OLMESARTAN ALTER 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan Alter 10 mg film-coated tablets EFG

Olmesartan Alter 20 mg film-coated tablets EFG

Olmesartan Alter 40 mg film-coated tablets EFG

Olmesartan medoxomil

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

1. What is Olmesartan Alter and what is it used for
2. What you need to know before you take Olmesartan Alter
3. How to take Olmesartan Alter
4. Possible side effects
5. Storage of Olmesartan Alter
6. Contents of the pack and other information

1. What is Olmesartan Alter and what is it used for

Olmesartan Alter belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

Olmesartan Alter is used to treat high blood pressure (also known as hypertension) in adults, and in children and adolescents from 6 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. Usually, high blood pressure does not present symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines like Olmesartan Alter tablets. Your doctor will probably also recommend that you make some changes in your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you drink, and reduce the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is important to follow this advice from your doctor.

2. What you need to know before you take Olmesartan Alter

Do not take Olmesartan Alter

• If you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also better to avoid Olmesartan Alter tablets at the start of pregnancy - see section Pregnancy).
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (bile obstruction, e.g., due to gallstones).
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
• Olmesartan Alter contains soya lecithin. Do not use if you are allergic to peanuts or soya.

Warnings and precautions

Tell your doctor before you start taking Olmesartan Alter.

Tell your doctor if you have abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan Alter. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan Alter on your own.

Tell your doctorif 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), 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 Olmesartan Alter”.

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 medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

Contact your doctor if you have severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessive blood pressure reduction 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.

You should inform your doctor if you are pregnant or think you might be. Olmesartan Alter is not recommended at the start of pregnancy, and it must not be taken 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

Olmesartan Alter has been studied in children and adolescents. For more information, consult your doctor. Olmesartan Alter is not recommended in children under 6 years of age, and it must not be used in children under 1 year of age, as there is no experience with it.

Taking Olmesartan Alter 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, as they may increase the effect of Olmesartan Alter. Your doctor may need to adjust 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 Olmesartan Alter” and “Warnings and precautions”).

• Potassium supplements, salt substitutes that contain potassium, medicines that increase urine production (diuretics), or heparin (to thin the blood). Using these medicines at the same time as Olmesartan Alter may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as Olmesartan Alter. If you need to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as they may increase the risk of kidney failure and reduce the effect of Olmesartan Alter.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan Alter. Your doctor may advise you to take Olmesartan Alter at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Olmesartan Alter.

Elderly patients

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

Black patients

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

Taking Olmesartan Alter with food and drinks

Olmesartan Alter can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan Alter is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

Olmesartan Alter 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 Olmesartan Alter

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended initial dose is 1 tablet of 10 mg per day. If your blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate kidney problems, the maximum dose is 20 mg once a day.

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

Children and adolescents from 6 to less than 18 years of age

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 to 20 mg or 40 mg once a day. In children who weigh less than 35 kg, the dose will not exceed 20 mg once a day.

If you take more Olmesartan Alter than you should

If you take more tablets than you should or if a child has taken some by accident, 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 the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Olmesartan Alter

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 Olmesartan Alter

It is important to continue taking Olmesartan Alter 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are usually mild and do not require treatment to be stopped.

The following side effects can be serious:

Rarely (may affect up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the whole body:

swelling of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Olmesartan Alter and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Olmesartan Alter may cause a pronounced drop in blood pressure, in susceptible patients or as a result of an allergic reaction. This can cause fainting or severe dizziness. If this happens to you, stop taking Olmesartan Alter, consult your doctor immediately, and remain lying down.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan Alter a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

These are other known side effects of Olmesartan Alter:

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

dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, nasal congestion and discharge, 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 in the results of certain blood tests have also been observed:

increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in blood, increases in liver and muscle function test values.

Uncommon side 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), vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives), angina pectoris (pain or discomfort in the chest).

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 in the results of certain blood tests have been observed, including increased levels of potassium in the blood (hyperkalemia) and increased levels of components 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:

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Alter

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Content and Additional Information

Composition of Olmesartán Alter

• The active ingredient is olmesartan medoxomil.

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

• The other components are: