ATOLME PLUS 40 mg/25 mg FILM-COATED TABLETS

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 substances similar to hydrochlorothiazide (sulfonamides).
• 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 that lowers blood pressure and contains aliskiren.
• If you have low potassium or sodium levels in your blood, 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 get an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular 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 your 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.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact 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 blood pressure treatment.
• 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 increased levels of lipids and uric acid (which can cause gout - painful swelling of the joints) in the blood. Your doctor will likely 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 likely 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, fatigue, drowsiness or restlessness, vomiting, decreased need to urinate, rapid heartbeat. 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 medicine contains a component that may result in a positive doping test.

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

Children and adolescents

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

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 blood pressure-lowering medicines (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 angiotensin-converting enzyme inhibitor (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 increase its toxicity 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 drugs (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.
• Sedatives, hypnotics, 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 cholesterol levels in the blood, 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 can 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 drinks

Atolme Plus can be taken with or without food.

Be careful when drinking alcohol while taking Atolme Plus, as some people may feel weak or dizzy. If this happens to you, do not drink any alcohol, including wine, beer, or drinks with 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 inform your doctor if you are pregnant or think you might be. 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 you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month of pregnancy onwards.

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 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 happens, do not drive or use machines until the symptoms have disappeared. 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 exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, consult 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, for example, at breakfast time. It is important that you continue to take 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 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, indicating 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 medicine, 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 may occur infrequently. If this happens to you, stop taking Atolme Plus, consult your doctor immediately, and remain lying down in a horizontal position.
• Unknown frequency: 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 evaluate your symptoms and decide how to continue with blood pressure treatment.

Atolme Plus is a combination of two active principles. 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 principles separately.

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

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.

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 cells called platelets (thrombocytopenia).

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

Kidney function deterioration, lack of energy.

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

Increased potassium 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 increased uric acid levels.

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of bloating, 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 reduced 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 SIGRE point in the pharmacy. 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 hypromellose, 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 packs of 14, 28, and 56 tablets.

Only some 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 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/.