Prospect: Patient Information

Atolme 10 mg Film-Coated Tablets

Atolme 20 mg Film-Coated Tablets

Atolme 40 mg Film-Coated Tablets

Olmesartan medoxomil

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as 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 prospect. See section 4.

Atolme belongs to a group of medications known as angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

Atolme is used in the treatment of high blood pressure (also known as hypertension) in adults, and in children and adolescents from 6 years of age to less than 18 years of age. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to a heart attack, heart failure, or kidney failure, stroke, or blindness. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent damage.

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

Do not take Atolme

• If you are allergic to olmesartan medoxomilo or any of the other components of this medication (listed in section 6).
• If you are more than 3 months pregnant. (It is also best to avoid Atolme tablets at the beginning of pregnancy - see Pregnancy section).
• If you have a yellowish skin and eye discoloration (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• Atolme contains soy lecithin. It should not be used in case of an allergy to peanuts or soy.

Warnings and precautions

Consult your doctor before starting to take Atolme.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Atolme. Your doctor will decide whether to continue treatment. Do not stop taking Atolme in monotherapy.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

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

Your doctor may monitor your renal 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”.

Tell your doctorif you have any of the following health problems:

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your treatment for high blood pressure.

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with alterations in blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnantor think you may bepregnant. Atolme is not recommended for use at the beginning 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 used from the third month of pregnancy (see Pregnancy section).

Children and adolescents

Atolme has been studied in children and adolescents. For more information, consult your doctor. Atolme is not recommended for children aged 1 to less than 6 years, and it should not be used in children under 1 year, as there is no experience.

Atolme 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, as they may increase the effect of Atolme. Your doctor may need to adjust your dose and/or take other precautions:

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

• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination (diuretics), or heparin (to thin the blood). The use of these medications at the same time as Atolme may elevate potassium levels in the blood.
• Lithium (a medication used to treat mood changes and certain types of depression), as used at the same time as Atolme may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as used at the same time as Atolme may increase the risk of kidney insufficiency and reduce the effect of Atolme.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Atolme. Your doctor may advise you to take Atolme at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Atolme.

Older patients

If you are over 65 years old and your doctor decides to increase the dose of olmesartan medoxomilo to 40 mg per day, your doctor will regularly monitor your blood pressure to ensure it does not decrease too much.

Black patients

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

Atolme with food and drinks

Atolme can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant,or think you may bepregnant. Your doctor will advise you to stop taking Atolme before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Atolme. Atolme is not recommended for use at the beginning 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 used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Atolme is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

You may feel drowsy or dizzy during high blood pressure treatment. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Atolme contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them 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 initial dose is 1 tablet of 10 mg per day. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate renal insufficiency, the maximum dose is 20 mg per day.

Tablets can be taken with or without food. Take the tablets with a sufficient amount of water (for example, a glass). If possible, take your dose at the same time each day, for example, at breakfast time.

Children and adolescents aged 6 to under 18 years

The recommended initial dose is 10 mg per day. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose up to 20 mg or 40 mg per day. In children weighing less than 35 kg, the dose will not exceed 20 mg per day.

If you take more Atolme than you should

In case you take a higher number of tablets than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency center immediately and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Atolme

If you forgot to take a dose, take the usual dose the next day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Atolme

It is essential to continue taking Atolme, 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. If they occur, they are often mild and do not require interrupting treatment.

The following side effects may be serious:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the entire body:

inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Atolme and consult your doctor immediately.

Very rarely (but slightly more often in elderly patients) Atolme may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking Atolme, 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 a long time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

These are other side effects known so far with Atolme:

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

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, congestion, and nasal secretion, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands, arms, blood in urine.

Some changes have also been observed in the results of certain blood tests:

increase in triglyceride levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in urea levels in the blood, increases in liver and muscle function test values.

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

Severe 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), dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), chest pain (chest discomfort or pain).

In blood tests, a decrease in the number of a type of blood cell called platelets (thrombocytopenia) has been observed.

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

Lack of energy, muscle cramps, worsening of kidney function, kidney failure.

Some changes have been observed in the results of certain blood tests. These include an increase in potassium levels in the blood (hyperkalemia) and an increase in levels related to kidney function.

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

Other side effects in children and adolescents:

Side effects similar to those reported in adults have been observed in children. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent side effect observed only in children.

Reporting 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 Pharmacovigilance 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.

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

No special storage conditions are required.

Medicines 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 packaging and unused medications. By doing so, you will help protect the environment.

Composition of Atolme

• The active ingredient is olmesartan medoxomilo.

Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomilo.

• The other components are:

lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, calcium stearate, cornstarch, talc (E553b), mannitol (E421), soy lecithin (E322) and titanium dioxide (E171). (See section 2 “Atolme contains lactose” and “Atolme contains soy lecithin”).

Appearance of the product and contents of the packaging

Atolme 10 mg is presented as film-coated tablets, white, round, biconvex, 6 mm in diameter, smooth on both faces.

Atolme 10 mg is presented in blisters in packs of 14, 28 and 56 tablets.

Atolme 20 mg is presented as film-coated tablets, white, round, biconvex, 8 mm in diameter, scored on one face and smooth on the other. The score should not be used to break the tablet.

Atolme 20 mg is presented in blisters in packs of 14, 28 and 56 tablets.

Atolme 40 mg is presented as film-coated tablets, white, round, biconvex, 11 mm in diameter, smooth on both faces.

Atolme 40 mg is presented in blisters in packs of 14, 28 and 56 tablets.

Only some pack sizes may be 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 10 mg / 20 mg / 40 mg film-coated tablets EFG

PortugalOlmesartan medoxomilo Atolme 10 mg / 20 mg / 40 mg film-coated tablets MG

Last review date of this leaflet: February 2025

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/.