Prospecto:information for the user

Amlodipino/Valsartán Macleods 10 mg/160 mg film-coated tablets

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medicine has been prescribedonlyto you, and you must not give it to other people even if they havethe same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Amlodipino/Valsartán Macleods and for what it is used

2.What you need to knowbeforestarting totake Amlodipino/Valsartan Macleods

3.How to take Amlodipino/Valsartán Macleods

4.Possible adverse effects

5Storage of Amlodipino/Valsartán Macleods

6.Contents of the package and additional information

Amlodipino/Valsartán Macleods tablets contain two substances called amlodipino and valsartán. Both substances help control high blood pressure.

-Amlodipino belongs to a group of substances called «calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.

-Valsartán belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing blood pressure. Valsartán acts by blocking the effect of angiotensin II.

This means that both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

Amlodipino/Valsartán Macleods is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipino or valsartán alone.

Do not take Amlodipino/Valsartán Macleods

-If you are allergic to amlodipine or any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.

-If you are allergic to valsartan or any of the other components of this medication (listed in section 6). If you think you may be allergic, inform your doctor before taking amlodipine/valsartán Macleods.

-If you have severe liver problems or bile duct problems such as biliary cirrhosis or cholestasis.

??If you are more than 3 months pregnant. (It is best to avoid taking Amlodipino/Valsartán Macleods also at the beginning of your pregnancy, see Pregnancy section).

-If you have a severe decrease in blood pressure (hypotension).

-If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation in which your heart cannot supply enough blood to your body).

-If you have heart failure after a heart attack.

-If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Do not take Amlodipino/Valsartán Macleods and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor before starting to take Amlodipino/Valsartán Macleods:

• If you have been sick (with vomiting or diarrhea).
• If you have liver or kidney problems.
• If you have had a kidney transplant or if you have been told that you have a narrowing of the kidney arteries.
• If you have a disease that affects the adrenal glands called "primary hyperaldosteronism".
• If you have had heart failure or have had a heart attack. Follow your doctor's instructions to start taking Amlodipino/Valsartán Macleods carefully. Your doctor may also check your kidney function.
• If your doctor has told you that you have a narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "hypertrophic obstructive cardiomyopathy").
• If you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking Amlodipino/Valsartán Macleods and contact your doctor immediately. Never take Amlodipino/Valsartán Macleods again.
• If you are taking any of the following medications used to treat high blood pressure:

• An ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) regularly.

See also the information under the heading "Do not take Amlodipino/Valsartán Macleods".

Inform your doctor before taking Amlodipino/Valsartán Macleods if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipino/Valsartán Macleods is not recommended for children or adolescents (under 18 years old).

Other medications and Amlodipino/Valsartán Macleods

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medications. This applies especially to the medications listed below:

• An ACE inhibitor or aliskiren (see also the information under the headings "Do not take Amlodipino/Valsartán Macleods" and "Warnings and precautions");
• Diuretics (a type of medication that increases urine production);
• Lithium (a medication used to treat certain types of depression);
• Diuretics that save potassium, potassium supplements, salt substitutes that contain potassium, and other substances that may increase potassium levels;
• A certain type of medication used to treat pain called nonsteroidal anti-inflammatory drugs (NSAIDs) or selective COX-2 inhibitors. Your doctor may also check your kidney function;

Agents used to treat seizures (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);

St. John's Wort;

Nitroglycerin and other nitrates, or other substances called "vasodilators";

Medications used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);

Medications used to treat fungal infections (e.g. ketoconazole, itraconazole);

Medications used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);

Verapamil, diltiazem (heart medications);

Simvastatin (a medication used to control high cholesterol levels);

Dantrolene (for severe abnormalities of body temperature);

Medications used to prevent rejection in a transplant (ciclosporin);

Taking Amlodipino/Valsartán Macleods with food and drinks

People taking Amlodipino/Valsartán Macleods should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may lead to unpredictable reductions in blood pressure.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking Amlodipino/Valsartán Macleods before becoming pregnant or as soon as you become pregnant, and recommend taking another medication instead of Amlodipino/Valsartán Macleods. Amlodipino/Valsartán Macleods is not recommended for use during the first 3 months of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered after the third month of pregnancy.

Breastfeeding

If you are breastfeeding or about to breastfeed, you should inform your doctor. Amlodipine has been shown to pass into breast milk in small amounts.

Amlodipino/Valsartán Macleods is not recommended for breastfeeding mothers and your doctor may decide to administer another treatment that is more suitable if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication may make you feel dizzy. This may affect your ability to concentrate. Therefore, if you are unsure how this medication will affect you, do not drive, operate machinery, or perform other activities that require concentration.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again. This will help you obtain the best results and reduce the risk of adverse effects.

The normal dose of Amlodipino/Valsartán Macleods is one tablet per day.

• It is preferable to take the medication at the same time every day.
• Swallow the tablets with a glass of water.
• You can take Amlodipino/Valsartán Macleods with or without food. Do not take Amlodipino/Valsartán Macleods with grapefruit or grapefruit juice.

Your doctor may suggest a higher or lower dose depending on your response to treatment.

Do not exceed the prescribed dose.

Amlodipino/Valsartán Macleods and Older Adults (65 years or older)

Your doctor should exercise caution when increasing the dose.

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

If You Take More Amlodipino/Valsartán Macleods Than You Should

If you have taken too many tablets of Amlodipino/Valsartán Macleods, or if someone else has taken your tablets, consult a doctor immediately.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

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

If You Forget to Take Amlodipino/Valsartán Macleods

If you forget to take this medication, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed doses.

If You Stop Taking Amlodipino/Valsartán Macleods

Stopping your treatment with Amlodipino/Valsartán Macleods may cause your condition to worsen. Do not stop taking your medication unless your doctor tells you to.

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

Some side effects may be serious and require immediate medical attention.A few patients have experienced these serious side effects(which may affect up to 1 in 1,000 patients).Notify your doctor immediately if you notice any of the following:

Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (dizziness, fainting).

Other possible side effects of Amlodipino/Valsartán Macleods:

Frequent(may affect up to 1 in 10 people): Cold; stuffy nose, sore throat, and discomfort swallowing; headache; swelling in the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and warming of the face and/or neck.

Infrequent(may affect up to 1 in 100 people):Dizziness; nausea and abdominal pain; dry mouth; somnolence, tingling, or numbness of the hands or feet; vertigo; rapid heartbeats including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint inflammation, back pain; joint pain.

Rare(may affect up to 1 in 1,000 people):Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased urine production or feeling of urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, fainting; excessive sweating; skin rash all over the body, itching, muscle spasms.Inform your doctor if any of these severely affect you.

Side effects reported with amlodipine or valsartan alone and not observed with Amlodipino/Valsartán Macleods or observed with a higher frequency than with Amlodipino/Valsartán Macleods:

Amlodipine

Consult your doctor immediately if you experience any of the following serious side effects, which are very rare after taking this medicine:

• Sudden hissing sounds while breathing (sibilant breathing), chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes severe difficulty breathing.
• Severe skin reactions that include intense skin rash, blisters, redness of the skin all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heart rhythm.
• Pancreatitis that may cause severe abdominal pain and back pain accompanied by severe discomfort.

The following side effects have been reported.Notify your doctor if any of these cause problems or last more than a week:

Frequent(may affect up to 1 in 10 people):Dizziness, somnolence; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, feeling unwell (nausea).

Infrequent(may affect up to 1 in 100 people):Mood changes, anxiety, depression, somnolence, tremor, altered taste, fainting; visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure; nasal congestion or secretion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, breast discomfort or enlargement in men, pain, discomfort, muscle pain, muscle cramps; weight gain or loss.

Rare(may affect up to 1 in 1,000 people):Confusion.

Very rare(may affect up to 1 in 10,000 people):Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycemia); inflammation of the gums, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests; muscle tension; inflammation of blood vessels often with skin eruptions, light sensitivity; movement disorders combining stiffness, tremor, and/or movement disturbances.

Valsartan

Unknown frequency(frequency cannot be estimated from available data):Decreased red blood cell count, fever, sore throat, or mouth ulcers due to infection; spontaneous skin bleeding or hematomas; increased potassium in the blood; abnormal liver function test results; decreased kidney function and severely decreased kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, red purpura patches; fever; itching; allergic reaction, blistering skin disease (sign of a disease called dermatitis bullosa).

Notify your doctor immediately if you experience any of the cases mentioned.

Reporting side effects

Notify your doctor or pharmacist if you experience any type of side effect, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use https://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.

Do not store at a temperature above 30°C

Do not use any Amlodipino/Valsartán Macleods packaging that is damaged or shows signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment

Composition ofAmlodipino/Valsartán Macleods.

• The active principles are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.

• The other components are: microcrystalline cellulose,crospovidone, colloidal silicon dioxide, andmagnesium stearate (core of the tablet) andhypromellose,polyethylene glycol, talc,di titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172)(coating film)

Appearance of the product and content of the container

Coated tablets with a yellow smooth film, oval, biconvex, marked with “C95” on one side and smooth on the other.

The following formats are available: boxes with blisters of 14, 28, 30, 56, 90 and 98 coated tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Macleods Pharma España S.L.U.

Avenida Diagonal, 409, 1st Floor

08008 Barcelona

Spain

Responsible for manufacturing

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz, Poland

O

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50,

90449 Nürnberg, Germany

O

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV Utrecht, Netherlands

O

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Last review date of this leaflet: March 2023

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