Leaflet: information for the user

Atolme Plus 40 mg/12.5 mg film-coated tablets

Atolme Plus 40 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 combined 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 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 best to avoid Atolme Plus at the start of pregnancy - see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine 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 moderate or severe liver problems, or 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. Do not use it if you are allergic to peanuts or soy.

If you think you have any of these conditions, 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 the sun 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, see your doctor 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 medicines used to treat high blood pressure (hypertension):

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

Your doctor may want to check your kidney function, blood pressure, and electrolyte levels in the blood (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 problems:

• Renal transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting (while feeling dizzy) or diarrhea.
• 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 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 assess 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 effusion) 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 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. 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, 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 circulatory problems in the heart or brain can cause a heart attack or stroke. 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 medicine 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. Atolme Plus is not recommended for use at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Children and adolescents

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

Atolme Plus with other medicines

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

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

• Other blood pressure-lowering medicines (anti-hypertensives), as they may increase 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 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.
• Glucocorticoids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medicine for treating mouth and stomach ulcers).
• Penicillin G sodium (antibiotic also known as benzylpenicillin sodium).
• Some analgesics such as aspirin or salicylates.

• Lithium (medicine 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) (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 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 medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medicines to reduce lipid levels in the blood.
• Colesevelam hydrochloride, a medicine that reduces 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 colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, that may change heart rhythm.
• Oral antidiabetic medicines, such as metformin, or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Atolme Plus may intensify the effect of increasing blood sugar that these medicines produce.
• Metildopa, 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.
• Ciclosporin, a medicine used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group or ciprofloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminium 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.

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 feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or fizzy drinks with alcohol.

Black patients

As with other similar medicines, 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 think you may 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 advise you to take another medicine instead of Atolme Plus. Atolme Plus is not recommended for use during pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period.

Lactation

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Atolme Plus is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment 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 medicine.

Driving and operating machines

You may feel drowsy or dizzy while taking treatment 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 medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

Take the tablets with water. If possible, take your doseat the same time every day, for example, with breakfast. It is essential to 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 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 or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atolme Plus

If you forget to take a 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 taking Atolme Plus, unless your doctor tells you to stop.

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 measures.

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 measures.

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 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, including:

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

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 can 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 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):

Severe 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 effusion) 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 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomilo and 12.5 mg of hydrochlorothiazide.

Atolme Plus 40 mg/25 mg: each film-coated tablet contains 40 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, 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 the previous section “Atolme Plus contains lactose”.

Appearance of the product and content of the container

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

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

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

Only some container sizes may be commercially marketed.

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:

SpainAtolme Plus 40 mg/12.5 mg / 40 mg/25 mg film-coated tablets EFG

PortugalOlmesartan medoxomilo + hidroclorotiazida Atolme 40 mg + 12.5 mg / 40 mg + 25 mg film-coated tablets MG

Date of the last review 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/.