Leaflet: information for the user

Atolme Plus 20mg/12.5 mg film-coated tablets

Atolme Plus 20 mg/25 mg film-coated tablets

Olmesartan medoxomil/Hydrochlorothiazide

Read this leaflet carefully before you start to take 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; do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

• Olmesartan medoxomilo belongs to a group of medications called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Atolme Plus will only be given if treatment with Olmesartan (olmesartan medoxomilo) alone has not adequately controlled your blood pressure. The concurrent administration of both active ingredients in Atolme Plus contributes to reducing blood pressure more than if each active ingredient were administered alone.

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

High blood pressure can be controlled with medications like Atolme Plus tablets. Your doctor may also have recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you engage in regular exercise, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Atolme Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also recommended to avoid Atolme Plus at the beginning of pregnancy - see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains 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 severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• Atolme Plus contains soy lecithin. Do not use it in case of allergy to peanuts or soy.

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

Warnings and precautions

Consult your doctor before starting to take Atolme Plus.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer 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 pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or 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 in monotherapy.

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

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as 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 problems:

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting (while feeling dizzy) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• Problems with the adrenal glands (for example, primary aldosteronism).
• Diabetes.
• 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 evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur from a few hours to several weeks after taking Atolme Plus. This can 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 cause an increase in blood levels of fats and uric acid (which causes gout - painful swelling of the joints). Your doctor will probably want to perform blood tests from time to time to monitor these possible changes. There may be a change in blood levels of certain chemical substances called electrolytes. Your doctor will probably want to perform blood tests 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are to undergo parathyroid function tests, stop taking Atolme Plus before the tests are performed.

It is reported to athletes that this medication contains a component that can establish a positive analytical result for doping control.

Inform your doctor if you are pregnant or think you may be pregnant. Do not use Atolme Plus at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant, as it can 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 old.

Taking Atolme Plus with other medications

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

Particularly, inform your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of Atolme Plus.

Your doctor may need to modify 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”).

• Medications 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).
• Medications that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Glucocorticoids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medication for the treatment of mouth and stomach ulcers).
• Penicillin G sodium (antibiotic also known as benzylpenicillin sodium).
• Some analgesics such as aspirin or salicylates.

• Lithium (medication used to treat mood changes and certain types of depression) if used at the same time as Atolme Plus may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications 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 failure 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.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medications to reduce blood fat levels.
• Colesevelam hydrochloride, a medication that reduces 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 colesevelam hydrochloride.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, that may change heart rhythm.
• Oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as Atolme Plus may intensify the effect of increasing blood sugar that these medications produce.
• Metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics in the tetracycline group, or enoxacin.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they 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 careful when drinking alcohol while taking Atolme Plus, as some people may feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Black patients

Like other similar medications, the blood pressure-lowering effect of Atolme Plus is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, (or if you suspect you may be). Your doctor will usually recommend that you stop taking Atolme Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of Atolme Plus. Do not use Atolme Plus during pregnancy, and in no case should it be administered from the third month of pregnancy, as it can cause serious harm to your baby if taken from that point on.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Do not use Atolme Plus during breastfeeding, and your doctor will choose another treatment for you if you want 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 medication.

Driving and operating machines

You may feel drowsy or dizzy while taking Atolme Plus for high blood pressure. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Atolme Plus contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doseis 1 tablet ofAtolme Plus20 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet ofAtolme Plus20 mg/25 mg per day.

Take the tablets with water. If possible, take your doseat the same time every day, for example, with breakfast. It is essential that you continue takingAtolme Plusuntil your doctor tells you to stop.

If you take more Atolme Plus than you should

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Atolme Plus

If you forget to take a daily dose, take the usual dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Atolme Plus

It is essential to continue takingAtolme Plus, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

However, the following side effects may be serious:

• In rare cases, an allergic reaction may occur that can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Atolme Plus and consult your doctor immediately.
• Atolme Plusmay cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Less frequently, dizziness or fainting may occur.If this happens, 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 taking Atolme Plus some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

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

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

If these effects occur, they are often mild andyou do not need to interrupt treatment.

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

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

Rare side effects (may affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

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

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

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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

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

Additional side effects reported with the use of olmesartán medoxomilo or hidroclorotiazida alone, but not with Atolme Plus or in a higher frequency:

Olmesartán medoxomilo:

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

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

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

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

Rare side effects (may affect up to 1 in 100 people):

Fast and intense allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), unpleasant sensation, skin rash, itching, exanthema (skin rash), skin swelling (hives).

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

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

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

Renal function deterioration, lack of energy.

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

Increased potassium levels in the blood.

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

Hidroclorotiazida:

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

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

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

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

Rare side effects (may affect up to 1 in 100 people):

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to light sensitivity, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, 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, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side 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 (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Side 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 hemorrhage) or acute angle-closure glaucoma).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging and on the blister after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Atolme Plus

• The active principles are:

Atolme Plus 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomilo and 12.5 mg of hydrochlorothiazide.

Atolme Plus 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan medoxomilo and 25 mg of hydrochlorothiazide.

• The other components are: lactose monohydrate*, microcrystalline cellulose, low-substitution hydroxypropyl cellulose, calcium stearate, hypromellose, triacetin, titanium dioxide (E171), and yellow iron oxide (E172).

Atolme Plus 20 mg/25 mg also contains red iron oxide (E172).

* See the previous section “ Atolme Plus contains lactose ”.

Appearance of the product and contents of the packaging

Atolme Plus 20 mg/12.5 mg: film-coated tablets, yellow in color, round, biconvex.

Atolme Plus 20 mg/25 mg: film-coated tablets, light pink in color, oblong, biconvex.

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible 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 20 mg /12.5 mg / 20 mg/25 mg film-coated tablets EFG

Portugal Olmesartan medoxomilo + hydrochlorothiazide Atolme 20 mg + 12.5 mg / 20 mg + 25 mg film-coated tablets MG

Last review date of this leaflet: February 2025.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .