AMLODIPINE/VALSARTAN MACLEODS 5 mg/160 mg FILM-COATED TABLETS

2. What you need to know before taking Amlodipine/Valsartan Macleods

Do not take Amlodipine/Valsartan Macleods

• If you are allergic to amlodipine or any other calcium channel antagonist. This may include 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/valsartan Macleods.
• If you have severe liver problems or biliary problems such as biliary cirrhosis or cholestasis.

If you are pregnant for more than 3 months. (It is also best to avoid taking Amlodipine/Valsartan Macleods at the start of your pregnancy, see section Pregnancy).

• If you have severe low blood pressure (hypotension).
• If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart cannot supply enough blood to the 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-lowering medication that contains aliskiren.

Do not take Amlodipine/Valsartan 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 Amlodipine/Valsartan Macleods:

• If you have been ill (with vomiting or diarrhea).
• If you have liver or kidney problems.
• If you have had a kidney transplant or have been told that you have narrowing of the renal 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 carefully start the dosage. Your doctor may also check your kidney function.
• If your doctor has informed you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "hypertrophic 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 Amlodipine/Valsartan Macleods and contact your doctor immediately. You should never take Amlodipine/Valsartan Macleods again.
• If you are taking any of the following medications used to treat high blood pressure:

• An ACE inhibitor (e.g., 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 (e.g., potassium) in your blood at regular intervals.

See also the information under the heading "Do not take Amlodipine/Valsartan Macleods".

Tell your doctor before taking Amlodipine/Valsartan Macleods if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipine/Valsartan Macleods is not recommended for use in children and adolescents (under 18 years of age).

Other medications and Amlodipine/Valsartan Macleods

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

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

Agent anticonvulsants (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 (in perfusion for severe body temperature abnormalities);
• Medications used to protect against rejection in a transplant (cyclosporine);

Taking Amlodipine/Valsartan Macleods with food and drinks

People taking Amlodipine/Valsartan Macleods should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effects of Amlodipine/Valsartan Macleods.

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 Amlodipine/Valsartan Macleods before becoming pregnant or as soon as you become pregnant, and recommend taking another medication instead of Amlodipine/Valsartan Macleods. Amlodipine/Valsartan Macleods is not recommended for use at the start of pregnancy (first 3 months) 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 start breastfeeding, you should inform your doctor. It has been shown that amlodipine passes into breast milk in small amounts.

Amlodipine/Valsartan 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 newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

This medication may make you feel dizzy. This can affect your ability to concentrate. If you are not sure how this medication will affect you, do not drive, use machines, or perform other activities that require concentration.

3. How to take Amlodipine/Valsartan Macleods

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again. This will help you get the best results and reduce the risk of side effects.

The normal dose of Amlodipine/Valsartan 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 Amlodipine/Valsartan Macleods with or without food. Do not take Amlodipine/Valsartan Macleods with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

Amlodipine/Valsartan Macleods and elderly people (65 years or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Amlodipine/Valsartan Macleods than you should

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

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

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

If you forget to take Amlodipine/Valsartan 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 missed doses.

If you stop taking Amlodipine/Valsartan Macleods

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

Other possible side effects of Amlodipine/Valsartan Macleods:

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

Uncommon(may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling, or numbness of the hands or feet; vertigo; rapid heartbeat, 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 urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over the body, itching, muscle spasms. Inform your doctor if you are severely affected by any of the cases mentioned.

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

Amlodipine

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

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat, causing great difficulty breathing.
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling of the skin, and inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heartbeat.
• Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a feeling of great discomfort.

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

Frequent(may affect up to 1 in 10 people): Dizziness, drowsiness; palpitations (feeling the heartbeat); flushing, swelling of the ankles (edema); abdominal pain, feeling of discomfort (nausea).

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

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

Very rare(may affect up to 1 in 10,000 people): Decreased number of white blood cells, decreased platelet count, which can cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests; increased muscle tension; inflammation of blood vessels, often with skin rashes; combined rigidity, tremor, and/or movement disorders.

Valsartan

Frequency not known(frequency cannot be estimated from available data): Decreased number of red blood cells, fever, sore throat, or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels 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, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

If you experience any of the cases mentioned, consult your doctor immediately.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Amlodipine/Valsartan Macleods

Keep this medication out of sight and reach of children.

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

Do not store above 30°C

Do not use any Amlodipine/Valsartan Macleods packaging that is damaged or shows signs of tampering.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAmlodipine/Valsartan Macleods.

• The active ingredients 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, and magnesium stearate (tablet core) and hypromellose, polyethylene glycol, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172) (film coating)

Appearance of the Product and Package Contents

Film-coated tablets of soft yellow color, 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 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona,

Moll de Barcelona, s/n,

08039 Barcelona,

Spain

Manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz, Poland

Or

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50,

90449 Nürnberg, Germany

Or

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV Utrecht, Netherlands

Or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of the last revision of this leaflet: March 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)