemia).

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

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches on the skin due to minor bleeding (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased white blood cell count, decreased platelet count in blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish vision when looking at objects, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus such as skin rash, joint pain and coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disorders).

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

Electrolyte imbalance that may cause abnormally low blood chloride levels (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Adverse effects of unknown frequency (cannot be estimated from available data):

Skin and lip cancer (non-melanoma skin cancer).

Reduced vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atolme Plus

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Atolme Plus

• The active substances are:

Atolme Plus 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

Atolme Plus 40 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

• The other components are: lactose monohydrate*, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, calcium stearate, hypromellose, triacetin and titanium dioxide (E171).

Atolme Plus 40 mg/12.5 mg also contains yellow iron oxide (E172).

Atolme Plus 40 mg/25 mg also contains red iron oxide (E172).

• See previous section “Atolme Plus contains lactose”.

Appearance of the product and contents of the pack

Atolme Plus 40 mg/12.5 mg: yellow, oblong, biconvex, film-coated tablets.

Atolme Plus 40 mg/25 mg: dark pink, oblong, biconvex, film-coated tablets.

The tablets are supplied in packs of 14, 28 and 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Atolme Plus 40 mg/12.5 mg / 40 mg/25 mg film-coated tablets EFG

Portugal Olmesartan medoxomil + hydrochlorothiazide Atolme 40 mg + 12.5 mg / 40 mg + 25 mg film-coated tablets MG

Date of the most recent review of this leaflet: February 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.