Prospect: information for the user

Valsartán Durban 80mg film-coated tablets

Valsartán

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 doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of this prospect

1.Whatis Valsartán Durbanand for what it is used

2.What you need to know before starting to takeValsartán Durban

3.How to takeValsartán Durban

4.Possible adverse effects

5.Storage ofValsartán Durban

6.Contents of the package and additional information

This medication contains the active substance: Valsartán and Valsartán belongs to a class of medications known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced by the body that causes vasoconstriction, and thus induces an increase in blood pressure. Valsartán Durban blocks the effect of angiotensin II. Therefore, blood vessels relax and blood pressure decreases.

Valsartán Durban 80mg film-coated tablets EFGcan be used to treat three different conditions:

•To treat high blood pressure in adults and in children and adolescents from 6 to less than 18years of age.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure also increases the risk of suffering heart attacks.The reduction of blood pressure to normal values reduces the risk of developing these disorders..

•To treat adult patients after arecent heart attack. Here "recent" means between 12hours and 10days.

•To treat symptomatic heart failure in adult patients.Valsartán Durban is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication to treat heart failure), or it may be used added to angiotensin-converting enzyme inhibitors when it is not possible to use other medications for the treatment of heart failure

The symptoms of heart failure are shortness of breath and swelling of feet and legs due to fluid accumulation. It occurs when the cardiac muscle cannot pump blood with sufficient force to supply the blood needed throughout the body.

Do not take Valsartán Durban:

-if you areallergic(hypersensitive) to valsartán or to any of the other components of this medication (listed in section 6.

-if you havesevere liver disease.

-if you arepregnant more than three monthsold.(It is better to avoid Valsartán during the first months of pregnancy – see section Pregnancy).

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

If any of the above situations apply to you, inform your doctor and do not take Valsartán.

Warnings and precautions

Consult your doctor before starting to take Valsartán Durban:

•if you have liver disease.

•if you have severe kidney disease or if you are on dialysis.

•if you suffer from a narrowing of the renal artery.

•if you have recently undergone a kidney transplant (you received a new kidney).

•if you have another serious heart disease that is not heart failure or heart attack.

if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor.If you have these symptoms when taking Valsartán, stop taking Valsartán immediately and never take it again.See also section 4 “Possible side effects”.

•if you are taking medications that increase the amount of potassium in the blood, such as potassium supplements and potassium-sparing diuretics, and heparin.You may need to have your potassium levels checked regularly.

•if you suffer from aldosteronism. This is a disease in which your adrenal glands produce excess aldosterone hormone. If this happens to you, it is recommended that you do not take valsartán.

• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production).

• if you are taking any of the following medications used to treat high blood pressure:

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, etc.), particularly if you have kidney problems related to diabetes.

- aliskiren

• if you are being treated with an ACE inhibitor along with other medications specifically for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

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

See also the information under the heading “Do not take Valsartán Durban”.

You should inform your doctor if you think you are (or could be) pregnant. Valsartán is not recommended at the beginning of pregnancy, and you should not take it if you are more than 3 months pregnant, as it could cause serious harm to your baby if you use it during this period (see the section on pregnancy

Other medications and Valsartán Durban

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

The effect of treatment may be altered if you take Valsartán with other medications. You may need to change the dose, take other precautions, or, in some cases, stop taking one of the medications. This applies to both prescription and over-the-counter medications, especially:

•other medications that lower blood pressure,especially diuretics(medications to eliminate fluid), ACE inhibitors(such as enalapril, lisinopril, etc.,), or aliskiren(see also the information under the headings“Do not take Valsartán” and “Warnings and precautions”).

•medications that increase the amount of potassiumin the blood, such as potassium supplements and potassium-sparing diuretics, and heparin.

•some types of painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs).

•some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporin), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán.

•lithium,a medication used to treat certain psychiatric disorders.

Also:

• if you are being treated aftera heart attack,do not recommend combining withACE inhibitors(a medication for treating a heart attack).
• if you are being treated forheart failuredo not recommend triple combinationwith an ACE inhibitor and medications specifically for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may need to modify your dose and/or take other precautions.

Administration of Valsartán Durban with food and drinks

You can take Valsartán with or without food.

Pregnancy, breastfeeding, and fertility

• You should inform your doctor if you think you are (or could become) pregnant.Normally, your doctor will advise you to stop taking Valsartán Durban before becoming pregnant or as soon as you know you are pregnant and advise you to take another medication instead of valsartán. Valsartán is not recommended at the beginning of pregnancy, and you should not take it if you are more than 3 months pregnant, as it could cause serious harm to your baby if you use it during this period (see the section on pregnancy

• Inform your doctor if you are breastfeeding or plan to start.Valsartán is not recommended for breastfeeding mothers, and your doctormay choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know how valsartán affects you. Like many other medications used to treat high blood pressure, Valsartán Durban may cause dizziness and affect your ability to concentrate in rare cases.

Always follow exactly the administration instructions of this medication as indicated by your doctor, to obtain the best results and reduce the risk of adverse effects. In case of doubt, ask your doctor or pharmacist. People with high blood pressure usually do not notice any signs of this problem. Many may feel well. For this reason, it is very important that you attend medical visits even if you feel well.

Adult patients with high blood pressure:The recommended dose is 80mg per day. In some cases, your doctor may indicate higher doses (for example, 160mg or 320mg). You may also combine Valsartán Durban with another medication (for example, a diuretic).

Use in children and adolescents (6 to less than 18years of age) with high blood pressure:In patients weighing less than 35kg, the initial recommended dose is 40mg of valsartán once a day. In patients weighing 35kg or more, the initial recommended dose is 80mg of valsartán once a day.

In some cases, your doctor may indicate higher doses (the dose may be increased to 160mg and up to a maximum of 320mg).

Adult patients who have suffered a recent heart attack:After a heart attack, treatment usually begins at 12hours, usually with a low dose of 20mg twice a day. To obtain the dose of 20mg, the 40mg tablet is divided. Your doctor will gradually increase this dose over several weeks to a maximum of 160mg twice a day. The final dose depends on what you can tolerate yourself.

Valsartán may be administered in combination with another treatment for heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:Treatment usually begins with 40mg twice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160mg twice a day. The final dose depends on what you can tolerate yourself. Valsartán Durban may be administered in combination with another treatment for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartán with or without food. Swallow the medication with a glass of water.

Take it every day at the same time.

If you take moreValsartán Durbanthan you should

If you notice a strong dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

If you forgot to take Valsartán Durban

If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take your next dose, skip the dose you forgot.

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

If you stop taking Valsartán Durban

Stopping your treatment with Valsartán may worsen your disease. Do not stop taking your medication unless your doctor tells you to.

If you have more doubts about the use of this product, consult your doctor or pharmacist.

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

Some side effects can be serious and may require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

•swelling of the face, lips, tongue, or throat

•difficulty breathing or swallowing

•hives (urticaria), itching

If you experience any of these symptoms, stop taking Valsartán and contact your doctor immediately (see also section 2 “Warnings and precautions”)

Other side effects are:

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

•dizziness

•low blood pressure with or without symptoms, such as dizziness and fainting when standing up

•renal function deterioration (signs of renal insufficiency)

Uncommon(may affect up to 1 in 100 people):

• angioedema (see the section “some symptoms that may be serious and require immediate medical attention”)

•sudden loss of consciousness (syncope)

•sensation of spinning (vertigo)

•severe renal function deterioration (signs of acute renal insufficiency)

•muscle spasms, abnormal heart rhythm (signs of hyperkalemia)

•shortness of breath, difficulty breathing while lying down, swelling of feet or legs (signs of heart failure)

•headache

•cough

•abdominal pain

•nausea

•diarrhea

•fatigue

•weakness

Frequency not known(cannot be estimated from available data):

•skin blisters (sign of dermatitis bullosa)

• allergic reactions such as urticaria, itching, or hives; symptoms of serum sickness, such as fever, pain, and swelling of joints, muscle pain, swelling of lymph nodes, or pseudogripal symptoms

•purple patches, fever, itching (signs of vasculitis)

•bleeding or petechiae (small red or purple spots on the skin) (signs of thrombocytopenia)

•muscle pain (myalgia)

•fever, sore throat, or ulcers in the mouth due to infections (symptoms of neutropenia)

•decrease in hemoglobin level and decrease in percentage of red blood cells in the blood (which may lead to anemia in severe cases)

•increase in potassium level in the blood (which may cause muscle spasms and abnormal heart rhythm in severe cases)

•increase in liver function values (which may indicate liver damage), including an increase in bilirubin in the blood (which may cause yellowing of the skin and eyes in severe cases)

•increase in urea nitrogen level in the blood and serum creatinine level (which may indicate abnormal kidney function)

•low sodium level in the blood (which may cause fatigue, confusion, muscle fasciculations or spasms, or convulsions in severe cases)

The frequency of some side effects may vary depending on your disease. For example, side effects such as dizziness and renal function deterioration were observed less frequently in adult patients treated for hypertension than in adult patients treated for heart failure or after a recent myocardial infarction.

Side effects in children and adolescents are similar to those observed in adults.

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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store at a temperature below 25°C in the original packaging. Protect from humidity.

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

Do not takethis medicationafter the expiration date that appears on the packaging after 'Cad'. The expiration dateis the last day of the month indicated.

Do not take any Valsartan Durban tabletsif you notice that thepackaging is damaged or shows visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications that you no longer need at the SIGREpoint of the pharmacy or at any other Medication Waste Collection System. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofValsartán Durban

-The active ingredient is valsartán.

-The other components are microcrystalline cellulose, crospovidone (type A), colloidal silicon dioxide, magnesium stearate.

-The coating of the tablet contains hypromellose 6 cp (E464), titanium dioxide (E171), Macrogol 8000, yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the package

Red clear-colored tablets, coated with a film, scored, oval, and biconvex, with the engraving “L” and “13” on both sides of the score in one face and smooth on the other face (approximate size: 13 x 6.2 mm).The score is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

The tablets are presented in blister-type packages of 7, 14, 28, 56, 98, and 280 coated tablets.

Some package sizes may not be commercially available.

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

Industrial Park La Redonda, IX Street, No. 2

04710 El Ejido ALMERÍA

Spain

Responsible for Manufacturing

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

or

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

or

Synoptis Industrial Sp. z.o.o.

Nl. Rabowicka 15

62-020 Swarzedz

Poland

You can request more information about this medication by contacting the marketing authorization holder.

This medication is authorized in the member states of the EEA with the following names:

Last review date of this leaflet:08/2020

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