VALSARTAN DURBAN 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan Durban 80mg film-coated tablets EFG

Valsartan

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 and other information

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

1. What is Valsartan Durban and what is it used for

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

Valsartan Durban 80 mg film-coated tablets EFG can be used to treat three different conditions:

• To treat high blood pressure in adults and in children and adolescents from 6 to less than 18 years of age. High blood pressure increases the strain on the heart and arteries. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering the blood pressure to normal reduces the risk of developing these disorders.
• To treat adult patients after a recent heart attack. Here "recent" means between 12 hours and 10 days.
• To treat symptomatic heart failure in adult patients. Valsartan Durban is used when it is not possible to use a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE 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 the feet and legs due to fluid buildup. It occurs when the heart muscle cannot pump blood with enough force to supply the blood needed throughout the body.

2. What you need to know before you take Valsartan Durban

Do not take Valsartan Durban:

• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6.
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan during the first months of pregnancy – see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor and do not take Valsartan.

Warnings and precautions

Tell your doctor before you start taking Valsartan Durban:

• if you have liver disease.
• if you have severe kidney disease or if you are on dialysis.
• if you suffer from narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have other 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 medicines (including ACE inhibitors), tell your doctor. If you have these symptoms when taking Valsartan, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.

• if you are taking medicines that increase the amount of potassium in your blood, such as potassium supplements and salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the amount of potassium in your blood.

• if you suffer from aldosteronism. This is a disease in which your adrenal glands produce too much aldosterone hormone. If this applies to you, it is recommended that you do not take valsartan.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine production).

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

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

Your doctor may need to 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 Valsartan Durban”.

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan. Your doctor will decide if you need additional treatment. Do not stop taking Valsartan on your own.

You must tell your doctor if you think you are (or might become) pregnant. Valsartan is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Other medicines and Valsartan Durban

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of the treatment may be altered if you take Valsartan with other medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, especially water pills (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan” and “Warnings and precautions”).
• medicines that increase the amount of potassium in your blood, such as potassium supplements and salt substitutes that contain potassium, potassium-sparing medicines, and heparin.
• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan.
• lithium, a medicine used to treat some psychiatric diseases.

Also:

• if you are being treated after a heart attack, it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack).
• if you are being treated for heart failure, it is not recommended to combine with a triple combination of an ACE inhibitor and specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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

Taking Valsartan Durban with food and drinks

You can take Valsartan with or without food.

Pregnancy, breast-feeding, and fertility

• You must tell your doctor if you are pregnant or think you might be pregnant. Normally, your doctor will advise you to stop taking Valsartan Durban before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of valsartan. Valsartan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

• Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan is not recommended for breast-feeding mothers, and your doctor may choose another treatment if you want to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, in rare cases, Valsartan Durban can cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Durban

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not notice any signs of this problem. Many may feel fine.

Adult patients with high blood pressure:The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan Durban can also be used in combination with another medicine (e.g., a diuretic).

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

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

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

Valsartan can be given with other treatments for heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:Treatment usually starts with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you can tolerate. Valsartan Durban can be given with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartan with or without food. Swallow the medicine with a glass of water.

Take it every day at the same time.

If you take more Valsartan Durban than 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 forget to take Valsartan Durban

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

Do not take a double dose to make up for a forgotten dose.

If you stop taking Valsartan Durban

Stopping your treatment with Valsartan may worsen your condition. Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and may need 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
• rash, itching

If you experience any of these symptoms, stop taking Valsartan 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
• worsening of kidney function (signs of kidney failure)

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

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

• sudden loss of consciousness (syncope)
• feeling that everything is spinning (vertigo)
• severe worsening of kidney function (signs of acute kidney failure)
• 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

• Rare(may affect up to 1 in 10,000 people)

• Intestinal angioedema: inflammation of the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• blistering of the skin (sign of bullous dermatitis)
  • allergic reactions may occur, such as rash, itching, or hives; symptoms of fever, pain, and swelling of joints, muscle pain, swelling of lymph nodes, or flu-like symptoms (signs of serum sickness)

• purple spots, fever, itching (signs of vasculitis)
• bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, known as neutropenia)
• decrease in hemoglobin and decrease in the percentage of red blood cells in the blood (which can lead to anemia in severe cases)
• increase in potassium levels in the blood (which can cause muscle spasms and abnormal heart rhythm in severe cases)
• increase in liver function values (which can indicate liver damage), including an increase in bilirubin in the blood (which can cause yellowing of the skin and eyes in severe cases)
• increase in blood urea nitrogen and serum creatinine levels (which can indicate abnormal kidney function)
• low sodium levels in the blood (which can cause fatigue, confusion, muscle twitching, 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 worsening of kidney function were observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

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

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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Valsartan Durban

Store at a temperature below 25°C in the original package. Protect from moisture.

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

Do not take this medicine after the expiry date which is stated on the packaging after 'EXP'. The expiry date refers to the last day of the month shown.

Do not take any Valsartan Durban tablet if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy or other authorized collection point for medicinal waste. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Valsartan Durban

• The active ingredient is valsartan.
• The other components are microcrystalline cellulose, crospovidone (type A), colloidal silicon dioxide, magnesium stearate.
• The tablet coating contains hypromellose 6 cp (E464), titanium dioxide (E171), Macrogol 8000, yellow iron oxide (E172), and red iron oxide (E172).

Product Appearance and Packaging Contents

Light red, film-coated, scored, oval, and biconvex tablets, with the engraving "L" and "13" on both sides of the score on one face and smooth on the other face (approximate size: 13 x 6.2 mm). The score is only for the purpose of breaking and facilitating swallowing, but not for dividing into equal doses.

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

Some pack sizes may not be marketed.

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido ALMERÍA

Spain

Manufacturer

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 under the following names:

Date of the last revision of this leaflet:08/2020

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