ATOLME PLUS 40 mg/12.5 mg FILM-COATED TABLETS

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

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

Atolme Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat 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 kidneys to remove excess fluid from the body, increasing urine production.

Atolme Plus will only be given if treatment with Olmesartan (olmesartan medoxomil) alone has not adequately controlled your blood pressure. The combination of both active substances in Atolme Plus helps to lower blood pressure more than either substance alone.

You may already be taking medicines to treat high blood pressure, but your doctor may think it is 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 has probably also advised you to make some changes to your lifestyle to help lower your blood pressure (e.g. losing weight, stopping smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have advised you to take regular exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before you take Atolme Plus

Do not take Atolme Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6) or to sulphonamides.
• If you are more than 3 months pregnant. (It is also better to avoid Atolme Plus at the start of pregnancy - see section Pregnancy).
• If you have kidney problems.
• If you have diabetes or kidney problems and are being treated with a medicine for high blood pressure that contains aliskiren.
• If you have low potassium or sodium levels, high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones), which do not improve with treatment.
• If you have moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with the drainage of bile from the gallbladder (bile duct obstruction, e.g. due to gallstones).
• Atolme Plus contains soya lecithin. Do not use if you are allergic to peanuts or soya.

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

Warnings and precautions

Talk to your doctor before you start taking Atolme Plus.

• 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 some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Atolme Plus.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or difficulty breathing severely after taking Atolme Plus, see a doctor immediately.

Tell 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 on your own.

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

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• 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 heading “Do not take Atolme Plus”.

Before taking the tablets, tell your doctorif you have any of the following health problems:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (while feeling nauseous) or diarrhea, which is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine production (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.

Consult your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your treatment for high blood pressure.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to a few weeks after taking Atolme Plus. This can lead to permanent vision impairment if left untreated.

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

Atolme Plus may cause an increase in lipid and uric acid levels in the blood (which can cause gout - painful swelling of the joints). Your doctor will probably want to perform a blood test from time to time to monitor these possible changes. There may be a change in the levels of certain chemicals in the blood called electrolytes. Your doctor will probably want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness or restlessness, vomiting, decreased need to urinate, rapid heart rate. Tell your doctor if you notice any of these symptoms. As with any other medicine that lowers blood pressure, excessive lowering of 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 going to have parathyroid function tests, you should stop taking Atolme Plus before these tests are performed.

Athletes are informed that this medicinal product contains a component that may give a positive doping test result.

You must tell your doctor if you are pregnant or think you might be pregnant. Atolme Plus is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy (see section Pregnancy).

Children and adolescents

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

Taking Atolme Plus with other medicines

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

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

• Other medicines that lower blood pressure (antihypertensives), as they may increase the effect of Atolme Plus.

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

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

• Medicines that may alter potassium levels in the blood if used at the same time as Atolme Plus. These include:

• Potassium supplements (as well as salt substitutes that contain potassium).
• Medicines that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine for treating mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
• Certain pain relievers such as aspirin or salicylates.

• Lithium (a medicine used to treat mood changes and some types of depression) may have its toxicity increased if used at the same time as Atolme Plus. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as Atolme Plus may increase the risk of kidney problems and reduce the effect of Atolme Plus.
• Sleep-inducing medicines, sedatives, and antidepressants used with Atolme Plus may cause a sudden drop in blood pressure when standing up.
• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Atolme Plus. Your doctor may advise you to take Atolme Plus at least 4 hours before colestipol hydrochloride.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, 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 erythromycin injectables, which may change 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 levels, respectively, as Atolme Plus may increase 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 decrease 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 of the tetracycline group or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum and magnesium hydroxide, as they may slightly reduce the effect of Atolme Plus.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Atolme Plus with food and drink

Atolme Plus can be taken with or without food.

Be careful when drinking alcohol while taking Atolme Plus, as some people feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or drinks containing alcohol.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

You must tell your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Atolme Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Atolme Plus. Atolme Plus is not recommended during pregnancy, and must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Atolme Plus is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want to breastfeed.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Atolme Plus contains lactose

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

3. How to take Atolme Plus

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again.

Recommended doseis 1 tablet of Atolme Plus 40 mg/12.5 mg per day. If your blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Atolme Plus 40 mg/25 mg per day.

Take the tablets with water. If possible, take your dose at the same time each day, e.g. at breakfast time. It is important that you keep 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 takes one or more tablets, contact your doctor or go to the nearest hospital emergency department immediately and take the medicine pack with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Atolme Plus

If you forget to take a dose, take your normal dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Atolme Plus

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

However, the following adverse effects may be serious:

• In rare cases, allergic reactions may occur that can affect the whole body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Atolme Plus and consult your doctor immediately.
• Atolme Plus may cause a pronounced drop in blood pressure, in susceptible patients or as a result of an allergic reaction. Dizziness or fainting can occur infrequently. If this happens to you, 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, skin itching, even if you started treatment with Atolme Plus a long time ago, contact your doctor immediatelywho will assess your symptoms and decide how to continue with blood pressure treatment.

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

These are other known adverse effects of Atolme Plus so far:

If these effects occur, they are often mild and it is not necessary to interrupt treatment.

Common 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):

Fast and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erection problems in men, blood in urine.

Also, some changes in blood tests have been observed infrequently, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

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

Feeling of discomfort, altered consciousness, skin swelling (hives), acute kidney failure.

Also, some changes in blood test results have been observed rarely, including:

Increased blood urea nitrogen, decreased hemoglobin, and hematocrit values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

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

Olmesartan medoxomil:

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

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

Also, some changes in blood test results have been observed frequently, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased liver or muscle function test values.

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

Rapid allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, angina (chest pain or discomfort known as angina pectoris), feeling of discomfort, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Also, some changes in blood test results have been observed infrequently, including:

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

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

Kidney function impairment, lack of energy.

Also, some changes in blood test results have been observed rarely, including:

Increased potassium levels in the blood.

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

Hydrochlorothiazide:

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

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

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

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

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

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

Decreased or lost appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, infection in the gallbladder, lupus erythematosus symptoms such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling, and blisters, 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 can cause an abnormally low level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

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

Decreased 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 it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Atolme Plus

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Atolme Plus

• The active ingredients 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 ingredients 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 Package Contents

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

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

The tablets are presented in packages of 14, 28, and 56 tablets.

Only some package 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 with 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 last revision of this prospectus: February 2025.

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